linjc16/ctgov huggingface dataset:
Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
I wan to check the effects of Nintendo Wii balance board therapy in children with CP.

Detailed Description
-----------------
Evaluate the effects of Nintendo Wii balance board therapy in combination with conventional physical therapy.

Official Title
-----------------
Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy

Conditions
-----------------
Balance Problem, Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Nintendo Wii balance board


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with age of 7-14 years. No history of falls. children able to stand independently. delays in gait development. Exclusion Criteria: Children with hemiplegic CP. Comorbidities. children with lower limb contractures. hearing disorders. children with epilepsy.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 14 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
Interventional Model Description: Effects of Nintendo Wii balance board in combination with conventional physical therapy in children with CP
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional physical therapy<br>stretching, strengthening and balance exercises | Other: Nintendo Wii balance board<br>* Experimental group was given Nintendo Wii balance board therapy in combination with conventional physical therapy for 16 sessions/8 weeks Control group was conventional physical therapy which include stretching of the hamstrings, quadriceps and calf muscles. strengthening of the lower limb. Balance exercises include walk in parallel bar<br>* Other names: Conventional physical therapy;|
| Experimental: Nintendo Wii balance board therapy<br>Nintendo Wii balance board therapy in combination with conventional physical therapy | Other: Nintendo Wii balance board<br>* Experimental group was given Nintendo Wii balance board therapy in combination with conventional physical therapy for 16 sessions/8 weeks Control group was conventional physical therapy which include stretching of the hamstrings, quadriceps and calf muscles. strengthening of the lower limb. Balance exercises include walk in parallel bar<br>* Other names: Conventional physical therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Nintendo Wii balance board in children with CP | Changes from the baseline. it was designed to measure the balance issues in children with pediatric balance scale and pediatric forward reach test. it consist of 14 items and total score of 56 | 8th week |
Intraoperative Hyperglycemia and Infections After Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative infections are a common complication. A relationship between perioperative severe hyperglycemia and postoperative infections has been found in patients undergoing craniotomy. The aim of this study is to evaluate the epidemiology of intraoperative severe hyperglycemia (BGC >180 mg/dL; 10 mmol/L) and postoperative infections (wound, urinary and prosthetic joint infection) and to investigate if severe intraoperative hyperglycemia is associated with an higher risk of early postoperative (within the 7th postoperative days) infections (wound, urinary and prosthetic joint infection).

Official Title
-----------------
Relationship Between Severe Intraoperative Hyperglycemia and Infections Within 7 Days After Orthopedic Surgery

Conditions
-----------------
Severe Hyperglycemia, Postoperative Infection, Orthopedic Patients

Intervention / Treatment
-----------------
* Other: Incidence of infections within 7 days postoperatively


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthopedic patients Exclusion Criteria: Non-orthopedic patients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Incidence of infections within 7 days postoperatively|Measure blood glucose concentration intraoperatively and evaluate incidence of infections 7 days after surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe hyperglycemia and incidence of infection | Evaluate the relationship between intraoperative severe hyperglycemia and incidence of infections at 7 days follow up. | Follow up of the patients for 7 days postoperatively |
The Correlation Between Genetic Polymorphism, Platelet Activity, Clopidogrel Responsiveness, and Serum Adipokine Concentration in Asian Acute Coronary Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
In this study, we evaluate the acute coronary syndrome patients to see if there is correlation between platelet activity, genetic polymorphism (CYP2C19 and ABCB1), serum adipokines level, and Clopidogrel responsiveness.

Official Title
-----------------
The Correlation Between Genetic Polymorphism, Platelet Activity, , Clopidogrel Responsiveness, and Serum Adipokine Concentration in Asian Acute Coronary Syndrome Patients

Conditions
-----------------
Acute Coronary Syndrome, Chronic Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 y/o Acute coronary syndrome patients Chronic coronary artery disease patients Healthy volunteers Exclusion Criteria: Patient refusal Allergy to Clopidogrel Receive Gp IIb/IIIa inhibitor simultaneously Cancer history Severe renal and liver function impairment Coagulopathy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute coronary syndrome patients<br> | |
| Chronic coronary artery disease patients<br> | |
| Healthy control<br> | |

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
-----------------
Acute coronary syndrome and chronic coronary artery disease patients
Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility)

Study Overview
=================
Brief Summary
-----------------
To test an interactive intervention to screen for Elder Abuse and Mistreatment (EM) in the Primary Care (PC) setting to promote self-identification and self-disclosure of EM.

Detailed Description
-----------------
The aim of this study is to perform a feasibility evaluation (N=80) of the VOICES screening tool among older adults in the primary care setting. If VOICES is feasible for identifying suspicion of EM in primary care setting, then it will be able to connect more victims of EM to necessary services and potentially prevent a multitude of poor EM outcomes

Official Title
-----------------
The Feasibility of the VOICES Digital Health Tool for Elder Mistreatment Screening in the Primary Care Setting (VOICES-PC Feasibility)

Conditions
-----------------
Elder Abuse

Intervention / Treatment
-----------------
* Behavioral: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60 years or older Alert and oriented to person and place Abbreviated Mental Test (AMT-4) score of 4 Able to consent and communicate in English Agrees and able to use the iPad Exclusion Criteria: subjects who live in nursing homes or other long-term care sitting and do not reside in community setting patients will be excluded if they cannot safely undergo the studies required for participation subjects with clear signs of EM Patient or clinician refusal to participate severe hearing and vision impairment COVID-19 positive

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: VOICES Elder Abuse Intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Older adults in Primary Care setting<br>Elder mistreatment in the Primary Care setting. | Behavioral: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)<br>* Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation | Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80). | 5-10 minutes before VOICES intervention use. | 
| Usage | Usage will be determined by the number of patients enrolled in the study that complete the VOICES tool. Our target is to enroll 80 older adults (N=80). | 5-10 minutes directly following VOICES intervention. |
Antimicrobial Hernia Repair Device Clinical Study

Study Overview
=================
Brief Summary
-----------------
This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.

Official Title
-----------------
Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia

Conditions
-----------------
Ventral Hernia, Incisional Hernia

Intervention / Treatment
-----------------
* Device: Cook® Antimicrobial Hernia Repair Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique Exclusion Criteria: Body Mass Index (BMI) < 25. Body weight < 45 kg Glycosylated Hemoglobin (Hgb A1c) > 10% Albumin < 2.5 g/dL or pre-albumin < 5.0 mg/dL Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 Known allergies to study device components Other relevant exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Hernia Repair<br>Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device. | Device: Cook® Antimicrobial Hernia Repair Device<br>* Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Surgical Site Infection |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence). |  | 12 months |
Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan

Study Overview
=================
Brief Summary
-----------------
To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.

Official Title
-----------------
A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: Celecoxib
* Drug: Placebo
* Drug: Loxoprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower Patients who have had low back pain for at least two weeks Exclusion Criteria: Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Celecoxib|nan|
|Drug: Placebo|nan|
|Drug: Loxoprofen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's pain assessment (VAS: Visual Analogue Scale) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ) |  |  |
Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. The influence of respiration on hepatic hemodynamics is still poorly understood, although some studies have shown a significant impact. The purpose of this project is to quantify the blood flow variations in the portal vein at different positions during the respiratory cycle by using a fast MRI sequence and an Echo Planar (EPI) acquisition.

Official Title
-----------------
Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers

Conditions
-----------------
MRI, Portal Blood Flow, Respiratory Amplitude, Echo Planar Imaging

Intervention / Treatment
-----------------
* Other: peripheral ECG
* Other: Standard MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 ans Healthy subject without history of hepatic disease Exclusion Criteria: history of hepatic pathology pregnant woman claustrophobia major obesity any contraindication to MRI exam

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: peripheral ECG|Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.|
|Other: Standard MRI|Standard MRI examination using a torso coil consists of morphological and phase-contrast flow sequences(standard and EPI acquisitions).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow rates variation between the fast sequence averaged values and the standard sequence | flow rates variation between the fast sequence averaged values and the standard sequence during free breathing. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory amplitude, Portal Blood Flow, MRI, Echo Planar Imaging
Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia

Official Title
-----------------
Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Other: bendamustine
* Other: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin Informed Consent Form for personal data handling signed by the program participant Exclusion Criteria: Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment Contraindications for Ribomustin usage in accordance with product label

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| bendamustine and rituximab<br> | Other: bendamustine<br>* Routine practice<br>* Other names: Ribomustin;Other: rituximab<br>* Routine practice<br>* Other names: Mabthera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Within 60-90 days after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions |  | At all post-treatment visits (up to 30 days after end of treatment) | 
| Treatment Failure (TF) |  | Within 60-90 days after end of treatment | 
| Time to Progression (TTP) |  | 60 months | 
| Progression-Free Survival (PFS) |  | 60 months | 
| Relapse following complete or partial remission |  | 60 months | 
| Overall survival |  | 60 months | 
| Quality of Life of patients receiving Ribomustin therapy |  | At all post-treatment visits (up to 30 days after end of treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
observational, chronic lymphocytic leukemia, bendamustine
Characteristics of Patients With Amyloidosis & Heart Failure Being Evaluated for a Heart Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the characteristics of patients with amyloidosis and severe heart failure being evaluated for cardiac and stem cell transplantation.

Detailed Description
-----------------
Systemic amyloidosis is a progressive disease leading to organ failure and death. Treatment has improved survival with stem-cell transplantation. Unfortunately, patients with amyloidosis and severe heart failure are not eligible for stem-cell transplantation. The average rate of survival for patients with amyloidosis who receive a heart transplant is decreased. Previous trials have raised the possibility that survival may be increased in patients with amyloidosis, if chemotherapy and stem-cell transplantation is performed after a heart transplant. We plan to review data of patients with amyloidosis and heart failure who were being evaluated for a heart transplant.

Official Title
-----------------
Characteristics of Patients With Systemic Amyloidosis and Severe Heart Failure Being Evaluated for a Sequential Cardiac and Autologous Stem Cell Transplantation

Conditions
-----------------
Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with amyloidosis NYHA class III or IV heart failure Patients undergoing heart transplant evaluation Patients less than 18 years of age Exclusion Criteria: Patients who have unstable pulse and blood pressure

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amyloidosis, heart failure, heart transplant, stem cell transplant