linjc16/ctgov huggingface dataset:
An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC

Study Overview
=================
Brief Summary
-----------------
To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.

Official Title
-----------------
Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.

Conditions
-----------------
Post-traumatic Stress Symptoms, Psychosocial Distress

Intervention / Treatment
-----------------
* Behavioral: Trauma-Focused Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Suicidal ideation (irrespective of score on any other measure) Exclusion Criteria: psychosis mental retardation inability to understand Swahili one standard deviation below the mean on every measure

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trauma-Focused Cognitive Behavioral Therapy<br> | Behavioral: Trauma-Focused Cognitive Behavioral Therapy<br>* 15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy<br>|
| No Intervention: Waiting List Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index |  | baseline, post-intervention and 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument |  | baseline post-intervention and 3-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma-Focused Cognitive Behavior Therapy, Sexually Exploited Girls, Post-traumatic Stress Symptoms, Psychosocial Distress
Hepatocellular Carcinoma Registry for Turkey (3K Trial)

Study Overview
=================
Brief Summary
-----------------
This registry study is national, multi-center, prospective study without any interventions to the treatment strategies and/or decisions of the investigators. It is designed in order to determine the general profile of HCC patients in Turkey. Socio-demographic characteristics, family history, medical history and treatment pattern of HCC patients will be evaluated.

Official Title
-----------------
Profile of the Hepatocellular Carcinoma Patients in Turkey

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be diagnosed with hepatocellular carcinoma in last 3 months To be older than 18 years old To sign informed consent form (ICF) Exclusion Criteria: Patients that does not sign or withdraw informed consent form. According to investigator's opinion; existence of any situation/condition that will significantly complicate patient follow up. Currently or previously taking part in 3K observational study

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 |
| --- | --- |
| Group 1<br> | Other: No Intervention<br>* All treatment options (inc. surgery, TACE, drugs) will be registered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of HCC risk factors | i.e. smoking and alcohol consumption status; family history for hepatitis, HCC, and other malignancies; history of hepatic disease and blood transfusion; concomitant diseases; treatments applied | Baseline | 
| Descriptive analysis of clinical profile of newly diagnosed HCC patients |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with underlying liver disease and family history |  | Baseline | 
| Treatment options as applied by doctors to HCC patients |  | Up to approximately 5 years | 
| Overall survival time since diagnosis |  | Up to approximately 5 years | 
| Number of participants with adverse events |  | Up to approximately 5 years | 
| Descriptive analysis of demographic characteristics of HCC patients |  | Baseline | 
| Descriptive analysis of clinical characteristics of HCC patients |  | Up to approximately 5 years | 
| Descriptive analysis of tumor properties |  | Up to approximately 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma, Registry, Turkey
Measurement of Cardiac Output Before and After Cardiopulmonary Bypass.

Study Overview
=================
Brief Summary
-----------------
Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current gold standard.

Official Title
-----------------
Ultrasound Dilution Measurement of Cardiac Output Before and After Adult Cardiopulmonary Bypass

Conditions
-----------------
Cardiac Output

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged > 21 years Patients undergoing surgery involving cardiopulmonary bypass Patients instrumented with a thermodilution catheter Exclusion Criteria: Patients aged < 21 years Patients undergoing surgery off pump (not involving cardiopulmonary bypass)

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Cardiac output after cardiopulmonary bypass | Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass. | Less than 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output before cardiopulmonary bypass | Cardiac output will be measured using an ultrasound dilution technique and compared to cardiac output measured using thermodilution. This will serve as a baseline measurement of the patient's cardiac output. | Less than 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac output, cardiopulmonary bypass, ultrasound dilution
Development of a MID for the 1-minute Sit-to-stand Test

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the minimal important difference (MID) for the 1-minute-sit-to-stand-test (STST) with an anchor-based method.

Detailed Description
-----------------
In this study we develop the minimal important difference for the 1-minute sit-to-stand-test (STST) with an anchor-based method. First step of this study is to find out the differences in the number of repetitions during 1-minute STST, 6-minute walk distance and health-related quality of life from pre to post inpatient pulmonary Rehabilitation program (3 weeks Duration) in the Schoen-Klinik Berchtesgadener Land. In Addition, Balance tests on the Leonardo-Mechanograph will be performed and the Hospital Anxiety and Depression Scale (HADS) and Chronic Respiratory Questionnaire (CRQ) will be assessed. For the second step we will use an anchor-based approach to estimate the MID of the STST. 6MWD and CRQ are used as anchors for which the MID has been established before.

Official Title
-----------------
Development of a Minimal Important Difference for the 1-minute Sit-to-stand Test

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Procedure: Pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COPD (GOLD-Stage II to IV) Ability to stand-up and walk written informed consent Exclusion Criteria: orthopaedic or other comorbidities that prevent patients from performing the STST, 6MWT or exercise Training acute exacerbation heart failure, acute coronary syndrome
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 |
| --- | --- |
| Other: Pulmonary rehabilitation<br>multimodal pulmonary Rehabilitation program (3 weeks Duration) | Procedure: Pulmonary rehabilitation<br>* Inpatient pulmonary rehabilitation has a duration of 3 weeks. This multimodal program consists of exercise training, breathing therapy, medical council, education and psychological support.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MID of the 1-minute-STST | Change of maximum 1-minute sit-to-stand repititions | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute-walk distance | Maximal walk distance reached in 6 minutes | 21 days | 
| CRQ Score | CRQ is a health-related Quality of life questionnaire | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, MID, 1-minute sit-to-stand-test
International Fetal Anesthesia Database

Study Overview
=================
Brief Summary
-----------------
This registry aims to gather anesthetic medications administered to fetuses directly as well as those administered via the mother during fetal intervention procedures. The goal is to assesss short and medium term outcomes as well as long term outcomes of these babies whao have received medication in utero. The long term outcomes will include but are not limited to neurodevelopmental outcomes.

Detailed Description
-----------------
Advances in technology have allowed for an increase in procedures performed on the fetus in utero; these procedures involve the administration of different anesthetics (sedative- hypnotic agents and or volatile agents) to the mother and sometimes directly to the fetus in order for succesful completion of the procedure. Very few instiututions in the world perform these procedures in any significant number. The establishment of this database will serve to consolidate information regarding anesthetic drugs administered for these procedures, thereby helping to establish best practice guidelines, determine medium and short term outcomes or complications and also facilitate long term neurodevelopmental assessment of children that have undergone these procedures in utero with 5 and 10 year neurodevelopmental assessment.

Official Title
-----------------
International Fetal Anesthesia Database

Conditions
-----------------
Determination of Neurological Outcomes

Intervention / Treatment
-----------------
* Procedure: Fetal intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women, fetuses and children Exclusion Criteria: Non-pregnant women
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fetal intervention|Type of fetal conditions requiring intervention and medications administered to fetuses undergoing varying types of fetal intervention will be documeted in this database.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal complications | resuscitation efforts during surgery or peri-operative demise | Peri-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hypotension or other maternal complications |  | Peri-operative period |
Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.

Official Title
-----------------
A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Drug: RSD1235


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have symptomatic AF Subject must have adequate anticoagulant therapy Exclusion Criteria: Subject may not have Class IV congestive heart failure. Subject may not have uncorrected electrolyte imbalance.

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: 1<br> | Drug: RSD1235<br>* IV<br>* Other names: Kynapid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute |  | Infusion plus 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety |  | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Investigational Therapies, Atrial Fibrillation, Treatment Efficacy, Treatment Effectiveness, Safety, RSD1235
Effects of Various Modalities Water Immersion on Veins

Study Overview
=================
Brief Summary
-----------------
Objectives In this study the investigators examined the changes in common femoral vein (CFV) and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT). Design Ten professional handball players visited the laboratory on three occasions. At each visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air (baseline) and then 16-minutes lower limbs TNI ( 35°C), CWI ( 12°C) or CWT (2:2minutes ( 12°C to  35°C) ratio), selected randomly. Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the end of 16 min immersion.

Official Title
-----------------
Effects of Thermo Neutral Water Immersion, Cold-water Immersion and Contrast Water Therapy on Lower Limb Veins Calibres

Conditions
-----------------
Hydrotherapy

Intervention / Treatment
-----------------
* Other: immersion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Free healthy voluntary Exclusion Criteria: hypersensitivity to cold

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cold water immersion<br>Participants immersed their lower limbs in water of  12°C | Other: immersion<br> <br> |
| Experimental: contrast water therapy<br>Participants immersed their lower limbs in water : alternated every 2 min between  12°C and  35°C for CWT | Other: immersion<br> <br> |
| Experimental: thermo neutral immersion<br>Participants immersed their lower limbs in water of  35°C | Other: immersion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in common femoral vein cross-section (mm2) during three immersion modalities immersion | thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT) | Change from Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements | 
| change in great saphenous vein antero posterior diameter (mm) during three immersion modalities immersion | thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT) | Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femoral vein, saphenous vein, hydrostatic pressure, temperature, recovery
Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
This study evaluates the function of the heart in young patients with muscular dystrophy type Duchenne or Becker. Participants have their hearts examined at regular intervals by ultrasound (echocardiography) and cardiac magnetic resonance imaging.

Detailed Description
-----------------
Muscular dystrophy leads to progressive loss of function in all muscles during childhood and adolescence, including the heart. The usual method to evaluate the heart is echocardiography, emphasizing few parameters. Cardiac magnetic resonance imaging is not as widely available as echocardiography, but early changes can be detected before they become visible on echocardiography. In this study, the investigators compare the methods of measuring heart function in order to find the best measurements for follow up and to see how fast the degenerative changes occur in the hearts of patients with muscular dystrophy.

Official Title
-----------------
Cardiac Involvement in Patients With Duchenne/Becker Muscular Dystrophy

Conditions
-----------------
Duchenne / Becker Muscular Dystrophy

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy Informed consent Exclusion Criteria: Other clinically significant concomitant disease states (e.g., renal failure) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or his/her parents or legal caregivers, Inability to lie still for the duration of the imaging procedures (approximately 45 minutes each for echocardiography and CMR) MR-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with muscular dystrophy<br>Boys aged 8 to 18 years with muscular dystrophy of the Duchenne / Becker type | |
| Children without heart disease<br>Children without heart disease, aged 8-18 years, as CMR comparison group | Other: Observation<br>* Observation by serial echocardiography with extended techniques and cardiac magnetic resonance imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction |  | 3 years per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of fibrosis by LGE/T1 mapping |  | 3 years per patient | 
| NT-proBNP |  | 3 years per patient |