linjc16/ctgov huggingface dataset:
Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study

Study Overview
=================
Brief Summary
-----------------
This randomized controlled pharmacokinetic based study will be carried out on patients with both sexes and various ages, plasma triglycerides levels, clinical health disorders and using different agents for treatment of their hyperlipidemia in order to access the optimal drug therapy with best cost effectiveness in the elderly cases under investigation.

Official Title
-----------------
Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study

Conditions
-----------------
Hyperlipidemia; Mixed

Intervention / Treatment
-----------------
* Drug: Ezetimibe 10mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of dyslipidemia with high triglyceride level (200 to 499 mg/100 ml). Total cholesterol level more than 200 mg/100 ml Male and female Age 35 - 70 years Exclusion Criteria: - Hypersensitivity of drugs Liver toxicity -Patients suffering from renal dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Simvastatin<br> | |
| Ezetimibe<br> | Drug: Ezetimibe 10mg<br>* Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites<br>|
| Omega -3 fatty acids-<br> | |
| Simvastatin+ Ezetimibe<br> | Drug: Ezetimibe 10mg<br>* Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites<br>|
| Simvastain + ezetimibe + omega<br> | Drug: Ezetimibe 10mg<br>* Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Total cholesterol | reduction of LDL | 3 months |
Virtual Reality a Novel Screening and Treatment Aid in Attention Deficit Disorder

Study Overview
=================
Brief Summary
-----------------
Using a virtual reality program in screening and treatment of ADHD.

Detailed Description
-----------------
Virtual Reality is a novel program designed to imitate a real classroom environment including various distractions. It includes a head monitor to track eye movements Children aged 10-20 years with ADHD will use the program with and without methylphenidate(1 mg/kg). Their results will be compared to a control group. Parental consent will be obtained.

Official Title
-----------------
Virtual Reality a Novel Screening and Treatment Aid in Attention Deficit Disorder

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ADHD-DSM4 criteria AGE 10-20 YEARS normal neurological examination IQ>80 Exclusion Criteria: ABNORMAL NEUROLOGICAL STATUS

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virtual Reality program test results |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality, ADHD, Methylphenidate
A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.

Official Title
-----------------
A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

Conditions
-----------------
Osteosarcoma

Intervention / Treatment
-----------------
* Drug: Chemotherapy
* Drug: Endostar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis At least one measurable lesion Life expectancy > 3 months ECOG performance status 0-2 Adequate hematologic, cardiac, renal, and hepatic function Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study Exclusion Criteria: Evidence of metastasis Serious infection Evidence of bleeding diathesis Significant cardiovascular disease Pregnant or lactating woman Allergic to E.coli preparation

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemotherapy<br> | Drug: Chemotherapy<br>* Week 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle).<br>|
| Experimental: Endostar plus Chemotherapy<br> | Drug: Chemotherapy<br>* Week 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle).<br>Drug: Endostar<br>* In each cycle, Week 1-2 day 1-14 endostar 7.5 mg/m2/day; Week 5-6 day 1-14 endostar 7.5 mg/m2/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb Salvage Rate |  | end of the first cycle | 
| Overall Survival |  | 5 years | 
| Clinical Response Rate |  | end of the first cycle | 
| Clinical Benefit Response |  | end of the first cycle | 
| Quality of Life |  | after 4 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteosarcoma, Endostar, Chemotherapy
Longitudinal Strain in Addition to Visual Assessment of Wall Motion for Ruling in Ischemia in the Emergency Room

Study Overview
=================
Brief Summary
-----------------
To assess the utility of technician-based analysis of echocardiograms with longitudinal strain for ruling-in ischemic chest pain in the emergency room, compared to emergency room (ER) physician opinion and expert echocardiographer analysis of wall motion, both the latter blinded to any relevant clinical data .

Conditions
-----------------
Chest Pain

Intervention / Treatment
-----------------
* Device: Echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chest pain No indication of acute myocardial infarction Exclusion Criteria: Patients admitted for acute myocardial infarction Patients with known coronary artery disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| I<br> | Device: Echocardiogram<br>* An echocardiogram will be repeated at every step, from baseline to peak heart rate setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Use of a Dietary Supplement to Support Digestive Health in Children With Chronic Diarrhea

Study Overview
=================
Brief Summary
-----------------
Micronutrients missing in the diet may assist in supporting digestive health in children with chronic GI issues. This study will monitor changes in symptoms associated with digestive problems in children provided with a dietary supplement that will be taken in conjunction with the standard of care.

Detailed Description
-----------------
Children with GI symptoms have varying response to the standard of care treatments. A dietary supplement of polyphenols from green tea and pomegranate extracts provides micronutrients often missing from conventional American diets. The objective of this study is to monitor changes in GI symptoms when the supplement is provided alongside the standard of care for children with symptoms that have been present for more than two weeks.

Official Title
-----------------
Assessment of the Utility of a Dietary Supplement as an Adjunct to Standard of Care for Children With Chronic Diarrhea

Conditions
-----------------
Antibiotic-associated Diarrhea

Intervention / Treatment
-----------------
* Dietary Supplement: polyphenol supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-patients with diagnosis of unresolved gastrointestinal distress Parent or guardian willing to administer the dietary supplement orally once daily for up to 21 days Parent or guardian willing to record changes in GI symptoms on a questionnaire Parent or guardian willing to bring the child for a clinic visit to close-out participation in the study Exclusion Criteria: requires care in an ICU has documented intestinal stricture, stenosis, obstruction, or abscess has concomitant congenital diseases are immunodeficient has malformation of the GI tract is unable to swallow fluids parent or guardian is unable or unwilling to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polyphenol supplement<br>Dietary supplement administered 8 mL once daily | Dietary Supplement: polyphenol supplement<br>* 8 mL once daily<br>* Other names: Traveler Protect;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of GI symptoms |  | 3 weeks |
Inflammatory Genomics in Human Carotid Artery Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the relationship between genetic variation in genes for inflammation and carotid artery atherosclerosis.

Detailed Description
-----------------
BACKGROUND: Atherosclerotic vascular disease is a major source of morbidity and mortality. Inflammation plays an important role in atherosclerosis. The tools to systematically study the extent to which genetic variation determines risk of and progression of atherosclerosis are only now becoming available. DESIGN NARRATIVE: The study will evaluate the role of genetic variation in inflammatory pathway genes at 29 loci on the risk and progression of carotid artery atherosclerotic disease (CAAD). Genes to be evaluated include those potentially involved in plaque initiation and progression. The investigators will evaluate single nucleotide polymorphisms (SNPs) informative for the common locus haplotypes. Choice of informative polymorphisms for evaluation is based on the genes' evolutionary history. They will evaluate progression effects in subjects with CAAD followed longitudinally by noninvasive magnetic resonance (MR) techniques over 3 years. Risk will be evaluated by case-control comparisons. In additions to evaluating genetic polymorphisms, they will evaluate the intervening phenotypes of protein level for fibrinogen, C-reactive protein, serum amyloid A, and interleukin-6. Independence of genetic predictors from traditional cardiovascular risk factors will be evaluated. The major specific aims are: Aim 1. Test for inflammatory genetic effects and protein level in CAAD progression in 550 subjects with CAAD (275 with 15-49% and 275 with 50-79% baseline CAAD stenosis) evaluated by 3-year magnetic resonance image follow-up of percent lumen stenosis; Aim 2. Determine whether the variation in the inflammatory genes or protein levels predicts 810 case vs. 810 control status with a case distribution of 335 subject with 15-49%, 275 with 50-75% and 200 with >80% carotid artery stenosis at baseline. Age (onset of vascular disease for cases, current age for controls)-, sex-, race-, and hospital-matched controls will have less than 15% stenosis on carotid duplex ultrasound. Genes that are implicated in disease may eventually allow targeted therapy.

Conditions
-----------------
Cardiovascular Diseases, Atherosclerosis, Carotid Artery Diseases, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Gated Radiotherapy in Left Sided Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To assess the need of respiratory gated radiotherapy in left sided breast cancer patients.

Official Title
-----------------
A Prospective Study on the Need of Gated (GAT) Radiotherapy in Left Sided Breast Cancer Patients Treated at the Technical University Munich (TUM) - the GATTUM Protocol

Conditions
-----------------
Breast Neoplasm Female, Radiotherapy Side Effect, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: left sided breast cancer patients treated with breast conserving surgery Exclusion Criteria: patients treated with mastectomy patients with positive lymph nodes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Measurement of distance from chestwall to the heart | Rigid and non-rigid measurement of distance from chestwall to the heart. | 3 years | 
| Measurement of distance from the heart to the mammary gland | Rigid and non-rigid measurement of distance from the heart to the mammary gland | 3 years |
Protein Ingestion and Skeletal Muscle Atrophy

Study Overview
=================
Brief Summary
-----------------
The effect of different protein intakes on skeletal muscle atrophy during short term unilateral leg immobilisation.

Official Title
-----------------
Understanding the Role of Protein Ingestion on Skeletal Muscle Atrophy During an Acute Period of Disuse

Conditions
-----------------
Muscle Atrophy

Intervention / Treatment
-----------------
* Other: Lower limb immobilisation (leg brace) with varying levels of protein intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >18 and <28 no prescription medications or current illness. Exclusion Criteria: BMI <18 and >28 current prescription medication no history of leg injury. Smoker Medical conditions including (cardiovascular disease ((e.g. hypertension)), metabolic disease ((e.g. type 2 diabetes)), any personal or family history of deep vein thrombosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein<br> | Other: Lower limb immobilisation (leg brace) with varying levels of protein intake<br>* Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake<br>|
| Experimental: Low protein<br> | Other: Lower limb immobilisation (leg brace) with varying levels of protein intake<br>* Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake<br>|
| Experimental: Minimum protein<br> | Other: Lower limb immobilisation (leg brace) with varying levels of protein intake<br>* Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle size |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength |  | 3 days |
Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetics and safety Profiles after administration of DA-5218 and co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in healthy adult volunteers

Official Title
-----------------
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DA-5218
* Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers BMI between 18 and 30 kg/m2 Body weight: Male≥50kg, Female≥45kg Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study Exclusion Criteria: Subjects with allergy or drug hypersensitivity Subjects with clinically significant medical history Subjects with history of drug abuse or addicted

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br> | Drug: DA-5218<br>* single dose administration (DA-5218 one tablet once a day)<br>Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3<br>* single dose administration (DA-5218-R1 one tablet once a day + DA-5218-R2 one tablet once a day + DA-5218-R3 one tablet once a day)<br>|
| Experimental: Sequence B<br> | Drug: DA-5218<br>* single dose administration (DA-5218 one tablet once a day)<br>Drug: DA-5218-R1 + DA-5218-R2 + DA-5218-R3<br>* single dose administration (DA-5218-R1 one tablet once a day + DA-5218-R2 one tablet once a day + DA-5218-R3 one tablet once a day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | pre-dose 72 hours post-dose | 
| Cmax | maximum plasma concentration | pre-dose 72 hours post-dose |
Changes of Pad Weight Results and Urethral Pressure Profiles After Reduction of Cystocele by Vaginal Gauze Packing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to retrospectively review the impact of vaginal packing on the urodynamic studies, especially for urethral pressure profiles.

Conditions
-----------------
Cystocele

Intervention / Treatment
-----------------
* Procedure: vaginal packing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with >= stage II cystocele and underwent urodynamic studies Exclusion Criteria: patients less than 20 patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cystocele<br> | Procedure: vaginal packing<br>* vaginal packing after urodynamic studies, and repeat urethral pressure profile<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of pad weight and values of urethral pressure profiles after vaginal gauze packing. | Changes of pad weight and values of urethral pressure profiles between before and after vaginal gauze packing | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of anti-incontinence surgery using the criteria of pad weight > 8 gm after vaginal gauze packing as the indication of concomitant anti-incontinence surgery during cystocele repair | The rate of anti-incontinence surgery in the follow-up period after cystocele repair using the criteria of pad weight > 8 gm after vaginal gauze packing in the initial urodynamic examinations as the indication of concomitant anti-incontinence surgery during cystocele repair. | 5 years |