linjc16/ctgov huggingface dataset:
Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal.

Official Title
-----------------
Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal

Conditions
-----------------
Post-prandial Glycemia

Intervention / Treatment
-----------------
* Dietary Supplement: Mulberry leaf extract
* Dietary Supplement: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female participants Healthy status (based on anamnesis) Age between 18 and 45 years BMI between 20 and 29.9 kg/m2 Ability to understand and sign an informed consent form Exclusion Criteria: Pregnant or lactating women Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments Known food allergy and intolerance to test product Medically known cutaneous hypersensitivity to adhesives and plasters Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Smokers Volunteer who cannot be expected to comply with the protocol Subject having a hierarchical link with the research team members.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Water administrated just before a meal | Dietary Supplement: Water<br>* Oral administration<br>|
| Experimental: Mulberry leaf extract before<br>250 mg of Mulberry leaf extract was administered before a standard meal | Dietary Supplement: Mulberry leaf extract<br>* Oral administration<br>|
| Experimental: Mulberry leaf extract during<br>250 mg of Mulberry leaf extract was administered during a standard meal | Dietary Supplement: Mulberry leaf extract<br>* Oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial glucose | Incremental area under the curve | Hour 0 to hour 3 after standard meal consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C max glucose | Incremental C max | Hour 0 to hour 3 after standard meal consumption | 
| T max glucose | Incremental T max | Hour 0 to hour 3 after standard meal consumption |
Automated Assessment of Mental Health in the Workplace

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (Telephone-Linked Communications for Detection of Mental Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health distress; educate them about seeking treatment; and follow up with them over a 6 month period.

Official Title
-----------------
Automated Assessment of Mental Health in the Workplace

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: Computer Assisted Education for Behavioral Change


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Employment with benefits at Boston Medical Center, Boston University, or Florida Power and Light Company Ability to speak and understand conversational English > 18 years of age Access to a touch-tone telephone Screen positive for the World Health Organization (WHO)-5 Well-Being Index Exclusion Criteria: Being under treatment (medication or therapy) for a mental health disorder Taking medication for a serious/major medical disorder that interferes with normal life Taking medication prescribed for mental health treatment on a daily basis Diagnosed with schizophrenia Planning to go on leave for over 6 months

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

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Computer Assisted Education for Behavioral Change|TLC-Detect will provide subjects in the intervention group with information about each diagnosed mental health disorder. TLC-Detect will then give the Treatment Module and will tell the intervention subjects that it will call back in one month for a follow-up or the next week if a subject is comorbid with other disorders.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absenteeism and presentism (functionality at work), measured every three months for 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment status, timing of measurement depends upon symptom severity |  | 6 months | 
| Health status measured every three months for 6 months |  | 6 months |
A Study to Evaluate Retisert in the Treatment of Patients With the Wet Form of Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
A study evaluating Retisert in patients with age-related macular degeneration

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Retisert Implant


Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- |
|Drug: Retisert Implant|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
-----------------
AMD, ARMD, Age-Related Macular Degeneration, Subfoveal Choroidal Neovascularization, CNV
Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fasting conditions.

Official Title
-----------------
Single-Dose Fasting Bioequivalence Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets (40 mg/25 mg; Mylan) to Benicar HCT® Tablets (40 mg/25 mg; Sankyo) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg
* Drug: Benicar HCT® Tablets 40 mg/25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg | Drug: Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg<br> <br> |
| Active Comparator: 2<br>Benicar HCT® Tablets 40 mg/25 mg | Drug: Benicar HCT® Tablets 40 mg/25 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 48 hours |
Family Research Study: Metabolism of Fats and Proteins in Specific Ethnic Groups

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that circulate in the blood. They contain cholesterol, fat, and protein in varying amounts depending on the body's need. Higher levels of lipoproteins in the blood can cause an increased risk of heart disease. The investigators believe that by studying the Lp(a) lipoprotein in Caucasians and African Americans, the investigators can assess for genetic variation factors related to cardiovascular (heart) disease. The investigators will be looking at 100 African-American families and 100 Caucasian families to confirm whether a higher Lp(a) level is an indicator of a higher risk for heart disease.

Detailed Description
-----------------
During the study visit the research staff will ask about the medical history, perform a brief physical exam, and draw approximately 4 teaspoons of blood of each family member.

Official Title
-----------------
Regulation of Lipoprotein(a) Metabolism in Humans With Reference to Ethnicity

Conditions
-----------------
Healthy, Heart Disease

Intervention / Treatment
-----------------
* Other: No intervention, observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Of Caucasian or African descent Families must have 2 natural/biological parents and 2 natural/biological offspring 6 years old or older Exclusion Criteria: Races other than African American or Caucasian Families without 2 natural/biological parents and 2 natural/biological offspring younger that 6 years old

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| African American Families<br>Families with 2 parents and 2 children - no intervention, observational study | Other: No intervention, observational study<br> <br> |
| Caucasian Families<br>Families with 2 parents and 2 children - no intervention, observational study | Other: No intervention, observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variation of Lp(a) levels in each group |  | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart disease, cardiovascular disease, lipoproteins, lipoprotein(a), Lp(a), apolipoprotein(a), apo(a), fats, proteins, metabolism
Characterization of Methylation Patterns in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Detailed Description
-----------------
Lots of information about the relationship between changes in methylation patterns and various diseases are accumulated in recent years. Characterization of methylation changes that occur in cancer may contribute to the development of methods for early detection of cancer by detecting cancer cells in liquids. Early detection of such changes and their correlation examining different cancers may lead to a diagnostic tool for the early detection of cancers and improve the treatment of these patients. Detection by molecular analysis can be a sensitive method and non-invasive early diagnosis of the disease In this study the investigators will collect Blood,sputum and saliva samples for Characterization of Methylation Patterns in lung Cancer.

Official Title
-----------------
Characterization of Methylation Patterns in Lung Cancer

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected lung tumor Exclusion Criteria: Patients who have active disease other than lung cancer during the sample collecting

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>patient who in the biopsy showed lung cancer | |
| control group<br>patient who in the biopsy showed not to have lung cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of Methylation Patterns in lung Cancer | Collecting and analyzing samples | two years |
Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

Study Overview
=================
Brief Summary
-----------------
This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.

Official Title
-----------------
An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct Exclusion Criteria: Patients with left ventricular ejection fraction (LVEF) < 45% Patients with thrombocytopenia, platelet count < 50 x109/L (50 x 103/µL). Patients with uncontrolled systemic arterial hypertension, systolic pressure > 160 mmHg or diastolic pressure > 90 mmHg. Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right bundle branch block. Other protocol-defined inclusion/exclusion criteria may apply
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QTI571<br>Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469). | Drug: Imatinib<br>* 200 mg or 400 mg qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Events, Serious Adverse Events and Deaths | Adverse event monitoring was conducted throughout the trial. | 144 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Six Minute Walk Distance (6MWD) |  | baseline, 144 weeks | 
| Time to Clinical Worsening (TTCW) Endpoints |  | 144 weeks | 
| Medical Resource Utilization |  | 144 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary arterial hypertension, imatinib, 6MWD
Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Study Overview
=================
Brief Summary
-----------------
An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Official Title
-----------------
An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP

Conditions
-----------------
Systemic Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Drug: MRA(Tocilizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria (MRA011JP patients) Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients) Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period Exclusion criteria Patients who were not enrolled by 3 months after completion of the previous study Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MRA(Tocilizumab)<br>* 8mg/kg/2weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study) |  | whole period | 
| Safety:Incidence and severity of adverse events and adverse reactions |  | whole period | 
| Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks |  | 0 week and every 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks |  | 0 week and every 2 weeks |
Medical Trial: Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. This data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future rheumatoid arthritis patients.

Official Title
-----------------
Observational Clinical Trial Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients Participating In Clinical Research

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been diagnosed with rheumatoid arthritis Patient has self-identified as planning to enroll in an interventional clinical trial Patient is 18 years old Exclusion Criteria: ECOG score of 4 Patient is pregnant Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient decides to enroll in clinical trial |  | 3 Months | 
| Patient remains in clinical trial to completion |  | 12 months |