linjc16/ctgov huggingface dataset:
Catheter Ablation and Rate Control of Atrial Fibrillation in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.

Detailed Description
-----------------
All patients received either catheter ablation for rhythm control or rate control before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

Official Title
-----------------
Catheter Ablation Versus Rate Control in Patients With Atrial Fibrillation and Heart Failure: A Multicenter Study

Conditions
-----------------
Catheter Ablation, Rate Control, Heart Failure, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years documented atrial fibrillation New York Heart Association Ⅱ-Ⅳ or left ventricular ejection fraction <50% Exclusion Criteria: heart failure that had a suspected reversible cause previous ablation any contraindication to catheter ablation

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 |
| --- | --- |
| catheter ablation group<br>atrial fibrillation patients with heart failure who received catheter ablation for rhythm control | |
| rate control group<br>atrial fibrillation patients with heart failure who received pharmacological approaches for rate control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | composite of all-cause mortality, stroke and unplanned hospitalization due to cardiovascular reasons | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | up to 3 years | 
| stroke | stroke must be certified by CT scan | up to 3 years | 
| unplanned hospitalization due to cardiovascular reasons | Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of heart failure and ventricular arrhythmias | up to 3 years |
Lendormin D® Tablet (Drug Use Result Survey)

Study Overview
=================
Brief Summary
-----------------
Study to investigate the safety and the efficacy in patients with insomnia, receiving Lendormin D tablet under condition of normal clinical practice.

Official Title
-----------------
Lendormin D® Tablet (Drug Use Result Survey)

Conditions
-----------------
Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Drug: Lendormin D tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with insomnia Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lendormin D tablets<br> | Drug: Lendormin D tablets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 2 months | 
| Number of patients with adverse drug reactions |  | up to 2 months | 
| Number of patients with serious adverse events |  | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's overall efficacy assessment on a 3-point scale |  | up to 2 months | 
| Patient's impression questionnaire |  | up to 2 months |
Uremic Toxins of Patients With Acute Kidney Failure

Study Overview
=================
Brief Summary
-----------------
Determination of the concentration of uremic toxins of sepsis patients with or without acute kidney failure compared to the concentrations of uremic toxins of chronically uremic patients

Detailed Description
-----------------
Determination of the concentration of uremic toxins of sepsis patients with or without acute kidney failure compared to the concentrations of uremic toxins of chronically uremic patients

Official Title
-----------------
Uremic Toxins of Patients With Acute Kidney Failure

Conditions
-----------------
Kidney Failure, Acute

Intervention / Treatment
-----------------
* Procedure: Blood sampling for determination of uremic toxins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intensive Care patients with sepsis Patients with acute kidney failure: serum creatinin > 2 mg/dl Chronic haemodialysis patients Exclusion Criteria: < 18 years

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

| Intervention/Treatment |
| --- |
|Procedure: Blood sampling for determination of uremic toxins|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode

Conditions
-----------------
Bipolar Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients Must sign informed consent prior to protocol-related procedures Exclusion Criteria: Women who are pregnant, trying to become pregnant, or nursing Significant risk of committing suicide Any serious unstable medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Aripiprazole<br>* Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.<br>* Other names: Abilify;|
| Placebo Comparator: A2<br> | Drug: Placebo<br>* Tablets, Oral, 0 mg, Once daily, 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I disorder with major depressive episode
The Effect of Television Watching on Liking of Food

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the effect of television viewing on liking of food.

Detailed Description
-----------------
The objective of this investigation is to determine whether participants will have a change of liking of food based on television viewing. The specific aims of the study are: Determine the effect of television on liking of food. Determine the effect of no television on liking of food.

Official Title
-----------------
The Effect of Television Watching on Liking of Food in Normal Weight Adults 18-35

Conditions
-----------------
Hunger

Intervention / Treatment
-----------------
* Other: Television
* Other: No Television


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 35 years Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2 Unrestrained eater (≤ 12 on the Three Factor Eating Questionnaire [TFEQ-R]) Report a favorable preference for foods served in the meal including: macaroni and cheese and salad (dressing will be chosen by the participant via initial phone screen), participants must rate each food item ≥ 3 during phone screen and ≥ 50 on a visual analogue scale (VAS) during the initial screening session Regularly eat a meal before 10:00 am Are able to complete all sessions within eight weeks of the screening session Report being a non-smoker Are not taking medications that affect appetite or food intake Are not pregnant or breastfeeding Are not on a dietary plan or have dietary restrictions that prevent consumption of certain types and/or amounts of food Exclusion Criteria: Binge eating; and/or Athletes in training

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No Television<br>The purpose is to determine whether a change in liking of food will occur with a lack of television. | Other: No Television<br>* The purpose is to determine whether the lack of television impacts liking of food.<br>|
| Experimental: Television<br>The purpose is to determine whether a change in liking of food will occur while watching television. | Other: Television<br>* The purpose is to determine whether television impacts liking of food.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of Television Watching on Liking of Food via Visual Analog Scale |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lunch, Television, Macaroni and Cheese, Salad tossed in dressing
Effect of Domperidone on QT Interval in Premature Infants

Study Overview
=================
Brief Summary
-----------------
30 premature infants treated by domperidone upon decision of the attending neonatologist will have a daily recording of electrocardiogram for the first 7 seven days of treatment, and pharmacokinetics dosages at Day 7. Their ECG will be compared to 30 non treated premature infants, matched for gestational age, postnatal age and sex.

Official Title
-----------------
Effect of Domperidone on QT Interval in Premature Infants

Conditions
-----------------
Prematurity and Feeding Intolerance

Intervention / Treatment
-----------------
* Drug: domperidone Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age less than 36 weeksPostnatal age greater than 10 days Treated / not treated by domperidone (case/control)Signed parental informed consent Exclusion Criteria: Severe cardiac arrhythmia Congenital heart disease (persistent ductus arteriosus excluded)Familial history of congenital long QT syndrome

Ages Eligible for Study
-----------------
Minimum Age: 10 Days

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: domperidone Drug|nan|

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
-----------------
Domperidone, QT, prematurity
Safety and Effect of Oral Doses of 5mg or 10mg of SLx-2101 for 14 Days in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on systolic, diastolic pressures and heart rate in patients with hypertension.

Detailed Description
-----------------
Placebo-corrected supine peripheral systolic, diastolic blood pressures and heart rate 24 hour ambulatory blood pressure and heart rate Safety and tolerability

Official Title
-----------------
A Pilot Phase IIa Randomised, Double-blind, Placebo-controlled, Crossover Study to Examine the Safety, Tolerability and Pharmacodynamic Effects on Blood Pressure of Repeat Oral Doses of SLx-2101 5 mg or 10 mg Once Daily for up to 14 Days in Patients With Hypertension

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

Intervention / Treatment
-----------------
* Drug: SLx-2101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects between 18 and 70 years old, inclusive Moderate to severe hypertension Body weight within a body mass index of 18-32kg/m2 Exclusion Criteria: The subject is receiving more than three antihypertensive agents A history of drug abuse Exposure to a new chemical entity within 3 months prior to the first day of dosing

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SLx-2101 | Drug: SLx-2101<br> <br> |
| Placebo Comparator: 2<br>Comparative Placebo Dose | Drug: SLx-2101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral systolic, diastolic blood pressures and heart rates |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 14 days |
Prevalence of Distal Radial Artery Occlusion in Cardiovascular Catheterization Via Distal Radial Access

Study Overview
=================
Brief Summary
-----------------
Explore the prevalence of distal radial artery occlusion after cardiac catheterization via distal radial artery and the risk factors

Detailed Description
-----------------
Cardiac catheterization via distal radial artery is prevalent worldwide, which can reduce the prevalence of radial artery occlusion. However, the distal radial artery occlusion has not been detected. This study is designed to explore the prevalence of distal radial artery occlusion in patients undergoing cardiac catheterization via distal radial access at 1 day and 3 months after the procedure, which is explored by ultrasound. In addition, the risk factors of distal radial artery occlusion are also analyzed.

Official Title
-----------------
Prevalence of Distal Radial Artery Occlusion (DRAO) in Patients Undergoing Cardiovascular Catheterization Via Distal Radial Access (DRA)

Conditions
-----------------
Catheterization, Complications, Distal Radial Artery

Intervention / Treatment
-----------------
* Procedure: cardiac catheterization via distal radial artery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years; Palpable distal radial artery Exclusion Criteria: Age ≥ 90years; Height≥ 185cm; Cardiogenic shock; Refuse to sign the written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cardiac catheterization via distal radial artery|cardiac catheterization via distal radial artery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of distal radial artery occlusion | Prevalence of the distal radial artery occlusion is detected using ultrasound | 3 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of distal radial artery occlusion | Prevalence of the distal radial artery occlusion is detected using ultrasound | 1 day after procedure | 
| Thickness of distal radial artery | Comparison of the thickness of distal radial artery intima using ultrasound | 3 months after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal radial artery occlusion;cardiac catheterization
Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

Study Overview
=================
Brief Summary
-----------------
Treatment of extensive traumatic acute bone defects or sequela in heel or ankle poses a formidable challenge for the reconstructive surgeon. These defects can be treated with the vascularized iliac crest transfer. The purpose of this study is to assess the reliability and the long-term outcomes of free iliac crest flap transfer for these indications.

Detailed Description
-----------------
Thirteen patients were included in this study. Data was collected retrospectively from the patient records. The study design included three outcome measures to assess the clinical long-term outcomes. These were the Visual Analogue Scale Foot and Ankle (VAS FA), the Oswestry Disability Index (ODI), and the 15-dimensions (15D) health-related quality of life (HRQoL) instrument. The data was collected with postal approach and a written informed consent obtained from the seven participants.

Official Title
-----------------
Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

Conditions
-----------------
Limb Salvage

Intervention / Treatment
-----------------
* Procedure: Reconstructive surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer. Exclusion Criteria: 1) Patients without treatment with the vascularized iliac crest transfer, Exclusion criteria for the cross-sectional assessment: deceased, below-knee amputation, permanent non-union

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Reconstructive surgery|Reconstructive surgery with the free iliac crest flap|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale Heel and Ankle (VAS FA) | Assesses the function of the heel and ankle | 2-26 years | 
| Oswestry Disability Index (ODI) | Assesses the function of the donor site | 2-16 years | 
| The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument | Assesses the HRQoL | 2-26 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Free iliac crest transfer, Bone reconstruction, Ankle reconstruction, Heel reconstruction
A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.

Official Title
-----------------
Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Drug: Copegus (ribavirin)
* Drug: Copegus (ribavirin)
* Drug: peginterferon alfa-2a [Pegasys]
* Drug: peginterferon alfa-2a [Pegasys]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >/= 18 years of age serologic evidence of chronic hepatitis C infection compensated liver disease negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment Exclusion Criteria: history or other evidence of a medical condition associated with chronic liver disease other than HCV hepatitis A, hepatitis B or HIV infection hepatocellular carcinoma severe concomitant disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Copegus (ribavirin)<br>* 800 - 1200 mg po daily for 24 weeks<br>Drug: peginterferon alfa-2a [Pegasys]<br>* 180 mcg sc once weekly for 24 weeks<br>|
| Experimental: B<br> | Drug: Copegus (ribavirin)<br>* 800 - 1200 mg po daily for 48 weeks<br>Drug: peginterferon alfa-2a [Pegasys]<br>* 180 mcg sc once weekly for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability with regard to clinical AEs and laboratory parameters |  | assessed every 2 weeks throughout study and after 8 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety with regard to hematological parameters |  | assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up |