ANZCTR search results

The purpose of this study is to investigate the efficacy of lithium as an adjunctive therapy to combined antiretroviral therapy in alleviating HIV associated neurocognitive impairment. We are also investigating whether lithium protects against brain changes that have also been observed in HIV associated neurocognitive impairment.

This study aims to determine whether adding the drug, Tocilizumab, to standard transplant immunosuppression is safe and effective at preventing acute graft versus host disease (GVHD). Who is it for? You may be eligible to join this study if you are aged between 18 and 65 years of age and are undertaking an HLA-matched allogeneic haematopoietic cell transplantation (HPCT). Trial details All participants in this trial will receive a single dose of 8mg/kg Tocilizumab by a 60 minute intravenous infusion (administered via the vein). This will occur one day before your HPCT. Participants will be assessed for up to 2 years to determine the incidence of GVHD.

In recent years there has been a national decline in smoking rates however, this reduction is least evident among the most disadvantaged sector of the Australian population. This is mainly attributable to lower levels of quit success among disadvantaged groups rather than differences in quit intentions or attempts. Recent research has shown that financial stress is a major barrier to sustained smoking cessation among socioeconomically disadvantaged smokers, even after controlling for nicotine addiction, psychological stress, and use of cessation counselling and pharmacotherapies. The aim of this project is to test an innovative approach to improving smoking cessation outcomes among low socioeconomic status (SES) smokers by providing financial counselling to reduce the financial stress experienced by disadvantaged smokers making quit attempts. This will be achieved by conducting a randomised controlled trial comparing cessation rates between low SES smokers who receive subsidised nicotine replacement therapy (NRT) with a Quitline call-back with those who receive subsidised NRT and Quitline call-back plus financial counselling. Smoking outcomes will be assessed at 2 and 6 months post-intervention. The results from this project will provide valuable information on the efficacy of targeted interventions for socioeconomically disadvantaged smokers.

All new patients presenting for hyperbaric oxygen therapy meeting the eligibility criteria will be randomized to either a Staged Compression Protocol (Trial regimen) or a Linear Compression Protocol (standard regimen) during their first hyperbaric chamber compression. Both protocols will achieve the treatment depth of 14 meters within 12-13 minutes. The Staged Protocol has a slightly faster compression rate (1.4 meters/min vs 1.1 meters/min) and has 2 holding stage with no pressure change to allow for patient to catch up with their ear equalization. The rate of compression and depth at the holding stages were choosen based on Boyle's Law calculation that middle ear volume will not change more than 30%. Photographs of the tympanic membranes will be taken pre and post the first session of hyperbaric oxygen therapy. The number of interrupted or aborted treatment and subjective pain score will also be recorded. The photographs will be assessed by a blinded experienced otolaryngologist for middle ear barotrauma grade. Primary outcome is incidence of middle ear barotrauma in staged versus linear protocols. Secondary outcomes are number of interrupted and aborted treatments and patient's comfort from the pain score. The hyperbaric doctors, hyperbaric nurses and the otolargyngologist assessor will all be blinded to protocol used. Only the chamber operator (who is not involved in the clinical management / assessment of the participants) will be aware of the protocol used. Sample size calculation require 50 participants per arm for a power of 80% to detect a difference. The department received on average 10 new patients per month and the research is anticipated to take one year.

This study aims to evaluate an online interactive decision aid for prostate cancer screening. Who is it for? You can join this study if you are a male aged 40-69 years who lives in Australia. You must have access to the internet and a reasonable command of the English language. Trial details Participants in this trial will complete an online decision aid for prostate cancer screening. This easy to use interactive decision aid asks men to rate the importance of factors that are relevant to making a high quality decision, and to weigh up the potential benefits (e.g. avoiding the potential loss of lifetime by early detection of prostate cancer) and harms (e.g. false positive test results and unnecessary treatments) of PSA testing for prostate cancer. Participants will be randomly (by chance) assigned to one of two groups. One group will complete the 'Fixed Attributes' version of the decision aid and the other group will complete the 'You Choose' version. The usefulness of the decision aid will be assessed via a series of questions asking the respondents to rate aspects of the quality of the decision about prostate cancer screening.

Deficits in balance are common and debilitating following stroke. Active gaming systems, such as the Nintendo Wii(TM), may provide a means of promoting physical activity to improve recovery post-stroke. We hypothesise that the Nintendo Wii(TM) gaming system, when used in addition to standard inpatient rehabilitation therapy will result in improved balance outcomes in a sub-acute stroke population. We also hypothesise that this system will be a feasible tool for use in an inpatient rehabilitation setting.

The Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) study, is a 6 month research study evaluating the effectiveness of a men only Type 2 Diabetes prevention study that focuses on diet and home-based exercise (aerobic and resistance exercise). Aims: To determine the feasibility and efficacy of a novel multi-component Type 2 Diabetes prevention program (diet + aerobic exercise + resistance exercise) Hypotheses: 1. Compared to the wait-list control, the diet + aerobic training + RT intervention will result in a significant and a clinically meaningful reduction in weight as well as improvements in important secondary outcomes such as plasma biomarkers at 3 and 6 months post-baseline. The Type 2 Diabetes PULSE intervention will consist of a diet and exercise (aerobic and resistance training) program. Men in the intervention group will receive a resource pack with information regarding Type 2 Diabetes prevention. The dietary intervention will consist of a resource manual with information/tips to improve diet quality and reduce Type 2 Diabetes risk such reducing overall energy intake, reading food labels, reducing portion size, reducing alcohol and sugared beverages, improving quality of diet (low GI carbohydrates, high fibre, low saturated fat), achieving an ideal macronutrient (carbohydrates-fat-protein) profile, reducing salt intake, and increasing fruit and vegetable intake. The exercise intervention will consist of both aerobic and resistance training and will be self-administered over the duration of the 6-month intervention. Men will be asked to perform at least 150 mins/wk (5 x 30 min sessions) of moderate intensity aerobic exercise (e.g., walking, jogging, swimming, cycling) and at least 60 mins/wk (2 x 30 min sessions) of resistance training using body weight and Gymstick (an elastic tubing) exercises. Men will be assessed at baseline, 3- and 6-months on a range of health outcomes. Primary outcomes for the study are weight and fasting plasma glucose. Secondary outcomes will include anthropometric, plasma biomarker, and diet and exercise/fitness measures. The wait-list control group will receive the intervention after the 6-month time-point and will be followed up for a further 6 months.

Key challenges faced by patients with cancer and their families include coping with a potentially life threatening disease, making decisions about cancer treatment, and managing the side effects of cancer and its treatment. In particular, those diagnosed with haematological cancers may be at high risk for psychosocial distress. Communicating treatment options, the likely impact of treatments, preparing patients for cancer treatments and providing them with information about how to manage side effects of treatment are likely to be key to helping patients and their families cope with a diagnosis of cancer. The purpose of this study is to examine whether an integrated approach (including access to a web-based program and nurse-delivered telephone support) to helping haematological patients with key psychosocial challenges is effective in reducing depression, anxiety, and unmet information needs among patients and their support persons. Participants will be assigned to either a 12-week period of accessing a web-based program designed to provide effective communication, decisional support and adjustment via research staff-provided iPads, or your usual standard of care normally provided by your care team. Who is it for? 10 tertiary referral hospitals that treat at least 15 patients per year will be invited to participate. In order to be eligible for this trial, you will need to be aged 18 years or older; English speaking; newly diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, Burkitt lymphoma, Lymphoblastic lymphoma (B or T cell), Diffuse large b cell lymphoma, potentially making a decision regarding treatment; have a life expectancy of 2 months or more as judged by their clinician; and be able to provide informed consent. This study will also include participation by a sample of support persons, where each patient will be asked to nominate a designated support person. Eligible support persons will be aged 18 or older, able to provide informed consent, and considered by the patient to be an important source of support in relation to the demands of their cancer diagnosis and treatment. Trial Details Consenting eligible patients will be consented into the study by the clinician in their first consultation. Each patient will be given an information statement and consent form to pass onto their nominated support person. Patients and support persons will then be block randomised by week to either the experimental or usual care group. Experimental group: Patients and support persons randomly allocated to the experimental group will be provided with access to a web-based program designed to provide effective communication, decisional support and adjustment. The website provides tailored information on a range of topics including information about diagnosis, treatment options, what is involved in each treatment, side effects, self-management strategies, impact of cancer on day to day life, available support, complementary and alternative therapies. Patients will be able to access the website through iPads provided by the research team. The intervention will also include access to a telephone helpline staffed by an experienced cancer nurse. Usual care: Patients and significant others allocated to the usual care group will receive care normally provided by their care team. Follow-up: Patient and support person follow-up surveys will be completed at approximately 2, 4, 8 and 12 weeks post-recruitment into the study.

The purpose of this study is aim to determine whether acute acupuncture intervention can improve cognitive functionality in a cohort of relatively healthy participants. We hypothesize that there will be a statistically significant increase in both behavioural and physiological measures of cognitive performance in comparison to untreated control after six acupuncture treatments.

There is good quality evidence that a link exists between negative driving outcomes and ADHD, yet reducing crash and traffic infringement risk for this group of drivers remains problematic. The pilot study aims are to: 1) Determine the magnitude of the between-group and within-subject change in hazard perception skills, reaction time and risk-taking propensity in young drivers with ADHD or ASD exposed to Drive Smart training. 2) Determine if any between-group or within-subject change in hazard perception, risk-taking propensity or reaction time is maintained over time. 3) Estimate the variance of the primary outcome variable to enable sample size calculation. 4) Determine the rate of recruitment and retention of participants in order to establish if a full-scale evaluation of Drive Smart is feasible. Young drivers aged between 16 and 25 years will be randomised to an intervention or control group. Participants in the intervention group will receive a computer training session using a PC-based CD-ROM interactive training program. A second phase is included, in which the control group will receive Drive Smart training as a delayed intervention. This is intended to maximise resources and data collection within the reduced number of participants recruited. This will facilitate investigation of the potential benefits of Drive Smart training beyond the current exposure with participants acting as their own control. An additional benefit of including a second phase is that all participants receive the intervention. This research will contribute to the evidence-base regarding the efficacy of interventions for improving the hazard perception skills of young novice drivers.