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NCT ID: NCT01533922 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD

NCT ID: NCT01533116 Completed - Parkinson Disease Clinical Trials

Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide

Start date: March 2009
Phase: Phase 1
Study type: Interventional

To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa pharmacokinetics

NCT ID: NCT01533077 Completed - Parkinson Disease Clinical Trials

Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa

Start date: March 2009
Phase: Phase 1
Study type: Interventional

To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA 9-1067 or 1 hour after.

NCT ID: NCT01532869 Completed - Sclerosis, Systemic Clinical Trials

A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

Start date: March 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with systemic sclerosis. Patients will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 49 to Week 96, all patients will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

NCT ID: NCT01532700 Completed - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

An Open-Label Phase 2 Study of Ofatumumab (Arzerra) in Combination With Oral GSK2110183 in the Treatment of Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL)

Start date: February 2012
Phase: Phase 2
Study type: Interventional

This is a phase 2, open-label, single institution trial of combination of intravenous (IV) ofatumumab and oral GSK2110183 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL). Patients must have received at least one prior line of therapy containing fludarabine (single-agent or combination therapy). During the initial 6 months Treatment Phase, ofatumumab will be administered weekly for 8 doses, then once every 4 week cycle for an additional 4 doses (dose and schedule identical to the pivotal phase 2 trial) and GSK2110183 will be given daily PO (Treatment Phase). There will be an initial 10 day lead-in with GSK2110183 alone prior to initiation of ofatumumab to allow for evaluation of changes in cell surface expression due to GSK2110183 and for GSK2110183 pharmacokinetic studies (Lead-in Phase). The official Cycle 1 Day 1 will start on the date of first dose of ofatumumab. Cycle duration = 4 weeks. Patients will be assessed for safety, disease assessment, response, and survival on day 1 of each cycle during the Treatment Phase. A formal review of safety data by the Data Safety Monitoring Board (DSMB) after the first 6 patients have completed cycle 1 of the Treatment Phase will be performed before continuing accrual. All patients achieving SD, PR or CR by the end of the Treatment Phase will proceed to the Maintenance Phase. Patients with PD at any time, including by the end of Treatment Phase, will be taken off study. During the Maintenance Phase, single-agent GSK2110183 will be administered daily for a maximum of 12 months (12 cycles). Maximum duration on any study drug is 18 months (18 cycles). During the Follow-up Phase, patients will be assessed for safety, disease assessment, response, and survival every 3 months through month 36 (year 3), or until subsequent CLL therapy or death, whichever comes first. Key indications for study withdrawal are progressive disease, intolerable toxicity, or completion of therapy

NCT ID: NCT01532648 Completed - Ulcerative Colitis Clinical Trials

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Start date: January 27, 2012
Phase: Phase 3
Study type: Interventional

This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

NCT ID: NCT01532310 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab (BENLYSTA®) Pregnancy Registry

Start date: July 16, 2012
Phase:
Study type: Observational [Patient Registry]

This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

NCT ID: NCT01531894 Completed - Cancer Clinical Trials

Continuation Study of the Oral AKT Inhibitor GSK2110183

Start date: February 8, 2012
Phase: Phase 2
Study type: Interventional

This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study. Subjects were enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study. Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location.

NCT ID: NCT01531816 Completed - Critical Illness Clinical Trials

Early Rehabilitation in Critically Ill Children Pilot Study

WeeHab in PCCU
Start date: February 2012
Phase: Phase 1
Study type: Interventional

Critically ill patients are often confined to bedrest, because of the nature of their illness. However, it has now been shown that prolonged bedrest and immobility, particularly in critically ill adults and children, can lead to serious outcomes such as muscle weakness and prolonged stay in the intensive care unit (ICU). Research in adults has demonstrated that preventing immobility and introducing exercise and rehabilitation in adult patients early during their ICU illness can prevent these serious outcomes, reduce the duration of hospital stay, and enhance their recovery after they leave the ICU. The purpose of our research is to investigate if early mobilization and rehabilitation can also be performed in critically ill children, and eventually evaluate this results in beneficial outcomes in these children, as it has been shown to be in adults. However, given that children are not the same as adults, but have varying abilities to understand and participate in activities when they are sick, the investigators first have to evaluate the most appropriate and safe ways of helping children "exercise" while they are in the ICU. This objective of this study is to evaluate if 2 methods of rehabilitation (a stationary bike and interactive video game) can be implemented in critically ill children. These methods have been used in hospitalized children and in critically ill adults. The investigators will evaluate if these methods are safe for critically ill children.

NCT ID: NCT01531673 Completed - Cystic Fibrosis Clinical Trials

Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation

Start date: February 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.