linjc16/ctgov huggingface dataset:
PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.

Study Overview
=================
Brief Summary
-----------------
To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment

Official Title
-----------------
A 6-Week Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study to Compare the Efficacy and Safety of Rosuvastatin (10 mg) With Atorvastatin (20 mg) in Subjects With Hypercholesterolaemia and Either a History of CHD or Clinical Evidence of CHD

Conditions
-----------------
Hypercholesterolaemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 or over. A history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or a CHD risk equivalent (10-year risk score > 20% for CHD as described in NCEP ATP III guidelines1. Exclusion Criteria: History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin Pregnancy History of homozygous familial hypercholesterolaemia.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|nan|
|Drug: Atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in LDL-c after 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other lipids and lipoproteins |  |  | 
| Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C |  |  | 
| Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment. |  |  | 
| Comparison of cost effectiveness and also safety |  |  |
Beetroot Enriched Bread, Blood Pressure and Vascular Function

Study Overview
=================
Brief Summary
-----------------
Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. We evaluated the effects of beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and blood pressure response in healthy men.

Official Title
-----------------
The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men

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

Intervention / Treatment
-----------------
* Dietary Supplement: Bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male A signed consent form Age 18-64 years Body mass index - 18.5-30 kg/m2 Non-smoking, healthy individuals Normal blood pressure at screening (< 150/90) Exclusion Criteria: Subjects with anaemia Sufferers of chronic illnesses Individuals with food allergies People with diabetes People with coeliac disease Women Vegetarians

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control white bread<br> | Dietary Supplement: Bread<br> <br> |
| Experimental: Beetroot bread<br> | Dietary Supplement: Bread<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular reactivity | Forearm blood flow by Laser Doppler Imaging with iontophoresis | Change from baseline at 2, 4 and 6 hours after bread consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness | Pulse wave analysis (PWA) and velocity (PWV) | Change from baseline at 2, 4 and 6 hours after bread consumption | 
| Blood pressure | By ambulatory blood pressure monitor | Change from baseline at 30 minute intervals for 7 hours | 
| Plasma nitrate |  | Every 30 minutes for 7 hours | 
| Plasma nitrite |  | Every 30 minutes for 7 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Beetroot, Blood pressure, Vascular function
Study of Artery Conditions of 'At-risk' Asian People Not on Lipid-lowering Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain the distribution of measurements of the intima media thickness of carotid arteries in people with high cardiovascular risk.

Official Title
-----------------
Prevalence of Atherosclerotic Disease in Asian Subjects Not on Lipid-lowering Agents, But With at Least Two CVD Risk Factors

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Procedure: Measurement of the Carotid Intima Media thickness
* Biological: Blood sample testing for hs-CRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed informed consent. Patients with at least two CVD risk factors but not on lipid-lowering agents Exclusion Criteria: Subjects with CHD, any conditions that may affect hs-CRP levels. Subjects on any lipid-lowering drug treatment within the last 3 months prior study entry.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Measurement of the Carotid Intima Media thickness<br>* one time, radiological procedure on both sides of the neck<br>Biological: Blood sample testing for hs-CRP<br>* one time, blood sample taking<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs |  | IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile of people with high risk of cardiovascular disease but not on lipid lowering drugs |  | Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular disease, Carotid Intima Media Thickness
Investigation Into the Differentiation of Tumour and Healthy Brain Tissue Using Multi-exponential T2 Components

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if a specialized imaging technique using MRI called multi-exponential T2 component analysis can reliably differentiate between normal brain and brain tumour.

Detailed Description
-----------------
Existing methods of contouring tumours for radiation therapy involve manual interpretations of qualitative diagnostic images. These methods, being qualitative, do not offer a consistent and reproducible platform for contouring, making it difficult to evaluate the effects of contouring choices on treatment outcome. T2 component analysis in MRI has the potential to offer a quantitive basis for identifying tumor tissue- this potential is investigated in this pilot study.

Official Title
-----------------
Investigation Into the Differentiation of Tumour and Healthy Brain Tissue Using a Specialized MRI Technique Called Multiexponential T2 Component Analysis

Conditions
-----------------
Glioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighteen years of age or older Clinical subjects must have not yet begun radiation therapy Must have signed our study-specific consent form Exclusion Criteria: -

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A. glioma<br>A. glioma population | |
| B. Normal brain<br>B. Normal brain | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T2 characteristics of glioma tissue versus normal |  | Before radiotherapy treatment begins | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging, Glioma
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.

Official Title
-----------------
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study

Conditions
-----------------
Amenorrhea, Menstrual Cycle, Breast Cancer

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-institutional (community dwelling) woman of any race Between 18-45 years at the first screening visit Have regular menstrual cycles Diagnosed with invasive breast cancer stage I, II, III within the previous eight months Have physician agreement for patient participation Exclusion Criteria: No menstrual bleeding cycles Psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance Previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer) Stage IV breast malignancy Residency outside United States No telephone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| 1<br> | Other: Questionnaire<br>* Data collection instruments will be obtained at baseline and every six months. Follow-up will range between 26-42 months for participants.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall goal of the proposed research is to recruit and follow young breast cancer patients aged 45 and younger, in order to examine menstrual cycle maintenance. |  | Conclusion of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables |  | Conclusion of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amenorrhea, menstrual cycle, Breast cancer, questionnaire, 97-127
Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood

Study Overview
=================
Brief Summary
-----------------
The study is a combination of outpatient and inpatient monitoring. During the 27-day inpatient portion of the study, the individual's sleep-wake schedule will be varied daily. Volunteers will be randomized to a regular or irregular inpatient schedule.

Official Title
-----------------
Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood

Conditions
-----------------
Physiology

Intervention / Treatment
-----------------
* Other: Sleep/Wake Schedule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy BMI between 18.5 and 29.5 Exclusion Criteria: medications recent night-work, shift-work, or travel across >2 time zones use of medications pregnant or within 6 months post-partum

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regular Schedule<br>Participant will be on a regular sleep/wake schedule | Other: Sleep/Wake Schedule<br>* Timing of sleep and wake<br>|
| Experimental: Irregular Schedule<br>Participant will be on an irregular sleep/wake schedule | Other: Sleep/Wake Schedule<br>* Timing of sleep and wake<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian phase | Circadian phase, as measured by melatonin, at end vs. beginning of inpatient portion of experiment | 27 days | 
| Learning | Sleep-dependent learning at 3-4 times during inpatient portion of the experiment | 27 days | 
| Mood | Mood (using a linear non-numeric scale) across difference days inpatient portion of the experiment | 27 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Learning, Circadian Rhythms
Measuring Patient Engagement in Diabetes Care

Study Overview
=================
Brief Summary
-----------------
We will develop a new measure of patient engagement/activation specific to the context of diabetes self-care

Official Title
-----------------
Measuring Patient Engagement in Diabetes Care

Conditions
-----------------
Diabetes Mellitus, Type II

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is age 21 and older Patient is English speaking Patient has been diagnosed with Type II Diabetes by a health care provider Exclusion Criteria: Severe, uncorrectable vision Hearing impairments Cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Diabetes Self-efficacy | Self-efficacy will be assessed using an 8-item measure developed by Sarkar and colleagues asking respondents to rate their confidence in their ability to perform individual diabetes self-care activities, such as monitoring their blood glucose, getting medical attention, and taking care of their health. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Distress | The Diabetes Distress Scale (DDS) is a 17-item measure of diabetes-related emotional distress. It has four subscales corresponding to emotional burden, physician-related distress, regimen distress, and diabetes interpersonal distress. | Baseline | 
| Functional Health Status | Patient-Reported Outcomes Measurement Information System (PROMIS) is a national resource providing state-of-the-art tools for assessing patient symptoms and health outcomes. Short form measures of physical health (function) and emotional health (depression, anxiety) will be collected. | Baseline | 
| Clinical Outcomes | Hemoglobin A1c (HbA1c) and LDL cholesterol lab values, along with systolic and diastolic blood pressure values are collected as part of routine clinical care at every 3 months, and will be recorded from the medical record from the most recent visit. | 3 months before baseline to 3 months after baseline |
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.

Detailed Description
-----------------
This study is a cross-over study design.

Official Title
-----------------
A Single-Center, Pediatric, Comparative Taste Test of Desloratadine and Cetirizine Antihistamine Syrup Medications

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

Intervention / Treatment
-----------------
* Drug: Desloratadine (Clarinex)
* Drug: Cetirizine (Zyrtec)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be: Between 6 and 11 years of age in good general health Premenarcheal if female Exclusion Criteria: Subjects who: Have known allergies or sensitivities to either of the drug formulations Have a medical condition that may interfere with the subject's ability to discriminate between tastes Have used any antihistamines within 24 hours prior to dosing Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs Were involved in another clinical or market research study within the past 30 days

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desloratadine and Cetirizine Crossover<br>To compare the preference in taste between desloratadine and cetirizine. | Drug: Desloratadine (Clarinex)<br>* Each subject received 5 mL of desloratadine syrup one time<br>* Other names: SCH 034117, Clarinex;Drug: Cetirizine (Zyrtec)<br>* Each subject received 5 mL of cetirizine syrup<br>* Other names: Zyrtec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste acceptability as determined from smiley-face scale of 1 (frowning child) to 5 (happy child face). |  | During the only study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste flavor preference between bubble-gum, banana-grape, or grape flavors |  | During the only study visit | 
| Adverse Events |  | During the only study visit |
Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome

Study Overview
=================
Brief Summary
-----------------
Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015. Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.

Detailed Description
-----------------
Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015. Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome. This comparison includes preoperative parameters (hemoglobin, creatinine, mini-mental test) and intraoperative parameters (such as type of anesthesia).

Official Title
-----------------
Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome in the Saint-Luc Bouge Hospital

Conditions
-----------------
Femoral Neck Fractures

Intervention / Treatment
-----------------
* Drug: General Anesthesia
* Drug: Loco Regional Anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures between 10/01/2014 and 30/09/2014 Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General<br>All patients included who underwent surgery with general anesthesia | Drug: General Anesthesia<br>* General anesthesia with proposal, rocuronium and sufentanil<br>|
| Loco Regional<br>All patients included who underwent surgery with loco regional anesthesia | Drug: Loco Regional Anesthesia<br>* Loco Regional Anesthesia with marcaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative assessment | Comparison of the impact of preoperative parameters (such as hemoglobin, creatinine, mini-mental test) on patient outcome. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative assessment | Comparison of the impact of the type of anesthesia (general versus loco regional) on patient outcome. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral Neck Fractures, Perioperative Care, Perioperative Period, Postoperative Complications