linjc16/ctgov huggingface dataset:
Physical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
It is the primary purpose of this pilot study to investigate if physical therapy with strength training is better at improving muscle and gait function after anti-spastic treatment with Botulinum toxin compared to physical therapy without strength training in children with cerebral palsy. The investigators hypothesize that it is.

Official Title
-----------------
Physical Therapy With Versus Without Strength Training After Botulinum-toxin Treatment in Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Physical therapy with strength training
* Other: Physical therapy without strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebral palsy (diplegia and hemiplegia) indication for anti-spastic treatment with Botulinum toxin Exclusion Criteria: fixed contractures

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Physical therapy with strength training. | Other: Physical therapy with strength training<br>* 12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training.<br>|
| Active Comparator: B<br>Physical therapy without strength training. | Other: Physical therapy without strength training<br>* 12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-dimensional gait analysis |  | 12 weeks | 
| Selective motor control |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity (modified Ashworth) |  | 12 weeks | 
| Range of motion |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor control, Spasticity
The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)

Study Overview
=================
Brief Summary
-----------------
In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical activation of the left heart chamber will cause abnormal contraction.This has been shown to be possible to treat by a special pacemaker treatment which includes pacing of the left heart chamber (= CRT treatment). In this study the researchers will investigate the effect of acute CRT treatment in the early phase after open heart surgery.

Detailed Description
-----------------
Patients with bundle branch block have a delayed electrical activation of the left ventricle causing abnormal contractility of the left ventricle. We hypothesize that patients may benefit from short term (= 72 hours) CRT (Cardiac Resynchronization Therapy) in the early phase after open heart surgery. Patients: reduced LV function and bundle branch block. Study type: randomisation to CRT versus standard postoperative treatment Study variables: cardiac output, echocardiographic measures, p-BNP and hours with inotropic therapy.

Official Title
-----------------
Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery

Conditions
-----------------
Bundle-Branch Block

Intervention / Treatment
-----------------
* Procedure: Temporary cardiac resynchronization therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for open heart surgery (coronary artery bypass graft [CABG] or mitral valve surgery or aortic valve surgery or combinations of the above mentioned surgical procedures) and LV ejection fraction < 35% and bundle branch block (QRS > 9.12 s) Exclusion Criteria: Severe right heart failure Permanent atrial fibrillation Congenital heart disease Serious non-cardiac disease

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Temporary cardiac resynchronization therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non invasive cardiac output after 72 hours CRT (versus control) treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic measures of left ventricular (LV) function |  |  | 
| Mixed venous oxygen saturation |  |  | 
| Invasively determined cardiac output |  |  | 
| Plasma brain natriuretic peptide (p-BNP) |  |  | 
| Number of hours with inotropic treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac resynchronization, Heart failure, open heart surgery, surgery
Autistic Women's Experiences of Self Compassion and Receiving Their Diagnosis in Adulthood

Study Overview
=================
Brief Summary
-----------------
Research highlights strong links between self-compassion and mental health, but there is very limited research specifically exploring autistic individual's experiences of self-compassion. The process of receiving a diagnosis on the autism spectrum can be complex and autistic women tend to experience several barriers to diagnosis. This study adds to the growing area of research exploring autistic women's experiences of receiving a diagnosis in adulthood. This study employs Interpretative phenomenological analysis to explore if receiving a diagnosis of Autism influences women's perceptions of self-compassion. The findings may inform client-centred practices in health care settings and potentially present positive aspects of autism diagnosis.

Official Title
-----------------
Autistic Women's Experiences of Self Compassion and Receiving Their Diagnosis in Adulthood

Conditions
-----------------
Autism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to consent to participate Cisgender female (female at birth and raised as female). Speak English fluently Received an Autism Spectrum Disorder diagnosis, aged 18 years old or above Exclusion Criteria: Lack capacity to consent to participate in the study Unable to speak English fluently Have not received an Autism diagnosis Have received Autism diagnosis prior to their 18th birthday Have an intellectual disability Born male

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience of receiving ASD diagnosis in adulthood based on semi structured interviews | Participants' experience of receiving ASD diagnosis in adulthood based on semi structured interviews, completed in one interview. | day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience of self-compassion before and after receiving ASD diagnosis based on semi structured interviews | Participants' experiences of self-compassion before and after receiving ASD diagnosis based on semi structured interviews, completed in one interview. | day one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, Self compassion
Narrow QRS HF Patients Assessed by ECG Belt

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study that is designed to provide data that can be used in designing and implementing a prospective study of cardiac resynchronization therapy (CRT) in narrow QRS patients selected and optimized using the ECG Belt.

Official Title
-----------------
Electrical Dyssynchrony in Narrow QRS Heart Failure Patients as Assessed by the ECG Belt

Conditions
-----------------
Heart Failure, Cardiac Resynchronization Therapy

Intervention / Treatment
-----------------
* Device: ECG Belt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject (or their legal guardian) must be willing to provide informed consent for their participation in the study Subject ≥ 18 years old Exclusion Criteria: Subject has unhealed-open wounds on the torso and/or has a history of severe allergic reactions from ECG electrode gel Subject is enrolled in a concurrent study that could confound the results of this study Subject is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Normal healthy controls<br> | Device: ECG Belt<br>* Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.<br>|
| Heart failure patients<br> | Device: ECG Belt<br>* Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical dyssynchrony quantification | Collect ECG data with ECG Belt | through acute study completion ( 60 minutes) |
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.

Official Title
-----------------
A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India

Conditions
-----------------
Hepatitis C Virus

Intervention / Treatment
-----------------
* Drug: SOF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV-infected patients living in India Treatment with a SOF-based regimen as determined by the patient's treating physician per the approved prescribing information. Patients who provide written and signed informed consent prior to initiation of treatment where required. Exclusion Criteria: Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products) Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country in a foreseeable future)

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 |
| --- | --- |
| SOF-based regimens<br>Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information. | Drug: SOF<br>* SOF tablets administered orally once daily based on approved prescribing information<br>* Other names: GS-7977;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen |  | Up to Posttreatment Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12) | SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ) 12 weeks following the last dose of study drug, respectively. | Posttreatment Week 12 |
RESponders and QUadripolar LV Lead in CRT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the evolution of the CRTD system with left quadripolar lead, in terms of electrical parameters in all pacing configurations and to evaluate the impact on the clinical outcome.

Detailed Description
-----------------
Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders. Pacing activation from proximal area with a left quadripolar lead might improve the depolarization pattern. To explore the effect of CRT pacing on cardiac activity, the investigators will enroll approximately 180 patients who already underwent CRT-D implantation with a quadripolar LV lead. After implant, as clinical practice, the device will be programmed with distal LV pacing configuration, after 6 months in patient non-responders to CRT therapy the pacing configuration will be changed (proximal configuration). After 12 months in patients non-responders will be changed the pacing configuration again, choosing, if it is possible, a multi point pacing (pacing activation from multiple separated left ventricular (LV) sites).

Official Title
-----------------
Responders and Quadripolar LV Lead in CRT

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRTD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be in NYHA II, III or IV functional class with approved standard indication by ESC/EHRA Guidelines Successful quadripolar LV lead implant Exclusion Criteria: Less than 18 years of age Epicardial Lead Life expectancy < 12 months Pregnant or are planning to become pregnant during the duration of the investigation

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 |
| --- |
|Device: CRTD|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months |  | 6-Months | 
| Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months |  | 12-Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months |  | 18 months |
The Prevalence of Rheumatic Heart Disease in School Children in Fiji

Study Overview
=================
Brief Summary
-----------------
This study is an epidemiological observational cross-sectional study designed to estimate the prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age in Fiji. The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions. School children will be enrolled after informed consent has been obtained. A standard cardiac examination (auscultation) will be performed as part of the routine annual health check by both school nurses, who have attended a training workshop, and by a paediatrician. All children with or without murmur will have a screening echocardiogram performed at a subsequent visit. Children found to have possible, probable or definite RHD or other cardiac pathology on the screening echocardiogram, will have a full echocardiogram performed by the echocardiography technician at the time of the second study visit. They will all also be referred to a paediatric cardiologist for further investigation and management and monitoring . Cases of RHD will be referred to and followed up by the National Fiji RHD register based at CWMH in Suva.

Official Title
-----------------
The Prevalence of Rheumatic Heart Disease in School Children in Fiji

Conditions
-----------------
Rheumatic Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent will be obtained for all participants All children between the ages of 5-14 Years are eligible for the study. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatic Heart Disease, Streptococcus, Fiji
SES, Health Behaviors and CVD Among Vietnam-Era Twins

Study Overview
=================
Brief Summary
-----------------
To further characterize the nature of the association between socioeconomic status (SES), health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a sample of over 4,000 twin pairs.

Detailed Description
-----------------
BACKGROUND: Cardiovascular disease (CVD) affects approximately 60,800,000 Americans each year, claiming the lives of nearly one million of these people (American Heart Association, 2001). CVD is likely to be complex in etiology, reflecting the combined effect of both genes and environment, as well as gene x gene and gene x environment interaction. Examination of environmental factors thought to affect CVD risk in the context of a genetically informative design can help elucidate the relative contribution of genetic and environmental factors and potentially aid in identifying environmental factors that may interact with genetic vulnerability in predicting CVD. Cardiovascular morbidity and mortality are over-represented among individuals in lower socioeconomic strata, as are behaviors that increase the likelihood of cardiovascular events, including smoking, heavy alcohol consumption and physical inactivity (Adler et al., 1994; Anderson & Armstead, 1995). Thus, it is commonly assumed that socioeconomic status (SES) serves as an important environmental influence on health and health behaviors. Twin studies partition genetic and environmental variance and detect gene x environment interaction and provide a unique opportunity to study the association between SES and health. DESIGN NARRATIVE: The study will characterize the nature of the association between socioeconomic status (SES), health behaviors and cardiovascular disease (CVD) in the existing Vietnam Era Twin (VET) registry, a sample of over 4000 male twin pairs with a mean age of 51 in 1999. Specifically, the study will: 1) determine how strongly environmental factors contribute to individual differences in SES, health behaviors and CVD, relative to genetic factors; 2) examine whether measures of SES are associated with health behaviors and CVD mortality when controlling for concomitant genetic influences; and 3) investigate whether SES interacts with genetic vulnerabilities to predict health behaviors and CVD (gene x environment interaction). Using VETdatasets, the primary method of analysis will be twin structural equation modeling.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
The Effect of Clip-traction on ESD Resection Time.

Study Overview
=================
Brief Summary
-----------------
Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.

Detailed Description
-----------------
Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD. Location, morphology and size of the lesion will be recorded. Time of the procedure will be measured using a stopwatch

Official Title
-----------------
The Effect of Clip-traction on ESD Resection Time. A Randomized Controlled Trial

Conditions
-----------------
Adenoma Colon

Intervention / Treatment
-----------------
* Device: clip-traction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a lesion in the colon or rectum suitable for removal by the ESD technique Exclusion Criteria: dementia inability to understand the written study information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Standard endoscopic submucosal dissection | |
| Active Comparator: Interventional<br>Mandatory use of the clip-traction device | Device: clip-traction<br>* A endoscopic clip with a loop of tied dental floss will be attached to the lesion. The loop will then be caught by another endoscopic clip and attached to adjacent bowel wall, thus creating tension in the tissue, making dissection easier.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection speed (mm2/min) | Measured as area of the removed lesion divided by procedure time. | Within completion of procedure |