linjc16/ctgov huggingface dataset:
Utilization of 31P-Nuclear Magnetic Resonance Spectroscopy to Monitor Brain Energy Deficit in Huntington Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.

Official Title
-----------------
Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Other: 31-Phosphorus RMN Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UHDRS < 50 Age > 18 years Ability to undergo MR scanning Covered by french social security Exclusion Criteria: Evidence of psychiatric disorder Attendant neurological disorder Contraindications to MRI (claustrophobia, metallic or material implants) Severe head injury Unable to understand the protocol Pregnancy Failure to give informed consent Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent) Unwillingness to be informed in case of abnormal MRI

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients<br>31-Phosphorus RMN Spectroscopy | Other: 31-Phosphorus RMN Spectroscopy<br> <br> |
| Other: Volunteers<br>31-Phosphorus RMN Spectroscopy | Other: 31-Phosphorus RMN Spectroscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr | 31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between primary outcome measure and clinical parameters | Correlating a brain energy deficit with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC). | 2 years | 
| Study of longitudinal changes in Pi/PCr ratio over time. | Patients will be retested after one month. | 2 years |
Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
Generalized epilepsy is rarely reported in patients with Wilson disease (WD) and lacks experience in clinical practice. We aim to provide better experience for the diagnosis and treatment for WD patients with epilepsy in the future.

Detailed Description
-----------------
A retrospective study was performed in 13 Chinese WD patients with generalized epilepsy. Each patient was diagnosed with WD by clinical evaluation and genetic screening. Patients were given small doses of antiepileptic drugs (AEDs), followed by copper-chelation therapy when the seizures stabilized. Clinical manifestations, brain imaging changes, and treatment and outcome after a long-term follow-up were analyzed.

Official Title
-----------------
Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients

Conditions
-----------------
Wilson Disease, Generalized Epilepsy

Intervention / Treatment
-----------------
* Genetic: genetic test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each patient was diagnosed with WD by clinical evaluation and genetic screening and had ever experienced generalized epilepsy Exclusion Criteria: Not WD & without generalized epilepsy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WD-seizures<br>Chinese WD patients with generalized epilepsy | Genetic: genetic test<br>* Sanger sequencing and multiplex ligation-dependent probe amplification (MLPA)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment stop seizures attacks | After standard treatment, the patients would stop attacks and get improved. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment have improved brain MRI | After standard treatment, the abnormalities of brain MRI would get better in patients. | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chinese, clinical features, generalized epilepsy, outcome, Wilson's disease
Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients

Study Overview
=================
Brief Summary
-----------------
Organic nitrates increase levels of circulating endothelial progenitor cells (Thum et al., Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54). Here, we want to test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function.

Detailed Description
-----------------
In this pilot study we test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function. These parameters will be measured before and after 14d of treatment.

Official Title
-----------------
Pilot Study of Organic Nitrates on Endothelial Progenitor Cells and Endothelial Function in Patients With Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: PETN, ISDN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery disease, 2- or 3-vessel disease Exclusion Criteria: Acute myocardial infarction, acute heart failure, cancer, acute infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PETN | Drug: PETN, ISDN<br>* Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day<br>|
| Experimental: 2<br>ISDN | Drug: PETN, ISDN<br>* Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day<br>|
| No Intervention: 3<br> | Drug: PETN, ISDN<br>* Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells |  | Baseline and after 14d | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease
Physiological Impact of Cloth Mask During Exercise

Study Overview
=================
Brief Summary
-----------------
Mask wearing during the Covid-19 pandemic has been proven substantially effective in containing the spread of infection, with cloth masks being the most universally used. However, cloth masks may be uncomfortable and have physiological repercussion during exercise. This study aims to investigate the impact of cloth masks during exercise.

Official Title
-----------------
Physiological Impact of Cloth Mask During Exercise

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Other: Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals active, non-active and athletic individuals; Exclusion Criteria: preexisting chronic conditions obesity physical limitation precluding exercise.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mask<br>cloth mask wearing | Other: Mask<br>* Mask wearing<br>|
| No Intervention: control<br>control, without mask. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived exertion ratings | assessed by a scale (7 to 20, with higher values meaning higher perceived exertion) | immediately after the intervention | 
| perceived exertion ratings | assessed by a scale (7 to 20, with higher values meaning higher perceived exertion) | during the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen consumption | assessed by cardiopulmonary test | immediately after the intervention | 
| spirometry/lung function (VeVCO2 Slope) | assessed by cardiopulmonary test | during the intervention | 
| spirometry/lung function (PetCO2) | assessed by cardiopulmonary test | during the intervention | 
| spirometry/lung function (OUES) | assessed by cardiopulmonary test | during the intervention | 
| spirometry/lung function (flow-volume loop) | assessed by cardiopulmonary test | during the intervention | 
| blood lactate | assessed by lactate analyzer | immediately after the intervention | 
| oxygen saturation | assessed by pulse oximetry | immediately after the intervention | 
| vertical jump | assessed by jump test | immediately after the intervention | 
| heart rate recovery | assessed by heart rate monitor | immediately after the intervention | 
| Scale of Measuring Subjective Perceptions to maskwearing | assessed by a scale (0 to 10, with higher values meaning more uncomfortable) | immediately after the intervention |
Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses. The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.

Official Title
-----------------
Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 20-40 years of age with regular monthly menses If over age 35 then must not use tobacco Negative pregnancy test No known allergy to raltegravir No known history of phenylketonuria Undetectable HIV viral load No active liver disease as determined by medical history and normal AST and ALT No history of hepatic adenomas, carcinomas or benign liver tumors Ho history of thrombophlebitis of thromboembolic disease No history of deep vein thrombosis No history of cerebral vascular or coronary artery disease No known or suspected carcinoma of the breast No undiagnosed abnormal genital bleeding Not taking concomitant CYP 450 inducing medications such as anti-seizure medications No use of oral contraceptives, depot-medroxyprogesterone acetate, contraceptive ring or patch within two months of screening No cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use Has used raltegravir prior to screening Has no history of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer) Must not have had an abnormal pap test defined without resolution in the last 18 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Change in cervicovaginal fluide milieu |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contraception, HIV, pharmacokinetics, pharmacodynamics
Naturalistic Study to Evaluate the Utilization of Care Services Associated to the Diagnostic Process of Any Kind of Epilepsy

Study Overview
=================
Brief Summary
-----------------
Naturalistic, multicentre, epidemiological study to evaluate the care services used during the process of diagnosis of any kind of epilepsy. Data about services since first seizure until confirmed diagnosis will be examined.

Official Title
-----------------
Naturalistic Study to Evaluate the Utilization of Care Services Associated to the Diagnostic Process of Any Kind of Epilepsy Until Being Confirmed (EPILIVE Study)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes 16 years old or older, being diagnosed of any kind of EPILEPSY (criteria ILAE) and with diagnosis being confirmed by a Neurologist over the last 6 months and with write informed consent. Exclusion Criteria: Patients with epilepsy diagnosis confirmed by a Neurologist over the last 6 months before the study or with incapacity to fulfill the requirements of the study.

Ages Eligible for Study
-----------------
Minimum Age: 16 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
-----------------
Naturalistic, retrospective, utilization of care services, diagnosis, epilepsy
Neutrophil Side Fluorescent Light (NEU-SFL) in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
Recently, a study showed that markers of neutrophil extracellular traps formation, a mechanism corresponding to neutrophil activation, were increased in patients who died of COVID 19 compared with survivors. The investigators propose to analyze the NEU-SFL parameter, obtained automatically on the Sysmex™ blood count machine (Sysmex Corporation, Kobe, Japan) and which is considered as a reflect of neutrophil extracellular traps formation, in these two groups of patients. The aim was to evaluate whether this parameter could be used to predict the risk of death related to COVID 19.

Official Title
-----------------
Neutrophil Side Fluorescent Light (NEU-SFL) in COVID-19 Patients Hospitalized in 2021

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalization for COVID 19 in 2021 Exclusion Criteria: Patients who refused the use of their data

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 |
| --- | --- |
| COVID-19 survivors<br>Patients hospitalized at Nimes university hospital in 2021 for COVID-19 who survived. | |
| COVID-19 Deceased<br>Patients hospitalized at Nimes university hospital in 2021 for COVID-19 who died. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the rate of NEU-SFL in patients hospitalized at Nimes hospital for COVID-19 in 2021, according they survived or not. | Data collection | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the rate of NEU-SFL in patients hospitalized at Nimes hospital for COVID-19 in 2021 who survived, between entry and discharge from Nimes hospital | Data collection | 3 months | 
| Compare the rate of NEU-SFL in patients hospitalized at Nimes hospital for COVID-19 in 2021 who died, between entry and discharge from Nimes hospital | Data collection | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, neutrophil extracellular traps (NETs)
PEEP During Induction of Anesthesia in Small Children

Study Overview
=================
Brief Summary
-----------------
Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of PEEP applied during anesthesia induction.

Official Title
-----------------
The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia on Atelectasis Formation and Non-hypoxic Apnea Time in Small Children: a Randomized Controlled Trials

Conditions
-----------------
Pediatric Anesthesia

Intervention / Treatment
-----------------
* Other: PEEP
* Other: ZEEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients undergoing general anesthesia using endotracheal intubation Exclusion Criteria: previous history of lung disease anticipated difficulty in airway management

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 2 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zero positive end expiratory pressure<br> | Other: ZEEP<br>* 0 cmH2O positive end expiratory pressure<br>|
| Experimental: Positive end expiratory pressure<br> | Other: PEEP<br>* 7cmH2O positive end expiratory pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Apnea |  | from the start of apnea until SpO2 reached 95%, maximum 5 minutes. |
ClearView Predicate Comparison Testing

Study Overview
=================
Brief Summary
-----------------
This study serves as a comparison study between the EPIC ClearView and a predicate device.

Detailed Description
-----------------
The EPIC ClearView is a galvanic skin response (GSR) measurement system that is intended to be used to determine autonomic response as psychological indicators by measuring the electrical resistance of the skin. The EPIC ClearView is a non-invasive digital bioelectrography instrument that is used to assess the electrophysiology of humans. The measurements are digital photographs taken in a brief exposure to an electric field. These measurements are quantified to produce a standardized Response Scale.

Official Title
-----------------
ClearView Predicate Comparison Testing

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sex: Male or Female. Age range: 18 to 85. The subject is able to understand and provide signed consent for the procedure. Every effort will be given to balance subjects by gender, age, and race. Exclusion Criteria: Subjects < 18 years in age or > 85 years in age. Inability or unwillingness to provide informed consent. Subjects with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body. Subjects missing all or part of any of their fingers. Subjects with hand tremors or involuntary oscillations (shaking) of the hands that prevent clear imaging.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| ClearView/Predicate<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between ClearView and Predicate | The primary objective of this study is to perform a point-to-point comparison of the EPIC ClearView™ galvanic skin response hand measurements (on a 0-25 scale) to those of a predicate device (on a 0-100 scale). We hypothesize that there will be a statistically significant correlation between the galvanic skin response measurements made by the two devices. | At time of study scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ambulatory adults with no apparent health conditions