linjc16/ctgov huggingface dataset:
Incidence of Paroxysmal Atrial Fibrillation (AF) in Patients With Acute Ischemic Stroke or Transient Ischemic Attacks (TIAs) by 48 Hours Holter Monitoring

Study Overview
=================
Brief Summary
-----------------
200 patients presenting with symptoms of acute ischemic stroke or transient ischemic attack were included. All patients free of AF on presentation underwent 48 hours Holter monitoring within one week.

Official Title
-----------------
Incidence of Paroxysmal Atrial Fibrillation (AF) in Patients With Acute Ischemic Stroke or Transient Ischemic Attacks (TIAs) by 48 Hours Holter Monitoring

Conditions
-----------------
Transient Ischemic Attack

Intervention / Treatment
-----------------
* Diagnostic Test: Holter ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with acute ischemic stroke or TIAs (within one week of onset) Exclusion Criteria: history of persistent AF initial ECG is AF primary hemorrhagic stroke acute large vessel dissection inability or refusal of consent

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| paroxysmal Af<br> | Diagnostic Test: Holter ECG<br>* all patients will be monitored for paroxysmal Af by holder ECG<br>|
| no paroxysmal Af<br> | Diagnostic Test: Holter ECG<br>* all patients will be monitored for paroxysmal Af by holder ECG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of paroxysmal Af | incidence of paroxysmal Af after TIA | March 2019 -November 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, transient ischemic attack
MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)

Study Overview
=================
Brief Summary
-----------------
This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus (Amphotericin B) Liposome for Injection as Empirical Therapy in Pediatric Patients With Persistent Fever and Neutropenia

Conditions
-----------------
Fever, Neutropenia

Intervention / Treatment
-----------------
* Drug: caspofungin acetate
* Drug: Comparator: AmBisome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 2 through 17 years of age Absolute Neutrophil Count (ANC) is below 500/microliter Have persistent fever (at least 4 days) despite antibiotic therapy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: caspofungin acetate|Duration of Treatment: 28-90 days|
|Drug: Comparator: AmBisome|Duration of Treatment: 28-90 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a favorable overall response |  |  |
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers

Study Overview
=================
Brief Summary
-----------------
About 32 healthy subjects are subjected to 4 weeks of exercise, 4 weeks of washout and 4 weeks of sedentary life style, randomization decides whether they start with exercise or with being couch potatoes. All participants are also randomized to also consume 150 g of blueberries on exercise days or not. The exercise is constituted of 5 km running 5 days a week during the 4 week period. The exercise period and the couch period are started and ended with a 5 km run at maximal speed and the fasting blood samples for cardiovascular risk factors are measured before and after this run, ie 8 times in total.

Official Title
-----------------
Effects of Exercise With or Without Blueberries on Cardiovascular Risk Markers

Conditions
-----------------
Risk Factors Cardiovascular Disease, Inflammation, Exercise, Sedentary Life

Intervention / Treatment
-----------------
* Biological: Blueberries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: significant disease and disabilities that hinder running

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional food<br>Regular eating habits during exercise period | |
| Active Comparator: Blueberries<br>Intervention: Addition of blueberries (150g/day) to regular food during the exercise period on days with exercise | Biological: Blueberries<br>* 150 grams of frozen blueberries on the same day as exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| markers for cardiovascular disease | Insulin levels, glucose levels, lipids, hs-CRP, troponin T | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammation, lipids, CRP
The Effect of Amiloride and Spironolactone in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone. The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner.

Detailed Description
-----------------
Purpose of the study is to examine the effect of amilorid and spironolacton on Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK), Pulsewavevelocity, augmentation index and centralt bloodpressure, Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and Ambulatory blood pressure

Official Title
-----------------
Effect of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables in Patients With Essential Hypertension in a Doublle-blinded Randomised Placebo-controlled, Cross-over Study.

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

Intervention / Treatment
-----------------
* Drug: Spironolactone
* Drug: Amiloride
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension Age 45-70 BMI: 18,5-30 Exclusion Criteria: Other diseases Drug or alcohol abuse Abnormal findings in the screening procedure

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spironolactone<br>Increases the level of potassium | Drug: Spironolactone<br>* 25 mg twice a day<br>|
| Active Comparator: Amiloride<br>Increases the level of potassium | Drug: Amiloride<br>* 5 mg twice a day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | 24 hours blood pressure measurements | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity | We will investigate the changes in cardiovascular variables using a Sphygmocor scanner. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Potassium, Blood-pressure
Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. In addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to catheter ablation treatment.

Official Title
-----------------
Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity

Conditions
-----------------
Ventricular Tachycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have non-sustained or sustained VA (VA ≥ 30s or receiving appropriate ICD therapies) are presented to the clinic or admitted to the hospital within 7 days of episodes. The causes of VA are associated with structural heart diseases including ischemic or nonischemic cardiomyopathy (idiopathic cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis or amyloidosis, and arrhythmogentic right ventricular dysplasia). Subjects are 18 years of age and older. Exclusion Criteria: Female patients who is pregnant or of childbearing potential and not on a reliable form of birth control. Allergic to skin patch electrodes. Vulnerable populations (fetuses, neonates, pregnant women, prisoners, institutionalized individuals).

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 |
| --- | --- | --- |
| Change in amplitude of skin sympathetic nerve activity | measured in µV | Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative | 
| Change in LF/HF ratio | low frequency (LF)/high frequency (HF) ratio of the skin sympathetic nerve activity | Baseline, 24 hours post catheter ablation and approximately 3-6 months post-operative |
Dynamic Profiles of Cytokine/Chemokine in Severe Acute Respiratory Syndrome

Study Overview
=================
Brief Summary
-----------------
Severe acute respiratory syndrome (SARS) is an emerging infectious disease caused by a novel coronavirus (SARS-CoV). The major clinical features of SARS include fever, dyspnea, lymphopenia, and a rapid progression of pulmonary infiltrates on chest radiologic images. The SARS-related deaths have resulted mainly from pulmonary complications, including progressive respiratory failure due to alveolar damage and acute respiratory distress syndrome (ARDS). Pathological changes in SARS suggest that SARS sequelae such as infiltration of PMN in lung tissue, multiple organ dysfunction and ARDS have been associated with cytokines and chemokine dysregulation. Some patients still manifested lung injury at a time when the viral load was falling also supports the immune nature of the lung damage. We therefore undertook an analysis of dynamic production of cytokine/chemokines in SARS patients with an initial normal chest radiograph in order to improve understanding of disease pathogenesis and improve patient management.

Conditions
-----------------
SARS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS group: Patients with SARS Exclusion Criteria: Hospital acquired pneumonia

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Aldosterone in Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether spironolactone are effective in the reduction of albuminuria and diastolic disfunction of subjects with diabetic nephropathy.

Official Title
-----------------
Effect of Aldosterone Antagonism in the Reduction of Albuminuria and Diastolic Disfunction of Patients With Diabetic Nephropathy.

Conditions
-----------------
Diabetic Nephropathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic subjects with maximum ten years after diagnostic Diabetic nephropathy with albuminuria Normal renal function Diastolic disfunction Taking a IECA or ARA drug family previously Exclusion Criteria: Diabetics subjects with macroangiopathy Acute coronary syndrome in the three months before Hyperkalemia > 5.5 mEq/L Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Spironolactone<br>* 25 mg per day for 9 months<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo 1 tablet per day for nine months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of albuminuria |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of diastolic disfunction |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aldosterone, albuminuria, diastolic disfunction, hyperkalemia
Comparison of Pulmonary Function and Efficacy of Different Nerve Block Catheters for Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate lung function and pain control of continuous supraclavicular versus suprascapular versus interscalene nerve catheters in subjects undergoing total shoulder replacement. The investigators hypothesize that all three groups would have similar pain control; the supraclavicular and suprascapular groups may have better lung function.

Official Title
-----------------
A Comparative Pulmonary Function Study of Continuous Supraclavicular, Suprascapular, and Interscalene Nerve Catheters After Total Shoulder Arthroplasty

Conditions
-----------------
Post-Operative Pain

Intervention / Treatment
-----------------
* Procedure: Continuous Nerve Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral total shoulder arthroplasty ASA physical status I-III >18 years old Non-pregnant (or lactating) Consent to participate in the study Exclusion Criteria: Refusal to participate < 18 years old Chronic opioid use Localized infection Pregnancy or lactating Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Diaphragmatic dysfunction

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interscalene<br>Continuous Interscalene Nerve Block | Procedure: Continuous Nerve Block<br> <br> |
| Active Comparator: Supraclavicular<br>Continuous Supraclavicular Nerve Block | Procedure: Continuous Nerve Block<br> <br> |
| Active Comparator: Suprascapular<br>Continuous Suprascapular Nerve Block | Procedure: Continuous Nerve Block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function | Vital Capacity, Spirometry | Post-Operative Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | NRS Pain Scale | Post Operative Day 1 | 
| Opioid Consumption | Total opioid consumption x 24 hours | Post Operative Day 1 | 
| Sensory and Motor Function | Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynometer | Post Operative Day 1 |
MultiOrgan Multi-Parametric MRI Study

Study Overview
=================
Brief Summary
-----------------
To determine the reproducibility of a single quantitative multiparametric MRI for the assessment of body composition and multiple organ structures.

Official Title
-----------------
MultiOrgan Multi-Parametric MRI Study

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

Intervention / Treatment
-----------------
* Other: Multiparametric MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any person over 18 years of age. Participant is willing and able to give informed consent for participation in the investigation. EITHER: Participant has Type 2 Diabetes OR: Person is a healthy volunteer Exclusion Criteria: The participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (incl. pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia). Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Multiparametric MRI|A standardised MRI protocol that provides a number of quantitative metrics on liver and other organs relevant to type 2 Diabetes - pancreas, kidneys, spleen, heart, lungs and aorta|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of repeatability (precision under the same conditions in the same subjects: 2 separate MRI acquisitions on the same scanner) of body composition and multiple organ metrics. | To determine the repeatability of multiparametric MRI in the assessment of body composition and multiple organ structures obtained within a single MR scanning session (liver, pancreas, aorta, heart, kidney, lungs and spleen) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the reproducibility (precision under different measurement conditions: same participants scanned on separate MRI scanners at both 1.5T and 3T) of multiparametric MRI for the assessment of body composition and multiple organ metrics. | To determine the reproducibility of multiparametric MRI in the assessment of body composition and multiple organ structures (liver, pancreas, aorta, heart, kidney, lungs and spleen) obtained within separate MR scanning sessions. | 24 months |
Korean Regulatory Post Marketing Surveillance for Somavert

Study Overview
=================
Brief Summary
-----------------
Non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)

Official Title
-----------------
Korean Post-marketing Surveillance for Somavert

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Somavert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible. Exclusion Criteria: Patients who are contraindicated for Somavert

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Participants receiving Somavert<br> | Drug: Somavert<br>* As provided in real world practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experience adverse events |  | Baseline through 28 days after last dose (approximately 52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experience Clinical Improvement as assessed by investigator |  | Baseline through approximately 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acromegaly, Somavert, Post-Marketing Surveillance