linjc16/ctgov huggingface dataset:
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.

Official Title
-----------------
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: EYEOP device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma in the study eye with maximally tolerated medical treatment Ocular hypertension defined as an intraocular pressure (IOP) > 21 mm Hg Subject has failed a conventional intraocular glaucoma filtering surgery Patient must be aged 18 years or more No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment No previous cyclophotocoagulation procedure in the study eye Patient able and willing to provide informed consent and to complete post-operative follow-up requirements. Exclusion Criteria: History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye History of ocular or retrobulbar tumor Retinal detachment, choroidal hemorrhage or detachment Ocular infectious disease within 14 days before HIFU treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EYEOP Treatment<br>Open label, all subject treated by the EYEOP device | Device: EYEOP device<br>* Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy measure : | IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures | The incidence of device and procedure-related complications during the follow-up | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Refractory glaucoma, Cyclocoagulation, High Intensity Focused Ultrasound
Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

Study Overview
=================
Brief Summary
-----------------
Scalp infiltration with Epinephrine- containing lidocaine solution is common method for craniotomy but it may result in transient but significant hypotension in patients undergoing neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during scalp incision in craniotomy. The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.

Official Title
-----------------
Randomized Controlled Trial to Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution for the Effect on Hemodynamic Response Due to Scalp Infiltration in Patients Undergoing Craniotomy

Conditions
-----------------
Craniotomy

Intervention / Treatment
-----------------
* Drug: scalp infiltration solution
* Drug: scalp infiltration solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II Aged between 20 and 70 year general anesthesia for craniotomy Exclusion Criteria: Congestive heart failure, coronary artery occlusive disease Bradycardia < 50 BPM, 2nd degree < AV block Poorly controlled hypertension ß blocker medication Coagulopathy Pregnancy, nursing

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dex group<br>dexmedetomidine-lidocaine solution, | Drug: scalp infiltration solution<br>* Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)<br>|
| Active Comparator: Control group<br>epinephrine-lidocaine solution | Drug: scalp infiltration solution<br>* 1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure | before scalp injection(T0), after scalp injection every half minute until five minutes(T0.5, T1, T1.5, T2, T2.5, T3, T3.5, T4, T4.5, T5), every minute(T6, T7, T8, T9, T10, T11, T12, T13, T14, T15) | before and after scalp injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, epinephrine, lidocaine, scalp infiltration, craniotomy
Stress Management for Chronic Headaches

Study Overview
=================
Brief Summary
-----------------
This interventional, randomized controlled study seeks to test the effects of a novel emotional awareness and expression intervention against relaxation training or no intervention for college students with chronic headaches. These two interventions are conceptually quite distinct, as the former seeks to activate and process anger, whereas the latter, more commonly used technique, seeks to suppress or avoid it.

Official Title
-----------------
Emotional Awareness and Expression Training and Relaxation Training for People With Chronic Headaches

Conditions
-----------------
Headaches

Intervention / Treatment
-----------------
* Behavioral: Anger Awareness and Expression
* Behavioral: Relaxation Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergraduate students at Wayne State University who have chronic headaches Exclusion Criteria: Insufficiently frequent headaches Uninterested in engaging in a stress management intervention Headaches appear due to substance use or head trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anger awareness and expression<br>Training for anger awareness and expression | Behavioral: Anger Awareness and Expression<br>* Teaches patients to recognize, experience, and express emotions<br>|
| Active Comparator: Relaxation Training<br>Teach patients relaxation training | Behavioral: Relaxation Training<br>* Teaches patients relaxation training<br>|
| No Intervention: No-treatment control<br>Assessment only control condition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency and severity |  | baseline, 6-weeks, 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache disability |  | baseline, 6-weeks, 6-months | 
| Mood, self-efficacy, stress symptoms |  | baseline and 6-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
headaches, stress management, assertiveness training, relaxation training, emotional expression
Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.

Official Title
-----------------
A Double-Blind, Parallel-group, 4-Week Trial to Assess the Efficacy and Safety of Etoricoxib 60 mg and Diclofenac 150 mg in Patients With Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib / Duration of Treatment: 4 weeks
* Drug: Comparator: diclofenac / Duration of Treatment: 4 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18 years of age or older, who have Chronic Low Back Pain after the discontinuation of their previous medication for their condition. Patients should have at least 3 months of Low Back Pain.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0663, etoricoxib / Duration of Treatment: 4 weeks|nan|
|Drug: Comparator: diclofenac / Duration of Treatment: 4 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower back pain intensity |  |  | 
| Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability questionnaire |  |  | 
| Patient global assessment of response to therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Improvement of Colonoscopy Preparation by New Media (APP)

Study Overview
=================
Brief Summary
-----------------
Feasibility of an newly programmed offline application for smartphones (SPA, APP) for colonoscopy preparation offering a 5 day guidance prior colonoscopy containing dietary- and behavioral recommendation.

Detailed Description
-----------------
First feasibility testing of a newly programmed app/SPA for android system named Colopr-APP. It is an strictly offline working, autonomous system downloaded to the smartphone. It creates an 5-day guidance prior outpatient colonoscopy with dietary and behavior recommendations.

Official Title
-----------------
First Experiences With an Offline App (SPA; Smartphone Application) for Colonoscopy Preparation- PERICLES-I APP; Prospective Evaluations of Improvement of Colonocopy Preparation by Optimized Visualization (PERICLES)

Conditions
-----------------
Gastrointestinal Neoplasms

Intervention / Treatment
-----------------
* Device: APP supported colonoscopy preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: outpatient colonoscopy smartphone owner with android system Exclusion Criteria: chronic renal failure anticoagulants pregnancy diabetes mellitus (IDDM)

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Regular colonoscopy preparation<br>Comparison group. Regular colonoscopy preparation | |
| Experimental: APP supported colonoscopy preparation<br>APP as additional device for colonoscopy preparation | Device: APP supported colonoscopy preparation<br>* additional usage of an app for colonoscopy preparation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | feasibility of app supported colonoscopy preparation (stable working and function of software on smartphone) | at day 0 colonoscopy after colonoscopy preparation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation | Evaluation of bowel preparation during colonoscopy by BostenBowelPreparation Scale | at day 0 after colonoscopy | 
| patient´s satification | Evaluation of patient´s satisfication by a questionaire | day 1 after colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, new media, APP, colonoscopy preparation, SPA, smartphone application
Assessment of the Prevalence of Major Psychiatric Disorders in a Cohort of Women With Clinical Criteria Corresponding to Pure, Abortive-form, Obstetrical, Antiphospholipid Syndrome

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to evaluate and compare the prevalence of the following psychiatric pathologies (based on the MINI5.0.0 questionnaire) among 3 groups of women (Leiden versus aP1Ab-positive versus thrombophilia-negative) with similar obstetrical histories 10 years after their initial assessment/diagnosis. Mood disorders, including depressive episodes during the previous two weeks, recurrent depressive disorders at any point in life, dysthymia in the last two years, or any current or past manic episode; Anxiety disorders, including current agoraphobia, current panic disorders, agoraphobia with panic disorders, current social phobia, generalized anxiety in the last 6 months, or current posttraumatic stress syndrome; Apparent psychotic syndromes, including isolated or recurrent psychotic syndromes, past or present (clinically validated), Current alcohol or drug problems (dependence or abuse).

Official Title
-----------------
Assessment of the Prevalence of Major Psychiatric Disorders in a Cohort of Women With Clinical Criteria Corresponding to Pure, Abortive-form, Obstetrical, Antiphospholipid Syndrome

Conditions
-----------------
Antiphospholipid Syndrome, Factor V Leiden Thrombophilia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Three unexplained consecutive spontaneous abortions before the 10th week of gestation (the recurrent embryo loss subgroup) - OR - One unexplained death of a morphologically normal fetus (fetal loss) at or after the 10th week of gestation (fetal loss subgroup). Exclusion Criteria: Any history of thrombotic events or any treatment given during previous pregnancies that might have modified the natural course of the condition Women whose pregnancy losses could be explained by infectious, metabolic, anatomic or hormonal facotrs, or associated with paternal or maternal chromosomal causes Seropositivity for HIV, hepatitis B or C Women with antithrombin, protein C, or protein S deficiency, and women with abnormal fibrinogen or with the JAK2 V617F mutation were further excluded.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leiden Group<br>Women with an isolated F5 rs6025 polymorphism or an isolated F2 rs1799963 polymorphism. | |
| aP1Ab-positive<br>Inclusion in the aP1Ab Group: Initially positive for aP1Ab Second positive aP1Ab test six months later | |
| Thrombophilia-negative<br>Women with completely negative thombophilia screening results. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Internationl Neuropsychiatric Interview 5.0.0 |  | 10 years |
Mycophenolate vs Azathioprin in Autoimmune Hepatitis

Study Overview
=================
Brief Summary
-----------------
A study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10 receiving mycophenolat mofetil.

Conditions
-----------------
Autoimmune Hepatitis

Intervention / Treatment
-----------------
* Drug: Treatment with mycophenolat mofetil
* Drug: Treatment with azathioprin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo autoimmune hepatitis Consent Exclusion Criteria: age below 18 pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>MMF | Drug: Treatment with mycophenolat mofetil<br> <br> |
| Active Comparator: II<br> | Drug: Treatment with azathioprin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prednisolone dosage
Effects of a Single Session of Integrated Yoga Therapy Compared With Other Relaxation Techniques

Study Overview
=================
Brief Summary
-----------------
Typically a course of yoga therapy for stress management takes place over a week, however, investigators are often asked to provide a single session for workers. The aim of this study is to assess the benefits of a single session of an integrated yoga program compared with other relaxation techniques for the staff of schools.

Conditions
-----------------
Yoga

Intervention / Treatment
-----------------
* Behavioral: integrated yoga program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: school staff members, including school managers, teachers, school nurses, school office workers, nutritionists and cooks volunteers attending a stress management workshop Exclusion Criteria: those who had any previous experience of practicing yoga or any relaxation procedures

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: other techniques group<br>theory and practice of pair massage with tapping, stretching of the ankle and neck, and autogenic training | Behavioral: integrated yoga program<br>* the program as a one-time session for 3 hours as a component of a Stress Management Education program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of scores on the Subjective Units of Distress (SUD) scale | SUD is a scale of 0 (comfort) to 10 (discomfort) for measuring the subjective intensity of disturbance or distress currently experienced by an individual covering both physical and mental aspects. | 1) immediately after the subjects arrived at the facility (baseline) and 2) immediately after the intervention |
Central Venous Saturation (ScvO2) Monitoring in Pediatric Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Children (ages 0-12) that have heart surgery are often at a high risk of developing complications and have to be continuously monitored. Part of the routine care at UCLA includes using a monitor (continuous central venous oxygen saturation-ScvO2) to measure the amount of oxygen saturation in the tissues (indirectly) during surgery and in the intensive care unit. However, there is not much data on the use and effectiveness of this monitor in comparison to other monitors used for children. The purpose of this study is to further evaluate the effectiveness of the continuous central venous oxygen saturation (ScvO2) monitor in children and compare it with other monitors during a heart surgery. This is an observational study and the patients will not undergo any research specific procedures in the operating room (OR). The investigators will observe and record de-identified information, such as vital signs (heart rate, blood pressure, etc.), to evaluate the importance of the monitor. This study will also look at the demographics (age, gender, diagnosis, etc.) and treatments (type of surgery) received children undergoing heart surgery to improve quality of care. The investigators will also observe the same parameters in the ICU. The investigators hypothesized that low central venous saturations are associated with worse clinical outcomes.

Official Title
-----------------
Central Venous Saturation (ScvO2) Monitoring in Pediatric Patients Undergoing Cardiac Surgery

Conditions
-----------------
Congenital Heart Defects, Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients (age 0-12 years) scheduled for cardiac surgery and requiring placement of a central venous catheter. Exclusion Criteria: Patients with contraindications for placement of a central venous catheter will be excluded from this study.

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- | --- |