linjc16/ctgov huggingface dataset:
A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis disease activity on MRI examinations, as well as decrease the rate of clinical MS exacerbations, compared to placebo

Official Title
-----------------
A Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: BMS 188667 (Abatacept)
* Drug: BMS 188667 (Abatacept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion relapsing-remitting MS at least 1 exacerbation in preceding 2 years at least 1 MRI lesion stable for 2 months prior to dosing Exclusion progressive MS currently treated with an immunomodulatory therapy previously treated with an approved MS drug where treatment was discontinued for lack of efficacy active bacterial or viral infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Other: 1<br> | Drug: Placebo<br>* Solution, i.v infusion, 0 mg, Days 1 & 15 then monthly, 10 months.<br>|
| Active Comparator: 2<br> | Drug: BMS 188667 (Abatacept)<br>* Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.<br>* Other names: Orencia;|
| Active Comparator: 3<br> | Drug: BMS 188667 (Abatacept)<br>* Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.<br>* Other names: Orencia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MS
Correlation of Family History, Age at Onset & Severity of Stuttering

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to Detect the influence of the family history of stuttering (distance of relative) on the onset and severity of stuttering in children in these families. Also to explore developmental differences among young stutterers.

Official Title
-----------------
Correlation of Family History, Age at Onset and Severity of Stuttering in School-age Children

Conditions
-----------------
Stuttering, Childhood

Intervention / Treatment
-----------------
* Other: Stuttering severity instrument for school-age children (SSI-3 Arabic version)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-Age: from 7 to 15 years old. 2-Gender: both sexes will be included in the study. 3-The participants are diagnosed as stutterers by an expert phoniatrician. 4-Children will be accepted only if full information is provided concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, and the age of onset of stuttering manifestations. 5-Mentality: IQ is 80 or more Exclusion Criteria: 1-Age below 7 years or above 15 years. 2-Failure to provide full information concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, or age of onset of stuttering manifestations.. 3- IQ less than 80

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 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 |
| --- | --- |
| children of possitive family history of stuttering<br> | Other: Stuttering severity instrument for school-age children (SSI-3 Arabic version)<br>* Stuttering severity instrument for school-age children (SSI-3 Arabic version) for measuring stuttering severity Stanford Binet test version 4 to evaluate the mentality (IQ)<br>* Other names: Stanford Binet test version 4;|
| children of negative family history of stuttering<br> | Other: Stuttering severity instrument for school-age children (SSI-3 Arabic version)<br>* Stuttering severity instrument for school-age children (SSI-3 Arabic version) for measuring stuttering severity Stanford Binet test version 4 to evaluate the mentality (IQ)<br>* Other names: Stanford Binet test version 4;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the correlation between family history, age of onset and severity of stuttering | family history may affect the onset of stuttering and its severity. children with possitive family history of stuttering may develope stuttering earlier than children with negative family history and stuttering could be more severe in the first group. | year |
Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography

Study Overview
=================
Brief Summary
-----------------
One of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. It can be performed by many techniques. In the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy.

Conditions
-----------------
Common Bile Duct Gallstones

Intervention / Treatment
-----------------
* Procedure: endoscopic sphincterotomy by conventional method
* Procedure: endoscopic sphincterotomy by rendezvous method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with MRCP evidence of common bile duct stones Exclusion Criteria: cholangitis pancreatitis ASA GRADE III, IV Unfit for laparoscopy unfit for ERCP

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: conventional technique of ERCP<br> | Procedure: endoscopic sphincterotomy by conventional method<br> <br> |
| Active Comparator: Rendezvous technique<br> | Procedure: endoscopic sphincterotomy by rendezvous method<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success/failure rate of common bile duct stones removal |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
common bile duct stones
A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week after surgery.

Official Title
-----------------
A Phase II, Randomised, Double-Blind, Placebocontrolled Study To Investigate The Effects Of ZD1839 (IRESSA™) On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery

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

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically-confirmed ER- and PgR- primary breast cancer Stage T .5 cm, N0-1, M0 No previous treatment for breast cancer Exclusion Criteria: ALT or AST greater than 2.5 times the ULRR Metastatic disease

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the effect of ZD1839 compared with placebo on the change in tumour cell proliferation in patients who have completely ER negative & PgR negative breast cancer |  |  | 
| Aassessment of biomarker Ki-67 in breast cancer tissue at baseline by core biopsy and after 4 weeks on the surgical specimen |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of 4 weeks of ZD1839 on the change in tumour size as assessed by ultrasounds. |  |  | 
| To correlate the expression of tissue biomarkers (HER family and epidermal growth factor [EGF] related pathways) in the baseline biopsy sample and in the surgical (endpoint) specimen with the anti-proliferative effect of ZD1839. |  |  | 
| To determine the effect of ZD1839 on HER-2 phosphorylation and other biomarkers in the surgical (endpoint) specimens when compared with the baseline biopsies |  |  | 
| To assess the effect of ZD1839 on apoptosis as assessed by TUNEL in the surgical (endpoint) specimens when compared with the baseline biopsies |  |  | 
| To determine plasma trough concentrations of ZD1839 and correlate these with molecular biomarkers detected in breast cancer tissue. |  |  |
Copeptin in Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Copeptin is accepted as a marker of stress. We want to evaluate the preoperative and early postoperative copeptin leavens in patients undergoing different aortic valve procedures

Official Title
-----------------
GE DHM-AN-OR-2012/01

Conditions
-----------------
Copeptin in Patients Undergoing Aortic Valve Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgical aortic valve replacment Patients undergoing transcatheter aortic valve replacment Exclusion Criteria: denial by patient

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 |
| --- | --- | --- |
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects

Study Overview
=================
Brief Summary
-----------------
Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis. Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables. Evaluate correlation between articular and enthesis ultrasound exam in this study. Compare patients and healthy individuals data, to calculate the ROC curve to estimate predictor value of disease.

Official Title
-----------------
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects

Conditions
-----------------
Spondylitis, Ankylosing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ankylosing spondylitis by the Modified New York Criteria (1984)or ASAS classification (2009) Healthy people with no history of joint pain, inflammatory lumbar pain inflammatory disease, 18 - 65 years old Exclusion Criteria: Fibromyalgia Corticosteroid injection in the last 3 months Previous surgery in joint or enthesis of study Peripheric neuropathy Diabetes mellitus Hypothyroidism Peripheric venous insufficiency (with edema or ocre dermatitis)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| ankylosing spondylitis<br>It will be held ultrasound exam in enthesis and joints in patients with ankylosing spondylitis and healthy subjects | |
| Healthy pelople<br>It will be held ultrasound exam in enthesis and joints of healthy subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects | a comparative study of enthesis by ultrasound revealed statistical differences among patients with ankylosing spondylitis and healthy volunteers in analysis of calcaneal enthesis, plantar fascia and quadriceps. | december | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound, MASEI index, clinical and ultrasound correlation, enthesis ultrasound, articular ultrasound, ankylosing spondylitis ultrasound, radiographic and ultrasound correlation
Study of Aripiprazole in Subjects With Alcoholism

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn whether subjects treated with aripiprazole are able to abstain from alcohol use for a greater number of days than subjects treated with placebo. The safety of using aripiprazole will also be studied.

Official Title
-----------------
A Randomized, Multicenter, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Aripiprazole in the Maintenance of Abstinence From Alcohol in Subjects With Alcoholism

Conditions
-----------------
Alcoholism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1<br> | Drug: Aripiprazole<br>* Tablets, Oral, 2-30mg, Once daily, 12 weeks.<br>* Other names: Abilify;|
| Placebo Comparator: A2<br> | Drug: Placebo<br>* Tablets, Oral, Once daily, 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of abstinence from the consumption of alcohol during the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence |  |  |
Rehabilitation to Patients Over 65 Years Undergoing THA

Study Overview
=================
Brief Summary
-----------------
Patients over 65 years do not have a self care ability the surgery benefits them. The aim of this study is development of a rehabilitation program based on patients' self-rated health. A cross section study including 600 patients RCT including 160 patients

Detailed Description
-----------------
Fase 1: 600 patients waiting for or already having received total hip-/knee-replacement participated in a questionnaire study using SF- 36. The aim was to document self-rated health among this population. Fase 2: Results from the cross section study form the base for the RCT, where 160 patients over 65 years undergoing THR, 80 patients are in an intervention group and 80 patients in a control group. A nurse intervention program is tested, and results from the study will form the base for a structured rehabilitation program.

Official Title
-----------------
Cross-section Study Among Patients Waiting for or Already Undergoing THA Followed by a RCT

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

Intervention / Treatment
-----------------
* Procedure: interview and advising
* Behavioral: 3 follow up interviews and personal advising
* Procedure: interview SF-36 self rated health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:patients over 65 years undergoing total hip replacement - Exclusion Criteria: patients dropping out

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 95 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: interview and advising|nan|
|Behavioral: 3 follow up interviews and personal advising|nan|
|Procedure: interview SF-36 self rated health|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selfrated health among the population shows significant dysfunction among patients over 75 years, patient living alone and patients depended on help from others |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| undergoing |  |  | 
| we know next year |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
selfrated health,, SF-36,, rehabilitation,, total hip replacement,, patients above 65
Investigating the Relationships Among Illness Cognition, Social Support, Stress, and Emotional Reactions of Infertile Patients

Study Overview
=================
Brief Summary
-----------------
The current study attempted to explore the relationships among stressors (cognitions of illness, socioeconomic status, social support, marital stressor, social stressor, etc), perceived stress level, and emotional reactions (anxiety and depression) of infertile patients and to propose the measurement and structural models of infertile aniexty and depression.

Detailed Description
-----------------
The current study attempted to explore the relationships among stressors (cognitions of illness, socioeconomic status, social support, marital stressor, social stressor, etc), perceived stress level, and emotional reactions (anxiety and depression) of infertile patients and to propose the measurement and structural models of infertile aniexty and depression. Structural Equation Modeling (SEM) will be utilized through AMOS 17 to analyze the data, construct the initial model, and afterward present the modified structural model of the psychological responses for infertile patients.

Official Title
-----------------
Health Service Administration China Medical University

Conditions
-----------------
Infertile Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:male infertile patients(ICD-9:606) and female infertile patients(ICD-9:628). Exclusion Criteria:non-infertile patients.
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 |
| --- | --- |
| infertile patients<br>male infertile patients(ICD-9:606),female infertile patients(ICD-9:628) | |

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
-----------------
infertile patients