linjc16/ctgov huggingface dataset:
MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

Study Overview
=================
Brief Summary
-----------------
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

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

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL Exclusion Criteria : Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>sitagliptin 100 mg | Drug: sitagliptin phosphate<br>* Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.<br>* Other names: Januvia;|
| Placebo Comparator: 2<br>placebo | Drug: Comparator: placebo<br>* placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 | A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. | Baseline and Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG. | Baseline and Week 18 | 
| Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 | Change from baseline at Week 18 is defined as Week 18 minus Week 0. | Baseline and Week 18 |
Stretching and Musculoskeletal Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether a daily, 15-minute stretching routine for one year reduces musculoskeletal pain and improves quality of life in personnel working in the radiology and cardiology departments at Mayo Clinics and Mayo Clinic Health System sites.

Official Title
-----------------
Stretching Exercises and Musculoskeletal Pain Among Employees Working in the Echocardiographic, Ultrasound and Interventional Laboratories

Conditions
-----------------
Musculoskeletal Pain

Intervention / Treatment
-----------------
* Behavioral: Stretching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A 15-minute daily stretching program will be implemented for 1 year. Personnel working in the departments of Cardiology and Radiology at Mayo Rochester, - Mayo Scottsdale, and Mayo Jacksonville and Mayo Clinic Health System. Willing to complete standardized questionnaires (DASH, ODI) to assess work-related pain at baseline and at 1 year. Employees who respond to questionnaires at baseline and 1 year but don't participate in the stretching exercises will be controls for the study. Willing and able to provide written, informed consent. Exclusion Criteria: Pregnancy. Inability to participate in the stretching exercises for any reason. Preexisting musculoskeletal problems that has required employees to seek active medical or orthopedic treatment.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment Group<br>15 minutes daily stretch for 1 year | Behavioral: Stretching<br>* One-year stretching program for 15 minutes every day<br>|
| No Intervention: Control Group<br>No stretches | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the DASH index score | The DASH (Disability Arm, Shoulder, and Hand outcomes) is scored on a 0-100 scale. Higher score indicates greater disability. A change of 10 more points from baseline, noted at the end of the study will be considered significant | 12 months | 
| Change in ODI (Oswestry Disability Index) | The OSI is scored on a 0-100 scale, zero being with no disability and 100 with maximum disability possible. A change of 10 points from baseline will be considered significant | 12 months |
The Early Diagnosis and Warning Role of Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Find the early diagnostic markers of erectile dysfunction; Study the warning role of ED in some diseases.

Official Title
-----------------
The Early Diagnosis and Warning Role of Erectile Dysfunction:a Multi-institutional Clinical Study.

Conditions
-----------------
Erectile Dysfunction, Endothelial Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and at least 18 years of age. Provide signed informed consent. Have a history of erectile dysfunction (ED: defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) . Have a stable monogamous relationship with a female partner. To some subjects with poor sexual experience, re-evaluation would be conducted after a 4-weeks sex education. Make at least four sexual intercourse attempts with the female sexual study partner during the 4-week therapeutic period without medication. Agree not to use any other ED treatment for at least 4 weeks. Exclusion Criteria: severe diseases (such as congestive heart failure, arrhythmia, significant renal or hepatic dysfunction and anemia); Had clinically noteworthy penile deformities, pelvic surgery or trauma of perineal region; Had received long-term pharmacotherapy (including antioxidant agents, vitamins and traditional Chinese drugs). An addiction problem (with a history of injection or administration of opium, poppy, heroin, hemp, morphine, cocaine, caffeine, ketamine and meperidine etc.)

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of Psychopharmacotherapy in Patients With Schizophrenia or Bipolar Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of long-term psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and side effects.

Detailed Description
-----------------
Schizophrenia and bipolar disorder are renowned for chronic and deteriorating course. Although atypical antipsychotics and mood stabilizers are widely used as treatment of choice for these illness based on acute efficacy and safety, long-term efficacy and safety of these agents are still open to debate. Prospective follow-up study in naturalistic condition may be a useful way of elucidating cons and pros of long-term psychopharmacotherapy.In this study, efficacy and various side effects of drugs will be measured, and the possibility of neurophysiological markers will be tested by serial measurements of electroencephalographic changes.

Official Title
-----------------
Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers

Conditions
-----------------
Schizophrenia, Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, 18-65 years of age. Patients must have a diagnosis of schizophrenia or bipolar disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Patients have not been received antipsychotics or mood stabilizers within the past 4 weeks prior to the study entry. Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation. Exclusion Criteria: History of taking antipsychotics or mood stabilizers within past 4 weeks. History of DSM-IV substance dependence. Mental retardation (IQ < 70)or patients who are not able to understand the informed consent. Definite or suspected organic mental disorders. Female patients who are not able to maintain contraception during this study Laboratory abnormalities with clinical significance History of epilepsy or electroconvulsive therapy within the past 3 months.

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 |
| --- | --- |
| Psychopharmacotherapy<br>patients under antipsychotic or mood stabilizer treatment | |

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
-----------------
schizophrenia, bipolar disorder, atypical antipsychotics, mood stabilizers, biological markers
Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis

Study Overview
=================
Brief Summary
-----------------
Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. However, clinical studies and records have shown that the lifetime of these implants was limited. The main cause of failure is the aseptic loosening influenced by many factors, foremost of which is due to periprosthetic osteolysis debris. This is a major concern for orthopedic surgeons loosening leads, in most cases, the recovery, the importance of osteolysis is a major cause of difficulties and poorer results. The main objective of the study is to compare, 2 years after the intervention, the penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC® conventional polyethylene.

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Device: radiostereometric analysis (RSA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient (18-70 years) with hip disease necessitating the establishment of a total hip replacement Exclusion Criteria: Patient aged 71 or more Pregnant woman or wishing to be for the duration of the study Resumption of total hip replacement, or cephalic prosthesis cups Primary or secondary malignant neoplasm of the hip Protected adult patient

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: acetabular liner in X3 polyethylene<br>acetabular in X3 polyethylene | Device: radiostereometric analysis (RSA)<br> <br> |
| Active Comparator: acetabular liner in N2VAC® conventional polyethylene<br>hip replacement with acetabular liner in N2VAC® conventional polyethylene | Device: radiostereometric analysis (RSA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration of the femoral head in the polyethylene measure in millimeters | The median head penetration in millimeters | change over baseline and 2 years |
Characteristics and Clinical Outcomes of Anorexia Nervosa : Siriraj Hospital Experience

Study Overview
=================
Brief Summary
-----------------
This study is aimed to determine clinical characteristics of patients with anorexia nervosa and outcome of treatment at Sirirraj Hospital.

Detailed Description
-----------------
Data is derived from the medical records

Official Title
-----------------
Characteristics and Clinical Outcomes of Anorexia Nervosa : Siriraj Hospital Experience

Conditions
-----------------
Anorexia Nervosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children and adolescents with newly diagnosed anorexia nervosa in Siriraj Hospiatl according to DSM IV criteria treated by multidisciplinary teams e.g. pediatricians specialized in nutrition and psychology and psychologist Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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 |
| --- | --- | --- |
| types and factors contributing to outcomes of anorexia nervosa |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of treatment of anorexia nervosa | By using core symptoms (bodyweight, menstruation, and eating behavior), outcome can be categorized into 4 groups, which are recovery, improvement, chronicity, and death. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia nervosa, Siriraj Hospital, Thai
A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.

Official Title
-----------------
A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: AD-4833 15 mg
* Drug: AD-4833 30 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator. Those who can sign and date a written, informed consent form prior to the initiation of any study procedures. Exclusion Criteria: Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc. Others who are assessed to be ineligible for the study by the investigator or subinvestigator.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYR-322 25 mg , AD-4833 15 mg<br> | Drug: AD-4833 15 mg<br> <br> |
| Experimental: SYR-322 25 mg , AD-4833 30 mg<br> | Drug: AD-4833 30 mg<br> <br> |
| Placebo Comparator: SYR-322 25 mg , AD-4833 placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Hemoglobin (HbA1c) | Measurement of change in HbA1c (ratio of hemoglobin bound to glucose) | 16 weeks |
A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711

Study Overview
=================
Brief Summary
-----------------
This is an open-label, randomised, single-dose, cross-over phase I study to evaluate the effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.

Official Title
-----------------
An Open-label, Randomised, Single Dose, Cross-over Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: BPI-7711


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, aged from 18 to 55 years. BMI from 18.5 to 28.0 kg/m2 Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance. Exclusion Criteria: Subjects with clinical significant diseases Subjects with allergic disease history Subjects with gastrointestinal disease history that can affect study drug absorption Subjects with drug abuse history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasted<br>BPI-7711 following a period of fasting | Drug: BPI-7711<br>* BPI-7711 180 mg<br>* Other names: BPI-7711 capsule;|
| Experimental: High-fat meal<br>BPI-7711 following a high-fat meal. | Drug: BPI-7711<br>* BPI-7711 180 mg<br>* Other names: BPI-7711 capsule;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration | Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose | 
| AUC(0-last) | Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint | Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose |
The Effects of Escitalopram on Cytokines

Study Overview
=================
Brief Summary
-----------------
The association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (MDD). Hence, the investigators will examine this association.

Detailed Description
-----------------
In addition to serotonin, inflammatory process has been suggested in the development of major depressive disorder (MDD) and in its associated treatment. Escitalopram is an antidepressant that has been widely used in patients with MDD because of the promising results. The association of cytokines with escitalopram has not been investigated in patients with MDD. Hence, the investigators will examine this association.

Official Title
-----------------
The Effects of Escitalopram on Cytokines in Depressive Patients

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV-defined Major depressive disorder, single episode Age 20-65 Drug-naive Hamilton Depression Rating Scale exceeding 14 scores Exclusion Criteria: Major medical disorders Substance use Pregnant Allergy to escitalopram

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>Escitalopram 10 mg/d to 20 mg/d | Drug: Escitalopram<br>* escitalopram 10 mg/d to 20 mg/d<br>* Other names: Lexapro;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in cytokines | Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α | Week 0, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in Hamilton Depression Rating Scale | Hamilton Depression Rating Scale, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, TNF-α | week 0, week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokine, depression, escitalopram