linjc16/ctgov huggingface dataset:
The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement

Study Overview
=================
Brief Summary
-----------------
The investigators research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient with tricuspid regurgitation and right heart failure after left heart valves replacement.

Conditions
-----------------
Tricuspid Regurgitation, Right Heart Failure

Intervention / Treatment
-----------------
* Drug: tolvaptan+torasemide
* Drug: placebo+torasemide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with tricuspid regurgitation and right heart failure after left heart valves replacement Patients who takes existing diuretic The patient is willing to participate in the study Exclusion Criteria: Patients with hypersensitivity to study drug Anuric patients Patients with hypernatremia Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant Malignant tumor Patients with serious hepatic disorder or Serious Renal failure Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: trial group(tolvaptan group)<br>trial group (tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv,n=20) | Drug: tolvaptan+torasemide<br>* tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv<br>|
| Placebo Comparator: control group<br>control group(placebo 15mg/d po(10 days) +torasemide 20mg/d iv,n=20) | Drug: placebo+torasemide<br>* placebo 15mg/d po(10 days) +torasemide 20mg/d iv<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment |  | 2015.01-2017.12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A cumulative urine volume for 72 hours (all subjects) |  | 2015.01-2017.12 | 
| Echocardiography results VS the baseline results(all subjects) |  | 2015.01-2017.12 | 
| Change of right heart failure signs(all subjects) |  | 2015.01-2017.12 | 
| Onset of cardiovascular event (all subjects) |  | 2015.01-2017.12 | 
| Onset of serious adverse event(all subjects) |  | 2015.01-2017.12 | 
| other adverse events(all subjects) |  | 2015.01-2017.12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tolvaptan, safety and efficacy, left heart valves replacement
Periprocedural Myocardial Infarction: the Role of Human Neutrophil Peptide-1 to 3

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the occurrence of periprocedural myocardial infarction.

Conditions
-----------------
Coronary Thrombosis

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Troponin negative patients Stable angina Unstable angina Positive screening tests Exclusion Criteria: Troponin positive Technical failure of procedure Hemodynamic unstability

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 |
| --- |
|Other: Blood sample|Blood sample drawn from participants for analysis of neutrophil peptide level|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Neutrophil Peptide Level | Laboratory analysis and measurement of Human Neutrophil Peptide-1 to 3 levels | Two hours |
Impact of a Computerized Guidelines on the Management of Hypertension and Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine wether an electronic decision support system based on national guidelines is effective to improve the follow-up and the treatment of two conditions: hypertension and diabetes, in primary care practices.

Detailed Description
-----------------
Existing computer-based ordering systems for physicians provide drug-centred checks but offer little assistance for optimizing the overall patient-centred treatment strategy. The ASTI project aims : to design a guideline-based decision support system for diabetic and/or hypertensive patients, to help general practitioners : to carry out procedures (clinical and biological tests) according to guidelines (the recommended procedure at the recommended moment), and to get a synthetic view of all the elements they need to follow-up the patient to avoid prescription errors and to improve compliance with therapeutic guidelines. The  critic mode  operates as a background process and corrects the physician's prescription on the basis of automatically triggered elementary rules that account for isolated guideline recommendations. The  guided mode  directs the physician to the best treatment by browsing a comprehensive guideline knowledge base represented as a decision tree. To measure the impact of ASTI when it is implemented with an electronic medical record system. We adopt a randomized design, with the practice as the unit of randomization.

Official Title
-----------------
Impact of a Computerized Decision Support System, Based on EBM French Guidelines, on the Management of Hypertension and Diabetes: a Randomised Controlled Trial in Primary Care

Conditions
-----------------
Diabetes Mellitus, Hypertension

Intervention / Treatment
-----------------
* Device: Evaluation of the impact of a guideline based computerized decision support system.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension Mellitus diabetes Follow-up by GP's

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Evaluation of the impact of a guideline based computerized decision support system.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients who underwent the recommended procedures during the last 12 months |  | 16 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Guideline based decision support system, Hypertension, Diabetes
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.

Official Title
-----------------
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia

Conditions
-----------------
Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
-----------------
* Drug: PA21 (2.5 g tablet containing 500 mg iron)
* Drug: Sevelamer carbonate
* Drug: PA21-1 (1.25 g tablet containing 250 mg iron)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL) Stable dose of phosphate binder Written informed consent Exclusion Criteria: Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH) Other significant medical conditions Pregnancy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA21 (2.5 g tablet)<br> | Drug: PA21 (2.5 g tablet containing 500 mg iron)<br>* Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).<br>|
| Active Comparator: Sevelamer carbonate<br> | Drug: Sevelamer carbonate<br>* Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)<br>|
| Other: PA21-1 (1.25 g tablet)<br> | Drug: PA21-1 (1.25 g tablet containing 250 mg iron)<br>* Low dose comparator (1.25 g/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Phosphorus Levels From Week 24 to Week 27 | Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27 | Week 24, Week 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Phosphorus Levels From Baseline to Week 12 | Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group. | Week 12 post Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PA21, Phosphate Binder
Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits

Study Overview
=================
Brief Summary
-----------------
Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa

Detailed Description
-----------------
Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa.

Official Title
-----------------
Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits

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

Intervention / Treatment
-----------------
* Other: Cocoa Pure
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults BMI between 18.5 and 30 kg/m2 Sedentary to moderate physical activity habits Exclusion Criteria: Consumption of dietary supplements, antioxidants or anti-inflammatory medication, such as aspirin, ibuprofen, naproxen, or any medication that can affect the study outcomes Actively smoking Suspected abuse of alcohol or illicit drugs Significant illness within two weeks prior to study start or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study Subject who cannot be expected to comply with study procedures Currently participating or having participated in another clinical trial during last 4 weeks prior to the beginning of this study Consumption of chocolate or its derivates 24 hours before the blood sample taken

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute dose/Chronic dose<br>Acute dose/Chronic dose. | Other: Cocoa Pure<br>* Cocoa Pure.<br>Other: Placebo<br>* Placebo.<br>|
| Experimental: Chronic dose/Acute dose<br>Chronic dose/Acute dose. | Other: Cocoa Pure<br>* Cocoa Pure.<br>Other: Placebo<br>* Placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of changes in SOD2 gene expression |  | after acute dose and 4 weeks of chronic dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of DNA methylation pattern in the chronic phase of the study |  | After 4 weeks of chronic dose | 
| Evaluation of (-)epicatechin bioavailability in plasma |  | After 4 weeks of chronic dose | 
| Determination of plasma antioxidant capacity as a marker of oxidative stress |  | After 4 weeks of chronic dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
The Effect of Arterial Oxygen Parameters on Antioxidant Parameters

Study Overview
=================
Brief Summary
-----------------
We aimed to measure the changes in your blood values caused by different but safe oxygen values used by us during your heart surgery under laboratory conditions.

Detailed Description
-----------------
Hyperoxia is often preferred due to the risk of tissue hypoxia that may develop in cardiac surgery. It is thought that with hyperoxemia, ischemia reperfusion damage increases, microcirculation is impaired and tissue oxygenation is impaired.Oxidative damage occurs in cases of increased oxidative stress and impaired antioxidant balance.It was aimed to investigate oxidative damage by recording modified albumin and thiol disulfide in blood simultaneously by recording arterial oxygen levels at determined times during cardiac surgery.

Official Title
-----------------
The Effect of Arterial Oxygen Levels on Thiol Disulfide Homeostasis and Ischemia Modified Albumin in Coronary Artery Bypass Surgery

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: taken venous sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient scheduled for cardiac surgery ASA>3 Aged 18-75 years Exclusion Criteria: those with valvular disease EF<%40 BMI>40 kg/m2 presence of arrhythmia that impairs hemodynamics previous history of cerebrovascular diagnosed with end-stage organ failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| group 1<br>Group 1: Pressure of arterial oxygen> 200 mmHg during the coronary surgery | Diagnostic Test: taken venous sample<br>* Venous blood samples taken during the operation and at the 48th hour after the operation will be examined after appropriate procedures.<br>|
| group 2<br>Group 2: Pressure of arterial oxygen<200 mmHg and >80 mmHg during the coronary surgery | Diagnostic Test: taken venous sample<br>* Venous blood samples taken during the operation and at the 48th hour after the operation will be examined after appropriate procedures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of oxidative damage | To measure the degree of oxidative damage in the patient's blood at different oxygen values used in cardiac bypass surgeries with thiol disulfide homeostasis and ischemia-modified albumin at times determined. | 48 hours after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular surgery, antioxidant, tiyol-disülfid homeostasis, ischemia modified albumin
Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and Olmesartan in healthy male volunteers

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

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Olmesartan
* Drug: Rosuvastatin and olmesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease Exclusion Criteria: History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease; Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests; Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication; Use of any substance that could induce or inhibit drug metabolism enzymes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin and Olmesartan<br>A multiple-dose administration of rosuvastatin, a multiple-dose administration of olmesartan, and a multiple-dose administration of rosuvastatin and olmesartan, given orally with a washout period of 8 days between each administrations | Drug: Rosuvastatin<br>* Single administration of rosuvastatin 20mg tablet QD for 7 consecutive days<br>Drug: Olmesartan<br>* Single administration of olmesartan 40mg tablet QD for 7 consecutive days<br>Drug: Rosuvastatin and olmesartan<br>* Co-administration of rosuvastatin 20mg tablet and and olmesartan 40mg tablet QD for 7 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Pharmacokinetics | Css,max, AUCtau | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Pharmacokinetics | AUCss,last, AUCss,inf, Css,min, T_1/2 | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, drug-drug interaction
Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral engorgement in pre-menopausal women, as well as examining the safety and toleration of the drug.

Official Title
-----------------
A Double Blind, Placebo Controlled 2-way Cross-over Study to Assess the Clitoral Engorgement Response as Measured by Non-contrast Magnetic Resonance Imaging (MRI) in Women With Female Sexual Arousal Disorder (FSAD) When Administered a Single Dose of Sildenafil (100mg) Followed by Audio/Visual Sexual Stimulation

Conditions
-----------------
Female Sexual Arousal Disorder

Intervention / Treatment
-----------------
* Drug: Sildenafil 100 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-menopausal women aged 18-45 with a primary diagnosis of Female Sexual Arousal Disorder for at least 6 months prior to entering the study. The FSAD could have been associated with female orgasmic disorder (FOD) and/or superficial or introital dyspareunia. Exclusion Criteria: Subjects with hypoactive sexual desire disorder. Subjects not using an acceptable mean of contraception for the duration of the study. Subjects who were prescribed and/or taking medication which were contraindicated or cautioned with concomitant intake of sildenafil.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Study Period 1 or 2 | Drug: Placebo<br> <br> |
| Experimental: Experimental<br>Study Period 1 or 2 | Drug: Sildenafil 100 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the % of subjects who respond within 30 minutes of dosing by achieving an increase in clitoral engorgement >50% from baseline measured by MRI following audio/visual sexual stimulation in females with FSAD. |  | Up to 30 minutes post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the % of subjects who respond to sildenafil 100mg by achieving an increase in clitoral engorgement >50% from baseline within 40, 50 and 60 minutes of dosing respectively. |  | Up to 60 minutes post-dose | 
| To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings. |  | 30 days post-dose | 
| Assess plasma levels of sildenafil and metabolite |  | Day of dosing |