linjc16/ctgov huggingface dataset:
Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults

Study Overview
=================
Brief Summary
-----------------
To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients

Official Title
-----------------
A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 Days in ART-Naive HIV-1 Infected Adults.

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

Intervention / Treatment
-----------------
* Drug: GW695634


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: CD4 cell count greater than or equal to 200 cells/mm3. HIV-1 RNA >2000 copies/mL. Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine. Normal resting 12-lead electrocardiogram. Exclusion criteria: Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion. Chronic diarrhea (>3 loose stools/day). An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial. Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1. Any acute laboratory abnormality. Positive for HCV antibody or HepBsAG. Active infections requiring therapy in the previous 4 weeks.

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: GW695634|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NNRTI, GW695634G, GW695634X, GW678248X, pharmacokinetics, HIV
Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.

Official Title
-----------------
A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms

Conditions
-----------------
Menopause, Postmenopausal Vaginal Atrophy

Intervention / Treatment
-----------------
* Drug: estradiol, 10 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women whose last menstruation was at least two years previously

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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: estradiol, 10 mcg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptoms |  | after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective parameters (vaginal Maturation Index/Value and vaginal pH) |  |  | 
| Hyperplasia rate |  |  |
Muscle Strength and Functional Autonomy of Elderly Women

Study Overview
=================
Brief Summary
-----------------
This study shows an evaluation of the correlation between the muscle strength levels and functional autonomy of elderly women.

Detailed Description
-----------------
The aim of this study was to evaluate the correlation between the muscle strength levels and functional autonomy of elderly women with impaired muscle-skeletal system depending on the normal IGF-1 level. The target-population was composed by elderly women aged between 60 and 75 years (age: 67.79 ± 5.11 years, BMI: 28.01 ± 5.4), residents of an asylum, with IGF-1 levels within the normal values for the age (normo-IGF-1). Evaluations of the muscle strength (1-RM test) and the functional autonomy (GDLAM Protocol) in the performance of activities of daily living (ADL), and a measurement of basal serum levels of IGF-1 (Chemiluminescence method) were performed.

Official Title
-----------------
Muscle Strength and Functional Autonomy of Normo-IGF-1 Elderly Women With Skeletal Muscle Dysfunctions

Conditions
-----------------
Muscle, Ligament and Fascia Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: present a muscle-skeletal dysfunction, such as osteoporosis, arthritis, tendinitis, but being able to perform their ADL without help from others; did not practice physical activity for at least 12 months; provide a normal IGF-1 level for their age; Exclusion Criteria: elderly women unfit to perform the strength and functional autonomy tests for the medical assessment;

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
Reaching Consensus on the Definition of Difficult Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Being able to predict the difficulty of a preoperatively can increase safety and improve results. However, a consensus must be reached regarding the definition of a cholecystectomy as difficult. The aim of this study is to achieve a national expert consensus. Methods A Delphi study was conducted. Based on the literature, a history of biliary pathology, preoperative clinical, analytical, and radiological data, and intraoperative findings were selected and rated on a Likert scale. Inter-rater agreement was defined as unanimous when 100% of the participants gave an item the same the Likert scale rating; as consensus when ≥80% agreed; as majority when the agreement was ≥70%.

Detailed Description
-----------------
A Delphi study was conducted. Inter-rater agreement was defined as unanimous when 100% of the participants gave an item the same the Likert scale rating; as consensus when ≥80% agreed; as majority when the agreement was ≥70%.

Official Title
-----------------
Reaching Consensus on the Definition of Difficult Cholecystectomy Among Spanish Experts. A Delphi Project. Qualitative Study

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Other: delphi project


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spanish surgeons experts in laparoscopic cholecystectomy, with more than 10 years of experience Exclusion Criteria: not Spanish not experts in laparoscopic cholecystectomy.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: delphi project|delphy study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consensus | Likert scale: 1: totally disagree, 2: disagree, 3: neither agree nor disagree, 4: agree, and 5: totally agree. | 1 month |
A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

Study Overview
=================
Brief Summary
-----------------
The goal of the project is to determine whether confocal endomicroscopy can be used to identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared with histologic specimens as a reference. The project will evaluate those at risk for or with known Barrett's esophagus, and those with known or suspected biliary strictures. It is our hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.

Detailed Description
-----------------
This study was amended from it's initial design to increase the number of patients to 200. The study was terminated in July 2016 after 106 patients were enrolled and had completed the study.

Official Title
-----------------
A Pilot Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

Conditions
-----------------
Digestive System Diseases

Intervention / Treatment
-----------------
* Device: Confocal Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia Patients undergoing ERCP for known or suspected biliary strictures. Exclusion Criteria: have a known allergy or have had a prior adverse reaction to fluorescent contrast agents or chromoendoscopy stains are younger than age 18 or who are mentally or legally incapacitated or unable to give informed consent are pregnant or breastfeeding patients with advanced esophageal cancer acute gastrointestinal bleeding coagulopathy impaired renal function

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 |
| --- | --- |
| Biliary Confocal Imaging<br> | Device: Confocal Imaging<br>* Confocal imaging performed of the digestive system with the use of confocal miniprobes such as the Gastroflex UHD and Cholangioflex miniprobes (Cellvizio, Mauna Kea, Paris, France)<br>|
| Esophageal Confocal Imaging<br> | Device: Confocal Imaging<br>* Confocal imaging performed of the digestive system with the use of confocal miniprobes such as the Gastroflex UHD and Cholangioflex miniprobes (Cellvizio, Mauna Kea, Paris, France)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare confocal image characteristics between benign and malignant tissue. |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
confocal, biliary, esophagus
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.

Official Title
-----------------
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension

Conditions
-----------------
Ocular Hypertension, Primary Open Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: VISION5 Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Primary open-angle glaucoma or ocular hypertension in both eyes Best-corrected distance vision of 20/100 or better Stable visual field Exclusion Criteria: Cup-to-disc ratio greater than 0.8 Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months Corneal refractive surgery within prior 6 months Past history of any incisional surgery for glaucoma at any time Corneal abnormalities that would interfere with tonometry readings Current participation in an investigational drug or device study or participation in such a study within 30 days of screening

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VISION5 Product<br>VISION5 Product in both eyes | Drug: VISION5 Product<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Tonometry (change from baseline) |  | Week 2, 6, 12 and Months 4,5,6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by Slit Lamp Exam |  | Weeks 2,6,12 and Months 4,5,6 |
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature

Study Overview
=================
Brief Summary
-----------------
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted. All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.

Official Title
-----------------
Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature

Conditions
-----------------
Growth Disorder

Intervention / Treatment
-----------------
* Drug: somatropin, rDNA origin, for injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in core, blinded phase and ability to be contacted by investigators. For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls. Exclusion Criteria: Diabetes mellitus. History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase. Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 16 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: somatropin, rDNA origin, for injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection. |  |  | 
| Every year: arm span measurements, head circumference measurements, x-ray for bone age, and |  |  | 
| laboratory blood draws. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Not applicable for Amendment (g). |  |  |
GLP Analogs for Diabetes in Wolfram Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
Wolfram syndrome, also referred to as DIDMOAD (diabetes insipidus, diabetes mellitus, optic atrophy and deafness) is a genetic syndrome characterized by beta-cell dysfunction and apoptosis leading to diabetes, neurodegeneration and psychiatric illness. Accumulating evidence indicates that beta-cell failure and neuronal cell dysfunction in Wolfram's syndrome results from a high level of ER stress in affected cells. The current treatment of Wolfram syndrome is insulin, which fails to prevent the progression of beta-cell failure. Several studies showed that GLP-1 analogs are very effective in protecting beta-cells from ER stress. Herein, the investigators suggest studying the impact of GLP-1 analogs in the treatment of patients with Wolfram syndrome. The investigators will Study the effects of GLP-1 analog (Exanatide) on beta-cell function and glycemic control of patients with Wolfram syndrome. Evaluation of beta cell function will be done by performing meal test and IVGTT test before starting GLP-1 therapy, and after 3 month of treatment.

Conditions
-----------------
Diabetes Mellitus Associated With Genetic Syndrome, Wolfram Syndrome

Intervention / Treatment
-----------------
* Drug: Exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetic or definitive clinical diagnosis of Wolfram's syndrome including: diabetes mellitus, optic atrophy and at least one additional neurological dysfunction (diabetes insipidus, sensorineural deafness, neurogenic bladder or other type of autonomic or peripheral neuropathy) Age >18 years Duration of diabetes of <10 years. Exclusion Criteria: pregnant women patients who are unable to give inform consent.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide<br> | Drug: Exenatide<br>* Exenatide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beta cell function | IVGTT test and meal test will be performed before starting treatment with Exenetide and after 3 months of treatment. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wolfram syndrome, Diabetes mellitus, Exenatide, GLP-1 analog, beta cell function
Prediction of Unfavourable Outcome in Newly Covid-19 Hospitalized Patient

Study Overview
=================
Brief Summary
-----------------
The project is a part of the Protocol for a multicentre study of nosocomial SARS-CoV2 transmission: The NOSO-COR Project registered in ClinicalTrials (NCT04290780). In the current pandemic context, medical resources have often been exceeded. Developing, using artificial intelligence techniques, an algorithm capable of detecting patients at risk of acute respiratory distress following Sars-Cov2 infection could help physicians to optimize the treatment of patients and health decision-makers to optimize resources. Thus, the goal of this project is to create a prediction model using artificial intelligence to predict an unfavorable evolution of Covid-19 at the hospital admission of patients

Official Title
-----------------
Bayesian Network to Predict Transfer in Intensive Care Units or Death in Newly Covid-19 Hospitalized Patient

Conditions
-----------------
to Predict an Unfavorable Evolution of Covid-19 at the Hospital Admission of Patients

Intervention / Treatment
-----------------
* Other: non applicable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must be 18 years or older at the time of signing the informed consent Volunteer patients, care givers and healthcare professionals in France and hospitals affiliated with the GABRIEL network. Demographic and clinical data will be collected using case-report forms designed especially for the purpose of the project. A nasopharyngeal swab will be collected and tested for SARS-CoV2 by RT-PCR. Admission to hospital Exclusion Criteria: Age lower than 18 years old Patients protected by the law

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 |
| --- |
|Other: non applicable|non applicable|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of mechanical ventilation, transfer to an intensive care unit or death within 21 days of admission. |  | within 21 days |