linjc16/ctgov huggingface dataset:
Evaluation of Performance of An Aspergillus PCR in Tissue and Pleural Effusion Samples of Immunocompromised Patients

Study Overview
=================
Brief Summary
-----------------
Although being a frequent and lethal complication in patients (pts) with hematologic malignancies, diagnosing invasive aspergillosis (IA) still remains a difficult issue as culture-based methods show low sensitivity especially under the current clinical practice of antifungal prophylaxis or rapid antifungal therapy. In certain clinical settings, performing biopsies for identification of the underlying infectious organism becomes important. However, as culture-based methods only yield results in a minority of patients, using non-culture-based methods like Aspergillus specific polymerase chain reaction (PCR) for detection of IA directly in clinical specimens is becoming increasingly important and might help to characterize the causative pathogen. Therefore the performance of an established Aspergillus-specific nested PCR in biopsies, re-section material or pleural effusions is evaluated.

Official Title
-----------------
Diagnostic Study of Performance of an Aspergillus Specific Polymerase Chain Reaction in Tissue and Pleural Effusion Samples of Immunocompromised Patients for the Diagnosis of Invasive Aspergillosis

Conditions
-----------------
Aspergillosis, Immunosuppression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Immunocompromised individuals with suspicion of harbouring an invasive fungal infection Definition by 2008 EORTC/MSG Criteria (de Pauw CID 2008) Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Proven/Probable IA Patients<br>Case Population | |
| possible/No IA Patients<br>Control population | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio | Evaluation of Sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio of aspergillus specific PCR in tissue and effusion samples by comparing the population with proven / probable invasive aspergillosis with patients suffering from No IA according to recent EORTC/MSG criteria of PCR in Biopsies/Effusion samples of Patients | 3 months |
Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes. Atrial fibrillation is a heart condition which effects a large percentage of the population . Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted . Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation. Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances. By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Fish oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker. Exclusion Criteria: Patients with chronic atrial fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil<br>Patients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio | Drug: Fish oil<br> <br> |
| No Intervention: Control<br>No fish oil exposure | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial tachycardia and atrial fibrillation burden |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and duration of atrial tachycardia/fibrillation episodes |  | 18 months |
Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects

Study Overview
=================
Brief Summary
-----------------
MOA-728, an investigational drug, is currently being studied for the relief of constipation associated with postoperative ileus and treatment of opioid induced constipation in patients receiving palliative care. This study will further investigate the IV formulation of MOA-728 comparing PK/PD time points for a 20-minute versus a 4-hour infusion.

Official Title
-----------------
A Randomized, Double-Blind, Double-Dummy, 2-Period Crossover Study to Characterize the PK/PD Relationship of a 20-Minute Versus a 4-hour Intravenous Infusion of MOA-728 in Subjects on Stable Methadone Maintenance

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: MOA-728


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy men and nonlactating, nonpregnant women age 18 to 65 years with BMI of 18.0 to 35.0 kg/m2 Must have been receiving methadone treatment of greater than or equal to 30 mg/day for at least one month and a positive drug screen for methadone High probability for compliance with and completion of the study Exclusion Criteria: Significant cardiovascular, hepatic, renal , respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Presence or history of any disorder that may prevent the successful completion of the study. Any surgical or medical condition that my interfere with the distribution, metabolism or excretion of the test article. Acute disease state, family history of long QT syndrome and/or sudden cardiac death, allergy to opioids or drugs. Use of any investigational or prescription drugs within 30 days, any OTC drugs including herbal supplements within 14 days and drugs required to maintain regulation of bowel movements 48 hours before study day 1. History of alcoholism within 1 month before study day 1, admitted alcohol abuse, or consumption of more than 2 standard units of alcohol per day.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MOA-728|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| It is not known if the activity of MOA-728 is related to the peak concentration or the overall exposure (AUC). This study is designed to evaluate the PK and PD effect of MOA-728 administered either as a 20-minute or 4-hour infusion. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioids, chronic pain
Cross-section Survey of Mechanical Ventilation and Acute Respiratory Distress Syndrome in China

Study Overview
=================
Brief Summary
-----------------
The characteristics and outcomes of a mixed group of critically ill patients who received mechanical ventilation are not known in China. A 1 month Cross-section survey will be performed with the aim of describing the characteristics and outcomes of conventional mechanical ventilation and treatment of acute respiratory distress syndrome in intensive care units in China.

Detailed Description
-----------------
From August 31th 2012 to September 30th 2012, all patients admit to ICUs were screened, mechanical patients and patients with ARDS be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality, and the treatment of ARDS will be recorded.

Official Title
-----------------
Southeast Univerity

Conditions
-----------------
Respiratory Failure, Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for mechanical ventillation patients: Meet one of the following criteria Patients who were admitted to ICU from September 1st to 31th 2012, and received invasive mechanical ventilation for more than 24 hours Patients who were admitted to ICU from September 1st to 31th 2012, and received non-invasive mechanical ventilation for more than 12 hours Patients who were admitted to ICU from September 1st to 31th 2012, and who fulifll the ARDS Berlin Definition or AECC Definiton Exclusion Criteria: 1. lesson than 18 years old or more than 85 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentange of mechanical ventilation | in the onw month period, How many patients in the intensive care unit are ventilated. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, ARDS, Ventilator strategy, outcome
ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer.

Conditions
-----------------
Lung Neoplasms

Intervention / Treatment
-----------------
* Drug: ALIMTA
* Drug: carboplatin
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of extensive stage small cell lung cancer and can be treated with chemotherapy. Have received no prior chemotherapy for your disease. Have at least one measurable lesion. have an adequate performance status. Sign an informed consent form. Exclusion Criteria: Have previously received chemotherapy for your lung cancer. Have been treated with a investigational drug within the last 30 days. Have previously completed or withdrawn from this study or any other study investigating ALIMTA. Have received radiation therapy within the last 1-2 weeks. Have brain metastasis that is uncontrolled. Have active infection or other serious condition.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALIMTA|nan|
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine differences in levels of serum chemokines from patients undergoing treatment with Boceprevir. The aim is to determine if non-responders have significantly different levels of chemokines than responders.

Detailed Description
-----------------
Patients undergoing standard of care at the UNC Liver Center are consented for collection of an additional serum sample under the UNC Liver Center serum and tissue bank study. These samples will be used to analyze differences in serum chemokines across responders and non-responders.

Official Title
-----------------
Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients (age 18 or older) treated with an antiviral Hepatitis C treatment regimen that includes Boceprevir. Exclusion Criteria: Inability to provide informed consent for a serum sample enrolled in the University of North Carolina Liver Center serum bank. No pre and post serum sample available within 6 months of the treatment period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sustained virological response<br>Patients who achieve sustained virological response (SVR) are defined as undetectable HCV RNA in serum obtained 12 weeks or beyond the end of antiviral therapy. | |
| Non-responders<br>Non-responders are defined as patients who have not achieved virological milestones during therapy or who have relapsed with detectable HCV RNA in serum after cessation of treatment. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level (ng/mL) of serum chemokines. | Compare levels of serum chemokines across Boceprevir responders (SVR) and non-responders for both Baseline (<=6-months pre-treatment) and Post-treatment (<=6-months post-treatment). | Baseline: <=6 months prior to start of treatment and Post-treatment: <=6-months after the last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis, Hepatitis C, Observational study, Biomarkers of treatment response
Screening for Fabry Disease in Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Single centre, prospective pilot study examining the relevance to screen for Fabry disease in a cohort of patients who have undergone renal transplantation for nephropathy of indeterminate cause, vascular nephropathy, diabetic nephropathy or secondary focal segmental hyalinosis with no established cause.

Detailed Description
-----------------
Exploration whether Fabry disease cases can be identified among patients who are followed at the Montpellier University Hospital after renal transplantation, with indeterminate cause of renal failure or diabetic nephropathy (due to its high frequency) or secondary focal segmental hyalinosis (FSH). At the population level, the identification of cases at the Montpellier centre could then justify to expand this screening to other French centres. The goal is to contribute to adapt current guidelines of renal failure assessment, by systematically including Fabry among the diagnostic tests. Whether all patients with renal failure are concerned, or only those with indeterminate cause, is an important question this study will address.

Official Title
-----------------
Screening for Fabry Disease in Renal Transplantation

Conditions
-----------------
Fabry Disease, Nephropathy

Intervention / Treatment
-----------------
* Diagnostic Test: Screening for Fabry disease
* Diagnostic Test: Screen for α-galactosidase mutation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nephropathy of indeterminate cause, or secondary FSH or diabetic nephropathy Patients with kidney transplanted Patients still followed at the Montpellier University Hospital Obtaining written informed consent Age > 18 years old, no upper age limit Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Screening for Fabry disease|Screening for the α-galactosidase (GAL) enzyme activity (men + women) and plasma Lyso globotriaosylsphingosine (GL3, women) for the diagnosis of Fabry disease.|
|Diagnostic Test: Screen for α-galactosidase mutation|If necessary (positive for GAL), genetic confirmation tests for Fabry disease will be performed (men + women).|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Positive screen result | The genetic analysis will be performed based on the biochemical results (low enzyme activity, raised lysoGL3) | Inclusion visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fabry disease, Renal transplantation, Diabetic nephropathy, Focal Segmental Hyalinosis (FSH), Undetermined nephropathy
Impact of Group Size in Weight Loss Interventions

Study Overview
=================
Brief Summary
-----------------
The present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.

Official Title
-----------------
Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment

Conditions
-----------------
Obesity, Weight Loss

Intervention / Treatment
-----------------
* Behavioral: behavioral weight loss program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (at least 21 years-old) Health insurance coverage with Capital Health Plan (CHP) Body mass index BMI between 30-45 kg/m2 Exclusion Criteria: BMI is less than 30 kg/m2 or greater than 45 kg/m2 Weight loss > 10 pounds in past 6 months Acute or chronic illnesses for which weight loss is contraindicated Unwilling or unable to give informed consent Unwilling to accept random assignment Unwilling or unable to travel to CHP clinic for assessments and groups Likely to relocate out of the area in the next 12 months

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small group<br>10-member groups | Behavioral: behavioral weight loss program<br>* weekly, group-based lifestyle weight loss program<br>|
| Active Comparator: Large group<br>30-member groups | Behavioral: behavioral weight loss program<br>* weekly, group-based lifestyle weight loss program<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in weight from baseline to month 12 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to treatment protocol | number and proportion of treatment sessions attended | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, weight loss, group size
Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.

Official Title
-----------------
Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: BMS-955176


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male subjects Ages 18-50 years Body weight of at least 110 lbs (50kg) BMI of 18 to 32 kg/m^2 non-smoking Exclusion Criteria: Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals). gastrointestinal disease including gastrointestinal surgery constipation or irregular bowel movements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single oral dose of [14C] BMS 955176<br>A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity. | Drug: BMS-955176<br>* Single dose of drug on Day 1<br>|
| Experimental: Nasoduodenal (ND) Tube Cohort<br>A single dose of [14C] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose. | Drug: BMS-955176<br>* Single dose of drug on Day 1<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the PK (AUC, Cmax) of a single oral dose | Serial blood samples for PK parameters determined from plasma concentration versus time | Day 1 through Day 13 (predose to 288 hours) | 
| To estimate extent of elimination of a single oral dose (% TRA recovery) | Sample of urinary/fecal/bile will be collected for determining total recovery. | Day 1 through Day 13 (predose to 288 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. | Day 1 through Day 13 |