ANZCTR search results

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.

This study will be investigating the use of a new whooping cough vaccine in adults aged 18 - 30 years. Pertussis infection rates within this age group have been rising since the early 2000s and this is likely due to the short-term protection offered by the current pertussis booster vaccine. The study will compare the use of this new vaccine to the vaccine currently used in Australia. Randomisation will be based on the pertussis vaccination history of each particular subject and all subjects will be followed up for one year. They will have blood sampled before vaccination, at 28 days following vaccination and 1 year after vaccination. The expected outcome is that the new pertussis vaccine will demonstrate superior immune response and therefore extended protection against pertussis.

The purpose of this study is to determine whether enteral feeding (via a tube through the mouth to the stomach) is tolerated post allogeneic Haematopoietic stem cell transplant. Who is it for? Patients 18 and over that have been diagnosed with a haematological malignancy and are planned for an initial allogeneic haematopoietic stem cell transplant. Study details: Patients will be recruited to the study during a pre-transplant appointment with the Transplant clinical nurse consultant (CNC) and eligible patients will be consented and randomly allocated (by chance) to the intervention or control group. The study will examine the feasibility of using enteral feeding post transplant. Following transplantation, both groups will continue with standard nutrition practice, by eating and drinking orally as tolerated. If patients are unable to tolerate oral intake, Parenteral Nutrition may be considered. One group (the intervention group) will also have a nasogastric tube inserted on the day of the transplant and will receive enteral feeds throughout the patient's admission. The rate of feed will start at 20mL/hr for 24 hours continuously and will be increased by 10mL/day to a goal rate of 40mL/hr. Enteral feeds will cease once the patient is meeting 60-75% of their nutrition requirements via their oral intake and they have engrafted. It is hoped that this study will assist in better addressing the optimal use of nutrition support to improve outcomes post transplant.

An observational cross-sectional multi-centre multi-level study design evaluating the organisational and departmental quality management, clinical management processes, and patient outcomes associated with perineal and obstetric anal sphincter injury (OASIS) trauma, at three health services across six maternity units, assessing: 1. Quality of care governance, practice and culture for each maternity unit organisation, using a set of modified Quality Management System and departmental pathway assessment instruments. 2. Clinical treatment processes by auditing medical records of all women diagnosed with OASIS, 5% of women having vaginal deliveries not diagnosed with OASIS and those undertaking the (Patient Measures of Safety) PMOS will be conducted comparing content and quality of clinical documentation and management against the institution’s evidence-based guidelines including conduct of a comprehensive perineal assessment. 3. Safety culture and clinical leadership, and pathways using a staff survey 4. Raw and risk-adjusted OASIS incidence rates, analysing perinatal data routinely collected through the Birthing Outcome System, compared between the six maternity units. 5. Women’s understanding of perineal injury risk and perception of safety using an antenatal and postnatal patient survey

This study is a single-centre, single-blind, prospective clinical trial evaluating the effect of a new diagnostic test for discrimination of CD and controls. We hypothesised that Mycobacterium avium subspecies paratuberculosis (MAP) is the leading infectious cause for CD. Therefore, developing a simple diagnostic test for MAP detection is worthy of investigation for diagnosis of CD and determining success of anti-mycobacterial therapy in patients with CD. The results of the study will provide evidence for the association between MAP and CD as well as establishing an affordable, less invasive, accurate and efficient diagnostic test for CD and/or monitoring.’