linjc16/ctgov huggingface dataset:
Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways

Study Overview
=================
Brief Summary
-----------------
Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank

Official Title
-----------------
Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways

Conditions
-----------------
Congenital Heart Defects

Intervention / Treatment
-----------------
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Echocardiographic diagnosis of congenital heart defect falling within the classification Houyel and Bonnet Necessity of making a blood test regardless of study Medical care in the AP-HM Timone Hospital children, medical-surgical unit of pediatric and congenital cardiology, Marseille - These Parent Child Exclusion Criteria: Pregnant women Patients or parent / legal guardian (if minor) in physical or mental incapacity to understand or sign the consent People in Emergencies Persons deprived of freedom Persons not beneficiaries of a social security scheme Persons in health or social institution
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Congenital heart defects<br> | Biological: blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patient with Congenital Heart Defects |  | 3years |
Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.

Study Overview
=================
Brief Summary
-----------------
Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with Levodopa/Carbidopa therapy.

Official Title
-----------------
A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: rasagiline mesylate
* Drug: rasagiline mesylate 1.0 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol. Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0. Patients must be willing and able to give informed consent. Exclusion Criteria: Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133. Premature discontinuation from study TVP 1012/133 for any reason. A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary hepatic, renal, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>0.5 mg rasagiline mesylate oral once daily | Drug: rasagiline mesylate<br>* 0.5 rasagiline mesylate<br>|
| Experimental: Expermental 2<br>1.0 mg rasagiline mesylate oral once daily | Drug: rasagiline mesylate 1.0 mg<br>* 1.0 mg rasagiline mesylate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term safety and tolerability of rasagiline | To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long- term clinical effect of rasagiline | To assess the long- term clinical effect of rasagiline on the course of the disease. | 6 months |
Mechanical Versus Manual Chest Compression

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators compared mechanical and manual chest compressions in out-of-hospital cardiac arrest cases.

Detailed Description
-----------------
In this study, the investigators retrospectively analyzed resuscitations performed over a 2-year period and compared manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge parameters.

Official Title
-----------------
Mechanical Versus Manual Chest Compression: A Retrospective Study in Out-of-hospital Cardiac Arrest

Conditions
-----------------
Cardiac Arrest, Cardiopulmonary Resuscitation

Intervention / Treatment
-----------------
* Device: LUCAS™ 2 Chest Compression System
* Other: Manuel chest compressions by human efforts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 age Cardiac arrest cases Out-of-hospital arrest Exclusion Criteria: <18 age

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 |
| --- | --- |
| Manuel chest compression<br>Manuel chest compressions will be handled by human efforts. | Other: Manuel chest compressions by human efforts<br>* In this way chest compressions will be handled by humans themselves.<br>|
| Mechanical chest compression<br>In the study, chest compression in the mechanical cardiopulmonary resuscitation group was performed with the Lund University Cardiopulmonary Assist System (LUCAS) Chest Compression System (LUCAS 2). | Device: LUCAS™ 2 Chest Compression System<br>* LUCAS is a portable device designed to rule out the problems encountered during manual chest compression, capable of performing standard and continuous chest compressions at a depth of 4-5 cm and at least 100 times per minute.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of the mortality on the 30th day | Mortality from the admission to the 30th day | 30 days | 
| Rate of the return of spontaneous circulation | Return of spontaneous circulation at least 5 minutes | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiopulmonary Resuscitation, Chest compression, Manuel, Mechanical
Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients

Study Overview
=================
Brief Summary
-----------------
An evaluation of the effects of genetically determined variant metabolizing and transporting proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal transplant recipients. In a five year follow-up study tacrolimus dose-corrected exposure changes significantly and the effect(s) of single nucleotide polymorphisms of the CYP3A4/CYP3A5 and MDR1 genes on the latter is assessed in this study.

Detailed Description
-----------------
A 5-year pharmacokinetic follow-up study in 95 renal allograft recipients assessing tacrolimus exposure using repeated abbreviated Area-Under-the-Concentration-time (AUC) curve measurements at regular time points after grafting. The effects of the CYP3A5*1, CYP3A4*1B, MDR1 G2677T/A and C3435T single nucleotide polymorphisms on the evolution of tacrolimus disposition are studied over 5 years in order to clarify the interrelationship between CYP3A5, CYP3A4 and MDR1 genotypes, time-dependent exposure and tacrolimus-related toxicity.

Official Title
-----------------
Prospective Study of the Influence of CYP3A4/CYP3A5 and MDR1 Gene Single Nucleotide Polymorphisms on Long-Term Tacrolimus Disposition in Renal Allograft Recipients: a Five Year Follow-up Study Using Abbreviated Concentration-Time Measurements.

Conditions
-----------------
Renal Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary or secondary single kidney transplantation Age older than 18 yrs Exclusion Criteria: Combined organ transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal transplantation, tacrolimus pharmacokinetics, CYP3A4 - CYP3A5, P-glycoprotein, single nucleotide polymorphisms, calcineurin-inhibitor-associated nephrotoxicity
Effects of Travoprost on Neovascular Glaucoma

Study Overview
=================
Brief Summary
-----------------
Prostaglandin analogues have not been used in the treatment of neovascular glaucoma because of suspicious lack of efficacy. This study aims at assessing the effect of travoprost on neovascular glaucoma.

Official Title
-----------------
Effects of Travoprost on Neovascular Glaucoma

Conditions
-----------------
Neovascular Glaucoma

Intervention / Treatment
-----------------
* Drug: Travoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neovascular glaucoma of known cause Older than 18 years Previously submitted to retinal photocoagulation Under medical treatment to glaucoma Exclusion Criteria: Need of antiglaucomatous surgery Previous ocular surgery in the last 6 months Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neovascular glaucoma, Travoprost
Newborn Screening Assay of Pompe's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the feasibility of a newborn screen assay for Pompe disease

Detailed Description
-----------------
DBS from newborn will be tested for acid alpha-glucosidase (GAA) activity. Babies with low GAA activity will be confirmed for Pompe disease.

Official Title
-----------------
Newborn Screening Assay of Pompe's Disease

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Other: Pompe disease newborn screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborns receiving newborn screening in Newborn Screening center of National Taiwan Univeristy Hospital parents signed inform consent for this study Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pompe disease newborn screening<br>newborns will be tested if they were affected by Pompe disease | Other: Pompe disease newborn screening<br>* DBS will be tested for acid alpha-glucosidase (GAA)activity. Newborns with low GAA activity will received a confirmatory blood sampling and clinical evaluation for the presence of cardiomyopathy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect patients with infantile onset Pompe disease |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pompe disease, alpha glucosidase deficiency
The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism

Study Overview
=================
Brief Summary
-----------------
Anticoagulation is the most important treatment for pulmonary thromboembolism (PTE). The thromboembolism risk is especially high in patients with chronic obstructive pulmonary disease (COPD) exacerbations. However, there's no agreement on the most appropriate duration of anticoagulation in COPD with PTE to balance the risk of recurrence of thrombosis and bleeding. This randomized, controlled trial aims to evaluate the risk and benefit of prolonged anticoagulation compared with the regular 3-month anticoagulation in COPD with PTE.

Official Title
-----------------
The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism-- A National Multicenter, Prospective, Randomized, Controlled Clinical Trial

Conditions
-----------------
COPD Exacerbation, PTE - Pulmonary Thromboembolism

Intervention / Treatment
-----------------
* Drug: Warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients due to chronic obstructive pulmonary disease exacerbation and diagnosed as newly developed pulmonary thromboembolism Regular anticoagulation for 3 months and got CT pulmonary angiography Exclusion Criteria: Patients with major bleeding during prior anticoagulation Patients need long term anticoagulation to treat other diseases Patients unwilling to receive prolonged anticoagulation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged anticoagulation<br>3 months longer anticoagulation after regular treatment | Drug: Warfarin<br>* tailored dose according to international normalized ratio (INR) for 3 months<br>|
| No Intervention: Regular anticoagulation<br>stop anticoagulation after regular treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism recurrence | recurrence rate in % | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic obstructive pulmonary disease exacerbations | total times | 3 year |
Effect of Inflammation on Voriconazole Concentration

Study Overview
=================
Brief Summary
-----------------
Voriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between the efficacy and safety of voriconazole and voriconazole trough concentrations. There are several factors that could influence voriconazole concentrations. Inflammation could be one of these factors. In a retrospective study was observed that reduced metabolism of voriconazole was related to inflammation in patients with severe infections. Reduced metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an algorithm to guide dosing of voriconazole during severe inflammation and to develop a multiple linear regression model to describe the contribution of CRP concentrations to the variability in voriconazole levels and metabolic ratio.

Official Title
-----------------
Managing Voriconazole Exposure During Severe Infection; Effect of Inflammation on Voriconazole Metabolic Ratio

Conditions
-----------------
Inflammation, Fungal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 yrs treatment with voriconazole written informed consent Exclusion Criteria: concomitantly using a strong inhibitor or inducer of CYP P450

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 |
| --- | --- | --- |
| Plamsa concentration of voriconazole and voriconazole N-oxide in patients during a severe inflammation | Plasma concentrations of voriconazole and voriconazole N-oxide will be determined using a validated method involving LC-MS/MS | Up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voriconazole, CRP, Inflammation, Pharmacokinetics
Association of Cognition With Functional Mobility in People With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This study aimed to investigate relationship between cognitive function and functional mobility in Alzheimer's disease.

Detailed Description
-----------------
Our hypothesis is that the decrease in cognitive function in individuals with Alzheimer's disease is associated with the level of functional mobility. Sociodemographic information of participants will be recorded. Cognition will assessed with Montreal Cognitive Assessment (MoCA), global score and MoCA's visuospatial executive functions, naming, attention, language, abstract thinking, delayed recall, orientation sub-scores will recorded. Functional mobility will assessed Timed Up and Go Test and 5 Times Sit&Stand Test.

Official Title
-----------------
Association of Cognition With Functional Mobility in People With Alzheimer's Disease

Conditions
-----------------
Alzheimer Dementia, Alzheimer's Disease, Dementia, Alzheimer Type

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Alzheimer's disease according to the National Institute of --Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria, Over 65 years old, Cases who could understand the instructions given in Turkish were included in the study, Having ambulation skill independently or with walking aid. Exclusion Criteria: Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia, Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise, Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.), Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
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 |
| --- | --- | --- |
| Montreal Cognitive Assesment (MoCA) | MoCA assesses cognitive skills such as visuospatial / executive functioning, object naming, memory, attention, language, abstraction, orientation. Higher scores reflect the better performance. | Baseline | 
| Timed Up and Go Test | Timed Up and Go Test measures the level of functional mobility skills and, assess fall risk and balance. The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded. The shorter time reflect the better performance. | Baseline | 
| 5 Time Sit to Stand Test | 5 Time Sit to Stand Test measures the level of functional mobility skills and, assess fall risk and lower extremity strength. The test measures the time taken to stand five times from a sitting position as quickly as possible. The shorter time reflect the better performance. | Baseline |