linjc16/ctgov huggingface dataset:
Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.

Official Title
-----------------
Drug Eluting Balloon in peripherAl inTErvention for In-Stent Restenosis: the DEBATE-ISR Study

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: DEB
* Device: POBA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years intermittent claudication (Fontane III or IV) angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm, previously treated with nitinol stent implantation, with at least one below-knee vessel to the ankle Exclusion Criteria: allergy to Paclitaxel contraindication for combined antiplatelet treatment life expectancy <1 year hypersensitivity or contraindication to one of the study drugs lack of consent need for amputation angiographic evidence of stent fracture

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 |
| --- | --- |
| DEB<br>paclitaxel-eluting balloon angioplasty | Device: DEB<br>* paclitaxel-eluting balloon angioplasty<br>|
| conventional PTA<br>historical conventional balloon angioplasty control group (patients referred to our institution between 2008 and 2009) | Device: POBA<br>* conventional balloon angioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic binary re-restenosis | incidence of angiographic binary re-restenosis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major amputation | incidence of major amputation | 24 months | 
| stent thrombosis | incidence of stent thrombosis | 24 months | 
| target lesion revascularization | incidence of target lesion revascularization | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral arterial disease, drug-eluting balloon, restenosis
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population

Official Title
-----------------
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Warfarin

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: YM150
* Drug: warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are eligible for the study if all of the following apply: Subject has paroxysmal permanent or persistent NVAF Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit. Legal minimum age requirement (country-specific). Written informed consent has been obtained. Exclusion Criteria: History of heart valve disorders History of rheumatic fever. History of stroke and/or systemic embolism (including TIA). History of Acute Coronary Syndrome (ACS). Indication for warfarin other than NVAF. Known hemorrhagic disorder and/or coagulation disorder. Active bleeding or any condition associated with increased risk of bleeding.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low dose | Drug: YM150<br>* Oral<br>|
| Experimental: 2<br>Middle dose | Drug: YM150<br>* Oral<br>|
| Experimental: 3<br>High dose | Drug: YM150<br>* Oral<br>|
| Active Comparator: 4<br> | Drug: warfarin<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All clinically relevant bleeds during the treatment period rated as major or clinically relevant non-major(CRNM) |  | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic stroke |  | 16 Weeks | 
| Incidence of transient ischemic attack (TIA) |  | 16 Weeks | 
| Incidence of systemic thromboembolic event |  | 16 Weeks | 
| Incidence of the bleeding rates |  | 16 Weeks | 
| Other safety assessments |  | 16 Weeks | 
| PK, PD variables |  | 16 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Factor Xa inhibitor, Atrial fibrillation, Stroke, Ischemic attack, thromboembolism, Prevention and control
Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.

Official Title
-----------------
A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Device: Hydros
* Device: Hydros-TA
* Drug: Triamcinolone Acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA. Symptoms in the index knee for at least 12 months. Fully ambulatory Subject (ability to perform a 15 meters walk test). Male and female Subjects 40 through 85 years of age. Exclusion Criteria: BMI >40 kg Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease. Intra articular steroid therapy in last 3 months Intra articular viscosupplementation in last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Hydros<br>Hydros Joint Therapy | Device: Hydros<br> <br> |
| Experimental: Hydros-TA<br>Hydros-TA Joint Therapy | Device: Hydros-TA<br> <br> |
| Active Comparator: Triamcinolone acetonide<br>Triamcinolone acetonide | Drug: Triamcinolone Acetonide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the WOMAC A subscale score for the treatment knee. |  | 2 weeks and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee
Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects

Official Title
-----------------
Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: BMS-779788
* Drug: BMS-779788
* Drug: BMS-779788
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women (not of child bearing potential) ages 18 to 45 Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Exclusion Criteria: Women of child bearing potential Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

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

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-779788 or Placebo (Arm 1)<br> | Drug: BMS-779788<br>* Oral Solution, Oral, 1 mg, Once daily, 7 days<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once daily, 7 days<br>|
| Active Comparator: BMS-779788 or Placebo (Arm 2)<br> | Drug: BMS-779788<br>* Oral Solution, Oral, 2 mg, Once daily, 7 days<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once daily, 7 days<br>|
| Active Comparator: BMS-779788 or Placebo (Arm 3)<br> | Drug: BMS-779788<br>* Oral Solution, Oral, <= 4 mg, Once daily, 7 days<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once daily, 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests |  | 8 times within 27 days of the first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers) |  | After each dose panel |
Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: teriparatide
* Drug: raloxifene
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Must be diagnosed with osteoporosis. Must be female, age 45 through 85. Must be at least 5 years postmenopausal. Must be free of other severe or chronically disabling conditions. Must be able to properly use injection device. Exclusion Criteria Must not have bone diseases other than osteoporosis. Must not have history of certain cancers. Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes). Must not have taken or are currently taking certain types of medicines. Must not have known allergy to the study agent or SERM.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: teriparatide|nan|
|Drug: raloxifene|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to evaluate the usefulness of Kansas University airway exam score (KU score) in predicting difficulty of placement of a breathing tube into the windpipe.

Official Title
-----------------
The KU Score: Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score; an Observational Study

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Other: KU Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-IV Patients scheduled for a surgical or any other diagnostic or therapeutic procedure that requires endotracheal intubation (ETI) Exclusion Criteria: Patients scheduled for an emergent surgery Obstetric patients

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 |
| --- | --- |
| KU Score<br>Participants asked to answer questions for the KU Score exam | Other: KU Score<br>* Exam with a max score of 10 and min score of 0. Designed as a preoperative assessment of the patient's airway.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between KU score and intubation difficulty scale (IDS) measure | The measure is assessed during the time period between the start of preoperative examination on the day of surgery and completion of a standard tracheal intubation in the operating room. Correlation measured using the Spearman correlation coefficient. | Time between preoperative exam to after intubation, up to 3 hours |
A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

Study Overview
=================
Brief Summary
-----------------
This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.

Official Title
-----------------
A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Procedure: fecal microbiota transplantation
* Drug: placebo fecal microbiota transplantation
* Procedure: FMT with antibiotic pre-treatment (v1)
* Procedure: FMT with antibiotic pre-treatment (v2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS with diarrhea

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fecal microbiota transplantation<br>fecal microbiota transplantation | Procedure: fecal microbiota transplantation<br>* fecal microbiota transplantation<br>|
| Placebo Comparator: placebo fecal microbiota transplantation<br>placebo fecal microbiota transplantation | Drug: placebo fecal microbiota transplantation<br>* placebo fecal microbiota transplantation<br>|
| Experimental: FMT after antibiotic pretreatment v1<br>fecal microbiota transplantation after antibiotic pretreatment | Procedure: fecal microbiota transplantation<br>* fecal microbiota transplantation<br>Procedure: FMT with antibiotic pre-treatment (v1)<br>* FMT with antibiotic pre-treatment (v1)<br>|
| Experimental: FMT after antibiotic pretreatment v2<br>fecal microbiota transplantation after antibiotic pretreatment | Procedure: fecal microbiota transplantation<br>* fecal microbiota transplantation<br>Procedure: FMT with antibiotic pre-treatment (v2)<br>* FMT with antibiotic pre-treatment (v2)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stable engraftment of donor microbiota | Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT. | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fecal Microbiota Transplantation
Reducing Obesity and Type 2 Diabetes in High Risk Youth

Study Overview
=================
Brief Summary
-----------------
Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months.

Official Title
-----------------
A School-based Internet Obesity Prevention Program for Adolescents

Conditions
-----------------
Obesity, Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: HEALTH[e]TEEN
* Behavioral: HEALTH[e]TEEN + CST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Student enrolled in Health, Biology, or Public Health course Exclusion Criteria: Cognitive ability unable to read or respond to questions in program

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HEALTH[e]TEEN<br>8 lessons over 6-8 weeks Education on healthy eating and physical activity Behavioral support for self-monitoring and goal setting | Behavioral: HEALTH[e]TEEN<br>* 8 lessons over 6-8 weeks<br>|
| Active Comparator: HEALTH[e]TEEN + CST<br>12 lessons over 6-8 weeks Education on healthy eating and coping skills training Behavioral support for self-monitoring and goal setting | Behavioral: HEALTH[e]TEEN + CST<br>* 12 lessons over 6-8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary behavior | Healthy eating | 6 months | 
| Sedentary behavior | Computer, TV, video games | 6 months | 
| Physical activity | Moderate to vigorous exercise | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internet, School based, Obesity Prevention Program, Adolescents
Non- Essential Amino Acid Requirements and Metabolism in Humans

Study Overview
=================
Brief Summary
-----------------
Protein is a major structural component of all cells in the body. The nutritional importance of protein is because of their amino acids. 9 are called essential and 11 are called non-essential, based on whether we need to get them from diet. This classification is based on studies done using older techniques. Recent studies suggest that these so called non-essential amino acids play important roles in our body's health. For the first time, this proposal defines an experimental design to examine non- essential amino acid/nitrogen requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO) technique. The objective of the current study is to examine the application of IAAO technique to determine the non-essential amino acid/nitrogen requirement in adult humans.

Official Title
-----------------
Application of Indicator Amino Acid Oxidation Technique to Determine Non-essential Amino Acids/Nitrogen Requirements in Adult Humans

Conditions
-----------------
Healthy Adult Males

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-40 years of age Male Classified as normal body weight based on body mass index (BMI) 18.5-25kg/m2 Free of any concurrent illness Exclusion Criteria: Men not in good health or have a metabolic, neurological, genetic or immune disorder including diabetes and hypertension Men who are classified as underweight(<18.5kg/m2), overweight(25-30kg/m2) or obese (>30kg/m2) using the BMI classification) Men who are allergic to milk, eggs and egg protein

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |
| 13 Carbon dioxide production | Urine and breath samples will be collected to measure the rate of oxidation of expired breath and flux by enrichment of urine. | 8 hours (1study day) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Indicator Amino Acid Oxidation, Non essential Amino acids, Protein, Amino acid