linjc16/ctgov huggingface dataset:
Diuretics, Hypertension, and Arrhythmias Clinical Trial

Study Overview
=================
Brief Summary
-----------------
To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.

Detailed Description
-----------------
BACKGROUND: The Multiple Risk Factor Intervention Trial (MRFIT) revealed an unexpected subgroup finding: an association between diuretic therapy (especially with hydrochlorothiazide) and an increased rate of sudden death in hypertensive men with left ventricular hypertrophy and other ECG abnormalities. The Diuretics, Hypertension, and Arrhythmias Clinical Trial sought to determine whether the finding resulted from random variation or represented a serious toxic response to hydrochlorothiazide. DESIGN NARRATIVE: Randomized, double-blind. Following one month of withdrawal from all diuretics and repletion with oral potassium and magnesium, the study participants were randomized to two months of treatment with one of six treatment groups: hydrochlorothiazide; hydrochlorothiazide with oral potassium; hydrochlorothiazide with oral potassium and magnesium; hydrochlorothiazide and triamterene; chlorthalidone; or placebo. The main outcome measures were ventricular arrhythmias on 24-hour Holter monitoring and serum and intracellular potassium and magnesium levels.

Conditions
-----------------
Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Arrest, Heart Diseases, Hypertension

Intervention / Treatment
-----------------
* Drug: hydrochlorothiazide
* Behavioral: diet, potassium supplementation
* Behavioral: diet, magnesium supplementation
* Drug: triamterene
* Drug: chlorthalidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Men, ages 35 to 70, with ECG abnormalities, diastolic blood pressure less than 95 mm Hg at entry. Subjects had been treated for at least six months by their own physicians with hydrochlorothiazide (HCT), HCT and potassium supplementation, triamteren

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hydrochlorothiazide|nan|
|Behavioral: diet, potassium supplementation|nan|
|Behavioral: diet, magnesium supplementation|nan|
|Drug: triamterene|nan|
|Drug: chlorthalidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Is There a Link Between Inflammation and Endocrinopathies in Turner Syndrome?

Study Overview
=================
Brief Summary
-----------------
Liver abnormalities are common in Turner syndrome. The physiopathology of these abnormalities is unknown for the moment but their potentially serious evolution requires additional explorations.

Official Title
-----------------
Is There a Link Between Inflammation and Endocrinopathies in Turner Syndrome?

Conditions
-----------------
Turner Syndrome

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Experimental group: Turner syndrome Inclusion Criteria Control group: healthy subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 56 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br> | Other: no intervention<br>* retrospective analysis<br>|
| Control group<br> | Other: no intervention<br>* retrospective analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pro inflammatory score |  | 18 years |
An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.

Official Title
-----------------
A Non-interventional Multicenter Study of MabThera® (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active rheumatoid arthritis Inadequate response to a single TNF inhibitor Participants receiving rituximab therapy in accordance with the prescribing information Signed data release form within 6 weeks (42 days) of initiating rituximab therapy Women of childbearing potential must use effective form of contraception Exclusion Criteria: Contra-indication to receive rituximab according to the local labelling Previous treatment with rituximab Treatment with any investigational drug within 30 days prior to enrolment

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Rituximab + Methotrexate<br>All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score Based on 28-joints Count (DAS28) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment |  | Up to 5 years | 
| Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab |  | 6 Months After the Re-treatment With Rituximab (up to 5 years) | 
| Demographics of Participants Eligible to Receive Rituximab |  | Baseline | 
| Number of Participants With Adverse Events |  | 5 years |
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER

Study Overview
=================
Brief Summary
-----------------
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).

Official Title
-----------------
An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)

Conditions
-----------------
Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: mavacamten


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Completed Study MYK-461-004. Prior participation in a non-interventional observational study is allowed. Body weight > 45 kg at Screening Has safety laboratory parameters (chemistry and hematology) within normal limits Key Exclusion Criteria: Has QTcF > > 500 ms or any other ECG abnormality considered by the investigator to pose a risk to subject safety (eg, second degree atrioventricular block type II) Since enrollment into Study MYK-461-004, has developed obstructive coronary artery disease (> 70% stenosis in one or more arteries) or known moderate or severe aortic valve stenosis Since enrollment into Study MYK-461-004, has developed any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the investigator or medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion Since enrollment into Study MYK-461-004 has developed clinically significant malignant 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mavacamten (MYK-461)<br> | Drug: mavacamten<br>* mavacamten capsules<br>* Other names: MYK-461;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of adverse events and serious adverse events. |  | Up to 260 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptomatic, Obstructive, Left ventricular outflow tract gradient
Effect of Low-calorie Diet on Serum Lipids, Adipokines, Insulin Resistance and Also Body Composition in Women With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a hypocaloric diet on biomarkers associated with insulin resistance, metabolic profile and body composition in women with Metabolic Syndrome.

Official Title
-----------------
Effect of Hypocaloric Diet on Biomarkers of Metabolic Profile, Insulin Resistance and Body Composition in Women With Metabolic Syndrome

Conditions
-----------------
Insulin Resistance, Adipokines, Weight Loss

Intervention / Treatment
-----------------
* Other: Low-calorie diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI of 30-34.9 kg/m2, diagnostic of metabolic syndrome based on National Cholesterol Education Panel ATPIII (2002) Exclusion Criteria: Diabetes mellitus, non-treated thyroid disease, treatment with lipid-lowering drugs and glucocorticoids or weight loss treatment within the previous 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Experimental: Low-calorie diet<br>The subjects were prescribed a daily energy intake 500 kcal lower than the estimated energy requirement. | Other: Low-calorie diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change from baseline weight (Kg) at 3rd month. | Change from baseline at 3rd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance markers | Change from baseline fasting glucose and insulin, homeostasis model assessment-insulin resistance and quantitative insulin sensitivity check index at 3rd month, samples were stored at -20 degrees. | Change from baseline at 3rd month |
Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects

Study Overview
=================
Brief Summary
-----------------
PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.

Official Title
-----------------
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Subcutaneous Doses Of PF-04603629 In Type 2 Diabetic Adult Subjects

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Biological: Placebo
* Biological: PF-04603629


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Hb A1c lower or equal to 11% Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Evidence of diabetic complications with significant end-organ damage

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Subjects will be given either Placebo or PF-04603629.<br>|
| Experimental: PF-04603629<br> | Biological: PF-04603629<br>* Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM. |  | 1 week per dose group | 
| To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM. |  | 1 week per dose group | 
| To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM. |  | 1 week per dose group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcomes listed in the protocol. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GLP-1
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.

Official Title
-----------------
A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibody, BRII-198 Administered Intravenously to Healthy Adult Volunteers

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: BRII-198
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 18 to 49 years of age inclusive; Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2 (inclusive); Male or female; Exclusion Criteria: Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; A history of significant hypersensitivity, intolerance, or allergy to any drug compound; History of alcohol or other substance abuse;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>BRII-198 dose level 1 or placebo | Drug: BRII-198<br>* BRII-198 given intravenously<br>Drug: Placebo<br>* Placebo given intravenously<br>|
| Experimental: Cohort 2<br>BRII-198 dose level 2 or placebo | Drug: BRII-198<br>* BRII-198 given intravenously<br>Drug: Placebo<br>* Placebo given intravenously<br>|
| Experimental: Cohort 3<br>BRII-198 dose level 3 or placebo | Drug: BRII-198<br>* BRII-198 given intravenously<br>Drug: Placebo<br>* Placebo given intravenously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) by CTCAE v5.0 |  | up to 24 weeks | 
| Proportion of subjects with SAEs |  | up to 24 weeks | 
| Proportion of subjects with infusion-related reactions |  | up to 24 weeks | 
| Proportion of subjects with hypersensitivity reactions |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Concentration of BRII-198 |  | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 phase I, monoclonal antibody
Improving Clinical Trial Awareness in NSCLC: Pilot Testing A Novel Healthcare IT Platform for Incorporating Education at the Point of Care

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to 1) evaluate the impact of a novel individualized care planning/ educational technology (the On Q Care Planning System or CPS) on oncology patient and provider knowledge, attitudes and beliefs about Non-Small Cell Lung Carcinoma (NSCLC) clinical trials, as well as 2) to evaluate the impact of the On Q CPS on patient referral to and enrollment in NSCLC clinical trials.

Official Title
-----------------
Improving Clinical Trial Awareness in NSCLC: Pilot Testing A Novel Healthcare IT Platform for Incorporating Education at the Point of Care

Conditions
-----------------
Non-Small Cell Lung Carcinoma (NSCLC)

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants must be 18 years of age or older. Patient participants must have Stage III, IV and/or recurrent NSCLC. Patient participants must be at a point of treatment initiation/change or evaluation for treatment initiation/change Patients must have working email address and internet access Exclusion Criteria: Any participant who cannot understand written or spoken English. Any participant who is not competent to provide informed consent for study participation per the investigator. Any participant who cannot be present for the related study visits and/or complete the post-test assessment

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient who completed surveys |  | 8 months |
Bioactive Milk Peptides and Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of bioactive milk peptides on blood pressure in mildly hypertensive subjects.

Conditions
-----------------
Stage 1 Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Milk peptides and plant sterols
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 30-60 years systolic blood pressure 140-160 mmHg and diastolic blood pressure 90-99 mmHg in office measurement apparently healthy Exclusion Criteria: antihypertensive and lipid-lowering drugs unstable coronary artery disease, diabetes, malignant diseases, secondary hypertension BMI > 32 kg/m2 milk allergy smoking alcohol abuse pregnancy, lactation simultaneous participation in other clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spread with milk peptides and plant sterols<br> | Dietary Supplement: Milk peptides and plant sterols<br> <br> |
| Placebo Comparator: Standard spread<br> | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, blood pressure, milk peptides, bioactive peptides, randomized controlled trial