linjc16/ctgov huggingface dataset:
A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.

Conditions
-----------------
Glomerulonephritis, IGA, Hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IgA nephropathy confirmed by renal biopsy Hypertension (<= 125/75 mmHg) Exclusion Criteria: Patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks Severe hypertension (<= 180/110 mmHg) or secondary hypertension Patients with history of allergy or adverse effect for aliskiren Renal dysfunction (estimated Glomerular Filtration Rate < 60 mL/min/1.73m2) Pregnancy Patient treated with cyclosporine Hyperkalemia (serum potassium >= 5.6 mmol/L) Autoimmune disease including systemic lupus erythematosus Patients inadequate for the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aliskiren|150 mg/day p.o.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function (Creatinine clearance) |  | One year (every 6 months) | 
| Urinary protein |  | One year (every 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary angiotensinogen |  | One year (every 6 months) | 
| Urinary type 4 collagen |  | One year (every 6 months) | 
| Urinary Transforming growth factor-beta |  | One year (every 6 months) | 
| High-sensitivity C-reactive protein |  | One year (every 6 months) | 
| Plasma Rennin Activity |  | One year (every 12 months) | 
| Aldosterone |  | One year (every 12 months) | 
| Asymmetric dimethylarginine |  | One year (every 12 months) | 
| Advanced glycation end product |  | One year (every 12 months) | 
| (Pro)renin receptor |  | One year (every 12 months) | 
| Oxidative stress |  | One year (every 12 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aliskiren, Albuminuria, Angiotensinogen, collagen type IV, Transforming Growth Factor beta, aldosterone, renin, prorenin receptor, des-angiotensin I renin substrate, oxidative stress, advanced glycosylation end-product receptor, N,N-dimethylarginine
Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort

Study Overview
=================
Brief Summary
-----------------
Due to better treatment options and earlier detection, survival rates of patients with breast cancer continue to increase. As such, (late) treatment toxicity, (long-term) quality of life and the cosmetic outcome are becoming more important. Also, many competing experimental interventions (e.g. treatment, lifestyle interventions) for breast cancer are being developed, all in need to be properly evaluated before being implemented in routine clinical care. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting. The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard. By setting up UMBRELLA, as a prospective cohort according to the cmRCT design, the investigators aim to: provide an infrastructure for efficient, fast and pragmatic evaluation and implementation of experimental interventions gain insight into short and long-term treatment response, toxicity, complications, quality of life and survival of patients with breast cancer.

Official Title
-----------------
Utrecht Cohort for Multiple Breast Cancer Intervention Studies and Long-term Evaluation - The UMBRELLA Cohort

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patients with breast cancer who undergo irradiation in the UMC Utrecht Informed consent - at least - for use of routinely collected clinical data and to fill out questionnaires. Exclusion Criteria: Inability to understand the Dutch language

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 |
| --- | --- | --- |
| Change from baseline Quality of Life at 10 years | Assesment of Health-related quality of life in breast cancer patients undergoing radiation | 10 years |
Impact of OCT on Outcomes in AMI

Study Overview
=================
Brief Summary
-----------------
This protocol describes a retrospective, single-center study intended to test the impact of optical coherence tomography(OCT) on long term clincical outcomes in patients with acute myocardial infarction(AMI). All the patients will be followed by intracoronary OCT at medium follow-up of 3 years.

Official Title
-----------------
Impact of Optical Coherence Tomography on Long-term Clincal Outcomes in Patients With Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: OCT guided coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18 years old Patients undergo cardiac catheterization and percutaneous coronary intervention(PCI) for AMI(STEMI or NSTEMI) ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction, symptoms onset≤ 24h.NSTEMI was defined as elevated troponin levels and the absence of ST elevation at the time of diagnosis, PCI was performed within 24hours after symtoms onset. Sufficient quality of the OCT recording allowing for CoreLab analysis. Exclusion Criteria: ostial of Left main disease Cardiogenic shock or severe hemodynamic instability Severe renal insufficiency (creatinine clearance ≤30 mL/min) Bacteraemia or septicaemia Severe coagulation disorders Patients with life expectancy less than 1 year Patients who refuse to sign the informed consent form

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 |
| --- | --- |
| OCT guided group<br> | Device: OCT guided coronary intervention<br>* patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group<br>|
| angiography guided group<br> | Device: OCT guided coronary intervention<br>* patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular event | including cardiovascualr death, myocardial infarction, and target lesion revascularization, target vessel revascularization | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tomography, Optical Coherence, STEMI, NSTEMI, Major adverse cardiovascular event
ERECTOR SPINAE BLOCK AFTER THORACIC SPINE SURGERY

Study Overview
=================
Brief Summary
-----------------
the effectiveness of ultrasound guided erector spinae plane block in patients undergoing thoracic spine sugery

Detailed Description
-----------------
bilateral erector spinae plane block would be given to patients with thoracic spine sugery for postoperative analgesia & its effectiveness would be evaluated for 2 days

Official Title
-----------------
THE EFFECTIVENESS OF AN ULTRASOUND GUIDED RECTOR SPINAE BLOCK IN PATIENTS UNDERGOING THORACIC SPINE SURGERY

Conditions
-----------------
Post Operative Analgesia

Intervention / Treatment
-----------------
* Procedure: ultrasound guided erector spinae plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postoperative thoracic spine sugery Exclusion Criteria: less then 18 years more than 65 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Randomized and Single-Arm Trials<br>a sham comparator (no intervention) | Procedure: ultrasound guided erector spinae plane block<br>* bilatral block given to patients under general anaesthesia for thoracic spine sugery to contorl post operative pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound guided erector spinae plane block can be used for postoperative analgesia for patients undergoing thoracic spine sugery | postoperative analgesia | 2 days |
Covering of the Abdominal Wall in Laparotomies: Differences in Surgical Site Infections Between an Approved Abdominal 3M™ Steri-Drape™ Wound Edge Protector and Standard Woven Swabs at Technische Universität München

Study Overview
=================
Brief Summary
-----------------
BaFo is a prospective, double-blinded randomized controlled clinical trial that assesses the numbers of surgical site infections in two different techniques of covering the abdominal wall in laparotomies. Standard covering with woven swabs is compared to a novel, approved 3M™ Steri-Drape™ Wound Edge Protector.

Official Title
-----------------
Standard-Bauchwandabdeckung Mit Bauchtüchern vs. Abdeckung Mittels ringförmiger Folie: Eine Doppelblinde Randomisiert-kontrollierte Studie

Conditions
-----------------
Comparing the Number of Surgical Site Infections, Covering of the Abdominal Wall in Laparotomies With an Approved Abdominal 3M™ Steri-Drape™ Wound Edge Protector and Standard Woven, Swabs

Intervention / Treatment
-----------------
* Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to sign the informed consent Patients older than 18 years Abdominal operations with longitudinal / cross section with clean wounds, clean-contaminated wounds or contaminated wounds (cdc-definitions of surgical wound infections) Exclusion Criteria: Pregnant or lactating women Revision Operations Operations with dirty or infected wounds (CDC definition of surgical wound infections) Laparoscopic operations Small operations without longitudinal- / cross-section e.g. appendectomy

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs<br> <br> |
| Active Comparator: Arm 2<br> | Procedure: Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infections |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body-Temperature during Operation |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical site infections, Covering the abdominal wound edge in laparotomies
The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) in Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to assess post ablation, if there are areas of Barrett's mucosa post ablation and to assess the ability of the Fujinon FICE system to detect this, as compared to white light endoscopy. A subgroup will also be compared with laser confocal microscopy

Official Title
-----------------
The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) for the Detection of Dysplasia in Barrett's Esophagus and in Post Ablation Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visible Barrett's esophagus Scheduled for Surveillance Endoscopy Able to undergo endoscopy Exclusion Criteria: Unable to undergo endoscopy Unable to stop blood thinning medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Surveillance Barrett's esophagus<br>Patients scheduled for endoscopic surveillance of Barrett's esophagus | |
| Barrett's esophagus post ablation<br>Patients scheduled for surveillance endoscopy who have undergone ablative therapies (PDT, RF ablation) for their Barrett's esophagus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of dysplasic areas | Areas of residual mucosa will be scored for being present, absent or suspicious. The ability of both FICE and white light endoscopy to find areas will be graded on the number of areas found, and the size of the areas estimated at the time of endoscopy | during surveillance endoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's Esophagus, Surveillance
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause

Conditions
-----------------
Vasomotor Symptoms Associated With Menopause

Intervention / Treatment
-----------------
* Drug: Bazedoxifene/Conjugated Estrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago Intact uterus Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week Exclusion Criteria: History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders History of active presence of stroke, TIA, heart attack or ischemic heart disease History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bazedoxifene/Conjugated Estrogen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause
Preventing Depression in Patients With Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).

Detailed Description
-----------------
AMD is the most common cause of blindness in older adults. The disease limits the ability to read, see familiar faces, and walk independently. Almost 2 million persons (about 5 percent of the U.S. population over age 65) are now affected, and this number will triple by the year 2020. This study will target patients with neovascular AMD (NV-AMD), a form of AMD which can lead to sudden vision loss, substantial disability, and depression. Because depression is itself disabling and not likely to be recognized nor treated by ophthalmologists, preventing depression in people with NV-AMD is important. Patients are randomly assigned to either PST or a usual care control condition. The primary outcome measure is a DSM-IV diagnosis of depression. Patients are evaluated at baseline, Month 2 (immediately post-intervention), Month 6 (for the primary efficacy analysis), and Month 12 (to evaluate sustained effects). The study will also assess the impact of PST on levels of disability and vision-related quality of life.

Official Title
-----------------
Preventing Depression in Macular Degeneration

Conditions
-----------------
Depression, Macular Degeneration

Intervention / Treatment
-----------------
* Behavioral: Problem Solving Treatment
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Bilateral macular degeneration Visual acuity of 20/40 or worse in better eye Residence within 40 miles of Wills Eye Hospital in Philadelphia, PA

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Problem Solving Treatment | Behavioral: Problem Solving Treatment<br>* Brief Cognitive Behavioral Therapy<br>|
| Active Comparator: 2<br>Control | Behavioral: Control<br>* No treatment control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depressive Disorder, Blindness, Aged
Screening for Abdominal Aortic Aneurysm Using a Portable Transthoracic Echocardiography Among Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is 1-2%. when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and 1% in women. As abdominal aortic aneurysm and coronary heart disease share common risk factors, patients with acute coronary syndrome represent a high risk population in which screening for another atherosclerotic site is recommended. Patients admitted for ACS undergo routinely TTE. during the same study, TTE may offer the opportunity to evaluate the cardiac morphology and function and to screen for Abdominal Aortic aneurysm. It was reported by different studies that the Sensitivity of this technique was between 91-96% for AAA screening. In addition, this method is cheap, available and requires only 2-3 minutes to be added to the standard TTE. we plan to examine patients admitted with ACS in our Intensive Care Unit for screening AAA by TTE in subcostal views in addition to the standard TTE examination.

Official Title
-----------------
Screening for Abdominal Aortic Aneurysm Using a Portable Transthoracic Echocardiography (TTE) Among Patients With Acute Coronary Syndrome in Intensive Cardiac Care Unit.

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 65 years old with ACS. patients capable of reading, understanding and signing informed concent Exclusion Criteria: suboptimal TTE windows

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Abdominal aortic diameter measurement of 30 mm or more by portable transthoracic echocardiography, will be defined as abdominal aortic aneurysm. |  | Average time period of 72 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal Aortic Aneurysm (AAA),, Echocardiography (TTE),, Acute Coronary Syndrome (ACS), Patients over 65 years old