linjc16/ctgov huggingface dataset:
Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Sleep disordered breathing (SDB) is common in cardiovascular patients. Patients after cardiac surgery will be screened for SDB with the ApnoeLink device at the beginning of cardiac Rehabilitation and then after 3 weeks and 3 months.

Detailed Description
-----------------
Objective(s) of the project Evaluate the prevalence of sleep apnea after cardiac surgery Compare results interindividually (group A vs. group B) and intraindividually (longitudinal assessment after 3 months) Outcome(s) Prevalence of sleep apnoe at day 1 and 20 of rehabilitation and 3 months after cardiac surgery composite endpoint of events at 3 months (cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, revascularisation procedure, new atrial fibrillation and stroke) change in 6-minute walking test (6-MWT) impact of heart surgery on sleep apnoe

Official Title
-----------------
Prevalence, Severity and Natural Course of Sleep Apnea After Cardiac Surgery

Conditions
-----------------
Sleep Disordered Breathing

Intervention / Treatment
-----------------
* Other: screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac surgery or orthopedic surgery <2 weeks Exclusion Criteria: known SDB
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cardiac surgery<br>active Group screening | Other: screening<br>* Screening for sleep disordered breathing with the ApnoeLink Air device<br>|
| orthopedic surgery<br>control Group screening | Other: screening<br>* Screening for sleep disordered breathing with the ApnoeLink Air device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of SDB prevalence after cardiac surgery measured with ApnoeLink Air device | • Prevalence of sleep apnoe at day 1 and 20 of rehabilitation and 3 months after cardiac surgery assessed with the ApnoeLink Air device (ResMed) | day 1, day 20, 3 months |
Post SARS-Cov-2 Disease Anesthesia Events

Study Overview
=================
Brief Summary
-----------------
Estimating and recording the rate of occurrence of pulmonary and cardiovascular complications during the perioperative period in patients with past covid infection

Official Title
-----------------
Post SARS-Cov-2 Disease Anesthesia Events

Conditions
-----------------
Intraoperative Hypertension, Pain Threshold, Postoperative Pain, Postoperative Hypoxemia

Intervention / Treatment
-----------------
* Other: Observation of hemodynamic status and post operative pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients above 18 years with past history of covid-19 during past 6 months undergoing surgery Exclusion Criteria: hemodynamically unstable Patients requiring oxygen therapy

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 |
| --- | --- |
| Group 1<br>Patients undergoing elective surgeries with past history of COVID-19 infection during the past six months | Other: Observation of hemodynamic status and post operative pain<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occurrence of pulmonary and cardiovascular complications | Measure all vital data and postoperative status | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-Cov-2, Anesthesia
Macular Function After Scleral Buckle

Study Overview
=================
Brief Summary
-----------------
Assess recovery of macula function after successful scleral buckling surgery for rhegmatogenous retinal detachment by using the multifocal ERG in the postoperative period i.e. recovery of functional integrity 2. Assess the relationship between the neurosensory retina and the retinal pigment epithelium/choriocapillaris after scleral buckling i.e. recovery of structural integrity 3. Assess if there is a difference between macula function postoperatively, in eyes with retinal detachments involving the macula and those that do not.

Detailed Description
-----------------
Patients with acute rhegmatogenous retinal detachments managed by scleral buckling surgery will be recruited into 3 groups. (Please see attached appendix A) We define the area of the macula as the area within the temporal vascular arcades with the horizontal radius defined between the optic disc and the foveal centre. Group A: Macula not detached Group B: Macula partially detached i.e. detachment stops within the macula Group C: Macula is totally detached After scleral buckling surgery for the retinal detachment, the patients will be examined at Day 1, week 1, month1, 3 and 6. During these visits, they will be examined clinically, as well as undergo tests - refraction, colour vision (D-15) & contrast sensitivity testing, OCT and multifocal ERG. (Please see attaced visit schedule).

Official Title
-----------------
Assessment of Recovery of Macula Function After Successful Scleral Buckling Surgery for Rhegmatogenous Retinal Detachment

Conditions
-----------------
Rhegmatogenous Retinal Detachment

Intervention / Treatment
-----------------
* Procedure: Scleral buckling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute rhegmatogenous retinal detachment undergoing scleral buckling surgery Exclusion Criteria: Only eye patients Patients who undergo surgery which require use of intravitreal gases Patients who will not be able to cooperate for the mfERG and OCT testing Patients with macula hole detachments Fellow eye with poor vision resulting in inability to fixate for the mfERG

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: Scleral buckling|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
-----------------
Retinal detachment, Macular function, Multifocal electrophysiology
Impact of Branched-chain Amino Acids in the Development of Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes

Detailed Description
-----------------
The proposed project aims to elucidate the role of the BCAA in the development of insulin resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin resistance and diabetes progression. The specific aims are to elucidate the effect of the diet induced decrease of BCAAs concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat distribution (III) energy metabolism (IV) metabolic and inflammatory status

Official Title
-----------------
Branched-Chain Amino Acid Dietary Reduction Under Weight Maintainance in Overweight Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Branched-chain amino acids reduced intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type 2 Non smokers Untrained Willingness to adhere to a diet intervention Exclusion Criteria: Chronic disease Pregnancy Cancer Antibiotic therapy Drug/alcohol abuse Competitive athletes

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| Placebo Comparator: Amino acid powder with all amino acids<br>amino acid powder 80 g oral Administration 1 week | Dietary Supplement: Branched-chain amino acids reduced intake<br> <br> |
| Active Comparator: Amino acid powder without BCAAs-reduced intake<br>Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week - | Dietary Supplement: Branched-chain amino acids reduced intake<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clamp test | Insulin sensitivity test | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mixed Meal Test | B cell function test | up to 24 weeks |
Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children

Study Overview
=================
Brief Summary
-----------------
Visual cognitive deficits in children are frequent, with an impact on working and daily activities. Optometric therapy may improve those functions, however few studies have been performed. We aim to evaluate the efficacy of such therapy by a comparative study between two groups of children aged between 5 and 12 after 6 months of rehabilitation.

Official Title
-----------------
Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children

Conditions
-----------------
Visual Cognitive Deficits

Intervention / Treatment
-----------------
* Other: Optometric therapy during 6 months
* Other: Optometric therapy during 12 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: visual cognitive deficits normal intelligence Exclusion Criteria: cerebral palsy mental deficiency visual acuity deficit

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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 |
| --- | --- |
| Active Comparator: Speech therapy<br>Speech therapy (30 min per week) alone for the 6 first months. Then speech therapy (30 min per week) and optometric therapy (30 min per week) for the 6 last months. | Other: Optometric therapy during 6 months<br>* Optometric therapy during 6 months, once a week<br>|
| Experimental: Speech therapy and optometric therapy<br>Speech therapy (30 min per week) and optometric therapy (30 min per week) for 12 months. | Other: Optometric therapy during 12 months<br>* Optometric therapy once a week, during 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of a composite score at Visit 1 | The composite score is calculated from the results obtained at several neuropsychology and optometric tests. Basal score is calculated at Visit 0 (inclusion visit). | Visit 1 (6 months of rehabilitation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of a composite score at Visit 2 | The composite score is calculated from the results obtained at several neuropsychology and optometric tests. | Visit 2 (12 months of rehabilitation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visual cognitive deficits
Brexpiprazole in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of brexpiprazole during long-term treatment.

Official Title
-----------------
Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Brexpiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has completed the lead-in study 14644A. The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator. The patient agrees to protocol-defined use of effective contraception. Exclusion Criteria: The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A. The patient has a clinically significant unstable illness diagnosed during Study 14644A. The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide. The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant. The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brexpiprazole<br> | Drug: Brexpiprazole<br>* 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Number of treatment-emergent adverse events (TEAEs) | Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP) |
the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression

Study Overview
=================
Brief Summary
-----------------
It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee OA cases were collected from the first affiliated hospital of Shihezi university and healthy controls were recruited from the community. The severity of knee OA was defined as kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Radiation: x-ray images


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons Exclusion Criteria: Participants who met the following criteria were excluded： the knee OA concomitant with hip OA, suppurative and rheumatoid arthritis, gout patients, patients who underwent knee arthroscopy surgery within 6 months, bilateral or unilateral knee replacements, the knee joint trauma patients, histories of glucocorticoid and/or sterol hormones.

Ages Eligible for Study
-----------------
Minimum Age: 38 Years
Maximum Age: 78 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 |
| --- | --- |
| knee OA<br>OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons Participants who met the following criteria were excluded：the knee OA concomitant with hip OA, suppurative and rheumatoid arthritis, gout patients, patients who underwent knee arthroscopy surgery within 6 months, bilateral or unilateral knee replacements, the knee joint trauma patients, histories of glucocorticoid and/or sterol hormones. | Radiation: x-ray images<br> <br> |
| Control<br>no often have pain, aching or stiffness in your Left/right knee during last month,no Left/right knee trauma history,no histories of glucocorticoid and/or sterol hormones normal knee X-ray images, | Radiation: x-ray images<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of Transforming Growth Factor Beta1 (TGF-β1) and Platelet Derived Growth Factor BB (PDGF-BB) may be novel biomarkers in knee osteoarthritis |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers
Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.

Official Title
-----------------
Phase 1 Trial Evaluating Tolerability and Pharmacokinetics of Chlorogenic Acid for Injection in Patients With Advanced Cancer

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: chlorogenic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced cancer with no effective treatment Karnofsky performance status no less than 70 adequated organ function informed consent Exclusion Criteria: allergic to chlorogenic acid persistent toxicities from previous treatment (no less than grade 2)

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorogenic acid<br> | Drug: chlorogenic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | within the first 60 days after the first dose of chlorogenic acid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose-limiting toxicity |  | within the first 30 days after the first dose of chlorogenic acid | 
| maximum tolerated dose |  | within the first 30 days after the first dose of chlorogenic acid | 
| Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid |  | within the first 30 days after the first dose of chlorogenic acid | 
| improvement in cancer-related symptoms and quality of life |  | within 1 year after the first dose of chlorogenic acid | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
no available effective treatment
An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.

Official Title
-----------------
A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Diagnosis of chronic hepatitis C Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label Exclusion Criteria: Contraindications against Pegasys or Copegus Not willing or unable to sign written informed consent form

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response |  | 24 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid virological response |  | 4 weeks after start of treatment | 
| Early Virological Response |  | 12 weeks after start of treatment | 
| Safety: incidence of adverse events |  | up to 24 weeks after end of treatment |