linjc16/ctgov huggingface dataset:
Effect of Laser in Treatment of Vulval Warts

Study Overview
=================
Brief Summary
-----------------
Vulval warts is a magor problem that affects women .

Detailed Description
-----------------
The causative organism for vulval warts is human papilloma virus There are many treatment modalities that can trat these warts

Official Title
-----------------
Effect of nd Yag Laser in Treatment of Vulval Warts

Conditions
-----------------
Vulval Wart

Intervention / Treatment
-----------------
* Device: nd yag laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women who have vulval warts Age between 18- 40 years Exclusion Criteria: warts that were previously treated by surgery or cryotherapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: applying laser for treatment of vulval warts
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nd yag laser<br>Applying nd yag laser to vulva | Device: nd yag laser<br>* nd yag laser will be applied on the vulval warts<br>* Other names: laser beam;|
| Sham Comparator: Co2 laser<br>Applying CO2 laser to vulva | Device: nd yag laser<br>* nd yag laser will be applied on the vulval warts<br>* Other names: laser beam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will be completely cured by laser beam | how laser will cure the warts | within 2 months |
Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal stromal tumor among filipino patients in usual clinical practice setting.

Detailed Description
-----------------
Open label

Official Title
-----------------
Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients

Conditions
-----------------
Metastatic Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Sunitinib malate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and above Diagnosed with metastatic renal cell carcinoma or gastrointestinal stromal tumor after imatinib treatment failure or intolerance Exclusion Criteria: Subjects with conditions that are contraindicated with sunitinib malate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Sunitinb malate<br> | Drug: Sunitinib malate<br>* sunitinib 50 mg, 4 weeks on, 2 weeks off<br>* Other names: Sutent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of sunitinib malate as measured by the incidence, severity, seriousness and relatedness to treatment adverse events (AEs), laboratory abnormalities, vital signs (blood pressure) and the use of concomitant medications. |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of sunitinib malate will be measured by the overall response as determined by the objective tumor assessments made according to the Response Evaluation Criteria in Solid Tumors (RECIST). |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
imatinib resistant or intolerant
Food Effect Study of Codeine Sulfate

Study Overview
=================
Brief Summary
-----------------
The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate tablet

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Codeine Sulfate Tablets Under Fasting and Fed Conditions

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Codeine Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Codeine Sulfate or any comparable or similar product.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Codeine Sulfate, 30 mg<br>tablet | Drug: Codeine Sulfate<br>* Tablet<br>|
| Active Comparator: Codeine Sulfate, 60 mg<br>tablet | Drug: Codeine Sulfate<br>* Tablet<br>|
| Active Comparator: Codeine Sulfate, 15 mg<br>tablet | Drug: Codeine Sulfate<br>* Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 8 days |
Hydroxyurea in Young Children With Sickle Cell Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.

Detailed Description
-----------------
Previous studies have shown that hydroxyurea therapy in adults and older children with SCA improves laboratory parameters and ameliorates the clinical severity of disease. Little is known, however, about the effects of hydroxyurea on the chronic organ damage that occurs in patients with SCA and leads to significant morbidity and mortality in young adults. The objectives of this study are to assess the safety and efficacy of HU in young children with SCA and to determine whether HU preserves renal function, reduces transcranial doppler ultrasound (TCD) values, and prevents development of brain ischemia as evidenced by MRI/MRA imaging. In addition, we will evaluate the effects of hydroxyurea on quality of life

Official Title
-----------------
Effects of Hydroxyurea on the Prevention of Chronic Organ Damage in Young Children With Sickle Cell Anemia

Conditions
-----------------
Sickle Cell Anemia

Intervention / Treatment
-----------------
* Drug: hydroxyurea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 5 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>hydroxyurea | Drug: hydroxyurea<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcranial doppler ultrasound velocity |  | 2 years | 
| Magnetic resonance imaging/angiography |  | 2 years | 
| Glomerular Filtration Rate |  | 2 years | 
| Quality of Life |  | 2 years | 
| Neurocognitive outcomes |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth parameters |  | 2 years | 
| Hematological parameters |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sickle cell anemia, hydroxyurea
The Mechanism of MicroRNAs Network in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
MicroRNAs network, such as MicRNA107 et al, regulate the pathology of Alzheimer's disease and the clinical validation in diagnosis AD.

Official Title
-----------------
Shanghai Mental Health Center

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

Intervention / Treatment
-----------------
* Diagnostic Test: MicRNAs test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NIA-AA MCI due to AD clinical criteria for MCI due to AD NIA-AA AD clinical criteria for AD Exclusion Criteria: Other type of dementia

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal elderly<br>normal cognitive group | Diagnostic Test: MicRNAs test<br>* plasma micRNAs concentration<br>|
| aMCI<br>amnestic mild cognitive impairment | Diagnostic Test: MicRNAs test<br>* plasma micRNAs concentration<br>|
| AD<br>Alzhiemer's disease | Diagnostic Test: MicRNAs test<br>* plasma micRNAs concentration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MicRNAs diagnosis validation for aMCI | MicRNAs concentration in plasma among three groups | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MicroRNAs, Alzheimer's Disease, Validation
Krill Oil and Muscle in Older Adults

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effects of krill oil supplementation on muscle mass in function in older adults. Half of the participants will receive krill oil supplements and the other half a placebo.

Official Title
-----------------
Effects of Krill Oil Supplementation on Muscle Function in Older Adults

Conditions
-----------------
Aging, Sarcopenia

Intervention / Treatment
-----------------
* Dietary Supplement: Krill Oil
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI less than 35kg/m2 Exclusion Criteria: Diabetes severe cardiovascular disease seizure disorders uncontrolled hypertension (>150/90mmHg at baseline measurement) cancer or cancer that has been in remission <5 years ambulatory impairments which would limit ability to perform assessments of muscle function dementia taking medication known to affect muscle (e.g. steroids) have an implanted electronic device (e.g. pacemaker/defibrillator/insulin pump) on anticoagulant therapy allergies to seafood regular consumption of more than 2 portions of oily fish per week.

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>4g/day of mixed vegetable oil supplements | Dietary Supplement: Placebo<br>* Mixed vegetable oil<br>|
| Experimental: Krill<br>4g/day krill oil | Dietary Supplement: Krill Oil<br>* Aker Biomarine Superba Krill Oil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle strength | knee extensor muscle strength | Change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Grip strength | Grip strength | Change from baseline to 6 months | 
| Change in Muscle thickness | Vastus lateralis muscle thickness | Change from baseline to 6 months | 
| Change in Short performance physical battery test | SPPB | Change from baseline to 6 months | 
| Change in Body Fat | Measured by BIA | Change from baseline to 6 months | 
| Change in Lean Mass | Measured by BIA | Change from baseline to 6 months | 
| Change in Fasting glucose | Fasting glucose | Change from baseline to 6 months | 
| Change in Blood lipids | Blood lipids | Change from baseline to 6 months | 
| Change in CRP | CRP | Change from baseline to 6 months | 
| Change in Erythrocyte fatty acid profile | Erythrocyte fatty acid profile | Change from baseline to 6 months |
Progress Pediatric Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the HIV disease progression in HIV-infected Thai children.

Detailed Description
-----------------
This is a multicenter, observational cohort study. HIV-infected children from 5 institutions are followed to assess HIV disease progression: 1. Bamrasnaradura infectious disease institute,2. Faculty of Medicine Siriraj Hospital, Mahidol University, 3. Chiangrai Prachanukroh Hospital, 4. Sanpatong Hospital and 5. HIV-NAT, Thai Red Cross AIDS Research Center.

Official Title
-----------------
The Thai Pediatric HIV Disease Progression: An Observational Database

Conditions
-----------------
HIV, Depression

Intervention / Treatment
-----------------
* Drug: standard ART according to the Thai Ministry of Public Health national guidelines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 18 years old Have confirmed HIV infection (ELISA,HIV-DNA PCR,HIV-RNA PCR) Signed consent form Exclusion Criteria: Hospitalization Emergency case Incomplete Medical Record

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| 1<br>long-term follow-up of HIV-infected children | Drug: standard ART according to the Thai Ministry of Public Health national guidelines<br>* Patients may receive any of the standard regimens. These regimens are recommended in the Thai Ministry of Public Health National guidelines for the treatment of HIV in children. Change of treatment will be according to the treating physicians.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV related adverse events | time to HIV related adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological failure | time to immunological failure | 1 year | 
| virological failure | time to virological failure | 1 year | 
| quality of life | time to change of quality of life | 1 year | 
| depression | when patient develops depression | 1 year | 
| genotypic resistance | time to genotypic resistance | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV related adverse events, Immunological failure, virological failure, quality of life, depression, genotypic resistance
Zenith® p-Branch® Endovascular Graft Pivotal Study

Study Overview
=================
Brief Summary
-----------------
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Official Title
-----------------
Zenith® p-Branch® Pivotal Study

Conditions
-----------------
Aortic Aneurysm Abdominal

Intervention / Treatment
-----------------
* Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation Exclusion Criteria: Age <18 years Life expectancy <2 years Pregnant, breast-feeding, or planning on becoming pregnant within 60 months Inability or refusal to give informed consent by the patient or a legally authorized representative Unwilling or unable to comply with the follow-up schedule Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) Additional medical restrictions as specified in the Clinical Investigation Plan Additional anatomical restrictions as specified in the Clinical Investigation Plan

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular<br>Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents | Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents<br>* Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.<br>* Other names: Fenestrated graft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success Proportion | Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal aortic aneurysm, Endovascular, Juxtarenal, Pararenal, Fenestrated
IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.

Official Title
-----------------
Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy

Conditions
-----------------
Oxygen Titration in Preterm Infants to Manage Lung Disease

Intervention / Treatment
-----------------
* Device: IntellO2
* Other: Manual control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants being treated with high flow nasal cannula therapy A need for supplemental oxygen as demonstrated by an required FiO2 > 0.25 at enrollment Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC). Exclusion Criteria: Major congenital abnormalities Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics Seizures Ongoing sepsis Meningitis Clinician's concern regarding stability of the infant
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IntellO2<br>Automated control of FiO2 | Device: IntellO2<br>* Automated FiO2 regulator that responds to pulse oximetry measures<br>|
| Active Comparator: Manual<br>Manual control of FiO2 | Other: Manual control<br>* Standard practice of manually titrating FiO2 as needed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent time in target range for oxygen saturation by pulse oximetry |  | 24 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasal cannula, high flow oxygen therapy, pulse oximetry