linjc16/ctgov huggingface dataset:
Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) Study (0954-133)

Study Overview
=================
Brief Summary
-----------------
The LIFE study was conducted from 1995-2001. This study was conducted in 9193 patients with high blood pressure and thickening of the main pumping chamber of the heart. The results showed that after an average treatment time of 4.8 years, treatment that was based on losartan was better than treatment based on atenolol for reducing the risk of having a stroke. The main study results were published in Dahlof et al. Lancet 2002;359:995-1003.

Official Title
-----------------
A Triple-Blind, Parallel Study to Investigate the Effect of Losartan Versus Atenolol on the Reduction of Morbidity and Mortality in Hypertensive Patients With Left Ventricular Hypertrophy

Conditions
-----------------
Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)

Intervention / Treatment
-----------------
* Drug: MK0954, /Duration of Treatment : 5 Years
* Drug: Comparator : atenolol /Duration of Treatment : 5 Years


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55 to 80 years Males and females Hypertension (160-200/95-115 mm Hg ECG evidence of left ventricular hypertrophy Exclusion Criteria: Need for treatment with angiotensin converting enzyme inhibitors, or open- label angiotensin receptor blockers or beta-blockers Myocardial infarction or stroke within 6 months

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0954, /Duration of Treatment : 5 Years|nan|
|Drug: Comparator : atenolol /Duration of Treatment : 5 Years|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cardiovascular death, fatal and nonfatal stroke, fatal and nonfatal myocardial infarction (heart attack) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular death, stroke, myocardial infarction, all-cause mortality, hospitalization for heart failure, new-onset diabetes mellitus |  |  |
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

Study Overview
=================
Brief Summary
-----------------
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

Detailed Description
-----------------
A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis: 5-year Results From the K0202 Extension Study

Official Title
-----------------
A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis : 5-year Results From the K0202 Extension Study

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Not applicable(observational study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication. Subjects who understand and voluntarily sign an informed consent form Exclusion Criteria: 1. Any other condition which the investigator judges would make patient unsuitable for study participation

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Rheumatoid arthritis<br> | Other: Not applicable(observational study)<br>* Not applicable(observational study)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | (Rate of Adverse Event, Number of Participants with Adverse Event) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate |  | 5 years | 
| 2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate |  | 5 years | 
| change in DAS(Disease activity scores)28-ESR from baseline | DAS range is from ≥ 3.2 (inactive) , >3.2 but ≤ 5.1(moderate), >5.1(very active) | 5 years | 
| change in KHAQ(Korean Health assessment questionnaire) from baseline | KHAQ range is from 0 (clear) to 60 (severe) | 5 years | 
| change in CDAI (clinical disease activity index) from baseline | CDAI range is from 0 (clear) to 76 (severe) | 5 years | 
| change in 100mm Pain VAS(Visual analogue scale) from baseline | 100mm Pain VAS range is from 0 (clear) to 100 (severe) | 5 years | 
| change in Modified Sharp/Van der Heijde Socre from baseline | Modified Sharp/Van der Heijde Socre range is from 0 (clear) to 448 (severe) | 5 years |
Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.

Official Title
-----------------
Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial

Conditions
-----------------
Pancreatic Surgery, Pancreatic Duct Stenting, Pancreatic Cancer, Distal Pancreatectomy, Pancreatic Diseases, Pancreatic Cyst, Pancreatic Ducts

Intervention / Treatment
-----------------
* Procedure: Pancreatic duct stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (greater than or equal to 18 years of age) Scheduled to undergo an elective laparoscopic or open distal pancreatectomy Willing to undergo pre-operative endoscopy Consenting to the procedure Exclusion Criteria: Contraindication to abdominal surgery Contraindication to general anesthesia or distal pancreatectomy Contraindication to upper endoscopy or ERCP Prior history of gastric bypass or other abdominal surgery in whom the ampulla will not be accessible via routine ERCP Ongoing pancreatitis Pancreatic necrosis or abscess History of sphincter of Oddi dysfunction History of ERCP-induced pancreatitis

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pre-operative pancreatic duct stenting | Procedure: Pancreatic duct stenting<br>* In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.<br>|
| No Intervention: 2<br>Control group, no endoscopy and no stent pre-operatively | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic leak |  | Post-operative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal fluid analysis |  | Daily | 
| Serum biochemical analysis |  | Daily | 
| Clinical outcomes |  | Daily | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreas surgery, Pancreatic adenocarcinoma, Pancreatic neuroendocrine tumor, Pancreatic duct stenting
Safety Study of the VEGA UV-A System to Treat Ectasia

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.

Conditions
-----------------
Ectasia

Intervention / Treatment
-----------------
* Device: VEGA UV-A Illumination System
* Drug: Riboflavin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 Years of age or older Diagnosis of Ectasia Presence of central or inferior steepening Topography consistent with ectasia BSCVA 20/20 or worse If contact lens wearer; removal of contact lenses for required period of time Signed informed consent Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision History of chemical injury or delayed epithelial healing A known sensitivity to study medications Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests A condition that would interfere with or prolong epithelial healing Presence or history of any other condition or finding that makes the patient unsuitable for treatment

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 |
| --- | --- |
| Sham Comparator: Sham Control<br> | Drug: Riboflavin<br>* Both treatment and sham groups will receive riboflavin<br>|
| Experimental: CXL Treatment<br> | Device: VEGA UV-A Illumination System<br>* Only subjects assigned to the treatment group will receive treatment with the UV Light<br>Drug: Riboflavin<br>* Both treatment and sham groups will receive riboflavin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Corneal Curvature |  | 6 Months |
Stem Cell Transplantation for the Treatment of Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find if autologous stem cell transplantation can improve clinical manifestations of knee osteoarthritis.

Official Title
-----------------
Phase 1 Study of Bone Marrow - Derived Stem Cell for the Treatment of Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Biological: Autologous Stem Cell Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate bilateral knee osteoarthritis Exclusion Criteria: No infectious or inflammatory arthritis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Knee osteoarthritis | Biological: Autologous Stem Cell Transplantation<br>* Autologous bone marrow aspiration (20 ml) from iliac crest. Separation of mononuclear cells using ficoll hypaque and culture in 10% fetal bovine serum and Dulbecco modified eagles medium. After confluent stage, detachment of cells with trypsin/EDTA, and subculture. Repeated passages until obtainment of required cell number. Confluent cells of last passage are washed with tyrode solution and incubate with M199 for 60 minutes. Cells are separated using trypsin/EDTA and washed 3 times with M199 and 1% HSA. Precipitate will be diluted with heparinized M199 to make solution with 6×106 cells /ml. Sample will be tested for viability and detection of CD45, CD34, CD90, CD44, CD13, CD105, and CD166 before injection. The number of cells for injection will be between 20-25 million cells; in a maximum volume of 4-6 ml. Cells will be injected in the knee joint with a 21 gauge needle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1- Comparison of pain in the injected knee with the controlateral knee 2- Comparison of joint motion of the injected knee with the controlateral knee |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of side-effects |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee osteoarthritis
Voriconazole as Prophylaxis for Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The study aims to determine if voriconazole prevents invasive fungal infections in liver transplant recipients. Endpoints would be: occurrence of invasive fungal infection and fungal colonization. Two groups will be compared: patients who received voriconazole as prophylaxis and historical controls who did not receive this prophylaxis.

Detailed Description
-----------------
The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, voriconazole usage prophylactically, physical exam findings, laboratory and radiographical data, antimicrobial usage, microbiological data and resistance patterns, choice of antifungal drugs once organism identified, suspected source of infection, microbiological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, weight, ethnicity, and past medical history.

Official Title
-----------------
Voriconazole as Prophylaxis for Liver Transplant Recipients

Conditions
-----------------
Fungemia, Mycoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving a liver transplant at University of Pittsburgh Medical Center (UPMC) between January 1, 2001 and June 30, 2005.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplant, voriconazole prophylaxis, liver transplantation, voriconazole
Evaluation of Mechanical Stapler for Aortic Anastomoses

Study Overview
=================
Brief Summary
-----------------
Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients

Official Title
-----------------
Evaluation of Mechanical Stapler for Aortic Anastomoses

Conditions
-----------------
Aortic Aneurysm, Abdominal, Leriche Syndrome

Intervention / Treatment
-----------------
* Procedure: AAA or AF/IB (end-to-end) in patients with Leriche Syndrome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age is between 21 to 85 years old. Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome. Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm. Patient is scheduled for AAA repair Exclusion Criteria: Pregnant women Active malignancy Ruptured aneurysm Thoraco-AAA Patient with at least one of the following unstable risk factors: Renal disease (Cr >2) Ischemic heart disease (unstable Angina) Obstructive Pulmonary Disease (contraindicated for open aortic surgery by respiratory function exam) Severe CHF (EF < 25%) Patient with known allergy to metals or to the contrast media Participation in current or recent (within 60 days prior to surgery) clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: AAA or AF/IB (end-to-end) in patients with Leriche Syndrome|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete each stapled anastomosis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative follow up: |  |  | 
| no leakage |  |  | 
| no dilatation |  |  | 
| no fistula or hematoma at the anastomotic sites |  |  |
Efficacy and Clinical Outcomes of Levosimendan in E-CPR

Study Overview
=================
Brief Summary
-----------------
Treatment of refractory cardiac arrest requiring cardiopulmonary resuscitation (CPR) may be augmented with Extracorporeal membrane oxygenation (ECMO) to re-establish perfusion in the absence of return of spontaneous circulation. Literature has demonstrated that ECMO initiated during advanced cardiopulmonary life support may confer superior survival rates with acceptable survival and a relatively low incidence of significant neurologic impairment. Levosimendan has not been investigated in patients with cardiac arrest who underwent Extracorporeal CPR (E-CPR). The current study aims to examine whether levosimendan use in the aforementioned patient population could improve survival and ECMO parameters.

Official Title
-----------------
Efficacy and Clinical Outcomes of Levosimendan in E-CPR

Conditions
-----------------
Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
-----------------
* Drug: Levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
IInclusion criteria: Hospitalized patients ≥ 18 years of age at the time of E-CPR use Patients suffered cardiac arrest (IHCA or OHCA) Patients received VA-ECMO for E-CPR Criteria as per HMC's Extracorporeal Membrane Oxygenation (ECMO) for Cardiac Arrest (E-CPR) clinical practice guidelines (attached with the study protocol) Exclusion criteria: Patients with incomplete key data Criteria as per HMC's Extracorporeal Membrane Oxygenation (ECMO) for Cardiac Arrest (E-CPR) clinical practice guidelines (attached with the study protocol)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levosimendan|examine whether levosimendan could improve in-hospital survival with good neurological outcomes in patients with cardiac arrest supported by E-CPR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to hospital discharge | Survival to hospital discharge with good neurological outcomes | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to decannulation | Survival to decannulation with good neurological outcomes | 6 months | 
| long term survival | long term survival | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levosimendan, ECPR, neurological outcome
Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT

Study Overview
=================
Brief Summary
-----------------
The investigators will enroll and scan normal eyes of healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the participants will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded. Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.

Detailed Description
-----------------
The investigators will enroll and scan 200 normal eyes of 100 healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the subjects will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded. Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.

Official Title
-----------------
Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT

Conditions
-----------------
Nerve Fiber Bundle Defect

Intervention / Treatment
-----------------
* Device: OCT exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 20/30 visual acuity (BCVA), refractive error less than ±6 diopters (D) spherical equivalent or 3 D of astigmatism, and normal-appearing optic nerve head and retina on dilated fundus examination. Exclusion Criteria: Any history or evidence of eye disease or surgery. Intraocular pressure (IOP) more than 22 mm Hg.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OCT exam<br>OCT exam No Arm No Intervention | Device: OCT exam<br>* OCT exam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between quality grading and retinal and RNFL thickness |  | up to 24 months |