linjc16/ctgov huggingface dataset:
Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine

Study Overview
=================
Brief Summary
-----------------
To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)

Detailed Description
-----------------
All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study period.

Official Title
-----------------
Assess the Safety & Reactogenicity of GSK Biologicals Hib Vaccine Co-administered With Chinese Local DTPw Vaccine When Compared to Chinese Local DTPw Vaccine Administered Alone, in Healthy Infants at 3,4 & 5 Mths of Age

Conditions
-----------------
Haemophilus Influenzae Type b Disease

Intervention / Treatment
-----------------
* Biological: Haemophilus Influenza type b vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination. Exclusion Criteria: Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose. Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 4 Months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Haemophilus Influenza type b vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Occurrence of solicited symptoms during the specific follow up period after vaccination. |  |  | 
| - Occurrence of unsolicited symptoms during the specific follow up period after vaccination. |  |  | 
| - Occurrence of serious adverse events during the study period. |  |  |
Innovation Platform

Study Overview
=================
Brief Summary
-----------------
In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR 5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.

Official Title
-----------------
Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Diagnostic Test: Novel in vitro diagnostics and medical applications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 5 years or older Presenting at the study site with symptoms and signs suggestive of malaria Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17) Willing to provide sample at enrolment Exclusion Criteria: Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Novel in vitro diagnostics and medical applications|Novel in vitro diagnostics and medical applications|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance assessment | Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of nPOC using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria | up to 6 months | 
| Concordance | Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading | up to 6 months |
Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection

Study Overview
=================
Brief Summary
-----------------
To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.

Official Title
-----------------
An Open Label Safety Study to Evaluate the Safety of Tipranavir Plus Ritonavir When Used in Combination With Other Agents for the Treatment of Patients With HIV Infection Who Have Failed and/or Are Intolerant to Combination Antiretroviral Therapy and Have Limited Treatment Options

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

Intervention / Treatment
-----------------
* Drug: Tipranavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients aho have a positive serology HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA or HIV culture and are highly pre-treated and virus resistant to multiple protease inhibitors.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tipranavir|Tipranavir 250 mg soft elastic capsules|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of VR and Accommdation Relax on Controlling Myopia in Children

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of virtual reality and accommodation relax technique on controlling onset and development of myopia in school-aged children. Half of the children will receive head-mounted video display which shows video with virtual reality and accommodation relax technique in combination, while the other half will receive no intervention.

Official Title
-----------------
Effect of Virtual Reality and Accommodation Relax Techniques in Combination on Controlling Myopia Development in School-aged Children

Conditions
-----------------
Myopia, Accommodation Spasm, Children

Intervention / Treatment
-----------------
* Device: Virtual reality and accommodation relax techniques in combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best corrected visual acuity >=20/20 for each eye; Astigmastism less than 1.5 D; Anisometropia less than 1.0D; No other ocular or systematic diseases; Exclusion Criteria: Can not endure virtual reality video; Can not cooperate with ocular examinations; Receiving other interventions for controlling myopia;

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Head-mounted video display which shows video with virtual reality and accommodation relax technique in combination,40 minutes per day | Device: Virtual reality and accommodation relax techniques in combination<br>* The children will be given head-mounted video display to watch video at break of classes, 40 minutes per day in total. The video will be shown by virtual reality and accommodation relax techniques in combination.<br>|
| No Intervention: Control group<br>No intervention will be performed in the control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myopia progression | The change in spherical equivalent | One year | 
| Axial elongation | Chnage in axial length | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accommodative lag | Difference between accommodative demand and accommodative response measured by an open-field autorefractor (WAM-5500, Grand Seiko Co Ltd, Hiroshima, Japan) | One week and One month |
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism

Study Overview
=================
Brief Summary
-----------------
This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).

Official Title
-----------------
A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism

Conditions
-----------------
Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)

Intervention / Treatment
-----------------
* Drug: Testosterone Gel (1%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP) Exclusion Criteria: Skin intolerance to alcohol or allergy to soy Generalized skin disease Contraindication to testosterone or androgen products

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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: Testosterone Gel (1%)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypogonadism
Covid-19 Fear and Compliance With Protective Measures of Students

Study Overview
=================
Brief Summary
-----------------
This study was carried out to determine the fear of Covid-19 and the compliance with protective measures of students who continue their education face-to-face during the covid-19 pandemic process.

Detailed Description
-----------------
The study was carried out descriptively. The study population of a province pandemic period junior ongoing training to face in Turkey. Sample constituted reached 188 students with snowball sampling method. The data of the study were collected using the Questionnaire Form prepared by the researchers and the Covid-19 Fear Scale. Data collection tools were applied to the participants electronically via Google Forms.

Official Title
-----------------
Covid-19 Fear and Compliance With Protective Measures of Students Continuing Face-to-Face Education in the Covid-19 Pandemic Process

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students who volunteered to participate in the study, had their parents' consent, had a web-based smart device, and continued face-to-face education were included. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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 |
| --- | --- | --- |
| Covid-19 Fear | Covid-19 Fear Scale: The scale developed by Ahorsu et al. (2020) was adapted to Turkish by Bakioglu, Korkmaz and Ercan (2020). The scale, consisting of seven questions, is a 5-point Likert (1: Strongly disagree, 5: Strongly agree) type. The scale consists of one dimension. The scores that can be obtained from the scale range from 7 to 35. The total score obtained from all items of the scale reflects the level of Covid-19 fear experienced by the individual. A high score means experiencing a high level of fear. | November-March | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, School, Student, Fear, Protective Measure
Characteristics of Post-Traumatic Stress Disorder (PTSD) and Non-PTSD Subjects

Study Overview
=================
Brief Summary
-----------------
Compare PTSD and non-PTSD subjects on several demographic, cognitive and military variables

Official Title
-----------------
Risk Factors for PTSD

Conditions
-----------------
PTSD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects applied for treatment in the MOH rehabilitation centers or the IDF unit for combat reactions and were diagnosed with PTSD Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of Spironolactone on Matrix Metalloproteinases (MMPs) in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels and insulin resistance in patients with chronic heart failure.

Detailed Description
-----------------
Myocardial fibrosis is observed in failing hearts. MMPs are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with chronic heart failure (CHF). It has been reported that spironolactone improves myocardial fibrosis in CHF animal models. Therefore, the purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels in patients with chronic heart failure.

Official Title
-----------------
Effects of Spironolactone on Circulating MMPs in Patients With Chronic Heart Failure

Conditions
-----------------
Chronic Stable Heart Failure

Intervention / Treatment
-----------------
* Drug: spironolactone + furosemide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic stable heart failure
Sexes Eligible for Study
-----------------
All

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: spironolactone + furosemide|spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMP levels |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, fibrosis, MMP, spironolactone, furosemide
Secondary Rupture of Aortic Aneurysm Post EVAR

Study Overview
=================
Brief Summary
-----------------
Post-stent rupture of the abdominal aorta is a rare occurrence and with few publications: only 2 multicenter studies and one meta-analysis in 2017 listed this complication As well as a few cases reports This study, the first carried out in France, aims to describe the survival in patients with secondary rupture of the aneurysm despite initial treatment with EVAR.

Official Title
-----------------
Secondary Rupture of Aortic Aneurysm After EVAR Management

Conditions
-----------------
Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient who had a ruptured aortic aneurysm between 01/01/1993 and 07/31/2020) Patients whose aortic aneurysm has been treated with EVAR Exclusion Criteria: No
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 |
| --- | --- | --- |
| describe survival in patient with secondary rupture aneurysm despite endovascular treatment | mortality describe in the group | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare survival in patients with rupture secondary aneurysm despite treatment | with endovascular according to: management of secondary rupture of the aneurysm the hemodynamic state on arrival in the center treating the size of the aneurysm sac | 20 years | 
| 2) Explore the risk factors for mortality in study patients |  | 20 years |
Influence of a Computer Game on Youth's Choices of Activities

Study Overview
=================
Brief Summary
-----------------
Study of activity choices after playing a computer game.

Official Title
-----------------
Influence of a Computer Game on Youth's Choices of Activities

Conditions
-----------------
Study Individuals' Activity Choices After Playing a Computer Game

Intervention / Treatment
-----------------
* Behavioral: Computer game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Like study foods, healthy Exclusion Criteria: Medical conditions, psychological disorders, food allergies

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Activity choices<br>Observe individuals' activity choices after playing a computer game. | Behavioral: Computer game<br>* Participants will play a computer game<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Changing the Eating Speed on Energy Intake

Study Overview
=================
Brief Summary
-----------------
It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and lesser feelings of hunger and desire to eat and higher levels of fullness after the meal compared to eating the same meal more quickly.

Official Title
-----------------
The Effect of Changing the Eating Speed on Energy Intake: a Randomized Cross-over Study

Conditions
-----------------
Oral Intake Reduced

Intervention / Treatment
-----------------
* Behavioral: Slow eating condition
* Behavioral: Fast eating condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ages 19-65 years. Exclusion Criteria: Severe obesity (BMI ≥ 40 kg/m2), dieting, taking medications that affect appetite, participating in > 150 min/wk of vigorous physical activity, smoking, drinking heavily (men: > 14 alcoholic drinks/wk; women: > 7 alcoholic drinks/wk), self-reported disordered eating, depression, type 1 or 2 diabetes, adrenal disease, or untreated thyroid disease.

Ages Eligible for Study
-----------------
Minimum Age: 19 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow eating condition<br>The subjects were asked to eat their meal slowly during the slow eating condition | Behavioral: Slow eating condition<br>* The subjects were asked to eat their meal slowly during the slow eating condition<br>|
| Active Comparator: Fast eating condition<br>The subjects were asked to eat their meal quickly during the fast eating condition | Behavioral: Fast eating condition<br>* The subjects were asked to eat their meal quickly during the fast eating condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal energy intake |  | Day 1 | 
| Meal energy intake |  | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger questionnaire |  | 0 and 60 min after the meal began | 
| Fullness questionnaire |  | 0 and 60 min after the meal began | 
| Desire to eat questionnaire |  | 0 and 60 min after the meal began | 
| Thirst questionnaire |  | 0 and 60 min after the meal began | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eating speed, energy intake