linjc16/ctgov huggingface dataset:
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the pharmacokinetic drug interaction and safety after oral administration of Udenafil(DA-8159) and Bosentan in healthy volunteers. Design: Randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, Williams design Investigational Product: Udenafil, Bosentan

Official Title
-----------------
A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Williams Design to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Bosentan After Oral Administration in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Udenafil
* Drug: Bosentan
* Drug: Udenafil/Bosentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers between the ages of 20 to 45 years old within the range of BMI between 18.5 and 25(Body Mass Index) having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination doctor determines to be suitable as subjects within 4 weeks ago before administration Exclusion Criteria: Hypersensitivity(or history of hypersensitivity) to Udenafil, Bosentan and PDE5 inhibitors Active Liver Diseases or exceed 1.25 times the normal range of AST, ALT Gastrointestinal diseases or surgeries that affect absorption of drug Excessive drinking(exceed 210g/week) and excessive caffeine(exceed 5cups/day) Smoking over 10 cigarettes per day pregnant or nursing female volunteers

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Udenafil<br> | Drug: Udenafil<br>* Udenafil is administered<br>|
| Experimental: Bosentan<br> | Drug: Bosentan<br>* Bosentan is administered<br>|
| Experimental: Udenafil/Bosentan<br> | Drug: Udenafil/Bosentan<br>* Udenafil and Bosentan are administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Udenafil, Bosentan C max,ss |  | Blood gathering point: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12h of D1, D15, D29(if Udenafil adminstrated alone), 0 h of D7, D21, D35, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 h of D8, D22, D36 | 
| Udenafil, Bosentan AUC tau,ss |  | Blood gathering point: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12h of D1, D15, D29(if Udenafil adminstrated alone), 0 h of D7, D21, D35, 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 h of D8, D22, D36 |
Results of Knee Arthroscopic Surgery for Treatment of Cruciate Ligament and Meniscus

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective review of chart. Clinical results including range of motion, muscle power and scores will be recorded. Arthrocopic surgery of cruciate ligament and meniscus will be re-evaluated for clinical application.

Official Title
-----------------
Results of Knee Arthroscopic Surgery for Treatment of Cruciate Ligament and Meniscus

Conditions
-----------------
Knee Arthroscopic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACL reconstructions PCL reconstructions Meniscectomy or Meniscus repair Exclusion Criteria: Open surgery for knee lesion Combined fracture or other associated injury around knee

Ages Eligible for Study
-----------------
Minimum Age: 20 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
-----------------
knee, Cruciate Ligament, Meniscus
Effect of Lactobacillus Probiotic on Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the risk of other infections, develop into more serious forms of disease, and lead to premature discontinuation of the needed antibiotic. The purpose of this study is to examine the safety and effectiveness of a capsule containing Lactobacillus rhamnosus GG in the prevention of diarrhea associated with antibiotic use.

Official Title
-----------------
Effect of Lactobacillus Probiotic on Healthy Adults

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

Intervention / Treatment
-----------------
* Biological: Culturelle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants (male or female inpatients) 18 to 64 years of age who are prescribed antibiotics (single or multiple antibiotics, oral or intravenous) will be recruited from the Fargo VAMC Primary Care Clinic area. Participants must be able to swallow a capsule. Exclusion Criteria: Exclusion criteria include diarrhea on admission or within the preceding week Reported recurrent diarrhea Antibiotics in the past four weeks Significant underlying conditions (e.g. diabetes, structural cardiac defects including valvular defects, history of infective endocarditis, poor cardiac function, immunosuppression, impaired gut integrity, moderate or serious intestinal disorders, malignancies, pancreatitis, indwelling catheters, recent surgery, recent prolonged hospitalization) Previous bowel surgery Nutritional restrictions that preclude participation Hypersensitivity to penicillin G, ampicillin, or erythromycin Persons who have been prescribed their antibiotic for a duration longer than 3 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactobacillus rhamnosus GG capsule three times per day while taking their antibiotic(s) and for 7 days following completion of the antibiotic. | Biological: Culturelle<br>* 10^10 Lactobacillus rhamnosus GG per capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diarrhea |  | Approximately one month |
Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.

Official Title
-----------------
Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations

Conditions
-----------------
Vaccine Refusal

Intervention / Treatment
-----------------
* Other: Childhood vaccination decision support tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke. Fluent in English Exclusion Criteria: Unable to understand the study objectives, procedures, risks, and benefits Unable to consent for themselves

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Childhood vaccination decision support tool<br>Participants receive childhood vaccination decision support tool | Other: Childhood vaccination decision support tool<br>* Participants receive childhood vaccination decision support tool<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire | Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention. | pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline) | 
| Change in Acceptability of Childhood Vaccinations |  | pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccination, childhood vaccines, vaccine hesitancy
Myocardial Perfusion Study to Detect Coronary Microvascular Abnormality in Diabetic Patients With Nonfatal Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to use MCE (myocardial contrast/perfusion echocardiography) to study and compare short/long term change of myocardial perfusion abnormality and cardiac outcome in diabetic patients after nonfatal MI (heart attack), who are treated with different glucose control agents.

Official Title
-----------------
Myocardial Perfusion Study to Detect Coronary Microvascular Abnormality in Diabetic Patients With Nonfatal Myocardial Infarction

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic and nondiabetic patients will be initially recruited and studied after acute nonfatal MI and revascularization with either PCI or CABG Exclusion Criteria: Patients are excluded if they are older than 70 year old, require mechanical ventilation, are receiving intravenous pressors or hemodynamic support, or if the motion of segments associated with infarct-related artery can not be accurately determined.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 71 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 |
| --- | --- | --- |
| Perfusion abnormalities in nondiabetic and diabetic patients |  | short term (3 month) and long term (12 month). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of different glycemic control strategies on the reduction of coronary injury in diabetic and non-diabetic subjects |  | short term (3 month) and long term (12 month) |
Drug Use Investigation for ALLERMIST

Study Overview
=================
Brief Summary
-----------------
To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray in Japanese subjects with allergic rhinitis under the practical use conditions

Official Title
-----------------
Drug Use Investigation for ALLERMIST

Conditions
-----------------
Rhinitis

Intervention / Treatment
-----------------
* Drug: Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of allergic rhinitis Use ALLERMIST for the first time Expected to use ALLERMIST for long-term (1 year) Exclusion Criteria: Subjects with infection which fluticasone is not effective Subjects with deep mycosis Subjects with hypersensitivity to fluticason
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed ALLERMIST<br>Subjects with allergic rhinitis prescribed ALLERMIST during study period | Drug: Fluticasone<br>* Collection of safety data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects with allergic rhinitis treated with fluticasone nasal spray |  | Four weeks |
Repeated High-dose Inhaled Corticosteroids for Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.

Official Title
-----------------
Repeated High-dose Inhaled Corticosteroids for Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Physician diagnosis of asthma. Age ≥18 years and ≤50 years Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines. Treatment for asthma with: daily inhaled corticosteroids and long-acting beta2-agonists, AND as-needed use of a short-acting beta2-agonist Exclusion criteria: History of >10 pack-year tobacco use Other pulmonary or cardiac diagnosis that is actively being treated History of adverse events or allergy to fluticasone Systemic corticosteroid therapy within 7 days of study visit Inability to obtain written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Placebo Comparator: 1<br>Placebo Comparator All patients assigned to this group will receive: Placebo via Metered Dose Inhaler (MDI). Albuterol via MDI. | Drug: Placebo<br>* Placebo via MDI.<br>|
| Active Comparator: 2<br>Active Comparator All patients assigned to this group will receive: Fluticasone via MDI. Albuterol via MDI. | Drug: Fluticasone<br>* Fluticasone MDI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airflow inflammation. |  | Pre-study and post-study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airflow obstruction. |  | Pre-study and post-study drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute asthma, fluticasone, inhaled corticosteroids
Natural History Study of Patients With Limb-Girdle Muscular Dystrophy 2I

Study Overview
=================
Brief Summary
-----------------
Prospective, longitudinal, interventional, single-group, multicenter natural history study to better know the LGMD2I disease physiopathology. The duration of participation for each patient will be up to 24 months.

Detailed Description
-----------------
Study duration Duration from First visit of first patient (FPFV) to Last visit of last patient (LPLV) : 3 years Study objectives Primary objective: To characterize the disease course in Limb-Girdle Muscular Dystrophy 2I (LGMD2I) patients using standardized and disease appropriate evaluations. Secondary objectives: To identify clinical, imaging and/or laboratory parameters that are indicators of the disease course in LGMD2I To identify the best outcome measure for further therapeutics approaches

Official Title
-----------------
Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Limb-Girdle Muscular Dystrophy 2I

Conditions
-----------------
LGMD2I

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients Patients ≥ 16 years old Clinical diagnosis of LGMD2I and gene testing demonstrating two pathogenic mutations in fukutin-related protein gene, FKRP) Ambulant patients Exclusion Criteria: 1. Patients presenting other disease which may significantly interfere with the interpretation of LGMD2I natural history

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| 6-Minute Walk Test | Primary endpoint | Baseline through 24 months | 
| 10-Meter Walk test (10MWT) | Primary endpoint | Baseline through 24 months | 
| Timed Up and Go (TUG) test | Primary endpoint | Baseline through 24 months | 
| Four-stair climb test | Primary endpoint | Baseline through 24 months | 
| North Star Assessment for Neuromuscular Disorders (NSAD) | Scale to assess patient's abilities necessary to remain functionnaly ambulant | Baseline through 24 months | 
| Upper limb assessment via the Performance of the Upper Limb (PUL) tool version 2.0 | Primary endpoint | Baseline through 24 months | 
| Recording of aids for ambulation | Primary endpoint | Baseline through 24 months | 
| Isokinetic muscle testing using the Biodex System (optional) | Primary endpoint | Baseline through 24 months | 
| Pulmonary function test | Primary endpoint | Baseline through 24 months | 
| Electrocardiogram | Presence of cardiac abnormalities or any ventricular extrasystoles will be investigated | Baseline through 24 months | 
| Echocardiography | Cardiac dimensions will be measured to investigate the presence of any dilated cardiomyopathy | Baseline through 24 months |
The Relationship Between the Residual Renal Function and Osteoporosis Treatment

Study Overview
=================
Brief Summary
-----------------
The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.

Detailed Description
-----------------
Chronic kidney disease (CKD)- mineral and bone disorder (CKD-MBD) is one of the topic in osteoporosis treatment. As many osteoporotic patients are older, many patients are under the deterioration of the renal function. In addition, several drugs might have the potential for kidney damage. But the relationship between osteoporosis drugs and kidney damage is unclear. The main objective of this study is to reveal relationship between osteoporosis drugs and kidney damage.

Official Title
-----------------
The Relationship Between the Residual Renal Function and Osteoporosis Treatment

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Bis, SERM Teriparatide, Denosumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporosis patients Exclusion Criteria: eGFR < 15

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Bisphosphonate<br> | Drug: Bis, SERM Teriparatide, Denosumab<br>* Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.<br>|
| Selective estrogen receptor modulator<br> | Drug: Bis, SERM Teriparatide, Denosumab<br>* Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.<br>|
| Teriparatide<br> | Drug: Bis, SERM Teriparatide, Denosumab<br>* Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.<br>|
| Senosumab<br> | Drug: Bis, SERM Teriparatide, Denosumab<br>* Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal renal function changes by osteoporotic treatment |  | Up to 120 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Bone mineral densisty, Renal function, CKD-MBD
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.

Official Title
-----------------
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation

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

Intervention / Treatment
-----------------
* Device: HeartLight(TM) Laser Balloon
* Device: irrigated radiofrequency current ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years persistent atrial fibrillation failure of at least one antiarrhythmic drug others Exclusion Criteria: contraindications for pulmonary vein isolation (PVI) previous PVI attempts inability to be treated with oral anticoagulation presence of intracardiac thrombi pregnancy others

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HeartLight(TM) Laser Balloon<br>Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation) | Device: HeartLight(TM) Laser Balloon<br>* With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided<br>|
| Active Comparator: irrigated radiofrequency current ablation<br>Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation | Device: irrigated radiofrequency current ablation<br>* The irrigated radiofrequency current ablation is used for pulmonary vein isolation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds |  | between day 90 and 365 days after index procedure |