ANZCTR search results

This randomised controlled trial compares the safety and efficacy of using supplemental Insulin Aspart (Novorapid) vs Actrapid to maintain tight glycaemic control in hospitalised patients with diabetes.

Five different injections are purported to be effective for lumbar radicular pain. Each has its advocates but each lacks convincing scientific data. This study is designed to test which of these injections is effective, for relieving pain and restoring function, in the greatest proportion of patients and for the longest duration.

Hepatitis C virus (HCV) is the most common blood borne virus affecting injecting drug users (IDUs). 90% of new cases of Hepatitis C in Australia are attributable to injecting drug use. Hepatitis C treatment is effective in clearing the virus in between 50% and 80% of cases and is cost effective when considering the averted treatment costs of chronic viral hepatitis. Despite this there are a number of barriers to the effective treatment of IDUs, and as a consequence only 2-3% of IDUs are estimated to have received HCV treatment.This study proposes to treat active IDUs for hepatitis C infection using directly observed (DOT) pegylated interferon and ribavirin therapy in accordance with current Pharmaceutical Benefits Scheme legislation. Participants will be regularly assessed for psychological status and drug use utilising a variety of registered questionnaires. Participants will be monitored and guided throughout the study with the support of a peer counsellor. This person will provide participants with the guardianship, advocacy, interaction and education required to effectively manage personal and study-related issues (physical and psychological), to encourage treatment compliance and to reinforce safe injecting practices.The primary outcomes are: (i) achievement of sustained virological response, which is defined as having no detectable hepatitis C virus 6 months after the completion of treatment, (ii) achievement of treatment compliance, which will be determined from the proportion of patients attending =80% of DOT visits and the proportion of patients taking =80% of the HCV treatment, and (iii) determination of the value of a peer counsellor in HCV treatment of active IDUs when the physical and mental health, substance use and treatment compliance of participants is actively monitored. This study is designed to increase the opportunity for effective and supported hepatitis C treatment in active injecting drug users. The study aims to show that active IDUs can achieve successful outcomes from hepatitis C treatment and to determine those variables which are important in achieving this, including the value of a peer counsellor to the treatment team.

This study looks at the feasibility and usefulness of a telephone-delivered lifestyle and psychosocial supportive care program for patients with cancer of the back passage (rectum) or large bowel (colon). CanChange: A psychosocial and lifestyle intervention for colorectal cancer survivors Who is it for? You can join this study if you have been diagnosed with first primary colorectal cancer between 01/07/08 and 01/07/09, and this has been notified to the Queensland Cancer Registry. Trial details Participants will be randomly divided into two groups. Participants in one group (the intervention group) will receive a telephone-delivered lifestyle and psychosocial supportive care program. The program will be delivered over 6 months and include up to 12 sessions two weeks apart for approximately 30 minutes each. Participants in the other group (the control group) will receive the standard care and will be posted a range of colorectal cancer and lifestyle materials. This study will implement and evaluate a telephone-delivered cancer rehabilitation program (CanChange) for colorectal cancer survivors. It is hypothesised that, compared with usual care participants, CanChange participants will have decreased psychological distress and cancer-related fatigue and will show improvements in quality of life, symptom management, nutrition and physical activity.

The Wellness Study will evaluate 6 weeks of very low dose Escitalopram (50 micrograms) compared to placebo on fatigue, anxiety and depression in chronic medical illness. Following a 3 week baseline run in-phase, participants will be randomised 'double blind' to the active or placebo treatment, incorporating 4 study centre visits in all. Associated clinical benefits may include improvements in sleep, weight reduction, heart rate and blood pressure. Although serotonin re-uptake inhibitors have never previously been studied at such a low dose, clinical results to date appear encouraging.

This phase IIIb study will include adult patients, 18 years or older,body weight 150kg or less, with moderate to severe active rheumatoid arthritis (RA) of duration 6 months or more, who are inadequate responders to DMARDs or anti-TNF therapies. The primary objective is to assess the safety and tolerability of tocilizumab (TCZ) monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). The secondary objectives is to assess the efficacy of TCZ monotherapy or in combination with non-biologic DMARDs. The study is designed so that patients would be on the study for 24 weeks, receiving 6 x 60min infusions of TCZ every 4 weeks. AEs and other safety variables will be analyzed using descriptive statistics. Safety and study data will be collected on an electronic CRF.

This is a randomised controlled trial of a home-based resistance training program using resistance exercise bands, for people with type 2 diabetes who are limited in their ability to perform aerobic exercise due to other co-morbidities.

This study will follow 50 patients for 12 months who undergo Total Disc Replacement in their lumbar spine using the Stryker Flexicore intevertebral disc. The Stryker Flexicore intevertebral disc is a single unit, all metal device. Pre-operatively the patients will have a clinical examination, x-rays, blood test, and complete three patient questionnaires (VAS, SF-12 and Oswestry). The study follow up visits will be at 6 weeks, 3 months, 6 months and 12 months post-operatively. These visits involve standard follow up care x-rays and clinical examination, in addition there will be three questionairres (VAS, SF-12 and Oswestry) for the patient to complete, and a blood test at the 12 month visit. The study aims to compare the Chrome and Cobalt metal ions level in the patient's blood after 12 months as well as assess the patient's pain and activity level outcomes pot-op.

The protection provided by sodium cromoglycate, against airway narrowing provoked by mannitol, is incomplete. This is likely due to the failure of SCG to prevent release of leukotrienes from cells other than mast cells. The protection against airway narrowing in response to mannitol will be more complete using a combination of SCG and a leukotriene antagonist.

The REGISTER study aims to maximise the treatment potential of Glivec (Registered trade mark) (also known as imatinib) in patients with metastatic or unresectable Gastro-intestinal Stromal Tumour (GIST) by individualising treatment. Treatment for each patient will be determined according to the biological features of their tumour when examined in the laboratory. We know that tumours with certain findings are less likely to do well on standard treatment. Patients with these types of tumours will be treated with an increased dose of Glivec (Registered trade mark). Patients with tumours that we know are more likely to do well will be treated with a standard dose of Glivec (Registered trade mark) but will move on to an increased dose when the standard dose stops being effective. The response to treatment will be measured using Computerized axial Tomography (CT) scans. Early response will be measured using Fluorodeoxyglucose Positron Emission Tomography (FDG PET) scans.