ANZCTR search results

A prototype bio-impedance recording device called Cardia [TIP2] has been developed by Melbourne based medical device company Grey Innovation. An earlier prototype of this device [TIP1] has already undergone a clinical study (CTN-03513-1) in dialysis patients where 16 patients wore the device over 19 sessions lasting 4-6 hours each. It was found that changes in bio-impedance were reliably measured with the Cardia [TIP2] prototype - correlating with fluid removed from the participant during dialysis. This study will enable the prototype to be tested in heart failure patients, the end user population over a longer period of time. This study will provide information that will enable us to move towards an optimised device that is to be tested in a large-scale home-based trial. The home-based trial will compare those who do have the real-time volume status information to act upon against those who do not and will assess whether relevant clinical outcomes can be improved, i.e. prevention of heart failure re-hospitalisation or minimisation of time in hospital for acute decompensation. Thus, this specific project is critical in advancing the commercial and therapeutic/diagnostic potential of the device, before such a study can be considered. Our goal is that this will ultimately lead to the development of a commercially viable, low-cost (potentially disposable), non-invasive approach to assessment of fluid status to allow early intervention and increase health outcomes in heart failure patients.

One-quarter of adolescents live with regular, debilitating kneecap pain. This causes substantial pain and disability, and reduces quality of life. Kneecap pain in adolescents is not a self-limiting condition – up to 95% continue to have pain after two to eight years. This can set the scene for a lifetime of knee pain and associated health implications, with many adolescents reducing or withdrawing from sport and physical activity. The problem is the lack of evidence and clinical guidelines for effective treatments for adolescents with kneecap pain. Best-evidence treatments for adults with kneecap pain, such as exercise, are not as effective for adolescents. This may be because adolescents simply do not do their prescribed exercises. 'Off-the-shelf' shoe inserts may be the solution. These are simple, accessible, low-cost devices that are easy for adolescents to wear in their regular footwear, such as school and sports shoes. The HAPPi Kneecaps! Trial will determine the feasibility of conducting a full-scale randomised clinical trial investigating shoe inserts for adolescents with kneecap pain. Secondary outcomes will explore whether shoe inserts can improve pain, function and quality of life in this population. Findings will inform future large-scale clinical trials, with the potential to advise clinical practice guidelines providing adolescents with effective, evidence-based options for managing their kneecap pain. This study is an essential first step in identifying effective interventions for adolescents with kneecap pain, with the potential to change the persistent, chronic nature of kneecap pain at its earliest onset.

The purpose is to test a simple, effective treatment package that can be delivered by non-doctor or non-nurse personnel but who are suitably trained in the delivery of the educational resources. The focus is on health literacy to improve self-care and connect to community support. We know that a comprehensive package is of benefit, but we don’t know which components of the package drive the benefit. We hypothesize that an In-hospital intervention in an Australian public hospital context for people identified as having Type 2 Diabetes will lead to improvements in blood sugars and reductions in diabetes related distress, and ultimately a lower probability of re-admission or if admitted and an admission of shorter duration.

This study will investigate the feasibility and acceptability of an eight-week behavioural activation programme, delivered by volunteers, designed to improve the wellbeing of residents in residential aged care facilities (RACFs), a group known to experience high levels of depression. The programme will involve training approximately 10 volunteers in behavioural activation (BA) techniques over two half-day training sessions. The volunteers will then work with aged care residents twice per week for eight weeks to deliver the BA programme. Behavioural activation is a well-supported treatment for depression that aims to improve mood by using a structured approach to increasing participation in enjoyable activities. The primary aim of this study is to investigate the feasibility of an 8-week volunteer-led BA intervention for RACF residents. The secondary aim of this study is to collect preliminary data to investigate if the intervention shows promise in being effective in reducing psychological symptoms (depression, anxiety) and improving the well-being of approximately 20 aged care residents.

A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.

This study aims to evaluate the safety and acceptability of iMove in patients undertaking Immunotherapy and to also assess the feasibility of conducting a future, definitive RCT. Who is it for? You may be eligible to join this study if you are aged 18 years or above with a diagnosis of Stage IV Melanoma and scheduled to receive Immunotherapy. Study details Participants will be randomly allocated to one of two groups, to either the intervention (iMove) or the control group (standard care, currently given to all cancer patients). For people who are allocated to the intervention group, the exercise program will run for 12 weeks and be personalised according to each participant's exercise ability. The exercise program is designed to be prescribed for when people begin receiving their immunotherapy infusions. Both the intervention and the control group will be asked to complete questionnaires at 5 time-points over three months and complete three physical assessments in the first twelve weeks. It is hoped that this research will help us assess whether exercise for people diagnosed with advanced melanoma receiving immunotherapy will be safe and feasible.

Exercise has many benefits for overall health and well-being, and is particularly beneficial for health; however, individuals often consume unhealthy, energy-dense, nutrient-poor foods and drinks following exercise, and such consumption can undermine—at least in part—some of the benefits of exercise. There is growing evidence to suggest that food and drink choices can be influenced by both the format of, and psychological experiences in, exercise. In particular, high-intensity intermittent exercise is associated with reduced food intake in the post-exercise period compared with traditional moderate-intensity continuous exercise (which is current standard care). Likewise, there is accumulating evidence to suggest that certain social conditions during exercise may reduce the propensity to engage in unhealthy food intake post-exercise. Unfortunately, to date, researchers have only considered these factors in isolation, with no previous work focused on the interactive effects of the exercise format and social conditions of exercise on subsequent food choices. Furthermore, the majority of studies have examined a one-off acute bout of exercise, leaving questions about the longer-term influence of these exercise conditions on individuals’ dietary patterns and overall health. We aim to address these issues to determine the optimal exercise ‘conditions’ that promote healthy food choices in the long-term. It is hypothesised that participants randomised to the high-intensity intermittent exercise with need-support condition will have a greater decrease in post-exercise food intake post-intervention compared with participants who complete the moderate-intensity continuous exercise intervention without need-support.

This study will examine how bright light administered in the morning will advance the internal body clock and reduce the symptoms of sleep onset insomnia. Sleep onset insomnia is chronic insomnia disorder that is primarily caused a difficulty initiating sleep. Re-Timer has previously been used to shift the internal body clock in good sleepers in the home environment. This study will build upon these findings by examining those with sleep onset insomnia in the home environment. It will be predicted that the individual's internal body clock will be advanced, night time sleepiness will increase, time taken to fall asleep will decrease, and insomnia symptoms will decrease.

It is estimated that in Australia 12% of cystic fibrosis patients are infected with Mycobacterium abscessus, a non-tuberculous mycobacteria (NTM) which is associated with a decline in lung function and increased mortality. Treatment is expensive, toxic and is unsuccessful in most patients. Mycobacterium abscessus is found more commonly in CF patients from Queensland than from more temperate southern states. Another common NTM infection is Mycobacterium avium-intracellulare which has a better cure rate however treatment is for at least twelve months and requires multiple antibiotics some of which cannot be used with newer gene therapies for CF. Despite this being a research priority in CF there have been no randomised trials carried out to determine optimum therapy. In the absence of these clinical trials, pharmacokinetics – the study of how drugs move through the body - is a key means of discovering the best dose to use in different groups. We believe that the current doses of mycobacterial drugs being used in CF are too low and may be contributing to high rates of treatment failure. We will test the blood levels of important drugs given to patients with CF with NTM infection and compare to the drug levels in people without cystic fibrosis published in other studies. In this way we can help determine whether the doses we are using are correct or need to be changed. If the doses of antibiotics being used in CF are too low this could lead to new dosing regimens being used in future drug trials.

The purpose of this study is to evaluate the safety and tolerability of 28 days of daily dosing of orally administered FP-045 400 mg into normal, healthy volunteers