linjc16/ctgov huggingface dataset:
Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The AFORRD trial is asking three important questions: What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given with or without a statin? Are there simple techniques that can help people to take their tablets on a regular basis?

Official Title
-----------------
A Multicentre, Randomised, Double Blind Placebo Controlled Trial Evaluating Atorvastatin in Factorial With Omega-3 Fatty Acids Cardiovascular Risk Reduction in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes, Type 2

Intervention / Treatment
-----------------
* Drug: Atorvastatin and Omega-3 fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They have a diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to entry. Are not known to have had a cardiovascular event Exclusion Criteria: They are taking prescribed lipid lowering therapy Have triglycerides > or = 8.0 mmol/L

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atorvastatin and Omega-3 fatty acids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured |  |  | 
| LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid: |  |  | 
| Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prop of pats who achieve LDL levels <2.6 mmol/L (<100 mg/dl) at 52 weeks, taking into account whether the patient received additional atorvastatin therapy or placebo at week 16. |  |  | 
| Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks. |  |  |
Raloxifene Use for The Heart

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.

Official Title
-----------------
Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events

Conditions
-----------------
Cardiovascular Diseases, Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: raloxifene
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with established coronary heart disease or at risk for a major coronary event. Exclusion Criteria: Postmenopausal symptoms that required estrogen replacement therapy. Suspected or known history of breast or endometrial carcinoma. Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis. New York Heart Association classes III or IV heart failure.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: raloxifene|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up. |  |  | 
| Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After an expected 5 to 7.5 years of follow-up: |  |  | 
| Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined) |  |  | 
| All-cause hospitalization and mortality |  |  | 
| Non-coronary artery revascularization |  |  | 
| Non-traumatic lower extremity amputation |  |  | 
| Fractures |  |  | 
| Venous thromboembolism. |  |  |
PIIR Study: Comparison of Genetic Tests for Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to compare two different genetic tests developed to determine an individuals risk of developing serious vision threatening complications from age-related macular degeneration (ARMD).

Detailed Description
-----------------
There are currently two different genetic tests that have been developed for this purpose. They both look at specific DNA components to determine the risk. Participants in the study will be over the age of 60 years and caucasian as this is the population of people in which these tests have been validated. Each participant will have the study explained to them and then will be asked to sign the informed consent document if they agree to participate. They will have a dilated exam of their eyes along with photographs taken of the retina. If their doctor sees that it is necessary they will also have a special scan or a special angiogram of their eyes to look at their retina in more detail. For the genetic testing a member of the research team will use two swabs from each of the genetic companies to gently scrap some cells from the inside of the cheek. These cells will be sent to each respective lab for analysis.

Official Title
-----------------
PIIR Study: Comparison of Genetic Tests for Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration (ARMD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian race Age >/= 60 years Patient's written informed consent Ability to comply with the protocol procedures Exclusion Criteria: Race other than Caucasian Age < 60 years Macular or retinal pathology other than ARMD Known hypersensitivity to any drug included in the treatment protocol Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| ARMD Free<br>Patient free of ARMD on clinical examination | |
| ARMD Positive<br>Patients with evidence of ARMD on clinical examination | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk score from RetnaGene | Risk score assigned after genetic analysis of a buccal swab by the RetnaGene (Sequenom) genetic test. | Day 1 | 
| Risk score from Macula Risk | Risk score assigned after genetic analysis of a buccal swab by the Macula Risk genetic test. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular Degeneration, Genetic testing, Age-Related Macular degeneration, Age-Related Maculopathies
Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
Retrospective review of the outcomes of severe sepsis patients in Surgical Intensive Care Unit of National Taiwan University Hospital from January 1, 2009 to December 31, 2011.

Detailed Description
-----------------
Patients suffered from severe sepsis or septic shock have a mortality of 20 54%. It is major healthcare problems, affecting millions of individuals around the world each year. An international group of experts in the diagnosis and management of infection and sepsis, representing 11 organizations, published the first internationally accepted guidelines that the bedside clinician could use to improve outcomes in severe sepsis and septic shock in 2004, and further outcome was reported in 2008. Lots of medical centers have joined the Surviving Sepsis Campaign and follow the latest guideline. Many reports have shown that Surviving Sepsis Campaign Guideline can reduce patient mortality. In surgical intensive care units of National Taiwan University Hospital (NTUH), the Surviving Sepsis Campaign Guideline was conducted since 2009. Our purpose is to investigate the characteristics and outcomes of severe sepsis patient in surgical intensive care units of NTUH by retrospective review of medical chart.

Official Title
-----------------
Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units of National Taiwan University Hospital: Retrospective Review

Conditions
-----------------
Severe Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were diagnosed as severe sepsis in Surgical Intensive Care units of National Taiwan University Hospital Exclusion Criteria: < 20 years old

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 |
| --- | --- |
| severe sepsis, septic shock<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate of severe sepsis patients in Surgical Intensive Care Units |  | up to 1 year |
Post-marketing Clinical Follow-up of the Medical Device DIVA®

Study Overview
=================
Brief Summary
-----------------
Observational, ambispective, longitudinal, comparative, open, multicentric study. The main objective is to compare the performance of care in patients operated with and without DIVA®.

Detailed Description
-----------------
The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.

Official Title
-----------------
Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery

Conditions
-----------------
Lumbar Disc Herniation

Intervention / Treatment
-----------------
* Procedure: Surgery lumbar disc herniation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant; Patient operated for at least 12 months; Patient able to understand the information related to the study; Patient having indicated his/her non-opposition to the collection of his/her personal data. Exclusion Criteria: History of pathologies, malformations or surgical interventions on the spine; Patient belonging to the first 30 operated by the surgeon with the DIVA® implant; Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision); Patient not benefiting from a social security scheme.

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 |
| --- | --- |
| Patient with medical device DIVA®<br>Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with DIVA® implant | Procedure: Surgery lumbar disc herniation<br>* Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation<br>|
| Patient without medical device DIVA®<br>Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated without DIVA® implant | Procedure: Surgery lumbar disc herniation<br>* Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively. | The main analysis will compare the rates of patients requiring reoperation due to any cause (excluding trauma) on the lumbar spine 5 years after surgery between the group with DIVA® and the group without DIVA®, using a Chi-square test. | 5 years |
Doripenem in the Treatment of Hospital-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).

Detailed Description
-----------------
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, open-label (though with blinded outcome assessments), randomized study of doripenem versus a comparator antibiotic in patients with hospital-acquired pneumonia. The study consists of screening phase, open-label treatment phase, and follow-up. Both patients on ventilator and not on ventilator are enrolled. The primary endpoint is the clinical response rate at early follow-up visit. The patients may receive either doripenem or comparator; total duration of the treatment is 7 to 14 days.

Official Title
-----------------
A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Effectiveness of Doripenem Versus a Comparator Antibiotic in Hospital-Acquired Pneumonia

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: doripenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized for >= 48 hours or those with prior hospital admission of at least 48 hours who were discharged within the last 48 hours. Exclusion Criteria: Hospital-acquired pneumonia known at the time of enrollment to be caused by pathogen(s) resistant to certain antibiotics Any rapidly progressing disease or immediately life-threatening illness

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

| Intervention/Treatment |
| --- |
|Drug: doripenem|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate at the early follow-up visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical response rate at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) monitored throughout the study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hospital-Acquired Pneumonia, Mechanical Ventilation
Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
Troponins are sensitive and specific markers of cardiac injury. Critically ill patients frequently have elevated troponins. In this population, distinguishing patients with elevated troponins from those with myocardial infarction is difficult. However, troponin elevations on their own seem to be associated with an increased risk of death. The optimal treatment of patients with type 2 myocardial infarction or non ischemia related troponin elevations during critical illness is unclear. There are no trials in the ICU setting to guide management. This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care units. The objective of this pilot study is to evaluate the ability to perform a larger study, which will determine the prevalence, incidence and risk factors for elevated troponin values, how patients with elevated troponin values are treated as a baseline, and the incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact of these conditions and understanding current management will thereafter guide researchers and clinicians on the importance of carefully evaluating potential risk-modifying therapies.

Official Title
-----------------
Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study

Conditions
-----------------
Troponin, Critical Care, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients admitted to the participating ICUs of study sites during the study enrollment period will be eligible. Exclusion Criteria: Patients who are admitted and die or are discharged within 12 hours Patients re-admitted to ICU during the index ICU enrolment month

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 |
| --- | --- | --- |
| Recruitment rate | Feasibility outcome | 1 month | 
| Data collection time per patient | Feasibility outcome | 3 months | 
| rate of successful deferred informed consent definition | Feasibility outcome | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause in-hospital mortality |  | 3 months | 
| Troponin elevations |  | 3 months | 
| Myocardial infarction |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
troponin, biomarkers, myocardial infarction, critical illness
A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.

Official Title
-----------------
A Phase I, Single Center, Double-blind Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects

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

Intervention / Treatment
-----------------
* Drug: AZD9742
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 19-30 Exclusion Criteria: Positive Fecal Occult Blood Test Prescriptions that inhibit liver function Received flu/H1N1 vaccine within 2 weeks before first dose

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD9742<br>* IV infusion, 15 days<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* IV infusion, 15 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry) |  | collected prior to treatment, during treatment and follow-up for a total of 25-30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the Pharmacokinetics of AZD9742 in blood and urine |  | PK-sampling during 14 pre-defined study days for PK profiling | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety
Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study

Study Overview
=================
Brief Summary
-----------------
This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy. The goal is to optimize the use of VAD therapy for patients, to create an online quality measurement tool for VAD treatment, and to create algorithms to estimate the prognosis for patients getting a VAD.

Detailed Description
-----------------
Patients eligible for VAD are being sampled before surgery for plasma as well as peripheral blood cells. After surgery patients are being sampled again at 24 h and 7 days. Inflammatory response is being monitored on gene expression as well as cell level and on cytokine level in relation to the outcome.

Official Title
-----------------
Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years of age Subject is treated with a VAD at the Butterworth Campus, Spectrum Health. Exclusion Criteria: Subject is less than 18 years of age. Known prisoners of the state. Subject is pregnant. Non- English speaking patients will be excluded from the blood sub-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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One year mortality | Mortality will be assessed yearly. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine Analysis |  | Pre-implant, within 24 hours of implant, and 7 days post-implant | 
| Inflammatory cell subtype |  | Pre-implant, within 24 hours of implant, and 7 days post-implant | 
| Hospital readmissions |  | Will be assessed yearly until death or explant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventricular Assist Device