linjc16/ctgov huggingface dataset:
Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess and compare the side effect profile, safety, tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially- responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day of quetiapine during 8 weeks.

Official Title
-----------------
A Canadian, Multicenter, Double-Blind, Randomized, Parallel-Group Study of the Safety, Tolerability, and Efficacy of Treatment With Higher Doses of Quetiapine Fumarate (Seroquel®) Greater Than 800 mg/Day in Schizophrenic or Schizoaffective Subjects.

Conditions
-----------------
Schizophrenia, Schizoaffective Disorders

Intervention / Treatment
-----------------
* Drug: Quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Men and women, age 18-65 years with persistent positive or negative symptoms with a PANSS total score of ≥ 70 and < 110 and a Clinical Global Improvement (CGI)- Severity of Illness score of at least 4 (moderately ill) at screening. Subjects may be treated as in- or out-patients. Subjects must give written informed consent. Exclusion Criteria: Subjects with other psychiatric, medical or behavioural comorbid disorder that may interfere with study conduct or interpretation. Female of childbearing potential, unless the subject is using a reliable method of contraception Subjects with alcohol or psychoactive-substance dependence not in full remission or with significant alcohol or substance abuse in the past 3 months will be excluded. Laboratory test results outside the range of reference considered by the investigator to be clinically significant. Inability to respect the visit schedule and known intolerance to quetiapine at 800mg/day.

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, schizoaffective disorders
Sepraspray™ Laparoscopic Myomectomy Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.

Official Title
-----------------
A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy

Conditions
-----------------
Laparoscopic Myomectomy

Intervention / Treatment
-----------------
* Device: Sepraspray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL. Exclusion Criteria: Pregnant/lactating women. The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid. The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sepraspray<br>Sepraspray applied directly to both sides of the uterus, Fallopian tubes, and ovaries (or opposing sites if not possible to apply directly). Sepraspray was applied via a sterile cannula at a tissue concentration of approximately 5 mg/cm^2. | Device: Sepraspray<br> <br> |
| No Intervention: Control<br>No anti-adhesion treatment was used. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage. |  | 30 Days post surgery | 
| Efficacy endpoints are on adhesion formation and will include the success the success criterion for the individual patients as either anterior or posterior uterus free of dense adhesions. |  | Until end of study |
The Detection of Barrett's Esophagus by Gastrointestinal Endoscopy Prevents Esophageal Carcinoma in Morbid Obese After Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Severe Gastroesophageal reflux disease (GERD) leading to a chronic aggression of esophagus mucosa, called Barrett's esophagus is a main complication of Sleeve gastrectomy for morbid obesity. Barrett's esophagus is considered as a early stage of neoplastic transformation to adenocarcinoma. Since this last years, six european bariatric centers have adopted the policy to realize endoscopy before and five years or more after sleeve gastrectomy. Investigators worked out a database comprizing the Endoscopic features and patient characteristics. Refleeve projet aim to analyse the long term follow-up datas of 100 patients, evaluate the prevalence of Barret's esophagus and investigate the advantage of the systemetic detection to prevent esophagus adenocarcinomas.

Official Title
-----------------
Refleeve : A Retrospective Study to Evaluate the Prevalence of the Barett's Esophagus by Gastro-osephagal Endoscopy in Morbid Obese Patients Treated by Sleeve Gastrectomy and the Advantage of the Systematic Detection in the Prevention of Esophageal Carcinoma

Conditions
-----------------
Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had had SG with a minimum follow-up of 5 years, without signs of Barrett's esophagus before SG; An upper GI endoscopy before the SG; An upper GI endoscopy indicating that no Barrett's esophagus was present at the time of the SG; An upper GI endoscopy done with the scope of searching for the endoscopic anomalies of the Barrett's esophagus according to the international guidelines for the diagnosis of Barrett's esophagus 9. Endoscopic biopsies according to the international guidelines for the diagnosis of Barrett's esophagus 9. Exclusion Criteria: SG as a conversional procedure from another bariatric procedure such as the gastric banding; No upper GI endoscopy before the SG Barrett's esophagus before the SG; A second procedure after the SG such as the conversion to Roux-en-Y gastric bypass or duodenal switch; An upper GI endoscopy done not following the international guidelines for the diagnosis of Barrett's esophagus9.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleeve gastrectomy | Gastroesophageal endoscopic features before and five years after sleeve gastrectomy | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity related comorbidity | obesity related comorbidity before and five years or more after sleeve gastrectomy | 5 years |
The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism

Study Overview
=================
Brief Summary
-----------------
Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism.

Conditions
-----------------
Idiopathic Hypogonadotropic Hypogonadism

Intervention / Treatment
-----------------
* Drug: hCG 1500 IU three times a week
* Drug: Pregnyl (hCG) ampule 1500 IU/three times a week


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, - Exclusion Criteria: Previous androgen treatment, diabetes mellitus, arterial hypertension other hormone deficiencies -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 16 treatment naive Hypogonadotropic hypogonadism patients<br>Treatment naive 16 patients with idiopathic hypogonadotrophic hypogonadism | Drug: hCG 1500 IU three times a week<br> <br> * Other names: Pregnyl (Organon) ampule 1500 IU;Drug: Pregnyl (hCG) ampule 1500 IU/three times a week<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL after hCG treatment | 2011-2013 | 2011-2013 | 
| LDL levels after hCG treatment |  | 2011-2013 | 
| total cholesterole levels after hCG treatment |  | 2011-2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat ratio after hCG treatment |  | 2011-2013 | 
| hsCRP levels after hCG treatment |  | 2011-2013 |
Prospective Data Collection of IVMRI Cases

Study Overview
=================
Brief Summary
-----------------
The study purpose is to prospectively collect data for a set of predefined variables in clinical cases where coronary plaque lipid characterization by IVMRI was performed during diagnostic or interventional procedures in order to gather incremental information beyond angiography and other diagnostic modalities.

Official Title
-----------------
Prospective Data Collection in Clinical Cases Where Coronary Plaque Lipid Characterization by IVMRI Was Performed During Diagnostic or Interventional Catheterization Procedures

Conditions
-----------------
Coronary Plaque Lipid Characterization

Intervention / Treatment
-----------------
* Device: IVMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An adult patient ≥ 18 years old. The patient, or legal guardian, has been informed of the nature of the study, agrees to its provisions, and has sign the approved informed consent. The patient and the treating physician agree to attend the follow-ups as defined in the study protocol. Indication for diagnostic and/or interventional procedure. Lesions in a native vessels where IVMRI interrogation may provide additional information beyond angiography and other diagnostic tools. Exclusion Criteria: Culprit lesions within 48 hours following STEMI. Tortuous vessels, calcified or thrombotic lesions. Significant stenosis of an unprotected left main coronary artery. IVMRI interrogation of an unprotected left main coronary artery. Patients with pacemaker or cardioverter defibrillator. The patient is suffering from transplant mediated coronary artery disease.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: IVMRI<br>* Intra Vascular Magnetic Resonance Imaging<br>* Other names: Cathamaran;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LFI - Lipid Fraction Index |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between LFI and a set of predefined parameters |  | 5 years |
Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

Study Overview
=================
Brief Summary
-----------------
The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. This study will answer whether using a VL will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Official Title
-----------------
Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: Direct laryngoscopy
* Device: Video laryngoscopy (Glidescope)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician Exclusion Criteria: Difficult airway Oxygen saturation < 92% despite adequate mask ventilation

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 |
| --- | --- |
| Active Comparator: Direct laryngoscopy<br>Intubation will be done using direct laryngoscopy | Procedure: Direct laryngoscopy<br> <br> * Other names: standard laryngoscope;|
| Active Comparator: Video laryngoscopy<br>Intubation will be done using video laryngoscopy | Device: Video laryngoscopy (Glidescope)<br> <br> * Other names: Glidescope Video Laryngoscope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Pass Success Rate |  | From begining of intubation to verification. Less then 5 minutes approximatly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Desaturation | sat <80% | For 10 minutes post intubation | 
| Hypotension | SBP<70 | For 10 minutes post intubation | 
| Cardiac Arrest |  | For 1 hour post intubation | 
| Complications of Intubation | Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury. | For 10 minutes post intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urgent endotrachel intubation, Direct laryngoscopy, Video laryngoscopy, Glidescope, Critical Care
Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

Study Overview
=================
Brief Summary
-----------------
To our knowledge, few cases of relapse in adulthood are described in the literature except in patients with sickle cell disease and the epidemiological, clinical, laboratory, radiological features and the management of osteomyelitis relapsing in adulthood are not described. The aim of this retrospective multicentric cohort study : in France is to describe the epidemiological, clinical, laboratory, and radiological features and the management of adult patients who experienced a relapse between 2003-2015 of an acute hematogenous osteomyelitis acquired in the childhood (description of characterization of the period between the first episode of osteomyelitis and the second episode, description of signs of relapse and description of treatments used in the relapse). The data are analysed with non-comparative descriptive statistics.

Official Title
-----------------
Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

Conditions
-----------------
Osteomyelitis, Hematogenous Osteomyelitis Relapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥ 18 years) who presented a relapse between 2003-2015 of a hematogenous osteomyelitis acquired in childhood. the time limit between the 2 episodes must be at least 2 years antecedent of osteomyelitis before 16 years Exclusion Criteria: inability to give the information to the patient patients opposed to the use of their data

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients having an osteomyelitis | Description of the population | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of bacteria responsible for infection | bacterial epidemiology | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 
| rate of management with surgery | Description of type of surgery | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 
| Rate of Treatment Failure | Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematogenous osteomyelitis, relapse, adulthood
Seizures Post Intracerebral Hemorrhage

Study Overview
=================
Brief Summary
-----------------
This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.

Official Title
-----------------
Are Post Intracerebal Hemorrhage Prevented By Anti-Epileptic Treatment?

Conditions
-----------------
Post Cerebral Hemorrhage

Intervention / Treatment
-----------------
* Drug: valproic acid
* Drug: placebo bid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebral hemorrhage spontaneous Exclusion Criteria: early seizures
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: valproic acid<br>Valproic acid given orally 400mg twice daily | Drug: valproic acid<br>* treatment of 1 month dosage of 400 mg BID<br>Drug: placebo bid<br> <br> |
| Placebo Comparator: placebo<br>Placebo twice daily for one month | Drug: placebo bid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of seizures |  | study drug for 1 month and 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological outcome NIHSS |  | during 1 month study drug and 1 year post follow up |
n-3 Polyunsaturated Fatty Acids in Obesity

Study Overview
=================
Brief Summary
-----------------
Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.

Official Title
-----------------
Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients

Conditions
-----------------
Adipose Tissue Inflammation, Morbid Obesity

Intervention / Treatment
-----------------
* Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
* Drug: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-diabetic morbidly obese patients (BMI > 40 kg/m2) supposed to undergo bariatric surgery Age 20-65 yrs Exclusion Criteria: Acute illness within the last two week Known diabetes mellitus or current anti-diabetic medication Acquired immunodeficiency (HIV infection) Hepatitis or other significant liver disease Severe or untreated cardiovascular, renal, pulmonary disease Untreated or inadequately treated clinically significant thyroid disease Anemia Active malignant disease Inborn or acquired bleeding disorder including warfarin treatment Pregnancy or breast feeding Drug intolerability that prohibits the use of the study drug

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: n-3 PUFA<br> | Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)<br>* 4g daily, 8 weeks<br>* Other names: Omacor®;|
| Placebo Comparator: Control<br> | Drug: control<br>* equivalent amount of fat as butter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adipose tissue inflammation |  | Eight weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control |  | Eight weeks of treatment | 
| Dependence of effects on Pparg polymorphisms |  | Eight weeks of treatment |