linjc16/ctgov huggingface dataset:
HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a five-session Human Immunodeficiency Virus/Acquired Immune Deficiency Disease (HIV/AIDS) group therapy designed specifically for heterosexual men. This therapy is compared to standard HIV/AIDS education, which generally consists of a single session of HIV education.

Official Title
-----------------
HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs

Conditions
-----------------
Behavior Therapy

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
All adult males age 18 and above in drug abuse treatment at participating Community Treatment Providers will be invited to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AIDS risk behavior |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavioral intervention
Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the administration of a standard anesthetic drug (propofol) using an automatic, expert-based system versus a manually controlled system by the anesthesiologist. In addition, the performance of the decision support system will be evaluated.

Official Title
-----------------
Comparison of Closed-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study

Conditions
-----------------
Conscious Sedation

Intervention / Treatment
-----------------
* Drug: controlled administration of propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing hip or knee replacement under spinal anesthesia Exclusion Criteria: contraindication to spinal anesthesia allergies to any study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: controlled sedation using propofol<br> | Drug: controlled administration of propofol<br>* comparison of propofol sedation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Controller performance |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid management | fluid management manual versus guided | end of surgery |
Role of Anxio-depressive History on Return to Work and Sport After Rotator Cuff Surgery

Study Overview
=================
Brief Summary
-----------------
Anxiety-depressive disorders are also very frequent, in the form of different pathologies that are often intertwined (prevalence of generalized anxiety disorders in 5% of the population, characterized depressive episodes in 5%, etc.). And it is even more frequent in patients with a cuff tendinopathy (26% and 23% of depression and anxiety respectively). These 2 pathologies are therefore responsible for significant economic expenses. It is in this context that the investigators' wish to carry out this study seems justified in order to better understand and therefore manage this problem, which is frequently encountered in daily practice and which would therefore allow better understanding and therefore better information for the patients concerned.

Official Title
-----------------
Study of the Role of Anxiety-related Antecedents on the Resumption of Work and Sport in a Series of Patients Operated on for Rotator Cuff Repair

Conditions
-----------------
Anxiety Depression Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥ 18 years) Operated between January 2008 and September 2009 arthroscopically for a symptomatic supraspinatus tendon rupture, retracted in zone 1, resistant to medical treatment with a mobile shoulder, fatty degeneration of stage 2 or less with also a preserved subacromial space Subject not objecting to the reuse of their data for scientific research purposes. Exclusion criteria: - Subject having expressed his opposition to the reuse of his data for scientific research purposes.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the duration of complete sports cessation after rotator cuff repair surgery |  | 6 months after rotator cuff repair surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety Depression Disorder, Rotator cuff repair
Aspirin and Clopidogrel Resistance Study

Study Overview
=================
Brief Summary
-----------------
Resistance to antiplatelet drugs (aspirin, clopidogrel) is a recognized phenomenon with a prevalence from 17% to 35%. Resistance as detected by in vitro tests such as Multiple Electrode Aggregometry (MEA) has been shown to predict clinical therapy failure. Resistance can be caused by clinical, cellular and pharmacogenetic factors. Non compliance is suspected to be an important contributing factor. In this study, compliance will be assured with an electronical compliance monitoring system. Factors to non response will be identified to find plausible explanations when in vitro platelet aggregation inhibition is insufficient despite assured compliance. This study will help to disclose the relationship between compliance, biomarker and clinical outcome as well as to quantify the impact of non compliance to the resistance phenomenon as measured by MEA.

Official Title
-----------------
Aspirin- and Clopidogrel-Resistance: Non-compliance and Other Contributing Factors

Conditions
-----------------
Drug Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients prescribed aspirin and/or clopidogrel for both including both cardiovascular and cerebrovascular indications seeing their general practitioner in or nearby Olten/SO for any medical purpose Patients with oral and written German language ability Exclusion Criteria: Patients living in care homes Patients not preparing their drugs on their own (e.g. outpatient medical assistance through spitex). Patients with acute cardiac symptoms

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 |
| --- | --- |
| dual therapy (ASS/CLO)<br>patients with a prescription for dual antiplatelet therapy with aspirin AND clopidogrel | |
| clopidogrel users (CLO)<br>patients with a prescription for clopidogrel | |
| aspirin users (ASP)<br>patients with a prescription for aspirin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation, initial and after one week under compliance monitoring. |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data on compliance (measured by electronic compliance monitoring, Morisky MMAS-8 and BMQ Score) |  | 1 week | 
| Frequency of contributing factors to non-response in responders compared to non-responders (pharmacogenetics, clinical factors and drug-drug interactions) |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacological biomarker, compliance monitoring, platelet aggregometry, resistance, Platelet Aggregation Inhibitors, Medication Non-Compliance
Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy

Study Overview
=================
Brief Summary
-----------------
Studies in animals have shown that beta2-adrenoceptor activation with selective agonists regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These effects may be mediated by cAMP/PKA dependent activation of several downstream sites that modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is well-described in animals, it is inadequately explored in humans. The purpose of the study is thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling) on muscle hypertrophy.

Official Title
-----------------
Role of 11 Weeks of Beta2-adrenergic Signaling and Resistance Training for Cardiac and Skeletal Muscle Hypertrophy in Men

Conditions
-----------------
Muscle Hypertrophy in Healthy Young Men

Intervention / Treatment
-----------------
* Drug: Salbutamol
* Drug: Placebo
* Other: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical active Non-smokers Non-asthmatics No chronic diseases Informed consent Exclusion Criteria: Smoker Allergy towards study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Beta2-adrenergic stimulation with salbutamol and resistance training for 10 weeks | Drug: Salbutamol<br> <br> Other: Resistance training<br> <br> |
| Placebo Comparator: Control<br>Placebo and resistance training for 10 weeks | Drug: Placebo<br> <br> Other: Resistance training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal Muscle Hypertrophy (lean body mass in Kilograms) | Lean body mass (kg) will be measured at two different days by Dual X-ray absorbance (DXA) | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Hypertrophy (mass in grams) | Left Ventricular Mass (g) will be measured by echocardiography of the heart | 1 day |
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-531 administered to healthy subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SAM-531


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Men or women of nonchildbearing potential aged 18 to 45 years Elderly men or women aged 65 years and above as of study day 1. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg. Exclusion criteria Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results. Tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or grapefruit or grapefruit-containing products 72 hours before study day 1, and until the end of the inpatient confinement period.

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SAM-531|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and pharmacodynamics |  |  |
The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.

Official Title
-----------------
The Effect of Funny Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.

Conditions
-----------------
Postural Tachycardia Syndrome

Intervention / Treatment
-----------------
* Drug: ivabradine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with POTS by the following criteria: The presence of characteristic orthostatic symptoms of the POTS for at least six months. An increase in the heart rate of at least 30 beats per minute (without concomitant significant decrease in blood pressure of more than 20/10 mmHg) within 10 minutes after assuming a standing position (or during tilt test) on at least 3 separate occasions. No other concomitant diseases that could explain the symptoms of POTS. Exclusion Criteria: History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE). History of cardiovascular disease. History of smoking, drug or alcohol abuse. Pregnancy, and also uncontrolled thyroid or adrenal disorders. Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivabradine<br>Ivabradine 10 mg once | Drug: ivabradine<br> <br> |
| Placebo Comparator: placebo<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in heart rate after the administration of Ivabradine |  | 60 minutes , during the whole trial | 
| the change in blood pressure after the administration of Ivabradine |  | 60 minutes |
Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of DW1903

Study Overview
=================
Brief Summary
-----------------
A Randomized, Open-label, Oral in healthy male volunteers

Official Title
-----------------
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of DW1903, DW1903-R1 and DW1903-R2 in Healthy Adult Volunteers

Conditions
-----------------
Gastritis

Intervention / Treatment
-----------------
* Drug: DW1903
* Drug: DW1903-R1
* Drug: DW1903-R2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers who are ≥19 years old BMI between 18 and 30 kg/m2 Body weight ≥50kg Exclusion Criteria: •Clinically significant Medical History

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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: DW1903<br>* DW1903<br>Drug: DW1903-R1<br>* DW1903-R1<br>Drug: DW1903-R2<br>* DW1903-R2<br>|
| Experimental: Sequence B<br> | Drug: DW1903<br>* DW1903<br>Drug: DW1903-R1<br>* DW1903-R1<br>Drug: DW1903-R2<br>* DW1903-R2<br>|
| Experimental: Sequence C<br> | Drug: DW1903<br>* DW1903<br>Drug: DW1903-R1<br>* DW1903-R1<br>Drug: DW1903-R2<br>* DW1903-R2<br>|
| Experimental: Sequence D<br> | Drug: DW1903<br>* DW1903<br>Drug: DW1903-R1<br>* DW1903-R1<br>Drug: DW1903-R2<br>* DW1903-R2<br>|
| Experimental: Sequence E<br> | Drug: DW1903<br>* DW1903<br>Drug: DW1903-R1<br>* DW1903-R1<br>Drug: DW1903-R2<br>* DW1903-R2<br>|
| Experimental: Sequence F<br> | Drug: DW1903<br>* DW1903<br>Drug: DW1903-R1<br>* DW1903-R1<br>Drug: DW1903-R2<br>* DW1903-R2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH monitoring | Pharmacodynamic Endpoint | up to day 5 |
Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.

Conditions
-----------------
Pulpitis, Dental Pulp Disease, Tooth Diseases

Intervention / Treatment
-----------------
* Drug: Formocresol
* Drug: Mineral Trioxide Aggregate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy people(without any systemic disease) teeth : no clinical or radiographic evidence of pulp degeneration the possibility of proper restoration of the teeth Exclusion Criteria: teeth : excessive bleeding from the exposure site internal root resorption interradicular and/or periapical bone destruction swelling or sinus tract

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mineral Trioxide Aggregate<br>pulpotomy with MTA | Drug: Mineral Trioxide Aggregate<br>* pulpotomy with MTA<br>|
| Active Comparator: Formocresol<br>pulpotomy with FC | Drug: Formocresol<br>* pulpotomy with formocresol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful outcome of treatment as indicated by clinical signs defined with observation and check list | success or failure of treatment defined with observation and check list | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful outcome of treatment as indicated by radiographic signs defined with observation and check list | success or failure of treatment defined with observation and check list | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical signs, child, pulpotomy
A Trial of Caries Prevention Effect of Fissure Sealants

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized clinical trial was to compare caries prevention of a conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and fissures over a one year period in a high caries children group. Additionally the concentration of Fluoride in saliva was evaluated.

Official Title
-----------------
A Randomized Controlled Trial of Caries Prevention Effect of a Glass Ionomer Sealant Versus a Resin Sealant

Conditions
-----------------
Caries Prevention, Fissure Sealant, Fluoride Concentration, Glass Ionomer Cement, Resin

Intervention / Treatment
-----------------
* Procedure: Fissure sealant application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Age range of 6 to 10 years 2.Having caries free, fully erupted first permanent molars 3.Deep and/or intermediate pits or fissures 4.dft ≥ 2 Exclusion Criteria: 1.Having any systemic disease 2.Topical fluoride was applied last six months 3.dft = 0

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 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: glass ionomer based fissure sealant<br>fissure sealant application | Procedure: Fissure sealant application<br> <br> |
| Active Comparator: resin based fissure sealant<br>fissure sealant application | Procedure: Fissure sealant application<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Fluoride concentration of saliva |  | 1 week, 6. months, 12. months |