ANZCTR search results

The aim of this project is to investigate if humans are able to detect small amounts of carbohydrate orally and investigate links with dietary consumption, ad libitum consumption of carbohydrate foods, and weight. Over the past decades, behavioural studies demonstrated that rats are very attracted to starch and that starch is preferred to sucrose at low concentrations, suggesting that rats have different taste receptors for sucrose and starch. Carbohydrates, in the form of sugar and starch, represent a major source of food energy. Except for some fruits, plants contain much more starch than sugar, but it is sugar with its sweet taste that is the most sought after carbohydrate. Compared to sugar, starch is rather bland to the human palate, and has been assumed to be tasteless for other animals as well. However, in the past decades, studies using animal models reported that rats are very attracted to the taste of maltodextrin (starch). The results of these studies suggest that starch and sucrose stimulate different taste qualities, indicating there is an independent taste receptor for polysaccharides. Recent studies investigating carbohydrate sensing in the human oral cavity through exercise performance have also found that exercise performance significantly improved after participants rinsed their mouth with solutions containing maltodextrin (see review by e-Silva et al., 2014). The results suggest that there may be an independent mechanism and pathway for oral carbohydrate detection, but as yet, there is not method for assessing carbohydrate detection thresholds in humans. A targeted sample of 150 participants will participate in this project and subjects must be over the age of 18 years. It is also preferred that subjects are non-smokers.

Factors for operative treatment include severity of diseases that affect the hip, symptoms, clinical finding on physical examination and radiological assessment of the hip. When referring to total hip replacement (THR) surgery, both the acetabular socket and the head of the femur are replaced with a suitable prosthetic device consisting of a cup fitted into the acetabulum (socket) and a new head (ball) with stem fitted into the upper shaft of the femur. Two major factors influence the outcome of THR (outside the surgery process itself) and these are the fixation of the components to the bone and wear of the implanted surfaces. (between the ball and socket). THR is an extremely successful operation due to continuous improvements in surgical techniques, bio-materials and implant design. It is necessary however, to safely evaluate new advances in the design of hip replacement components so that improvements are sought to continually enhance patient outcomes. The design and materials used in the MASTER-SL femoral implant are very similar to other prosthesis already used by surgeons. The aim of this trial is to assess the clinical performance of the MASTER-SL femoral stem over a two year period under standard condition of use in THR.

Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for Australian workers. This is intended to cover the evaluation via a multisite randomised controlled trial (RCT) of a smartphone intervention aimed at promoting mental health and well-being. Specifically, this study aims to evaluate the efficacy of a smartphone application (‘app’) designed to prevent depression in workers, with an intervention condition (‘HeadGear’ app) and attention-matched control condition (‘HeadGear lite’ app). Specifically, the relative efficacy of the application as a tool for primary prevention of common mental disorders will be evaluated. All employees of several partner organisations will be invited to participate, and directed to their app store via advertisements or via visiting the trial website. Upon downloading the app, participants will undergo initial screening, provide informed consent, and complete baseline assessments of outcomes including: depression (PHQ-9) and anxiety (PHQ-2) symptomatology, wellbeing (WHO-5 Well-being Index) and work performance (HPQ). Participants scoring below 9 on the PHQ-9 at baseline will then be randomised to receive either the intervention ‘HeadGear’ application or the attention-matched control version of the app. Those scoring above 9 or meeting MDD diagnosis using the PHQ-9 algorithm will be provided with appropriate referral information to health services and crisis lines, and will be encouraged to seek help from their GP. Participants are encouraged to use the smartphone application for 30 days. Post-intervention assessment will occur at 5 weeks post-baseline, and 3 and 12 months later at follow-up, with measures similar to those assessed at baseline. All assessment (apart from diagnostic interviews) will be completed online. Individuals whose results indicate depressive symptomatology or diagnosis (via PHQ-9); and a random sample of 10% of participants at 3 months, will receive a follow-up diagnostic telephone calls from trial staff. Researchers will be evaluating the relative impact of the smartphone application intervention on the prevention of common mental disorders, primarily depression, and its effects on health and wellbeing outcomes, immediately after trial participation, and 3 and 12 months later.

Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for Australian Workers.. This is intended to cover the evaluation via a multisite randomised controlled trial (RCT) of a smartphone intervention aimed at promoting mental health and well-being. Specifically, this study aims to evaluate the efficacy of a smartphone application (‘app’) designed to treat depression in workers, with an intervention condition (‘HeadGear’ app) and attention-matched control condition (‘HeadGear lite’ app). Specifically, the relative efficacy of the application as a tool for treatment of common mental disorders will be evaluated. All employees of several partner organisations will be invited to participate, and directed to their app store via advertisements or via visiting the trial website. Upon downloading the app, participants will undergo initial screening, provide informed consent, and complete baseline assessments of outcomes including: depression (PHQ-9) and anxiety (PHQ-2) symptomatology, wellbeing (WHO-5 Well-being Index), Overall health (SF-12), resilience (CD-RISC 10) and work performance (HPQ). Participants scoring below 14 or not meeting diagnostic criteria on the PHQ-9 on the PHQ-9 at baseline will be excluded from this trial. Eligible users will then be randomised to receive either the intervention ‘HeadGear’ application or the attention-matched control version of the app (users will also be provided with appropriate referral information to health services and crisis lines, and will be encouraged to seek help from their GP). Participants are encouraged to use the smartphone application for 30 days. Post-intervention assessment will occur at 5 weeks post-baseline, and 3 and 12 months later at follow-up, with measures similar to those assessed at baseline. All assessment (apart from diagnostic interviews) will be completed online. Individuals whose results indicate depressive symptomatology or diagnosis (via PHQ-9); and a random sample of 5% of participants at 3 months, will receive a follow-up diagnostic telephone calls from trial staff. Project researchers will be evaluating the relative impact of the smartphone application intervention on the treatment of common mental disorders, primarily depression, and its effects on health and well-being outcomes, immediately after trial participation, and 3 and 12 months later.

Intensive care patients face health issues that extend beyond their critical illness, including weakness, changes in quality of life, and an increase likelihood of disease and death. One area of post-ICU illness that may be preventable is fragility fracture. Fragility fractures occur due to weakening of bone, most commonly due to osteoporosis in postmenopausal women. Fragility fractures have devastating effects, resulting in hospitalisation, loss of independence and function, and increased likelihood of dying in the following year. Critical illness appears to increase the rate of bone loss, with studies showing an increased in markers of bone turnover, an accelerated loss of bone mass, and an increase in rate of fragility fractures, during and after critical illness. This is particularly evident in women, suggesting critically ill women face an extra injury to their bones at a time when they are already at risk. Medications that prevent or reduce bone loss have been extensively tested and shown to be effective in post-menopausal women, and other groups at risk of losing bone rapidly. This includes some types of cancer, and patients receiving therapies that cause bone loss. There is limited experience in using antiresorptive medications in critical illness, although some evidence suggests they may be effective at reducing bone turnover. Denosumab is a more recent antiresorptive medication that acts to prevent bone loss, and has been shown to be effective in large trials. It has not be used in critical illness, so we would like to perform a small study to ensure it is safe and effective in this group. Bisphosphonates, like Zoledronic Acid, have been used to treat critically ill patients with biochemical evidence of bone resorption, and shown to be associated with reduced mortality in retrospective studies of critically ill patients. Denosumab and Zolderonic Acid have side effects, including acute hypocalcaemia, flu like symptoms, osteonecrosis of the jaw, real impairment (zoledronic acid), change in immune function (denosumab), and post cessation bone loss (denosumab). Given these we plan to delay study drug administration until there is no active infection, and stable renal function. At the completion of this study we will examine the safety and effect of denosumab and zoledronic acid on bone turnover in postmenopausal critically ill women. If it appears safe and show signs of benefit, we will plan a larger study to assess effect on bone mass, fractures, and survival.

The purpose of this trial is to evaluate the impact of the Burn 2 Learn (B2L) intervention on students' cardio-respiratory fitness and secondary outcomes (muscular fitness, body composition, vigorous physical activity, cognitive control, motivation, basic needs satisfaction and psychological health). Our primary hypothesis is that students allocated to the intervention condition will experience improved cardio-respiratory fitness relative to students allocated to the control condition by the primary study end point (14 weeks post-baseline). We aim to recruit 80 grade 11 students from two schools (x40 per school) who will be randomly allocated (by school) to received the B2L intervention or participate in usual practice (control group to receive the intervention after the final assessments). The B2L intervention will involve students participating in 2-3 sessions per week of High Intensity Interval Training (HIIT) for 14 weeks, delivered at school by peer leaders (trained grade 11 students). To facilitate the intervention, 2 x teachers will be recruited as school champions and will attend a one-day professional learning workshop. Peer leaders (x 5-10 students) will be identified and recruited from the intervention school. Peer leaders and students will participate in a 2 hour workshop delivered by the research team. The HIIT sessions will involve a variety of engaging exercises and will occur for 15-20 minutes at a time. The intervention school will receive an equipment pack (heart-rate monitors, iPad, Bluetooth speaker, exercise cards) to facilitate session delivery. To gain support from the home environment, parents of study participants will receive 2 x eNewsletters via Facebook or the Skoolbag app during the study period.

Many people with diabetes experience problems with their balance and walking, which can make day to day activities difficult and increase the chance of sustaining a fall. Nerve damage (a common complication of diabetes) can severely disrupt the quality of the signals transmitted from the feet to the brain, which provide vital cues about the ground we stand on and the relative position of our body above, to help people remain upright. Novel footwear devices are emerging as an attractive treatment option to help alleviate balance and walking problems and reduce the risk of falling in adults with diabetic peripheral neuropathy (nerve damage). Textured shoe insoles (comprising raised nodules) are designed to enhance the signals from foot skin receptors, which is important for good balance. This randomized controlled trial will be the first to explore whether use of different shoe insole surfaces (over 4-weeks) can improve balance and walking performance in adults with diabetic peripheral neuropathy. We will also investigate whether any alterations in balance or walking are associated with underlying changes in the amount of remaining feeling in participants’ feet (measures of foot sensation and foot position awareness). Additionally, we will explore whether wearing different shoe insole surfaces lead to improvements in physical activity levels or measures of self-reported foot heath and falls in adults with diabetic peripheral neuropathy. This study will bring new perspective to our understanding of the therapeutic role of footwear interventions, as a means to address deficient postural control in adults with neuropathic changes at the feet. The findings will be used to inform the development of new rehabilitative approaches that will help advance clinical guidelines and policy, and reduce the escalating personal, societal and economic burden of falls in people with diabetes.

Increasing energy expenditure to reverse obesity may be possible using beta-3 adrenergic receptor agonist drugs, however it was not until recently that such drugs have been available under prescription. These approved drugs were developed for purposes other than treatment of obesity, so they have never been studied in this context. In this proposal, we will conduct a pilot study to determine the effects of multiple doses (the highest prescription dose of 50 mg, plus 100, 150 and 200mg) of the beta-3 adrenergic receptor agonist, mirabegron, on whole body energy expenditure and cardiovascular responses. This will be a dose finding study for which the purpose is to obtain data in order to inform a larger trial which will be conducted subsequently. We aim to determine the highest dose which will maximise energy expenditure without effects on the cardiovascular system.

The aim of this study is to test if panitumumab is a potentially useful treatment for pancreatic cancers which do not have mutations in the KRAS gene. Panitumumab has been shown to be effective in colon cancer, but only in those patients with cancers that lack a mutation in the KRAS gene. The fact that 90% of patients with pancreatic cancer have a mutation in the KRAS gene may explain why panitumumab has not been found to be effective when it has been administered to all patients with pancreatic cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with locally advanced (unresectable) or metastatic pancreatic ductal adenocarcinoma (PDAC) which has progressed following first line chemotherapy. Study details Participants enrolled who have KRAS wild-type PDAC will be allocated to the treatment arm. These participants will receive panitumumab by injection, once every two weeks for up to 24 months, with chemotherapy started at 4 months if your treating doctor determines that this would be beneficial. Participants enrolled who have KRAS mutated PDAC will be allocated to the observation group. These participants will receive standard treatment as determined by their treating doctor, and will simply complete trial assessments. Assessments for all participants will include CT scans and blood tests to monitor cancer progression for up to two years. It is hoped that the findings from this trial will provide information on whether panitumumab is an effective therapy for KRAS wild-type PDAC.

The purpose of the intervention is to improve the social and communication skills of children with autism. We aim to do this by using children's everyday school context and their typically-developing class peers. We suspect, that both children with autism and their class peers will demonstrate signicant improvements in their social and communication skills following the intervention.