linjc16/ctgov huggingface dataset:
Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Official Title
-----------------
A Phase III Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in an Adult Population With BMI ≥ 35

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: VI-0521
* Drug: VI-0521
* Drug: Placebo matched phentermine/topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥ 35 kg/m2 Informed consent 70 years of age or less Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension Fasting blood glucose level of ≤ 110 mg/dL Exclusion Criteria: Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months Clinically significant renal, hepatic or psychiatric disease Unstable thyroid disease or replacement therapy Nephrolithiasis Obesity of known genetic or endocrine origin Participation in a formal weight loss program or lifestyle intervention History of glaucoma or intraocular pressure Pregnancy or breastfeeding Alcohol abuse Smoking cessation within previous 3 months or plans to quit smoking during study Eating disorders Cholelithiasis within past 6 months Excluded medications Type 2 diabetes Previous bariatric surgery History of bipolar disorder or psychosis

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: VI-0521 Low<br>VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg) | Drug: VI-0521<br>* 3.75 mg phentermine/23 mg topiramate<br>|
| Experimental: VI-0521 Top<br>Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate. | Drug: VI-0521<br>* 15 mg phentermine/92 mg topiramate<br>|
| Placebo Comparator: Placebo<br>Placebo to match | Drug: Placebo matched phentermine/topiramate<br>* Placebo matched phentermine/topiramate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Loss From Baseline to Week 56 |  | baseline to 56 weeks | 
| Percentage of Subjects With at Least 5% Weight Loss at Week 56 |  | baseline to 56 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, morbid obesity
Family-Centered Diabetes Project

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to determine whether a diabetes lifestyle program will improve the lives of Native American people living with diabetes. We recruited Native American people living in 8 Pueblo communities served by 3 Indian Health Service clinics. Forty percent of people living with diabetes in those communities participated in an interview and had height, weight, blood pressure and hemoglobin A1c measured at the beginning. Then they received a lifestyle program in either groups or one-on-one, or another group which got the intervention after one year (comparison group). The program was developed using input from community members, tribal leaders, and clinic staff, and was taught by community members in or near the participating communities. After each session, participants were asked for feedback about the curriculum. After the program ended, the interview and clinical measures were repeated. Feedback to tribal leaders and clinical staff is ongoing.

Official Title
-----------------
Family-Centered Diabetes Project for Pueblo Native Americans

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

Intervention / Treatment
-----------------
* Behavioral: lifestyle (exercise, diet, and family and community support)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years or older with diabetes living in a participating Native American community served by one of three participating Indian Health Service clinics. Exclusion Criteria: Unable to complete a yearly interviewer administered questionnaire and clinical measures of height, weight, blood pressure, and fingerstick hemoglobin A1c. Unable to participate in 5 lifestyle intervention meetings occurring over a one year period.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: lifestyle (exercise, diet, and family and community support)|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
-----------------
diabetes, lifestyle intervention, Native American, community intervention, diet, exercise
Laparoscopic Versus Open Left Colonic Resection

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection. 268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.

Detailed Description
-----------------
The study design was explained to the potential participants who were asked to sign a written informed consent before randomization. Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.

Official Title
-----------------
Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial

Conditions
-----------------
Colon Cancer, Benign Disease

Intervention / Treatment
-----------------
* Procedure: laparoscopic left colonic resection
* Procedure: open left colonic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years suitability to elective surgery Exclusion Criteria: cancer infiltrating adjacent organs assessed by computed tomography cardiovascular dysfunction (New York Heart Association class > 3) respiratory dysfunction (arterial pO2 < 70 mmHg) hepatic dysfunction (Child-Pugh class C) ongoing infection plasma neutrophil level < 2.0x109/L

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: LPS<br>laparoscopic left colonic resection | Procedure: laparoscopic left colonic resection<br>* laparoscopic colonic resection<br>|
| Active Comparator: Open<br>open left colonic resection | Procedure: open left colonic resection<br>* conventional open colonic resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short-term morbidity rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term outcome |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left colon cancer
A Hospital Based Survey on Lung Cancer Related-pain in Northern China

Study Overview
=================
Brief Summary
-----------------
This cross-sectional study, utilizing two sets of questionaire designed for patients and physicians respectively, aims at the epidemiology, the clinical features, and the current status of evaluation and management of lung cancer related pain in 20 participating hospitals in Northern China.

Detailed Description
-----------------
Lung malignancies have become the most common cause of mortality among patients with cancer in China. A significant proportion of lung cancer patients suffer from cancer related pain, however few studies have reported the prevalence and clinical features of such pain, especially in China. This study is a cross-sectional survey in 20 hospitals in Northern China. We designed two separate series of questions to be answered by patients and cancer management professionals. In the patient questionaire, we collect information on the prevalence, location, intensity, impact on life of lung cancer related pain. Questions on how doctors evaluate and manage the pain are included in both the patients' and physicians' surveys. In the doctors' questionaire, we also assess current situation of cancer pain educational programs attended in medical schools and post graduation through related questions.

Official Title
-----------------
Clinical Characteristics, Evaluation and Management of Lung Cancer Related-pain in Northern China: a Hospital-based Cross-sectional Study

Conditions
-----------------
Cancer Pain, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient questionaire All patients (outpatient and inpatient) diagnosed with lung cancer visiting the participating hospitals on the designated day of investigation Informed consent must be obtained from the participating patients The physician questionaire All physicians who receive lung cancer patients (outpatient and inpatient) in the participating hospitals on the designated day of investigation
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 |
| --- | --- | --- |
| Prevalence of cancer-related pain in lung cancer patients in 20 hospitals in northern China | the proportion of self-reported pain related to cancer affecting the enrolled lung cancer patients over the past 24 hours | 24 hours |
Frequency and Causes of Failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi Endoscopy Unit

Study Overview
=================
Brief Summary
-----------------
The failure can be traced backed to operator causes, technical causes and patient causes. the most common etiology is cannulation failure. ERCP complications includes post-ERCP pancreatitis, perforation, bleeding, cholangitis and cholecystitis.

Official Title
-----------------
Frequency and Causes of Failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi Endoscopy Unit

Conditions
-----------------
ERCP, Failure, Complications, Cannulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cases underwent ERCP in our center from 1st of January, 2013 to 1st of January. 2021 with any causes of jaundice or any indication for which ERCP was done. Exclusion Criteria: incomplete data or missing files were excluded from this study

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Frequency and causes of failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi endoscopy unit |  | 2 years |
Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Primary aim is to compare the effectiveness of the posterior approach Transversus abdominis plane block (P-TAP) and the lateral approach Transversus abdominis plane block (L-TAP) technique on the pain management of the laparoscopic nephrectomy in terms of visual analog pain scale and postoperative opioid consumption. Secondary aim is to compare complication rates of the two techniques.

Official Title
-----------------
Comparison of Two Different Approach Ultrasound Guided TAP Block on Pain Management of Laparoscopic Nephrectomy: Posterior or Lateral Approach?

Conditions
-----------------
Analgesia, Patient-Controlled, Postoperative Pain, Acute

Intervention / Treatment
-----------------
* Procedure: lateral tap block
* Procedure: posterior tap block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASAI-III patients undergoing laparoscopic nephrectomy 18<BMI<40 Exclusion Criteria: infection at the block site coagulation disorder pregnancy kidney failure liver failure heart failure allergy to local anesthetics patient refusal

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group L<br>Lateral transversus abdominis plane(TAP) block | Procedure: lateral tap block<br>* In the axial plane on the midaxillary line between the subcostal margin and the iliac crest with a linear probe using a 12 cm insulated nerve block needle is advanced in planely from skin, external, and internal oblique muscles to the target of fascial plane between the internal oblique and the transversus abdominis muscles.<br>|
| Active Comparator: Group P<br>Posterior transversus abdominis plane block | Procedure: posterior tap block<br>* In the axial plane on the midaxillary line a linear probe using a 12 cm insulated nerve block needle is advanced posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain scale 0 |  | at the PACU arrival | 
| Visual analog pain scale 1 |  | Postoperative first hour | 
| Visual Analog Pain scale 2 |  | Postoperative second hour | 
| Visual analog pain scale 6 |  | Postoperative sixth hour | 
| Visual Analog Pain scale 12 |  | Postoperative 12. hour | 
| Visual Analog Pain scale 18 |  | Postoperative18. hour | 
| Visual Analog Pain scale 24 |  | Postoperative 24. hour | 
| opioid comsuption |  | Within 24 hours postoperatively |
Inflammatory Bowel Disease (IBD) and Covid-19 Infection

Study Overview
=================
Brief Summary
-----------------
Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.

Official Title
-----------------
SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management

Conditions
-----------------
Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over the age of 18 years IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis) Patient agreeing to participate in the study Exclusion Criteria: Patient unable to understand the study protocol or to answer simple anamnestic questions due to language barrier Patient under guardianship or trusteeship Patient under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients |  | Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Inflammatory Bowel Disease, IBD, Crohn's disease, Ulcerative colitis, Immunosuppressant therapy, Biologicals, Severe respiratory disease, intensive care unit, Mechanical ventilation, Death
Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.

Official Title
-----------------
Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study. Exclusion Criteria: Patients who do not agree to be included in the study.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| <40 years<br>subjects aged less than 40 years | |
| 40-60 years<br>subjects aged 40-60years | |
| > 60 years<br>subjects aged greater than 60 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydroxyproline Concentration | Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule. | 3-4 months | 
| Neoangiogenesis | Measure new blood vessels in AlloMaxTM and adjacent capsule | 3-4 months | 
| Collagen I and III | Measure collagen I and III in AlloMaxTM and adjacent capsule | 3-4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast reconstruction, Hydroxyproline concentration, neoangiogenesis, collagen deposition
Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) increase cardiovascular risk and endothelial dysfunction. Hydroxychloroquine (HCQ) is expected to improve endothelial dysfunction through some metabolic effects. The investigators intend to find the role of HCQ to improve endothelial dysfunction in RA patients. This study will also evaluate correlation HOMA-IR (homeostasis model assessment-estimated insulin resistance), FFA (free fatty acid) and ox-LDL (oxidized-LDL) level change, with endothelial dysfunction improvement.

Official Title
-----------------
Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid Arthritis patients (2010 ACR/EULAR criteria) Being or will be treated with methotrexate (monotherapy) Agree to join the study Exclusion Criteria: Autoimmune diseases other than RA Acute severe infection, acute coronary syndrome, heart failure, stroke Malignancy or chronic inflammatory diseases Eye disease involving the retina and visual field defects G6PD (glucose 6-phosphate dehydrogenase) deficiency History of smoking within last 5 years Lipid lowering, insulin resistance lowering, antidiabetic, insulin, ACE(angiotensin converting enzyme)-inhibitor or ARB(angiotensin receptor blocker) drugs

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine<br> | Drug: Hydroxychloroquine<br>* Hydroxychloroquine 400mg once daily initially<br>* Other names: HCQ;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial dysfunction marker | VCAM | 3 months | 
| Endothelial dysfunction marker | E-Selektine | 3 months |