linjc16/ctgov huggingface dataset:
Novel Screening Strategies for Scleroderma PAH

Study Overview
=================
Brief Summary
-----------------
Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. However, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. This study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. The study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.

Official Title
-----------------
Novel Screening Strategies for Scleroderma PAH (Pulmonary Arterial Hypertension)

Conditions
-----------------
Pulmonary Arterial Hypertension, Scleroderma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30 years or older; diagnosis of limited or diffuse scleroderma (American College of Rheumatology criteria) for the high risk group, one of the following features: resting transthoracic echocardiogram showing elevated right-sided pressures within previous 3 months [tricuspid regurgitation (TR) jet >2.8 m/s or evidence of right ventricular dysfunction] pulmonary function testing (PFT) showing abnormal diffusing capacity of carbon monoxide (DLCO) not due to significant interstitial lung disease (DLCO<60% predicted or FVC: DLCO ratio >1.4) Exclusion Criteria: Pregnancy prior diagnosis of pulmonary hypertension treatment with endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogues previous diagnosis of obstructive lung disease or pulmonary thromboembolic disease current smoker significant valvular disease resting echocardiogram showing left ventricular ejection fraction<50% within previous 3 months resting echocardiogram showing significant (greater than Grade I) diastolic dysfunction pulmonary emboli (past or present).

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Scleroderma and diagnosed PAH<br> | |
| Low risk scleroderma<br> | |
| Healthy volunteers<br> | |
| High risk scleroderma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of pulmonary arterial hypertension |  | Two years after enrollment. |
Cross-sectional Study of Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
This study is designed to collect data on precipitating factors, diagnosis, morbidity, therapy, quality of life, and symptom severity, etc. informations in patients with fibromyalgia.

Detailed Description
-----------------
Patients fulfilling 1990 ACR criterion for fibromyalgia will be recruited in Fibromyalgia outpatient service which is belonged to the Department of Rheumatism. Except collecting patients' demographic and social characteristic informations, rheumatologist also carry out a comprehensive evaluation including patient current history, current medication use, and tender point examination for a diagnosis or confirmation of fibromyalgia and treatment recommendations. Patients with fibromyalgia will be asked to fill a set of questionnaires to evaluate their quality of life, symptoms severity, quality of sleep and emotion. The study will be conducted in Beijing, China.

Official Title
-----------------
A Cross-sectional Study of Fibromyalgia in Beijing

Conditions
-----------------
Fibromyalgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older. Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia. Exclusion Criteria: Don't fulfill any classification criterions for Fibromyalgia.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ) |  | up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL as measured by Short Form-36 Health Status Questionnaire (SF-36) |  | up to 1 week | 
| Pain scores as measured by Numerical rating scale (NRS) |  | up to 1 week | 
| Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF) |  | up to 1 week | 
| Depression scores as measured by Beck depression inventory (BDI) |  | up to 1 week | 
| Stress scores as measured by Perceived Stress Scale (PSS) |  | up to 1 week | 
| Sleep scores as measured by Pittsburgh sleep quality index (PSQI) |  | up to 1 week |
Dietary Salt Intake and Vascular Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.

Detailed Description
-----------------
Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.

Official Title
-----------------
Dietary Salt Intake and Vascular Function

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: High sodium
* Dietary Supplement: Low sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male, African-American volunteers 18-35 years of age, No personal or first degree relative with hypertension or diabetes, Blood pressure <130/85 mmHg and > 90/60 at the screening visit, Body mass index <30 kg/m2, No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis and electrocardiogram). Exclusion Criteria: Alcohol intake >2 beverage/night, Smoking, Recreational drug use, Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months, Prescription or herbal medication use, Ischemic changes on resting electrocardiogram, Known hypersensitivity to any of the study drugs, Other active medical problems detected by examination or laboratory testing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Sodium<br>High sodium | Dietary Supplement: High sodium<br> <br> |
| Active Comparator: Low sodium<br>Low sodium | Dietary Supplement: Low sodium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sodium, dietary salt, blood vessels, vascular function, endothelial function, heart disease risk, cardiovascular disease risk
Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?

Study Overview
=================
Brief Summary
-----------------
Mechanism-based choice of therapy for pain: Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?

Official Title
-----------------
Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Amitriptyline
* Drug: Topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female and male migraine patients with a number of month attacks ≥ 4, age 18-75, without any other chronic pain. Exclusion Criteria: any migraine preventive treatment for last 6 month & psychiatric, language or cognitive dysfunction precluding use of psychophysics.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Amitriptyline.<br>Amitriptyline | Drug: Amitriptyline<br>* Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks<br>|
| Active Comparator: 2 Topiramate<br>Topiramate | Drug: Topiramate<br>* For the first 5 days of treatment 25mg is prescribed and should be ingested in one evening dose. For another 5 days, 25g dose should be taken twice a day (morning and evening). For the next 5 days, morning dose will be 25mg; evening dose will be 50mg. For the remaining 6 weeks of treatment, a dose of 50mg twice a day will be advised<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic response to the analgesic drugs |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine patients
Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that different types of starch vary in their effects on appetite, blood sugar and food intake. In this study, subjects consumed five soups containing 50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added starch at one week intervals. The investigators measured food intake at 30 minutes, appetite and blood sugar.

Official Title
-----------------
The Effect of Different Types of Starch on Glycemic Response, Subjective Appetite and Short-term Food Intake in Young Men

Conditions
-----------------
Obesity Prevention, Diabetes Prevention

Intervention / Treatment
-----------------
* Dietary Supplement: soup with or without starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males with a BMI of 20-24.9 kg/m2 Exclusion Criteria: Females Smokers Breakfast skippers Individuals with diabetes or other metabolic diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soup with no added starch<br> | Dietary Supplement: soup with or without starch<br> <br> |
| Experimental: Soup + 50 g of whole grain starch<br> | Dietary Supplement: soup with or without starch<br> <br> |
| Experimental: Soup + 50 g of high amylose corn starch<br> | Dietary Supplement: soup with or without starch<br> <br> |
| Experimental: Soup + 50 g of regular corn starch<br> | Dietary Supplement: soup with or without starch<br> <br> |
| Experimental: Soup + 50 g maltodextrin starch<br> | Dietary Supplement: soup with or without starch<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose |  | 0-170 min | 
| Food intake |  | at 30 min after the treatment | 
| Appetite |  | 0-170 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Water intake |  | at 30 min | 
| Palatability of treatments |  | 0-170 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
starch, carbohydrates, blood glucose, food intake, satiety, appetite
PET Scan as a Screening Tool for Liver Transplant in Patients With Hepatocellular Carcinoma (HCC)

Study Overview
=================
Brief Summary
-----------------
This study aims at testing the utility of PET Scan as a screening tool for liver transplantation in patients with Hepatocellular Carcinoma. Patients being worked up for liver transplant for hepatocellular carcinoma will undergo a PET Scan and will be followed until 2 years after transplantation. At that time survival data will be analysed according to PET Scan results to determine if it can be used to predict outcome.

Official Title
-----------------
PET Scan as a Screening Tool for Liver Transplant in Patients With HCC

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

Intervention / Treatment
-----------------
* Other: PET Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient over 18 years of age Diagnosis of HCC confirmed by histology if available or by two imaging modalities Able to give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. Exclusion Criteria: Unable to give consent to the study Unable to undergo a PET Scan

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Milan Criteria<br>Patients meeting the Milan Criteria | Other: PET Scan<br>* All patients will have a PET scan as part of their pre-transplant assessment<br>|
| Other: No Milan Criteria<br>Patients not meeting the Milan Criteria | Other: PET Scan<br>* All patients will have a PET scan as part of their pre-transplant assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The primary objective of the study is to compare, according to PET scan results, the post-transplantation overall survival of patients meeting Milan criteria to those not meeting Milan criteria | up to death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplant
Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy

Study Overview
=================
Brief Summary
-----------------
The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.

Official Title
-----------------
Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Erector spinae plane block
* Procedure: No injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for thoracoscopy physical status I-III Exclusion Criteria: allergy to local anaesthetics other contraindications to peripheral nerve blocks patients suffering from chronic pain condition

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erector spinae plane block<br> | Procedure: Erector spinae plane block<br>* Injection of local anaesthetics below the erector spinae muscle after induction of anaesthesia<br>|
| Placebo Comparator: Placebo<br> | Procedure: No injection<br>* No injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV morphine consumption | mg | 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV morphine consumption | mg | 2 postoperative hours | 
| IV morphine consumption | mg | 48 postoperative hours | 
| Pain scores | Visual analog scale, 0-10 | 2, 24, 24 postoperative hours | 
| Chronic pain scores | Visual analog scale, 0-10 | 3 and 6 postoperative months | 
| Forced vital capacity | L | 24 and 48 postoperative hours |
Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women.

Official Title
-----------------
Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour: a Randomized Trial

Conditions
-----------------
Labour Induction

Intervention / Treatment
-----------------
* Drug: Misoprostol, modified-release pessary
* Drug: Misoprostol, per-oral tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous Singleton at term pregnancy (>36+6 weeks) Unfavourable cervix (Bishop score < 6) Fetal cephalic position Exclusion Criteria: Pre-term pregnancy (<37 weeks) Multiple pregnancy Rupture of membranes Other than fetal cephalic position Intra-uterine growth retardation Severe pre-eclampsia Severe hypertension Previous cesarean section
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: Misoprostol modified-release pessary<br> | Drug: Misoprostol, modified-release pessary<br>* Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours<br>* Other names: Misodel;|
| Active Comparator: Misoprostol, per-oral tablets<br> | Drug: Misoprostol, per-oral tablets<br>* First day: 50 ug PO in every 4 hours maximum 3 times per day. Second day: 100 ug PO in every 4 hours maximum 3 times per day. Third day: 50 ug vaginally in every 4 hours maximum 3 times per day or until labour is induced.<br>* Other names: Cytotec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean section rate |  | at time of child birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time from beginning of induction to child birth |  | up to child birth | 
| Neonatal Apgar score |  | 1, 5, 10 minutes after child birth |
Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting from cardiac resynchronization therapy.

Official Title
-----------------
Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy

Conditions
-----------------
Heart Failure, Atrial Fibrillation, Ventricular Dysfunction

Intervention / Treatment
-----------------
* Device: Atrial Overdrive Pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HF patients New York Heart Association (NYHA) III - IV Spontaneous QRS ≥130 ms and/or mechanical interventricular delay > 50 ms Left ventricular ejection fraction (LVEF) ≤ 35% Left ventricular end diastolic diameter (LVEDD) ≥ 55 mm Optimized medical regimen Age > 18 years Exclusion Criteria: Unstable angina or acute myocardial infarction (MI) (< 3 months) Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) < 3 months Life expectancy < 6 months Permanent AF Pregnancy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CRT + AF Suppression turned ON | Device: Atrial Overdrive Pacing<br>* Pacemaker/ ICD implant<br>|
| Active Comparator: 2<br>CRT + AF Suppression turned OFF | Device: Atrial Overdrive Pacing<br>* Pacemaker/ ICD implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of permanent atrial fibrillation |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventricular Dyssynchrony