Clinical Trials Logo

Filter by:
NCT ID: NCT01424423 Terminated - Multiple Sclerosis Clinical Trials

NOGO-A in Multiple Sclerosis FTIH

Start date: February 11, 2010
Phase: Phase 1
Study type: Interventional

The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth. The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).

NCT ID: NCT01424280 Completed - Asthma Clinical Trials

Single Dose Study of GSK1440115 in Patients With Asthma

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess bronchodilator effect after single dose administration of GSK1440115 in a population of mild to moderate asthmatic patients.

NCT ID: NCT01424150 Completed - Abdominal Surgery Clinical Trials

REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study

RELIEF
Start date: July 2013
Phase: Phase 4
Study type: Interventional

The optimal fluid regimen, haemodynamic (or other) targets and fluid choice (colloid or crystalloid) for patients undergoing major surgery are based on rationales that are not supported by strong evidence. Practices vary substantially, guidelines are vague, small trials and meta-analyses are contradictory. The strongest and most consistent evidence, and biological plausibility because of tissue edema, supports a restrictive fluid strategy. But other evidence supports goal-directed therapy, requiring additional IV fluid. There is no good evidence that use and choice of colloids improves outcome. RELIEF will study the effects of fluid restriction, and the possible effect-modification of goal-directed therapy and colloids. The first will be randomly assigned; the latter will be measured covariates dictated by local practices and beliefs. Study Hypotheses A restrictive fluid regimen for adults undergoing major abdominal surgery leads to reduced complications and improved disability-free survival when compared with a liberal fluid regimen. Secondary hypothesis: The effects of fluid restriction are similar whether or not goal-directed therapy is used (assessed as a statistical test of interaction). A restrictive fluid regimen will reduce a composite of 30-day septic complications and mortality.

NCT ID: NCT01423552 Not yet recruiting - Clinical trials for Heart Transplantation

Pharmacology of Immunosuppressants Following Heart Transplantation

Start date: November 2011
Phase: N/A
Study type: Observational

The ongoing success of transplantation is largely due to the development of drugs to stop the patient's body from rejecting the new organ. In addition to steroids, two main types of drug are used to suppress the immune system following heart transplantation: calcineurin inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate. However, different patients respond in different ways to these drugs, with the same dose leading to different levels of the drug in the blood. This varies due to genetic and other factors such as age, kidney function and the use of other drugs. Therefore, the levels of immunosuppressive drugs in the blood are routinely measured and the dose adjusted accordingly. However, some patients still experience episodes of rejection despite apparently acceptable levels. In this study, the investigators will measure levels of the drugs (in the blood, in a type of white blood cell called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells. The investigators will compare these levels with patient genetic factors and the amount of rejection measured on heart biopsies. This will enable us to better understand how the blood and tissue levels of these drugs change with genetic and other factors in order to optimise immunosuppressive therapy and further improve outcomes from heart transplantation.

NCT ID: NCT01423448 Withdrawn - Depression Clinical Trials

Effectiveness of an Online Bulletin Board for Depression: a Longitudinal Randomized Controlled Trial

ShareIT
Start date: n/a
Phase: Phase 0
Study type: Interventional

This study is a randomised controlled trial that aims to examine the efficacy of an established online bulletin board for depression. It has been estimated that millions of people worldwide use peer-to-peer bulletin boards, forums or internet support groups (ISGs) for health conditions. However, little is known about the effectiveness of these groups in terms of symptom reduction or improvement in quality of life. The current project investigates the effectiveness of an established online bulletin board for depression available to the public. To our knowledge, this is the first randomised controlled trial of the effectiveness of a pre-existing, well-established online bulletin board for depression in the community. The aims of the project are to determine whether the bulletin board improves mental health, quality of life, and related outcomes among members of the community with high levels of self-reported psychological distress and previous history or current experience of depression.

NCT ID: NCT01423227 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

HomeBase
Start date: October 2011
Phase: Phase 3
Study type: Interventional

Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program. We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months. If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system

NCT ID: NCT01423084 Completed - Clinical trials for Meningococcal Disease

Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.

NCT ID: NCT01422941 Completed - Obesity Clinical Trials

Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.

NCT ID: NCT01422876 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

Start date: August 2011
Phase: Phase 3
Study type: Interventional

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

NCT ID: NCT01422616 Completed - Ischemic Stroke Clinical Trials

Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)

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

ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)? The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study addressing questions (2) and (4) concluded with a publication of the results in February 2019.