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NCT ID: NCT02241642 Completed - Clinical trials for Percutaneous Common Femoral Artery Arteriotomy Closure

Safety and Performance Study of Large Hole Vascular Closure Device

FRONTIER-II
Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures. This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation is no worse than those associated with cut-down and sutured close.

NCT ID: NCT02240680 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin as Add on to Basal Insulin in the Elderly

Start date: September 23, 2014
Phase: Phase 4
Study type: Interventional

To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed. In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.

NCT ID: NCT02234843 Completed - Clinical trials for Venous Thromboembolism

EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

EINSTEIN Jr
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

NCT ID: NCT02234323 Completed - Hemophilia A Clinical Trials

An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

Start date: January 12, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.

NCT ID: NCT02234310 Completed - Hemophilia B Clinical Trials

Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B

PUPs B-LONG
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.

NCT ID: NCT02233699 Completed - Clinical trials for Chronic Idiopathic Cough

A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic idiopathic cough. The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester Cough Questionnaire (LCQ) will be evaluated.

NCT ID: NCT02230969 Completed - Clinical trials for Relapsing Forms of Multiple Sclerosis

Plegridy Observational Program

POP
Start date: November 12, 2014
Phase:
Study type: Observational

The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

NCT ID: NCT02230813 Completed - Cellulitis Clinical Trials

Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis

Start date: March 2015
Phase: N/A
Study type: Observational

The term cellulitis is a medical term describing a bacterial infection of the skin and tissues beneath the skin. Although it is usually easily treated with antibiotics given either orally or through a vein (intravenously), knowing which route of antibiotic treatment to prescribe to a person attending an Emergency Department with cellulitis is not clear. A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which patients require oral and which patients require intravenous antibiotics for cellulitis from their first visit to an emergency department. The aim of this is to provide safer care by reducing the risk of a patient returning to the hospital with a worsening infection. It will also promote more cost-effective care by reducing hospital re-attendance rates and wasted antibiotics. Patients attending the department with cellulitis who are suitable for oral antibiotic treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of study participants in order to reduce bias. A set of physical signs and symptoms will be recorded from each patient in order to determine which ones are associated with them "failing" prescribed oral treatment. A study investigator will then phone the patient after 14 days to see whether they are better or whether they required intravenous antibiotics to get better.

NCT ID: NCT02225704 Completed - Prostate Cancer Clinical Trials

Radium-223 in Combination With Enzalutamide

Start date: June 3, 2015
Phase: Phase 2
Study type: Interventional

This study aims to determine the safety and tolerability of Radium-223 when administered in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.

NCT ID: NCT02223169 Completed - Hypertension Clinical Trials

Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk

CardiProtein
Start date: April 2014
Phase: N/A
Study type: Interventional

Heart disease and stroke are the most common cause of death in Ireland today.One of the main risk factors for heart disease and stroke is high blood pressure or hypertension. Research has found that certain specific proteins or peptides found in foods such as dairy, meat, fish and eggs may promote heart health reducing blood pressure in adults with hypertension. The aim of this study is to investigate the potential beneficial effects egg peptides may have on heart health, in particular, effects on blood pressure.