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NCT ID: NCT02277990 Completed - Clinical trials for CIED Related Infection

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

WRAP-IT
Start date: January 2015
Phase: Phase 4
Study type: Interventional

Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

NCT ID: NCT02277769 Completed - Dermatitis, Atopic Clinical Trials

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

SOLO 2
Start date: November 30, 2014
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT02274259 Completed - Clinical trials for Central Retinal Vein Occlusion

Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Comparing ranibizumab and aflibercept in a treat and extend algorithm evaluating the number of needed injections over a 18 month period in patients with newly diagnosed CRVO.

NCT ID: NCT02272621 Completed - Clinical trials for Aortic Valve Stenosis

Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

Start date: November 2013
Phase: N/A
Study type: Interventional

This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery. Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

NCT ID: NCT02269917 Completed - Clinical trials for Human Immunodeficiency Virus Type 1

Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants

Start date: March 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter [copies/mL]) HIV-1 infected participants.

NCT ID: NCT02268214 Completed - Clinical trials for Type 1 Diabetes Mellitus

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

DEPICT 1
Start date: November 11, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

NCT ID: NCT02266459 Completed - Healthy Clinical Trials

Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke

Start date: October 2014
Phase: N/A
Study type: Interventional

This is a prospective, open, multicenter study that will enroll patients admitted to and hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers. The main purpose of the study is to evaluate the ability of the Microwave Technology to deliver adequate measurement data.

NCT ID: NCT02266186 Completed - Tocophobia Clinical Trials

Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy

(Victoria)
Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this project To study the efficacy of Internet-based guided self-help program of Cognitive Behaviour Therapy (ICBT) compared to traditional individual live CBT in a group of women with severe fear of childbirth (S-FOC). The treatment groups are compared with a control group receiving individual support at their antenatal clinics.

NCT ID: NCT02264574 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Start date: October 6, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.

NCT ID: NCT02264470 Completed - Accidental Falls Clinical Trials

Fall Study in Gothenburg (FallsGOT)

FallsGOT
Start date: October 1, 2014
Phase:
Study type: Observational

Falls after stroke are common. Previous research has shown that almost every other, 48%, of patients with a first-ever stroke fell at least once during the first year after stroke (1). Moreover, most of the patients fell during the first three months after stroke onset. However, the exact time-point for the falls was not analyzed (1). In addition, many patients are falling already during hospital stay (2-5). Reducing the number of falls during inpatient rehabilitation on a stroke unit is a high-priority mission. Greater knowledge concerning the factors that best predict falls is eligible. The aim of the study is to analyze the significance of different physiological, psychological and medical factors for predicting the risk of falling in patients with stroke per day of care at a stroke unit.