linjc16/ctgov huggingface dataset:
Yoga Exercise for Improving Balance in Patients With Subacute &Ｃhronic Stroke

Study Overview
=================
Brief Summary
-----------------
Hypothesis: This study investigated the hypothesis that subacute and chronic stroke patients who received a combination of yoga and traditional physiotherapy were getting more improvement in standing balance than traditional physiotherapy. And we also hypothesis yoga can improve post-stroke depression symtom.

Official Title
-----------------
Yoga Exercise for Improving Balance in Patients With Subacute &Ｃhronic Stroke : A Pilot Study

Conditions
-----------------
Depression, Stroke

Intervention / Treatment
-----------------
* Behavioral: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The time of stroke onset is more than 91 days. Able to stand for more than 1 minutes. Between the ages of 30 and 80. Exclusion Criteria: Now receive others palliative therapy. Significant psychotic disease. Obvious language disorder. Medical contraindication(clincans evaluate cannot included).

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga training, Tradiational physiotherapy<br>Experimental Group(20 people) receive tradiational physiotherapy(4 times in a week, every time 1 hour), and 8-weeks yoga training(2 time in a week, every time 1 hour) | Behavioral: Yoga<br> <br> |
| No Intervention: Tradiational physiotherapy<br>Control Group(20 people)only receive tradiational rehabiliation( 4 times in a week, every time 1 hour ) for 8 weeks. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale |  | within 7 days after finish yoga therapy course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taiwanese Depression Questionnaire |  | within 7 days after finish yoga therapy course | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yoga, Stroke, Standing balance, Depression
Motivational Interviewing Integrated With Social Network Counseling for Teens

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to test the feasibility and efficacy of a brief (one session) preventative intervention using motivational interviewing integrated with social network counseling for substance use among adolescent patients in a primary care setting. One hundred participants will be randomly assigned to either motivational interviewing integrated with social network counseling or attention control conditions. The motivational interviewing integrated with social network counseling condition is expected to show improvement when compared to the attention control condition.

Official Title
-----------------
Motivational Interviewing Integrated With Social Network Counseling for Teens

Conditions
-----------------
Substance Use

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing w/Social Network Counseling
* Behavioral: Active Control Condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14-18 years old Resident of Richmond VA or greater Richmond area Patient at Virginia Commonwealth University or Richmond City Department of Health Exclusion Criteria: Ward of the state Not fluent in English Incapable of providing consent

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motivational Interviewing w/Social Network Counseling<br>Motivational Interviewing integrated with Social Network Counseling, 20-minute session. | Behavioral: Active Control Condition<br>* 20-minute health counseling<br>|
| Sham Comparator: Health Counseling<br> | Behavioral: Motivational Interviewing w/Social Network Counseling<br>* This is the active arm of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of counseling on substance use factors in teens | To assess the efficacy of motivational interviewing integrated with social network counseling compared to an attention control condition on substance use factors in teens assessed via self-report questionnaires at baseline, 1, 3, and 6 months. | Feb. 2015 |
Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Phase II Open-label Study of SH L 749 in Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphomas

Conditions
-----------------
Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Lymphoma, Low-Grade

Intervention / Treatment
-----------------
* Drug: Zevalin (SH L 749 , BAY86-5128)
* Drug: Zevalin (SH L 749 , BAY86-5128)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Platelet counts of >/= 100,000/mm3 Absolute neutrophil counts of >/= 1,200/mm3 Bone marrow involvement < 25% Exclusion Criteria: Patients who received hematopoietic stem cell transplantation, including bone marrow transplantation, peripheral blood stem cell transplantation, etc. Patients presenting with marked bone marrow hypocellularity (any suspected bone marrow hypocellularity should be confirmed by bone marrow biopsy) Patients with previous myocardial infarction within the past 1 year, with heart disease that requires treatment or with pulmonary dysfunction Patients with serious concomitant diseases (cardiac failure, renal failure, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Zevalin (SH L 749 , BAY86-5128)<br>* 0,3mCi/kg<br>|
| Experimental: Arm 2<br> | Drug: Zevalin (SH L 749 , BAY86-5128)<br>* 0,4mCi/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response rates (the percentage of patients who achieved PR or better response) |  | After 9 weeks or 13 weeks | 
| The incidence of critical toxicity |  | During treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation |  | During treatment period | 
| Complete response (CR or CRu) rates |  | After 9 weeks or 13 weeks | 
| Progression-free survival (PFS) |  | After end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antigen, CD20
Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan.

Detailed Description
-----------------
In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed every three years for three years. We will compare this to a control group of 10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen.

Official Title
-----------------
Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria for study subjects: To be between ages 3 to 10 years Have been diagnosed with type 1 diabetes for at least 6 months; and Do not have plans to move out of the area within the next 36 months. Inclusion Criteria for control subjects: To be between ages 3 to 10 years Exclusion Criteria: No history of head trauma with any loss of consciousness, Cystic fibrosis, Prematurity (born less than 30 weeks of gestation), Significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age), Neurologic disease independent of diabetes (eg seizure disorder); or Medical contraindication to MRI procedure (eg metal appliances such as braces).

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 diabetes mellitus
Surgical Management of Posterior Tibial Plateau Fractures

Study Overview
=================
Brief Summary
-----------------
This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a safe technique with adequate visualisation of the posterior tibial surface. The investigators will thoroughly evaluate all important clinical, radiological and functional variables. The functional outcome will be reported in patient reported outcome measures by means of the validated Knee injury and Osteoarthritis Outcome Score (KOOS).

Official Title
-----------------
Surgical Management of Posterior Tibial Plateau Fractures

Conditions
-----------------
Tibial Fractures

Intervention / Treatment
-----------------
* Procedure: Osteosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis Exclusion Criteria: Absent contact information living abroad and cannot participate in the follow-up visits non-functional leg prior to treatment/injury pathological fractures bilateral fractures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Osteosynthesis|Osteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective evaluation: outcome | Total Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire to measure patient's opinion about his or her knee and the associatede problems. | 1 year | 
| Subjective evaluation: pain | Visual analogue scale (VAS) to indicate the daily pain level. | 1 year | 
| Clinical evaluation | Recording of demographic and fracture-related characteristics. | 1 year | 
| Radiographic evaluation | Parameters derived from CT and RX. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Recording of complications: infection, nonunion, wound related problems, implant related complaints, compartment syndrome, neurological disorder, muscle atrophy and deep vein thrombosis. | 1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
classification, questionnaires, open reduction, internal fixation
A Study to Assess the Ingestion of Dentifrice by Children

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to examine the amount of dentifrice ingested and used by various age groups of children.

Official Title
-----------------
A Study to Assess the Ingestion of Dentifrice by Children

Conditions
-----------------
Healthy Individuals

Intervention / Treatment
-----------------
* Drug: Marketed Dentifrice
* Drug: Marketed Flavored Dentifrice
* Drug: Marketed Flavored Dentifrice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 2 and 12, inclusive Be healthy, with no illness that, in the judgment of the investigator or examining dentist, would interfere with the conduct of the test Be currently, and have been for at least three months immediately prior to the start of the study, brushing (or being brushed by care giver) their teeth on a daily basis Have parent/guardian complete and return the consent form Exclusion Criteria: Have diabetes Be on dialysis Have an oral health condition that, in judgment of investigator or study medical personnel, could interfere with the conduct of the study. Wear metal braces Have an incomplete or missing consent form

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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 |
| --- | --- |
| Active Comparator: Crest Cavity Protection<br>Marketed Dentifrice | Drug: Marketed Dentifrice<br>* Marketed Dentifrice<br>|
| Active Comparator: Crest for Kids Hawaiian Punch Paste<br>Marketed Dentifrice | Drug: Marketed Flavored Dentifrice<br>* Hawaiian Punch Flavored<br>|
| Active Comparator: Crest for Kids Bubble Gum Paste<br>Marketed Dentifrice | Drug: Marketed Flavored Dentifrice<br>* Bubble Gum Flavored<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of dentifrice ingested and used by various age groups of children. |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentifrice ingestion amount as a function of dentifrice flavor and age of participants. |  | 10 weeks |
Normal Pressure Hydrocephalus (NPH) Registry

Study Overview
=================
Brief Summary
-----------------
The overall aim of the registry is to develop a longitudinal, observational database that is focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a source of clinical information for individual surgeons, as well as a national data repository for scientific inquiry and publications.

Detailed Description
-----------------
This is a prospective, multi-center, observational database to collect data on the characteristics, management practices, and patient outcomes of NPH patients. It will be offered to a geographically representative group of U.S. physicians who will enroll NPH patients. The physician makes his/her own clinical decisions; thus, the data captured provides current practice patterns related to diagnosis, management, and results. The registry may also assist physicians in patient follow-up and certain practice management tasks. The data collected will serve to inform the medical community on optimal care for this patient population

Official Title
-----------------
Normal Pressure Hydrocephalus (NPH) Registry

Conditions
-----------------
Normal Pressure Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient meets the diagnosis criteria for Normal Pressure Hydrocephalus Patient is a candidate for a hydrocephalus shunt system, per the discretion of the investigator Patient or legal representative has signed an informed consent form. Competency to sign the consent form will be left up to the discretion of the investigator Exclusion Criteria: Patient is under the age of 18 years Patient has a known contraindication for a shunt Patient has an expected life span of less than 24 months Patient has an unwillingness or inability to return for required follow-up visits

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 |
| --- | --- | --- |
| Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment) |  | End of trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine frequency of the various treatments for NPH and the outcomes of those treatment (assessed during surgery and at follow-up/no safety assessment) |  | End of trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPH, Hydrocephalus
Study of 0416 Ointment in the Treatment of Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis. Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.

Official Title
-----------------
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: 0416
* Drug: Vehicle of 0416 test product
* Drug: tacrolimus ointment 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Atopic Dermatitis Good health with the exception of Atopic Dermatitis Percent Body Surface Area minimum requirements Exclusion Criteria: Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Test product that contains the active pharmaceutical ingredient | Drug: 0416<br>* Topical 0416 test product applied twice daily for 2 weeks<br>|
| Active Comparator: Reference<br>Reference product that contains active pharmaceutical ingredient | Drug: tacrolimus ointment 0.1%<br>* Reference Product for 0416 test product. Apply twice daily for 2 weeks.<br>|
| Placebo Comparator: Vehicle<br>Placebo that contains no active pharmaceutical ingredient | Drug: Vehicle of 0416 test product<br>* Vehicle of 0416 test product applied twice daily for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA). |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis