linjc16/ctgov huggingface dataset:
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

Study Overview
=================
Brief Summary
-----------------
Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.

Official Title
-----------------
Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

Conditions
-----------------
Chickenpox, Herpes Zoster

Intervention / Treatment
-----------------
* Drug: famciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female children 1-12 years of age Clinical or laboratory evidence of varicella zoster infection Patients suspected of having varicella zoster infection Exclusion Criteria: Patients unable to swallow Concomitant use of probenecid Positive pregnancy Additional protocol-defined inclusion/exclusion criterial may apply. For detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step A: Single-dose safety and pharmacokinetics |  |  | 
| Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steps A & B: Acceptability of pediatric formulation by patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, chickenpox, herpes zoster, Famvir, varicella zoster virus
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3 (VITAD/3)

Study Overview
=================
Brief Summary
-----------------
Validation of a screening tool for identification of subjects at risk for suboptimal vitamin D status. Developed questionnaire-based screening tool will be used on subjects with various risks for vitamin D deficiency, and compared with 25-OH-vitamin D levels.

Official Title
-----------------
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3: Screening Tool for Identification of Subjects at Risk for Suboptimal Vitamin D Status

Conditions
-----------------
Vitamin D Serum Levels

Intervention / Treatment
-----------------
* Other: Screening tool for vitamin D deficiency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed consent form (ICF), Age between 18 and 65 years at the time of the signature of Informed consent form (ICF), Did not change use of vitamin D conatining drugs/supplements for last 6 weeks Willingness to follow all study procedures Exclusion Criteria: Pregnancy or breastfeeding, Change in use of food supplements containing Vitamin D in last 6 weeks Acute ilness Mental incapacity that precludes adequate understanding or cooperation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Screening tool for vitamin D deficiency|(1) Determination of 25(OH) Vitamin D3 in human serum samples and (2) Question based screening tool with personal (age, gender,...), lifestyle (e.g. sun exposure, outdoor activity) and dietary factors that affect the status of vitamin D in the human body.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between vitamin D status (deficiency) assessed by two different methods | Vitamin D serum level will be measured for assessment of Vitamin D status. Risk for vitamin D deficiency will be assessed using questionaire-based screening tool. Two methods will be compared. | 1 year |
Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine effects of laser therapy on blood flow and sweating responses in burn-injured skin.

Detailed Description
-----------------
This is a longitudinal study in which the effects of laser therapy on cutaneous vascular responses and sweating of the treated areas are assessed. Specifically, burn survivors who will undergo standard of care laser therapy to treat burn-related scars will perform whole-body heating and local heating procedures prior to the initiation of laser therapy, at an intermediate point during the laser therapy regimen, and upon conclusion of the laser therapy regimen. For this pilot investigation a placebo will not be incorporated. Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin.

Official Title
-----------------
Laser Therapy on Burned Skin

Conditions
-----------------
Burn Injury

Intervention / Treatment
-----------------
* Device: fractional CO2 laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old Experience a severe burn injury that warrant laser therapy. Free of any significant underlying medical problems based upon a detailed medical history and physical exam Exclusion Criteria: Known heart disease Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia. Abnormality detected on routine screening suggestive of cardiac ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram. Subject with a body mass index >35 kg/m2 Pregnant or planning to become pregnant within the subsequent 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: fractional CO2 laser|Standard of care laser treatment of burn-related injuries will be performed. This protocol assesses the effects of those treatments on skin blood flow and sweating responses.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin blood flow | Primary outcome variables will be skin blood flow and sweating responses from skin treated with laser therapy and adjacent untreated/uninjured skin. | Upwards to 6 months after the final laser treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laser treatment, laser therapy, skin blood flow, sweating
NOTES-Assisted Laparoscopic Cholecystectomy Surgery

Study Overview
=================
Brief Summary
-----------------
This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

Detailed Description
-----------------
A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites. A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Official Title
-----------------
Assisted Laparoscopic Cholecystectomy Surgery

Conditions
-----------------
Cholelithiasis, Cholecystitis

Intervention / Treatment
-----------------
* Procedure: NOTES-Assisted Cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to undergo general anesthesia Age >= 18 yrs. of age and <= 85 yrs. of age Ability to give informed consent Exclusion Criteria: Acute cholecystitis BMI >= 40 Contraindicated for EGD Presence of common duct stones Presence of esophageal stricture Altered gastric anatomy

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: NOTES-Assisted Cholecystectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystectomy, NOTES, Transgastric
Microfracture in Rotator Cuff Injury Repair

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.

Official Title
-----------------
Microfracture in Rotator Cuff Injury Repair

Conditions
-----------------
Rupture of the Rotator Cuff

Intervention / Treatment
-----------------
* Procedure: Microfracture
* Procedure: NO microfracture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients over the age of 18 with a full thickness rotatorcuff rupture. Exclusion Criteria: Isolated rupture of the subscapularis Tendon atrophia Goutallier grade 3-4 fatty degeneration Fracture surgery in same shoulder Inflammatory or neurologic affection of shoulder Other disabling disease Unwilling to participate in study

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: Microfracture<br>Rotator Cuff Repair AND Microfracture at rotatorcuff footprint | Procedure: Microfracture<br>* Rotator Cuff Repair AND Microfracture<br>|
| Active Comparator: NO microfracture<br>Rotator cuff reinsertion without microfracture | Procedure: NO microfracture<br>* Rotator Cuff Repair without microfracture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario Rotator Cuff Index (WORC) | Standardized questionnaire | 0, 3 and 12 months | 
| Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) | Standardized questionnaire | 0, 3 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI integrity of the rotatorcuff | Intact rotatorcuff Partial rupture Full thickness rupture | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healing, Rotator Cuff, Injury, Repair, Microfracture
The Kilimanjaro Cervical Screening Project

Study Overview
=================
Brief Summary
-----------------
Although highly curable, cervical cancer kills thousands of women in developing countries annually. The investigators will pilot a project to improve detection of cervical cancer in Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise available in a large medical centre and remote use of a mobile phone camera application.

Official Title
-----------------
The Kilimanjaro Cervical Screening Project

Conditions
-----------------
Uterine Cervical Neoplasms, Cervical Cancer

Intervention / Treatment
-----------------
* Other: Cervical cancer screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Over 18 years of age Exclusion Criteria: Previous removal of uterus

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Cervical cancer screening<br> | Other: Cervical cancer screening<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure accuracy and feasibility of non-physician healthcare workers ability to obtain adequate cervical images via smart phone camera photographs. |  | 3 months |
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.

Official Title
-----------------
Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fed Conditions.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA
* Drug: Inspra 50 mg Tablets GD Searle LLC, USA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: 1<br>Eplerenone 50mg Tablets | Drug: Eplerenone 50 mg Tablets Sandoz Inc., USA<br> <br> |
| Active Comparator: 2<br>INSPRA 50mg Tablets | Drug: Inspra 50 mg Tablets GD Searle LLC, USA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines |  | 10 days |
Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type.

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

Intervention / Treatment
-----------------
* Drug: aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Institutionalized patients with Alzheimer's Disease

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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
-----------------
Psychosis Associated with Dementia of the Alzheimer's Type
Soft Robotic Hand System for Stroke Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.

Official Title
-----------------
Soft Robotic Hand System for Stroke Rehabilitation

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: soft robot hand system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic); sufficient cognition to follow simple instructions as well as understand the content and purpose of the study; able to sit up for 45 minutes (with or without assistance). Exclusion criteria: Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication; any additional medical or psychological condition affecting their ability to comply with the study protocol; history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMG-driven soft robot hand<br>subjects will receive EMG-driven soft robot hand system. | Device: soft robot hand system<br>* subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.<br>|
| Placebo Comparator: sham group<br>subjects will receive passive pre-programmed soft robot hand system. | Device: soft robot hand system<br>* subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb Fugl Meyer Assessment |  | 3-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test |  | 3-month follow up | 
| Modified Ashworth Scale | Scale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension | 3-month follow up | 
| Box and Block Test |  | 3-month follow up | 
| Max Voluntary Grip Force |  | 3-month follow up |
Effect of Exercise Intervention on Various Physiologic Factors That Change With Increasing Age

Study Overview
=================
Brief Summary
-----------------
This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised exercise versus no exercise. Several end points were evaluated after 16 weeks including insulin sensitivity and muscle physiology.

Detailed Description
-----------------
Healthy subjects performing < 30 min exercise twice per week were studied prior to randomization and after of sixteen weeks exercise. They were randomized to sixteen weeks of supervised exercise performed on a stationary bike vs. placebo exercise (a series of flexibility exercises performed at home). Intensity, duration and frequency of exercise were gradually increased to four sessions per week lasting forty minutes each and achieving 80% target heart rate. Participants were weighed perioidically and counseled appropriately when weight changed by > 2 %. Insulin sensitivity and muscle mitochondrial protein synthesis were studied.

Official Title
-----------------
Impact of Aerobic Exercise Training on Age Related Changes in Insulin Sensitivity and Muscle Oxidative Capacity

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy subjects performing < 30 min exercise twice per week. Age 20-90 years. Willing to be randomized to exercise versus no exercise. Willing to be studied in General Clinical Research Center with studies including Muscle Biopsy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Mitochondrial Protein Synthesis |  |  | 
| mRNA of mitochondrial genes |  |  | 
| mRNA of genes involved in mitochondrial biogenesis |  |  |