ANZCTR search results

A large scale randomised controlled trial conducted using a smartphone application to evaluate the comparative effects of four different forms of front-of-pack nutrition labelling against the current back-of-pack nutrition information panel on the healthiness of foods purchased. The four front-of-pack nutrition labelling formats tested will be: 1. Colour-coded multiple traffic-light labels; 2. Monochrome daily intake guide labels; 3. The "energy stars" based front-of-pack nutrition labels; and 4. Advisory labels. The findings will feed directly into the ongoing policy debate about the format of front-of-pack nutrition labelling to be introduced in Australia.

Venous thromboembolism (VTE) is a significant health problem especially in hospitalized patients, with a high associated morbidity and mortality. For most patients, the standard of care is to use prophylactic anticoagulation (heparin) and intermittent pneumatic compression to both lower limbs. There is a group of patients who are at very high risk of VTE but these VTE prophylactic measures cannot be used or considered adequate, either for physical reasons (lower limb fractures / open wounds ) or risk of bleeding from anticoagulants (such as severe brain injury). In these patients, the options are to use no intervention or to insert an Inferior Vena Cava filter (IVCF). Although IVCFs are widely used as a mechanical VTE prophylaxis in patients who have contraindications to conventional VTE prophylactic measures, their effectiveness in this regard has not been established. This phase II / III randomized controlled trial aims to assess the clinical effectiveness, benefits and harms, and also the cost- effectiveness of the early use of IVCFs (<72 hrs of admission after severe injury) for trauma patients who have contraindications to conventional VTE prophylactic measures (pharmacological thromboprophylaxis). This trial has the capacity to influence the management of trauma patients worldwide, and to establish the place of IVCFs in modern medical practice.

ANDROFEME (Registered trademark) cream is currently the only available testosterone product in Australia with widespread use in clinical practice. The available pharmacokinetics indicate the most appropriate dose for women is 0.5ml (5mg)/day. However the absorption of transdermal preparations is known to vary according to the area of application. This was not controlled for in prior studies. Furthermore, the investigators believe the upper arm is not an appropriate site for the drug application as 1) there is a greater risk of transfer of the applied drug to others; 2) contamination when blood is drawn for measuring testosterone levels is common (resulting in falsely elevated levels) and 3) the possibility of increased blood levels of testosterone in the ipsilateral breast. In this study we will evaluate the pharmacokinetics of two application sites of 0.5ml (5mg) of this testosterone 1% cream in postmenopausal women: an area on the upper outer thigh/ lower buttock approximately the size of the palm (approximately 80cm2) and a broad area on the outer thigh/ lower buttock (approximately 300cm2).

Research suggests that there are an insufficient number of services available to help the large number of Australians who experience mental illness. Therefore the focus should be on prevention. The internet has been shown to be an effective way of delivering mental health education and prevention in schools. One such internet delivered intervention is the Managing Stress program (from ‘THIS WAY UP Schools’ a sector of CRUfAD), which has previously been evaluated in a large RCT with an adolescent population (van Vliet and Andrews, 2009). The current research aims to address the need for early intervention by replicating van Vliet and Andrews (2009) study in evaluating the effects of the Managing Stress online program for children in year 5 of primary school.

This pilot study is to define the acceptability of short vs. long course of antibiotics for the treatment of young children hospitalized with pneumonia

PULSAR stands for ‘Principles Unite Local Services Assisting Recovery’. The overall aim of the PULSAR project is to imbed recovery-oriented practice in primary care and specialist mental health services throughout the Monash Health catchment. Recovery-oriented practice involves supporting a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential. A package of training interventions has been developed in the United Kingdom that promotes recovery-oriented practice in teams. We adapt these materials for the Australian setting so that the content and processes of training and development are sensitive to needs of the Victorian mental health care system, the local cultural and legal contexts. The PULSAR intervention involves training staff in recovery-oriented practice using these adapted materials. This trial pertains to the evaluation of the PULSAR intervention within specialist community-based mental health services; the evaluation of PULSAR in primary care services is being evaluated in separate trial, which is separately registered with ANZCTR. In the specialist care trial, we are delivering the PULSAR intervention to staff at 14 specialist community mental health care settings (clusters) and evaluating the effect on adult consumers of these services. Half of the clusters are randomised to receive the PULSAR intervention in year 1, and the other half receive the PULSAR intervention in year 2. Our key hypotheses are that consumers in the PULSAR intervention clusters will experience significantly greater gains in personal recovery and in health and wellbeing compared to consumers receiving care in control groups. Data will be collected cross-sectionally from a minimum of 252 volunteer service users at three time points: baseline, end of year 1 and again at the end of year two. The total number of participants will be at least 756 consumers (i.e. minimum of 18 consumers per cluster per time point). Consumers are recruited into the study if they respond to an invitation letter by completing and returning a short recovery-focused survey. A subset of participants who also return a signed "consent to future contact form" are invited to attend a face-to-face interview where more detailed data will be collected assessing recovery, health and well-being, service satisfaction, perceived coercion in accessing services and health economic impact. Longitudinal data are collected from a further subset of participants invited to attend two face-to-face interviews at time points corresponding to the pre and post intervention periods for their particular cluster. The significance of the work will be to develop, evaluate, and make readily available a set of training materials and organisational change tools that would facilitate participating mental health services working together to successfully deliver recovery-oriented practice.

This study aims to investigate the interactions and effects of salt and fat consumption on palatability. The objective is to quantify the contributions of different concentrations of salt and fat in food on subjective liking and wanting in humans classified according to fatty acid taste sensitivity. Fifty participants, aged 18-45 will participate in the study and will taste food samples with varying salt and fat contents. Subjective liking and wanting will be assessed in addition to assessing individuals oral fatty acid sensitivity.

To determine if the Kanmed WarmCloud reduces the incidence of hypothermia in patients when compared with the Bair Hugger warming system in patients undergoing a liver transplant

Stroke survivors with severe upper limb paresis have the poorest functional prognosis. There is growing evidence of the benefits of repetitive training to promote recovery of upper limb function. In addition, there is accumulating evidence that non-invasive brain stimulation techniques, such as tRNS, can augment activity within the cortical areas that are engaged during various forms of training. The aim of this study is to investigate the therapeutic and neuroplastic effects of combining repetitive training with tRNS in stroke survivors with chronic and severe upper limb paresis. A triple-blind randomised controlled pilot trial will be conducted. Ten stroke survivors will be randomly allocated to 4-weeks of SMART Arm training with active tRNS or sham-tRNS. To determine the clinical benefit, all participants will be assessed pre- and post-training and 2-months follow-up using a range of impairment, activity, participation and quality of life measures. To determine the structural (DTI) and functional (resting state fMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre- and post-training.

The aim of this study is to determine whether an alternating regime of imatinib and regorafenib improves disease control in patients with metastatic gastrointestinal stromal tumours (GIST). Who is it for? You may be eligible to join this study if you aged 18 years or more and have a confirmed diagnosis of metastatic GIST. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive an alternating regime of treatment with the drugs imatinib and regorafenib (administered orally by tablet). One treatment cycle lasts for 8 weeks. Participants in the other group will receive treatment with daily imatinib tablets only. Imatinib is currently used as the initial treatment for incurable GIST. Although many people with metastatic disease initially respond to imatinib, the cancer usually becomes resistant to this drug and starts to grow. The cancer drug called regorafenib works in a similar way to imatinib and has been shown to be effective against GIST after other treatments have stopped working. Participants will be regularly monitored for a minimum of 24 months follow-up in order to determine whether the alternating treatment approach improves disease control. If it is found to have benefit and be tolerable, this alternating approach will be further evaluated in a larger study.