linjc16/ctgov huggingface dataset:
Absorption Kinetics of Polyphenols in Angel's Plant (Angelica Keiskei)

Study Overview
=================
Brief Summary
-----------------
The absorption kinetics of polyphenols in angel's plant (Angelica keiskei), which is a dark green leafy vegetable rich in antioxidant nutrients, will be determined in older adults in this pilot study.

Official Title
-----------------
Absorption Kinetics of Polyphenols in Angel's Plant (Angelica Keiskei)

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Dietary Supplement: angel's plant (Angelica keiskei)
* Dietary Supplement: Angel's plant (Angelica keiskei)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects (>60 yr, n=5) subjects with metabolic syndrome (>60 yr, n=5) Subjects who has high fasting plasma glucose (>5.6 mmol/L), central obesity (waist-hip ratio, >0.9 for men, >0.85 for women) either high blood pressure (>130/85 mmHg) or high triacylglycerol (>1.7 mmol/L) will be selected to have metabolic syndrome. normal hematological parameters, normal serum albumin, normal liver function, and normal kidney function no history of smoking or alcoholism. Exclusion Criteria: consume >7 alcoholic drinks/wk taking cholesterol medication or hormone replacement

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Healthy control, 5g dry power of angel's plant (Angelica keiskei) | Dietary Supplement: angel's plant (Angelica keiskei)<br>* Healthy control, one time dose of 5g dry power of Angelica keiskei<br>|
| Experimental: 2<br>Metabolic syndrome, 5g dry powder of angel's plant (Angelica keiskei) | Dietary Supplement: Angel's plant (Angelica keiskei)<br>* Metaboic syndrome subjects, one time dose of 5g dry powder of angel's plant (Angelica keiskei)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma quercetin |  | 0, 30, 60, 100, 180, 240, 300, 360, 420 & 480 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angelica keiskei, absorption kinetics, quercetin
Evaluating the Health Outcomes of the Joslin Why WAIT? Program

Study Overview
=================
Brief Summary
-----------------
Evaluating the health outcomes of patients that were enrolled in Joslin's Why WAIT Program. These outcomes include BMI, A1C, lipid profile.

Detailed Description
-----------------
This study is aimed to evaluate the health outcomes of patients enrolled in Joslin's Why WAIT Program. This program aims to control diabetes and help patients lose weight.

Official Title
-----------------
Evaluating the Health Outcomes of the Joslin Why WAIT? Program (Weight Achievement & Intensive Treatment Program)

Conditions
-----------------
Diabetes, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 diabetes with BMI over 35 Exclusion Criteria: Patients with type 1 diabetes

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 |
| --- | --- | --- |
| Weight loss of 7% body weight |  | 13 weeks |
Epidemiology of Ulcerative Colitis and Crohn's Disease in Non Jewish Israel Population

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to describe the incidence and prevalence of IBD in non Jewish Israel population

Detailed Description
-----------------
We are interest to collect the detail of gender, age, duration of the disease and therapy To obtain the information we wont to contact each physician by e-mail, phone , and fax .

Official Title
-----------------
Epidemiology of Ulcerative Colitis and Crohn's Disease in Non Jewish Israel Population

Conditions
-----------------
Ulcerative Colitis, Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ulcertive colitis and crohn's disease patients Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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 |
| --- | --- | --- |
| Prevalence and incidence of IBD |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevalence, Incidence, crohn's disease, ulcerative colitis, Epidemiology
Examining Perceptions of the 24-Hr Movement Guidelines

Study Overview
=================
Brief Summary
-----------------
The main objective of the proposed research is to experimentally test and inform the most effective brand attributes that is to be featured in the forthcoming Canadian 24-Hour Movement Guidelines for Adults. Specifically, there are two main objectives. The first objective is to determine the most preferred tagline associated with the new Guidelines among a sample of Canadian adults. The second objective is to experimentally test if this new attribute fosters stronger perceptions of self-efficacy among an adult sample, when compared to previous threshold-based approaches.

Official Title
-----------------
Examining Perceptions and Brand Approaches for the Canadian 24-Hour Movement Guidelines for Adults

Conditions
-----------------
Health Behavior, Self Efficacy

Intervention / Treatment
-----------------
* Other: Generic Message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 18-64 years Canadian Exclusion Criteria: cannot read/write in English already self-reported meeting Guideline recommendations for all three behaviours (physical activity, sedentary behaviour, and sleep) self-reported medical condition and/or sleep condition that would prevent individual from meeting the Guideline recommendations

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Generic Message)<br>Receives promotional materials that feature a generic messaging approach. | Other: Generic Message<br>* Exposed to four sets of promotional materials hypothesized to increase perceptions of self-efficacy to meet Guidelines.<br>|
| No Intervention: Control (Threshold Message)<br>Receives promotional materials that use traditional, threshold messages. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participants self-efficacy to meet Guidelines measured using the Multi-Dimensional Self-efficacy for Exercise Scale (adapted, scale 0-10; 0=not at all confident, 10=extremely confident) following pre and post exposure to promotional materials. |  | 3 time points: measuring change from baseline, immediately after viewing message, 2-week follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Movement Behaviors, Physical Activity, Sedentary Behaviour, Sleep, Knowledge Translation
Study to Evaluate the Effect of the Treatment With Micardis® or MicardisPlus® on Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The primary objective was to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose, insulin Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential hypertension and diabetes mellitus

Official Title
-----------------
Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Micardis®
* Drug: MicardisPlus®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Hypertension Diabetes mellitus Exclusion Criteria: Age < 18 years

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 |
| --- | --- |
| Patients with hypertension and diabetes mellitus<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in systolic blood pressure (SBP) |  | Baseline, after 6 months | 
| Change from Baseline in diastolic blood pressure (DBP) |  | Baseline, after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on a 6-point scale |  | after 6 months | 
| Assessment of metabolic effect on a 3-point scale |  | after 6 months | 
| Change from Baseline in laboratory parameters | Metabolic parameters - Triglyceride, total cholesterol, blood glucose, insulin, HOMA-Index, HbA1c | Baseline, after 6 months | 
| Assessment of tolerability by investigator on a 5-point scale |  | after 6 months | 
| Number of patients with adverse events |  | up to 6 months |
Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis

Official Title
-----------------
A Phase 3 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple Dose Safety and Efficacy Study of Epinastine Nasal Spray vs. Placebo in Subjects With Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: epinastine nasal spray, low concentration, low dose volume
* Other: placebo nasal spray
* Drug: epinastine nasal spray, low concentration, high dose volume
* Drug: epinastine nasal spray, high concentration, low dose volume
* Drug: epinastine nasal spray, high concentration, high dose volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen Exclusion Criteria: Significant medical condition Significant nasal abnormality Significant cardiac condition Recent infection Use of other allergy medication during the study Use of asthma medication other than as-needed albuterol

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Experimental: Epinastine low concentration:low dose volume<br> | Drug: epinastine nasal spray, low concentration, low dose volume<br>* 2 sprays in each nostril, dosed twice a day<br>|
| Experimental: Epinastine low concentration:high dose volume<br> | Drug: epinastine nasal spray, low concentration, high dose volume<br>* 2 sprays in each nostril, dosed twice a day<br>|
| Experimental: Epinastine high concentration:low dose volume<br> | Drug: epinastine nasal spray, high concentration, low dose volume<br>* 2 sprays in each nostril, dosed twice a day<br>|
| Experimental: Epinastine high concentration:high dose volume<br> | Drug: epinastine nasal spray, high concentration, high dose volume<br>* 2 sprays in each nostril, dosed twice a day<br>|
| Placebo Comparator: Placebo nasal spray<br> | Other: placebo nasal spray<br>* 2 sprays in each nostril, dosed twice a day<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasal symptom scores |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular symptom scores and quality of life scores |  | 14 days | 
| Standard safety assessments |  | 14 days |
Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

Detailed Description
-----------------
The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

Official Title
-----------------
Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia

Conditions
-----------------
Iron Deficiency Anemia (IDA)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must present for the first dose of a current cycle of IV treatment for IDA Must be over 18 years of age Must be willing and able to provide informed consent, including permission to obtain information from their medical records. Must be able to read and understand English. Exclusion Criteria: Subjects not diagnosed with IDA. Subjects requiring more than one treatment cycle within 30 days. Subjects receiving maintenance IV iron therapy. Subjects treated with IV iron within the 30-day period prior to study enrollment. Subjects who received investigational medication in the six months prior to the study.

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 |
| --- | --- |
| Ferric Carboxymaltose (FCM)<br>Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician. | |
| Iron Sucrose<br>Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician | |
| Iron Dextran<br>Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician | |
| Ferumoxytol<br>Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form). |  | 30 day observation period |
Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy

Study Overview
=================
Brief Summary
-----------------
Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.

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

Intervention / Treatment
-----------------
* Procedure: Scalp block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective craniotomy for supratentorial lesion Exclusion Criteria: Allergy to local anaesthetic Psychiatric disease Inability to consent Uncontrolled intracranial hypertension

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 |
| --- | --- |
| Experimental: Treatment<br>Full scalp block performed with a total of 30 ml of levobupivacaine 0.33 %. | Procedure: Scalp block<br>* Full scalp block<br>|
| Placebo Comparator: Control<br>Full scalp block performed with a total of 30 ml of normal saline. | Procedure: Scalp block<br>* Full scalp block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic stability | Increased in mean arterial pressure or heart rate of more than 15 % within 5 minutes of head pinning | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative intraoperative remifentanil consumption |  | 24 hours | 
| Cumulative postoperative morphine consumption |  | 48 hours | 
| Postoperative pain scores |  | 48 hours |
Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.

Official Title
-----------------
An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency

Conditions
-----------------
Turner Syndrome, Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written Informed Consent by patient and/or guardian/parents Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires Patients on growth hormone therapy for at least 6 weeks before entering the trial Exclusion Criteria: Pregnancy or breast feeding women Suspected or known allergy to trial product Other daily injection therapy (non-growth hormone, e.g insulin-therapy) Participating in any other trial involving other investigational products within the last 3 months
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: Somatropin<br> | Drug: somatropin<br>* Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptance of the new liquid growth hormone formulation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AE) |  |  | 
| Number of Serious Adverse Events (SAE) |  |  |
Gadolinium-Enhanced Extracranial MRA Prior to Mechanical Thrombectomy Is Not Associated With an Improved Procedure Speed

Study Overview
=================
Brief Summary
-----------------
The objective was to assess if performing a pre-intervention gadolinium-enhanced extracranial magnetic resonance angiogram (MRA) in addition to intracranial vascular imaging was associated with improved thrombectomy time metrics. Consecutive patients (912) treated by mechanical thrombectomy (MT) at a large comprehensive stroke center between January 2012 and December 2017 who were screened using pre-intervention MRI were included. Patient's characteristics and procedural data were collected. Analyses were performed to compare mechanical thrombectomy speed, efficacy, complications, and clinical outcomes between patients with and without pre-intervention gadolinium-enhanced extracranial MRA.

Official Title
-----------------
Gadolinium-Enhanced Extracranial MRA Prior to Mechanical Thrombectomy Is Not Associated With an Improved Procedure Speed

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: gadolinium-enhanced extracranial magnetic resonance angiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke Exclusion Criteria:

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

| Intervention/Treatment |
| --- |
|Procedure: gadolinium-enhanced extracranial magnetic resonance angiogram|288 of the 912 acute ischemic stroke patients received gadolinium-enhanced extracranial MRA additionally to the standardized stroke MRI imaging protocol.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from groin puncture to clot contact | in minute time from onset to recanalization complications [embolic or hemorrhagic] | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Score |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical thrombectomy, Magnetic resonance angiography, Angiogram, Angiography, Magnetic resonance imaging, Revascularization