linjc16/ctgov huggingface dataset:
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)

Study Overview
=================
Brief Summary
-----------------
To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer

Detailed Description
-----------------
For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.

Official Title
-----------------
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)

Conditions
-----------------
Gastric Neoplasm

Intervention / Treatment
-----------------
* Procedure: Surgery: abdominal and transhiatal approach
* Procedure: Surgery: left thoraco-abdominal approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven adenocarcinoma 75 years old or younger forced expiratory volume in one second ≥ 50 % arterial oxygen pressure in room air ≥ 70 mmHg clinically T2/T3/T4 with ≤3 cm esophageal invasion written consent Exclusion Criteria: Carcinoma in the remnant stomach Borrmann type 4 (linitis plastica) synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma history of left thoracotomy, or left pleural adhesion past history of myocardial infarction or positive results of exercise ECG liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%

Ages Eligible for Study
-----------------
Maximum Age: 75 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 |
| --- |
|Procedure: Surgery: abdominal and transhiatal approach|nan|
|Procedure: Surgery: left thoraco-abdominal approach|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse-free survival |  |  | 
| operative morbidity and mortality |  |  | 
| quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stomach neoplasms, lymph node resection, cardia, thoracotomy
The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Vaginal cuff closure - vertical
* Procedure: Vaginal cuff closure - horizontal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital Age 18 or older Able to give informed consent to participate in the research study Exclusion Criteria: Age less than 18 Unable to give informed consent Patients undergoing radical hysterectomy Patients receiving vaginal cuff radiation within the study period Patients undergoing concomitant pelvic floor or vaginal suspension procedure

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vertical<br>Vaginal cuff closure performed in a vertical manner. | Procedure: Vaginal cuff closure - vertical<br>* Vaginal cuff is closed vertically.<br>|
| Active Comparator: Horizontal<br>Vaginal cuff closure performed in a horizontal manner. | Procedure: Vaginal cuff closure - horizontal<br>* Vaginal cuff is closed horizontally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal length | Vaginal length will be measured in cm by standard POP-Q measurements | 1-3 weeks postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal length | Vaginal length will be measured in cm by standard POP-Q measurements | 3-4 months postop | 
| Cuff closure time | Time will be recorded by the circulating nurse in seconds | intra-op |
Study to Investigate Sleep Apnea Patients at Altitude

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the effect of an altitude sojourn on patients with the obstructive sleep apnea syndrome

Detailed Description
-----------------
Previous observations do not allow to draw firm conclusions on the effect of altitude sojourn on sleep, breathing and daytime performance in patients with the obstructive sleep apnea syndrome. Furthermore, the susceptibility of sleep apnea patients to high altitude related illness is not known. Therefore, the purpose is to study untreated patients with obstructive sleep apnea syndrome living at low altitude during a sojourn of a few days at moderate altitude in order to evaluate the physiologic effects of hypobaric hypoxia in these patients. We hypothesize that: 1. Sleep and nocturnal breathing disturbances in untreated OSA patients are more pronounced at moderate altitude compared to low altitude. 2. The increase in sleep related breathing disturbances at moderate altitude is due to an increase in central apnea/hypopnea

Official Title
-----------------
Study to Investigate Sleep Apnea Patients at Altitude

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Other: altitude exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstructive sleep apnea syndrome based on symptoms and a sleep study Exclusion Criteria: Sleep disorders other than obstructive sleep apnea syndrome Other than mild, stable cardiovascular disease Other than mild lung disease Chronic rhinitis, previous uvulopalatopharyngoplasty Treatment with drugs that affect respiratory center drive Internal, neurologic or psychiatric disease that interferes with sleep quality Previous intolerance to moderate or low altitude < 2600m

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: altitude exposure|sojourn at moderate altitude (1860m and 2590m) during 2 days/nights each|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and severity of sleep disordered breathing |  | during altitude sojourn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alterations in sleep structure and vigilance; high altitude related illness |  | during altitude sojourn |
Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. an fMRI Study

Study Overview
=================
Brief Summary
-----------------
This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Specifically, this project aims to assess neurophysiological (fMRI - activation and functional connectivity) and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar disorders and the therapeutic response to the psychoeducation. The results of this thesis project would also contribute to the validation of a pathophysiological model of the bipolar disorder.

Official Title
-----------------
Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.

Conditions
-----------------
Conditions Influencing Health Status, Bipolar Disorders

Intervention / Treatment
-----------------
* Behavioral: psychoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of bipolar disorders euthymic (Montgomery and Asberg depression rating scale < 10, Young Mania rating scale < 10) Exclusion Criteria: other concomitant psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psychoeducation<br>psychoeducation (12 weeks) | Behavioral: psychoeducation<br>* Bipolar disorders are educated to learn about their pathology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI measurement (neurophysiological [fMRI - activation and functional connectivity]) | measurements were performed before (T1) and after (T2) educational program of 12 sessions .One session last one hour and half once a week (they come at the hospital for all sessions : i.e. during 12 weeks). Thus, T1 to T2 is 3 months (average). | measurements were performed at T1 and T2 (up to 3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorders, euthymic, psychotherapy, Functional magnetic resonance imaging
OSA Screen Negative With Spinal Duramorph

Study Overview
=================
Brief Summary
-----------------
Non emergent scheduled cesarean sections will be consented to participate in this study of patients who have screened negative for obstructive sleep apnea and who are also BMI>/= 35 to have capnography monitoring postoperatively. The capnography and pulse oximetry will be initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data will be retrieved after that time period in a deidentified fashion. Medication usage will be reviewed as well as the standard of care information from the duramorph monitoring will be retrieved.

Official Title
-----------------
A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression and Sleep Disorder Pattern During Postoperative Neuraxial Opioid Analgesia in OSA Screened Negative With BMI>=35 Kg/m2 Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry/Capnography

Conditions
-----------------
Respiratory Depression

Intervention / Treatment
-----------------
* Device: Capnography monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSA screen negative per hospital protocol age 18 or greater BMI>35 consent to participate to wear capnography and pulse oximetry monitoring devices post delivery Exclusion Criteria: Spanish speaking only under age 18 contraindication to receiving drugs utilized in delivery anesthetic

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: capnography monitoring<br>single arm, all subjects receiving duramorph will receive capnography monitoring | Device: Capnography monitoring<br>* capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery<br>* Other names: pulse oximetry;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Depression/Suppression | defined by values obtained utilizing capnography and pulse oximetry | up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea screen negative, respiratory depression, cesarean section
IL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous coronary intervention and coronary artery bypass surgery. Animal studies suggest remote ischemic preconditioning increases levels of interleukin 10. The investigators aim to determine whether remote ischemic preconditioning results in an increase in IL-10 levels in patients following acute myocardial infarction.

Official Title
-----------------
Interleukin-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction.

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Blood pressure cuff insufflation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Acute myocardial infarction Exclusion Criteria: - Cardiogenic shock Active ischemia

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic preconditioning<br>Remote ischemic preconditioning performed with Blood pressure cuff insufflation | Other: Blood pressure cuff insufflation<br>* Blood pressure cuff will be inflated to a pressure of 200mmHg for 5 minutes. This will be repeated x 3, separated by 5 minutes.<br>|
| No Intervention: Standard of care<br>Standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 10 levels |  | 24 hours following RIPC | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote ischemic preconditioning, inflammation
Patent Foramen Ovale in Cryptogenic Stroke Study

Study Overview
=================
Brief Summary
-----------------
The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.

Official Title
-----------------
Patent Foramen Ovale in Cryptogenic Stroke Study

Conditions
-----------------
Ischemic Stroke, Patent Foramen Ovale

Intervention / Treatment
-----------------
* Drug: Warfarin
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 30-85 Ischemic stroke within 30 days Glasgow outcome scale ≥ 3 No contraindications to warfarin/aspirin Exclusion Criteria: Basal INR > 1.4 Post-procedural stroke Severe carotid atherosclerosis Cardioembolic stroke Contraindications to transesophageal echocardiography

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Warfarin<br>Warfarin (target International Normalized Ratio: 1.4 to 2.8) plus placebo aspirin | Drug: Warfarin<br>* Warfarin once a day, titrated to obtain an INR of 1.4 to 2.8; placebo aspirin once a day<br>* Other names: Coumadin;|
| Active Comparator: Aspirin<br>Aspirin 325 mg plus placebo warfarin | Drug: Aspirin<br>* Aspirin 325 mg once a day; placebo warfarin once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent ischemic stroke and death |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebrovascular diseases, ischemic stroke, patent foramen ovale, warfarin, aspirin, transesophageal echocardiography
National Exhaustive Cohort of Hereditary Stomatocytoses and Other Channelopathies Affecting the Red Blood Cell

Study Overview
=================
Brief Summary
-----------------
Hereditary stomatocytosis is a heterogeneous group of rare constitutional diseases of dominant transmission in the vast majority of cases. The data concerning their clinical and biological presentation, and their evolution are few, and come from about thirty clinical cases. The constitution of an exhaustive French cohort of hereditary stomatocytosis will improve the establishment of the diagnosis and the management of patients

Detailed Description
-----------------
The patient is prospectively included. The referring hematologist will inform the patient about participation in the cohort, give him the information note and obtain his non-objection agreement to the use of his data for research purposes. The data will be collected from the medical file of each patient as part of his usual annual follow-up.

Official Title
-----------------
National Exhaustive Cohort of Hereditary Stomatocytoses and Other Channelopathies Affecting the Red Blood Cell

Conditions
-----------------
Stomatocytosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with a diagnosis of stomatocytosis without age limit Patient affiliated or beneficiary of french Social Security No objection from the patient or legal representative Exclusion Criteria: Diagnosis of stomatocytosis excluded by ektacytometry and / or genetics Patient under guardianship, with curators or legal protection
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 |
| --- | --- | --- |
| Obtain a description of the clinical and laboratory data of patients at the time of diagnosis of stomatocytosis | Descriptive analysis of clinical and biological data for the diagnosis of stomatocytosis | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the proportion of recurrent genetic mutations and private mutations within our cohort | Number of recurrent genetic mutations and private mutations within our cohort | Baseline | 
| Establish phenotypes-genotypes relationships | Specify the phenotypic presentation of each mutation and isolate any correlations genotype-phenotype | through study completion, an average of 15years | 
| Describe the appearance of complications | Rate of occurrence of complications over time | through study completion, an average of 15years | 
| Describe possible new phenotypic presentations of hereditary stomatocytosis | Description of the phenotypic presentations of hereditary stomatocytosis | through study completion, an average of 15years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rare genetic disease