linjc16/ctgov huggingface dataset:
Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Vitamin D supplementation lower renin-angiotensin system activity in obesity. Specific Aim: To investigate whether Vitamin D supplementation in obesity improves the vascular sensitivity to angiotensin II.

Detailed Description
-----------------
Vitamin D deficiency and obesity are international epidemics that have both been associated with increased activity of the renin-angiotensin system (RAS). Because increased RAS activity is associated with cardiovascular disease, interventions to lower RAS will have favorable public health impacts. This study aims to evaluate whether the supplementation of Vitamin D in obese subjects will lower local tissue RAS activity. RAS activity will be evaluated by cross-sectional measurement of RAS components and by quantifying the vascular response to an infusion of angiotensin II. Subjects will be studied while Vitamin D deficient, and will return for repeat study following Vitamin D supplementation, for comparison.

Official Title
-----------------
Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity

Conditions
-----------------
Obesity, Vitamin D Deficiency, Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D (cholecalciferol)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 65, Cr < 1.6, 25-hydroxyvitamin D < 25 ng/mL, BMI > 30 kg/m2, stage I hypertension. Exclusion Criteria: diabetes, coronary heart disease, heart failure, renal failure, liver failure, hyperparathyroidism, granulomatous disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>15000IU of vitamin D3 daily: open-label, single-arm | Dietary Supplement: Vitamin D (cholecalciferol)<br>* cholecalciferol 15,000 IU daily for 30 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II |  | baseline and 1 month following vitamin D3 therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II |  | baseline and 1 month following vitamin D3 therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Renin Angiotensin System, Vitamin D deficiency, Hypertension
Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including parameters of dry eye syndrome and MGD. Dry eye syndrome parameters included TBUT, Schirmer's test type I, Oxford staining score, and the Ocular Surface Disease Index (OSDI) Questionnaire. MGD parameters consisted of lipid layer thickness (LLT), lid margin abnormality, meibum quality, meibum expressibility, MG orifice obstruction, MGD stage, and MG dropout.

Official Title
-----------------
Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery

Conditions
-----------------
Cataract Patients

Intervention / Treatment
-----------------
* Device: Lipiview 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cataract surgery planning with phacoemulsification and intraocular lens implantation with or without mild dry eye syndrome Exclusion Criteria: the previous use of eye drops, except artificial tears within 3 months before cataract surgery a history of previous ocular surgery or trauma the presence of ocular comorbidities such as glaucoma, uveitis, cystoid macular edema, and any surgical complications including rupture of the posterior capsule during cataract surgery.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cataract patients<br>cataract patients undergoing phacoemulsification | Device: Lipiview 2<br>* Tear film lipid layer thickness and meibomian gland dropout were measured by LipiView interferometer (TearScience Inc, Morrisville, NC)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of parameters associated with dry eye syndrome | Analysis the change of parameters associated with dry eye syndrome before and after cataract surgery measured by lipiview 2. | baseline and 1 month after POD(postoperative day) | 
| the change of parameters associated with meibomiangland dysfunction | Analysis the change of parameters associated with meibomiangland dysfunction before and after cataract surgery measured by lipiview 2. | baseline and 1 month after POD(postoperative day) |
Appropriate Care of URI (ACURI): Early Head Start

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to comparatively assess the effectiveness of a tailored educational intervention to improve health literacy levels regarding upper respiratory infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino households in Early Head Start.

Conditions
-----------------
Upper Respiratory Infection

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending an infant or toddler EHS group at participating site Exclusion Criteria: Participant in pilot study Participant in community intervention regarding URI
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education<br>Upper Respiratory Infection education in Fall | Behavioral: Education<br> <br> |
| No Intervention: Standard Curriculum<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pediatric emergency department visits |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of over-the-counter medication |  | 5 months | 
| Use of incorrect measuring tool |  | 5 months | 
| Use of unprescribed antibiotic |  | 5 months | 
| Knowledge regarding URI | Composite score | 5 months |
Middle East MED-EL Observatory Study

Study Overview
=================
Brief Summary
-----------------
In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness. Longitudinal comparisons of data collected in different clinics is challenging due to the heterogeneity in measures and procedure. This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as anonymized data sets, derived from original clinical records on appropriately informed subjects. Each subject will be treated as per clinical routine. The Registry will be implemented through a secure, cloud-based, platform that enables collection of anonymized data at consistent time intervals, thus enabling the comparison of repeated measures over time.

Official Title
-----------------
Middle East MED-EL Observatory Study

Conditions
-----------------
Cochlear Implants

Intervention / Treatment
-----------------
* Device: MED-EL CI systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are implanted or will be implanted with a MED-EL CI system. Signed written informed consent for data collection for registry purposes. Exclusion Criteria: Lack of compliance with any inclusion criteria. Subjects not receiving a MED-EL CI system due to medical or personal reasons after having consented. Anything that, in the opinion of the Investigator would place the subject at increased risk or preclude the subject's full compliance with or completion of the registry procedures.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MED-EL CI systems|• Cochlear Implant (CI) and external audio processor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing threshold level | Audiometry testing (unaided) | 5 years | 
| Quality of hearing - adults | Results from the Hearing Implant Sound Quality Index (HISQUI 19) | 5 years | 
| Auditory development - children (CAP) | Results from the Categories of Auditory Performance (CAP) | 5 years | 
| Auditory development - children (SIR) | Results from the Speech Intelligibility Rating (SIR) | 5 years | 
| Auditory development - children (LEAQ) | Results from the LittlEARS Auditory Questionnaire (LEAQ) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry, Observational Study
Effect of Long-term Psoriasis on Patients' Life - CORONATE

Study Overview
=================
Brief Summary
-----------------
Psoriasis, is an inflammatory chronic skin disease which has a heavy physical and psychosocial impact on participant's life. This is a study to finalize and validate a questionnaire to assess the long-term effect of long-term psoriasis in adult participants. Approximately 550 adult participants with moderate to severe plaque psoriasis will be enrolled in approximately 15 dermatology centers in Italy. Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. The duration of this study is up to 22 months. There is no additional burden for participants in this study. Participants will attend regular visits during the course of the study at a hospital or clinic.

Official Title
-----------------
EffeCt Of Long-Term PsoRiasis ON PAtienTs' lifE- CORONATE

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with a diagnosis of moderate-to-severe plaque psoriasis (PASI≥10 or PASI<10 with involvement of sensitive areas) since at least 10 years. Adult partner in relationship with the participant since at least 3 years(Part 2 only). Exclusion Criteria: - Participants with psychiatric conditions.

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Phase-1<br>The draft CORONATE questionnaire will be administered to participants to create the final version of the questionnaire. | |
| Phase-2<br>The questionnaire created in Phase 1 will be administered to a new group of participants for validation. All partners who are in a relationship with the participants since at least 3 years will be asked to participate in the study for the comparison between participants' and partners' perspectives on the impact of long-term psoriasis on participants' life. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CORONATE Questionnaire Score | The CORONATE Questionnaire is a self-administered 25 item questionnaire used to assess the long term effect of moderate to severe psoriasis. Scores range from 0 (false) to 3 (true). | Up to 22 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, CORONATE questionnaire
Vein External Support Trial

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease.

Official Title
-----------------
Vein External Support Trial

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Device: Fluent (VGS Fluent external support device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Patient scheduled for on-pump CABG on clinical grounds Vein grafts indicated for right and circumflex coronary arteries and LIMA indicated for the LAD on clinical grounds Native circumflex and right coronary arteries have at least one stenosis in each vessel> 75% Primary Exclusion Criteria: Concomitant non-CABG cardiac procedure Prior peripheral vascular or cardiac surgery Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Device applied to saphenous vein graft | Device: Fluent (VGS Fluent external support device)<br>* Fluent external support device applied to saphenous vein graft<br>|
| No Intervention: Control<br>Saphenous vein graft without device support | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Thrombophilic Risk Factors in Pediatric Patients Diagnosed at the Ha'Emek Medical Center

Study Overview
=================
Brief Summary
-----------------
The study will assess the clinical and laboratory data of about 100 pediatric patients diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007 because of thrombotic events. The results, the treatment given, and the outcome of the patients will be summarized.

Official Title
-----------------
The Study Will Summarize the Clinical and Laboratory Data of All the Pediatric Patients Diagnosed With Thrombotic Events at the Pediatric Hematology Unit

Conditions
-----------------
Thrombosis

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:All the patients diagnosed since 1980. Exclusion Criteria:Patients with insufficient data records.

Ages Eligible for Study
-----------------
Maximum Age: 20 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 |
| --- | --- |
| A<br>Patients with thromboembolic events | Other: Observational<br>* Data summary only<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
-----------------
Factor V Leiden, Prothrombin Mutation, Hypercoagulability, Pediatrics
Efficacy and Safety of InSan Bamboo Salt on Improvement of Helicobacter Pylori Infection

Study Overview
=================
Brief Summary
-----------------
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of InSan Bamboo Salt on improvement of Helicobacter pylori infection. The investigators measured improvement of Helicobacter pylori infection parameters , including 14C-UBT(Urea breath test), and subjects' symptoms, and monitored their blood pressure.

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Dietary Supplement: InSan Bamboo Salt
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 19-65 years old 14C-UBT test ≥ 100 cpm Endoscopy results showing gastritis Able to give informed consent Exclusion Criteria: Diagnosed of gastrointestinal disease such as ulcer, cancer, more than 10 erosions Taken antibiotics and stomach medicines such as steroid, bismuth compound, H2-receptor antagonist and proton pump inhibitor within 2 weeks Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InSan Bamboo Salt<br> | Dietary Supplement: InSan Bamboo Salt<br>* InSan Bamboo Salt (10g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (10g/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 14C-UBT(Urea breath test) | 14C-UBT(Urea breath test) was measured in study visit 1(0 week) and visit 3(4 week). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in subjects' symptoms | subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week). | 4 weeks |
The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010 were reevaluated. We used a structured headache questionnaire through a phone interview with the patients and their caregivers. Data regarding demographics, the patients' and families' medical history, and headache history, past and current (age at onset, location, quality, frequency, duration of episodes, aura, associated symptoms and treatment) were collected.

Official Title
-----------------
The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents

Conditions
-----------------
Children, Only, Headache, Migraine, Headache, Tension

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of migraine or TTH headache according to the ICHD-3 criteria. Can describe the current headache status. Exclusion Criteria: * Secondary headaches.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children with migraine<br>Children that were diagnosed at the neurology clinic with migraine at the years 2007-2010. A follow up visit at 2020 of their current headache condition. | Other: No intervention<br>* No intervention<br>|
| children with TTH<br>children that were diagnosed at the neurology clinic with TTH at the years 2007-2010. A follow up visit at 2020 of their current headache condition. | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache diagnosis according to the ICHD-3 criteria | The diagnosis of headache episodes at follow-up according to the ICHD-3 criteria; either Migraine or TTH. | 10 years from initial diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcome, Headache, Migraine, Tension Type Headache, Adolescents