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Deficiency of vitamin D has been increasingly recognised as a significant public health problem, even in a sunny country like Australia. We and other groups have found that this deficiency is even more common and pronounced in critically ill patients in the Intensive Care Unit.(ICU) There is now scientific evidence suggesting that vitamin D has widespread roles outside its traditionally recognised role in bone health. Its deficiency has been associated with cardiovascular disease, some cancers, autoimmune and inflammatory diseases, etc. We therefore propose that supplementing vitamin D in critically ill patients while they are in the ICU, particularly those showing signs of an inflammatory response, may improve their outcomes. This needs to be studied in depth within the context of a well-designed, large clinical trial. As a variety of doses are currently used in clinical practice, the appropriate dose that is required, particularly in patients who are critically ill, is not known. The design of such trials can only be achieved by obtaining extensive background information on safety and the effects of supplementation using different doses, which are in common use, to determine which dose to use in further trials of critically ill patients and what effects can be achieved with this. Such studies are not available currently. Fortunately, vitamin D is a medication that can be used safely in a wide range of doses and we plan to use 2 doses within this range. In this study, 50 patients admitted to the ICU who meet certain criteria, suggesting that they have signs of the inflammatory response, will be randomly allocated to receive one of 2 single doses of vitamin D by intramuscular injection. We will collect a small quantity of blood for testing at baseline and on days 1,3,7 and 14 following the dose. We will measure vitamin D and metabolite levels and markers of inflammation in order to study whether target levels can be obtained with these doses and also what effect it has on the inflammatory response. We will monitor closely for any side effects, although these would be extremely unlikely in the doses that we propose to use. We will also collect information from the patients record on routinely collected clinical data and certain outome measures. All information collected and presented will be de-identified and all records will be securely maintained to ensure privacy. This study will provide us with vital information that we require for the next stage of this project, which is the development of a large study in a number of ICUs to explore the effects of vitamin D supplementation on outcome in this patient group. If shown to be beneficial, this could be an intervention that has a widespread global impact, including in low and middle income countries, as vitamin D is a cheap, safe and easily available medication.

Pre-eclampsia (PE) is a condition that occurs only in human pregnancy. The condition is a multi-system disorder and is typically recognised by the new onset of high blood pressure (‘hypertension’) after 20 weeks of pregnancy, which can also be accompanied by protein in the urine (‘proteinuria’). While the exact cause and mechanisms of PE have yet to be determined, we do know that the placenta (‘after birth’) plays an important part in development of the condition, and that once the baby has been born, and the placenta is then removed, a mother’s PE usually begins to get better. Consequently, the only effective treatment for PE at this time is to deliver the baby and unfortunately, for many mothers with PE, this will mean that their baby will need to be born early in their pregnancies i.e. preterm, between 24-36 weeks. As a result, PE has the potential to be a significant cause of problems, for both mothers and their babies, in the immediate and long term. Evidence derived from both the laboratory and also human studies, involving people who are not pregnant, has shown that sulforaphane, a compound that can be found naturally in broccoli sprouts, protects against cardiovascular disease and improves the health of blood vessels. For this reason, we believe that the administration of a broccoli sprout extract supplement containing sulforaphane, may offer a new ‘low risk, potential treatment for PE. Such a treatment would be highly beneficial to both the mother and her baby, since it could help doctors (obstetricians) to stabilize a mother’s PE and as a result, prolong the pregnancy. The aim of this project is to test whether a nutritional supplement containing broccoli sprout extract, which is high in sulforaphane, can prolong the time to delivery in pregnant women who have been diagnosed early onset preeclampsia.

The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can reduce the rate of respiratory complications in acute tetraplegia. The secondary objectives of this study are to analyse whether this intervention also affects: (1) respiratory function, (2) quality of life and (3) mortality.

Lewy body diseases are a common form of neurodegenerative disorders which includes Parkinson’s disease (PD), Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB). DLB and PDD are both termed Lewy body dementias, with many overlaps clinically and pathologically. Lewy body dementias also share many features with Alzheimer’s disease (AD). Dementia with Lewy bodies is a common form of dementia in older age (approximately 1 in 6 of all dementia cases), However there are very few longitudinal studies that investigate the changes that occur in the brain and in the body of people with DLB. People with DLB have an abnormal accumulation of the protein alpha-synuclein in their brain which may affect memory, thinking, behaviour, mood and movement. Many cases of DLB have multiple changes in brain pathology, such as vascular disease changes, or the accumulation of other proteins, such as amyloid and tau, that are found in Alzheimer’s disease. However it is not known what effect these changes have when there are also Lewy bodies present. In order to understand the disease process and offer potentially effective treatments in the future, these changes need to be investigated. The Lewy Body Study will establish an Australian cohort of 100 individuals diagnosed with DLB and follow them over the course of 3 years to investigate factors which may help to predict disease outcomes, and which may lead to effective treatments being available in the future. As comparison groups, 20 people diagnosed with PDD, 20 people diagnosed with AD and 20 healthy control participants will also be enrolled. So that the rate of disease changes can be monitored DLB participants will undergo clinical and cognitive (memory and thinking) assessments and health related questionnaires, a blood test and brain MRI scans every 12 months; and optional brain PET imaging scans. There is also an opportunity for participants to undergo cerebrospinal fluid collection (optional). DLB is currently widely under-diagnosed. The Lewy Body Study will provide the largest depository of DLB disease related data in Australia that will be made available to approved researchers both nationally and internationally to help further dementia research. We aim to establish whether there are any disease biomarkers (genetic, blood, imaging, cognitive) which may help improve the diagnosis rate of DLB which may in turn improve the treatments and outcomes for those diagnosed with this disease.

Chronic venous leg ulcers are a major health problem affecting approximately 1.1/1000 of the Western Australian population and previous community studies have shown that venous leg ulcers contribute to 50% of all wounds managed by community nurses. Although most leg ulcers will heal with compression bandages, approximately 20% fail to respond to this treatment possibly due to the presence of unhealthy tissue. Therefore this study is looking at two different types of debridement treatments used to breakdown the unhealthy tissue to encourage the dressings and compression bandaging to be more effective at healing the venous leg ulcers. Participants who have had a leg ulcer for more than 4 weeks but less than 5 years that have failed to respond to dressings and compression bandaging because of the presence of unhealthy tissue would be eligible to participate in the study. The participants after consent with be randomly assigned to either low frequency ultrasonic debridment or sharp debridement treatment on a weekly basis for a maximum of 12 weeks or less (if healing occurs before the 12 weeks) carried out by an experienced wound Nurse Practitoner and then have a silver dressing and compression bandaging applied. The wounds will be measured on a weekly basis using 3-dimensional laser digital planimetry system which is uploaded on a secured computer to allow automatic calculation of wound tissue volume including the percentage of reduction or increase. In addition the wound assessment and care plan will be completed using an electronic on-line secured platform (Comcare Wound Module) to analyse healing outcomes and costs for all treatments of all participants. Each participant will complete a quality of life assessment prior to commencement of treatment and on completion of the study. The study will analyse the healing rates for both debridement treatments, compare the healing rates of the two treatments to determine which treatment was more effective and analyse the cost of healing for the two treatments.

This study aims to develop a multi-centre trial and to assess which children with acute respiratory failure benefit using Nasal High Flow Therapy (NHF). For this purpose we will perform a randomised controlled trial comparing current best practice (standard oxygen delivery via subnasal prongs, facemask, venturi mask) versus NHF therapy. With the introduction of this simple to use respiratory system in regional and tertiary centres we aim to investigate if NHF therapy has a lower treatment failure rate in comparison to standard oxygen delivery reducing the hospital length of stay.

The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can reduce mechanical ventilation duration in critically ill patients. The secondary objectives of this study are to analyse whether this intervention also affects: (1) the thickness of respiratory muscles, (2) respiratory function, (3) Intensive Care Unit (ICU) length of stay, (4) ICU and hospital representations, (5) re-intubations and (6) mortality.

In this study, we propose to study the effects of 2 types of treatment for positional sleep apnoea. Positional sleep apnoea is when you have more sleep apnoea, when you sleep on your back. The first treatment is called MAS or a mouthguard which is like a denture worn during sleep to improve sleep apnoea. the second treatment is called night shift, this is a vibrating collar, which will vibrate when you sleep on your back. We are hoping to try these two treatments in a controlled fashion by adding the collar in different time periods of the trial. Our study hypothesis is that adding the vibrating collar will improve the treatment efficacy. We are hoping to look at the benefits of treatments by looking at the treatment compliance which will be assessed by a chip inserted in the outhguard and by llong at the data obtained by the vibrating collar. We will also look at how your sleepiness scores have improved.

In Australia, 35,000 people are living with cerebral palsy (CP). People with CP have poorer health outcomes, are less active and have a 1.2 to 1.6 greater risk of chronic health conditions such as diabetes, hypertension and stroke compared with those without a disability. We have promising data about a new intervention called Participate-CP, which is a therapy that improves children’s participation in physical activity goals that are meaningful to them. In this trial for 100 children with CP, we will compare Participate-CP to Standard Care to see whether or not the intervention delivers additional benefits over Standard Care.

The DMTS has been evaluated in 3 completed clinical studies. This study was designed to evaluate the safety and pharmacokinetics of a 4-day application of DMTS as well as to identify an appropriate oral water/liquid hydration volume to be administered starting 2 hours before DMTS application through 6 to 12 hours after DMTS application.