linjc16/ctgov huggingface dataset:
A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

Detailed Description
-----------------
This a prospective, randomized study in primary care practices.

Official Title
-----------------
GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals

Conditions
-----------------
Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
-----------------
* Other: Zio®XT Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women at least 70 years of age who are new or established participants in the primary care practice Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the Center for Medicare & Medicaid Services (CMS) Medicare Claims Database and to access data from health records Health insurance by Medicare Parts A & B (Medicare Fee-for-service) Exclusion Criteria: Oral anticoagulation (OAC) for any indication at the time of enrollment History of Atrial Fibrillation (AF) or Atrial Flutter (AFL) as documented in the participant's current medical problem list Any condition the investigator considers a contraindication to OAC, e.g., bleeding that required medical attention or severe renal impairment Any condition the investigator considers will prevent compliance with study instructions Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders) History of allergy to adhesive Not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver Other protocol-defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Zio®XT Monitor Arm<br> | Other: Zio®XT Monitor<br>* A Zio® XT monitor will be affixed to the participant's chest<br>|
| No Intervention: Usual Care Arm<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all strokes leading to hospitalization |  | From 2.5 years to 5 years after study start | 
| Incidence of bleeding leading to hospitalization |  | From 2.5 years to 5 years after study start |
Newborn Screening for Adrenoleukodystrophy

Study Overview
=================
Brief Summary
-----------------
To test if the routine newborn screening dried blood spots can be used to test if elevation of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy (ALD)

Detailed Description
-----------------
Parents of newborns will be invited to test if their newborns are affected with ALD. The routine newborn screening dried blood spots sample will be used to test the concentration of C26:0-lyso-PC . If positive of a screening test, further confirmation tests including physical examination and other methodology for ALD confirmation will be provided. Genetic counseling and treatment option will be provided, too.

Official Title
-----------------
Newborn Screening for Adrenoleukodystrophy

Conditions
-----------------
Adrenoleukodystrophy

Intervention / Treatment
-----------------
* Procedure: newborns testing for ALD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Babies born in Taiwan receive regular newborn screening suggested by Ministry of Heath and Welfare. Parents or Legal Guardian sign in the informed consent form. Exclusion Criteria: Parents or Legal Guardian do not agree to sign in the informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 3 Months

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 |
| --- | --- |
| newborns testing for ALD<br>newborns testing for ALD | Procedure: newborns testing for ALD<br>* Routine newborn screening dried blood spots sample is used to test if elevation of C26:0-lyso-PC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numbers of newborn with ALD |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adrenoleukodystrophy, C26:0-lyso-PC
Risk Prediction in Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.

Detailed Description
-----------------
Autonomic function will be assessed by presence of severe autonomic failure (defined by combination of abnormal heart rate turbulence and deceleration capacity). Autonomic function will also be assessed by respiration and repolarization abnormalities.

Official Title
-----------------
Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function

Conditions
-----------------
Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmHg Exclusion Criteria: life expectancy <1 year due to non-cardiac causes
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 |
| --- | --- | --- |
| Total mortality |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | 2 years | 
| Combination of cardiovascular mortality and cardiac adverse events |  | 2 years | 
| Correlation of presence of autonomic dysfunction with severity of aortic stenosis | It will be assessed whether patients with cardiac autonomic dysfunction have more severe aortic stenosis. Autonomic dysfunction will assumed to be present when patients suffer from severe autonomic failure (i.e. combination of abnormal Heart Rate Turbulence and Deceleration Capacity). Severity of aortic stenosis will be assessed by clinical (symptoms, NYHA class), hemodynamic (mean aortic gradient, aortic valve area) and biochemical (Nt-BNP, high sensitive troponins) markers. | at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic stenosis, autonomic function
Ultrasound Elasticity Imaging of Venous Thrombi

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the investigators can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Detailed Description
-----------------
Deep vein thrombosis (DVT) is a blood clot and is a common illness that can result in pain and death if not recognized and treated well. Death can occur when the venous clots break off and form pulmonary emboli (PE), which can block the arteries of the lungs. DVT and PE most often complicate the course of sick patients but may also affect healthy persons. DVT can also be a chronic disease. In those instances in which DVT and PE develop, in addition to the death risk, hospitalization is drawn out and healthcare costs are increased. Therefore, the purpose of this study is to see if we can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Official Title
-----------------
Aging Venous Thrombi With Ultrasound Elasticity Imaging

Conditions
-----------------
Thrombosis

Intervention / Treatment
-----------------
* Procedure: Ultrasound
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects who have a diagnosis of chronic DVT that is at least 2 weeks old and are free from an acute DVT on top of your chronic DVT. Male and female patients who have been diagnosed with an acute blood clot by the Diagnostic Vascular Lab and w/symptoms occurring within the previous 2 weeks. Patients under the age of 18 who give assent (permission) and whose parents give consent. Adult patients who give consent. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ultrasound imaging of Acute DVT (deep vein thrombosis) | Procedure: Ultrasound<br>* Ultrasound imaging of Acute DVT<br>|
| Experimental: 2<br>Ultrasound imaging of Chronic DVT (deep vein thrombosis) | Procedure: Ultrasound<br>* Ultrasound imaging of Chronic DVT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots |  | approximately one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up with subjects who have been diagnosed with Acute DVT to see if they develop post-thrombotic syndrome (PTS) |  | first year following diagnosis of acute DVT |
Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

Study Overview
=================
Brief Summary
-----------------
The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2 different antiretroviral therapies for 28 days after accidental exposure to HIV.

Official Title
-----------------
Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Combivir+Kaletra
* Drug: Combivir+Reyataz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 HIV exposure requiring prophylaxis under current guidelines Exclusion Criteria: Pregnancy Suspected drug resistance in source case Contraindications to the study drugs

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Combivir+Kaletra|nan|
|Drug: Combivir+Reyataz|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of patients completing 28-day antiretroviral treatment (ARVT) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HIV-seropositive at 6 months |  |  | 
| Incidence of adverse effects (clinical and laboratory) during ARVT |  |  | 
| Adherence to ARVT, time to adherence loss. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV seronegativity
An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The CONTROL study is an out patient based prospective observational cohort study. The main aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day under real life conditions in usual clinical practice in essential hypertensive patients in the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24 weeks.

Official Title
-----------------
An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice.

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female. Aged 20 to 80 years old. Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic BP > 140 mmHg but < 180 mmHg, and/or diastolic BP > 90 mmHg but < 110 mmHg). Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication. Exclusion Criteria: Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert). Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets. Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications. Patients participating in any other protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion | A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding). | 24 weeks | 
| Change From Baseline in Microalbuminuria at 24 Weeks |  | Baseline and 24 weeks |
Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Neutrophil Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage occurring from post-op cardiac surgery, being critical patients and contrast medium use is already proven. But NGAL's usefulness for renal function after non-cardiac surgery is not proven and especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal disease patients is not proven.Therefore, the investigators will study about renal function decrease after non-cardiac surgery with NGAL and serum creatinine.

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: The level of NGAL after pre op,post op 4hr, post op 12hr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 43 patients who had non-cardiac surgery in Seoul Paik Hospital. Exclusion Criteria: have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase > 2 time of normal level severe lung disease severe heart failure ( Ejection Fraction < 40% ) pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| kidney function normal group<br>kidney function normal group : defined by the normal level of NGAL after post operation 4hrs | Other: The level of NGAL after pre op,post op 4hr, post op 12hr<br> <br> |
| kidney function decreased group<br>kidney function decreased group : defined by the increased level of NGAL after post operation 4hrs | Other: The level of NGAL after pre op,post op 4hr, post op 12hr<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum NGAL level |  | up to post operation 12 hours |
Evaluation of Elastic Properties of Ascending Aorta

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to assess a correlation between local patient specific elastic modulus distribution of the ascending aorta from a biaxial tensile test and MRI measurements of the elastic properties of the aorta. A total of 70 patients referred for ascending aorta (AA) replacement underwent a preoperative cardiac-MRI for the evaluation the elastic properties and ascending aorta tissue was collected for biaxial testing to obtain maximum elastic modulus

Detailed Description
-----------------
Observational and prospective trial on medical data only. The patients are operated of planned aortic aneurysm without additional intervention. The preoperative cardiac MRI are planned in standard of care.

Official Title
-----------------
Elastic Properties of the Ascending Aorta Evaluated by Imaging and Biaxial Testing

Conditions
-----------------
Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic Modulus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient referred for ascending aorta aneurysm requiering replacement elective patient Exclusion Criteria: claustrophobia contraindication to performing cardiac MRI

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 |
| --- | --- | --- |
| aortic compliance of ascending aorta (mm2/mmHg) | aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processsing | preoperative cardiac MRI performing between 1 month and 1 day before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum elastic modulus (MPa) of ascending aorta | maximum elastic modulus is a local measurement of elastic properties which is obtained by biaxial testing | biaxial testing performing between 1 and 6 hours after procedure |
Compression Is Life In Cardiac Arrest - Fatigue Study

Study Overview
=================
Brief Summary
-----------------
Context: Chest compressions represent an important physical effort leading to fatigue and cardiopulmonary resuscitation quality degradation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality during an extended cardiopulmonary resuscitation remains to be assessed. Study design: simulated prospective monocentric randomized crossover trial. Participants and methods: Sixty professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed 10 minutes of continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously). Hypothesis: Feedback device delay fatigue effect arises during cardiopulmonary resuscitation.

Official Title
-----------------
Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality During Extend Cardio-pulmonary Resuscitation. A Manikin Study.

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operational staff of University hospital of Caen pre-hospital unit Exclusion Criteria: medical contraindication refusal

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 |
| --- | --- | --- |
| Correct compression score | Correct compression score is defined by reached target of rate, depth and leaning at the same time | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease time of 30% of correct compression score |  | 24h | 
| chest compression deep |  | 24h | 
| chest compression rate |  | 24h | 
| percentage of chest compression without leaning |  | 24h | 
| percentage of chest compression with correct deep |  | 24h | 
| percentage of correct chest compression rate |  | 24h | 
| participants' fatigue (Borg's scale) |  | 24h |