linjc16/ctgov huggingface dataset:
Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in patients with a history of venous thromboembolism.

Official Title
-----------------
YM150 Long Term Study - Long-term Study in Patients With a History of Venous Thromboembolism

Conditions
-----------------
Venous Thromboembolism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis Written informed consent obtained before screening Exclusion Criteria: Subject has history of deep vein thrombosis and/or pulmonary embolism Subject has a hemorrhagic disorder and/or coagulation disorder Subject has had clinically important bleeding occurred within 90 days prior to the screening visit Subject has an acute bacterial endocarditis Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke Subject is receiving anticoagulants/antiplatelet agents Subject has a body weight less than 40 kg

Ages Eligible for Study
-----------------
Minimum Age: 20 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: YM150 group<br> | Drug: YM150<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint incidence of deep vein thromboembolism or pulmonary thromboembolism |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of each thromboembolism |  | 52 weeks | 
| All cause mortality |  | 52 weeks | 
| Incidence of bleeding event |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM150, Bleeding, VTE, FXa inhibitor, Venous thromboembolism
2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula

Study Overview
=================
Brief Summary
-----------------
Will the technique of adding lidocaine to bupivacaine fasten the onset of bupivacaine alone for infraclavicular brachial plexus block in end-stage renal disease (ESRD) patient?

Official Title
-----------------
Comparison of Onset of Action Between 2% Lidocaine Plus 0.5% Bupivacaine and 0.5% Bupivacaine in Brachial Plexus Anesthesia for Creation of Arteriovenous Fistula in ESRD Patient

Conditions
-----------------
Infraclavicular Brachial Plexus Block

Intervention / Treatment
-----------------
* Drug: Bupivacaine plus lidocaine
* Drug: Bupivacaine 30 ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESRD patient for AVF procedure age >17 year BMI 20-35 kg/m2 communicable Exclusion Criteria: BMI > 35 kg/m2 BMI < 20 kg/m2 หรือ BW < 35 kg History of allergy to local anesthetic drugs Pre-operative neurological deficit, Neuromuscular disorder หรือ old CVA Psychiatric disorder Coagulation disorder Uncontrolled seizure Pregnant and lactating women

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine plus lidocaine<br>Group 1: bupivacaine 20 ml plus lidocaine 10 ml | Drug: Bupivacaine plus lidocaine<br>* Bupivacaine 20 ml plus lidocaine 10 ml<br>* Other names: Marcaine Xylocaine;|
| Experimental: Bupivacaine alone<br>Group 2: bupivacaine 30 ml | Drug: Bupivacaine 30 ml<br>* Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block<br>* Other names: lidocaine, marcaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of sensory block |  | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of motor block |  | 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound guided infraclavicular brachial plexus block, Bupivacaine, Bupivacaine plus lidocaine, End stage renal disease, Arteriovenous fistula
Brain Awake Surgery Using Virtual Reality Headset

Study Overview
=================
Brief Summary
-----------------
Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.

Official Title
-----------------
Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance

Conditions
-----------------
Brain Tumor, Virtual Reality

Intervention / Treatment
-----------------
* Device: Virtual reality headset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral tumor or any type of brain lesion localized at the vicinity of eloquent area Exclusion Criteria: Emergency Any contra-indication to awake brain surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain surgery with virtual reality headset<br> | Device: Virtual reality headset<br>* Feasibility and tolerance<br>* Other names: awake craniotomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset. |  | During awake surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, glioma surgery, awake craniotomy, brain tumor, glioma, neurosurgery
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage

Study Overview
=================
Brief Summary
-----------------
So far the evaluation of scar treatment was based on subjective criteria. The patient groups were divided into treated versus non-treated. In this study we use patients undergoing ear reconstruction with autologous rib cartilage. The thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during second stage of reconstruction. Therefore we have a ideal model of clinical, physiological and histological scar evaluation in a homologous patient group. All patients randomly treat one half of the scar with a silicone gel (Dermatix). The other half is untreated as an internal control.

Official Title
-----------------
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction

Conditions
-----------------
Cicatrix, Hypertrophic, Keloid

Intervention / Treatment
-----------------
* Drug: Silicone gel (Dermatix®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with high grade microtia requiring a reconstruction with autologous rib cartilage Exclusion Criteria: diabetes mellitus vascular disease known allergic reaction to silicone

Ages Eligible for Study
-----------------
Minimum Age: 9 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control. | Drug: Silicone gel (Dermatix®)<br>* The half one the scar to treat was randomised among patients. After regular cleaning of the skin around the scar one half was thinly creamed with the silicone gel from medial to lateral and let dry for 5 minutes. It was done twice daily.<br>* Other names: Dermatix®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.) |  | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic reaction compliance |  | retrospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound healing, silicone gel, cicatrix, scar, keloid
Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage

Study Overview
=================
Brief Summary
-----------------
Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient. The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator. The investigators can chose the plot using a software (Guide Xt), which can delete the exhausting test. The investigators would like to study the non inferiority of this tool to choose the best plot .

Official Title
-----------------
Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage

Conditions
-----------------
Parkinson Disease, Subthalamic Nucleus Stimulation, Directional Electrodes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age : >18Y All patient with Parkinson disease eligible for sub thalamic surgery (CAPSIT criterias) in CHU AMIENS Exclusion Criteria: patient doesn't consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| testing all the plots<br>the investigator chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator ( plot by plot ) | |
| Guide X Software<br>the investigator can chose the plot using a software (Guide Xt), which can delete the exhausting test | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of MDS UPDRS 3 score | The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living; II: Motor Experiences of DailyLiving; III: Motor Examination; IV: Motor Complications.Twenty questions are completed by the patient/caregiver. Item-specific instructions and an appendix of complementary additional scales are provided. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, Subthalamic nucleus stimulation, directional electrodes
Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether VPI-2690B Injection is effective in the treatment of diabetic nephropathy.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group, Phase 2, Two-Part Adaptive Study to Evaluate the Safety and Efficacy of VPI-2690B Injection in Patients With Nephropathy Due to Diabetes

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: VPI-2690B low dose
* Drug: VPI-2690B medium dose
* Drug: Placebo to match VPI-2690B
* Drug: VPI-2690B high dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented diabetic nephropathy in patients with either Type 1 or Type 2 diabetics HbA1c of 7.5-10.5% eGFR 30-110 mL/min/1.73m2 stable ACEi/ARB dose regimen stable blood pressure BMI less than or equal to 45 kg/m2 Exclusion Criteria: non-diabetic renal disease history of solid organ or islet cell transplant history of malignancy within previous 5 years systemic immunosuppression therapy clinically significant liver disease, hepatitis B or C or HIV monoclonal antibody treatment within previous year recent acute renal injury or major surgery significant, recent body weight change biopsy proven glomerular disease

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VPI-2690B low dose<br>6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks | Drug: VPI-2690B low dose<br>* Comparison of different doses of study drug<br>|
| Active Comparator: VPI-2690B medium dose<br>18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks | Drug: VPI-2690B medium dose<br>* Comparison of different doses of study drug<br>|
| Placebo Comparator: Placebo<br>6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks | Drug: Placebo to match VPI-2690B<br> <br> |
| Active Comparator: VPI-2690B high dose<br>48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks | Drug: VPI-2690B high dose<br>* Comparison of different doses of study drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in albuminuria |  | 50 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in eGFR |  | 50 weeks |
Exploration the Effect of Walking Program in Patients With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The aims of this four-year study are to explore the relationships between fatigue and muscle strength (i.e., upper limbs and lower legs) comparison with the effects of 8-week, 12-week moderate intensity of walking program on muscle strength and fatigue. develop a clinical guidelines of home-based walking program for patients with colorectal cancer receiving active treatment and survivors in Taiwan. explore the relationships among the self-report fatigue intensity and metabolism.

Official Title
-----------------
Exploration the Effect of Individualized Home-based Walking Program on Muscle Strength and Fatigue in Patients With Colorectal Cancer Both During and After Treatment

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: muscular strength


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with colorectal cancer in receiving active treatment or completed treatment within 5years. Patients in Different Stages. Aged above 18. Exclusion Criteria: KPS<60

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: walking group<br> | Behavioral: muscular strength<br>* 12-week moderate intensity walking program<br>|
| No Intervention: usual care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploration the Effect of Walking Program in Patients With Colorectal Cancer. | change of walking program on muscle strength and fatigue | five-year study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer,fatigue,6-minute walking test
Exercise Intensity and Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a single session of aerobic exercise effectively controls the blood pressure (BP) of individuals with type 2 diabetes mellitus (T2DM) over the 24h of post-exercise period, and the effects of intensity of aerobic exercise on these BP responses.

Official Title
-----------------
Effects of Exercise Intensity on 24-h Ambulatory Blood Pressure in Type 2 Diabetics

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Aerobic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sedentary a diagnosis of T2DM for at least one year glycemic control through nutrition and/or medication Exclusion Criteria: be not under use of exogenous insulin and do not present chronic complications such as diabetic foot nephropathy retinopathy neuropathies and cardiovascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exercise<br> | Other: Aerobic exercise<br>* Intensity of aerobic exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure - Ambulatory blood pressure monitoring (ABPM) |  | Participants will be followed for the duration of experimental tests, an expected average of 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aerobic Exercise, Blood Pressure
A Second Dose of Measles Vaccine (MV) in the Second Year of Life

Study Overview
=================
Brief Summary
-----------------
This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.

Official Title
-----------------
Boosting the Beneficial Non-specific Effects of Live Attenuated Vaccines: A Randomized Controlled Trial (RCT) of a Second Dose of Measles Vaccine (MV) in the Second Year of Life

Conditions
-----------------
Child Mortality, Child Morbidity

Intervention / Treatment
-----------------
* Biological: Measles vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination. Exclusion Criteria: Having severe malformations that impairs their health Having received a second dose of measles vaccine Severely ill (requiring hospitalization) upon clinical examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 24 Months

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Measles vaccine<br>Measles vaccine, 1 dose of 0.5 ml | Biological: Measles vaccine<br> <br> |
| No Intervention: Control<br>Nothing | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality registered monthly by Health and Demographic Surveillance System fieldworkers. Mortality will be combined with hospital admissions in the analysis to form the outcome severe morbidity. This will be examined overall and by sex | 30 months | 
| Hospital admissions | Hospital admissions registered daily at the national hospital. Hospital admissions will be combined with mortality in the analysis to form the outcome severe morbidity. This will be examined overall and by sex | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admission by cause | Causes of hospital admissions registered daily at the national hospital. These will be examined overall and by sex | 30 months | 
| Consultations | Consultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex | 30 months |
ROTATEQ™ Post-Marketing Surveillance in the Philippines

Study Overview
=================
Brief Summary
-----------------
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.

Official Title
-----------------
Protocol for ROTATEQ™ Post-Marketing Surveillance

Conditions
-----------------
Rotavirus Infections, Gastroenteritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received ROTATEQ™

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

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 |
| --- | --- |
| All Participants<br>Infants who were vaccinated with ROTATEQ™ | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events following administration of ROTATEQ™ |  | Three-year period following vaccine marketing approval (August 2007 to August 2010) |