linjc16/ctgov huggingface dataset:
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Green tea consists of several components, with most research focusing on the polyphenol fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has been shown to effectively reduce the inflammation associated with animal models of inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.

Official Title
-----------------
A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis

Conditions
-----------------
Mild to Moderately Active Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Polyphenon E®
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female with mildly to moderately active ulcerative colitis Exclusion Criteria: Off prohibited medications for proscribed period of time Evidence of infectious colitis Labs outside of range Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyphenon E treatment<br>Polyphenon E® therapy was given for 56 days. | Drug: Polyphenon E®<br>* Oral capsules<br>|
| Placebo Comparator: Placebo<br>Oral Placebo | Drug: Placebo Oral Tablet<br>* Oral tablet: placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission. | This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity. Each variable is scored from 0-3 so that the total index score ranges from 0-12; 0-2: remission; 3-6: mild; 7-10: moderate; >10: severe UC. | day 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, Ulcerative colitis, EGCG, Green tea polyphenols, Inflammatory bowel disease, Colitis, Green tea
A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults

Study Overview
=================
Brief Summary
-----------------
The primary objective of this trial is to examine the weight-loss efficacy of Freshly Fit meals, as well as body composition, waist/hip circumference, metabolic markers, and quality of life in overweight and obese adults.

Official Title
-----------------
A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Other: FreshlyFit Meals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 21-55 years of age, inclusive, at Visit 1 (Day -10). BMI of 25.00 to 34.99 kg/m2, inclusive, at Visits 1 and 2 (Day -10 and -3). Non-smoker and has no plans to change smoking habits during the study period. Willing to follow study instructions. Willing and able to comply with the visit schedule (e.g., subjects with travel plans and cannot fully comply with study instructions will be excluded). Exclusion Criteria: Abnormal laboratory test result of clinical significance at Visit 1 (Day -10), at the discretion of the Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day -3) for subjects with abnormal laboratory test results. History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurological disorders that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator. History of gastrointestinal surgery for weight reducing purposes. Participation in a weight loss trial within 12 mo of Visit 1 (Day -10). Weight loss or gain ≥10 lb (4.5 kg) within the 6 mo prior to Visit 1 (Day -10). Participation in a program/service intended to alter body weight (e.g., Nutrisystem, Weight Watchers, Noom) within 6 mo of Visit 1 (Day -10).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Low carbohydrate, high protein meals | Other: FreshlyFit Meals<br>* FreshlyFit meals are low carbohydrate, high protein meals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change |  | 16 Weeks |
Mobile Phone Technology to Increase Genetic Counseling

Study Overview
=================
Brief Summary
-----------------
This innovative project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. Using the Fogg Behavioral Model, developed from the concept of persuasive technology, this study proposes to develop the Mobile Application for Genetic Information on Cancer (mAGIC) intervention to motivate ovarian cancer survivors to undergo genetic counseling. The overall study objective is to develop and assess the feasibility and effectiveness of a theory-based intervention aimed to encourage ovarian cancer survivors to receive genetic counseling

Detailed Description
-----------------
This project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. Using the Fogg Behavioral Model31 (FBM), developed from the concept of persuasive technology, this study proposes to develop the Mobile Application for Genetic Information on Cancer (mAGIC) week-long intervention to motivate ovarian cancer survivors to undergo genetic counseling.

Official Title
-----------------
Mobile Phone Technology to Increase Genetic Counseling for Women With Ovarian Cancer and Their Families

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

Intervention / Treatment
-----------------
* Behavioral: mAGIC app


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman diagnosed with ovarian, primary peritoneal or fallopian tube cancer 18 years old or older At least a fifth grade education Able to read and write in English Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: • Known major psychiatric or neurological diagnosis

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receive 7-day mAGIC app intervention and handout | Behavioral: mAGIC app<br>* 7-day app to encourage uptake of genetic counseling<br>|
| No Intervention: Control<br>Handout only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of cancer genetic counseling | Report of attendance of an appointment with genetic counselor to discuss cancer genetics related to ovarian cancer diagnosis | 3 months |
Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women

Study Overview
=================
Brief Summary
-----------------
This study partially replicates two previous studies with normal weight women, and overweight women. Both found that women could compensate for sucrose added to the diet in carbonated soft drinks (4 x250ml total1800 kJ per day) when it was given blind over a period of 4 weeks. The hypothesis is that this applies also to obese women, who will not gain weight, increase overall energy intake in the diet, or eat differently whilst consuming sucrose. 42 participants shall be randomly assigned to either be given carbonated drinks that contain sucrose, or drinks that are artificially sweetened.

Official Title
-----------------
Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women

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

Intervention / Treatment
-----------------
* Dietary Supplement: Sucrose
* Dietary Supplement: Aspartame


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female BMI 30-35 kg/m² at least one period of dietary restriction of 4 weeks or more in the last 24 months Exclusion Criteria: dislike of popular sweet carbonated drinks dieting during the last month history of diabetes having an eating disorder depression, being a smoker pregnant lactating, wearing a pacemaker currently taking medication for mood or thyroid disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: Sucrose<br>Receives sucrose | Dietary Supplement: Sucrose<br>* Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day)<br>* Other names: Irn Bru;|
| Placebo Comparator: Aspartame<br>Receives Aspartame sweetened drinks | Dietary Supplement: Aspartame<br>* Intensely sweetened soft drink (no energy content)<br>* Other names: Diet Irn Bru;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from baseline |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily dietary intake estimated from unweighed food diaries |  | 4 weeks |
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Detailed Description
-----------------
Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

Conditions
-----------------
Depression, Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Levomilnacipran ER
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18-65 years old Currently meet the DSM-IV-TR criteria for Major Depressive Disorder The patient's current depressive episode must be at least 4 weeks in duration Exclusion Criteria: Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control Patients with a history of meeting DSM-IV-TR criteria for: any manic or hypomanic episode schizophrenia or any other psychotic disorder obsessive-compulsive disorder Patients who are considered a suicide risk

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing. | Drug: Levomilnacipran ER<br>* Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.<br>|
| Placebo Comparator: 1<br>Matching placebo capsules, oral administration, once daily dosing. | Drug: Placebo<br>* Matching placebo to be given orally, in capsule form, once daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Relapse (Days) | Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4 | 24 Weeks |
Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria

Study Overview
=================
Brief Summary
-----------------
To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.

Official Title
-----------------
A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients With Type 2 Diabetes and Albuminuria.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: CS-3150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 20 to 80 years at informed consent Subjects with type 2 diabetes and albuminuria (urine albumin-to-creatinine ratio ≥ 30, < 1000 mg/g/Cr) Subjects with hypertension (Sitting SBP ≥ 140 mmHg, <180 mmHg and Sitting DBP ≥ 80 mmHg, <110 mmHg Treatment with an ARB or ACE inhibitor eGFR ≥ 30 mL/min/1.73m^2 Exclusion Criteria: Secondary hypertension or malignant hypertension Type 1 diabetes Secondary glucose intolerance Diagnosed with non-diabetic nephropathy Serum potassium level < 3.5 or ≥ 4.8 mEq/L

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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: CS-3150<br>CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks | Drug: CS-3150<br>* CS-3150 1.25 to 2.5, 5mg, orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic and diastolic blood pressure | Change from baseline in sitting systolic and diastolic blood pressure | Baseline to end of Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of systolic and diastolic blood pressure | Time course of systolic and diastolic blood pressure | Baseline to end of Week 12 | 
| Proportion of patients achieving blood pressure control | Proportion of patients achieving blood pressure control | Baseline to end of Week 12 | 
| Change rate from baseline in urine-albumin-to-creatinine ratio | Change rate from baseline in urine-albumin-to-creatinine ratio. | Baseline to end of Week 12 | 
| Time course of urine-albumin-to-creatinine ratio | Time course of urine-albumin-to-creatinine ratio. | Baseline to end of Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension with Type 2 Diabetes and Albuminuria, Diabetic nephropathy, Diabetic renal disease, Albuminuria, Mineralocorticoid receptor antagonist
Kidney Allograft Recipients in England - an Observational Cohort Study

Study Overview
=================
Brief Summary
-----------------
Kidney transplantation is the renal replacement therapy of choice for the majority of patients with end-stage kidney disease. Epidemiological studies of kidney allograft recipients can aid in the understanding of cause and effect of health and disease post-transplantation. The combination of health care and information technology has made the potential of transplant professionals to use health information effectively crucial to guide kidney transplant management. The aim of this study is to undertake an observational cohort study of kidney allograft recipients, supported by linking analysis across different database sources, to provide a comprehensive biomedical dataset of information.

Official Title
-----------------
An Observation Cohort Study of Kidney Allograft Recipients in England by Data Linkage Analysis

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant alone English Transplant centre All ages Kidney allograft receipt between April 2001 and March 2012 Exclusion Criteria: Multiple organ transplant Transplant performed at non-English centre
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney allograft recipients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality within the first year post kidney transplantation |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality beyond the first year post kidney transplantation |  | Up to 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplant, Kidney, England
Common Bile Duct Stones - Natural History and Interventions

Study Overview
=================
Brief Summary
-----------------
The aims of this study were to investigate what measures were taken when common bile duct stones (CBDS) were found intraoperatively in Sweden during the period May 2005 to December 2009 by using data from this population-based nationwide registry, and analyze the outcome in terms of complications and success rates of bile duct clearance in relation to various stone sizes and interventions used. In order to further characterize the natural course of CBDS of various sizes, particular interest was focused on patients with positive findings where no peroperative measures to clear the bile ducts were taken or planned postoperatively.

Official Title
-----------------
Common Bile Duct Stones - Natural History and Interventions : Data From the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangio Pancreatography (ERCP) (GallRiks)

Conditions
-----------------
Common Bile Duct Stone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: common bile duct stones Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 11 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 |
| --- | --- |
| common bile duct stone<br>Patients undergoing cholecystectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications in relation to strategy for handling CBDS | Complications reported to the registry at 30 day follow up after surgery | 30 days post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications in relation to stone size | Complications reported to the registry at 30 day follow up after surgery | 30 days post operative |
To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Postherpetic Neuralgia.

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term safety and efficacy of pregabalin in patients with postherpetic neuralgia.

Official Title
-----------------
An Open-Label Extension Safety and Efficacy Study of Pregabalin in Patients With Postherpetic Neuralgia

Conditions
-----------------
Neuralgia

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the inclusion criteria for preceding double-blind BID study in postherpetic neuralgia Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks. Exclusion Criteria: Patients cannot participate if they experienced a serious adverse event during preceding double-blind BID study which was determined to be related to the study medication.

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Efficacy |  |  |