linjc16/ctgov huggingface dataset:
Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.

Official Title
-----------------
Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation

Conditions
-----------------
Exercise Capacity, Heart Transplantation

Intervention / Treatment
-----------------
* Behavioral: exercise training; psychosocial support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart transplant (6-9 mts post Tx) stabile health condition at study entry (pt stays within home environment) Age ≥ 18 yrs Sufficient language skills to answer questionnaire Follow-up at our center Willingness to participate by written informed consent Exclusion Criteria: TVP diagnosis before study inclusion Episodes of recurrent acute rejections Medical contra-indication for regular exercise ergometer training Malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise training; psychosocial support|supervised home-based endurance training; recommendation to exercise every other day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQoL,exercise capacity |  | 36 mts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain; cardiovascular risk factors; social re-integration |  | 36 mts | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRQoL, exercise capacity
TCA Cycle in the Dentate in Friedreich's Ataxia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVE: To measure the tricarboxylic acid (TCA) cycle rate in the dentate nucleus in a group of control subjects and subjects with Friedreich's Ataxia (FRDA). HYPOTHESIS: The TCA cycle rate will be lower in FRDA subjects than in controls APPROACH: The investigators will infuse carbon-13 (13C) labeled glucose and measure the rate of 13C label incorporation from glucose to glutamate in the brain using in vivo magnetic resonance spectroscopy.

Detailed Description
-----------------
The investigators will measure the TCA cycle rate in the dentate nucleus in a group of FRDA patients and in a group of age-matched healthy controls using 13C MRS in vivo together with systemic i.v. infusion of 13C-labeled glucose. The investigators aim to obtain adequate data in 16 subjects grouped as follows: n=4 pilot subjects (healthy subjects) for testing and optimization of the experimental setup. n=6 healthy controls n=6 FRDA patients In other to reach this goal, the investigators plan to recruit up to 20 subjects, in case some subjects withdraw before completion of the MR scan, or in case the measured data are not adequate (e.g. technical problem with the scanner).

Official Title
-----------------
Measurement of the TCA Cycle Rate in the Dentate Nucleus in Friedreich's Ataxia

Conditions
-----------------
Friedreich Ataxia

Intervention / Treatment
-----------------
* Device: MR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older able to consent for themselves considered healthy (controls) OR be diagnosed with FRDA. Exclusion Criteria: All subjects: Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant) Pregnancy Clautrophobia Diabetes Clinically significant cardiac disease Control subjects: - Neurological disease

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 |
| --- | --- |
| Control<br>Healthy subjects | Device: MR<br>* MR<br>|
| Friedreich's Ataxia<br>Diagnosed for Friedreich's Ataxia | Device: MR<br>* MR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCA cycle rate in the dentate nucleus | value between 0 to 2 micromol/g/min | Baseline |
International Multicenter Study on Lipin-1 Deficiency

Study Overview
=================
Brief Summary
-----------------
LIPIN1 is an international registry that allows the collection of data on the follow-up, management and treatment of patients with Lipin-1 deficiency.

Detailed Description
-----------------
This study evaluates survival, cardiac function, quality of life, fatigability, treatment tolerance and comparison of the efficacy of different current treatments in patients with Lipin-1 deficiency.

Official Title
-----------------
Etude Multicentrique Internationale Sur le déficit en Lipin-1

Conditions
-----------------
Lipin-1 Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at least 12 months with Lipin1 deficiency confirmed by molecular biology (two causal mutations in the LPIN1 gene) Exclusion Criteria: Opposition of the patient or his parents to participate to the study

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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 |
| --- | --- | --- |
| Evaluation of survival in patients with Lipin-1 deficiency | Patient survival as assessed by long-term follow-up | According to routine care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of cardiac function in patients with Lipin-1 deficiency | Cardiac function, assessed by cardiographic ultrasound | According to routine care | 
| Comparison of the effectiveness of different current treatments in patients with Lipin-1 deficiency | Comparison of the number of severe rhabdomyolysis and biological assessment (CPK measurement performed as part of care) in patients | According to routine care | 
| Evaluation of the quality of life of patients with Lipin-1 deficiency | Quality of life, assessed by standardized questionnaires | According to routine care | 
| Evaluation of the tolerance of treatments in patients with Lipin-1 deficiency. | Treatment side effects, assessed by abdominal pain, skin allergy and other adverse effects | According to routine care | 
| Evaluation the fatigability of patients with Lipin-1 deficiency | Exercise capacity, assessed by walking tests | According to routine care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inherited Metabolic Diseases, enzymatic deficiency, rhabdomyolysis
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)

Study Overview
=================
Brief Summary
-----------------
The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF).

Detailed Description
-----------------
The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF). The pandemic of COVID-19 is unique in terms of a multitude of patients suffering from ARF and requiring invasive mechanical ventilation with single underlying inciting etiology.The experts have given divergent opinions on respiratory support of C-ARF which may have confused physicians globally. The investigators are going to use a modified Delphi based methodology involving global participating experts. The objective is to achieve consensus statement on the management of C-ARF using collective intelligence. The whole process of this study will be done in the form of two-three rounds of Google Forms-based Delphi surveys. In this survey questionnaire, the investigators have prepared statements on the concern areas in the respiratory support of C-ARF. The survey has been divided into five sections related to C-ARF management. The majority of these statements are to be rated on Likert scale and others have multiple choices. There is an option for collecting participating experts comments in provided open space in round one which will be considered during round two questionnaire.

Official Title
-----------------
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF) Using Modified Delphi Methodology

Conditions
-----------------
Covid19, Acute Respiratory Failure, Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Other: Experts consensus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (All the three criteria should be there) H index more than 10; one or more publication on respiratory failure in indexed journal; actively involved in management of COVID-19 related acute respiratory failure. Exclusion Criteria: Not meeting inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Experts consensus|Consensus opinion using Delphi Methodology|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consensus using participating experts opinions. | Survey Questionnaire containing seven point Likert scale and multiple choice questions. | 20 days |
Soothe Versus Refresh

Study Overview
=================
Brief Summary
-----------------
To determine the ocular efficacy and safety of Soothe and Refresh Tears.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: Soothe
* Drug: Refresh Tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with a diagnosis of dry eyes Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test Exclusion Criteria: contact lens use during the active treatment periods of the trial history of Sjogren's Syndrome temporary punctal occlusion that is still effective the current or anticipated use during the study of punctual plugs current treatment with Restasis

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Soothe|nan|
|Drug: Refresh Tears|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT

Study Overview
=================
Brief Summary
-----------------
The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction. However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973) was a randomized controlled secondary CHD prevention trial testing whether selectively increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival. A full analysis of mortality outcomes has not been published. The investigators recovered the original SDHS dataset, which included detailed longitudinal dietary, smoking and coded mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also permitted the first complete meta-analysis of LA intervention trials on mortality outcomes. Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed mortality differences.

Official Title
-----------------
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: a Randomized Controlled Dietary Trial

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Other: Safflower oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of myocardial infarction, angina, or coronary insufficiency Willingness to attend Coronary Clinic in Sydney Australia on a regular basis

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 59 Years

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

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: Safflower oil<br> | Other: Safflower oil<br>* Liquid safflower oil and safflower oil polyunsaturated margarine<br>|
| No Intervention: Control group (no diet instruction)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, all-cause |  | Up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death due to cardiovascular disease |  | Up to 7 years | 
| Death due to coronary heart disease |  | Up to 7 years |
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.

Official Title
-----------------
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Ateronon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women with demonstrated Coronary Disease AtheroAbzyme positive during screening process Elevated Total Cholesterol Willingness to take study nutritional supplement once a day for 3 months Exclusion Criteria: Women who are pregnant, nursing or intend pregnancy during the period of treatment Known milk, soy or whey allergy

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | |
| Active Comparator: Ateronon<br> | Drug: Ateronon<br>* Ateronon daily for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease |  | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the potential effectiveness of Ateronon in lowering pulse rate as well systolic and diastolic blood pressure in patients with demonstrated coronary disease |  | Baseline and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asymptomatic Myocardial Ischemic patients
Plasma Levels of GDF-9 and GDF-15 in Patients With Polycystic Ovary Syndrome.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the plasma levels of GDF-9 and GDF-15, and their association with bone and cardiovascular parameters in patients with Polycystic Ovary Syndrome.

Official Title
-----------------
1. Association of Plasma GDF-9 or GDF-15 Levels With Bone Parameters in Polycystic Ovary Syndrome. 2. Plasma GDF-15 Levels and Their Association With Hormonal and Metabolic Status in Women With Polycystic Ovary Syndrome Aged 25-35.

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients at ages 25-35 diagnosed with polycystic ovarian syndrome and idiopathic hirsutism Exclusion Criteria: acute infectious disease, a thyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorder; history of cardiovascular disease or pulmonary embolism; a family history of coronary artery disease; smoking history; hypertension; diabetes mellitus; use of oral contraceptives, anti-androgens and drugs known to interfere with cytokine release, such as corticosteroids, immunosuppressors, or nonsteroidal antiinflammatory drugs. any medication known to affect hormonal or metabolic parameters.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Polycystic Ovary Syndrome<br> | |
| Idiopathic hirsutism<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association of GDF 9 AND GDF 15 with bone and cardiovascular parameters in women with polycystic ovary syndrome |  | 1 year |
Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with resistant oral cGvHD.

Official Title
-----------------
Double-blind, Randomised, Placebo-controlled Multicentre Phase III Clinical Study Followed by Open-label Phase on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic GvHD

Conditions
-----------------
Oral Chronic Graft vs Host Disease

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Karnofsky >= 70 Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation Oral cGvHD of erosive and/or ulcerative type NIH scale >= 3 Resistant oral cGvHD with no oral response to conventional primary treatment Exclusion Criteria: Uncertain diagnosis of resistant oral cGvHD Symptomatic oral cGvHD of hyperkeratotic type solely Current active oral bacterial, viral, or fungal infection Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain Requiring addition of new systemic therapy including steroids, or radiation therapy Local intestinal infection Abnormal hepatic function or liver cirrhosis If careful medical monitoring is not ensured: tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection Second line treatment of oral cGvHD with topical steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Budesonide<br>* 3 mg TID<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* 0 mg TID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with objective response |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete/partial response, stable disease, progressive disease |  | 12 weeks | 
| Time to initial objective response |  | x weeks | 
| Rate of subjective improvement |  | 12 weeks |