linjc16/ctgov huggingface dataset:
Edwards Cardioband European Post-Market Study, MiBAND

Study Overview
=================
Brief Summary
-----------------
To demonstrate reduction of MR with durable performance and im-provements in functional status

Detailed Description
-----------------
MiBAND is a prospective, single arm, European post-market study to assess the safety and efficacy of the Edwards Cardioband system. Patients will be followed up at 30D, 6months, 1, 2 and 3 years.

Official Title
-----------------
Transcatheter Repair of Mitral Regurgitation With Cardioband System Post Market Study:A European Prospective, Multicenter Study to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System in Patients With Symptomatic MR

Conditions
-----------------
Mitral Regurgitation, Mitral Insufficiency, Mitral Repair, Mitral Valve, Annuloplasty, Edwards Cardioband

Intervention / Treatment
-----------------
* Device: Edwards Cardioband System


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Age ≥ 18 years; MR (≥ 2+ by echocardiography); Patient is eligible to receive the Edwards Cardioband Mitral System Main Exclusion Criteria: Active bacterial endocarditis Severe organic lesions with retracted chordae or congenital mal-formations with lack of valvular tissue Heavily calcified annulus or leaflets Patients in whom transesophageal echocardiography is contraindicated Patients who cannot tolerate an anticoagulation/antiplatelet regimen Patients with known severe reaction to contrast agents that cannot be adequately pre-medicated. Pre-existing prosthetic heart valve or annuloplasty in the Mitral position Life expectancy of less than twelve months Patient is pregnant or lactating

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

| Intervention/Treatment |
| --- |
|Device: Edwards Cardioband System|Transcatheter mitral valve repair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success at discharge | Reduction in Severity of Mitral Regurgitation at discharge | Hospital discharge; approximately 2-8 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | Reduction in Severity of Mitral Regurgitation | 30 days, 6months, 1, 2 and 3 years | 
| Major Adverse Events Rate | Rate of Major Adverse Events | 30 days, 6months, 1, 2 and 3 years | 
| Change in Quality Of Life-KCCQ | Improvements in Quality Of Life as assessed by KCCQ | 30 days, 6 months, 1, 2 and 3 years | 
| Change in Quality Of Life-EQ-5D-5L | Improvements in Quality Of Life as assessed by EQ-5D-5L | 30 days, 6 months, 1, 2 and 3 years |
The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.

Official Title
-----------------
The Pharmacokinetics and Electrocardiographic Implications of Adjunctive Amiodarone and Ranolazine Therapy in Patients on Implantable Cardioverter Defibrillators: The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Drug: Amiodarone Plus Ranolazine
* Drug: Amiodarone with Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an ICD who were on a stable dose of amiodarone for the past 60 days Exclusion Criteria: Patients with a life expectancy of less than 6 months Patients with moderate or severe hepatic impairment (Child-Pugh Classes B or C) or requiring hemodialysis. Pregnancy or lactation. Treatment with potent CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir Treatment with CYP3A inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Amiodarone with Placebo<br> | Drug: Amiodarone with Placebo<br>* stabel dose of amiodarone as prescribed by cardiologist<br>|
| Active Comparator: Amiodarone with Ranolazine<br> | Drug: Amiodarone Plus Ranolazine<br>* Ranolazine 500mg by mouth twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Parameter Estimates | Absorption, Peak concentration, time to peak concentration, clearance, area under the curve | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiogram (ECG) | The QT/QTc interval and other ECG parameters | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia
A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer

Study Overview
=================
Brief Summary
-----------------
The main purpose of this observational study with Oxaliplatin onkovis is to determine the number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose under the special circumstances of ambulant chemotherapy. Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective. Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this end, data regarding co-medication and adverse events are also collected.

Official Title
-----------------
Open, Multicenter Observational Study of Oxaliplatin Utilized in Combination Therapy for Adjuvant Treatment of Colon Carcinoma of Stage III After Complete Removal of the Primary Tumor and for Treatment of Metastasizing Colorectal Carcinoma.

Conditions
-----------------
Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for Oxaliplatin according to the Summary of Product Characteristics (SmPC) and treating physician Exclusion Criteria: According to the Oxaliplatin SmPC
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carcinoma, Oxaliplatin onkovis (Oxaliplatin)<br>Treatment in combination therapy for adjuvant treatment of colon carcinoma of stage III (Dukes C) after complete removal of the primary tumor, as well as for treatment of metastasizing colorectal carcinoma. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quantity of Oxaliplatin onkovis needed per treatment cycle | Determine the quantity of Oxaliplatin onkovis needed per treatment cycle | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events during and after treatment | The number and type of adverse events during and after the intra-venous application of Oxaliplatin will be assessed and documented. | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carcinoma, colon cancer, colorectal cancer, ambulant chemotherapy, treatment cycles, Oxaliplatin, Oxaliplatin onkovis, Quantity of Oxaliplatin, Packaging Sizes
The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's Disease

Study Overview
=================
Brief Summary
-----------------
Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial dysfunction plays a prominent role in the pathogenesis of the disease, we considered angiogenic cytokines as an interesting target for investigation in BD. The aim of this study was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the pathogenesis of BD. Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.

Conditions
-----------------
Behçet's Disease

Intervention / Treatment
-----------------
* Other: serum levels of angiogenin, bFGF, VEGF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18-65 fulfilling the international diagnostic criteria for Behçet's disease Exclusion Criteria: to have another systemic disease

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 |
| --- | --- |
| Behçet's patients<br>Serum levels of angiogenin, bFGF, VEGF levels in Behçet's patients with ocular involvement group, without ocular involvement group and control group | Other: serum levels of angiogenin, bFGF, VEGF<br>* Behçet's patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of angiogenin in Behçet's patients with or without ocular involvement | The median serum angiogenin level was significantly higher in all patients with BD than controls (P=0.001). However there was no statistically significant difference between all patients and patients with or without ocular involvement. The mean serum bFGF and the median serum VEGF levels were higher in patients with ocular involvement than all patients, patients without ocular involvement and controls. But these differences did not reach statistical significance. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of bFGF in Behçet's patients with or without ocular involvement |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angiogenin, Behçet's disease, bFGF, VEGF
Prevalence of Delirium in Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine prevalence of postoperative delirium and confusion in patients undergoing cardiac surgery. This proposal is a pilot study designed to evaluate effect of cardiac surgery on prevalence of delirium and confusion. The primary aim is to evaluate prevalence of delirium and confusion in patients undergoing cardiac surgery and to determine risk factors for this condition. A secondary aim is to evaluate organic brain injury by early postoperative diffusion weighted magnetic resonance imaging (DW-MRI) in patients who develop delirium and confusion. The hypothesis to be tested is that patients with postoperative delirium and confusion have high incidence of organic brain injury as detected by DW-MRI.

Official Title
-----------------
Prevalence of Delirium in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All patients undergoing cardiac surgery in our institute in 2 year period Signed informed consent Exclusion criteria: Past history of transient ischemic attacks, stroke, symptomatic carotid artery disease. Past history of psychiatric disorders History of alcohol and drug abuse History of severe kidney or liver disease (creatinine >2.5mg/dL and bilirubin > 2mg/dL) Known contraindications to MRI

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
-----------------
Delirium, Confusion, Cardiac Surgery, Organic Brain Injury, Diffusion Weighted Magnetic Resonance Imaging (DW-MRI)
Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited

Study Overview
=================
Brief Summary
-----------------
Celiac disease is an autoimmune disorder characterized by a chronic inflammation of the small bowel mucosa, triggered by the ingestion of gluten-containing grains. The diagnosis of celiac disease was initially based on duodenal biopsies obtained from upper endoscopy. Since 1990, the availability of serological tests has contributed to a different perception of the disease. Serological testing is now considered fundamental for celiac disease screening, even if duodenal biopsies remain the gold standard. Celiac markers usually include anti-TG2 antibodies, anti-endomysium antibodies, anti-gliadin antibodies and anti-reticulin antibodies. Recently, several studies showed that deamidated products of gliadin may enhance T-cell stimulatory activity and improve the reactivity of anti-gliadin antibodies. Thus, detection of anti-deamidated gliadin peptide antibodies has been introduced into the wide spectrum of serological tests for celiac disease.

Detailed Description
-----------------
The aim was to assess the clinical relevance of anti-deamidated gliadin peptide antibodies compared with the other common celiac markers.

Official Title
-----------------
Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Other: Data record


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed between 1 april 2012 to 31 december 2014
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group celiac disease<br> | Other: Data record<br> <br> |
| group no celiac disease<br> | Other: Data record<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| celiac disease | The celiac disease diagnosis was based on the histological lesions at duodenal biopsies (villous atrophy). Biopsy samples were obtained during upper gastrointestinal tract endoscopy. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-deamidated gliadin peptide antibodies, Celiac disease, serological tests
Focused Cardiac Ultrasound

Study Overview
=================
Brief Summary
-----------------
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.

Official Title
-----------------
Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.

Conditions
-----------------
Ventricular Dysfunction, Pericardial Effusion, Valvular Disease, Septal Defect

Intervention / Treatment
-----------------
* Device: Philips EPIQ 7 ultrasound machine
* Device: Philips Lumify Broadband sector array transducer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting to pediatric cardiology clinic at Holtz Children's hospital requiring comprehensive or limited transthoracic echocardiogram. Willing and able to provide informed consent or assent. In clinically stable condition as assessed by the principal investigator.. With adequate echocardiographic windows. Exclusion Criteria: Patients with poor echocardiographic windows. Patients who refuse informed consent. Pregnant women. Prisoners. Patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Experimental: treatment group<br>All participants to receive standard transthoracic echocardiogram and hand held echocardiogram | Device: Philips EPIQ 7 ultrasound machine<br>* Standard transthoracic echocardiography<br>Device: Philips Lumify Broadband sector array transducer<br>* Portable hand-held ultrasound device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography | Day 1 |
Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the effect of Sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.

Official Title
-----------------
Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin

Conditions
-----------------
Diabetic Foot

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus at least 1 diabetic foot ulcer with a size between 1 and 20 sqcm stable size of the foot ulcer for at least 2 weeks HbA1c <= 8% under Treatment with Insulin, metformin, sulfonylureas, SGLT2 Inhibitors, glinides or glitazones Exclusion Criteria: local purulent signs of Inflammation at ulcer site planned interventional or surgical therapy of a macro vessel disease of the lower limb glomerular filtration rate <30ml/min liver cirrhosis CHILD B or C pregnancy, lactation allergy against Sitagliptin ongoing treatment with dipeptidyl peptidase 4 (DPP4) Inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sitagliptin<br>Sitagliptin tablets, 100mg per day, 12 weeks treatment | Drug: Sitagliptin<br> <br> * Other names: Chemical Abstracts Service (CAS) number 654671-77-9;|
| Placebo Comparator: Placebo<br>Placebo tablets, 1 tablet per day, 12 weeks treatment | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean ulcer size after a treatment period of 12 weeks |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic foot ulcer, Sitagliptin
The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients

Study Overview
=================
Brief Summary
-----------------
In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are included with the aim to investigate the potential underdosing in this patient group. Four regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken before the next dose is administered for three consecutive days.

Official Title
-----------------
The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: No intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current treatment with beta-lactam antibiotics and admission to the ICU Exclusion Criteria: Pregnancy, age below 18 years

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

| Intervention/Treatment |
| --- |
|Other: No intervention.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome |  | 30 days | 
| The rate of patients below 100% time over MIC in relation to the bacteria causing the infection. |  | 3 days | 
| Kidney function measured as eGFR in relation to initial levels of beta-lactam antibiotics as defined in primary outcome |  | 3 days | 
| SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome |  | 3 days | 
| Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome |  | 30 days |