linjc16/ctgov huggingface dataset:
Comparison of Antisecretory Effect of a Single Dose of Rabeprazole 20 mg and Omeprazole 20 mg in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
This study aims to determine, in obese subjects, the antisecretory effect of a single dose of placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric pH monitoring, in a prospective, monocentre, randomized manner. Monitorings are separated between 6 and10 days. The main outcome criteria of analysis is the percentage of time with gastric pH above 3 during 24hours.

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: Omeprazole
* Drug: Rabeprazole
* Drug: Lactose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Helicobacter negative obese subject (BMI 30 to 40), 18 to 55 years old, normal hepatic biology and morphology (echography) Contraceptive methods in women. Exclusion Criteria: Subjects with previous abdominal surgery, with diabetic or immunosuppressive treatment.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omeprazole<br> | Drug: Omeprazole<br> <br> |
| Experimental: Rabeprazole<br> | Drug: Rabeprazole<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Lactose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In order to measure antisecretory effect, the main outcome criteria of analysis will be the percentage of time with gastric pH above 3 and measured during 24hours following rabeprazole administration in comparison with omeprazole administration. |  |  |
Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection

Study Overview
=================
Brief Summary
-----------------
Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief.

Detailed Description
-----------------
Pain relief; Comparatle Cement Leakage; Comparacle Irradiation dose：less

Official Title
-----------------
Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection

Conditions
-----------------
Osteoporosis, Compression Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all painful fracture that can not be relieved by pain killer. Exclusion Criteria: infection and malignancy in local region

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| pain relief |  | immediately after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cement leak |  | immediate after procedure |
Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy

Study Overview
=================
Brief Summary
-----------------
Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.

Detailed Description
-----------------
Assessment will be done for maternal serum anti-beta 2 glycoprotein 1 antibodies and anticardiolipin antibodies in cases of preeclampsia after 32 weeks of pregnancy. In addition, fetal Doppler changes will be assessed.

Official Title
-----------------
Role of Maternal Anticardiolipin and Anti-B2 Glycoprotein I Antibodies in Correlation With Fetal Doppler in Prediction of Adverse Pregnancy Outcome in Patients With Preeclampsia

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Diagnostic Test: Doppler
* Diagnostic Test: serum antibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women 32 weeks or more gestational age Pre-eclampsia Singleton pregnancy Exclusion Criteria: Intrauterine fetal death Fetus with apparent congenital anomalies Pregnant females with other medical disorders History of essential hypertension. History of antepartum hemorrhage. History of rupture of membranes.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Eclampsia<br>pregnant women with Pre-Eclampsia will be assessed by serum antibodies and Doppler | Diagnostic Test: Doppler<br>* Doppler will be done to pregnant women with Pre-Eclampsia<br>Diagnostic Test: serum antibodies<br>* serum antibodies will be measured for pregnant women with Pre-Eclampsia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of cases that develop severe pre-eclampsia | percentage of cases that develop severe pre-eclampsia will be assessed by an investigator | It will be calculated after 1 year from the start of the study |
Facilitating Implementation of Cognitive Behavioral Therapy in Primary Care and Community Clinics

Study Overview
=================
Brief Summary
-----------------
The investigators propose to test the effect of external facilitation on the extent that brief cognitive behavioral therapy (CBT) for depression is incorporated into routine practice in primary care and community based clinics in the VA. The investigators will provide training in brief CBT to mental health providers in participating clinics. To the investigators' knowledge, this will be the first study of the effect of external facilitation on outcomes of a training intervention.

Detailed Description
-----------------
We will test the effect of external facilitation on the extent that brief CBT for depression is incorporated into routine practice in primary care and community based clinics in the VA. We will provide training in brief CBT to mental health providers in participating clinics. To our knowledge, this will be the first study of the effect of external facilitation on outcomes of a training intervention.

Official Title
-----------------
Facilitating Implementation of Cognitive Behavioral Therapy in Primary Care and Community Clinics

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: External facilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mental health clinicians in selected clinics who do or are willing to do psychotherapy. Exclusion Criteria: clinicians who do not do psychotherapy in eligible clinics.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facilitation<br>Therapists receive assistance with adopting CBT | Behavioral: External facilitation<br>* Study facilitator meets regularly with therapists to aid implementation of CBT<br>* Other names: Facilitation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBT progress notes |  | Monthly post-training for 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implementation, facilitation, psychotherapy, training
Effects of Work Shop for Children With Developmental Delays

Study Overview
=================
Brief Summary
-----------------
To identify the effects of family work shop for children with speech developmental delays.

Detailed Description
-----------------
To assess the improvement of functional performance of children with speech developmental delays by 2-3 hours per session, one session per week, a total of 6 weeks of family work shop

Official Title
-----------------
Effects of Family Work Shop for Children With Speech Developmental Delays

Conditions
-----------------
Developmental Delays

Intervention / Treatment
-----------------
* Other: family work shop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 M/O to 36 M/O of children with speech development delay Exclusion Criteria: less than 18 M/O older than 36 M/O

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 36 Months

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: family work shop<br>2 to 3 hours per session, one session per week, for a total of 6 weeks of family work shop | Other: family work shop<br>* 2-3 hours per session, one session per week, a total of 6 weeks of family work shop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of pediatric health related quality of life (Pediatric Quality of Life Inventory) | participants receive one 2-hour session of work shop per week for a 6-week duration | participants will be evaluated at before and after 6 weeks of work shop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family work shop, speech developmental delays, children
Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to evaluate safety and effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination with antidiabetes agents other than sulfonylurea under post-marketing normal clinical practice conditions.

Official Title
-----------------
Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol) Patients with T2DM (type 2 diabetes mellitus) who the physician has decided to start treatment with Victoza® in combination with insulin or OAD (oral anti-diabetes drug) other than SU (sulfonylurea) Male or female, no age limitation Exclusion Criteria: Previous participation in this study or NN2211-3772 Participation is defined as informed consent obtained for this study or enrolment for NN2211-3772 Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Patients who are on Victoza® or have previously been on Victoza® within 3 month before the enrolment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide<br> | Drug: liraglutide<br>* Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions. No treatment given.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of AEs (adverse events) |  | Week 0-52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse reactions (ARs) |  | Week 0-52 | 
| Change in HbA1c (glycosylated haemoglobin) |  | Week 0, week 52 |
A Long-Term Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients

Conditions
-----------------
Spinocerebellar Degeneration

Intervention / Treatment
-----------------
* Drug: KPS-0373, High dose
* Drug: KPS-0373, Low dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese SCD patients with ataxia Exclusion Criteria: Patients with secondary ataxia Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KPS-0373<br> | Drug: KPS-0373, High dose<br> <br> Drug: KPS-0373, Low dose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARA (Scale for the Assessment and Rating of Ataxia) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-8 (QOL) |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA)
TopQ Cut-off Determination Study For 3D-OCT 1 Maestro and 3D OCT-2000

Study Overview
=================
Brief Summary
-----------------
To determine optimal cut-off value for the TopQ cut-off on the Maestro and 3D OCT-2000.

Official Title
-----------------
TopQ Cut-off Determination Study For 3D-OCT 1 Maestro and 3D OCT-2000

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No known ocular pathologies Exclusion Criteria: Any known ocular pathologies

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retinal Thickness |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
normal Eyes
Australian Screening Mammography Decision Aid Trial: A Decision Aid for Women Aged 40 Thinking About Starting Mammography Screening

Study Overview
=================
Brief Summary
-----------------
Women who access the website, are aged between 38-45 years and are considering screening mammograms will be randomized to either the Decision Aid (a booklet providing information and exercises to help them to make a decision about whether to having screening mammograms) group or the Control Group. The Decision Aid group will first read the decision aid, and then will be asked some demographic and knowledge questions. The control group will be asked the demographic and knowledge questions only. The control group will have access to the Decision Aid after they have completed the questions

Official Title
-----------------
A Randomised Controlled Trial of an On-line Decision Aid for Women Aged 40 Considering Whether to Have Screening Mammograms to Evaluate the Change in Knowledge Regarding Mammography Screening.

Conditions
-----------------
Knowledge of Mammography Screening

Intervention / Treatment
-----------------
* Behavioral: Decision Aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female aged between 38-45 have access to the internet Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 38 Years
Maximum Age: 45 Years

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Decision Aid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the change in knowledge about the issues involved in screening mammography in women who have read the decision aid. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| elicit womens views on the decision aid including ease of use, content and presentation of information, |  |  | 
| assess the differences in intention to screen |  |  | 
| assess the impact of the decision aid on informed choice |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
informed choice, shared decision making, decision aid, mammography screening, decision support
Management of Plasma Cell Gingivitis by Two Surgical Techniques

Study Overview
=================
Brief Summary
-----------------
Two surgical protocols for management of Plasma cell Ginigivitis; either by surgical enblock resection of cold laser resection

Detailed Description
-----------------
Tow groups will be included the first will have six cases and second will have six cases. the first will be treated by ordinary surgical resection and second will be removed using soft tissue laser.

Official Title
-----------------
Management of Plasma Cell Gingivitis by En-block Removal

Conditions
-----------------
Plasma Cell Gingivitis

Intervention / Treatment
-----------------
* Device: soft tissue laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients suffering from the plasma cell gingivitis Exclusion Criteria: - Patient not eligible for maxillofacial surgery
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 |
| --- | --- |
| study group<br>Removal by soft tissue laser of the tumor | Device: soft tissue laser<br>* Surgical laser used in excision purpose<br>|
| control group<br>Removal by ordinary surgical scalpel | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete removal | complete removal of lesion with safety margin | one month |
Comparing Eye Pressure Using Maximal Tolerated Local Therapy or Systemic Acetazolamide

Study Overview
=================
Brief Summary
-----------------
Local therapy for glaucoma is known to induce a conjunctival inflammation. Because of this, trabeculectomy is more likely to fail. The investigators exchange the local therapy by systemic therapy using acetazolamide and measure the eye pressure using local therapy and systemic therapy using acetazolamide. The investigators suspect an elevated eye pressure using acetazolamide compared to local therapy. In summary acetazolamide could be a better choice in reference to conjunctival inflammation, but a worse choice in reference to controlling eye pressure.

Official Title
-----------------
Comparing Eye Pressure Using Maximal Tolerated Local Therapy or Systemic Acetazolamide. A Possible Pretreatment for Trabeculectomy Surgery.

Conditions
-----------------
Control of Elevated Eye Pressure by Local and Systemic Therapy

Intervention / Treatment
-----------------
* Drug: Acetazolamide for glaucoma patients to lower eye pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with uncontrolled intraocular eye pressure Patients with planed trabeculectomy in 3 to 4 weeks Exclusion Criteria: Patients not meeting the inclusion criteria Patients with known intolerance to acetazolamide
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with a trabeculectomy planed<br> | Drug: Acetazolamide for glaucoma patients to lower eye pressure<br>* Acetazolamide tablets 3 times daily for 3 to 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye pressure | The eye pressure is measured at the beginning of the study, when the patient is using the maximal tolerated local therapy and 3 to 4 weeks later, when using systemic acetazolamide treatment. | Once at the beginning of the study and once 3 to 4 weeks later |