ANZCTR search results

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.

To determine the effects of community applied functional electrical stimulation in ambulant children with unilateral spastic cerebral palsy. A device known as the Walk Aide will be given to the intervention group to wear daily for a period of 8 weeks. This controlled trial will determine the effects of using such a device on a range of outcome measures covering the International Classification of Functioning (child and youth version). The outcome of this trial will deepen our understanding of the effects of functional electrical stimulation in a paediatric population and shape our clinical recommendations based on the available evidence.

Onychomycosis is a common nail infection. Current topical therapies are largely ineffective, systemic drugs have significant safety risks, and are limited in broader range of patients. A safe, relatively inexpensive, alternative topical treatment is required to minimise treatment failures and relapses, and also as an adjuvant treatment to improve cure rates. The present study compared the efficacy and safety of topical kunzea oil (twice daily) with amorolfine (once weekly) for the management onychomycosis (study duration 40' +/-' 2 weeks). The study recruited patients from single site (Royal Hobart Podiatry).

The prevalence of obesity has steeply grown in the last decades due to changes in food production, marketing and availability. Food intake largely rests on our ability as an individual to manage to control eating and drinking behaviours within the context of an obesogenic environment. Importantly, it has been found that overweight adults with higher levels of visceral fat have a poorer performance on measurers of risk taking and impulsive behaviours than healthy weight adults with low visceral fat. Those with higher levels of visceral fat are more likely to engage in greater risk taking behaviours and have more unhealthy food choices to those who have less visceral fat stores. It has been shown that visceral fat is more strongly related to cognition than body mass index (BMI). We aim to investigate: (a) the association between visceral fat and cognition, specifically performance as measured by behavioural tests of impulsivity, compulsivity and decision-making; (b) whether reductions in visceral fat are associated with improvement in cognitive control.

Chronic heart failure is a progressive and burdensome syndrome with thirst as a major reason for non-compliance to self- care practices such as fluid restriction. Due to the life threatening effects of non- compliance to fluid restricted therapy, evidence based interventions are needed to manage thirst. Systematic evaluation of available strategies such as chewing gum is essential in ensuring that the best possible management is provided to CHF patients. The purpose of this study is to test the hypothesis that chewing gum can reduce thirst in people with chronic heart failure.

The primary objective of this study is to measure and track the psychosocial consequences of a severe burn injury in terms of its impact of patients’ mental health. Screening all severe burns injury patients admitted to the Severe Burns Injury Unit will offer all patients the opportunity for outcome tracking and collect the necessary extensive cohort data on which to base future treatment, policy and advocacy as well as a targeted study on early intervention for PTSD. Burn patients are at risk of developing this disorder, which is associated with increased rates of medical morbidity, poor health-related quality of life, and functional impairment. It is important to note that primary care, rather than specialty mental health services, has been the point of contact with the health care system for the majority of individuals with PTSD. Improving detection of PTSD, adverse coping styles and depression are important steps in addressing the health and mental health burden experienced by these patients.

In 2011, members of our research team published the results of the Quality in Acute Stroke Care (QASC) Trial. This cluster randomised controlled trial evaluated the effectiveness of team-building workshops and education to introduce three clinical protocols to manage fever, sugar and swallowing (the FeSS protocols) in the acute stroke unit. We found that patients cared for in stroke units who received our intervention were 16% more likely to be alive and independent 90 days following their stroke. They also had fewer episodes of fever, lower mean temperatures, lower mean blood glucose levels, and better screening for swallowing difficulties. This landmark trial demonstrated that teamwork and good nursing care can improve patient outcomes. Building on this previous work (1) we will evaluate using a cluster randomised controlled trial, an organisational intervention in EDs. Our evidence-based T3 Trial intervention will comprise: A) evidence-based clinical protocols for triage, treatment and transfer in acute stroke comprised of: (Ai) routine assignment of stroke patients to triage Category 1 or 2; (Aii) time-sensitive ‘trigger’ screening for tPA eligibility; (Aiii) instigation of protocols for prompt management of fever, hyperglycaemia and swallowing; (Aiv) rapid transfer of patients from ED to the stroke unit. To support implementation of the protocols we will use: B) an evidence based implementation strategy consisting of: (Bi) workshops to identify local barriers and enablers and to identify clinical champions; (Bii) didactive and interactive education; (Biii) use of local clinical opinion leaders (site clinical champions); and (Biv) reminders in the form of email, telephone and site visits. This trial will be conducted in the EDs of hospitals with pre-existing dedicated stroke units in NSW, Victoria, Queensland and the ACT. EDs will be randomised to receive either the T3 Trial intervention or no additional support. At 90-days post-admission, we will measure death or dependency (mRS) (primary outcome); health status; and quality of life (secondary outcomes). A separate process analysis will examine contextual factors that may influence successful intervention uptake. Our novel and timely intervention will bridge the theory-practice gap aiming to deliver improvements in 90-day health outcomes for a group of patients currently underserved by evidence-based practice Reference 1. Middleton S, McElduff P, Ward J, Grimshaw J, Dale S, D’Este C, Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D, Levi C. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia and swallowing dysfunction in acute stroke improves 90-day outcomes: QASC, a cluster randomised controlled trial. The Lancet 2011; 378 (9804): 1699-1706.

The current project aims to conduct a Pilot Study, to obtain qualitative and quantitative data on the impact of a combined treatment, comprising an existing online alcohol support program – OnTrack (www.ontrack.org.au), together with emails and newsletters focusing on nutrition and healthy lifestyle "OnTrack to Cutting Down and Feeling Good" emailed newsletters. Approximately fifteen male and female participants, aged over 18 years and drinking more than 14 standard drinks per week will be recruited in to the OnTrack online alcohol program. They will be assessed on their drinking behaviour, physical activity, and diet at the start of the Pilot Study and then again after participating in OnTrack Alcohol and receiving the emailed "OnTrack to Cutting Down and Feeling Good" newsletters. The participants will also be questioned by phone interview about their experiences using OnTrack Alcohol and the "OnTrack to Cutting Down and Feeling Good" emailed newsletters.

Comparison of plastic cannulae and metal fistula needles. The different outcomes associated with the use of plastic fistula cannulae compared with metal fistula needles will be investigated in haemodialysis in-centre patients.

Mobility limitation is common in rehabilitation patients and can be improved by well-designed exercise programs. Exercise in people with mobility limitation is associated with better functional outcomes if the exercises relate closely to functional movements required for daily task independence. The broad aim of this project is to enhance mobility outcomes for people undergoing aged care and neurological rehabilitation. The specific hypothesis of this trial is that the addition of technology-based interactive exercises involving feedback to usual care will lead to better mobility outcomes than usual care alone for people admitted to aged care and neurological rehabilitation wards with mobility limitations. This study also aims to assess the cost-effectiveness of the intervention compared with usual care, establish predictors of greater use of the technologies and enhance understanding of participant experiences of technology use with qualitative methods. Participants will be randomised into a control and intervention group (n=300). Both groups will include hospital patients undertaking a usual rehabilitation program and the intervention group will receive one extra 30 to 60-minute session per day of video and computer or tablet-based interactive exercises. After discharge from the inpatient stay, participants in the intervention group will be encouraged to continue using the technologies at home. The total duration of the intervention will be six months after randomisation. Participants will be loaned necessary technology and trained in the safe use and progression of the games/exercises during a home visit by therapy staff. Weekly support via telephone, email of videoconference will also be provided during this phase of the study. This support will aim to assist study participants to maintain motivation and will identify and address any barriers to technology use at home. A baseline assessment will be conducted and follow-up assessments will occur at 3 and 12 weeks and 6 months after randomisation.