linjc16/ctgov huggingface dataset:
Effects of Playing Video Games on Energy Balance

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effects of playing video games on various components of energy balance and substrate metabolism as well as on glucose homeostasis and relevant hormonal systems that might be involved in the underlying mechanisms.

Official Title
-----------------
Effects of Playing Video Games on Energy Balance: a Randomized, 2-condition, Crossover Study in Adolescents

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: 1-hour video game play


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male adolescents between 15 and 19 years of age Normal weight (5th percentile to less than the 85th percentile) Exclusion Criteria: Smoking Unstable body weight (±4 kg) during the 6 months preceding testing Regular physical exercise (>3 hours/week) Excessive intake of alcohol (>7 drinks/week) Substance abuse Metabolic disease (e.g. thyroid disease, heart disease, diabetes, etc.) Medication that could interfere with the outcome variables Eating disorder High restraint eating behavior (score ≥8 for cognitive dietary restraint in the Three-Factor Eating Questionnaire) Irregular eating schedule (e.g. skipping breakfast) Unfamiliar with the use of video games Unable to comply with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video game play<br> | Other: 1-hour video game play<br>* FIFA 2009, a football video game played on Xbox 360<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake and energy expenditure |  | 1 time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Video games, Energy balance, Metabolism, Appetite control
The Effects of Self-Moxibustion Therapy on Subjective Physical Symptoms and Health-related Quality of Life of the Elderly. The Effects of Self-Moxibustion Therapy

Study Overview
=================
Brief Summary
-----------------
There will be significant differences between control and experimental group after the moxibustion intervention as to, subjective physical symptoms and quality of life.

Official Title
-----------------
The Effects of Self-Moxibustion Therapy on Subjective Physical Symptoms and Health-related Quality of Life of the Elderly.

Conditions
-----------------
Health Improvement of the Elderly

Intervention / Treatment
-----------------
* Other: moxibustion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female older adults age between 65-85 Agree to participate and sign for the trail after understanding of study purpose, and method. Able to answer for questions by verbally or literally Able to participate in 2weeks after follow-up Exclusion Criteria: Having physical disorder such as thyroids, severe heart disease, dietetic mellitus, severe liver disease, allergy Subjects who can not attend more than 3 times of intervention session Subjects who are eligible by the decision of investigator

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moxa<br>moxibustion treatment 3 times a week for 3 weeks | Other: moxibustion<br>* modernly developed moxibustion treatment device with safe cover on top of it.<br>* Other names: company: bosungsa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective physiological symptoms |  | 2 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 2 weeks after the intervention |
Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the response to cardiac resynchronization therapy when the interventricular pacing interval was optimized by Tissue Doppler Imaging (TDI) to response when it was optimized following QRS width criteria.

Conditions
-----------------
Heart Failure, Cardiac Resynchronization Therapy

Intervention / Treatment
-----------------
* Device: Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves
* Device: Electrocardiographic optimization of the interventricular pacing delay according to QRS width


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients submitted to de novo implant due to conventional cardiac resynchronization therapy indications. Exclusion Criteria: -
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tissue Doppler Imaging (TDI) optimization<br>Interventricular pacing delay optimized according to Tissue-Doppler echocardiography | Device: Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves<br> <br> |
| Active Comparator: Electrocardiographic optimization<br>Interventricular pacing delay optimized according to QRS width observation in the 12-lead surface electrocardiogram | Device: Electrocardiographic optimization of the interventricular pacing delay according to QRS width<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month echocardiographic response | Reduction of the end-systolic volume (measured in mililiters according to transthoracic echocardiography) of >10% as compared to the baseline value. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month clinical response | Combined end-point consisting in no death due to cardiovascular reasons, no heart transplantation and distance increase of >10% (measured in meters) in the 6-minute walking test. |  |
Impact of Culture Conditions on the Embryo Quality

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare different culture conditions. The effect of the type of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5% versus 20%) will be evaluated on the embryo quality

Conditions
-----------------
Embryo Development

Intervention / Treatment
-----------------
* Procedure: Standard incubator
* Procedure: Mini incubator
* Procedure: 5% oxygen
* Procedure: 20% oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: embryos of patients younger than 36 years old Exclusion Criteria: embryos of patients older than 36 years old

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Type of incubator<br>Embryos are cultured in a standard incubator or a mini-incubator | Procedure: Standard incubator<br> <br> Procedure: Mini incubator<br> <br> |
| Other: Oxygen concentration<br>Embryos are cultured in an incubator with a gas mixture with 20% oxygen or with 5% oxygen | Procedure: 5% oxygen<br> <br> Procedure: 20% oxygen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryo quality |  | day 1- day 3 |
Bevacizumab Against Recurrent Retinal Detachment

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.

Official Title
-----------------
Bevacizumab Against Recurrent Retinal Detachment

Conditions
-----------------
Retinal Detachment, Proliferative Vitreoretinopathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Eyes with rhegmatogenous retinal detachment Exclusion Criteria: Presence of PVR Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy. Recent intravitreal injection of an anti-VEGF agent less than 3 months prior Secondary retinal detachment repair Use of silicone oil as tamponade agent Patients less than 18 years of age Pregnancy Known allergy or contraindication to intravitreal bevacizumab

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br>Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner. | Drug: Bevacizumab<br> <br> * Other names: Avastin;|
| No Intervention: Chart review<br>Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery | Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal detachment, Proliferative vitreoretinopathy
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Study Overview
=================
Brief Summary
-----------------
Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.

Official Title
-----------------
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam (Keppra)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: partial onset seizures with or without secondary generalisation with epilepsy. Exclusion Criteria: hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam (Keppra)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and the tolerability of Keppra in a broad population of patients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain further information about optimal daily dose. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, Keppra
Ultra Low-Resolution Pressure Reactivity Index in Moderate or Severe Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The pressure reactivity index (PRx) has emerged as a surrogate method for the continuous bedside estimation of global cerebral autoregulation and a significant predictor of unfavorable outcome. However, calculations require continuous, high-resolution monitoring and are currently limited to specialized ICU with dedicated software. To overcome this problem, new indices calculated using one-minute average data, instead of 10 seconds average data as performed by the PRx, has been proposed. The study aims to test some indexes appropriately modified to adapt to the scarcity of output data generated by standard hospital systems by analyzing the effectiveness of the Ultra Low-frequency Pressure Reactivity index (UL-PRx sampled at  0.0033 Hz, about 5 minutes period) to evaluate association with outcome. The results indicate that sampling at ultra-low frequency might be of enough resolution to derive information about the state of cerebrovascular autoregulation and outcome of TBI patients. Indexes significantly associated with outcome, as UL-PRx, open new research fields between static and dynamic autoregulation, expanding the possibilities of investigation in TBI.

Detailed Description
-----------------
Participants will be grouped into 2 cohorts by age: child cohort (0 - 17 years old), adult cohort (≥18 years old).

Official Title
-----------------
Evaluation and Application of Ultra Low-Resolution Pressure Reactivity Index in Moderate or Severe Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of TBI The availability of continuous intensive care monitoring of physiological data (ICP, MAP, and CPP). Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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 |
| --- | --- | --- |
| mortality | The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months | 12-months | 
| Glasgow Outcome Scale - Extended (GOSE) | The global functional outcome at 12 months assessed by Glasgow Outcome Scale-Extended (GOS-E), dichotomized into favorable (a score of 5-6 defines a score of 5 to 8, Moderate Disability) and unfavorable (a score of 1 to 4, Dead is characterized by a score of 1). | 12-months |
Role of REM Sleep Alterations in Post Operative Delirium After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Acute confusional states known as delirium frequently occur in Intensive Care Units (ICU), mostly after cardiac surgery, leading to serious consequences. Sleep deprivation has been described in ICU patients and is considered as a risk factor for delirium but its role is still unknown. It is therefore essential to identify whether sleep deprivation and more specifically REM sleep alterations could facilitate occurence of delirium in ICU.

Conditions
-----------------
Delirium Symptoms

Intervention / Treatment
-----------------
* Procedure: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had a cardiac surgery with extracorporeal circulation. Patients who were extubated at Day 0. Patients without any operation or anesthetic complication. Patients who speak French. Patients without TNC at Day 1. Patients who had completed the questionnaires before operation. Exclusion Criteria: Age < 18 years old. Delirium at Day 1. Central nervous system pathology or psychiatric pathology known and treated. Concomitant use of neuropsychiatric treatment before surgery that interferes with sleep. Clinical condition alteration before polysomnography exam. Continue sedation required before Day 3 polysomnography exam. Agitation or clinical alteration that did not allow Day 3 polysomnography exam.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Polysomnography<br> | Procedure: Polysomnography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant difference of REM sleep quantity in polysomnography at day 3 |  | Day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient
AZD0837 Extended Release (ER) Japan Study

Study Overview
=================
Brief Summary
-----------------
This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.

Official Title
-----------------
A Single-blind, Randomised, Placebo-controlled, Parallel-group, Single Centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended-release Tablets AZD0837 After Single and Repeated Oral Administration to Young Healthy Male Japanese Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD0837
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Japanese subject aged between 20 to 45 years inclusive Exclusion Criteria: Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2 Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2 Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low dose | Drug: AZD0837<br>* tablet, oral, once daily, 1+5 days<br>|
| Experimental: 2<br>Middle dose | Drug: AZD0837<br>* tablet, oral, once daily, 1+5 days<br>|
| Experimental: 3<br>High dose | Drug: AZD0837<br>* tablet, oral, once daily, 1+5 days<br>|
| Placebo Comparator: 4<br>placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects. |  | All assessments are made at each visit, at least daily, during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects. |  | Blood samples will be taken before and after study drug administration. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Healthy volunteers