linjc16/ctgov huggingface dataset:
Arrhythmic Effects of Hight Dose Caffeine

Study Overview
=================
Brief Summary
-----------------
Heart failure patients represent a group of individuals at higher risk for cardiac arrhythmias. There is a perception that caffeine consumption may represent an increase in this risk. Although the medical staff and health professionals suggest a reduction in the intake of this substance to patients considered at risk, there is no scientific proof for this recommendation. Some animal studies suggest a possible association between arrhythmias and caffeine use with higher doses, but this finding did not appear in human studies. In particular, little is known about the association between caffeine consumption and arrhythmias in patients with heart failure, especially at higher doses of consumption. More specific and safe guidelines on caffeine consumption are needed.

Official Title
-----------------
Effect of High-dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure - a Randomized Clinical Trial

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Dietary Supplement: caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure in NYHA functional class I-III LV Ejection fraction <45% Age > 18 y.o. Cardio-defibrillator implanted with normal functioning with at least 30 days. Exclusion Criteria: Impossibility of take caffeine Inability to perform an exercise test Initial use of amiodarone in the last 2 months Unstable ventricular arrhythmias, shock or ATP in the last 60 days Hospitalization in the last two months due to decompensated heart failure

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caffeine<br>Caffeine 500mg | Dietary Supplement: caffeine<br>* Five doses of 100mg of caffeine diluted in 100 ml of decaffeinated coffee. One dose every hour for five hours<br>|
| Placebo Comparator: Placebo<br>Lactose 500mg | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmias |  | 6 hours |
PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV. This study secondary is to enhance NotalVision normative database.

Detailed Description
-----------------
The study is prospective, multi-center, comparative study. A clinical trail with FDA approval device (510K).

Official Title
-----------------
PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD Age >50 for AMD subjects Age >18 for Myopic subjects VA 20/160 or better in the study eye Mental and physical ability to performed a PHP test Exclusion Criteria: Evidence of macular disease other than AMD or high myopia in the study eye. Previous surgical or laser treatment within the macular erea. Concurrent intraocular drug therapy (within 30 days). Present of any significant media opacity that preclude a clear veiw of the macula. Any non macular related ocular surgery performed within 3 months prior to the study. CNV subjects inability to tolerate intravenous fluorscien angiography.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>Intermediate AMD | |
| 2<br>Newly diagnosed CNV | |

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
-----------------
AMD
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

Official Title
-----------------
A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

Conditions
-----------------
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy

Intervention / Treatment
-----------------
* Drug: SBR759
* Drug: Sevelamer HCl
* Drug: SBR759
* Drug: Sevelamer HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Men or women of at least 18 years old. Stable maintenance of renal replacement therapy 3 times per week. Controlled Serum phosphate if under phosphate-binder therapy. Serum phosphate level ≥ 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation. Exclusion criteria Peritoneal dialysis. Parathyroidectomy or transplant scheduled during the study. Uncontrolled hyperparathyroidism History of hemochromatosis or ferritin > 1000 µg/L. Clinically significant GI disorder Unstable medical condition other than Chronic Kidney Disease. Treated with oral iron. Other protocol-defined inclusion/exclusion criteria may apply.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1g tid | Drug: SBR759<br>* Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.<br>|
| Active Comparator: 2<br>Sevelamer HCl | Drug: Sevelamer HCl<br>* 0.8 g tid<br>|
| Experimental: 3<br>SBR759 1.5 g tid | Drug: SBR759<br>* 1.5 g tid<br>|
| Active Comparator: 4<br>Sevelamer HCl | Drug: Sevelamer HCl<br>* 1.6 g tid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks |  | Time Frame: 12 weeks + 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months |  | Time Frame: 12 weeks / 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, hemodialysis, hyperphosphatemia, hemodiafiltration
Surgical Outcomes of Vaginal Prolapse Repair With Elevate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .

Detailed Description
-----------------
The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.

Official Title
-----------------
Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit

Conditions
-----------------
Vaginal Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who have had a vaginal repair with Elevate prolapse repair kit Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Comparison of Outcomes | To evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Profift. | 3 Months |
Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System

Study Overview
=================
Brief Summary
-----------------
Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.

Official Title
-----------------
A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System

Conditions
-----------------
Aortic Aneurysm, Aortic Aneurysm, Thoracic, Aortic Diseases, Aortic Arch Aneurysm, Stroke

Intervention / Treatment
-----------------
* Procedure: Increased saline flush volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal Exclusion Criteria: concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1xIFU<br>Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device. | |
| Experimental: 4xIFU<br>Subjects in this arm are randomized to have a saline flush volume of 4x of what is stated in the IFU of the used device. | Procedure: Increased saline flush volume<br>* Additional flushing of the stentgraft delivery system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air volume | Total volume of air inside the aneurysm sac on discharge CT imaging. | within 7 days after index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endovascular, evar, tevar, stentgraft, de-airing
Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure

Official Title
-----------------
Effects of 12-weeks Endurance Training in Patients With Chronic Heart Failure Due to Dilated Cardiomyopathy

Conditions
-----------------
Dilated Cardiomyopathy, Chronic Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Endurance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic heart failure NYHA stage 2 and 3 Exclusion Criteria: Valvular disease recent decompensation Other complaints that might interfere with ergometer exercise

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>12 weeks of endurance training on the cycle ergometer under supervision on a physician | Behavioral: Endurance training<br>* 45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks<br>|
| No Intervention: Control<br>Control condition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical capacity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular function |  |  | 
| occurence of complications |  | within study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, heart failure, dilated cardiomyopathy, Endurance training
Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

Study Overview
=================
Brief Summary
-----------------
A pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the surface of the cornea. Frequently, these pterygia will recur even after surgical resection. Bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. The use of bevacizumab is poorly understood in inhibiting pterygium growth. The objective of this study is to compare the effects of wound healing and recurrence rates in postoperative bevacizumab versus pterygium excision alone.

Detailed Description
-----------------
This is a prospective trial. Thirty-one patients with a primary pterygium of at least 2 mm in size and without any previous ocular surgery will be included. Outcome measures will include best corrected visual acuity, intraocular pressure, recurrence, and any sight threatening complications at two weeks, two months, and six months postoperatively.

Official Title
-----------------
Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient 18 years of age or older with a primary pterygium that extends at least 2 mm past the limbus Exclusion Criteria: history of glaucoma previous ocular surgery steroid-response glaucoma previous myocardial infarct bleeding disorder pregnancy lack of patient cooperation

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Pterygium Excision Alone<br> | |
| Experimental: Pterygium Excision with Bevacizumab Injection<br> | Drug: Bevacizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of recurrent pterygia with postoperative bevacizumab | The number of recurrent pterygia with patients who received bevacizumab after pterygium excision was compared to the number of recurrences in those patients who only had pterygium excision. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, pterygium, recurrence of pterygium
Heredity of Retinal Vessel Tortuosity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged 20-46 years. We expect to find a high heredity for the variation in tortuosity. This knowledge can contribute to the elucidation of the pathology in retinal diseases.

Detailed Description
-----------------
All persons underwent an ophthalmic examination including refraction, slit lamp biomicroscopy and digital fundus photography. Two independent graders (both with an MD degree) made a visual grading of the severity of tortuosity of the retinal arterioles in the fundus images.

Official Title
-----------------
Heredity of Retinal Vessel Tortuosity - A Twin Study

Conditions
-----------------
Retinopathy of Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samesex twin pairs of self-assessed good health Exclusion Criteria: Diabetes mellitus Hypertension Thyroid disease Cataract or other opacities of the refractive media Missing fundus photographs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 46 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
-----------------
retinal vessels, tortuosity
Virtual Acoustic Localization Experiment

Study Overview
=================
Brief Summary
-----------------
The present study has the evaluation of a test to measure the localization performance goal . It is about the perception of danger audio signals in everyday listening environments nearby which are reproduced in controlled laboratory conditions. In addition, a dereverberation algorithm regarding speech intelligibility and localization ability is evaluated . The research hypothesis is that the dereverberation of the audio signals can improve speech intelligibility for both normal hearing and hearing-impaired persons. In addition, the binaural dereverberation algorithm should not affect the localization ability in everyday situations.

Official Title
-----------------
Virtual Acoustic Localization Experiment for the Evaluation of a Dereverberation Algorithm in Terms of Speech Intelligibility & Localization Performance of Normal Hearing & Hearing Impaired Subjects

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Other: Oldenburger sentence test, localization test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults , in general healthy (no diagnosis of dementia and/or stroke known), mother tongue: (swiss) german, normal hearing or with hearing aid wearers both sides or with CI support on both sides, symmetrical hearing loss Exclusion Criteria: deviation of inclusion criteria, known fluctuating, rapidly progressive hearing loss, test person is not able to come one time a week to the University Hospital of Zurich or to handle 1-2 hours appointments or is not able to use touchscreen

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dereverberation condition<br>Oldenburger Sentence test, localization test | Other: Oldenburger sentence test, localization test<br> <br> |
| Experimental: reverberation condition<br>Oldenburger Sentence test, localization test | Other: Oldenburger sentence test, localization test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oldenburger sentence test and localization test with 30 subjects | The impact of a dereverberation algorithm for hearing aids and / or cochlear implants will be checked | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in localization ability | By VALE (localization test) can differences in the localization ability between normal hearing and hearing-impaired people be measured | 1 day |
Transfer From a Point-of-care Ultrasound Course

Study Overview
=================
Brief Summary
-----------------
This study explores the effect of a four-hour ultrasound course on physicians' point-of-care ultrasound performance on patients representing acute abdominal surgical conditions.

Detailed Description
-----------------
A randomized controlled trial with physicians was conducted. The intervention group participated in a four-hour abdominal POC US course before performing ultrasound on four patients with different abdominal surgical conditions. The control group did not participate in a course before performing ultrasound on the patients.

Official Title
-----------------
Transfer From a Point-of-care Ultrasound Course to Diagnostic Performance on Patients - a Randomized Controlled Trial

Conditions
-----------------
Ultrasonography

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical Doctor Signed up for a courses in abdominal point-of-care ultrasound Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>participating in a four-hour course in abdominal POC US | Other: Education<br> <br> |
| Placebo Comparator: Control<br>no training | Other: Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound performance | An Objective Structured Assessment of Ultrasound Skills (OSAUS) scoring form was used to assess ultrasound performance | 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances | 
| Diagnostic accuracy | The ultrasound diagnoses were evaluated as correct, inconclusive, or false, and the diagnostic accuracy was calculated by sensitivity and specificity | 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances |