linjc16/ctgov huggingface dataset:
Procalcitonin Use in Pneumonia Patients in the Critical Care Setting

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to determine the impact of procalcitonin (PCT)-guided therapy on duration of antibiotic therapy in critical care unit (CCU) patients with suspected pneumonia at Mayo Clinic Health System Eau Claire.

Official Title
-----------------
Impact of Measuring Serum Procalcitonin Levels on Duration of Antimicrobial Therapy in Critical Care Patients With Suspected Pneumonia

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

Intervention / Treatment
-----------------
* Other: Use of procalcitonin as biomarker to guide therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 18 years old admitted to critical care unit placed on pneumonia protocol Exclusion criteria: patients who received outpatient antibiotic therapy within previous 21 days

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Therapy<br> | |
| Experimental: Procalcitonin-guided therapy<br>Procalcitonin levels will be measured to determine when it is appropriate to discontinue antibiotic therapy. | Other: Use of procalcitonin as biomarker to guide therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of antibiotic therapy | Participants will be followed for the entire time they are on antibiotics to treat pneumonia, an expected average of 30 total antibiotic days. | Indefinite | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in critical care unit | Participants will be followed for their entire length of stay in the critical care unit, an expected average of 7 days. | Indefinite | 
| Cost | The average cost of antibiotics per patient, measured in US dollars, based on total antibiotic days. | Once | 
| Length of stay in the hospital | Participants will be followed their entire length of stay in the hospital, an expected average of 14 days. | Indefinite | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
procalcitonin, antimicrobial stewardship, pneumonia
Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

Study Overview
=================
Brief Summary
-----------------
This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017.

Detailed Description
-----------------
4 point scleral fixation of PC- IOL (Posterior Chamber-PC) BunnyLens with Gore-Tex sutures is a surgical technique for implanting IOL in patients with capsular support absence, due to trauma, abnormal anterior chamber, IOL dislocation, or ciliary zonule defect. The 4 point fixation enables to align the PC- IOL with minimal vertical and horizontal deviation;The Gore-Tex sutures maintain stable scleral fixation with no suture erosion or breakage.

Official Title
-----------------
Gore-Tex Suture and BunnyLens Scleral Fixation - Historical Retrospective Trial

Conditions
-----------------
Aphakia, Acquired

Intervention / Treatment
-----------------
* Other: Visual Acuity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures. Exclusion Criteria: Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 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 |
| --- | --- |
| BunnyLens and Gore-Tex suture<br>All patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures | Other: Visual Acuity<br>* Ocular Examination<br>* Other names: Biomicroscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity | Degree of Visual Acuity is measured in LogMar (-0.3 to1) and by Decimal Value (0.0-2.0) | Up to 24 months from surgery. | 
| Ocular Refraction | Refraction of the Ocular surfaces, measured in sphere, cylinder and axis. | Up to 24 months from surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Biomicroscopy | Slit lamp examination of the anterior and posterior segments. | Up to 24 months from surgery. |
Study of Endoscopic Versus Open Surgery for Urinary Reflux

Study Overview
=================
Brief Summary
-----------------
This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical complications, and quality of life measures after ARS.

Official Title
-----------------
A Randomized Trial of Endoscopic vs. Open Anti-Reflux Surgery For Treatment of Low-Grade Vesicoureteral Reflux: Surgical Treatment of Reflux: Endoscopic vs. Traditional CHoices (STRETCH) Study

Conditions
-----------------
Vesicoureteral Reflux

Intervention / Treatment
-----------------
* Procedure: Anti-reflux surgery
* Procedure: Endoscopic injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age <12 years Unilateral or Bilateral Primary VUR Grade 2 or 3 (VCUG) or Grade 2 (RNC) VUR in at least 1 ureter Recommended for surgical correction of VUR by Urologist Exclusion Criteria: Grade 4 or 5 (VCUG) or Grade 3 (RNC) VUR Secondary VUR (neurogenic bladder, exstrophy, or other causes of secondary VUR) Ureterocele Periureteral diverticulum Complete duplication of duplex collecting system on side with VUR Prior ARS, either open or endoscopic, regardless of success or failure History of other prior urinary tract surgery other than circumcision Solitary functional kidney Congenital or acquired immunodeficiency Chronic renal insufficiency or renal failure

Ages Eligible for Study
-----------------
Maximum Age: 11 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 |
| --- | --- |
| Active Comparator: Open Surgery<br> | Procedure: Anti-reflux surgery<br>* Open ureteroneocystostomy for correction of vesicoureteral reflux<br>|
| Active Comparator: Endoscopic Surgery<br> | Procedure: Endoscopic injection<br>* Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of VUR at 4 months |  | 4 months |
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.

Detailed Description
-----------------
About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.

Official Title
-----------------
Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Device: Strattice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary cancers undergoing curative surgery (R0) Life expectancy > 2 yrs Neoadjuvant radiotherapy with or without chemotherapy Exclusion Criteria: Pelvic extenteration or extended resections Previously irradiated patients (i.e. radiation therapy for a previous cancer) Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder sensitivity to porcine derived products or polysorbate

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 |
| --- | --- |
| Strattice<br>eLAPE | Device: Strattice<br>* Perineal reconstruction and stoma reinforcement with Strattice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perineal wound healing | Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of perineal herniation | Incidence of perineal hernia | 24 months | 
| Incidence of parastomal hernia | Stoma will be assessed for herniation at Months 3, 6, 12 and 24 | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eLAPE,, perineum,, pelvic floor reconstruction
Incorporation of Vitamin K Into Uremic Lipoproteins

Study Overview
=================
Brief Summary
-----------------
Chronic kidney disease (CKD) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. CKD patients exhibit a functional vitamin K deficiency. Calcification can be prevented by vitamin K intake. The aim of this study is to investigate the cause for the vitamin K deficiency beyond a diminished dietary vitamin K uptake.

Detailed Description
-----------------
This study is a monocentric, 1-armed interventional trial. Participants will be recruited at the University Hospital of the RWTH Aachen. We will analyse serially collected serum from 10 dialysis patients, after ingestion of a single vitamin K supplement, compared to healthy controls. Lipoprotein fractions will be isolated and the corresponding vitamin K contents will be measured by chromatography. The vitamin K supplement contains 3 subforms of vitamin K: vitamin K1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).

Official Title
-----------------
Incorporation of Vitamin K Into Uremic Lipoproteins

Conditions
-----------------
Vitamin K Deficiency

Intervention / Treatment
-----------------
* Drug: Vitamin K supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age ≥ 18 years Controls: adequate kidney function (GFR > 60 ml/min/1,73m2) Patients: chronic haemodialysis Written consent to take part in the study Exclusion criteria Intake of vitamin K antagonists gastro-intestinal diseases interfering with vitamin K intake profound anemia with an Hb < 10 g/dl judicial or official commitment to an institution pregnancy and lactation

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin K supplement<br>Administration of a single dose vitamin K | Drug: Vitamin K supplement<br>* Single dose of vitamin K supplement<br>* Other names: High dose vitamin K1 and K2 supplement;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin K content in lipoproteins | Assessment of vitamin K incorporation into lipoproteins | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PIVKA-II levels | PIVKA-II in serum as assessed by ELISA | 1 year |
Detection of COVID-19 Using Breath Analysis - Validation Study.

Study Overview
=================
Brief Summary
-----------------
Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.

Detailed Description
-----------------
A diagnostic prospective single-site study, with no anticipated risks or constraints. Primary objective- To validate the value of a set of breath VOC biomarkers that enable the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.

Official Title
-----------------
Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study.

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: VOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 75 years at the time of consent Capable of understanding written and/or spoken language Able to provide informed consent Was not treated with Anti-viral drugs Exclusion Criteria: Age under 18 years old Under guardianship or deprived of liberty Pregnant or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drive In<br>Drive In attendees will undergo one breath sampling. | Diagnostic Test: VOX<br>* Breath exhalation into the mouthpiece of the VOX breath diagnostic device.<br>|
| Experimental: Healthy<br>Healthy attendees will undergo two successive breath sampling. | Diagnostic Test: VOX<br>* Breath exhalation into the mouthpiece of the VOX breath diagnostic device.<br>|
| Experimental: Corona Department<br>Healthy attendees will undergo five successive breath sampling. | Diagnostic Test: VOX<br>* Breath exhalation into the mouthpiece of the VOX breath diagnostic device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Volatile Organic Compounds indicating carriers of COVID-19. | Obtain early verification accuracy of measures for a set of VOCs biomarkers indicating carriers of Corona virus. | Through the study completion, up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.) | Correlation level between exhaled biomarkers and participants' demographic characteristics. | Through the study completion, up to 3 months. |
Remote Ischemic Preconditioning in Aortic Valve Surgery

Study Overview
=================
Brief Summary
-----------------
RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of troponin-I.

Detailed Description
-----------------
The hypothesis tested in this research proposal is that remote ischemic preconditioning initiated immediately before aortic valve surgery reduces myocardial damage related to surgery.

Official Title
-----------------
Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)

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

Intervention / Treatment
-----------------
* Procedure: Control
* Procedure: Remote ischemic preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Aortic valve surgery for aortic stenosis Written informed consent Exclusion Criteria: Aortic valve surgery combined with CABG or an other valve surgery Previous Q-wave myocardial infarction or previous coronary artery bypass graft Coronary artery stenosis >70% Ejection fraction <35% Surgery performed in emergency Nicorandil ou metformin treatment within 8 days before surgery Patient refusal / patient not having provided written informed consent.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br> | Procedure: Control<br>* Deflated blood pressure cuff placed on upper arm for 30min<br>|
| Active Comparator: Remote ischemic preconditioning<br> | Procedure: Remote ischemic preconditioning<br>* Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated before aortic clamping and repeated 3 times in total<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size | Infarct size as assessed by 72 hours area under curve serum troponin-I | 72 hours |
Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis. To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with low-gradient, severe aortic stenosis. To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.

Detailed Description
-----------------
To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with impaired left ventricular function and / or low-gradient, severe aortic stenosis. To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with impaired left ventricular function and / or low-gradient, severe aortic stenosis. To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.

Official Title
-----------------
Clinical Outcome of Patients With Low Ejection Fraction or Low-gradient Severe Aortic Stenosis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 and low gradient (mean gradient across the aortic valve <40 mmHg) by echocardiography Symptomatic patients with aortic stenosis referred for medically indicated AVR Signed informed consent to participate in the study. Exclusion Criteria: Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test). Need for emergency surgery for any reason. Any case in which the practicing physician asserts that enrollment in the protocol will adversely affect the patient treatment course.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular ejection fraction after aortic valve replacement |  | 2±1 months |