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30% of Australians will be affected by Insomnia making it the most common and socially costly sleep disorder. The total cost to Australia in 2010 was estimated to be $10.9 Billion. Insomnia patients suffer from poor health related quality-of-life, increased risk of depression, increased workplace disability and costs, impaired driving performance and increased risk of death from motor and unintentional fatal injuries. The current health system solution to this highly prevalent condition is hypnotic pharmacotherapy. This is despite substantial evidence that drugs are only marginally better than placebo and recommendations against long term drug therapy. Hypnotic therapy also comes with significant risk for a range of side-effects some caused by inappropriate use including falls, car crashes, accidents and potentially increased overall mortality. Cognitive Behaviour Therapy for Insomnia (CBT-I) is a much more effective long-term solution. However, CBT-I suffers from major drawbacks as it requires specifically trained therapists, and is a complex time consuming composite therapy that may include therapeutically redundant components. Sleep Consolidation Therapy is a standardised behavioural component of CBT-I that has been specifically tested in isolation and been found to be as effective as multi-component interventions. In Sleep Consolidation Therapy, patients are asked to ‘consolidate’ their sleep-wake schedules (minimum time in bed is five and a half hours). The clinical delivery time for Sleep Consolidation Therapy alone can be relatively short (typically 1 hour delivery + weekly 10 minute telephone calls), but still requires clinician input regularly. Sleep Consolidation Therapy maybe able to be delivered more widely as it has been shown to be feasible in Primary care settings. We have developed a proof-of-concept smartphone application following participatory design and user experience focus groups. We now wish to test the use of this smartphone application to deliver Sleep Consolidation Therapy in participants with Insomnia Disorder. The app has the potential to deliver population-based therapy for Insomnia patients thereby improving therapy options.

Perioperative hypoglycaemia during elective surgery can potentially cause serious consequences. In neonates, hypoglycaemia can cause lethargy, apnoea, seizures and coma (Pediatrics, 2011; 127(3): 575-579). In severe cases, neurodevelopment in neonates is impaired with white matter changes, haemorrhage, infarction and basal ganglia changes seen on MRI. (Pediatrics, 2008; 122(1)). A recent study has shown that children, especially infants, can be ketotic and have low normal BSL (Blood sugar level) following preoperative fasting periods (Eur J Anaesthesiol 2015; 32:857–861). Anecdotal reports at Royal Children's Hospital have indicated that children between 6-12 months may be at a higher risk of hypoglycaemia due to prolong preoperative fasting and physiology which has resulted in BSL in the 1.0-2.0 range which required urgent intervention perioperatively. There is belief that the stress response of surgery will mitigate the potential hypoglycaemic effects of fasting however, there are lack of literature to show the effect in this age group. There is a current lack of consensus regarding best practice fasting guidelines. Young children are extremely vulnerable to the risk of preoperative hypoglycaemia and determining evidence based fasting guidelines could have significant benefits for the patient and department. Methods. Using a prospective observational design of 200 infants, aged 6-12months with an ASA (American Society of Anaesthesiologist Score)of 1-2, and undergoing elective surgery will be observed during the perioperative period for hypoglycemia. Blood of around 6 microliters will be obtained to test blood sugar and ketones using commercially available handheld point of care testers at induction after insertion of IV cannula. Hypoglycemia will be defined as a BSL of 3.0mmol or less and hypoglycaemia will be treated as per local guidelines. On completion of surgery, a further 6 microliters will be obtained to test for blood sugar and ketones using the same testers. Outcome. Primary outcome is incidence of hypoglycemic events on induction. Secondary outcomes are change in BSL and ketone levels during the perioperative period. Sample size calculations were carried out using the G*Power software. We are planning to recruit a total of 200 children where 100 at Royal Children's hospital (RCH) and 50 each at both Lady Cilento Children's Hospital (LCCH) and Gold Coast University Hospital (GCUH) as per calculations. Statistics. Analyses will in the first instance compare LCCH and RCH patients, and hence their different fasting protocols, with respect to BSL and ketones by means of two sample t-tests immediately before and after anaesthesia. Linear regression analyses will also be undertaken to take into consideration the various covariates that may impact on BSL and ketones

This study is evaluating the performance of Cxbladder tests in determining whether patients are at low or high risk of bladder cancer when presenting with blood in urine. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are undergoing investigative cystoscopy at either the Princess Alexandra, Redland, Redcliffe or Queen Elizabeth II hospitals for investigation of recent (within the last 3 months) macroscopic or microscopic haematuria (i.e. blood in urine). Study details All participants in this study will undergo a Cxbladder urine diagnostic test as well as standard investigative cystoscopy. Results of both of these tests will then be compared in order to evaluate accuracy of the Cxbladder test. It is hoped that our study will determine the utility of the Cxbladder urine diagnostic test in an Australian clinical setting by demonstrating performance characteristics while also showing efficacy in clinical practice.

This pilot study will determine the effects of dignity therapy for palliative care patients with cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are a cancer patient with a palliative diagnosis. Study details All participants in this trial will be randomly allocated (by chance) to receive either dignity therapy with a cancer care coordinator who is trained in dignity therapy or standard palliative care. Participants will be followed-up at 4 weeks post intervention commencement with questionnaires to determine effect of treatment on levels of distress We hope to provide evidence that may allow us to introduce Dignity Therapy into the routine care of our patients in Mater Cancer Care Centre.

The aim of this study is to evaluate the safety and efficacy of a new medication called lipegfilgrastim to reduce a frequent complication of chemoimmunotherapy used to treat Non Hodgkin Lymphoma (NHL). Who is it for? You may be eligible to join this study if you are aged 18 years or older, have a confirmed diagnosis of NHL requiring chemoimmunotherapy, and are at risk of febrile neutropenia. Study details All participants in this study will receive preventive treatment with a drug called lipegfilgrastim. Lipegfilgrastim is a growth factor that stimulates the bone marrow to produce neutrophils, white cells that help fight infection. Lipegfilgrastim is administered via an injection under the skin 24-72 hours after each dose of chemotherapy. Nursing staff will administer the growth factor. In conjuction with your treating haematologist, you will be monitored until approximately 14-21 days you complete your last cycle of chemotherapy. There will also be a follow up phone call 3 months after completing the study. During the study, you will undergo medical consultation, physical examination and regular blood tests (all but one are additional to 'standard of care' for your condition) This trial will produce safety and efficacy data for this preventive treatment and may reduce a complication of NHL chemoimmunotherapy.

The aim of the Sydney 1000 Bowel Cancer Study is to collect a broad range of information from 1000 prospective bowel cancer patients recently diagnosed with any stage of colorectal cancer for up to 10 years. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have a diagnosis of colorectal cancer (any stage). Study details The clinical research program involves the collection of clinical data at pre-defined time points detailing patients’ response to treatment, supplemented with patient reported outcome data collected from questionnaires during active treatment, regular follow-up (usually 5 years) and for the remainder of the study (up to 10 years). This longitudinal clinical data will be correlated with findings from the biological research program that involves the analysis of longitudinally collected biological samples (tumour, blood, and faeces) and experimental results. The resulting Sydney 1000 Bowel Cancer Study Biobank is expected to contain approximately 1,250 tissue specimens and 25,000 blood and faecal specimens from 1000 participant donors by 2029.

This is a study of two medications that may increase the sensitivity of metastatic melanomas to a currently used immunotherapy. Who is it for? You may be eligible for this study if you are 18 years or older and have an unresectable or metastatic melanoma which has primary resistance to previous immunotherapy (anti-PD1 therapy). Study details All participants in the study will receive a course of the two study drugs (azacitidine and carboplatin) for 8 weeks, before a ongoing course of immunotherapy (avelumub). Over the course of the study, blood samples and tumour biopsies will be taken to assess the treatment’s effect on the melanoma. It is hoped this study will provide evidence of these study substances increasing the sensitivity of melanomas to the anti-PDL1 antibody class of immunotherapy agents.

The aim of the research is to investigate if the option to choose a particular diet strategy as opposed to being prescribed a set strategy leads to greater weight loss. We hypothesise that freedom to choose the diet strategy will result in greater weight loss. This randomised parallel study and will include both men and women. Participants will be randomised to Choice or No Choice. The No Choice arm will be the 5 & 2 strategy (5 days of habitual eating with 2 very low energy intake days of 2000 - 3000kJ/day) compared with a Choice of 2 & 5 or continuous energy restriction (daily energy restriction between 4000-5000kJ/day). Participants will be asked to follow the diet for 8 weeks and attend the Sansom CTF at the start for randomisation and dietary instruction and every two weeks for 8 weeks. They will have height measured once and weight measured on each occasion. The first visit will take approximately 30 minutes and subsequent visits will take 15 minutes.

Clozapine is one of the most effective medications used for the treatment of schizophrenia. Up to 80% of patients treated with clozapine may complain of an increased secretion of saliva in the mouth (known as hypersalivation) as a result of being treated with clozapine. Hypersalivation may result in an overspill of saliva outside the mouth (known as drooling). Excessive production of saliva may disrupt sleep and speech, and cause aspiration pneumonia. Drooling is not pleasant and may damage the skin around your mouth. Atropine sulfate is one of the medications used most often in inpatient units in New South Wales-Australia to treat hypersalivation or drooling that is caused by clozapine. However, studies testing the effect of atropine are lacking. The aim from this study is to test the effect of atropine sulfate when administered under the tongue for the treatment of hypersalivation and/or drooling that is caused by clozapine. One sub-study to this study involves testing the chemical content of saliva by researchers in the ANZAC Research Institute at Concord Hospital. This research is designed by the mental health pharmacist Omar Mubaslat and overseen and supervised by consultant psychiatrist Professor Tim Lambert.

Updated criteria for the diagnosis of gestational diabetes (GDM) mean that larger numbers (approximately 18%) of women screened meet diagnostic criteria placing an increasing burden upon limited healthcare professional (HCP) resources. We hypothesise that while the 75g OGTT provides the standard for the diagnosis of GDM, continuous glucose monitoring (CGM) technology could provide a useful adjunct increasing efficiencies in patient care by more effectively triaging patients according to CGM profiles to identify those most likely to require intervention and expediting therapeutic decision-making by the health professional with the provision of more detailed data. All women with GDM diagnosed on OGTT between 24 to 28 weeks gestation will be offered retrospective CGM for a week, in addition to routine fingerprick glucose monitoring. They will also keep a record of HCP visits and time spent for the duration of the pregnancy. GDM management and maternal-fetal outcome data will be collected from medical records. Both OGTT (glucose levels) and CGM profiles (glucose levels and glycaemic variability) will be compared with subsequent therapeutic interventions, healthcare resource utilization and clinical outcomes to determine whether a set of criteria based on the glucose data obtained prior to 31 weeks can be employed to triage patients to either routine or more intensive follow up.