linjc16/ctgov huggingface dataset:
Economic Evaluation German Drug-Eluting Stent Registry

Study Overview
=================
Brief Summary
-----------------
Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis. The study Economic Evaluation of the German Drug-Eluting Stent Registry examines the cost-effectiveness of drug-eluting stents compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment of daily activities, and re-intervention rates.

Official Title
-----------------
Economic Evaluation German Drug-Eluting Stent Registry

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for coronary stent implantation Additional inclusion criteria BMS cohort: Acute Coronary Syndrome Diabetes Mellitus Previous Percutaneous Coronary Intervention/Coronary Artery Bypass Graft 3-Vessel Disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 DES<br>Patients receiving drug-eluting stent | |
| 2 BMS<br>Patients receiving bare metal stent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost equivalence of drug-eluting coronary stents versus bare metal stents |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE |  | 12 months | 
| Quality of life |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary heart disease, chd, stent
St. Jude Medical Product Longevity and Performance (SCORE) Registry

Study Overview
=================
Brief Summary
-----------------
SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM) products. This registry will be conducted in the United States (US). The primary purpose of the registry is to evaluate and publish acute and long-term performance of market-released SJM CRM products by analyzing product survival probabilities. Product status and any related adverse events will be collected to measure survival probabilities.

Official Title
-----------------
St. Jude Medical Product Longevity and Performance (SCORE) Registry

Conditions
-----------------
Bradycardia, Tachycardia, Heart Disease

Intervention / Treatment
-----------------
* Device: Cardiac Rhythm Management device


Participation Criteria
=================
Eligibility Criteria
-----------------
Enrollment Criteria: Patient has a standard indication for a CRM implantable device. Patient is implanted with at least one new market-released SJM CRM product from a list provided by SJM (e.g pacemaker, ICD, CRT-D, CRT-P, pacing/sensing lead, defibrillation lead) within the last 90 days. Complete system implant information (e.g. model, serial number, location) is available at enrollment. Any product-related adverse event information at implant is available at enrollment. Patient or appropriate legal guardian is willing to provide authorization for registry participation.

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 |
| --- | --- |
| Cardiac Rhythm Management device<br>Implanted with implantable defibrillator or pacemaker system | Device: Cardiac Rhythm Management device<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival |  | 5 year average | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bradycardia, Tachycardia, Arrhythmia, ICD, pacemaker, pacing lead
Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about nutrition-related changes that identify biomarkers related to cancer. It may also help doctors predict a woman's risk of developing breast cancer. PURPOSE: This laboratory study is looking at nutrition-related biomarkers in predicting breast cancer risk in women.

Detailed Description
-----------------
OBJECTIVES: To complete characterization of metabolic serotypes based on the metabolome, and to adapt these profiles for human epidemiological studies. To determine the extent to which metabolic profiles that are reflective of or independent of long-term caloric intake predict breast cancer risk in nested case-control studies. To identify critical serum metabolites. OUTLINE: Laboratory studies, including metabolome profiling by high performance liquid chromatography; and small molecule identification by mass spectroscopy, are performed on previously collected blood samples.

Official Title
-----------------
Nutrition Modulated Metabolism as a Disease Risk Factor

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: high performance liquid chromatography
* Other: laboratory biomarker analysis
* Procedure: spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Confirmed breast cancer that was diagnosed at least 2 years after blood sample collection (case) No prior diagnosis of cancer Healthy participant (control) Enrolled in the Nurses' Health Study Banked blood samples available Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: high performance liquid chromatography|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: spectroscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generation of metabolome profiles that reflect nutritional status |  | ongoing | 
| Utility of rat metabolome profiles for human epidemiological studies |  | ongoing | 
| Utility of metabolome profiles in predicting relative risk of developing breast cancer |  | ongoing | 
| Identification of critical serum metabolites |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer
Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the potential interactions between iv cocaine and GBR 12909.

Detailed Description
-----------------
This is a single dose with escalation, double-blind, placebo-controlled inpatient study in which 24 cocaine experienced volunteers that meet protocol eligibility criteria during a 30 day screen period will be randomized into three dose groups.

Official Title
-----------------
Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: GBR 12909


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must understand study procedures and provide written informed consent For additional inclusion criteria information, please contact study site for more information. Exclusion Criteria: Please contact study site for more information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GBR 12909|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter comparison |  |  |
Palmitate Study - A Method Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are.

Detailed Description
-----------------
The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are. These molecules are not dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine samples or more) after drinking the fat molecules, we will be able to measure how fast your toddler is sending out (excreting) these samples in the urine. This will tell us how fast your toddler is using fat for energy. This will also help determine the best urine collection schedule for studies using this technology.

Official Title
-----------------
Measurement of Dietary Lipid Oxidation in Toddlers - a Method Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male or female Toilet trained or not Exclusion Criteria: Diagnosed metabolic disease

Ages Eligible for Study
-----------------
Minimum Age: 23 Months
Maximum Age: 25 Months

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How toddlers burn fat | collect urine | 24 hours |
Which Apparatus for Inhaled Pentamidine?

Study Overview
=================
Brief Summary
-----------------
The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®, disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have comparable properties and better availability to the hospital. Several studies remark that all nebulizers with comparable properties could be used for the nebulization.The aim of our work will be to evaluate and compare the pulmonary deposition between the reference nebulizer Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will measure and compare these data's for each of the nebulizers via nebulization Amikacine and urinary dosage.

Official Title
-----------------
Which Apparatus for Inhaled Pentamidine? A Comparison of Drug Delivery to the Lung Between Two Nebulizers: The Respirgard II and the Isoneb.

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

Intervention / Treatment
-----------------
* Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)
* Device: Respirgard II
* Device: Isoneb®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be in good health Exclusion Criteria: Known Tachycardia Renal Dysfunction Respiratory Diseases and history

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Respirgard II<br>Determination of pulmonary deposition | Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)<br> <br> Device: Respirgard II<br> <br> |
| Active Comparator: Isoneb<br>Determination of pulmonary deposition | Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)<br> <br> Device: Isoneb®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amikacine urinary dosage |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumocystis, Nebulizer, Pentamidine
A Double-masked, Randomized, Placebo-controlled,Pilot Study of Diquafosol Tetrasodium in Subjects Following Photorefractive Keratectomy (PRK)

Study Overview
=================
Brief Summary
-----------------
The objectives of this trial are to: Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus placebo following one week of treatment in subjects undergoing photorefractive keratectomy (PRK). Evaluate the potential of diquafosol to accelerate corneal wound healing/re-epithelialization following PRK.

Conditions
-----------------
Photorefractive Keratectomy

Intervention / Treatment
-----------------
* Drug: diquafosol tetrasodium ophthalmic solution 2%
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between age 18 - 45 years old candidate for bilateral PRK Exclusion Criteria: dry eye disease any corneal pathologies previous corneal or intraocular surgeries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diquafosol tetrasodium ophthalmic solution 2%<br>topical ophthalmic solution | Drug: diquafosol tetrasodium ophthalmic solution 2%<br>* opthalmic solution 2 drops in each eye QID<br>|
| Placebo Comparator: Placebo<br>saline ophthalmic solution | Drug: placebo<br>* opthalmic solution 2 drops in each eye QID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing time |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post PRK wound healing
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

Conditions
-----------------
Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost/timolol fixed combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of glaucoma or ocular hypertension in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical conditions Contraindication to beta-adrenoceptor antagonist therapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bimatoprost/timolol fixed combination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP |  |  |
A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery

Conditions
-----------------
Congenital Skelectal Anomaly

Intervention / Treatment
-----------------
* Drug: fentanyl
* Drug: dexmedetomidine
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients aged from 3 to 12 years undergoing orthopedic mechanical correction surgery Exclusion Criteria: coagulopathy, refusal (parents), current infection on the lumbar area, spinal tract pathology

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fentanyl<br>0.2% ropivacaine+ 1 mcg/kg fentanyl | Drug: fentanyl<br> <br> Drug: Ropivacaine<br> <br> |
| Experimental: dexmedetomidine<br>0.2% ropivacaine+1 mcg/kg dexmedetomidine | Drug: dexmedetomidine<br> <br> Drug: Ropivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | CHEOPS, FLACC score were measured | During 48 hrs after pediatric orthopedic surgery |
Effectiveness of a Vitamin Mineral Supplement

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete vitamin supplement with or without a combined omega-3 fatty acid supplement on selected clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

Detailed Description
-----------------
Participants will be randomized to 1 of 3 groups: vitamin with omega-3, vitamin w/o omega-3, or omega-3 alone. They will take the vitamin 12 weeks, after which time they will return for all laboratory tests. Persons who are currently taking a supplement must undergo a 2-week washout period before beginning the study. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

Official Title
-----------------
Effectiveness of a One-a-Day Cooper Complete Vitamin / Mineral Supplement With or Without Omega-3 Fatty Acid Ingestion

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

Intervention / Treatment
-----------------
* Drug: Cooper Complete One-A-Day Vitamin Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30-70 years of age, maintain current diet and exercise regimen, not currently taking vitamins or agree to stop for 6 weeks Exclusion Criteria: BMI <18.5 or >34.9, recent blood donation, elevated blood pressure, cholesterol, or fasting blood glucose that requires medication, plans to move soon, or pregnant or plans to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: multivitamin<br>1 tablet morning and evening | Drug: Cooper Complete One-A-Day Vitamin Supplement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| homocycsteine |  |  | 
| LDL cholesterol oxidation rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose |  |  | 
| C-reactive protein |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
supplement, omega-3 fatty acid, Homocysteine, LDL cholesterol