linjc16/ctgov huggingface dataset:
A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

Conditions
-----------------
Hypertension, Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg
* Drug: Olmesartan 40 mg, Rosuvastatin 20mg
* Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 80 years patients with hypertension and hyperlipidemias Exclusion Criteria: orthostatic hypotension History of ventricular tachycardia, atrial fibrillation uncontrolled diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Amlodpine, Olmesartan, Rosuvastatin<br>co-administration of Olmesartan, Amlodipine and Rosuvastatin | Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg<br>* co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg<br>|
| Placebo Comparator: Olmesartan, Rosuvastatin<br>co-administration of Olmesartan and Rosuvastatin | Drug: Olmesartan 40 mg, Rosuvastatin 20mg<br>* co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).<br>|
| Placebo Comparator: Amlodipine, Olmesartan<br>co-administration of Amlodipine and and Olmesartan | Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)<br>* co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of sitSBP based on baseline between Treatment arm and control 1 arm |  | 8 weeks | 
| the change of LDL-C based on baseline between Treatment arm and control2 arm |  | 8 weeks |
The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.

Detailed Description
-----------------
Hemodialysis patients are at high risk of influenza infection due to suppress immune status.It is recommended to immunize them against influenza annually.in intradermal vaccination antigens directly present to the large numbers of antigen-presenting cells in the skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and three groups of immunocompromized patients including Rheumatologic patients treated with anti-TNF, HIV-infected and stem cell transplanted patients. In this study we compare the efficacy of influenza vaccines in half dose intradermal and standard intramuscular methods among hemodialysis patients.

Official Title
-----------------
The Comparison of Serum Antibody Response to Standard Intramuscular and Half Dose Intradermal Influenza Vaccine in Hemodialysis Patients in Shiraz City in 1388.

Conditions
-----------------
Hemodialysis Patients

Intervention / Treatment
-----------------
* Biological: intradermal influenza vaccine
* Biological: intramuscular influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under chronic hemodialysis Exclusion Criteria: history of flu infection in last month history of flu vaccination in 2009 hospitalization in last month taking immune suppressants drugs hemodialysis less than twice weekly

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intradermal influenza vaccine<br> | Biological: intradermal influenza vaccine<br>* 0.25ml ,intradermal<br>|
| Active Comparator: intramuscular influenza vaccine<br> | Biological: intramuscular influenza vaccine<br>* 0.5ml,intramuscular<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaccine effectiveness | serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intradermal influenza vaccine, hemodialysis patients
Normal Values of Brain Oxygenation

Study Overview
=================
Brief Summary
-----------------
New technology allows non-invasive monitoring of brain oxygenation (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various adult age groups. We hypothesised that baseline values in patients breathing room air are lower in old patients than in younger subjects and that younger patients respond increase their brain oxygenation more in response to supplemental oxygen.

Official Title
-----------------
Normal Values of Cerebral Oxygenation

Conditions
-----------------
Cerebral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 25 and 95 years undergoing a elective surgical procedure Exclusion Criteria: History of cerebral disease Dependence on supplemental oxygen

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 95 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
-----------------
Aging
Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate whether statin therapy can help prevent recurrence of hepatocellular carcinoma (HCC) in transplant recipients who had liver transplantation for HCC. Multiple logistic regression analysis will be performed to evaluate the association between statin therapy and the risk of HCC recurrence after LT.

Official Title
-----------------
Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received LT at the Severance Hospital from 2006 to 2016. Exclusion Criteria: early postoperative mortality (defined as death within 2 months after LT without signs of tumor recurrence) patient with distant lymph node metastasis confirmed within 1 month after LT Patients younger than 20 years of age patients who had LT for cirrhosis without confirmed HCC

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Statin group<br>Statin therapy was defined as the administration of statins for more than 30 days after liver transplantation | Drug: Statin<br>* Patients who used statins over 1 month for the treatment of dyslipidemia after LT were enrolled as statin group.<br>|
| Non-statin group<br>the administration of statins for less than 30 days after liver transplantation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A new lesion with radiographic features compatible with HCC was defined as recurrence of HCC. | Usually, liver CT is performed at 1 week, 1 month, 6 months, and every year until 5 years after surgery. Afterwards, liver CT is performed at 2-year intervals. Measurement of blood tumor markers [AFP and prothrombin induced by vitamin K absence-II] is performed every month for 6 months after discharge from the hospital and every 3 months thereafter. Additional liver CT, liver magnetic resonance imaging, or positron emission tomography-CT is performed when elevated tumor markers or suspicious lesions were noted. A new lesion with radiographic features compatible with HCC is defined as recurrence of HCC based on the reports of specialist in radiology. | up to December, 2017 |
Screening of Psycho-cognitive Troubles in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to assess the rate of patients with psycho-cognitive troubles among hospitalised elderly patients.

Detailed Description
-----------------
It also aims to assess this rate among patients 1) when the geriatrics mobile unit is involved in the screening of these troubles and 2) when it is not. All the patients (75 and older) hospitalised in the internal medicine department of a suburban Parisian hospital are included in the study and their psycho-cognitive functions assessed by a geriatrics physician, using 3 validated tests. The result of this screening provides the rate of psycho-cognitive troubles among patients that would not have been tested by a geriatrics physician in usual care. It assesses the interest of a systematic evaluation of elderly patients by the geriatric mobile unit.

Official Title
-----------------
Impact of a Geriatric Mobile Unit on the Screening of Psycho-cognitive Troubles in Internal Medicine Departments and Circumstances of Calling in This Unit.

Conditions
-----------------
Psycho-cognitive Troubles

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 75 years old or more hospitalised in internal medicine Exclusion Criteria: patient confused (interference with the assessment of psycho-cognitive functions) diagnosis of dementia at admission refusal of the patient or close relative for participating in the study poor understanding of French language hospitalisation for less than 3 nights

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- | --- |
| rate of patients with psycho-cognitive troubles among hospitalised elderly patients |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of patients with psycho-cognitive troubles 1) when the geriatrics mobile unit is involved in the screening of these troubles and 2) when it is not; and comparison of these rates |  | 1 day | 
| comparison of the rates of diagnosed dementia among 300 hospitalised patients, between 2006 and 2008 (before and after the creation of the geriatric mobile unit) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
geriatrics, psycho-cognitive troubles, elderly, mobile unit, elderly patients
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.

Official Title
-----------------
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Device: Intramesh T1 implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is older than 18 years Written informed consent is obtained from patient Patient with a primary or incisional ventral hernia Exclusion Criteria: Patient with a recurrent ventral hernia Patient with ASA class 5 and 6 Patient underwent emergency surgery Patient is pregnant Patient with a known allergy to components of the ePTFE prosthesis Patient has a life expectancy less than 1 year Patient is unable to be compliant with the follow-up visits due to geographical, social or psychological factors

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 a ventral hernia<br> | Device: Intramesh T1 implantation<br> <br> * Other names: Intramesh T1 Cousin Biotech;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate at 12 months determined by clinical examination |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative complications | Defined as complications occurring during index-procedure from skin-into-skin. The following events must be reported in the case report form: enterotomy (bowel injury) major bleeding requiring blood transfusion or reintervention complications due to anesthesia minor bleeding at a trocar insertion site | peri-procedural | 
| Post-operative complications | Defined as complications up to 30 days after index-procedure. The following events should be reported in the case report form: local numbness hematoma seroma superficial trocar site infection mesh infection hernia recurrence death | up to 30 days | 
| Seroma | The rate of seroma at 1 month after index-procedure. | 1 month | 
| Freedom from hernia-related reinterventions | Reinterventions at 12 months after index-procedure | 12 months | 
| Late complications | Late complications at 12 months after index-procedure: prolonged pain more than 8 weeks local numbness hernia recurrence | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hernia, Treatment, laparoscopic, open technique
Flavanol-Rich Cocoa and Cerebral Blood Flow

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to learn whether or not cocoa has a beneficial effect on blood flow to the brain in older subjects with diabetes mellitus or hypertension (high blood pressure). We hypothesize that cocoa, which contains flavanols (a type of polyphenol), may help to promote blood flow to the brain in older people with diabetes or hypertension.

Official Title
-----------------
Flavanol-Rich Cocoa, Vascular Responses and Mechanisms

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes and/or hypertension Exclusion Criteria: alzheimers disease, dementia, stroke, recent angina or heart attack

Ages Eligible for Study
-----------------
Minimum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flavanol-rich cocoa<br> | Dietary Supplement: cocoa<br>* two servings of cocoa daily for one month<br>* Other names: Cocoa Pro;|
| Placebo Comparator: flavanol-poor cocoa<br> | Dietary Supplement: cocoa<br>* two servings of cocoa daily for one month<br>* Other names: Cocoa Pro;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional transcranial doppler measures |  | 1 month |
HemoSonics-UVA Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.

Detailed Description
-----------------
HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients. A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology

Official Title
-----------------
HemoSonics-UVA Spinal Surgery Clinical Study Protocol

Conditions
-----------------
Deformity of Spine

Intervention / Treatment
-----------------
* Other: Procedure: Blood specimen collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Subject is scheduled for major deformity correction spine surgery Subject is older than 18 years Subject is willing to participate and he/she has signed a consent form Exclusion Criteria: • Subject is unable to provide written informed consent Subject is incarcerated at the time of the study Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl) Subjects with history of active liver disease Subjects affected by Factor V Leiden mutation Subjects affected by von Willebrand disease Subjects with an history of thrombotic disease (more than one DVT)

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: Procedure: Blood specimen collection|Blood specimen collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assay inter-instrument variability | Demonstrate assay inter-instrument variability below 15% | 1 day | 
| Establish normal ranges | Establish normal ranges | 1 day |
Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss

Study Overview
=================
Brief Summary
-----------------
To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.

Official Title
-----------------
Endoplasmic Reticulum Stress in Recurrent Pregnancy Loss

Conditions
-----------------
Recurrent Pregnancy Loss, Endoplasmic Reticulum Stress

Intervention / Treatment
-----------------
* Other: x box binding protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with three or more miscarriages before 20 th week of gestation had no chronic or acute inflammatory disease used no steroids, anti-inflammatory, or antioxidant medications Exclusion Criteria: had inflammatory diseases had systemic disease Anatomical abnormalities, infectious, endocrine, or genetic etiologies

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| recurrent pregnancy loss group<br>Women between the ages of 18 and 45 who had a history of miscarriage under 3 weeks and above 22 weeks were included in this group. | Other: x box binding protein<br>* Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.<br>|
| women who had healthy birth<br>Women between the ages of 18-45 who have not had a history of pregnancy loss and who have had at least one healthy birth and no known chronic diseases are included in this group. | Other: x box binding protein<br>* Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss | Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured. | 3 months |