linjc16/ctgov huggingface dataset:
Sarcopenia in Children

Study Overview
=================
Brief Summary
-----------------
Juvenile idiopathic arthritis (AJI), is a frequent inflammatory disease in children, characterized by pain, arthritis, and deformities. Chronic inflammation leads to physical inactivity and can be associated with muscle weakness around affected joints, low bone strength, and mass(3). To our knowledge, no study has focused on the prevalence of sarcopenia in JIA and the data on the muscle disorder are lacking. The purpose of the present study is to detect sarcopenia and identify associated factors in children with JIA

Official Title
-----------------
Sarcopenia; a New Issue in Juvenile Idiopathic Arthritis

Conditions
-----------------
Sarcopenia, Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Diagnostic Test: densitometry/ handgrip dynamometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with juvenile idiopathic arthritis fulfilling the ILAR criteria Exclusion Criteria: We excluded patients who have a prosthesis, nutritional problems, inflammatory bowel disease, coeliac disease, temporomandibular involvement, or another chronic disease.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 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 |
| --- | --- |
| 1<br>healthy children aged between 4-16 years | Diagnostic Test: densitometry/ handgrip dynamometer<br>* all patients will undergo the Dual-energy X-ray absorptiometry (DXA) and the muscle strength assessment using the handgrip dynamometer<br>|
| 2<br>children aged between 4-16 years, suffering from juvenile idiopathic arthritis | Diagnostic Test: densitometry/ handgrip dynamometer<br>* all patients will undergo the Dual-energy X-ray absorptiometry (DXA) and the muscle strength assessment using the handgrip dynamometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skeletal muscle mass | Dual-energy X-ray absorptiometry (DXA) measures the appendicular lean mass ( the sum of the lean mass of the arms and legs) and adjusted to the body mass index | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strenght | Three consecutive trials will be measured by the handgrip dynamometer between the dominant and non-dominant sides. the highest value will be used and adjusted to the body mass index | 5 months |
Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of mesh fixation using absorbable versus non-absorbable sutures.

Official Title
-----------------
Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing initial unilateral Open Inguinal Hernia Repair surgery. Exclusion Criteria: patients having repeated Inguinal Hernia or bilateral Hernia patients undergoing laparoscopic surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: absorbable sutures<br>patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using absorbable sutures. | Procedure: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures<br>* use of absorbable sutures to fixate mesh inguinal hernia repair.<br>|
| Other: non absorbable sutures<br>patients attributed to that arm, undergoing surgery of Open Inguinal Hernia Repair With Mesh Fixation using non absorbable sutures,this is the method being considered the standard of care thus far. | Procedure: Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures<br>* use of absorbable sutures to fixate mesh inguinal hernia repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of absorbable sutures in inguinal hernia repair on hernia recurrence and post operative outcome | Absorbable sutures efficacy will be assessed according to:severity of post surgical pain(using NRS-Numerical Rating Scale measure),hernia recurrence (assessed by physical examination during the follow-up period) and other post surgical complications such as nerve entrapment,hematoma and stich granuloma | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
absorbable sutures efficacy, reducing Adverse effect to be caused from surgery, Inguinal Hernia repair with mesh
Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The metabolic syndrome is a collection of health risks that includes obesity, high blood pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to insulin. The purpose of this study is to find out if the medication, rosiglitazone, influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons with the metabolic syndrome. This is an early step to see if a medication, such as rosiglitazone, will be beneficial in people who have the metabolic syndrome.

Official Title
-----------------
The Effect of Rosiglitazone on Adipocyte-derived Cytokines in Nondiabetics With the Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nondiabetic subjects with an NCEP/ATP III diagnosis of the metabolic syndrome Exclusion Criteria: Statin Medications, liver disease, cardiovascular disease, heart failure, diabetes, chronic kidney disease,

Ages Eligible for Study
-----------------
Minimum Age: 30 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)

Study Overview
=================
Brief Summary
-----------------
The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as designed. The study will last about 3 months with up to 6 days of inpatient time.

Official Title
-----------------
An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Device: AID System
* Drug: Insulin Lispro


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months Have a body mass index of 18.5 to 37 kilogram per meter squared Have a hemoglobin A1c level ≥6.0% and ≤9.0% Exclusion Criteria: Have known allergies or history of hypersensitivity to insulin lispro Have had an episode of severe hypoglycemia within the past 6 months Have had more than 1 episode of diabetic ketoacidosis in the past 6 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AID System Containing Insulin Lispro<br>The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. | Device: AID System<br>* AID system<br>* Other names: LY8888AU;Drug: Insulin Lispro<br>* Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.<br>* Other names: LY275585;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) | Number of AEs | In-Patient Period (6 Days) | 
| Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL | CGM measured percentage of time <70 milligrams per deciliter (mg/dL) | In-Patient Period (6 Days) |
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.

Official Title
-----------------
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin NPH
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for at least 12 months Informed consent obtained BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2. HbA1c equal to or less than 12.0% Exclusion Criteria: Proliferate retinopathy or maculopathy Total daily insulin dose greater than 2.00 IU/kg Any condition or disease that rule out trial participation according to the judgement of the investigator. Mental incapacity, unwillingness or language barriers precluding understanding or cooperation. A life-style incompatible with trial participation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin NPH|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| body weight |  |  | 
| Antibodies |  |  | 
| Blood glucose |  |  | 
| Hypoglycaemia |  |  |
Aging and Cellular Mechanism for Insulin Action After Exercise Training

Study Overview
=================
Brief Summary
-----------------
This study will determine whether the metabolic and cellular mechanisms contributing to improved insulin action after aerobic or resistive exercise are different in older, obese, insulin resistant veterans. The hypothesis is that regular exercise, whether aerobic or resistive, will improve whole body insulin action, but the nature and magnitude of changes in skeletal muscle will differ between the two types of exercise.

Detailed Description
-----------------
Veterans will be of comparable body composition and age, and randomly assigned to either aerobic or resistive exercise. They will be instructed in a weight maintenance diet prior to beginning the exercise program, and maintain this diet throughout the study. Metabolic testing will be performed at baseline and after 6 months of exercise training. Testing will include measurement of body composition (anthropometry, dual-energy Xray absorptiometry, computed tomograph scan), maximal oxygen consumption, and muscle strength, glucose tolerance (oral glucose tolerance test), insulin sensitivity (euglycemic-hyperinsulinemic clamp), and muscle biopsies to examine skeletal muscle metabolic characteristics (fiber type distribution, capillary density, oxidative and glycolytic enzyme activities, and levels of key proteins important in insulin signaling and glucose transport). Data will be analyzed using analysis of variance to determine differences between the two exercise groups, and multiple regression analysis to determine the primary adaptations that are associated with the improvements in whole body insulin action.

Official Title
-----------------
Aging and Cellular Mechanism for Insulin Action After Exercise Training

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

Intervention / Treatment
-----------------
* Procedure: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Males between 50 years and 80 years Overweight Non-smoker Sedentary (no regular exercise for one year)

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Investigation of Factors Affecting Children's Attitudes Towards Peers With Disability

Study Overview
=================
Brief Summary
-----------------
Children with disabilities can be exposed to stigma and discrimination because of poor attitudes. The role of peer is crucial for development of disabled children. The aim of the study was to investigate the attitudes of children towards their peers with disabilities and to identify factors associated with them. 1305 elementary school students included to the study. The students participating in the study, 48.9% (534) were female, 51.1% (558) were male. The Chedoke-McMaster Attitudes towards Children with Handicaps (CATCH) scale was used to investigate the children's attitudes.

Detailed Description
-----------------
Being important in terms of epidemiological investigation. Giving new results from society with different cultural and national characteristics. Investigating the three components of the CATCH.

Official Title
-----------------
Investigation of Factors Affecting Children's Attitudes Towards Peers With Disability

Conditions
-----------------
Disability Physical

Intervention / Treatment
-----------------
* Other: implementation of CATCH scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were being a student of elementary school, being aged between 11-15 years and being volunteer. Exclusion Criteria: Students who had a congenital or acquired disability or a handicap and who did not complete the scale were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 11 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

| Intervention/Treatment |
| --- |
|Other: implementation of CATCH scale|subject completed the CATCH scale|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CATCH | The Chedoke-McMaster Attitudes towards Children with Handicaps Scale The CATCH scale contains 36 items. It is divided into three components. First, the affective component contains 12 items that focus on feelings towards people with disabilities. Second, the cognitive component contains 12 items that focus on beliefs towards people with disabilities. Third, the behavioural component contains 12 items that focus on behaviours towards people with disabilities. The CATCH scale was designed for children aged 9-13 years. The highest possible mean score on the overall scale or in any component is 40. A high score represents a more positive attitude | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attitude, CATCH, children, disability, peers
Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

Study Overview
=================
Brief Summary
-----------------
The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON). Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed. The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey. Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.

Conditions
-----------------
Leber Hereditary Optic Neuropathy (LHON)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with genetically confirmed diagnosis of LHON
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with LHON<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF). | average 0 to 10 years (retrospective) |
Timely Reperfusion in Acute ST-segment Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients.

Detailed Description
-----------------
In the regional health trust of North Norway, time to reperfusion in acute ST-elevation myocardial infarction is below the national average and below recommendations. The aim of this study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients. The study period is supposedly lasting for approximately 4 months, the time estimated to observe the clinical course of 100 patients. Before and during the study period, clinical leaders are encouraged to improve guideline adherence and to closely monitor the results of their own and collaborating institutions.

Official Title
-----------------
Mobilizing Clinical Leadership to Achieve Timely Reperfusion in Acute ST-segment Elevation Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Behavioral: Mobilizing clinical leaders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with acute myocardial infarction with ST-elevations within our regional health trust during Nov 1st and for approx 4 months, and with an indication for reperfusion therapy (thrombolysis and/pr PCI) Exclusion Criteria: Reperfusion therapy not indicated or contraindicated
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mobilizing clinical leaders|Clinical leaders and clinical personnel will regularly receive feedback regarding performance of their own hospital as well as other providers in the regional health trust of North Norway.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reperfusion | Interval between 1st medical contact and opening of the infarction-related coronary artery. | This parameter will be recorded within 1 week after patient inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection fraction at discharge | Systolic function of the left ventricle | This parameter will be recorded up to 6 months after patient inclusion | 
| Survival | Survival after 30 days from incident | This parameter will be collected from patient's records during Nov -20 till Aug -21. |