linjc16/ctgov huggingface dataset:
Study of Women Who Have AIDS

Study Overview
=================
Brief Summary
-----------------
To study the effect of pregnancy, age, drug use, and coinfections on HIV progression rate. To document the prevalence, incidence, characteristics, and course of HIV infection and anogenital intraepithelial neoplasia among HIV-positive and HIV-negative women. To study the effect of HIV disease on gynecologic health including infections and reproductive function.

Official Title
-----------------
Women's AIDS Cohort Study (WACS)

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

Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

Study Overview
=================
Brief Summary
-----------------
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

Detailed Description
-----------------
An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)

Official Title
-----------------
An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

Conditions
-----------------
Advanced Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: ABT-869


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subject must be greater than or equal to 18 years of age Subject must be diagnosed with unresectable or metastatic HCC Subjects must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 No other active malignancy within the past 5 years Exclusion Criteria Subject has received targeted VEGF/PDGF/TKI therapy. Prior Avastin is allowed Subject has Child-Pugh grade Class C hepatic impairment The subject has proteinuria Common Toxicity Criteria (CTC) grade > 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention The subject has a documented left ventricular Ejection Fraction < 50% Subject is receiving therapeutic anticoagulation therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-869<br> | Drug: ABT-869<br>* 0.25 mg/kg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Rate |  | Week 16 | 
| Objective Response Rate |  | Week 16 |
A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.

Detailed Description
-----------------
The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.

Official Title
-----------------
A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Device: AWBAT Wound Dressing
* Device: AWBAT™, Biobrane®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Superficial partial thickness burns Two non-contiguous burn sites or the same approximate size/depth for comparison, OR One burn site large enough to accommodate both a 6 square AWBAT™ dressing and a 6  square Biobrane® dressing Burn wounds measuring >2% - <40% TBSA Patient age: >1 - 70 years Exclusion Criteria: Ventilator dependence Pregnancy/Lactation Mechanism of injury was electrical, chemical or frostbite Co-morbidity which may compromise healing Known allergy to porcine or porcine products

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AWBAT Wound Dressing|nan|
|Device: AWBAT™, Biobrane®|Comparison of burn dressings on randomized body sites using patient as own control|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of healing |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scarring |  | 6 months, 1 year, 18 months and 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, Superficial burns, Partial thickness burns, Rate of healing, Infection rate, Pain perception, Non adherence, Scarring
Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.

Conditions
-----------------
Intermittent Claudication

Intervention / Treatment
-----------------
* Drug: K-134
* Drug: Cilostazol 100 mg BID
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Stable claudication symptoms Exclusion Criteria: Lower extremity amputation Signs or symptoms of critical leg ischemia (CLI) Uncontrolled hypertension Tachycardia Poorly controlled diabetes Hypercholesterolemia

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose K-134<br> | Drug: K-134<br>* K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.<br>|
| Experimental: mid dose K-134<br> | Drug: K-134<br>* K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.<br>|
| Experimental: high dose K-134<br> | Drug: K-134<br>* K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.<br>|
| Active Comparator: Comparator<br> | Drug: Cilostazol 100 mg BID<br>* Cilostazol 100mg BID for 26 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo BID for 26 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in peak walking time at 26 weeks |  | 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in claudication onset time at 26 weeks |  | 26 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermittent Claudication, Peripheral Arterial Disease
Fibromyalgia in Men Suffering From PTSD

Study Overview
=================
Brief Summary
-----------------
Assessing FM and psychiatric state among PTSD, MDD and healthy participants

Conditions
-----------------
Fibromyalgia, Posttraumatic Stress Disorder, Major Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers without any current or past psychiatric disorder Current diagnosis of PTSD Current diagnosis of MDD Exclusion Criteria: - Psychotic features

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the accuracy of second generation colon capsule (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using conventional endoscopy as the gold standard.

Detailed Description
-----------------
Consecutive patients with ulcerative colitis will be recruited. Second generation colon capsule endoscopy (C2) and conventional colonoscopy will be performed one after another on the same day. Colonic mucosal inflammation will be scaled by physicians who review C2 videos and those who perform conventional colonosocpies independently. Physicians who review C2 videos and colonoscopists will be blinded to the findings of colonoscopies and C2 videos, respectively.The accuracy of C2 in evaluating mucosal inflammation will be evaluated, using conventional endoscopy as the gold standard.

Official Title
-----------------
The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

Conditions
-----------------
Colitis, Ulcerative

Intervention / Treatment
-----------------
* Device: C2
* Procedure: colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-80 years suspected or known UC written informed consent Exclusion Criteria: patients with severe UC according to Truelove and Witts' criteria current pregnancy/lactating patients with a pacemaker or other implanted electromedical device the presence of dysphagia patients at higher risk of capsule retention (including Crohn's disease, small bowel tumor, radiation enteropathy, previous intestinal surgery, acute abdominal pain without regular defecation) patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition) patients with an allergy to polyethylene glycol, sodium phosphate solution, metoclopramide or bisacodyl suppository

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C2 & colonoscopy<br>C2 and colonoscopy | Device: C2<br>* C2 and colonoscopy will be performed one after another on the same day<br>Procedure: colonoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with extent and severity of colonic inflammation | extent and severity of mucosal inflammation will be assessed by each investigation | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsule colonoscopy, ulcerative colitis
Revealing Increased Axonal Loss in Treated HIV Patients

Study Overview
=================
Brief Summary
-----------------
HIV patients may suffer sooner from aging than average population, including brain aging. Our hypothesis is that if brain dysfunctions are explained by a quicker loss of neurons in HIV patients, this loss could be detected earlier by a thinning down of retinal nerve fiber layer (RNFL), compared to non HIV patients of the same age.

Detailed Description
-----------------
The investigators aim to compare the thickness of the RNFL and the thickness of the RCGs measured by spectral domain OCT between patients infected by HIV and patients of same age non infected by HIV.

Official Title
-----------------
Revealing Increased Axonal Loss in Treated HIV Patients

Conditions
-----------------
HIV Seropositivity

Intervention / Treatment
-----------------
* Other: ophthalmologic examination and MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection known since at least 10 years viral load undetectable under ARV treatment since at least 5 years, whatever the type of ARV lymphocytes CD4 > 350, whatever the CD4 nadir signed informed consent Exclusion Criteria: History of ocular pathology, eye surgery, or intraocular injection Familial History of glaucoma ametropia (>3 dioptres on the sphere and >1,5 dioptres on the cylinder) known neurological pathology, active or former History of ethambutol or synthetic antimalarial drug consumption History of chemotherapy Active and regular use of drugs non-weaned chronic alcoholism contra indication to MRI diabetes cognitive disorders (MoCA<26) non covered by health insurance patient under legal protection pregnant or breast-feeding woman Non inclusion criteria for control patients: known HIV infection

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 |
| --- | --- |
| patients<br>HIV patients infected for more than ten years with undetectable viral load, undergoing ophthalmologic examination and MRI | Other: ophthalmologic examination and MRI<br>* thorough investigation of patients, not included in usual care.<br>|
| control<br>non HIV patients (same gender and age) undergoing ophthalmologic examination and MRI | Other: ophthalmologic examination and MRI<br>* thorough investigation of patients, not included in usual care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of the RNFL and the RCGs measured by spectral domain OCT, between the two groups of patients |  | one day of examinations |
Patient Reported Experience Measures Following a First Remote Orthodontic Consultation : a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The objective of this present randomized controlled trial was to investigate patient's and practitioner's Reported Outcomes Measures (PROMs) following a first standard face-to-face consultation versus a first orthodontic teleconsultation (video-assisted remote orthodontic consultation).

Official Title
-----------------
Patient and Practitionners Reported Experience Measures (PREMs) Following a First Remote Orthodontic Consultation Versus a First Face-to-face Orthodontic Consultation

Conditions
-----------------
Odontologic Disorders

Intervention / Treatment
-----------------
* Other: e-Consultation
* Other: Consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : - Patients requesting a first orthodontic consultation. Exclusion criteria : - children not accompanied by their legal guardian (under 18 years old).

Ages Eligible for Study
-----------------
Minimum Age: 6 Years


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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test<br>first remote-assisted orthodontic teleconsultation | Other: e-Consultation<br>* first orthodontic consultation in remote<br>|
| Control<br>classic first consultation (face-to-face consultation) | Other: Consultation<br>* first orthodontic consultation in face-to-face<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall patient satisfaction between first remote-assisted orthodontic teleconsultation and classic first consultation | satisfaction questionnaire | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall practionner satisfaction between first remote-assisted orthodontic teleconsultation and classic first consultation | satisfaction questionnaire | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remote-assisted teleconsultation
Efficacy of Zinc in the Treatment of Pneumonia

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy of zinc supplementation in the treatment of children under the age of two years who have been hospitalized with severe pneumonia.

Detailed Description
-----------------
This study was a randomized, double-blind, placebo-controlled clinical trial conducted between September 2003 and August 2004 at the Christian Medical College (CMC) Hospital in Vellore, India. CMC Hospital is a large teaching hospital and medical center that is accessed directly by the population of Vellore and adjoining districts and by referrals from local medical practitioners.

Official Title
-----------------
Efficacy of Zinc in the Treatment of Pneumonia in Hospitalized Children Less Than 2 Years of Age

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: Zinc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children under two years old hospitalized with Pneumonia Exclusion Criteria: healthy children

Ages Eligible for Study
-----------------
Maximum Age: 23 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Children with severe pneumonia were randomly assigned to receive supplementation with elemental zinc. | Drug: Zinc<br>* Elemental Zinc<br>|
| No Intervention: Control<br>Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of severe symptoms |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery from severe pneumonia |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, zinc
Study of Skin and Muscle Parameters Using a Skin Sensor

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.

Official Title
-----------------
A Pilot Study of Skin and Muscle Parameters Using a Multifunctional Skin Sensor

Conditions
-----------------
Skin Wounds

Intervention / Treatment
-----------------
* Device: Skin sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females age 18 and over Recent (post-operative day 0-90) skin surgery of the trunk,extremities, head or neck for minor skin problems resulting in sutured wounds or open granulating wounds. Otherwise good general health as assessed by the investigator The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. Exclusion Criteria: Under 18 years of age Pregnancy or Lactation Subjects who are unable to understand the protocol or to give informed consent

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms surgery side and non-surgery side in parallel.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin sensor on surgery side<br>Skin sensor will be placed on the side that had surgery. This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body. | Device: Skin sensor<br> <br> |
| Active Comparator: Skin sensor on non-surgery side<br>Skin sensor will be placed on the contralateral side from surgery site.This is split-body, interventional, parallel-design study. All participants will have the skin sensor measured twice on their bodies: on the side with surgery and a contralateral, control site of the body. | Device: Skin sensor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Temperature at 3 Time Points |  | Baseline, 48 hours from baseline, and 2 weeks from baseline |