linjc16/ctgov huggingface dataset:
Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease

Study Overview
=================
Brief Summary
-----------------
This epidemiological, transversal, cohort study aims to determine the potential influence of an active long-term hydroxychloroquine intake over the prevalence of a history of symptoms evocative of a COVID-19 infection in patients with a history of systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome or psoriatic arthritis, during the epidemic period in France. The information is gathered using a standardized questionnaire, by phone call.

Official Title
-----------------
Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease

Conditions
-----------------
SARS-CoV-2, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjogren's Syndrome, Psoriatic Arthritis

Intervention / Treatment
-----------------
* Other: Questionnaire by phone call


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of Systemic Lupus Erythematosus, Rheumatoid arthritis, Sjogren's Syndrome or Psoriatic Arthritis. Exclusion Criteria: beginning, or end, of an hydroxychloroquine treatment between Jan 1, 2020 and day of the phone call. Bad treatment compliance

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 |
| --- | --- |
| Patient with autoimmune disease<br>Selected using appropriate keywords in the Foundation Rothschild Hospital EMR, consenting to participate in the study. | Other: Questionnaire by phone call<br>* 2 questionnaires : at inclusion and 4 months later. The exposure to hydroxychloroquine and the history of autoimmune disease is determined during the phone call along with other exposure factors. The symptoms presented by the patient are classified in Suggestive of a COVID-19 infection or Not suggestive of COVID-19 infection by a team of internists and infectious diseases specialists, by studying the questionnaires after the completion in a blind-manner regarding the hydroxychloroquine intake.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Odds Ratio | Adjusted Odds Ratio measuring the association between an exposure to long-term hydroxychloroquine intake and a history of symptoms compatible with a COVID-19 infection. | 4 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydroxychloroquine
Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms

Study Overview
=================
Brief Summary
-----------------
Actually, there are few data about the effectiveness of remote monitoring (RM) and patient centered alarms setting in patients with unexplained syncope underwent implanted loop recorder (ILR) monitoring. The aim of this study is to evaluate the time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.

Official Title
-----------------
Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms in Real World Setting.

Conditions
-----------------
Syncope, Loop Recorder, Remote Monitoring

Intervention / Treatment
-----------------
* Other: Remote Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with unexplained syncope underwent ICM implantation according to current gudelines. Exclusion Criteria Patients do not provied signing Patient Informed Consent Form

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ILR Group followed with RM<br>Patients with unexplained syncope underwent ILR monitoring and followed with RM | Other: Remote Monitoring<br>* Remote Monitoring Follow-up<br>|
| ILR Group followed with in-hospital visits<br>Patients with unexplained syncope underwent ILR monitoring and followed with in-hospital visits | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to medical treatment | Time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits. | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Syncope, Loop Recorder, Remote Monitoring
Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of somatropin (Norditropin®) on final height in children with Noonan syndrome having being treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal final height in the original trial S/GHD/004/NOO.

Official Title
-----------------
Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit

Conditions
-----------------
Genetic Disorder, Noonan Syndrome

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the original S/GHD/004/NOO trial or following the protocol for S/GHD/004/NOO without being randomised in the trial

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose 33 mcg/kg/day<br> | Drug: somatropin<br>* Retrospective data collection based on data obtained from a prospective, open-label, randomised, parallel-group trial (S/GHD/004/NOO) combined with a present follow-up visit<br>|
| Experimental: High dose 66 mcg/kg/day<br> | Drug: somatropin<br>* Retrospective data collection based on data obtained from a prospective, open-label, randomised, parallel-group trial (S/GHD/004/NOO) combined with a present follow-up visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final height SDS |  |  | 
| Change in height SDS from start of treatment to final height (referenced to Noonan population) |  |  | 
| Height velocity |  |  | 
| Change in height velocity |  |  | 
| Sitting height |  |  | 
| Number and proportion of subjects with final height SDS above -2 SDS |  |  | 
| Adverse events |  |  |
Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).

Official Title
-----------------
Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device

Conditions
-----------------
Positive End Expiratory Pressure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia SAD was used for mechanical ventilation Exclusion Criteria: Abdominal distension, risk of pulmonary aspiration Bronchopulmonary dysplasia/respiratory distress syndrome Pneumothorax Airway surgery Thoracic surgery or laparotomy Surgery under prone position

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Applying tidal volume 7 ml/kg without PEEP | |
| Experimental: PEEP group<br>Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP | Other: PEEP<br>* 6 cmH2O of PEEP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory system compliance | total lung and chest wall compliance, ml/cmH2O | at the end of surgery, about 2 hours after starting of mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory system compliance | total lung and chest wall compliance, ml/cmH2O | 10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation | 
| oropharyngeal leak pressure | cmH2O | immediate after SAD insertion | 
| Electrical impedance tomography parameter - dynamic compliance | ventilation/airway pressure (cmH2O) | throughout anesthesia (about during 1-3 hours) | 
| Electrical impedance tomography parameter - regional ventilation delay | assessment of ventilation homogeneity (no unit) | throughout anesthesia (about during 1-3 hours) | 
| Electrical impedance tomography parameter - pulmonary opening pressure | pressure requiring opening of alveoli (cmH2O | throughout anesthesia (about during 1-3 hours) |
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

Study Overview
=================
Brief Summary
-----------------
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.

Official Title
-----------------
Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Drug: tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Steroid refractory lupus nephritis more than 10mg of steroid failed to control disease activity patients who failed to reduce the amount of steroid patients who couldn't increase the amount of steroid due to side effects Exclusion Criteria: Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration CNS( Central Nerve System) Lupus patients hepatic failure patients Serum creatinine ≧1.5mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 64 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: tacrolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Lupus Nephritis - Disease Activity Index total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tacrolimus, FK506, lupus nephritis
The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers

Study Overview
=================
Brief Summary
-----------------
Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells.

Detailed Description
-----------------
This study investigates the following questions: Does occupational exposure to nanoparticles influence permeation of such particles to respiratory airways? Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and their pulmonary functions. Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and respiratory tract infections. The study protocol includes the following steps: Initial interview of the patient Measurement of nanoparticles in samples of exhaled breath condensate using NanoSight LM 20 Measurement of nanoparticles in induced sputum. And finally examination of the relationship between the measured parameters and the indices of pulmonary infection, and pulmonary function as measured by the pulmonary department of the TASMC.

Official Title
-----------------
The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers (Nanoexposure)

Conditions
-----------------
Inadequate or Impaired Respiratory Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 20 years of age who visit Ichilov Hospital for medical complaints/inquiries regarding respiratory tract. Study population is composed of people who are exposed to environmental particles form industrial sources. Informed consent is requested from each subject. Exclusion Criteria: Unemployed individuals. Individuals who are not working in industrial jobs, such as office workers and secretaries.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Nanoparticle exposed<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the size distribution of nano-particles in exhaled breath condensate | Each subject will be examined once. The total time for collection of data is estimated as about one year. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung, Alveoli, Nanoparticles, Particulate matter, Exhaled breath condensate, Induced sputum, Forced expiratory volume, Force vital capacity
the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population

Study Overview
=================
Brief Summary
-----------------
This study observed the relationship between cerebral collateral circulation and the prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The participants' clinical performance caused by leukoaraiosis will be assessed by a series of scales.

Detailed Description
-----------------
Case collection information is sent daily to clinical trial supervisors. The clinical trial team meets once a week to monitor the quality of clinical trials. The severity of the leukoaraiosis will be evaluated by a scale. The patients whose score is more than 2 will take additional magnetic resonance examination including magnetic resonance angiography (MRA) and arterial spin labeling (ASL). And their cognitive ability will be evaluated by a series of scales including Mini-Mental State Examination (MMSE) and Montreal cognitive assessment (MoCA) and gait by the short physical performance battery (SPPB). The blood sample will be taken for biochemical detection and hair and nail samples for trace element detection. Data were analyzed by regression analysis.

Official Title
-----------------
Prospective, Single Center, Observational, Clinical Trial of the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population

Conditions
-----------------
Leukoaraiosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical Examinees or out-patients The MRI scale score ≥ 2 Exclusion Criteria: History of stroke History of malignant tumor History of connective tissue disease Pregnant, trying to become pregnant or within 6 weeks after delivery serious infections

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| change in cognitive assessment scale score | It will be assessed by the Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA). Each assessment is scored 0-30, yielding a total between 0-60. | baseline and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in mood assessment Scale score | It will be assessed by Hamilton Depression Scale (HAMD). It is scored 0-30. | baseline and one year | 
| change in gait evaluation score | It will be assessed by the short physical performance battery (SPPB). It is scored 0-11. | baseline and one year | 
| stroke | The participant is diagnosed with stroke | baseline and one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive impairment
Safety and Efficacy of Propionate for Reduction of LDL Cholesterol

Study Overview
=================
Brief Summary
-----------------
The objective of the trial is to evaluate a potential impact of food supplements with the short chain fatty acid propionate on blood LDL cholesterol level.

Detailed Description
-----------------
62 patients with low cardiovascular risk will be 1:1 randomized to receive either placebo (b.i.d.) or 500mg of propionate (b.i.d.). The primary endpoint is the change (delta) in blood LDL cholesterol levels after 8 weeks.

Official Title
-----------------
Safety and Efficacy of PROPionatE for Reduction of LDL Cholesterol (PROPER-LDL Trial) - A Phase 2 Randomized Placebo Controlled Double-blind Trial

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Dietary Supplement: Calcium-Propionate 500mg
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with hypercholestrolemia and a LDL serum level of > 115 mg/dl age of patient between 20 and 70 years participant is fully competent and has given his/her written informed consent to the scheduled trial conduct Exclusion Criteria: patients with acute coronary syndrome in the last 4 weeks patients with chronic symptomatic heart failure (NYHA 2-4) patients with chronic renal failure and a GFR < 45 ml/min patients with chronic liver disease patients with hematological diseases patients with severe diseases of other organ systems (tumors, infections) pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>31 patients will be treated with 500mg Calcium-Propionate capsules (twice a day) for 8 weeks. | Dietary Supplement: Calcium-Propionate 500mg<br>* Calcium-Propionate capsules<br>|
| Placebo Comparator: Arm 2<br>31 patients will be treated with placebo capsules (twice a day) for 8 weeks. | Other: Placebo<br>* Placebo capsules without any active ingredient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol reduction | mg/dL | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total cholesterol | mg/dL | 8 weeks | 
| HDL-cholesterol | mg/dL | 8 weeks | 
| non HDL | mg/dL | 8 weeks | 
| Ratio HDL/LDL |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propionate