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NCT ID: NCT01782196 Terminated - Ileostomy Clinical Trials

A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy

U366
Start date: October 2012
Phase: N/A
Study type: Interventional

Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.

NCT ID: NCT01779466 Terminated - Nocturia Clinical Trials

Daytime Impact Sleep Study

DAISS
Start date: April 2013
Phase: Phase 2
Study type: Interventional

This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.

NCT ID: NCT01777724 Terminated - Parenting Clinical Trials

Evaluation of a Parenting and Stress Management Programmme

HAPPY
Start date: January 2013
Phase: N/A
Study type: Interventional

The study will use a randomised controlled trial design to evaluate the effects of a combined intervention of Triple P-Positive Parenting Program Discussion Groups and Stress Control in comparison to a waitlist condition. The combined intervention will be evaluated with parents in Glasgow, United Kingdom, with a 3-8 year old child.

NCT ID: NCT01773746 Terminated - Clinical trials for Extreme Prematurity - Less Than 28 Weeks

Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants

PRESOX
Start date: August 2013
Phase: N/A
Study type: Interventional

The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.

NCT ID: NCT01773616 Terminated - Clinical trials for Systemic Lupus Erythematosus, Lupus Nephritis

Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis

RITUXILUP
Start date: April 2015
Phase: Phase 3
Study type: Interventional

The treatment of the multisystem autoimmune disease systemic lupus erythematosus (SLE) remains a challenge, particularly when there is renal involvement (lupus nephritis). For the last 60 years corticosteroids have been the backbone of the treatment of lupus nephritis but they are associated with significant toxicity. Although randomized placebo controlled trials of Rituximab in non-renal lupus and lupus nephritis did not meet their primary end-points, there is accumulating data that suggests that B cell depletion with Rituximab may be efficacious in lupus disease refractory to conventional therapy. Furthermore, our pilot data suggests that the addition of Rituximab to mycophenolate mofetil (MMF) without oral steroids is at least as effective at inducing a renal response as the standard of care therapy comprising MMF and high dose oral corticosteroids. RITUXILUP is a proof of concept, open labeled, randomized, controlled, multicentre trial that aims to demonstrate whether the addition of Rituximab to MMF therapy is useful in treating a new flare of lupus nephritis and whether it has a long lasting steroid-sparing, beneficial effect with equal efficacy and greater safety than a conventional regimen of MMF and oral prednisolone. If successful, this trial has the potential to dramatically change the management of lupus nephritis.

NCT ID: NCT01773187 Terminated - Clinical trials for Primary Myelofibrosis

Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

Start date: January 2013
Phase: Phase 3
Study type: Interventional

Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.

NCT ID: NCT01769196 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF)

RAINIER
Start date: January 2013
Phase: Phase 2
Study type: Interventional

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with idiopathic pulmonary fibrosis.

NCT ID: NCT01767857 Terminated - Clinical trials for Metastatic Colorectal Cancer

A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer

XCITE
Start date: March 31, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.

NCT ID: NCT01766336 Terminated - Alzheimer's Disease Clinical Trials

A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease

Start date: January 2013
Phase: Phase 2
Study type: Interventional

To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.

NCT ID: NCT01764997 Terminated - Clinical trials for Rheumatoid Arthritis

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

RA-COMPARE
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX). To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX). To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA).