ANZCTR search results

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

Rabies is a fatal disease, present in most countries outside Australia, so poses a risk to Australian travellers. Although deaths in travellers are rare (60 reported cases 1990 – 2012 ), rabies risk exposures are relatively common (2-13/1000 travellers per month). In travellers who are aware the horrors of this untreatable disease, a potential rabies exposure can be stressful, and cause major disruption to travel plans in the quest for appropriate treatment. Pre-exposure rabies vaccination (PrEP) simplifies the treatment of animal exposures if they occur during travel. The standard recommendations for rabies PrEP is to give 2-3 doses of vaccine prior to departure. The Australian guidelines recommend PrEP - one dose of Rabies vaccine given on day 0,7,and 21-28. Many travellers are leaving at short notice and do not have time to complete this pre departure rabies vaccine course. Recent research has suggested that two doses or even one dose may be sufficient to prime the immune system, and simplify the post exposure treatment of at risk animal exposures. Much of the research in the past has be done on young soldiers. There is very limited research in persons over the age of 50 years to confirm that persons in this age group mount an adequate immune response to lower doses of rabies vaccine.

The use of Intradermal (ID) rabies vaccine was described in 1976, with the promise of allowing cheaper protection from a disease, which has been feared throughout history. Although deaths in travellers are rare (60 reported cases 1990 – 2012 ), rabies risk exposures are relatively common (2-13/1000 travellers per month) In travellers who are aware the horrors of this untreatable disease, a potential rabies exposure can be stressful, and cause major disruption to travel plans in the quest for appropriate treatment. The standard Pre Exposure Rabies vaccination course (PrEP) of one dose ID vaccine on day 0,7,21-28 has been recommended for some time. A modified ID course of two doses of ID rabies vaccine on day 0, and 7 with one dose on day 21-28 has been documented in our clinic and published in 2011 [Mills et al. Journal of Travel Medicine. 2011;18(5):327–332]. This project aims to document the long term persistence and boostability of rabies antibodies in travellers who have had a course of ID rabies vaccine.