linjc16/ctgov huggingface dataset:
A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability

Official Title
-----------------
A Study to Assess the Effect of a High-fat Meal and Increased Gastric pH on the Bioavailability of an Extended-release Formulation of BMS-663068 in Healthy Subjects

Conditions
-----------------
Infection, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: BMS-663068


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Target population: Healthy males and females. Males and females Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test Women must not be breastfeeding Men and WOCBP must agree to follow instructions for contraception Exclusion Criteria: History of any chronic or acute illness or gastrointestinal disease Any major surgery within 4 weeks of study drug administration Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population. History of allergy to HIV attachment inhibitors, famotidine or high fat meal History of smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Single BMS-663068 tablet under fasted conditions | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Treatment B<br>Single BMS-663068 tablet with a high fat meal | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Treatment C<br>Single BMS-663068 tablet after a single famotidine tablet under fasted conditions | Drug: BMS-663068<br>* BMS-663068<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Days 1-12 | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF) |  | Days 1-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation | Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment. | Days 1-12; for SAEs up to 30 days post discontinuation of dosing |
Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

Study Overview
=================
Brief Summary
-----------------
Acute low back pain is one of the most common reasons for all physician visits(1). Phospholipase A2 (PLA2), a potent inflammatory mediator, has demonstrated to be released by discs following injury(4). Clinical practice and animal research suggest that lumbar radicular pain is the result of inflammation of the nerve root in the epidural space(5). The study will evaluate the efficacy of intravenous Dexamethasone for acute disc herniation-induced sciatica. 40 patients aged 18 years or older, who will be transferred to the emergency room due to sciatic pain will be blindly randomized to receive Dexamethasone 30 mg IV for 3 days an tapering off, 10 mg daily, or normal saline. 20 patients will be in each group. The patients will continue their standard care during the study period. Follow up will last for 3 months. Mann-Whitney test will be used for parametric correlation, Wilcoxon for numeral and x² for categorial variables. Dexamethasone IV can help physicians in treating patients with acute sciatic pain.

Official Title
-----------------
Efficacy of Intravenous Dexamethasone for Acute Disc Herniation-Induced Sciatica

Conditions
-----------------
RADICULAR PAIN

Intervention / Treatment
-----------------
* Drug: DEXAMETHASONE
* Other: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or older presented with acute radicular pain for less than 6 weeks. Exclusion Criteria: Patient with acute infection, Psychiatric disorder, Uncontroled diabetes, Uncontrolede hypertension, Severe congestive heart failure, Cauda equina syndrome, Moderate or severe motor deficit, Primary spinal stenosis, Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: 1 TREATMENT GROUP<br>20 PATIENTS WILL RECEIVE DEXAMETHASONE 30 MG IV 3 DAYS AND 20 AND 10 MG FOR THE OTHER TWO DAYS | Drug: DEXAMETHASONE<br> <br> |
| Placebo Comparator: 2<br>20 PATIENTS WILL RECEIVE PLACEBO FOR 5 DAYS | Other: PLACEBO<br> <br> |

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
-----------------
RADICULAR PAIN, DISC HERNIATION, DEXAMETHASONE, VAS
Effect of Rapid Transfusion With Fluid Management System (FMS) on Plasma Potassium in Liver Transplantation Recipients

Study Overview
=================
Brief Summary
-----------------
Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However, potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in the reservoir of rapid infusion system and its effect on the plasma potassium change during rapid transfusion are unknown. This study is designed to investigate these changes while massive transfusion is performed during liver transplantation surgery.

Official Title
-----------------
Potassium Change in the Fluid Management System (FMS) Reservoir and Its Effect on the Plasma Potassium Concentration During Liver Transplantation Surgery

Conditions
-----------------
Condition Requiring Rapid Transfusion During Liver Transplantation Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preoperative anemia (hemoglobin < 10 g/dl) preoperative coagulopathy Exclusion Criteria: children under age 18 low risk of intraoperative bleeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- |
| Potassium concentration<br>plasma potassium concentrations in the Fluid Management System (FMS) reservoir, arterial blood, and central venous blood | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| potassium concentration in the Fluid Management System (FMS) reservoir | During bolus transfusion (300ml) of blood mixture, blood sample is taken from the side port of infusion line of Fluid Management System (FMS) when 150 ml of blood mixture was transfused. Because the priming volume of the internal circuit is approximately 100 ml, blood sample that was taken after 150 ml transfusion represents the content in the reservoir. | after transfusion of 150 ml of blood mixture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma potassium of the patient | Just before transfusion starts, blood samples are taken from the central venous catheter and arterial line at the same time to measure baseline values. At the immediate end of transfusion, blood samples are taken again from the same sites to measure the resultant changes. | before and after transfuison of 300 ml of blood mixture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transfusion, liver transplantation, potassium
Influence Positive End-expiratory Pressure on Autoregulation in Patients With Respiratory Insufficiency

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to characterize the influence of an elevated positive end-expiratory pressure in patients with acute respiratory distress syndrome or acute lung injury on the cerebrovascular autoregulation.

Detailed Description
-----------------
Cerebral blood flow velocity will be measured using transcranial Doppler sonography and then correlate with the invasive arterial blood pressure curve to calculate the index of cerebrovascular autoregulation Mx (Mx>0.3 indicates impaired AR). The index of cerebrovascular autoregulation Mx was measured during baseline positive end-expiratory pressure (PEEP) levels and after lung recruitment with higher level of PEEP. The equality between this two PEEP levels was estimated and calculated with one side Wilcoxon test.

Official Title
-----------------
Influence of Positive End-expiratory Pressure on the Cerebrovascular Autoregulation in Patients With Respiratory Failure

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Procedure: positive end-expiratory pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: respiratory failure Age >18 years Invasive ventilation Exclusion Criteria: Sepsis preexisting cerebral illness traumatic brain injury meningitis or encephalitis 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| respiratory failure<br>patients with respiratory failure and need of high positive end-expiratory pressure ventilation. | Procedure: positive end-expiratory pressure<br>* Elevation of positive end-expiratory failure for recruitment<br>* Other names: PEEP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integrity of the cerebrovascular autoregulation (CA) | Cerebrovascular autoregulation will be calculated as a moving correlation index (Mx) from the cerebral blood flow velocity and the arterial blood pressure. It is a parameter without unit (index). | 30 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute respiratory distress syndrome, acute lung injury, cerebrovascular autoregulation, transcranial Doppler, ventilation
Cost-effectiveness of Extracorporeal Life Support Treatment

Study Overview
=================
Brief Summary
-----------------
This study evaluates patients on ECLS treatment as considered appropriate with mortality and health related Quality of life and costs.

Detailed Description
-----------------
A direct comparison between usual care and ECLS treatment is difficult. Alternatively we compare predicted mortality for every patient based on validated scoring systems at the initiation of ECLS treatment with the actual outcome, so every patient is his own control. Primary outcome is HRQoL assessed with the EQ-5D questionnaire at 1 year. Healthcare costs and costs from a societal perspective are prospectively measured.

Official Title
-----------------
A Multicenter Prospective Observational Cohort Study Determining the Cost-effectiveness of Extracorporal Life Support (ECLS) Treatment

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Behavioral: Health related Quality of life EQ-5D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to intensive care Treated with extracorporeal life support Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Health related Quality of life EQ-5D|Quality of Care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health related quality of life | health related quality of life with EQ-5D questionnaire at 6 and 12 months | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extracorporeal life support, health related quality of life
Evolution of Perceived Stress in General Practice Residents During COVID-19 Sanitary Crisis

Study Overview
=================
Brief Summary
-----------------
Over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. Because of COVID-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress.

Detailed Description
-----------------
This prospective non-interventional study aims to evaluate via two questionnaires the evolution of perceived stress in general practice residents of two centres in France, Rouen and Caen. The two questionnaires contain the Perceived Stress Scale, as well as items regarding socio-demographic data and stress factors. The first questionnaire is to be distributed during the epidemic COVID-19 wave and the second questionnaire at the end of the epidemic COVID-19 wave.

Official Title
-----------------
Evaluation of Evolution of Perceived Stress in General Practice Residents of Rouen and Caen During COVID-19 Sanitary Crisis

Conditions
-----------------
Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a general practice resident in Rouen or Caen Participant informed and non-objection of him/her Exclusion Criteria: Being on maternity leave or not working during the period concerned with the questionnaires

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of perceived stress during the epidemic wave of COVID19 vs. at the end of the epidemic wave of COVID19 | The perceived stress will be evaluated using the Perceived Stress Scale. This scale contains 10 items, with scores ranging from 0 to 40, with higher scores meaning a higher level of stress. | maximum 6 months, according to the evolution of the epidemic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of general characteristics of residents and their feelings and experiences with the sanitary crisis | This include socio-demographic characteristics, work-related information and potential stress factors | maximum 6 months, according to the evolution of the epidemic | 
| Assessment of residents' profile stress according to their socio-demographic and working characteristics | Identification of stress factors among residents | maximum 6 months, according to the evolution of the epidemic |
Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester

Study Overview
=================
Brief Summary
-----------------
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.

Official Title
-----------------
Serum Cholesterol Reduction Efficacy of Biscuit With Added Plant Stanol Ester

Conditions
-----------------
Dyslipidemias, Hypercholesterolemia, Hyperlipidemias

Intervention / Treatment
-----------------
* Dietary Supplement: Plant stanol ester
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l) fasting serum triglyceride levels below 3.0 mmol/l normal liver, kidney and thyroid function no lipid lowering medication no history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, temporal ischemic attack and malignant diseases Exclusion Criteria: alcohol abuse (> 4 portion/per day) pregnancy use of plant stanol and plant sterol products and equivalent cholesterol lowering products, though the ones who have discontinued the consumption of these products minimum 3 weeks before the beginning of the study, can be included

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo biscuit<br>Biscuit without plant stanol ester | Dietary Supplement: Placebo<br> <br> |
| Experimental: Plant stanol ester biscuit<br>Biscuit with plant stanol esters | Dietary Supplement: Plant stanol ester<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption in subjects consuming the biscuit with or without a meal |  | 4 weeks |
Lung Transplant Specimen Repository and Data Registry Protocol

Study Overview
=================
Brief Summary
-----------------
All patients enrolled in the registry will be recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts). During the routine management of lung recipients frequent surveillance of the lung allograft is necessary. This routinely involves: measurement of pulmonary functions, chest radiography, collection of peripheral blood to assess other organ function and monitor therapeutic drug levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung tissue biopsy. This surveillance normally follows a set schedule during the first one to two years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8, 12, 24, 36, and 52 during the first year following the transplant procedure. Additional surveillance may be performed at any time when clinically indicated for the optimal management of the recipient. Information and specimens collected from each of these encounters will be entered in the data registry and specimen repository.

Detailed Description
-----------------
The collection of disposable lung allograft (transplant tissue samples), blood samples and information from medical records for storage, future analysis and research. Stored samples will be available to other researchers who have obtained separate review and approval from an ethics committee called an Institutional Review Board. Immediately prior to the transplant surgery, the surgeon or pulmonologist will routinely examine the lungs via bronchoscopy during which subjects will be medicated for pain. The samples that are obtained during this and post-surgery (clinically scheduled) bronchoscopies, including bronchial lavage, are either sent to pathology or are discarded if they do not qualify to go to pathology. For this research, the researchers are asking that the samples that do not qualify for pathology be placed into the repository instead of being thrown away.

Official Title
-----------------
Lung Transplant Specimen Repository and Data Registry Protocol

Conditions
-----------------
Lung Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).

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 |
| --- | --- | --- |
| data registry and lung tissue repository |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung tissue repository
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The study aimed to prove EEN is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult CD patients. They plan to include about 50 patients and observe the effect of EEN.

Conditions
-----------------
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment

Intervention / Treatment
-----------------
* Drug: EEN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old Patients with CD was diagnosed clinically according to previously established international criteria [9] The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis. Exclusion Criteria: Patients do not macth the inclusion criteria and those who refuse to taking part in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission after 12 weeks EEN |  | July 2013 to October 2015 |