linjc16/ctgov huggingface dataset:
B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
Aim: To dissociate the effects on plasma concentrations of the inflammatory marker c-reactive protein of a negative energy balance and a reduction in body fat stores. Secondly to compare CRP with fibrinogen and interleukin-6 (IL-6).

Detailed Description
-----------------
Background: Previous epidemiological studies have associated elevated levels of acute phase proteins, mainly C-reactive protein, with cardiovascular diseases (CVD) and cardiac death. Levels of several cy-tokines and acute phase proteins as CRP, haptoglobin and fibrinogen have been found associated with elevated body fat and the risk of diseases associated to the metabolic syndrome. Method: Thirty-six otherwise healthy obese subjects (BMI: 34.23.2 kg/m2, age: 43.410.5 y) participated in a 20-week controlled dietary intervention divided into 4 periods. Weight reduction was induced by an 8-week low caloric diet (LCD) (3.4 MJ/d) followed by a 4-week weight stable maintenance program (M1). Subsequently, they underwent another 4-week LCD (4.2 MJ/d) followed by a final 4-week weight stable maintenance diet (M2). Blood samples and anthropometrical measures were assessed at baseline and after each of the four periods (8, 12, 16 and 20 weeks).

Official Title
-----------------
B195: Effect of Diet-Induced Energy Deficit and Body Fat Reduction on Inflammatory Markers in Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: energy restriction and maintenance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 41 participants (20 men, 21 women) were included in the study. They were between 24-62y, healthy, non-athletic, weight stabile (< 3 kg in last 2 mo) but overweight to obese (BMI: 28-40 kg/m2). Exclusion Criteria: evidence of metabolic or systemic diseases other than obesity. Frequent use of medication, a systolic blood pressure >165 mmHg and diastolic blood pressure >95 mmHg.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: energy restriction and maintenance|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  |  | 
| C-reactive protein |  |  | 
| cardiovascular diseases markers |  |  | 
| obesity |  |  | 
| energy restriction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss, obesity, energy restriction
Effects of Nitrous Oxide: A Dose-Response Analysis - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine the subjective, psychomotor, and reinforcing effects of nitrous oxide in healthy volunteers. This is a dose-response analysis.

Official Title
-----------------
Effects of Nitrous Oxide: A Dose-Response Analysis

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 10% N2O
* Drug: 20% N2O
* Drug: 30% N2O
* Drug: 40% N2O


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 37 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo + 10% N2O<br>0% N2O inhaled during psychomotor testing, 10% N2O inhaled during psycho motor testing, then subject's choice of the 2. | Drug: 10% N2O<br> <br> |
| Active Comparator: Placebo + 20% N2O<br>Placebo inhaled during psychomotor testing, 20% N2O inhaled during psychomotor testing, then subject's choice of the 2. | Drug: 20% N2O<br> <br> |
| Active Comparator: Placebo + 30% N2O<br>Placebo inhaled during psychomotor testing, 30% N2O inhaled during psychomotor testing, then subject's choice of the 2. | Drug: 30% N2O<br> <br> |
| Active Comparator: Placebo + 40% N2O<br>Placebo inhaled during psychomotor testing, 40% N2O inhaled during psychomotor testing, then subject's choice of the 2. | Drug: 40% N2O<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice of N2O vs. placebo | Subjects underwent 4 sessions consisting of 2 sample tests (inhaling placebo and inhaling varying doses of N2O), then choosing which inhalant they wanted for a choice test. The subject & the technician administering the inhalant were blinded. During each intervention and each session, subjects underwent psychomotor testing. | After each pair of sample tests | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitrous oxide, inhalant, subjective effects, healthy volunteer
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed Description
-----------------
All the patients whom an investigator prescribes the first Rescriptor® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Official Title
-----------------
Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)

Conditions
-----------------
HIV-1 Infection

Intervention / Treatment
-----------------
* Drug: Rescriptor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients need to be administered Rescriptor® in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Rescriptor®.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Delavirdine Mesilate<br>Patients administered. | Drug: Rescriptor<br>* RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-HIV drugs.<br>* Other names: Rescripter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported Unlisted Adverse Drug Reaction. | Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document). | One Year | 
| Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category). | Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies. Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts. Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category. | One year |
Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect a large amount of data that may assist in addressing the gap in knowledge of understanding pupillometer readings using a pupillometer device. The aim of this project is to establish normative values for pupillometer data. Measures of central tendency will be developed for the variables provided by automated pupillary exams, which will provide an enhanced understanding of clinically appropriate pupil values for size, reactivity, and neurological pupil index.

Detailed Description
-----------------
Data will be collected on patients in the intensive care units at the selected hospitals on patients who have been assigned, by the attending physician, to have regular pupillary assessments, and in whom staff nurses are performing pupillary assessments with the pupillometer. While a sample size estimate would be considered inappropriate for registry development, power analysis techniques were used to examine the potential of this registry to generate adequate information to begin to fully describe normative data for pupillary exams. Using the assumption that the desire is to understand neurological pupil index (NPi) and size differences within 0.1, and that the spread of data would be approximately normally distributed, a minimum of 3,250 observations is required (alpha = 0.05, beta = 0.80). It must, however, be repeated that this is simply a rough estimate. The registry data generated will, in fact, be the source of data from which future studies will be powered.

Official Title
-----------------
Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

Conditions
-----------------
Critical Illness, Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Data will be collected on patients admitted to enrolling hospitals who have been assigned, by the attending physician, to have regular pupillary assessments, and in whom staff nurses are performing pupillary assessments with the pupillometer. Exclusion Criteria: Out-patients Patients that do not have orders for regular pupillary assessments
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 |
| --- | --- | --- |
| Oculomotor evaluation of pupillary variance during ICU admission | Pupil size and reactivity per neurological pupil index | Daily at 9:00am |
Diastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study will be to assess whether Biventricular pacing improves exercise capacity, and Quality of Life in patients with symptomatic drug resistant Non-Obstructive Hypertrophic Cardiomyopathy, using a Biventricular pacemaker.

Official Title
-----------------
Diastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy

Conditions
-----------------
Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronisation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic Hypertrophic Cardiomyopathy, Exclusion Criteria: Rhythm other than normal sinus Left ventricular outflow tract gradient greater than 30mmHg Inability to exercise v02 max greater than 70% of predicted.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cardiac Resynchronisation Therapy | Device: Cardiac Resynchronisation Therapy<br>* Biventricular Pacemaker Implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

Detailed Description
-----------------
The duration of treatment is 8 weeks.

Official Title
-----------------
A Double-Blind, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: aprepitant
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Major Depressive Disorder

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aprepitant|nan|
|Drug: Comparator: placebo (unspecified)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD-17 total score at week 8. Tolerability. |  | at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-I score at week 8, at least 50% reduction in the HAMD-17 total score, and Sheehan Disability Score at Week 8 |  | at week 8 |
Accuracy of Visual Range of Motion Estimates

Study Overview
=================
Brief Summary
-----------------
Examine the accuracy of visual estimates of various joint angles by physical therapists at various levels of education and clinical practice, taking into account years of experience, areas of practices and specialty certifications.

Detailed Description
-----------------
Physical therapists oftentimes will estimate rather than measure joint range of motion. The accuracy of visual estimates of various joint measurements has not been previously assessed. No comparison has been done for years of experience and accuracy of estimations. This study will create a survey with pictures of joints at previously measured angles and therapists and students will be asked to estimate the range of motion. Various statistical analyses will be performed to determine accuracy and comparisons.

Official Title
-----------------
Accuracy of Visual Range of Motion Estimates Among Physical Therapists and Physical Therapy Students

Conditions
-----------------
Accuracy of Estimation of Joint Range of Motion

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: licensed physical therapists students currently enrolled in an accredited doctorate of physical therapy program Exclusion Criteria: students have not been trained in range of motion measurements are not licensed physical therapists
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Practicing Physical Therapists<br>licensed physical therapists currently practicing | Other: No intervention<br>* No interventions separated the groups. Each group reviewed pictures and wrote down their estimated ROM of the joint pictured.<br>|
| Student Physical Therapists<br>students currently enrolled in DPT program | Other: No intervention<br>* No interventions separated the groups. Each group reviewed pictures and wrote down their estimated ROM of the joint pictured.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of estimated ROM to actual ROM | Compare the estimated ROM provided by the student/clinician to the actual measured ROM of the joint of the model. | 6 months after completion of survey |
Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine. Design: Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization). End points: End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.

Official Title
-----------------
IBS Treatment With H1-receptor Antagonists

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: ebastine
* Drug: placebo capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Irritable Bowel Syndrome (ROME III criteria) age 18-65 years Exclusion Criteria: medication: antidepressants or H1-receptor antagonists pregnancy, breast feeding co-morbidity: severe kidney- and/or liver disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo capsule<br> | Drug: placebo capsule<br>* one capsule once daily<br>|
| Active Comparator: ebastine<br> | Drug: ebastine<br>* 20 milligram capsule once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment on visceral sensitivity measured with rectal barostat. |  | after 12 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment on IBS symptoms. |  | after 12 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visceral hypersensitivity, mast cells
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The investigators aim to determine the clinical and metabolic outcomes of two available bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI > 35 with comorbidities or BMI > 40) in VETERANS. The investigators hypothesize that the short and long term outcomes between laparoscopic adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.

Detailed Description
-----------------
This is a bariatric surgery Phase 3 prospective trial.

Official Title
-----------------
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective Trial

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Laparoscopic restrictive procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI > 40) Age > 18 y/o Exclusion Criteria: Pregnancy Severe uncontrolled medical or psychiatric conditions Previous bariatric surgery Multiple previous abdominal surgeries

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 LAP BAND<br> | Procedure: Laparoscopic restrictive procedure<br>* Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.<br>|
| Experimental: 2 Sleeve gastrectomy<br> | Procedure: Laparoscopic restrictive procedure<br>* Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short and long term clinical outcomes |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic outcomes |  | 5 years | 
| Esophago-gastric physiology |  | 2 years | 
| Hormonal physiology |  | 5 years | 
| Procedure costs |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, Bariatric surgery, Obesity surgery, Gastric banding, Sleeve gastrectomy