linjc16/ctgov huggingface dataset:
Evaluating the Relationship Between Fatty Acids and Heart Disease

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. Individuals with low levels of n-3 fatty acids and high levels of trans-fatty acids may have an increased risk of developing CVD. This study will evaluate the link between fatty acids and the presence of CVD in older adults.

Detailed Description
-----------------
CVD includes diseases that affect the heart and blood vessels, including congestive heart failure (CHF), atrial fibrillation (AF), and stroke. CVD may be associated with low levels of n-3 fatty acids and high levels of trans-fatty acids, but more research is needed to determine the role of various fatty acids in the development of CVD. Results from prior studies on this topic have not always been reliable because data from self-reported dietary questionnaires on fatty acid intake have sometimes been inaccurate. A more effective way to measure levels of fatty acids is to analyze blood samples. This study will use blood samples of participants in the Cardiovascular Health Study, a study that examined CVD risk factors in older adults, to determine the link between various fatty acids and the incidence of CHF, AF, and stroke. The results from this study may help researchers identify the dietary factors that influence the development of CVD in older adults. This study will examine previously collected data from participants in the Cardiovascular Health Study. There will be no study visits specifically for this study. Plasma samples obtained from participants will be analyzed for the presence of n-3 fatty acids and trans-fatty acids. The study will also determine the incidence of CHF, AF, and stroke and the way in which fatty acids are related to hemodynamics, heart structure and function, electrophysiology, insulin sensitivity, inflammation, endothelial function, and obesity.

Official Title
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n-3 and Trans Fatty Acids and Major Cardiovascular Outcomes

Conditions
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Cardiovascular Diseases, Heart Failure, Congestive, Atrial Fibrillation, Cerebrovascular Accident

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in the Cardiovascular Health Study

Ages Eligible for Study
-----------------
Minimum Age: 65 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
-----------------
Stroke
Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to collect heart rate, respiration data and motion data of patients admitted to sleep lab and to determine the current accuracy level of the EarlySense system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep lab in monitoring heart rate and respiration rates monitors (ECG, respiratory belts, oximeter) that are currently used in the sleep lab among different population (Obese, patients with or without apnea, patients with or without arrhythmia). It is emphasized that no interpretations or clinical decisions will be made based on data received from the ES study device.

Detailed Description
-----------------
The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Official Title
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Official Title Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined

Conditions
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Over Weight, Sleep Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age 18 years or more 2. Is willing to sign the consent form. Exclusion Criteria: Age < 18 years Is not willing to sign the consent form.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the detection rate and the accuracy of the EarlySense system in measuring HR and RR and motion as well as capability of system to detect patient turns, bed-exit and entries | Determine the detection rate and the accuracy of the EarlySense system in measuring HR and RR and motion as well as capability of system to detect patient turns, bed-exit and entries | one year |
A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.

Official Title
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A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
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* Drug: Placebo
* Drug: RO4998452


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18-75 years of age Type 2 diabetes mellitus, diagnosed for at least 3 months at screening Treatment with diet and exercise BMI between 27 and 40 kg/m2 Exclusion Criteria: Type 1 diabetes History of ketoacidosis, hyperosmolar coma, or lactic acidosis Renal disease or renal dysfunction Evidence of significant diabetic complication Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation) History of anti-diabetic triple therapy

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: RO4998452<br>* single oral doses<br>|
| Experimental: B<br> | Drug: RO4998452<br>* single oral doses<br>|
| Placebo Comparator: C<br> | Drug: Placebo<br>* single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on postprandial plasma glucose concentration |  | Following meal 13 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean postprandial daily plasma glucose concentration (3 consecutive meals) |  | 25 hours | 
| Mean daily blood glucose concentration, pre-meal plasma glucose concentration, plasma insulin concentration |  | Assessments up to 25 hours after dosing | 
| Urinary glucose excretion |  | Assessments up to 25 hours after dosing | 
| Safety and tolerability: AEs, laboratory parameters |  | AEs throughout study, laboratory assessments on 3 treatment days and on follow-up |
Biomarker-based Prognostic Assessment

Study Overview
=================
Brief Summary
-----------------
Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. However, there is no available biomarker-based prediction rule for risk assessment of adverse events in patients with stable angina and acute coronary disease. Therefore, we aim to develop and validate a new biomarker-based risk model to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.

Detailed Description
-----------------
Patients enrolled in Qilu Hospital of Shandong University (Jinan, China), Chinese PLA General Hospital Hospital (Beijing, China) and Peking University First Hospital (Beijing, China) are designed as the development cohort to derive the risk prediction models of ischemic and bleeding events. Patients enrolled in Peking University Third Hospital ( Beijing, China) Zibo Central hospital (Zibo, China) are designed as the independent validation cohort.

Official Title
-----------------
BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)

Conditions
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Acute Coronary Syndrome, Stable Angina

Intervention / Treatment
-----------------
* Biological: Plasma biomarker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with the diagnosis of any type of coronary artery disease (stable angina, unstable angina, non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction) Age ≥18 years of age and <85 years of age Patient or guardian provided informed written consent Exclusion Criteria: Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al) Patient with non-cardiac co-morbidities with life expectancy less than 12 months Patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Plasma biomarker|New emerging plasma biomarkers carrying prognositic information|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | a composite of cardiac death, myocardial infarction or stroke | 12 months | 
| Major bleeding | BARC 3 or more bleeding | 12 months |
Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin

Study Overview
=================
Brief Summary
-----------------
Healthy volunteers (n = 28) were recruited from the workplace (14 male, 14 female; age range 20-50 years). Ethical approval, which included informed consent, was from Cardiff University, Schools of Medicine and Dentistry Research Ethics Committee (SMREC16/02). Following a 2-week period free from non-steroidal anti-inflammatory drugs (NSAIDs), peripheral blood was obtained and platelets isolated. Participants were commenced on aspirin 75 mg once daily for seven days and then provided a repeat blood sample. Following a 2-month period, participants were invited to repeat samples pre- and post-aspirin, and again a third time 2 months later.

Official Title
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Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin

Conditions
-----------------
Platelet Dysfunction Due to Aspirin

Intervention / Treatment
-----------------
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: two-week washout period from any non-steroidal anti-inflammatory drugs (NSAIDs) use. Ability to take aspirin 75 mg once daily for seven days and sampled thereafter, before stopping the aspirin. Willingness to repeat this process after two months and four months of the initial sampling date. Exclusion Criteria: * Recent NSAID use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin supplemented<br> | Drug: Aspirin<br>* 1 week of aspirin supplementation prior to sampling<br>|
| No Intervention: Off aspirin<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet EoxPL differences in amounts (ng) as measured by liquid chromatography with tandem mass spectrometry | Samples on and off aspirin will be quantified for the 47 most common eoxPL species (as described by Slatter et al, Cell Metabolism 23, 930-944, May 10, 2016) using established liquid chromatography with tandem mass spectrometry (LC-MS/MS). Differences in amounts on and off aspirin will be quantified and tested for statistical significance. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelets, phospholipids, aspirin
Clearblue Home Pregnancy Test Consumer Study

Study Overview
=================
Brief Summary
-----------------
Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to the UK trial centre. Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void. Trained technicians will conduct a second test from the urine sample.

Detailed Description
-----------------
Approximately 120 female volunteers attending the study site requesting a pregnancy test will be recruited locally to the UK trial centre. Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void. Trained technicians will conduct a second test from the urine sample to evaluate performance between consumer and technician testing.

Official Title
-----------------
Clearblue Home Pregnancy Test Consumer Study

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 year old Female Requesting a pregnancy test Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Consumer Agreement | The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample. | During testing approximately 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy,
Effect of Pulse Fractions on Indices on Cardiovascular Disease and Diabetes Risk Factors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if whole and fractionated yellow pea flour, administered at USDA recommended dosages (50 g/day), improve risk factors associated with cardiovascular disease and diabetes.

Official Title
-----------------
Effect of Pulse Fractions on Indices of Lipid, Carbohydrate and Energy Metabolism as Well as Oxidative Status in Overweight, Hyperlipidemic Individuals

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: Whole yellow pea flour
* Other: Fractionated pea flour
* Other: White wheat flour


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25 and 40 kg/m2 Hypercholesterolemic Exclusion Criteria: Smoking Use of prescription and natural lipid lowering therapies Myocardial infarction Coronary artery bypass Angina Congestive heart failure, Inflammatory bowel disease Pancreatitis Renal disease Diabetes Chronic alcohol usage (> 2 drinks/day). Cancer Eating disorders Expending > 4000 kcal/week through exercise

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Whole yellow pea flour | Other: Whole yellow pea flour<br>* Whole pea flour was administered at 50 g/day.<br>|
| Experimental: 2<br>Fractionated yellow pea flour | Other: Fractionated pea flour<br>* Fractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day<br>|
| Experimental: 3<br>White wheat flour | Other: White wheat flour<br>* White wheat flour will be administered at 50 g/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid levels |  | Day 1 & 2 and Day 28 & 29 of each treatment phase | 
| Postprandial glucose response |  | During week 1 and week 4 of each treatment phase | 
| Fasting Insulin |  | Day 1 & 2 and Day 28 & 29 of each treatment phase | 
| Insulin homeostasis modeling assessment |  | Day 1 & 2 and Day 28 & 29 of each treatment phase | 
| Energy expenditure |  | During week 1 and week 4 of each treatment phase | 
| body composition |  | Day 1 and Day 29 of each treatment phase | 
| Antioxidant status |  | Day 1 & 2 and Day 28 & 29 of each treatment phase | 
| Postprandial substrate utilization |  |  | 
| Postprandial dietary fatty acid oxidation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peas, Cardiovascular, Diabetes, Insulin, Insulin resistance, Abdominal fat
Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.

Study Overview
=================
Brief Summary
-----------------
A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.

Official Title
-----------------
Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.

Conditions
-----------------
Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18years of age suspected of Interstitial lung Disease cryobiopsies performed. Exclusion Criteria: FVC below 50% of predicted DLCO below 35% Body Mass Index (BMI) above 35 pulmonary hypertension with a tricuspidal gradient above 40 mmHg other cardiac or other comorbidities that would increase the risk of complications

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Pneumothorax | Pneumothorax, hemorrhage, acute exacerbation and death | 2 weeks | 
| Hemorrhage | Hemorrhage during the procedure | 3 days | 
| Acute exacerbation | Acute exacerbation after the procedure | 100 days | 
| Mortality | Mortality after the procedure | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Diagnostic yield is discussed at multidisciplinary team meetings i.e, adequate biopsies (>50% alveolated biopsies), histologic pattern, kontribution to the diagnosis. | 1 month | 

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