linjc16/ctgov huggingface dataset:
A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.

Official Title
-----------------
A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Phentermine/Topiramate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed the qualifying OB-202 trial If females of child-bearing potential, subjects must be using adequate contraception Provide written informed consent Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures Exclusion Criteria: Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Phentermine/Topiramate<br>* phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Oral placebo capsules, once daily, 28 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c Change From Baseline Week 0 to Week 56 |  | Baseline to 56 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Loss From Baseline to Week 56 |  | Baseline to 56 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Type 2 Diabetes, Diabetes Mellitus, Metabolic Diseases, Glucose Metabolism Disorders, Glycemic Control
Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

Detailed Description
-----------------
This study aims to investigate the therapeutic efficacy of PIPAC using doxorubicin and cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin.

Official Title
-----------------
Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase II Clinical Trial

Conditions
-----------------
Recurrent Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: chemotherapy with doxorubicin and cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 2 lines of previous chemotherapy recurrent ovarian cancer patient is mobile informed consent Exclusion Criteria: ileus necessity of parenteral nutrition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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: intraperitoneal chemotherapy<br>Intraperitoneal chemotherapy with cisplatin at a dose of 7.5 mg/m2 body surface in a 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi. | Drug: chemotherapy with doxorubicin and cisplatin<br>* intraperitoneal chemotherapy applied as an aerosol and under pressure<br>* Other names: CISPLATIN Teva, Adrimedac;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Rate | The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | left heart ejection fraction, neurological status, laparoscopy complications intraoperative, laparoscopy complications postoperative until hospital discharge, re-admission to hospital, death | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, recurrent, chemotherapy, intraperitoneal
Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.

Official Title
-----------------
Randomized Comparison of Radiofrequency Catheter Ablation vs. Antiarrhythmic Therapy With Amiodarone for Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Radiofrequency catheter ablation
* Drug: Amiodarone and cardioversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic atrial fibrillation Exclusion Criteria: Left atrial diameter >55 mm Left ventricular ejection fraction <0.30 Contraindication to amiodarone therapy or anticoagulation with warfarin Presence of a mechanical prosthetic valve History of a cerebrovascular accident Presence of left atrial thrombus on TEE Prior attempt at catheter or surgical ablation for atrial fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Radiofrequency catheter ablation|nan|
|Drug: Amiodarone and cardioversion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of complications |  |  | 
| changes in left atrial diameter |  |  | 
| changes in left ventricular ejection fraction |  |  | 
| changes in symptom severity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, catheter ablation, amiodarone, cardioversion
Study of Stress Hyperglycemia as an Indicator of Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. All subjects are consented and have a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes mellitus over the course.

Official Title
-----------------
Stress Hyperglycemia as an Indicator for Future Diabetes Mellitus: A Prospective Cohort Study

Conditions
-----------------
Stress Hyperglycemia, Diabetes Mellitus Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the intensive care unit at the Yale New Haven Hospital St. Raphael Campus and Norwalk Hospital Exclusion Criteria: Patients with prior history of diabetes mellitus Elevated admission HbA1c (≥6.5%) Age >80 years Metastatic disease with expected life expectancy of less than 12 months Pregnancy or a woman who plans to become pregnant

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stress Hyperglycemic Group<br>Repeat HbA1C in 1 year | |
| Euglycemic Group<br>Repeat HbA1C in 1 year | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects with an HbA1c greater than or equal to 6.5% |  | 1 year |
Chances in Portal System Flow After Two Bariatric Procedures

Study Overview
=================
Brief Summary
-----------------
Obesity if a health endemic problem over the entire world. Bariatric surgery is the best chance for those patients with morbid obesity to loss weight and to maintain the loosed weight. Metabolic surgery is the new name for bariatric surgery like sleeve gastrectomy and gastric by pass due to the recognized changes in the homeostasis of the hormonal secretion responsive to the hunger status. After sleeve gastrectomy we observe many patients with thrombus of the portal vein system. This phenomena may be attributed to changes in the portal flow due to devascularization of the great curvature of the stomach. The aim of the study is to compare the portal flow by intra-operative Doppler ultrasound before and after surgery of the two procedures as sleeve gastrectomy and gastric bypass, were the vascularization is not changed by the surgery.

Official Title
-----------------
Comparison in Portal Flow After Sleeve Gastrectomy and Mini Gastric Bypass

Conditions
-----------------
Portal Vein Thrombosis

Intervention / Treatment
-----------------
* Procedure: Laparoscopic sleeve gastrectomy
* Procedure: Laparoscopic mini gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients accepted for bariatric surgery for the bariatric surgery committee. Primary procedure No hypercoagulability status know Exclusion Criteria: Hypercoagulability status patients after any abdominal surgery of the forgut

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleeve gastrectomy<br>US DOopler for Patient with BMI of 40 or more than 35 with co-morbidities underwent Sleeve gastrectomy | Procedure: Laparoscopic sleeve gastrectomy<br>* Doppler ultrasound.<br>Procedure: Laparoscopic mini gastric bypass<br>* Doppler ultrasound.<br>|
| Active Comparator: Mini Gastric Bypass<br>US DOopler for Patient with BMI of 40 or more than 35 wtih co-morbidities underwent mini gastric bypass | Procedure: Laparoscopic sleeve gastrectomy<br>* Doppler ultrasound.<br>Procedure: Laparoscopic mini gastric bypass<br>* Doppler ultrasound.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Portal flow | physiological parameter | three month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the relation between the operation and thrombosis | physiological parameter and number of thrombosis found. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | three month |
Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to a 6-month course of leuprolide versus ethinyl estradiol/norethindrone (Ovcon 35) versus leuprolide plus Ovcon 35. Leuprolide is administered intramuscularly in depot form every 28 days.

Conditions
-----------------
Hyperandrogenism

Intervention / Treatment
-----------------
* Drug: leuprolide
* Drug: Ethinyl estradiol/norethindrone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Disease Characteristics Ovarian hyperandrogenism with Lorenzo hirsutism score 7 to 20, with or without severe acne Serum hormone levels: Follicle-stimulating hormone no greater than 40 mIU/mL Luteinizing hormone no greater than 40 mIU/mL Testosterone 60 to 200 ng/dL Dehydroepiandrosterone sulfate no greater than 430 micrograms/dL 17-hydroxyprogesterone no greater than 3.3 ng/mL in follicular phase Prolactin no greater than 18 ng/dL No adrenal or ovarian tumors Prior/Concurrent Therapy At least 6 months since exogenous steroids At least 48 hours since drugs other than acetaminophen, ibuprofen, and aspirin Patient Characteristics No malignancy, including the following carcinomas: Breast Cervix Ovary Uterus No other serious illness No cigarette smokers No nursing women No pregnancy within 6 months prior to entry

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: leuprolide|nan|
|Drug: Ethinyl estradiol/norethindrone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endocrine disorders, hyperandrogenism, rare disease
Peak Systolic Global Longitudinal Strain and Low Cardiac Output Syndrome After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This is a retrospective observational study to assess the relationship between peak systolic global longitudinal strain measured on pre-cardiopulmonary bypass trans-esophageal echo images predicts post-operative low cardiac output syndrome defined as the need for an inotropic support during 24 hours or longer.

Conditions
-----------------
Low Cardiac Output Syndrome After Adult Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: Cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery involving the use of cardiopulmonary bypass Availability of pre-cardiopulmonary bypass trans-oesophageal echo images allowing measurement of the peak systolic global longitudinal strain Exclusion Criteria: Preoperative atrial fibrillation Preoperative critical state Emergent/salvage surgery Heart transplant surgery Left ventricular assist device implantation

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 |
| --- |
|Procedure: Cardiac surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative low cardiac output syndrome | Need for pharmacological inotropic support during 24 hours or more post-operatively | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of intensive care unit stay |  | 30 days | 
| Length of hospital stay |  | 30 days | 
| 30-day or in hospital mortality |  | 30 days | 
| duration of post-operative mechanical ventilation |  | 30 days | 
| post-operative acute kidney injury |  | 30 days | 
| Need for readmission to the intensive care |  | 30 days |
Efficiency of Neurostimulation of Tibial Nerve in the Treatment of Low Anterior Resection Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficiency of the Neuroestimulation of the Posterior Tibial Nerve for the treatment of this syndrome. A multicentric, prospective, randomized study will be performed in patients affected with severe LARS symptoms. Patients will be randomized in two groups: Control group- placebo Treatment group: neuroestimulation of the posterior tibial nerve

Official Title
-----------------
Prospective and Randomized Study to Evaluate the Efficiency of Percutaneous Neurostimulation of Posterior Tibial Nerve in the Treatment of Low Anterior Resection Syndrome (LARS)

Conditions
-----------------
Colorectal Surgery

Intervention / Treatment
-----------------
* Device: Posterior tibial nerve stimulation
* Device: Sham posterior tibial nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 and under 75 years who have been undergone anterior resection of the rectum with sphincter preservation for rectal cancer Patients with LARS score > 29 Exclusion Criteria: Patient with intestinal inflammatory disease Patients with known irritable colon disease Pregnancy patients Patients with others intestinal resection segments different from the rectum Patients with metastatic disease Patient with previous history of posterior tibial neurostimulation or sacral nerve stimulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibial nerve stimulation<br>Tibial nerve stimulation during 16 sessions | Device: Posterior tibial nerve stimulation<br> <br> |
| Sham Comparator: Sham comparator<br>Sham tibial nerve stimulation during 16 sessions | Device: Sham posterior tibial nerve stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tibial nerve stimulation efficacy measured by LARS score |  | 1 month | 
| Tibial nerve stimulation efficacy measured by LARS score |  | 3 months | 
| Tibial nerve stimulation efficacy measured by LARS score |  | 6 months | 
| Tibial nerve stimulation efficacy measured by LARS score |  | 12 months |
Myofascial Pain and Central Sensitization

Study Overview
=================
Brief Summary
-----------------
This prospective, observational cohort pilot study compared pain phenotyping and functional measures in 30 participants with non-acute neck and/or shoulder girdle pain consistent with primary myofascial pain at 3-months following a physical therapy referral to study the impact of their baseline degree of pain amplification.

Official Title
-----------------
The Impact of Nociplastic Pain Features on the Response to Physical Therapy in Patients With Primary Myofascial Pain: A Pilot Study.

Conditions
-----------------
Myofascial Pain, Physical Therapy

Intervention / Treatment
-----------------
* Other: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking participants Diagnosed by their physician with non-acute (more than two weeks) neck and/or shoulder girdle primary myofascial pain Referred to a physical therapy treatment. Exclusion Criteria: In an effort to reduce the potential that another medical condition could lead to a secondary myofascial pain response, extensive comorbid exclusion criterion. Use of chronic high-dose opioid medication greater than 100 mg oral morphine equivalents per day. Individuals receiving or applying for compensation or disability. The inability to provide informed consent. Severe physical impairment (e.g., blindness, deafness) Co-morbid medical condition limiting function (e.g., malignant cancer) Reported illicit drug use Severe psychiatric condition that would limit judgment. Lack of internet access.

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 |
| --- | --- |
| Patients with myofascial pain having centralized pain features<br>Adult patients with myofascial pain having centralized pain features who will be undergoing physical therapy | Other: Physical Therapy<br>* Physical therapy for chronic upper quarter myofascial pain syndrome, as prescribed by the patients' physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neck Disability Index | Function neck scale with a total possible score of 50 indicating worse function compared to a score of 0. | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PEG Score | Multidimensional measure for initial assessment and follow-up of chronic pain in a primary care setting. The average of 3 domains with an averaged score of 0 to 10; 0 means lower pain interference and 10 means higher pain interference with life. | Baseline to 3 months |