linjc16/ctgov huggingface dataset:
Extended-release vs Immediate-release Metformin in PCOS Women

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with PCOS in accordance with Rotterdam criteria Exclusion Criteria: pregnancy diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) past history of cardiovascular diseases past history of gastro-intestinal diseases significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal); neoplasms.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PCOS women treated with 1500 mg/die of extended-release metformin | Drug: Metformin<br> <br> |
| Experimental: 2<br>PCOS women treated with 1500 mg/die of immediate-release metformin | Drug: Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro intestinal disorders |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cycles in 6 months of therapy |  | 6 months | 
| insulin levels |  | 6 months | 
| hirsutism score |  | 6 months | 
| androstenedione levels |  | 6 months | 
| testosterone levels |  | 6 months | 
| free androgen index |  | 6 months | 
| dheas levels |  | 6 months | 
| ovarian volume |  | 6 months | 
| total cholesterol |  | 6 months | 
| tryglycerides levels |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, metformin
Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.

Detailed Description
-----------------
Schizophrenic patients taking any kind of antipsychotics for at least 1 year at the Seoul National Hospital will be participated in this study. we are planning to enroll approximately 1000 patients with schizophrenia. For each subject abdominal circumference body mass index lipid profile : TG, HDL-chlo, total chol systolic/diastolic blood pressure fasting blood glucose will be measured. we will calculate the rates of patients who meet the criteria for the Metabolic syndrome. Abdominal obesity : absolute criteria 2 or more of followings Triglyceride ≥ 150mg/dL or ongoing treatment HDL-cholesterol < 40mg/dL (men) HDL-cholesterol < 50mg/dL (female) or ongoing treatment Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment FBS ≥ 100mg/dL or previous diagnosis of type II DM

Official Title
-----------------
Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics

Conditions
-----------------
Metabolic Syndrome, Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients taking a same antipsychotics at least more than one year schizophrenia or schizoaffective disorder Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| A, observatoin<br>inpatients and outpatients in Seoul National Hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic syndrome |  | cross-sectional | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| each factor of metabolic syndrome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, antipsychotics, metabolic syndrome, prevalence
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.

Official Title
-----------------
Pre-operative PSG Assessment of Cardiac Surgery Inpatients

Conditions
-----------------
Sleep Disordered Breathing, Obstructive Sleep Apnea, Central Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia. Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment. Exclusion Criteria: Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days. Subjects undergoing Maze procedure for atrial fibrillation. Subjects unable to comply with study procedures.
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 Surgeries: CABG, valve replacements<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients |  | September 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Post-Operative Complications of Patients with Sleep Disordered Breathing |  | September 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, apnea, obstructive, central
A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.

Official Title
-----------------
A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Antidepressant + Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18 years or older Experiencing Major Depressive Disorder with a duration of minimally 8 weeks. Treatment history of an inadequate response to at least one and no more than four antidepressants

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Antidepressant + Aripiprazole<br> | Drug: Antidepressant + Aripiprazole<br>* Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments |  | throughout the study |
Changes of Dendritic Cells in Acute Lung Injury

Study Overview
=================
Brief Summary
-----------------
To observe changes of circulating and tissue dendritic cells in acute lung injury,including invasive aspergillosis pneumonia

Detailed Description
-----------------
Change of circulating and tissular dendritic cells of patients with acute lung injury was still unclear, we used a flow cytometry-based assay to quantify circulating and tissular DCs and their HLA-DR surface expression at the time of diagnosis and during the first week of evolution in patients with acute lung injury, and healthy people as controls.

Official Title
-----------------
Changes of Dendritic Cells in Acute Lung Injury

Conditions
-----------------
Acute Lung Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sepsis induced acute lung injury Exclusion Criteria: Younger than 18-year-old Pregnancy Cancer or organ transplant Asthma COPD Heart Failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients with acute lung injury<br>Patients with sepsis induced acute lung injury | |
| Postsurgery patients<br>Postsurgery patients without acute lung injury and sepsis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality |  | 28day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dendritic cell
Pentax Videolaryngoscopy in Children

Study Overview
=================
Brief Summary
-----------------
Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in pediatric patients

Detailed Description
-----------------
Pentax video laryngoscope (Pentas AWS, Pentax, Tokyo, Japan) is one of indirect optical laryngoscopes which is recently developed. Several studies have shown that the Pentax-AWS® provides full views of the glottis in the majority of patients. It makes successful tracheal intubation in patients after failed intubation using a Macintosh laryngoscope. In pediatric patients who is expected to be difficult to intubate, Pentax makes successful intubation.

Official Title
-----------------
A Comparison of Pentax AWS Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children: a Randomized Controlled Trial

Conditions
-----------------
Intubation;Difficult

Intervention / Treatment
-----------------
* Device: Pentax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1, 2 Scheduled surgery under general anesthesia Exclusion Criteria: Intraoral disease Congenital anomaly C-spine injury Patients who need Rapid sequence induction

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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 |
| --- | --- |
| Pentax group<br>Intubation using Pentax | Device: Pentax<br>* Intubation using Pentax video laryngoscope in Pentax group<br>|
| Macintosh group<br>Intubation using Macintosh | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | from laryngoscope pass incisors to end tidal CO2 appears | less than 10 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation difficulty score | IDS parameter is Number of attempts > 1 = N1 Number of operators >1 = N2 Number of alternative techniques = N3 Cormack and Lehane grade minus 1 = N4 Operator perception of lifting force required Normal N5 = 0 Greater than in routine practice N5=1 Laryngeal pressure applied Not applied N6=0 Applied N6=1 Vocal core mobility Abduction N7=0 Adduction &/or impending tube passage N7=1 Total IDS = sum of scores N1 N7 | less than 10 minute |
Hyponatremia and Myometrium Contractility. An Invitro Study

Study Overview
=================
Brief Summary
-----------------
Hyponatremia during labour has been associated with prolonged labour, and increased incidence of instrumental delivery and emergency caesarean section. Sodium influx in myometral cells are involved in contractility,and and influence of hyponatraemia on contractility can be suspected.

Detailed Description
-----------------
Biopsies will be obtained from pregnant women undergoing planned caesarean section at term. The biopsies will divided into 3 strips that will be stored overnight in chilled NaCl 0.9%. The following morning each strip will be mounted isometrically with one end fixed to a holder and the other end to a force transducer. One strip will be maintained in a solution containing 140mmol/L Na,acting as control, whereas the other two strips will be placed in fluids with diminishing Na concentration, from 140 mmol/L, to 130 mmol/L and 120 mmol/L. Contractility will be measured with force transducers and a polygraph

Official Title
-----------------
Will Reduction in Plasma Sodium Reduce Myometrium Contractility in Humans? An Invitro Study of Pregnant Myometrium at Term.

Conditions
-----------------
Hyponatremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy at term Exclusion Criteria: Preeclampsia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 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 |
| --- | --- | --- |
| Contractility | Contractility will be measured, and data analyzed. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contractility, human, myometrium, hyponatraemia
3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS).

Detailed Description
-----------------
This is an open-label, non-randomized, non-comparative expanded access study. Up to 25 patients with clinically proven paraneoplastic or primary autoimmune LEMS per EMG and positive voltage-gated calcium channel antibody serology, OR patients with clinically proven CMS per electromyogram (EMG), biopsy or genetic testing who meet the selection criteria outlined in sections 3.1 and 3.2 will be enrolled in this study. Subjects will receive 3,4-diaminopyridine (3,4-DAP) starting with a low dose and titrating up per efficacy and patient tolerance to a maximum daily dose of 100mg . Treatment will continue until the subject experiences a treatment-limiting toxicity, voluntarily withdraws consent, transfers to another site, dies, becomes lost to follow-up, is no longer receiving clinical benefit from 3,4-DAP (in the opinion of the subject and/or the investigator), or the Jacobus Pharmaceuticals or the FDA discontinues the study.

Official Title
-----------------
Open Label Trial Of 3,4-Diaminopyridine In Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS)

Conditions
-----------------
Lambert-Eaton Myasthenic Syndrome, Congenital Myasthenic Syndrome

Intervention / Treatment
-----------------
* Drug: 3,4-DIAMINOPYRIDINE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LEMS diagnosis OR Pre or Post Synaptic CMS diagnosis 18 years or older Females must have negative pregnancy test and be willing to practice an effective form of birth control No prolonged QT syndrome as indicated by baseline EKG Exclusion Criteria: Known sensitivity to 3,4-DIAMINOPYRIDINE History of seizures and/or severe asthma

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 |
| --- |
|Drug: 3,4-DIAMINOPYRIDINE|Treatment will begin with a low dose and will be increased as clinically needed as tolerated. The upper limit will be a total of 100mg/day.|

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
-----------------
LEMS, CMS, 3,4 DIAMINOPYRIDINE, 3,4 DAP
Endothelial Cell Gene Networks of CVD

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to identify relevant signature gene networks of cardiovascular disease in endothelial cells derived from circulating endothelial progenitor cells of individuals with established cardiovascular disease (CVD).

Detailed Description
-----------------
The investigators propose to enroll CVD and healthy subjects between 30 and 60 years of age, matched for age, gender, body mass index, and medication (statin and anti-hypertensive) use. Circulating endothelial progenitor cells will be isolated from blood and cultured in vitro to differentiate into endothelial cells.

Official Title
-----------------
Endothelial Cell Gene Networks of CVD

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Other: isolation of endothelial cells precursors in blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for CVD subjects:: • >50% stenosis of one or more coronary arteries Inclusion Criteria for Healthy subjects: • absence of coronary artery stenosis Exclusion Criteria for all subjects: type 2 diabetes mellitus chronic kidney disease, other chronic diseases dyslipidemia (fasting plasma LDL-C >160 mg/dL and triglyceride levels >150 mg/dL)

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| CVD subjects<br>CVD will be defined as >50% stenosis of one or more coronary arteries as assessed by coronary angiography. | Other: isolation of endothelial cells precursors in blood<br>* Circulating endothelial precursor cells will be isolated and then cultured in vitro. RNA will be then isolated.<br>|
| healthy controls<br>healthy controls defined as not having stenosis of coronary arteries as assessed by coronary angiography. | Other: isolation of endothelial cells precursors in blood<br>* Circulating endothelial precursor cells will be isolated and then cultured in vitro. RNA will be then isolated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression | Gene expression [ identify relevant signature gene networks of cardiovascular disease in endothelial cells] | 10 weeks |
Treatment of Polytraumatisms With Corticoids

Study Overview
=================
Brief Summary
-----------------
Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic complications and organs injuries.

Official Title
-----------------
Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency

Conditions
-----------------
Polytraumatism

Intervention / Treatment
-----------------
* Drug: hydrocortisone
* Drug: NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age superior of 15 years Hospitalization in reanimation for polytraumatism (lesion of two organs with a vital risk) SISS score more than 15 Intubation for more than 48 hours. Agreement of a family member Patient with insurance Exclusion Criteria: History of corticothérapies within 6 months History of adrenocortical insufficiency. Treatment by immunosuppressor Immunodeficiency.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Experimental: H<br>Hydrocortisone | Drug: hydrocortisone<br>* 200mg/jour (solution of 48mL), Day 1 to Day 4 100mg/jour (solution of 48mL), Day 5 50mg/jour (solution of 48mL), Day 6<br>|
| Placebo Comparator: P<br>Treatment by NaCl (placebo) | Drug: NaCl<br>* 48mL from Day 1 to Day 6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc. |  | 28 days | 
| Incidence of nosocomial pneumopathy |  | Day 8 |