linjc16/ctgov huggingface dataset:
Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

Study Overview
=================
Brief Summary
-----------------
The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration. The effect of liraglutide on insulin release will be tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be performed without medication and repeated 12 hours after first dose of liraglutide and after 3 weeks of treatment with liraglutide.

Official Title
-----------------
Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

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

Intervention / Treatment
-----------------
* Drug: Liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight 50-100 kg Exclusion Criteria: Chronic disease Concomitant drug use Pregnancy or lactation Fasting glucose >6 mmol/L.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br>Liraglutide 0.6 mg/day subcutaneously. | Drug: Liraglutide<br>* Graded glucose infusion test (GGIT)will be performed on baseline. 1 week later treatment with liraglutide 0.6mg/day (injected between 21.00-23.00) will be initiated. GGIT will be repeated 12 hours after first injection and after 21 days on-treatment (12 hours after last injection).<br>* Other names: Victoza;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the glucose-sensitivity of the beta cells | Graded glucose infusion test will be used to create insulin secretion rate- plasma glucose curve. The primary outcome is the change of the slope of the curve from baseline after acute administration of liraglutide compared to the repeated administration (after 3-weeks of treatment). | baseline, first dose, after 3-weeks on treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on adrenal hormones | change in ACTH/cortisol levels and renin / aldosterone levels after acute and repeated administration of liraglutide. | baseline, acute administration, 3 weeks |
Does the Natural Medicinal Plant St John's Wort Affect the Glucose Tolerance in Healthy Individuals

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to examine if healthy individuals that ingest St John's wort will have a significantly difference in glucose tolerance.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: St John's wort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40 years Males Fasting plasma-glucose < 7.0 mmol/L Glycosylated haemoglobin A1c within reference or clinically insignificant deviation hereof Body mass index < 30 kg/m^2 Exclusion Criteria: Hypersensitivity to St John's wort Chronical or daily alcohol abuse Known liver disease Ingestion of drugs requiring prescription, except locally acting drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: St John's wort<br>Subjects will undergo 3 oral glucose tolerance tests: Without taking any St John's wort After 3 weeks pretreatment with St John's wort Minimum 6 weeks after last St John's wort ingestion | Other: St John's wort<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose area under curve (AUC) 0-2 hours | At time=0, the subjects will ingest 75g glucose. Plasma glucose will be measured at 0, 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion. | Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St John's wort pharmacokinetics | At time=0, the concentration of active components hypericin and hyperforin will be measured. | At time=0 | 
| Other metabolic markers | C-peptide and serum insulin will also be measured during the oral glucose tolerance test. | At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose tolerance
Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: dutogliptin
* Drug: sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of all required visits of a qualifying Phase 3 core protocol Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302 Exclusion Criteria: Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

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: dutogliptin/PHX1149T<br> | Drug: dutogliptin<br>* 400 mg<br>|
| Active Comparator: sitagliptin<br> | Drug: sitagliptin<br>* 100 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, DPP4 inhibitor, dutogliptin
Early Childhood Prevention of Childhood Overweight

Study Overview
=================
Brief Summary
-----------------
You are invited to participate in a research study to understand more about childhood obesity and how to prevent it. We hope to learn how families influence each others eating habits.

Detailed Description
-----------------
This study aims to understand more about childhood obesity and how to prevent it. Two different methods of prevention will be tested and participants will be allocated at random to one of these methods. The investigators hope to learn how families influence each others eating habits. Participants in this study will attend a series of five classes, once a week for five weeks, on the topic of child feeding. The aim of the classes is to learn how to feed your child so as to prevent future eating and weight problems. The research component includes filling out some surveys before classes begin and at the end of the last class. Classes are small and interactive so that parents have a chance to voice concerns and get feedback.

Official Title
-----------------
Development of an Early Intervention for the Prevention of Childhood Obesity

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Behavioral: 5-keys counseling
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One or both parents with BMI > or = to 27.5 Healthy child ages 2-4 years Exclusion criteria. - Inadequate understanding of the English language

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-keys feeding program<br>Counseling in small groups aimed at enhancing children's self control over eating | Behavioral: 5-keys counseling<br>* 5-session small group intervention<br>Behavioral: Lifestyle counseling<br>* 5-session small group behavioral intervention<br>|
| Active Comparator: Healthy lifestyle counseling<br>Counseling in small groups aimed at achieving healthy eating patterns aimed at both the family and young children | Behavioral: Lifestyle counseling<br>* 5-session small group behavioral intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental control of feeding | Assessed by Questionnaire pre and post treatment. | 5-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily patterns of child and family meals | Assessed by questionnaire pre and post treatment | 1-week |
Matching, Outcomes and Costs in Substance Abuse/Psychiatric Treatment

Study Overview
=================
Brief Summary
-----------------
This project�s goal is to improve the quality of care and reduce treatment costs for veterans with substance abuse and psychiatric problems.

Detailed Description
-----------------
Background: This project�s goal is to improve the quality of care and reduce treatment costs for veterans with substance abuse and psychiatric problems. Objectives: This project is evaluating a patient-treatment matching strategy to improve residential treatment for substance abuse patients with psychiatric disorders. Its immediate objective is to examine whether the matching strategy results in more effective and cost-effective treatment in VA programs. We hypothesize that patients with severe clinical problems will have better outcomes when they are matched to service-intensive programs; patients with moderate problems will have better outcomes when they are matched to programs having a lower intensity of services. For both patient groups, community treatment should prove to be more cost-effective than hospital treatment. Methods: The project utilized a stratified randomized design. We paired each of three VA hospital programs that treat dual diagnosis patients and are high on intensity with a nearby high-intensity community residential facility (CRF) that contracts with the VA. We also paired four VA hospital and four CRFs that are low on intensity. Veterans who applied for substance abuse treatment at VA facilities were randomly assigned to either the VA hospital or CRF. Patient assessments have been conducted at intake (N=230), discharge, and a 4-month follow-up. Primary outcomes are patients� severity of substance abuse and psychiatric problems. Secondary outcomes are patients� functional status and their VA and non-VA health care utilization and its costs. Status: Completed.

Official Title
-----------------
Matching, Outcomes and Costs in Substance Abuse/Psychiatric Treatment

Conditions
-----------------
Dual Diagnosis

Intervention / Treatment
-----------------
* Procedure: Matching Symptom Severity to Service Intensity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be entering a VA inpatient substance abuse or psychiatric treatment program and be clinically judged as appropriate for inpatient or community residential care. Exclusion Criteria:
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 |
| --- | --- |
| Other: Arm 1<br> | Procedure: Matching Symptom Severity to Service Intensity<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Detailed Description
-----------------
The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.

Official Title
-----------------
An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Teduglutide (ALX-0600)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have completed participation in the Pilot Active Crohn's Disease Study. Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions: CDAI score greater than 220 Stool samples not required C-reactive protein levels are not an exclusion criterion Exclusion Criteria: Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions: Participation in a clinical study of an experimental drug or device within 30 days before signing consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All subjects in the study dosed at 0.1 mg/kg teduglutide | Drug: Teduglutide (ALX-0600)<br>* 0.1 mg/kg injected subcutaneously daily<br>* Other names: teduglutide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study. |  | 12 weeks after start of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved. |  | 12 weeks after study start | 
| The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study |  | 12 weeks after study start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn Disease, Crohn's Disease
Efficacy and Safety of Kochujang Pills on Improvement of Blood Lipids

Study Overview
=================
Brief Summary
-----------------
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Kochujang pills on improvement of blood lipids. The investigators measured improvement of blood lipids parameters , including Total Cholesterol, LDL-C, Triglyceride and HDL-C, and monitored their blood pressure.

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Kochujang Pills
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 19-55 years old Total Cholesterol 200 260 mg/dl or LDL-C 110 190 mg/dl Able to give informed consent Exclusion Criteria: Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kochujang Pills<br> | Dietary Supplement: Kochujang Pills<br>* Kochujang Pills (34.5g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (34.5g/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Total Cholesterol | Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol) | LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Triglyceride | Triglyceride was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in HDL-C(High Density Lipoprotein-cholesterol) | HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks |
Alitretinoin in the Treatment of Chronic Hand Eczema

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.

Detailed Description
-----------------
Chronic hand eczema is a frequent and distressing disease. The course of the disease is of chronic-relapsing nature. In a phase III study alitretinoin was clinically effective for patients with severe chronic hand eczema refractory to topical treatment. This study investigates the safety and efficacy of alitretinoin who previously have participated in a clinical trial involving alitretinoin.

Official Title
-----------------
Open Label Treatment of Patients With Chronic Hand Dermatitis Who Have Participated in a Previous Clinical Trial Involving Oral Alitretinoin

Conditions
-----------------
Eczema

Intervention / Treatment
-----------------
* Drug: alitretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in therapeutic trials involving chronic hand eczema Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score Exclusion Criteria: Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy

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

Design Details

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


Arms and Interventions

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

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (Physicians Global Assessment) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hand eczema, Chronic hand dermatitis, Patients with chronic hand eczema, who are refractory to topical corticosteroids