linjc16/ctgov huggingface dataset:
Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea

Study Overview
=================
Brief Summary
-----------------
Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.

Conditions
-----------------
Chronic Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 < Age < 70 HBV DNA > 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+) HBV DNA > 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-) Exclusion Criteria: With HCV or other liver disease With kidney disease decompensated liver cirrhosis with hepatocellular carcinoma refuse this clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| virologic response | Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir | changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of alanine transaminase | Patients will check the level of alanine transaminasel at 3, 6, 9, 12 months after taking entecavir and tenofovir | changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Entecair, Tenofovir
The Safety and Efficacy of 1064-nm Picosecond Laser With Microlens Array for Pore Tightening; a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of 1064-nm Picosecond laser 1064 With Microlens Array for Pore tightening.

Detailed Description
-----------------
The Safety and Efficacy of Picosecond laser 1064 Nanometers With Microlens Array for Pore tightening; a Pilot Study Primary outcome : pore size Secondary outcome : side effect, patient satisfaction, global evaluation the patient recieved laser treament once a month for 3 months and then follow up after last treatment at 1, 3 ,6 month Enlarged facial pores is one of the skin signs in photoaging. There are 3 major clinical causes of enlarged facial pores: highs sebum excretion, decreased elasticity around pores and increased hair follicle volume. Possible causative factors of enlarged facial pores include many exogenous and endogenous factors include genetic predisposition, seborrhea and chronic ultraviolet light exposure. Picosecond laser are new device which has been used in skin rejuvenation. The main mechanism of action is laser induced optical breakdown (LIOB).

Official Title
-----------------
The Safety and Efficacy of 1064-nm Picosecond Laser 1064 With Microlens Array for Pore Tightening; a Pilot Study

Conditions
-----------------
Enlarged Pores

Intervention / Treatment
-----------------
* Device: Fractional picosecond 1064 nm laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both male and female age 25-40 years No underlying disease Exclusion Criteria: History of retinoid or other keratolytic drugs used within 6 months before enrolled History of keloid photosensitivity Immunocompromised host

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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: Fractional picosecond laser 1,064 nm laser<br>1 arm The subjects with enlarged pores were treated with fractional picosecond laser 1,064 nm laser | Device: Fractional picosecond 1064 nm laser<br>* The parameter of laser was 8 mm spot size, 0.8 mJ/CM2, 750 ps, 5 Hz, 2 passes The treatment was done in every 4 weeks for 3 sessions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pore size by Antera 3D image |  | change from baseline in pore size at 6 months |
Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation to Treat Chronic Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether left atrium substrate based ablation plus circumferential is effective in the treatment of persistent and long-standing atrial fibrillation.

Official Title
-----------------
Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation in the Treatment of Persistent and Long-standing Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Procedure: radiofrequency catheter ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication. Exclusion Criteria: Patients with paroxysmal AF (self-terminating episodes lasting < 7 day) Patients who have had a previous AF ablation procedure Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: catheter ablation<br> | Procedure: radiofrequency catheter ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 3,6,12,18 and 24 months after a single-ablation. procedure. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation |  | December 31, 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, catheter ablation, Mapping
Colorectal Cancer Awareness in Turkey

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer is among the most common types of cancer worldwide. Population-based screening programs for breast, cervical, and colorectal cancer have been introduced as part of cancer control in many high-income countries. Population-based cancer screening programs do not exist in most low- and middle-income countries. There are some studies that report the awareness of colorectal cancer in Turkey.

Detailed Description
-----------------
Colorectal cancer is the third most common type of cancer in both men and women. According to World Health Organization data, in 2012, 694 thousand people were thought to be due to colorectal cancer and this number increased to 862 thousand people in 2018. Especially in most low- and middle-income countries where cancers are mainly detected through very-late-stage symptoms and many are not reported. Recent researches may lead to new approaches to early detection and treatment using improved awareness of the symptomatic disease and population-based screening of asymptomatic people. The increasing of colorectal cancer awareness could help early detection of colorectal cancers. In this study, the investigators aimed to determine the level of awareness of colorectal cancer and knowledge about colorectal cancer screenings in patients who applied to general surgery outpatients clinic where a colorectal cancer diagnosis was most frequently diagnosed.

Official Title
-----------------
Assessment of Colorectal Cancer Awareness in Patients Admitted to the General Surgery Outpatient Clinic

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

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who apply to the general surgery outpatients clinic Exclusion Criteria: Younger than 18 years old Older than 80 years old Mental retardation or other mental illness Refusing to join the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survey<br>All of the patients that enrolled in this study will be in this group. | Other: Survey<br>* A survey with 13 questions will be applied to the patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The awareness of patients about colorectal cancer | To assess the awareness of patients about colorectal cancer with a survey | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Cancer, Awareness, Screening
Cardiac Vagal Effects of GES in Patients With Gastroparesis and Vagal Nerve Action Potentials in Vagus Nerve

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine if Gastric Electrical Stimulation may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.

Detailed Description
-----------------
This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device The study will be conducted at one center and approximately 200 subjects will be enrolled. Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.

Official Title
-----------------
Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus Nerve in Patients With Gastroparesis

Conditions
-----------------
Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age. Documented diagnosis of gastroparesis. Will undergo implantation of a GES device or already has a GES device implanted Exclusion Criteria: Pregnancy History of allergic reaction to EKG lead placement adhesives. unable to give informed consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if GES influences vagal outflow | The objective of this study is to determine if GES may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System (CNS). The development of a method to record and analyze compound action potentials from the vagus nerve will enhance our knowledge of the mechanism of action of Vagal Nerve Stimulation (VNS) in the treatment of gastroparesis. In addition, noninvasive measures of vagus nerve excitability are an important initial step towards 1) improved stimulus parameter tuning protocols in new device recipients before direct nerve recording technology is available, 2) a method of monitoring the nerve response over extended periods of time to ensure optimal device settings for the duration of the implantation, and 3) the development of completely noninvasive VNS device option. Furthermore, the technique itself may be of value in other clinical settings in which it would be useful to evaluate the physiological integrity of the vagus nerve | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vomiting, gastroparesis, gastric electrical stimulator, GES, nausea, bloating, postprandial fullness, epigastric pain
Impact of Night Shift Work on 24-hour Blood Glucose Levels

Study Overview
=================
Brief Summary
-----------------
This study will determine whether nurses regularly working night shifts have elevated 24-hour glucose levels compared to nurses regularly working day shifts, using continuous glucose monitoring (CGM).

Official Title
-----------------
Impact of Regular Night Shift Work on 24-hour Blood Glucose Levels in Nurses

Conditions
-----------------
Circadian Rhythm; Inversion, Metabolic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • RNs working at least a 0.6 FTE and 12-hour night or day shift (not able to alternate between days and nights) for at least the past two months Free from presence of uncontrolled chronic illness and specifically prediabetes, Type 1 or Type 2 diabetes (but not including history of gestational diabetes) and not currently taking any glucose-lowering or steroid medication Not currently pregnant or breastfeeding English speaking and able to provide informed consent Must own and know how to operate a Smartphone Must be willing and able to wear two small sensors attached by adhesive for the study duration, the Fibion SENS activity monitor and the Dexcom G6 continuous glucose monitor Must regularly consume food during shifts and refrain from actively attempting weight loss during the study duration Must work only one job at the time of study participation

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Day Shift<br>Nurses regularly working 12hr day shifts | |
| Night Shift<br>Nurses regularly working night shift | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24hr glucose | continuous glucose monitoring | 7 days |
Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.

Official Title
-----------------
A 12-week Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Once Monthly Subcutaneous Erenumab 70 mg in Adult Chronic Migraine Patients

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Biological: Erenumab
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
key inclusion Criteria: History of at least 5 attacks of migraine ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period >=80% diary compliance during the baseline period Key exclusion Criteria: Older than 50 years of age at migraine onset History of cluster or hemiplegic headache Evidence of seizure or major psychiatric disorder Cardiac or active hepatic disease Pregnant or nursing

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erenumab<br>Administered by pre-filled syringe | Biological: Erenumab<br>* Administered by pre-filled syringe<br>* Other names: AMG334;|
| Placebo Comparator: Placebo<br>Administered by pre-filled syringe | Other: Placebo<br>* Administered by pre-filled syringe<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in migraine-related disability and productivity as measured by the mMIDAS during the last 4 weeks of the 12-week treatment period |  | 12 weeks | 
| Achievement of at least a 50% reduction from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period |  | 12 weeks | 
| Change from baseline in monthly acute headache medication days during the last 4 weeks of the 12-week treatment period |  | 12 weeks | 
| Number of subjects with adverse events as a measure of safety |  | through study completion, an average of 20 weeks | 
| Number of subjects with anti-AMG 334 antibodies (binding and if positive, neutralizing) |  | Day1, Week 12, Week 20 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMG334, erenumab, migraine, chronic, headache, Chinese
Juvenile Dermatomyositis

Study Overview
=================
Brief Summary
-----------------
This is a retrospective descriptive cross-sectional and observational multicenter clinical and progressive study of juvenile dermatomyositis. The aim is to determine the clinical, paraclinical, and evolutive characteristics and therapeutic modalities from a series of juvenile dermatomyositis identified in Alsace between 2000 to 2015.

Official Title
-----------------
Retrospective Descriptive Study of Juvenile Dermatomyositis in Alsace

Conditions
-----------------
Juvenile Dermatomyositis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age under 16 years Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975 Exclusion Criteria: Refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 16 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of clinical characteristics of juvenile dermatomyositis |  | The period from from January 1st, 2000 to December 31st, 2015 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Juvenile dermatomyositis, Inflammatory myopathy, Clinical features, Treatment
EMOTION & COGNITION IN MYOCLONUS DYSTONIA (AGENT10-ECODYST)

Study Overview
=================
Brief Summary
-----------------
Background: Myoclonus dystonia (DYT-SGCE) is characterized by myoclonus and dystonia. Such condition is associated with a high prevalence of psychiatric symptoms which are part of the phenotype. The mechanisms underlying these non-motor symptoms are still poorly understood. Objective: To investigate the neural correlates of cognition and emotion in DYT-SGCE. Design: Participants will have 1 - 2 visits at the clinical center. The total participation time is less than 24 hours. Participants will have a medical interview and a neurological exam. They may give a urine sample before MRI. Participants will have a short neuropsychologic and psychiatric interviews. Participants will have MRI scans. They will do small tasks or be asked to imagine things during the scanning.

Detailed Description
-----------------
Eligibility: DYT-SGCE patients and healthy volunteers (HV) between 15 and 60 years old.

Official Title
-----------------
CEREBELLAR INVOLVEMENT IN MOTOR, COGNITIVE AND EMOTIONAL PROCESSES IN MYOCLONUS DYSTONIA

Conditions
-----------------
Myoclonus-Dystonia, DYT11

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For all participants: Age between 15-60 years Able to give informed consent. For patients: An established diagnostic of DYT-SGCE No change in medication (related to DYT-SGCE) for a month For controls: No neurological symptoms No medication except oral contraception Exclusion Criteria: No deprivation of liberty Inability to give a consent Established cognitive alteration Contraindication to MRI (per MRI safety checklist) Severe chronic psychiatric illness

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DYT-SGCE<br>Patients with myoclonus dystonia (DYT-SGCE) | |
| Healthy volunteers<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD signal derived from the functional magnetic resonance imaging | Explore the differences in DYT-SGCE compared to HV | 46 month |