linjc16/ctgov huggingface dataset:
Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

Study Overview
=================
Brief Summary
-----------------
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Simvastatin Alone.

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: Fenofibrate/Simvastatin
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mixed dyslipidemia Exclusion Criteria: Diabetes, Known hypersensitivity to fenofibrate or simvastatin, Pregnant or lactating women, Contra-indication to fenofibrate or simvastatin, Unstable or severe cardiac disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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> | Drug: Fenofibrate/Simvastatin<br>* Combination of Fenofibrate and Simvastatin 40mg<br>|
| Active Comparator: 2<br> | Drug: Simvastatin<br>* Simvastatin 40mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides |  | 12 weeks | 
| Percent change from baseline to 12 weeks of treatment in HDL-C |  | 12 weeks | 
| Percent change from baseline to 12 weeks of treatment in LDL-C |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 24 weeks of treatment in Triglycerides |  | 24 weeks | 
| Percent change from baseline to 24 weeks of treatment in HDL-C |  | 24 weeks | 
| Percent change from baseline to 24 weeks of treatment in LDL-C |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia Combined, Combination of fenofibrate and simvastatin
Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.

Official Title
-----------------
A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Bicalutamide
* Drug: Tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed prostate cancer Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy Exclusion Criteria: Age > 75 yrs No metastatic disease (M1). No presence of gynaecomastia and/or mastalgia at screening No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bicalutamide|nan|
|Drug: Tamoxifen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual functioning, Quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Casodex monotherapy
Better Disease Control by Multidrug Regimen in Scabies

Study Overview
=================
Brief Summary
-----------------
Scabies is associated with significant discomfort and social taboo. Existing treatment regimen frequently fails due to lack of patient compliance. We compared single use regimen to existing standard repeat application regimen for treatment of scabies.

Official Title
-----------------
Better Disease Control by Multidrug Regimen in Scabies: A Randomized Controlled Trial

Conditions
-----------------
Scabies

Intervention / Treatment
-----------------
* Drug: Permethrin Lotion 5%
* Drug: Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing patients Clinical diagnosis of scabies Within the age limits Exclusion Criteria: Unwilling patients Patients with severe co-morbidities requiring long term medication Pregnant women Patients who don't fulfill the age limit criteria

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| Active Comparator: Group 1 Permethrin only<br>Standard regimen of permethrin 5% topical application to be repeated after 1 week. | Drug: Permethrin Lotion 5%<br>* Topical permethrin 5% lotion to apply on day 1 and repeat after 1 week.<br>|
| Active Comparator: Group 2 Permethrin and Ivermectin<br>A combination regimen of permethrin 5% topical application with oral ivermectin 200 mcg/kg given on the single day only | Drug: Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg<br>* Topical permethrin 5% lotion and oral ivermectin 200 mcg/kg to be taken on day 1 only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus | Rate of relief from pruritus assessed using visual analog scale | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin lesions | Rate of eradication of skin lesions assessed using physician global assessment scale | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Permethrin, Ivermectin, Combination Regimen, Scabies
A Trial Investigating the Effect of a Treatment With Zinkgluconaat for Verrucae Vulgares

Study Overview
=================
Brief Summary
-----------------
A Double-blind, placebo-controlled trial investigating the effect of a treatment with zinkgluconaat for verrucae vulgares

Detailed Description
-----------------
A Double-blind, placebo-controlled trial investigating the effect of a treatment with zinkgluconaat for verrucae vulgares

Official Title
-----------------
A Double-Blind, Placebo-Controlled Trial Investigating the Effect of a Treatment With Zinkgluconaat for Verrucae Vulgares

Conditions
-----------------
Verrucae Vulgares

Intervention / Treatment
-----------------
* Drug: Administration of zinkgluconaat or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with verrucae vulgares Exclusion Criteria:

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of zinkgluconaat or placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearence of the verrucae vulgares after 3 months |  |  |
Resting Metabolic Rate in Chronic Bed-Ridden Patients

Study Overview
=================
Brief Summary
-----------------
Research objective: to measure resting metabolic rate (REE) in long term, bed ridden, chronically ill patients and to compare their measured energy needs to standard REE equations

Detailed Description
-----------------
Are standard REE equations suitable for estimating resting metabolic rate in long term, bed ridden, chronically ill patients? Research objective: to measure resting metabolic rate (REE) in long term, bed ridden, chronically ill patients and to compare their measured energy needs to standard REE equations

Official Title
-----------------
Resting Metabolic Rate in Chronic Bed-Ridden Patients

Conditions
-----------------
Chronic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age (years): 18-30, 31-60, 61-74, 75-100 Confinement to bed at least for a year Exclusion Criteria: Mechanical ventilation Tracheostomy

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
-----------------
resting metabolic rate, bed ridden, vegetative, low conscious, minimal conscious state, immobilized, resting energy expenditure
Development of an Assessment Tool for Health-related Quality of Life in Children and Adolescents With Pompe Disease

Study Overview
=================
Brief Summary
-----------------
Health related quality of life (HrQoL), is the patient's subjective perception of the impact of his disease and its treatment on his daily life, physical, psychological and social functioning and well-being and thus constitutes a patient reported outcome (PRO) of utmost importance. Generic HrQoL instruments can by definition not capture disease-specific parameters nor are they sensitive enough to detect their changes. In this study, a disease-specific HrQoL questionnaire for children and adolescents will be developed. Patients and parents will be involved in focus groups and interviews to identify relevant contents. The instrument will be tested for validity and reliability.

Official Title
-----------------
Development and Validation of a Standardized Assessment Instrument for Health-related Quality of Life (HrQoL) in Children and Adolescents With Pompe Disease (PD): a Joint Effort of Patients, Caregivers and Metabolic Experts

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Other: Testing of reliability / validity of new questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PD from age 8 years Parent of patient(s) < 18 years with PD Able to give informed consent as documented by signature Sufficient command of the German language Exclusion Criteria: - Inability to follow the procedures of the study, e.g. due to language problems or severely reduced health status

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Testing of reliability / validity of new questionnaire<br> | Other: Testing of reliability / validity of new questionnaire<br>* Participants will answer new questionnaire and other, established, generic and chronic generic HrQol instruments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability/ validity of questionnaire |  | 15 months |
Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

Study Overview
=================
Brief Summary
-----------------
While thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. It is often difficult to manage and relatively resistant to opioids. The investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.

Official Title
-----------------
Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia

Conditions
-----------------
Post Thoracic Surgery

Intervention / Treatment
-----------------
* Drug: Bupivacaine-epinephrine
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy Exclusion Criteria: ASA >3, morbid obesity BMI>40, Previous cardiac or ipsilateral thoracic surgery, Renal or hepatic failure, anemia, allergy to local anesthetics, contraindications to receive regional anesthesia, patient refusal, reiteration due to complication

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: RCT with one active group and a control (placebo) group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Patients in this group receive Normal Saline injection in the inter pleural space | Drug: Normal saline<br>* See previous descreption<br>|
| Experimental: Experimental group<br>Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space | Drug: Bupivacaine-epinephrine<br>* See previous description<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS scores | ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours | from 0 hour to 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Vital Capacity |  | from 0 hour to 48 hour | 
| Total epidural infusion |  | from 0 hour to 48 hour | 
| Co-analgesia consumption |  | from 0 hour to 48 hour |
Post-Operative Rehabilitation of Knee Osteochondral Defect: A Case Series

Study Overview
=================
Brief Summary
-----------------
A case-series review was performed on five collegiate athletes with osteochondral lesions of the knee at California State University, Northridge (CSUN). All subjects received surgical intervention to treat the defect. The surgeries performed were either an Osteoarticular Transfer System (OATS) procedure and/or a Microfracturing procedure. Subjects were treated post-operatively by the CSUN team physical therapist and/or athletic trainers at CSUN. This paper seeks to provide information about osteochondral defects of the knee, the surgical interventions, and a protocol for post-operative treatment and rehabilitation of such injuries.

Official Title
-----------------
Examination and Post-operative Rehabilitation of University Athletes With Osteochondral Lesions of the Knee: A Case Series Report

Conditions
-----------------
Osteochondral Defect, Osteochondritis Dissecans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Student athlete at CSUN Diagnosed with Osteochondral dissecans (OCD) Underwent surgical procedure to treat OCD Treated postoperatively by the team physical therapist and/or athletic trainers at CSUN. Exclusion Criteria: - No concurrent ligamentous injures to the knee during the time of subject participation in the study
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 |
| --- | --- | --- |
| Level of Function | Determined by subject's ability to return to play of his/her respective sport | Through study completion; an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain as measured by the Visual Analog Scale (VAS), 0 (No pain) - 10 (Severe Pain) | Monthly until the completion of the study; an average of 6 months |
Access to Healthcare and the Right to Health of People Living in Disadvantaged Neighborhoods Around Cayenne in French Guiana

Study Overview
=================
Brief Summary
-----------------
ACSES aims to describe the health behaviours and vulnerabilities of poor urban communities living in the greater Cayenne area. It was a questionnaire based study conducted around a red cross truck providing testing.

Official Title
-----------------
Access to Healthcare and the Right to Health of People Living in Disadvantaged Neighborhoods Around Cayenne in French Guiana

Conditions
-----------------
Health Care Acceptability

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living in poor neighborhoods around cayenne Exclusion Criteria: minors refusal to participate

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

| Intervention/Treatment |
| --- |
|Other: survey|no intervention just survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Acceptability - Questionnaire survey |  | one year |
Smartphone and Posture Control In Healthy Adolescents

Study Overview
=================
Brief Summary
-----------------
This is a study to determine if smartphone use affect posture control in adolescents.

Detailed Description
-----------------
It is within subject repeated measure study to determine if touch screen use affect posture control in healthy adolescents. 200 normal adolescents between 14 and 18 years old will be included. 1st they will be assessed for posture control to determine normal values for their ages, then each child will be given smartphone to play a game while the sound is muted for 15 min then their balance will be re-assessed, finally they will use the phone for another 15 min but the children will use headphone piece this time then re-assess balance.

Official Title
-----------------
Smartphone Dual Tasking and Posture Control In Healthy Adolescents

Conditions
-----------------
Balance

Intervention / Treatment
-----------------
* Device: smartphone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age from 14 to 18 years old. Both genders will be included. Normal Body mass index (BMI) for age. Children using smartphone for at least 1 year. Exclusion Criteria: Obese children. children with vestibular or visual problems. Children with neurological disorders. Children with congenital deformities or musculoskeletal disorders. Children with cognitive impairment. Injuries or inflammatory conditions involving the extremities.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum 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 |
| --- | --- |
| 1 group<br>1 group will be assessed then will be given smartphone to use and assessed | Device: smartphone<br>* modern technology<br>* Other names: touch screen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| center of pressure | a metric for measuring changes in posture control | 6 months |
A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic macular edema Criteria for visual acuity and macular thickness are met Exclusion Criteria: History of glaucoma Known steroid-responder Use of systemic steroids Use of Warfarin/Heparin Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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
-----------------
eye diseases, diabetic eye problems