linjc16/ctgov huggingface dataset:
Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes

Study Overview
=================
Brief Summary
-----------------
To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women

Detailed Description
-----------------
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)
* Drug: Menostar (Estradiol transdermal)
* Drug: Placebo transdermal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Menopause Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days) Exclusion Criteria: Hormonal treatment Contraindication to estrogen/progestogen therapy

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)<br>* 2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch<br>|
| Active Comparator: Arm 2<br> | Drug: Menostar (Estradiol transdermal)<br>* 1mg 17 Beta-estradiol transdermal patch<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo transdermal<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest effective dose in decreasing the frequency and severity of hot flushes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other symptoms related to menopause |  |  |
Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates

Study Overview
=================
Brief Summary
-----------------
This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for gram-negative blood stream infections based on known pharmacodynamic parameters.

Detailed Description
-----------------
Bacterial cultures will be ordered in the normal clinical course of the management of patients in the liver transplant ICU by the medical team. These cultures are then processed by the clinical Microbiology laboratory in the normal manner. If these cultures grow a Gram-negative bacteria, they are eligible for this study. Typically the clinical Microbiology laboratory saves these bacteria for a period of time after the final microbiology report. At this time, unless asked otherwise, the bacteria will be placed in biohazardous waste containers for proper disposal. If these cultures have grown a Gram-negative bacteria, they are eligible for this study, and will not be disposed of but will be given to the investigators without identifiers for this study. The antibiotic susceptibility of these organisms will be tested by the investigators in a separate research laboratory. Mechanisms of antibiotic resistance may also be assessed.

Official Title
-----------------
Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates

Conditions
-----------------
Gram-negative Bacterial Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with positive gram-negative bacteria Exclusion Criteria: Less than 18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| dead or alive | health status | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gram negative bacteria, culture, infection
Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping

Study Overview
=================
Brief Summary
-----------------
The aim of the proposed project is to perform a clinical study in which volunteers will receive autologous blood transfusions in DEHP-free blood bags.

Official Title
-----------------
Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion Using a Combination of Multiple Biomarkers in Different Matrices.

Conditions
-----------------
Transfusion Reaction

Intervention / Treatment
-----------------
* Biological: Autologous blood transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have to fill the swiss blood donation formulary Exclusion Criteria: Anemia Cardiovascular disease Neurologic disease Not performed a blood donation for 5 weeks ago the start of the study. Immunological disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood bags without DEHP<br>Intervention : Autologous blood transfusion | Biological: Autologous blood transfusion<br>* Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.<br>|
| Experimental: Blood bags with DEHP<br>Intervention : Autologous blood transfusion | Biological: Autologous blood transfusion<br>* Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of blood parameters profile, iron metabolism and genomic compounds | Blood profiling such as measurement of concentration of different blood cells and hemoglobin will be measured up to 15 days after blood-reinfusion. Concentration of free-iron, ferritin and hepcidin will be measured in plasma and serum up to 15 days after blood re-infusion. Concentration of circulating microRNAs will be measured in plasma also up to 15 days after blood re-infusion. All measures are compared. | 1 month |
Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients

Study Overview
=================
Brief Summary
-----------------
Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients

Official Title
-----------------
24h BP Under Micardis in Daily Practice

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

Intervention / Treatment
-----------------
* Drug: Micardis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who have recently been diagnosed with hypertension Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion. Exclusion criteria: None (according to investigator)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| arterial hypertension<br> | Drug: Micardis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (Change of Systolic Blood Pressure) | Change from baseline in 24h systolic blood pressure (BP) at week 8 | baseline to 8 weeks | 
| Efficacy (Change of Diastolic Blood Pressure) | Change from baseline in 24h diastolic blood pressure (BP) at week 8 | baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Tolerability Scale | Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10 | 8 weeks |
Comparison of Tolerability Between Two Allergy Drops

Study Overview
=================
Brief Summary
-----------------
Comfort is compared between two allergy drops

Official Title
-----------------
Comparison of Tolerability Between Two Allergy Drops

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: alacaftadine and naphazoline HCl & pheniramine maleate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and over inclusive. Males or females Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. History of allergic conjunctivitis Current symptoms of allergic conjunctivitis assessed by the investigator Exclusion Criteria: Corneal refractive surgery or contact lens wear within 6 months of this study. Current use of Restasis Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

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

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alacaftadine and naphazoline HCl & pheniramine maleate|once a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Tolerability measured by questionnaire Visual Analog scale 1 to 100 | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic conjunctivitis
Ondansetron Treatment for Alcoholism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be typed into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.

Official Title
-----------------
Pharmacological Treatment for Alcoholism

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: ondansetron (Zofran)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet criteria for alcohol dependence. Subjects with early onset alcoholism must also have a diagnosis of antisocial personality disorder. Understand the requirements of the study and be able to complete the questionnaires and rating scales. Exclusion Criteria: Current diagnosis of substance dependence or self-report of having used narcotics (opiates, cocaine, amphetamine-like substances, and hallucinogens) in the 30 day period prior to study. Positive urine drug screen test for narcotics, barbiturates, or benzodiazepines. Receiving current psychotropic medications. Current history of other psychiatric disorders excluding nicotine dependence. Hepatocellular disease. Pregnant females.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ondansetron (Zofran)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Analysis of Proinflammatory Factors in the Synovial Fluid In Patients With Rotator Cuff Disease

Study Overview
=================
Brief Summary
-----------------
Role of proinflammatory factors in Patients with Rotator Cuff Disease Objective: To measure the levels of various cytokines and metalloproteases in patients with rotator cuff disease, and control group and to determine the correlations among them.

Detailed Description
-----------------
We hypothesize that cytokines and MMP's level will be significantly higher in patients with RC pathology than in control group and will be related to the time frame since injury (i.e. - higher levels as close to the injury). In addition we will examine possible relation of those levels to the pain curve by using Visual Analogue Scale.

Conditions
-----------------
Rotator Cuff Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation. Patients between age 18-65 scheduled for a surgery in a Shoulder unit Patients suffering from Rotator Cuff Disease Patients suffering from any noninflammatory shoulder condition which requires surgical intervention Exclusion Criteria: Revision rotator cuff repair Recurrent shoulder surgery Psychiatric illness Inflammatory condition. Current use of anti-inflammatory drugs. Previous or current shoulder infection.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RC tear<br>This study will include a consecutive series of patients who met the study inclusion criteria. Study group patients will be diagnosed RC tear on clinical examination and imaging findings (US and MRI) that will be verified at arthroscopy in order to complete the enrollment. | |
| Control group<br>Control group will include patients suffering from shoulder instability that scheduled for elective surgical repair. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokines and MMP's levels in patients with RC pathology and in control group |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of pain curve by using Visual Analogue Scale |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotator cuff, synovial fluid, proinflammatory cytokines
Preoperative RRI and Long-term Risk for CKD

Study Overview
=================
Brief Summary
-----------------
Renal resistive index (RRI) is calculated from ultrasonographic Doppler measurements of flow velocities in intraparenchymal renal arteries. Normal values are around 0.60, and 0.70 is considered the upper normal threshold in adults. Both preoperative and postoperative elevation of RRI has shown promise in early detection of AKI after cardiac surgery. Further, elevated RRI before coronary angiography is associated with an increased risk of cardiovascular complications up to 1 year after the procedure. The role of preoperative RRI in predicting long-term renal and cardiovascular complications after elective surgery is however not known. The aim of this study is to assess the role of preoperative RRI to predict the risk of persistent renal dysfunction as well as renal- and cardiovascular complications up to 5 years after surgery.

Official Title
-----------------
Preoperative Renal Resistive Index to Predict Long-term Development of Chronic Kidney Disease in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Acute Kidney Injury, Acute Kidney Disease, Chronic Kidney Disease, Cardiac Surgery, Renal Resistive Index

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 Elective coronary artery bypass grafting, heart valve surgery, or aortic surgery performed at Karolinska University Hospital between September 2014 and April 2015 Preoperative measurement of RRI performed with satisfactory Doppler reading Written informed consent Exclusion Criteria: Kidney transplant Dialysis-dependent kidney disease Cancelled surgery Missing follow-up data

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Long-term renal dysfunction | Reduced estimated glomerular filtration rate (eGFR) ≥25% from baseline | 5 years after surgery or end of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term renal dysfunction | Reduced eGFR ≥25% from baseline | 30 days after surgery | 
| Intermediate renal dysfunction | Reduced eGFR ≥25% from baseline | 90 days after surgery | 
| Major adverse kidney events (MAKE) | Composite outcome during follow-up time including one of; death, renal replacement therapy, reduced eGFR ≥25% from baseline | 30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up | 
| Major adverse cardiac and cerebrovascular events (MACCE) | Composite outcome during follow-up time including one of; death, myocardial infarction, heart failure, stroke | 30 days, 90 days, 1 year, and 5 years after surgery or end of follow-up |
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System

Study Overview
=================
Brief Summary
-----------------
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

Detailed Description
-----------------
A prospective, international, single arm, multi-center post market clinical follow-up study.

Official Title
-----------------
Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: Transcatheter Aortic Valve Replacement (TAVR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe native valve calcific aortic stenosis Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator). Exclusion Criteria: Known hypersensitivity to Nitinol (nickel or titanium) Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis Inability to tolerate anticoagulation/antiplatelet therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Edwards CENTERA THV<br> | Device: Transcatheter Aortic Valve Replacement (TAVR)<br>* TAVR with the Edwards CENTERA THV System and accessories<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | All-cause mortality at 30 days | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CENTERA, THV, Transcatheter Heart Valve