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NCT ID: NCT00884117 Completed - Influenza Clinical Trials

Influenza Resistance Information Study

IRIS
Start date: January 2009
Phase: N/A
Study type: Observational

This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.

NCT ID: NCT00883974 Completed - Preterm Birth Clinical Trials

Sensitivity Training For Parents of Preterm Infants

Start date: April 2004
Phase: N/A
Study type: Interventional

Immediately following birth, preterm infants face a period of stressful environmental inputs, which may have negative consequences on early brain development and subsequent neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in reducing stressful experiences early in life. The investigators hypothesized that this intervention would insulate preterm infants from the harmful effects of acute and chronic stress, which in turn would result in enhanced brain development. The primary aim of the current study was to investigate if this intervention was associated with improved brain development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary aim was to assess some possible short-term medical benefits.

NCT ID: NCT00883753 Completed - Clinical trials for Rheumatoid Arthritis

An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy

Start date: March 2009
Phase: Phase 3
Study type: Interventional

This study was an extension to study MA21573 [NCT00750880], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was > 500 individuals.

NCT ID: NCT00882908 Completed - Hepatitis C Clinical Trials

A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment

PILLAR
Start date: June 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.

NCT ID: NCT00882453 Completed - Multiple Sclerosis Clinical Trials

Physical Activity and Fatigue in Early Multiple Sclerosis (MS)

BEGIN
Start date: August 2006
Phase: N/A
Study type: Observational

The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

NCT ID: NCT00881946 Completed - Clinical trials for Hematologic Malignancies

Repeat Dose Safety Study for Compound to Treat Hematologic Cancer

Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to characterize the safety and tolerability of repeat doses of compound GSK2110183 in subjects with hematologic cancer.

NCT ID: NCT00880490 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

NCT ID: NCT00880321 Completed - Cancer Clinical Trials

A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors

Start date: June 4, 2009
Phase: Phase 1
Study type: Interventional

BRF112680 is a first-time-in-human study to establish the recommended dose and schedule of the orally administered GSK2118436. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after the treatment of subjects with solid tumors. This is a two-part study. Part 1 will identify the recommended Part 2 dose using a dose-escalation procedure. Escalation may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached. The recommended Part 2 dose will be expanded to up to 12 patients. Part 2 will explore further the safety, tolerability, and clinical activity of GSK2118436 in subjects with BRAF mutation-positive tumors. In addition, the effect of GSK2118436 on midazolam will be assessed in a subset of patients in Part 2. Biologically active doses will be identified by measurement of pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may be explored in Part 2.

NCT ID: NCT00880269 Completed - Clinical trials for Acute Myelogenous Leukemia

Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Start date: August 2009
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.

NCT ID: NCT00879749 Completed - Celiac Disease Clinical Trials

Safety Study of Nexvax2 in Subjects With Coeliac Disease

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

The main purpose of this study is to determine the safety of weekly injections of Nexvax2 given for three weeks to patients with coeliac disease who have been on a gluten-free diet. The second purpose of this study is to compare the immune response over the three week study period in coeliac disease patients given Nexvax2 compared to those given saline.