linjc16/ctgov huggingface dataset:
Effect of Corticosteroid Treatment on Prognosis in ARDS Secondary to Covid-19

Study Overview
=================
Brief Summary
-----------------
Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.

Official Title
-----------------
Effect of Early Corticosteroid Therapy on Mortality in Patient With Acute Respiratory Distress Syndrome Secondary to Covid-19

Conditions
-----------------
Acute Respiratory Distress Syndrome Secondary to Covid-19

Intervention / Treatment
-----------------
* Drug: Corticosteroids and Derivatives


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU hospitalized with acute respiratory distress syndrome secondary to Sars-Cov-2 infection diagnosed by PCR test Hospitalized from 01/03/2020 to 30/04/2020 Exclusion Criteria: Mechanical ventilation more than 48 hours at admission Transfert to another ICU during stay for bed management Corticosteroid treatment at admission

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early corticosteroid<br>Corticosteroid treatment within first seven days after ICU admission | Drug: Corticosteroids and Derivatives<br>* Any systemic corticosteroid treatment administrated during ICU stay<br>|
| Late corticosteroid<br>Corticosteroid treatment later than seventh day's after ICU admission | Drug: Corticosteroids and Derivatives<br>* Any systemic corticosteroid treatment administrated during ICU stay<br>|
| No corticosteroid<br>No corticosteroid treatment during ICU stay | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in ICU | Mortality rates in ICU in each group | within ICU stay, on average 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality d28 | mortality at day 28 after ICU admission | 28 days | 
| acquired infections incidence | cumulative incidence of infection acquired during ICU stay | 28 days | 
| antibiotics duration | number of treatment days with antibiotics during ICU stay | 28 days | 
| mechanical ventilation duration | number of days of treatment by mechanical ventilation during ICU stay | 28 days |
Comparing 3 Schedules of Alimta Plus Gemzar

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms

Intervention / Treatment
-----------------
* Drug: Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of non-small lung cancer No prior chemotherapy Able to care for self Exclusion Criteria: An ongoing infection Pregnancy or breast feeding Other serious medical condition Cancer that has spread to the brain Inability to take folic acid

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

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)|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
-----------------
Lung cancer, cancer, neoplasm, non-small, chemotherapy
HemoSonics-UVA HemoSonics-UVA Cardiac Surgery Clinical Study Protocol

Study Overview
=================
Brief Summary
-----------------
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.

Detailed Description
-----------------
HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients. A clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the University of Virginia Health System and will involve patients undergoing cardiac surgery requiring bypass.

Official Title
-----------------
HemoSonics-UVA Cardiac Surgery Clinical Study Protocol

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is scheduled for cardiac surgery involving bypass circuit Subject is older than 18 years Subject is willing to participate and he/she has signed a consent form Exclusion Criteria: Subject is unable to provide written informed consent Subject is incarcerated at the time of the study Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks Patients with renal disease (defined as serum creatinine greater than 1.5 mg/dl) Patients with history of active liver disease Patients on emergency cases Patients on heparin anticoagulation before the beginning of the study

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 |
| --- | --- |
| Cardiac Surgery Patients<br>Intervention: Procedure: Blood specimen collection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clot time | Coagulation Function | 1 day | 
| Clot Amplitude | Coagulation Function | 1 day |
Interest of Tissue Oxygen Pressure (PtiO2) Monitoring to Detect a Vasospasm Post Aneurysmal Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and often associated with brain ischemia. This complication is difficult to detect, because clinical examination is hardly helpful in sedated patients and the performances of transcranial doppler can only detect the spasm of middle cerebral arteries. Tissue Oxygen Pressure (PtiO2) Monitoring allows early detection of brain oxygenation local modifications and of brain ischemia, via continuous monitoring. This study aims to assess the performance of the tissue oxygen pressure monitoring in detecting a vasospasm post aneurysmal subarachnoid hemorrhage.

Official Title
-----------------
Interest of Tissue Oxygen Pressure (PtiO2) Monitoring to Detect a Vasospasm Post Aneurysmal Subarachnoid Hemorrhage

Conditions
-----------------
Subarachnoid Hemorrhage, Aneurysmal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe aneurysmal subarachnoid hemorrhage patient sedated patient hospitalized in intensive care unit between January 2013 and August 2015 multimodal neurologic monitoring including Tissue Oxygen Pressure and transcranial doppler Exclusion Criteria: insonation impossible

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 |
| --- | --- | --- |
| Tissue Oxygen Pressure |  | baseline |
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fed conditions.

Official Title
-----------------
Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fed Conditions

Conditions
-----------------
Bioequivalency

Intervention / Treatment
-----------------
* Drug: Naproxen Tablets, 500 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men or women, non-smoker, 18 years of age or older willing to participate and sign a copy of the informed consent form Exclusion Criteria: clinically significant illnesses or surgery within 4 weeks prior to study dosing body mass index greater than or equal to 30.0 recent history of drug or alcohol addiction or abuse pregnant or lactating women history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs history or known presence of gastrointestinal ulceration, bleeding and perforation use of tobacco products within 6 months prior to study dosing evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant receipt of any drugs as part of a research study within 30 days prior to study dosing

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Product<br> | Drug: Naproxen Tablets, 500 mg<br> <br> |
| Active Comparator: Reference Product<br> | Drug: Naproxen Tablets, 500 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioequivalency, naproxen
Measuring Physiology to Determine if Pre-panic Attack Detection is Possible

Study Overview
=================
Brief Summary
-----------------
Participants will be asked to wear a physiological monitoring device for 1 week and record when panic events occur. Once the device is returned, the data will be downloaded and analyzed.

Official Title
-----------------
Measuring Physiology in Individuals With Panic Disorder to Determine if Panic Attack Detection is Possible

Conditions
-----------------
Panic Disorder

Intervention / Treatment
-----------------
* Device: Garmin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Panic disorder as described in the Diagnostic and Statistical Manual - 5 (DSM-5) Exclusion Criteria: Pregnancy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Garmin|A commercial grade health wearable|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panic event | A timestamp of when a panic attack occurred | 1 year | 
| Heart Rate | Beats per minute | 1 year |
A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be effective in the ICU and emergency room setting for detecting increased ICP and is an accepted standard for such measurements. The primary hypothesis is that changes in ICP occur following CPB without clinically appreciable signs and symptoms. These changes in ICP will be reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.

Official Title
-----------------
A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Conditions
-----------------
Congenital Heart Disease, Congenital Heart Defect

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients less than 18 years of age undergoing cardiac bypass. Exclusion Criteria: None

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fontan<br>Patients undergoing Fontan procedure to redirect blood flow from the lower body to the lungs. | Diagnostic Test: Ultrasound<br>* Ocular ultrasound to measure optic nerve sheath diameter (ONSD).<br>|
| Active Comparator: Non-Fontan<br>Patients undergoing other cardiac surgeries requiring cardiopulmonary bypass. | Diagnostic Test: Ultrasound<br>* Ocular ultrasound to measure optic nerve sheath diameter (ONSD).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic Nerve Sheath Diameter | Optic nerve sheath diameter normal values: ≤4.0 mm for patients <1 year and ≤4.5 mm used for patients ≥1 year of age, thus there is potential for worse outcomes with higher diameters. | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic Nerve Sheath Diameter: Short Versus Long Cardiopulmonary Bypass (CPB) Time | Short CPB time defined as <100 minutes. Long CPB time defined as ≥ 100 minutes. | Day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary bypass
Supplementation in Tennis

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to examine supplementation (e.g. caffeine or creatin) use in both male and female professional tennis players.

Official Title
-----------------
Supplementation in Tennis: an Observational Study

Conditions
-----------------
Supplements, Tennis, Nutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professional tennis player Exclusion Criteria: Any metabolic disease or a possible pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Tennis players<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supplementation questionnaire | The participants will be asked about their supplementation use using a questionnaire. Participants will have a list of possible supplements on this questionnaire and they will be asked to indicate which supplement they take on a regular basis (at least once every three months). The primary outcome measure will be the frequency (as a percentage) of the supplement intake. | October 2017 - September 2018 |
Determination of Immune Phenotype in Glioblastoma Patients

Study Overview
=================
Brief Summary
-----------------
Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite intensive research efforts and a multimodal management that actually consists of surgery, radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the current observational study is to determine immune phenotypes in individual patients with GBM at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase (MGMT), epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data, such as progression free and overall survival, Karnofsky index (progression free survival (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes, biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages, myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could predict a positive response to specific immunological therapeutic strategies and select the individual therapeutic plan for an individual GBM patient.

Official Title
-----------------
Determination of Immune Phenotype in Glioblastoma Patients

Conditions
-----------------
Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult glioblastoma multiforme Exclusion Criteria: pregnancy, unable to give consent

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 |
| --- | --- |
| Isocitrate dehydrogenase - 1 mutated<br>Immunophenotype of Glioblastoma and correlation with outcome | Procedure: Surgery<br>* Tumor resection<br>|
| Isocitrate dehydrogenase - 1 wild type<br>Immunophenotype of Glioblastoma and correlation with outcome | Procedure: Surgery<br>* Tumor resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3 months | 
| Karnofsky performance score |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune phenotype, Cytokines, Genetic aberration, Overall survival, Progression free survival
Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for suspected ACS patients at the emergency department (ED) and intensive care unit (ICU).

Detailed Description
-----------------
The present study is a single-center, prospective diagnostic study among patients presenting to the ED or ICU within 24 h of onset of chest pain suggestive of suspected ACS. We propose to construct the biobank of ACS and evaluate the potential diagnostic value of circulating microRNAs compared with cTnI for suspected ACS patients. All the patients are to be followed up for 6 months. Final diagnosis was made by an expert panel cardiologist, based on all available clinical information including cTnI measurements, ECG, coronary angiography, cardiac exercise tests and information from hospital discharge letters. The concentrations of microRNAs will be evaluated by quantitative reverse transcription PCR, using highly specific primers and hybridization probes.

Official Title
-----------------
Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected ACS patients (STEMI, NSTEMI, and UA): Age>18 years; Informed consent. Exclusion Criteria: Patients who will undergo immediate PCI; Pregnant and lactating women; Patients with mental disorders; Patients are using other experimental drugs; Refusal to provide informed.
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 |
| --- | --- |
| Suspected ACS group<br>Patients admitted to the hospital with the diagnosis of ACS | |
| Blank control group<br>Patients admitted to the hospital without the diagnosis of ACS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the diagnostic value of microRNAs in qPCR，in ACS |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the prognostic value of microRNAs in ACS |  | 6 months |