linjc16/ctgov huggingface dataset:
A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, prospective, observational cohort study of  5000 Xolair-treated and  2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.

Official Title
-----------------
An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS)

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative) ≥12 years of age Physician diagnosis of moderate to severe persistent asthma Evidence or history of positive skin test or in vitro reactivity to an aeroallergen Willingness to participate fully for the duration of the study (5 years) For patients in the Xolair-treated cohort, have received at least one dose of Xolair therapy at the time of enrollment Exclusion Criteria: Contraindication to Xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to Xolair) Acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization Acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months Use of an experimental drug within 30 days prior to study screening Diagnosis of cystic fibrosis For patients in the non-Xolair-treated cohort, any prior treatment with Xolair

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate to severe asthma
Performance Measurement in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the relationship between the perioperative blood pressure and postoperative mortality after cardiac surgery using performance measurement (PM) of mean arterial pressure (MAP).

Detailed Description
-----------------
The authors conducted a retrospective cohort study of adult patients who underwent cardiac surgery requiring cardiopulmonary bypass (CPB). Median performance error (MDPE), median absolute performance error (MDAPE), and wobble of MAP were calculated using preoperative MAP as the reference value, and MBPs before, during and after the bypass as measured values. Univariable and multivariable logistic regression analyses were performed using PM parameters to predict in-hospital mortality. Survival after cardiac surgery was compared using the Cox proportional hazard model. Predictability of PM was assessed using the area under the receiver-operating characteristic curve (AUROC).

Official Title
-----------------
Relationship Between Performance Measurement of Intraoperative Mean Arterial Pressure and Mortality in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Procedure: Cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital. Exclusion Criteria: Patients without information on preoperative blood pressure or mortality.

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 |
| --- | --- |
| cardiac surgery<br>Patients who underwent cardiac surgery with cardiopulmonary bypass | Procedure: Cardiac surgery<br>* The relationship between performance measurement of blood pressure during cardiac surgery (before, during and after cardiopulmonary bypass) and postoperative mortality<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | mortality after cardiac surgery | through study completion, average 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure, performance measurement, cardiac surgery, mortality
A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
An Open labeled, Paralled, Randomized, Prospective, study was conducted on 60 patients who were randomized into 3 groups, 22, 20 and 18 patients in Control, Selenium and, Thiotacid groups respectively. Serum levels of ROS, CoQ10, and miRNA-126 were assessed at base line and after three months for all patients.

Official Title
-----------------
A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients Randomized, Prospective, Controlled Study

Conditions
-----------------
Antioxidative Stress, End Stage Renal Disease on Dialysis

Intervention / Treatment
-----------------
* Drug: Alpha lipoic acid
* Drug: Selenium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prevalent hemodialysis patients Exclusion Criteria: Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| No Intervention: Control<br>25 hemodialysis patients who received their routine therapy only. | |
| Active Comparator: Selenium<br>23 hemodialysis patients who received Selenium 200µg once daily with their routine therapy just after the dialysis sessions for 3 months. | Drug: Selenium<br>* 23 patients who received Selenium 200µg once daily with their routine therapy just a<br>|
| Active Comparator: Alpha Lipoic acid<br>20 hemodialysispatients who received Alpha Lipoic acid (ALA) (Thiotex fort®) 600mg once daily with their routine therapy just after the dialysis sessions for 3 months. | Drug: Alpha lipoic acid<br>* 20 patients who received Alpha Lipoic acid (ALA) (Thiotex fort®) 600mg once daily with their routine therapy just after the dialysis sessions for 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in miRNA-126 level | Fold expression | 3 months | 
| Change ROS level (ng/ml) | Using ELISA kit | 3 months | 
| Change in Co Q10 level (ng/ml) | Using ELISA kit | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxidative stress, Antioxidants, mitochondrial function, CoQ10, miRNA-126, Hemodialysis
Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.

Official Title
-----------------
Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a neoplastic solid tumour with an indication for insertion of a PCVC. Exclusion Criteria: Haematological neoplasm pathology, PCVC removal scheduled within 2 weeks of insertion, Therapeutic doses of anticoagulants required at inclusion, PCVC inserted by the femoral vein

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 |
| --- | --- |
| PCVCs<br>Cohort of cancer patients with indication PCVC under the usual practice | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic complications: |  | one year | 
| Locoregional or disseminated infectious complications: |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical and economic consequences of these complications |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoplastic solid tumour, PCVC, thromboembolic complications, infectious complications, risk factors
VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Validation Study

Study Overview
=================
Brief Summary
-----------------
Our group has developed a device called Velocidad Onda de Pulso Indice Tobillo Brazo (VOPITB) . In this device the oscillometric method is used for easily and accurately measure the pulse wave velocity PWV in the arms and legs separately, allowing new arterial stiffness indices to be studied (sum, difference, ratio, baPWV and CAVI). The aim of our study will be to validate the PWV measures by VOPITB with other references devices that measures arterial stiffness. Moreover we will perform a clinical study to assess the clinical utility of VOPITB.

Official Title
-----------------
VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Protocol for Validation Study

Conditions
-----------------
Cardiovascular Risk Factor, Cardiovascular Diseases, Atherosclerosis of Artery

Intervention / Treatment
-----------------
* Device: arterial stiffness measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects ≥ 18 years who agree to participate in the study and do not meet any of the exclusion criteria. Exclusion Criteria: History of CVD (ischaemic heart disease, stroke or peripheral arterial disease) Atrial fibrillation or other cardiac rhythm disorders Pacemaker-dependent Impalpable arterial pulse at site of measurement Pregnancy Terminal condition Age under 18 years

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 |
| --- | --- |
| < 30 years<br> | Device: arterial stiffness measurements<br>* We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB<br>|
| 30-60 years<br> | Device: arterial stiffness measurements<br>* We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB<br>|
| > 60 years<br> | Device: arterial stiffness measurements<br>* We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardio-ankle vascular index (CAVI) validation | We will determine CAVI with VOPITB, as well as its validation against the reference device (VaSera VS-1500) and assess its clinical utility. | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arterial stiffnes, pulse wave velocity, VOPITB, validation
Correlates of Physical Activity With Quality of Life in College Women of Manipal University

Study Overview
=================
Brief Summary
-----------------
To find out the relationship between physical activity and self-esteem, sleep quality, anxiety & depression, body fat percentage, quality of life, in college females

Detailed Description
-----------------
After receiving approval from the Institutional Research Committee and Institutional Ethical Committee clearance. Advertisement of the research project will be done via the Head of Department of each faculty of the university Subjects will be recruited on a voluntary basis and a written informed consent will be obtained after the research idea is explained. Demographics of each participant will be obtained Each of the following questionnaires will be administered: Depression, Anxiety and Stress Scale (DASS-21) Rosenberg Self-Esteem Scale Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Pittsburgh Sleep Quality Index (PSQI) International Physical Activity Questionnaire-Long Form (IPAQ)

Official Title
-----------------
Correlates of Physical Activity With Anthropometric Traits, Mental Health and Quality of Life in College Women of Manipal University

Conditions
-----------------
Physical Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female gender age group 18-25 Indian ethnicity Exclusion Criteria: Known cardio-respiratory symptoms and musculoskeletal disorders curtailing form physical activity in the last 3 months, known thyroid dysfunction, known anxiety-depression disorders, recent surgery (last 3months), polycystic ovary disease (PCOD), polycystic ovary syndrome (PCOS) & pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical Activity Questionnaire-Long Form (IPAQ) | score of the questionnaire in MET/hr | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PA,menatal health,QOL
Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients

Study Overview
=================
Brief Summary
-----------------
In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.

Official Title
-----------------
Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: cabergoline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active disease, under octreotide treatment at least 9 months Exclusion Criteria: Cabergoline allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Responders to cabergoline<br>patients with active disease under octreotide treatment received addition of increasing doses of cabergoline (1.0, 2.0 and 3.5mg/week) | Drug: cabergoline<br>* cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal<br>* Other names: cabergoline-Dostinex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of IGF-I levels |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| control IGI-I levels |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromegaly resistant, combined-treatment, dopamine agonist
An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients

Official Title
-----------------
An Open-Label, 2-Way Crossover Study of Steady-State Intragastric pH Control Comparing 2 Dosage Regimens of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: Lansoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented history (within 2 yrs of histologically proven BE; Aged 18-70 (inclusive); Willing and able to comply with all study procedures Exclusion Criteria: Signs of clinically significant GI bleeding within 3 days prior to randomization; History of gastric or esophageal surgery; Clinically significant illness within 2 weeks prior to first dose of study drug or during study

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|nan|
|Drug: Lansoprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare pharmacodynamic efficacy of esomeprazole 40 mg & lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients by evaluation of the percentage of time that intragastric pH is >4.0 over a 24 hr period steady state |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare pharmacodynamic efficacy of esomeprazole 40 mg & lansoprazole 30 mg bid in controlling intragastric pH in BE patients by evaluation of the % of time intragastric pH is >4.0 over 24 hr period at steady state |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's Esophagus
Association Between Renal and Right Cardiac Functions After Urinary Sodium Depletion Following Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Following cardiac surgery, right ventricular function may be altered leading to increase central venous pressure and decrease in renal blood flow. The investigator's standard care includes use of diuretic to avoid interstitial fluid accumulation. The aim of the study is to assess cardiac and renal function before and after depletion by using diuretics

Detailed Description
-----------------
The study will compare cardiac and renal data before and 6 hours after use of diuretic Echocardiographic measure of right function (S wave, TAPSE, ventricle surfaces, inferior vena cava diameter) and left function (LVEF, cardiac output Renal function: cumulative diuresis, creatinine level variation and incidence of acute kidney injury using KDIGO classification (creatinine level>26.5 or diuresis<0.05 ml kg-1 h-1)

Official Title
-----------------
Association Between Renal and Right Cardiac Functions After Urinary Sodium Depletion Following Cardiac Surgery: a Prospective Observational Study

Conditions
-----------------
Cardiorenal Syndrome

Intervention / Treatment
-----------------
* Procedure: diuretic use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient undergoing elective cardiac surgery under cardiopulmonary bypass Exclusion Criteria: heart transplantation use of vasopressor chronic renal disease (DGF under 30 ml min-1) endocarditis patient under ECLS or CPIA patient under 18-year-old

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: diuretic use|use of diuretic|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in renal glomerular filtration before and 6 hours after use of diurectic | change in renal glomerular filtration before and 6 hours after use of diurectic | at baseline (o hours) and 6 hours after use of diuretic | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, venous congestion, diuretic depletion