linjc16/ctgov huggingface dataset:
Virtual Reality Game Playing in Amblyopia Therapy

Study Overview
=================
Brief Summary
-----------------
Background: Amblyopia is a neurodevelopmental disorder in both monocular and binocular functions and it extends even beyond the primary visual integration centers, therefore, amblyopia is not a lazy eye but it is a lazy brain. Purpose: The investigators aimed to compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy on amblyopic children. Methods: This RCT was performed on 50 children with unilateral amblyopia ,4 to 10 years old. They were randomly divided to case and control (each= 25) groups. case group were trained binocularly using the virtual reality games through head set for one hour a day, 5 days in a week for 4 to 6 weeks. Controls occluded their non- amblyopic eyes, 2, 4 and 6 hours for mild (0.2 to 0.3 LogMAR), moderate (0.3 to 0.6 LogMAR) and severe (BCVA < 0.6 LogMAR) amblyopia, respectively.

Official Title
-----------------
Virtual Reality Game Playing in Amblyopia Therapy

Conditions
-----------------
Amblyopia

Intervention / Treatment
-----------------
* Device: Virtual Reality
* Other: Patching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The best corrected visual acuity worse than 0.3 LogMAR Exclusion Criteria: Patients with abnormal fixation Patients with neurological problems Patients with any types of ocular pathologies

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Dichoptic playing games with fine stimulation will present to the amblyopic eye. | Device: Virtual Reality<br>* New treatment for amblyopia therapy using playing games<br>* Other names: No additional intervention;|
| Active Comparator: Patching<br>Non- amblyopic eye will be recommended to patch. | Other: Patching<br>* Patching<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (BCVA) | Change from baseline BCVA at 6 months | baseline and 6 months after training |
Transpulmonary Gradient After Cardiac Surgery Under Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Get a better understanding of the pathophysiological processes of acute respiratory failure following cardiopulmonary bypass to initiate timely therapies targeted on a cell line. Demonstrate that there is a relationship between increased transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery under cardiopulmonary bypass.

Official Title
-----------------
Transpulmonary Gradient of Inflammation Biomarkers and Pulmonary Vascular Resistance in Acute Respiratory Failure After Cardiac Surgery Under Cardiopulmonary Bypass

Conditions
-----------------
Acute Respiratory Distress Syndrome After Cardiac Surgery Under Cardiopulmonary Bypass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient man or woman > 18 y.o. Patient has signed informed consent prior to the study Patient affiliated to a social security administration Patient operated on for cardiac surgery at the University Hospital of Strasbourg. Patient at high risk for postoperative respiratory failure defined by a SLIP score (Kor et al.) ≥ 22 Kor: High-risk cardiac intervention under cardiopulmonary bypass (19 pts) COPD (10 pts) Diabetes (6 pts) gastroesophageal reflux (7 pts) Alcohol abuse (11 pts) Scheduled use of a pulmonary artery catheter and a left atrial catheter Exclusion Criteria: Inability to obtain informed consent from the patient and / or unable to give informed patient information (difficulty understanding ...) Urgent surgery (<24h) Acute heart failure Patient ventilated preoperatively Allergy to Latex Persons deprived of liberty or under judicial protection Patient placed under guardianship Pregnancy Breastfeeding

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 |
| --- | --- | --- |
| transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance | Demonstrate that there is a relationship between increased transpulmonary gradients of inflammation biomarkers (sRAGE, sICAM-1, SPB, PAI-1, ROS) and pulmonary vascular resistance on the one hand and alveolo-capillary gas exchange on the other hand after cardiac surgery under cardiopulmonary bypass. | during the surgery |
Study of Neutrophils and Circulating Platelets in Correlation With the Activity of T Lymphocytes in Patients With NAFLD (Nonalcoholic Fatty Liver Disease)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to define the relationship between neutrophils, platelets and the activity of T lymphocytes in patients with NAFLD (nonalcoholic fatty liver disease). This study may predict, in the course of hepatic steatosis, specific phenotypic patterns expressed by PMNs and circulating platelets to evaluate their role in disease progression.

Official Title
-----------------
Study of Neutrophils and Circulating Platelets in Correlation With the Activity of T Lymphocytes in Patients With NAFLD (Nonalcoholic Fatty Liver Disease)

Conditions
-----------------
NAFLD- Non Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 No alcoholic abuse Hepatic steatosis diagnosticated by abdominal ultrasound Negative hepatitis B and C tests No history of hepatic cirrhosis Exclusion Criteria: Under 18 History of alcoholic abuse Positive serology for hepatitis B or C History of hepatic cirrhosis

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NAFLD cohort<br> | Diagnostic Test: Data collection<br>* Clinical data collection<br>|
| Validation cohort<br> | Diagnostic Test: Data collection<br>* Clinical data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-8(interleukin 8) |  | 12 months | 
| Morphology of Circulating Platelets in healthy donors, NAFL, and NASH patients wondering how they may drive and modulate the activity of T cells in this disease |  | 12 months | 
| Platelets count in healthy donors, NAFL, and NASH patients |  | 12 months | 
| number of Neutrophilis |  | 12 months | 
| Morphology of Neutrophilis |  | 12 months |
Efficacy of an Early Rehabilitation on Decannulation Time of Patients With Severe Acquired Brain Injury

Study Overview
=================
Brief Summary
-----------------
All the patients hospitalized in the neuro-rehabilitation after a severe acquired brain injury carrying a tracheal cannula will be retrospectively analyzed. Patients coming from emergency department started a rehabilitative treatment during their hospitalization in ICU. Patients transferred from an external ICU started the rehabilitation in neurorehabilitation department. Aim of the study is to evaluate if an early rehabilitation, started since the acute stage of the damage, is able to reduce the decannulation time in this group of patients.

Conditions
-----------------
Brain Injury, Tracheostomy, Neurological Rehabilitation

Intervention / Treatment
-----------------
* Other: early neurological rehabilitation
* Other: no-early neurological rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of a tracheostomy at admission in NRehab patient moved from an ICU GCS≤11 at admission in ICU tracheostomy performed for decreased mental status due to the ABI, Exclusion Criteria: tracheostomy performed prior to admission to the ICU need for ventilation support.

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 |
| --- | --- |
| early rehabilitation<br>Patients started rehabilitative treatment during ICU hospitalization | Other: early neurological rehabilitation<br>* start of neurological rehabilitation between 3rd and 15th day after ABI<br>|
| no-early rehabilitation<br>Patients started rehabilitative treatment after admission in Neuro-rehabilitation department | Other: no-early neurological rehabilitation<br>* start of neurological rehabilitation between 20th and 90th day after ABI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decannulation time | number days between tracheostomy positioning and removal | at data collecting, an average of 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay ICU | number days between admission and discharge from ICU | at data collecting, an average of 1 day | 
| decannulation time in NRiab | number days between NRehab admission and decannulation | at data collecting, an average of 1 day | 
| Coma Recovery Scale revised score at discharge |  | at data collecting, an average of 1 day | 
| Glasgow Coma Scale score at discharge |  | at data collecting, an average of 1 day | 
| Disability Rating Scale Score at discharge |  | at data collecting, an average of 1 day | 
| Levels of Cognitive Functioning score at discharge |  | at data collecting, an average of 1 day |
Do the SPPB and 4-metre Gait Speed Predict Hospital Readmission in Patients Hospitalised for Acute Exacerbation if COPD?

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate simple tests of physical function in hospitalised patients with chronic obstructive pulmonary disease (COPD) and to assess whether they can predict future hospital readmission. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed (4-metre gait speed) and ability to stand from a chair, which reflects global physical functioning and frailty. We hypothesise that the SPPB or 4-metre gait speed can predict future hospital readmissions.

Official Title
-----------------
Do the SPPB and 4-metre Gait Speed Predict Hospital Readmission in Patients Hospitalised for Acute Exacerbation if COPD?

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive, Bronchitis, Chronic, Pulmonary Emphysema, Disease Progression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital admission with an exacerbation of COPD Must have capacity to consent Able to walk Exclusion Criteria: Co-morbibities that limit walking ability Co-morbidities that make walking unsafe

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Exacerbation<br>Patients with Chronic Obstructive Pulmonary Disease (COPD) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission rate |  | 12 months | 
| Time to first hospital readmission |  | 12 months | 
| Hospital Bed days |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cohort Studies, Longitudinal Studies, Patient Readmission, Hospitalization, Disability Evaluation
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

Study Overview
=================
Brief Summary
-----------------
The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream

Official Title
-----------------
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µG/Inhalation; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Salmeterol/fluticasone Easyhaler
* Drug: Salmeterol/fluticasone Easyhaler with charcoal
* Drug: Seretide Diskus
* Drug: Seretide Diskus with charcoal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained Good general health ascertained by detailed medical history, and laboratory and physical examinations Exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed Known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug Pregnant or lactating females

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salmeterol/fluticasone Easyhaler<br>Single dose of Salmeterol/fluticasone Easyhaler | Drug: Salmeterol/fluticasone Easyhaler<br> <br> |
| Experimental: Salmeterol/fluticasone Easyhaler with charcoal<br>Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules) | Drug: Salmeterol/fluticasone Easyhaler with charcoal<br> <br> |
| Active Comparator: Seretide Diskus<br>Single dose of Seretide Diskus | Drug: Seretide Diskus<br> <br> |
| Active Comparator: Seretide Diskus with charcoal<br>Single dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules) | Drug: Seretide Diskus with charcoal<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of plasma salmeterol and fluticasone propionate |  | within 34 h | 
| AUCt of plasma salmeterol and fluticasone propionate |  | 34 h |
Early Revalvulation After Fallot Repair Improves Clinical Outcome

Study Overview
=================
Brief Summary
-----------------
Aim With this retrospective study, the investigators would like to evaluate and, if possible confirm, whether earlier revalvulation of the right ventricular outflow tract is better than late revalvulation. Up to now, no analysis is done to validate this policy change. Patient selection All patients registered in the database of paediatric and congenital cardiology of the University Hospitals in Leuven, with sufficient follow-up data, and who underwent transannular patching at repair will be included in the study. Methodology and statistical analysis All files will be reviewed for demographic, electrocardiographic, echocardiographic, and outcome data. Besides descriptive statistics, Cox regression will be performed to detect whether the time period between repair and revalvulation influences clinical outcome (defined as death, heart failure hospitalization, redo-revalvulation, implantation of automatic defibrillator, endocarditis).

Conditions
-----------------
Tetralogy of Fallot

Intervention / Treatment
-----------------
* Other: Revalvulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tetralogy of Fallot patients repaired with transannulaire patch. 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 |
| --- | --- |
| Revalvulation time early<br>Early revalvulation by homograft or percutaneous valve | Other: Revalvulation<br> <br> |
| Revalvulation time late<br>Late revalvulation by homograft or percutaneous valve | Other: Revalvulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endocarditis |  | 10 years | 
| re-intervention |  | 10 years |
Mortality Follow-Up and Analyses of Men in the MRFIT

Study Overview
=================
Brief Summary
-----------------
To extend mortality followup through 25 years for two cohorts of men in the Multiple Risk Factor intervention Trial (MRFIT): the 361,662 men screened and the 12,866 men randomized, and to pursue the general aim of elucidating unresolved research issues on the epidemiology, natural history, etiology, prevention, and control of major chronic diseases, particularly cardiovascular and neoplastic diseases and diabetes.

Detailed Description
-----------------
BACKGROUND: MRFIT was initiated in 1972 as a randomized, multicenter primary prevention trial designed to determine whether a special intervention consisting of smoking cessation, cholesterol reduction and control of high blood pressure, would result in a significant reduction in coronary heart disease (CHD) mortality, compared to usual care. Follow-up and analysis has continued on the 361,662 men screened and the 12,866 men randomized. DESIGN NARRATIVE: The National Death Index (NDI) will be used for continued follow-up of the MRFIT cohorts. An additional assay to establish IGF-1 and IGF binding protein will be added to the data set as a potential prognostic factor. The effort will focus on three primary aims related to long-term mortality. Aim 1 will relate nutritional-dietary data to twenty-five year mortality from coronary heart disease (CHD), stroke, cardiovascular disease (CVD), colon cancer, prostate cancer, and all causes for the 12,866 men randomized. Aim 2 will relate age, ethnicity, socioeconomic position, geographic location, major risk factors, low risk status, prior diabetes, and prior myocardial infarction to twenty-five year mortality for the 361,662 men screened. Aim 3 will relate insulin-like growth factor 1 (IGF-1), IGF binding protein, and fasting and one-hour glucose measurements from frozen baseline sera to mortality for the 12,866 men randomized.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Ischemia, Diabetes Mellitus, Cerebrovascular Accident, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Prospective Bone Marrow Biopsy Safety and Efficacy Study

Study Overview
=================
Brief Summary
-----------------
Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed annually in the U.S. Most of them are performed by practicing hematologists/oncologists in their offices or hospitals. However, a significant number are performed by hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of complications associated with bone marrow biopsy are largely unknown. This study has two goals: The first goal is to objectively determine by CT and clinical assessment, the actual risk to patients of the bone marrow biopsy and the rate of pelvic injury in an unselected group of hematology patients requiring a bone marrow biopsy, as performed by hematologist-in-training. The second goal is to determine the quality of bone marrow biopsies obtained, using the lateral angulation technique.

Conditions
-----------------
Bone Marrow

Intervention / Treatment
-----------------
* Other: Pelvis CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a hematological or oncological condition which requires a bone marrow aspiration and biopsy procedure, and no alternative procedures are available for diagnosis, staging, monitoring or follow up of their disease. Subjects must be able to understand the risks/benefits and provide written informed consent to participate in the study, and be willing to participate in all required study activities for the duration of the study. Subjects must be 40 years of age or older. Exclusion Criteria: Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome. Psychiatric or cognitive illness or recreational drug/alcohol abuse that, in the opinion of the investigator would effect subject safety and/or compliance. Patients with uncontrolled bleeding disorders. Pregnant and lactating females (due to radiation exposure during the CT scans).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pelvis CT scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates associated with bone marrow biopsy | Complications will be assessed by a modified pelvic CT | 5 days after the bone marrow biopsy | 
| Quality of bone marrow biopsy | Length of the bone marrow biospy specimen in mm is measured by a pathologist blindly | 5 days after the bone marrow biopsy |