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The primary purpose of this pilot trial is to examine the efficacy of decitabine in combination with carboplatin for the treatment of metastatic melanoma. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, and have been diagnosed with metastatic melanoma which has been resistant to all previous treatments. Study details All participants enrolled in this trial will receive combination therapy with two chemotherapy agents, decitabine and carboplatin, according to the following treatment regime. On days 1-5, patients will receive a daily intravenous infusion of decitabine, followed by a single infusion of carboplatin on day 8. There will then be no treatment administered for the remainder of the cycle, until the regime is repeated starting on day 29. Researchers will perform tests on blood and tumour biopsy samples to examine the efficacy of the treatment in altering tumour cells so that they are more vulnerable to the immune system, and thus treating the cancer. It is hoped that information from this trial will provide preliminary information on the efficacy of decitabine in combination with carboplatin for the treatment of metastatic melanoma, and provide data to inform a larger clinical trial of this therapy.

This project aims to substantiate the effects of acute ingestion of high pinitol carob fibre on glycaemic control and subjective satiety and appetite responses. A secondary aim is to distinguish any additional clinically relevent effects of the pinitol compared to the fibre alone. We hypothesise that high pinitol carob fibre within a cereal-based test food will lower glycaemic and insulinaemic responses and increase satiety resulting in lower dietary intake.

Small and premature babies often need help to breathe after birth, sometimes for many weeks. Established methods of providing breathing support are Continuous Positive Airway Pressure (CPAP) and Nasal Intermittent Positive Pressure Ventilation (NIPPV). CPAP and NIPPV use warmed air and oxygen given into the baby’s nose using small soft plastic prongs. This is very effective, but sometimes the plastic prongs can cause the skin in and around the nose to become sore or damaged. Skin damage is particularly common during CPAP /NIPPV treatment in very preterm and tiny babies. The aim of the ProNose study is to see whether using a barrier dressing over the nose can reduce damage to the nose in very small babies receiving CPAP/NIPPV. To work out whether the barrier makes a difference, we organise babies receiving CPAP/NIPPV into two groups one group will have the barrier dressing and the other will not. The group results are then compared to see if there is any difference in the number of babies who get a sore nose. Babies can join this study if they are born before 30 weeks' gestation or weigh less than 1250 grams at birth, and need CPAP/NIPPV treatment. Some babies will need this from soon after birth; other babies will need support from a ventilator (breathing machine) to begin with, and become ready for CPAP/NIPPV later on. When a baby is ready to start CPAP/NIPPV, or soon after they have started this, babies will be randomly placed in one of the two study groups: (1) using the barrier dressing (BARRIER group) or (2) normal care – without the barrier dressing (NO BARRIER group). Babies in the BARRIER group will have the barrier dressing applied within the hour, and will continue to have the barrier dressing whenever they are receiving CPAP/NIPPV for at least 2 weeks, or until they are 30 weeks from the start of pregnancy and weigh more than 1250 grams, unless they stop CPAP/NIPPV before then. The barrier dressing material will be replaced when required, as assessed by the clinical teams. Babies in both groups will be followed for the study throughout their time at the Women’s. We will also take regular photographs of babies' noses whilst they are in this study and on breathing support. This is so that we can objectively assess whether there is any injury to the nose. The ProNose study will enroll 206 babies at the Women’s and will take about 18 months to complete.

We propose a first-in-man clinical trial of human amnion epithelial cells (hAEC), a type of stem cell obtained from the placenta, The placenta is normally discarded after delivery so the use of hAEC does not pose any ethical issues. In laboratory studies we have shown that these cells can reduce liver fibrosis (scar tissue in the liver) and stimulate regeneration of liver cells.. Worldwide, cirrhosis is the sixth most common cause of death and liver transplantation remains the only chance for survival for some people with cirrhosis. In this study we will assess the safety and tolerability of giving hAEC to patients with stable liver cirrhosis. Our long-term goal is to develop hAEC as a clinically useful therapy to reduce the need for liver transplantation.

Aim Delirium is associated with increased mortality, ventilator time, hospital length of stay, poor functional status and cognitive impairment, use of physical restraints and medical costs. This study will help determine whether the use of melatonin prophylactically decreases the incidence of delirium in Intensive Care patients. Secondary aims will be to see if melatonin prophylaxis via its effect on delirium and sleep results in reduced mortality, length of stay (hospital and ICU), ventilator days and use of anti-psychotics, sedatives and physical restraints. The economic analysis will evaluate the cost benefits of the intervention Participant recruitment 850 patients from Adult Public ICUs who meet all of the inclusion and none of the exclusion criteria. Randomisation and enrolment will only occur Monday-Friday due to limitation of resources although treatment and assessment will occur on weekends and after-hours. Randomisation and consent Patients may be unable to consent at time of enrolment. In these cases an emergency waiver of consent will be used, as allowed for in the NHMRC National Statement, in conjunction with acknowledgement from the patient’s next-of-kin that they are not aware of any reason why the patient would have chosen not to participate. All patients will be followed up and provided the opportunity to consent to continued study participation once capacity is regained. Intervention Melatonin 4mg in oral suspension or placebo (similar appearance) will be given at 21:00 for 14 days or until discharge from ICU. A subset of 100 patients will have two separate sleep EEGs done which is the gold standard to assess sleep quality and duration on days 2-3 and 5-7 of their admission Analysis described earlier. An interim analysis will take place after 100 patients and 400 patients (employing peto-haybittle rule with p value 0.001) and a pre-planned economic analysis Outcome assessment will be done by trained intensive care registrars. Data recording and management will be done by the principal investigators and research nurses

The study design is a single blinded longitudinal Randomised Controlled Trial. The primary outcome measures are the incidence of post-operative pulmonary complications (PPCs) and hospital length of stay (HLOS). Study participants will be 60 pre-operative high risk frail elderly cardiac surgical patients identified by the principal research physiotherapist and randomised into an intervention and control group. Eligibility to enter the study will be assessed in the cardiac surgical pre-operative clinic, and patient consent obtained. Pre-intervention measures tested in the clinic will be frailty, the timed up and go test (TUGT), the SF-36, and respiratory measures of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Patients in the control group will receive standard physiotherapy pre-operative education from an associate research physiotherapist. Patients in the intervention group will receive standard physiotherapy education, from an associate research physiotherapist, and in addition receive an IMT device and be taught in its use and safe progressions at home. They will also be prescribed an individualised physical home-based exercise program. They will receive written education on IMT and exercise and an exercise diary, and will receive one follow-up phone call by an associate research physiotherapist to encourage compliance. On hospital admission (immediately pre-surgery), patients in both groups will be managed by the principal research physiotherapist who is blinded to the pre-operative interventions. All patients will receive standard physiotherapy during their hospital admission as per usual practice. Pre-operative assessment measures of TUGT and MIP/MEP will be done on admission and on day 4-5 (pre-discharge home). Time dependent events (length of intubation time, time to first walk, length of stay in ICU, hospital length of stay),pulmonary complications, morbidity/mortality, and discharge destination will be recorded by the principal research physiotherapist. All patients will have TUGT and MIP/MEP measures done by the principal research physiotherapist at 6 weeks post discharge at their usual post-operative clinic appointment. At 12 weeks post discharge, another follow-up call will be made by the principal research physiotherapist to assess compliance with exercise, attendance at cardiac rehabilitation, post-discharge complications and confirm discharge destination. The SF-36 will be assessed at this 12 week mark.

The emerging focus in healthcare is to have care services delivered using strategies that are cost-efficient and evidence-based, while engaging with the broadest applicable workforce. Therein is the opportunity for the chiropractic profession to play an expanding role within the context of a multi-disciplinary care, particularly in the area of musculoskeletal/spinal health. Practice-based data collection would offer insight into the nature of chiropractic practice and contribute to resolving the conundrum of chiropractic’s role in contemporary healthcare, latterly informing care service policy. However, there is little formal data available about chiropractic practice to inform us about the nature and role of chiropractic within the context of a modern multidisciplinary healthcare context in Australia, particularly at a local and regional level. This purpose of this prospective, mixed-methods, cross-sectional, external pilot study was to provide a critique of the research design and collect data from a selected sample of chiropractic practices, with a view to offer recommendations related to the design, feasibility and implementation of a future confirmatory study. A narrative critique of the research methods of this pilot study is offered, covering: (a) practice and patient recruitment, (b) enrollment of patients, (c) data collection methods, (d) acceptability of the study methods, (e) sample size calculations, and (f) design critique. The result of this critique provides a sensible sample size estimate and recommendations as to the design and implementation of a future confirmatory study. Furthermore, we believe that a confirmatory study is not only feasible, but indeed necessary, with a view to offer meaningful insight into chiropractic practice in Western Australia.

Endurance performance lasting >90 min is limited by carbohydrate stores. Therefore for the past few decades’ researchers have proposed ways to increase the use of fat as a fuel source, reducing reliance on carbohydrate sources during endurance events and ‘sparing’ muscle glycogen. Recent studies have focused on high fat, low carbohydrate diets, which have become increasingly popular amongst athletes, with the expectation of a greater response to training and improved performance. High fat, low carbohydrate diets (~ 65% energy intake from fat) for up to 2 weeks have been shown to increase the use of fat as a fuel source during low to moderate intensity cycling however an improvement in cycling performance is yet to be reported. Another nutritional strategy prescribed to increase the use of fat during training is a high protein, low carbohydrate diet, otherwise known as ‘train low’ (i.e. with low carbohydrate stores). Although both strategies increase the use of fat stores, the complex muscular responses and mechanisms behind these adaptations have yet to be reported. The aim of this study is to determine whether low carbohydrate availability in the presence of high fat or high protein is the driver of the increased fat oxidation and reduced glycogenolysis reported following a 5 day high fat diet.

Tulsi (Holy basil) is a sacred Indian herb with a remarkable therapeutic range in the treatment of common conditions including metabolic disorders. Considerable evidence in preclinical models indicates a role for Tulsi in improving metabolic disorders, mood as well as cognitive related diseases. There is emerging evidence from few randomized clinical trials demonstrating the efficacy of Tulsi in metabolic disorders and improvement of mood and cognition state in healthy individuals. Similarly, turmeric administration (another Indian culinary herb) has been found to improve cognitive function and mood in healthy and pre-diabetic adults. There have been considerable efforts to characterize transcriptomes and identify biomarkers specific for metabolic pathways. Recent studies using whole blood have identified micro RNA involved in various metabolic pathways such as glucose and lipid metabolism. Similarly, short-term changes in transcriptome have been correlated with change in metabolic foot print/transcriptome after exercise in competitive elite athletes. Furthermore, whole genome studies using microarray analysis have shown that a single bout of 30-minute exercise significantly alters skeletal muscle gene expression after 1 hour and up to 48 hours following post exercise. Other studies have confirmed these findings revealing major changes in skeletal muscle gene expression occurs after 1 hour. Previously, the consumption of an herbal tea such as tulsi has been shown to influence metabolic function, however to date no study has shown whether herbal tea consumption exerts any effect on exercise performance or recovery. Elite athletes are a homogenous group of highly trained individuals and ideal to measure effects of herbal tea on exercise performance and cognition. The relevance of tulsi consumption includes its potential efficacy, along with its cost-effectiveness, wide spread availability, and high safety profile as an adjunct treatment modality for metabolic diseases. This research has also relevance for people with stress and anxiety, metabolic syndrome and athletes who wish to enhance their performance. This will be the first human study on the short terms effects of tulsi tea and the first to compare the mood, cognition and metabolic function after consumption of different beverages. The objective of the present study is to investigate the acute effects of different beverages on cognition in healthy adults, elite athletes and people with impaired glucose control. Also, to identify effect of different beverages on mood, blood pressure, and metabolic function as measured by transcriptome analysis in the above three groups.

Given the hypothesis that reactive hypoglycemia may occur during hypotensive (neurocardiogenic) syncope we wish to study blood glucose levels in patients who may have a hypotensive syncopal event. Establishing a link between reactive hypoglycemia and neurocardiogenic hypotensive syncope could be beneficial to these patients as it may lead to new strategies to help these patients manage their events. This study differs from previous studies by testing the blood glucose levels in a large number of patients referred for an investigation of neurocardiogenic before and during syncope induced by a Tilt Table Test, using referred patients who do not have syncope induced during the test as a control group.