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NCT ID: NCT01905215 Completed - Clinical trials for Infections, Respiratory Syncytial Virus

Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines

Start date: July 22, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.

NCT ID: NCT01905020 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes

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

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes. The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.

NCT ID: NCT01904591 Completed - Spinal Cord Injury Clinical Trials

The Effects of Anti-oxidants on Clinical Outcomes and Radiological Features of Chronic Spinal Cord Injury: A Pilot Study

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

This study will enroll 10 adults with a chronic spinal cord injury. The investigators will image their damaged motor tracts using MRI tractography scanning, and the investigators will formally assess their ASIA motor level at the outset of the study. Then, the investigators will treat them with one year of 'over the counter' dosage of selenium and vitamin E. These are two vitamins known to be anti-oxidants. After one year the investigators will repeat the MRI scans and ASIA assessments to determine if their has been any change in the appearance of motor tracts on MRI tractography, or in motor level on ASIA exam. As this is a pilot study the investigators are primarily concerned with establishing safety of this intervention, with a view to conducting a larger and more rigorous controlled trial in the future. The investigators also have a small hope that in fact some improvement might be found with vitamin treatment.

NCT ID: NCT01904292 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis

Start date: August 15, 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.

NCT ID: NCT01904279 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Subcutaneously Administered RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis

Start date: July 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis. Patients will receive RoActemra/Actemra subcutaneously every 2 or 3 weeks for 52 weeks.

NCT ID: NCT01904266 Completed - Pain, Postoperative Clinical Trials

Paravertebral Blocks for Breast Cancer Surgery

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

This research project intends to look at the effect that a certain type of freezing injection, called a paravertebral block, has on the pain after an operation for breast cancer, the amount of pain relief that is needed and the side effects from this pain relief. The hypothesis is that the paravertebral block, in combination with a general anesthetic will reduce both pain scores and the amount of strong pain killers (opioids) that is needed. This will reduce the side effects of the pain killers such as nausea and vomiting. This will be assessed by comparing it a general anesthetic with pain killers given through the intravenous (IV) as is routine practice. Patients requiring breast cancer surgery, who agree to be involved in the trial, will be randomly allocated into two groups: both groups will receive a block, then a standardised and optimised general anesthetic. In one group however the block is simply a small injection under the skin (a sham block), whereas the other group will receive a proper paravertebral block prior to this. Both groups will receive opioids as necessary, depending on both their bodies reaction during the surgery and their pain scores when they wake up. The paravertebral block is a very safe procedure with a very low side effect profile, and many studies have shown a benefit in breast cancer surgery. The investigators would like to assess this in our own practice. The block is normally inserted under some light sedation, with freezing into the skin initially. It is normally very well tolerated. The sham block will also be performed under light sedation and freezing into the skin. The patients will not be able to tell whether they are having the sham block or the paravertebral block, because both are very well tolerated. There are no potential complications from the sham block.

NCT ID: NCT01904058 Completed - Clinical trials for Primary Biliary Cirrhosis

Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis

CLARITY
Start date: August 2013
Phase: Phase 2
Study type: Interventional

The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.

NCT ID: NCT01903993 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

Start date: August 6, 2013
Phase: Phase 2
Study type: Interventional

This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

NCT ID: NCT01903785 Completed - Bronchoconstriction Clinical Trials

Salbutamol, Pharmacogenetics and Breathing Mechanics

Start date: May 2013
Phase: Phase 4
Study type: Interventional

Athletes using asthma medications called β2-agonists win a disproportionately high number of medals at Olympic Games. Due to a large variety in the genes that affect how individuals respond to β2-agonists, the investigators will look at variations in the genetic response to these medications by dividing athletes into high-responders and low-responders. The investigators will then compare athletic performance after the inhalation of β2-agonists to placebo. Furthermore, the investigators will analyze the effect of β2-agonists on breathing mechanics. Due to differences in their anatomy females may decrease the energy needed for breathing during high-intensity exercise to a greater extent compared to male athletes after the inhalation of β2-agonists.

NCT ID: NCT01903733 Completed - Clinical trials for Chronic Myeloid Leukemia

Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

Start date: August 28, 2013
Phase: N/A
Study type: Interventional

The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.