linjc16/ctgov huggingface dataset:
Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate usefulness of the respirophasic variation in carotid artery peak flow velocity measured by Doppler ultrasound, which is noninvasive and easily accessible, as a predictor of fluid responsiveness in patients with coronary artery disease.

Conditions
-----------------
Coronary Artery Occlusive Disease

Intervention / Treatment
-----------------
* Other: Volume expansion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. patients scheduled for elective isolated off-pump coronary artery bypass graft surgery Exclusion Criteria: cardiac rhythm other than sinus congestive heart failure left ventricular ejection fraction <35% history of transient ischemic attack pre-existing cerebrovascular disease and peripheral arterial occlusive disease presence of carotid artery stenosis >50%

Ages Eligible for Study
-----------------
Minimum Age: 20 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: fluid responsiveness<br> | Other: Volume expansion<br> <br> * Other names: volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive power of the respirophasic carotid flow peak velocity variation for the fluid responsiveness | After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased ≥15% after volume expansion. The receiver operating characteristic curve analysis to descriminiate fluid responder is performed. | Measurement of respirophasic carotid flow peak velocity variation before the volume expansion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluid responsiveness, carotid artery peak velocity variation, coronary disease
Pharmacokinetics and Safety of DWJ1451 in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax

Official Title
-----------------
An Open-label, Randomized, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1451 and Co-administration of DWC202008 and DWC202009 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: DWJ1451


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 to 55 years Healthy Adult Exclusion Criteria: Non-Healthy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group1<br>subject take DWC202008 and DWC2020091 on a fasted condition, and after wash out period, take DWJ1451 with on a fasted condition | Drug: DWJ1451<br>* DWC202008 DWC202009<br>|
| Experimental: group2<br>subject take DWJ1451 on a fasted condition, and after wash out period, take DWC202008 and DWC202009 with on a fasted condition | Drug: DWJ1451<br>* DWC202008 DWC202009<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter of DWJ1451:AUC0-t | Area under the plasma xonxentration-time curve from time 0 to t | 0 - 72 hours after dosing | 
| Pharmacokinetic parameter of DWJ1451:Cmax | Maximum plasma drug concentration | 0 - 72 hours after dosing |
BioimPEDance of Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.

Official Title
-----------------
Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Other: Foot ulcer impedance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic patient (Type 1 or 2) with diabetic foot ulcer or lower limb ulcer written informed consent signed insured by the French national health insurance scheme Exclusion Criteria: wound in the similar position on the other limb people under legal protection unilateral limb oedema contra-indication to impedancemetry : pregnancy, patient with a pacemaker, neurostimulator or any other implanted electrical device, metallic prostheses patients participating to other protocols involving foot ulcers measurement, if it interfers with the current protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Foot ulcer impedance<br>Diabetic patients with a diabetic foot ulcer | Other: Foot ulcer impedance<br>* lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in impedance | Correlation between electrical impedance of the wound measured with ECG electrodes placed at the periphery of the wound and changes in the size of the wound and the clinically observed stage of healing. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impedance of different wound tissues | Characteristic impedance of different types of wound tissue | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic foot ulcer
Influence of Hormone Therapy on Heart Attack Incidence in Men Undergoing Prostate Brachytherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review cause of death in patients undergoing prostate brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing androgen deprivation therapy and whether or not this contributed to cardiovascular deaths, specifically myocardial infarction.

Official Title
-----------------
Influence of Androgen Suppression Therapy for Prostate Cancer on the Timing and Onset of Fatal Myocardial Infarctions in Men Undergoing Prostate Brachytherapy

Conditions
-----------------
Prostate Cancer, Cardiovascular Death

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deceased anytime after prostate brachytherapy treatment Exclusion Criteria: Patients whose cause of death was unable to be determined
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>All deceased patients who underwent brachytherapy at Chicago Prostate Center between 10/14/1997 and 6/15/2007 | Other: No intervention was required<br>* Death records were reviewed, therefore, there was no intervention<br>* Other names: Death records were reviewed, therefore, there was no intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure (the Coffee-it Study)

Study Overview
=================
Brief Summary
-----------------
To evaluate canrenone effects compared to other therapies on cardiovascular mortality in patients with congestive heart failure and preserved systolic function after 12 years of evaluation.

Detailed Description
-----------------
The investigators will verify patients with cardiac heart failure (CHF) and preserved systolic function and each patient must have all clinical evaluation through basal measurements of blood pressure, heart rate, biochemical tests, and color Doppler echocardiographic parameters for at least 12 years. The investigators will evaluate the effects of an aldosterone antagonist as canrenone compared to a group without canrenone and the investogators will verify how many patients reported cardiovascular mortality or will survive.

Official Title
-----------------
Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure: the Coffee-it Study

Conditions
-----------------
Cardiac Heart Failure Patients

Intervention / Treatment
-----------------
* Drug: Canrenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with CHF preserved systolic function (FE ≥ 45%) Exclusion Criteria: severe hypertension identified by blood pressure ≥180/110 mmHg patients with impaired systolic function (FE < 45%) history of active hepatitis or cirrhosis impaired renal function hyperpotassemia diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With canrenone<br>Patients with canrenone | Drug: Canrenone<br>* Evaluation of canrenone therapy in patients with CHF<br>|
| Without canrenone<br>Patients without canrenone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of CHF | Echocardiografic data | 12 years | 
| Haemodynamic data | Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR) | 12 years | 
| Metabolic data | fasting plasma glucose (FPG), total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (Tg), LDL-cholesterol (LDL-C), lipoprotein (a) [Lp(a)], | 12 years | 
| Renal function | Sodium, Potassium, Creatinine, Uric acid | 12 years | 
| Endocrine data | Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA) | 12 years | 
| Cardiovascular mortality | Register data | 12 years | 
| Survival | Register data | 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHF, Canrenone
Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Detailed Description
-----------------
The duration of treatment is 10 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Added to Existing Atorvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.

Conditions
-----------------
Hypercholesterolemia, Coronary Disease

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: ezetimibe, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with elevated cholesterol and coronary heart disease Exclusion Criteria: Patients who have cholesterol levels within normal ranges as identified by 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe|nan|
|Drug: Comparator: ezetimibe, placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elevated Cholesterol
Lollipop on Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of chewing lollipop on gastric volume and gastric emptying in healthy volunteers drinking water.

Official Title
-----------------
Effect of Chewing Lollipop on Gastric Emptying

Conditions
-----------------
Gastric Emptying

Intervention / Treatment
-----------------
* Other: lollipop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteer aged 18 years-45 years old volunteer with a body mass index between 18 and 28 kg/m2 Exclusion Criteria: those with history of diabetes mellitus those with gastric diseases those with history of gastro-intestinal surgery those with history of smoking those with use of gastric mobility medicines those with pregnancy or breeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lollipop<br> | Other: lollipop<br>* chewing lollipop for 10 minutes<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| half time of gastric emptying |  | from drinking water to gastric volume return to half of top volume before drinking water,on an average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of gastric emptying |  | from drinking water to gastric volume return to baseline before drinking water,on an average of 2 hours |
Quality of Life in Chronic Arthritis

Study Overview
=================
Brief Summary
-----------------
Chronic joint complaints are prevalent in clinical practice. If chronic arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis (AS) is not adequately controlled, it can not only affect patient's working ability but also produce indirect cost in patient's family. Quality of life will also be affected. Health-related quality of life issues are assuming increasing importance in chronic rheumatic diseases. However, studies on quality of life in rheumatic patients are limited. Factors related to quality of life are not clear. Application of quality of life measurement for improving clinical care of RA and AS patients is still difficult. The objective of this study was to evaluation the validity of EQ-5D life quality measurement in chronic arthritis patients in Taiwan. Factors associated with life quality will be addressed. This will also provide useful information for public health policy making.

Official Title
-----------------
A Study on Quality of Life in Patients With Chronic Arthritis

Conditions
-----------------
Ankylosing Spondylitis, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with rheumatoid arthritis or ankylosing spondylitis Exclusion Criteria: Patients with mental illness which interfered with questionaire answering

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| patients with rheumatoid arthritis<br> | |
| patients with ankylosing spondylitis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of life quality measurement EQ-5D in chronic arthritis patients | Effect of age, gender, diagnosis, disease duration and education on subjective feeling of quality of life (by EQ-5D) will be analyzed. Repeated measurements will be used for analysis of association between disease activity and quality of life. | EQ-5D at recruitment and 6 months later in chronic arthritis patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankylosing spondylitis, Disease activity, EQ-5D, Quality of life, Rheumatoid arthritis
Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims at developing an accurate, simple, and cost-effective method for screening and early detection of uterine cancers

Detailed Description
-----------------
The present study aims at developing an accurate, simple and cost-effective method for screening and early detection of uterine cancers in women using novel inventions and biotechnology methods for collection and assay of uterine cells. Results of P2X7 assays using tissues obtained from women with known uterine cancer and from women with histologically normal endometrium will be compared. These data will also serve as basis for future studies to test the predictive value of the method in population-based studies.

Official Title
-----------------
Feasibility Clinical Study: Accuracy of the P2X7 Biomarker in Detection of Endometrial Cancers in Women

Conditions
-----------------
Uterine Cancer, Endometrial Cancer

Intervention / Treatment
-----------------
* Other: P2x7 assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women scheduled to undergo hysterectomy ages 18 years and older Exclusion Criteria: pregnant women students or employees under the direct supervision on the investigators.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P2x7 Assay<br>Compare assay results with biopsy | Other: P2x7 assay<br>* compare P2X7 assay to biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the accuracy potential of the P2X7 (protein and mRNA levels) for the detection of uterine endometrial cancers in women. |  | Upon review of the assays. |