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Assessing the effect of mirabegron to treat high blood pressure in the lungs
Expand descriptionPulmonary hypertension (PH) is a disease in which blood pressure in lung circulation is abnormally high. PH remains highly-debilitating and deadly – half of patients may die within 5-years of diagnosis. Therefore, new PH treatments are urgently needed. This project builds on discovery by our group that medications working through "beta3 adrenergic receptors" reduce blood pressure in lung circulation of laboratory animals. This study aims to assess the safety and effect of mirabegron - a medication from this family that is used for overactive bladder in Australia – in adult patients with PH. We will administer mirabegron at the hospital and closely monitor the patients. We will measure the blood pressure in the lung circulation using special catheters that are routinely used for this purpose. If mirabegron is safe and effective, we will prescribe it for 8 days and assess the effects by ultrasound of heart in follow-up.
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Investigating the effect of light on sleep and performance during two night-shift protocols
Expand descriptionThe overarching aim of this project is to investigate a strategy to help maximise human cognitive performance in an encapsulated shift-work environment through evidence-based LED lighting design interventions optimised to support successful circadian physiology entrainment. We will conduct a randomised counter-balanced crossover experimental study designed to investigate the effectiveness of standard versus optimised LED lighting systems on cognitive performance, circadian entrainment, and objective sleep parameters during an 8 day simulated shift-work schedule in a laboratory environment.
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OzHarvest’s FEAST (Food Education and Sustainability Training) Program: promoting healthy eating, food waste reduction and cooking skills in Year 5 and 6 children in Australian primary-schools.
Expand descriptionOzHarvest, Australia’s leading food rescue organization has developed a primary school program called FEAST (Food Education and Sustainability Training). OzHarvest will provide resources, support, and training to primary-school teachers so that they can implement the FEAST program in the classroom setting. FEAST is designed to provide Year 5 and 6 students with knowledge about healthy eating, food waste, and the impact food choices make on the environment while teaching students to cook. The program is integrated into the Australian Curriculum and embraces Year 5-6 key learning areas (Science, Technology, English, Mathematics) and cross-curriculum priority of Sustainability. The aim of this study is to explore the impact of the FEAST program on children’s fruit and vegetable intakes, cooking behaviour, self-efficacy and skills, and food waste knowledge and behaviours, as well as student’s satisfaction with the program. It is hypothesized that students that undertake this program will increase their fruit and vegetable intake, learn how to follow recipes and prepare simple meals, reduce their food waste by eating their lunch box contents, eat fruits and vegetables that are not ‘perfect’ looking, and understand the impact of their choices on the environment.
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Effect of Systane hydration on ocular comfort and ocular surface damage among type 2 diabetics with dry eye disease and diabetic neuropathy
Expand descriptionDry eye disease affects between 5 and 50% of the population. In many cases, dry eye disease is idiopathic, however dry eye disease secondary to systemic disease has been identified as a major risk factor in the 2017 Tear Film and Ocular Surface Dry Eye Workshop II (TFOS DEWSII) report. In a study of 199 patients with type 2 diabetes, 54.3% were found to have dry eye disease, with dry eye frequency correlating with the duration of diabetes, where a 100% frequency was reported in patients who had a history of diabetes of greater than 15 years. The concurrent presence of dry eye disease in diabetes poses an additional risk to a potentially already compromised ocular surface: diabetes is known to increase the risk of corneal erosion formation, neurotrophic ulceration and persistent epithelial defects. Diabetes is currently estimated to affect 1.7 million Australians, with this figure predicted to rise to 3 million by 2025. It is associated with a multitude of microvascular and macrovascular complications due to the widespread effects of hyperglycaemia on the body’s various systems. The most commonly recognized diabetes-related complications are diabetic retinopathy and diabetic peripheral neuropathy. The prevalence of diabetic neuropathy is 26.4%15-70% depending on the method of detection used. The prevalence rises to 50% following 10 years of disease duration in type 2 diabetes. The clinical consequences are neuropathic pain, weakness with an increased risk of falls, and loss of sensation which may progress to foot ulceration and even amputation. The cornea, being one of the most densely innervated tissues, contains myelinated A-d and unmyelinated C fibers and has been advocated as a surrogate measure of peripheral neuropathy. We, and others, have previously reported a reduction in corneal nerve fiber length, fiber density and branch density with increasing neuropathic severity in both type 1 and type 2 diabetes. We hypothesize that the presence of neuropathy will increase the prevalence and severity of dry eye disease among those with diabetes. We further hypothesize that treating those with secondary dry eye disease with Systane Hydration will reduce these signs and symptoms, whether or not there is existing neuropathy. Primary Objective: This study will establish the odds of dry eye disease in diabetes when neuropathy is present, compared to diabetes without neuropathy (phase 1). Secondary objectives: This study will establish whether regular ocular lubrication with Systane Hydration can alleviate the signs and symptoms of secondary dry eye disease, whether it be due to diabetes alone or diabetic neuropathy (phase 2).
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Mallet and Extension Relative Motion Splinting Trial
Expand descriptionThe primary purpose of this study is to improve the healing of an injury to the extensor tendon of the finger known as ‘mallet finger’ by improved splinting. The disorder is caused by disruption of the extensor tendon to the most distal bone of the finger, resulting in an inability to fully straighten the finger. The current standard care for mallet finger injuries uses a splint that statically immobilises the most distal finger joint (DIPJ) in extension. However, in many patients the tendon heals slightly long, ending up with them losing the ability to fully extend their finger, known as a lag. Therefore, we propose using an additional splint that attaches to the adjacent (uninjured) fingers just beyond the knuckles and lifts the injured finger up slightly, known as an extension relative motion splint (ERMS). This results in the injured finger adopting a slightly flexed posture that relaxes the extensor tendon. We hypothesise that this will result in improved healing of the extensor tendon and therefore a reduced risk of lag. Importantly, the uninjured joints can still be fully straightened whilst wearing the ERMS, to prevent them becoming contracted in one position. This project will randomise around 60 patients to have either one (standard) or two (standard and ERMS) moulded plastic splints. The patients will also be stratified according to whether or not they have a small associated fracture. Splinting will be for eight weeks, with an additional two weeks if there is a lag noted after 8 weeks. The primary outcome will be extensor lag measured at two weeks after ceasing full time splinting. Secondary outcomes will be patient satisfaction, active range of motion (AROM) at the DIPJ, change in AROM at the proximal finger joint, total AROM of the finger, and complications.
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Probiotic use and post-operative recovery following appendicectomy in children.
Expand descriptionThe study aims to determine the health benefits of oral probiotics in improving the post-operative recovery following appendicectomy for acute appendicitis. Children with appendicitis will randomly allocated to receive probiotics or placebo for 1 month following appendicectomy. We will collect information regarding post-operative recovery (e.g. return to normal physical activities, number of bowel actions, etc.) to confirm if probiotics might be beneficial following surgery and provide a quicker recovery.
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A Double-Blind, Randomized, Parallel, Controlled, Study to Compare Pharmacokinetics and Pharmacodynamics of BP13 (filgrastim) with EU-approved Neupogen® in Healthy Male Adult Subjects
Expand descriptionThe purpose of this study is to compare the pharmacokinetics (what the body does to a drug), Pharmacodynamics (effect of drugs on the body), immunogenicity (ability to provoke an immune response) and safety of BP13 with Neupogen in healthy males. Who is it for? Healthy male aged 18 to 55 years. Study details All participants in this study will undergo treatment utilizing a double-blind, randomized, parallel, controlled study design. The total study duration for each subject is expected to be approximately 15 days (excluding the 28-day screening period). This drug is recommended for use in cancer patients undergoing chemotherapy, to reduce the incidence of infection. All participants will undergo regular blood tests and safety assessments throughout the study, in order to evaluate how the body responds to the drug. We hope that BP13 (filgrastim) will be comparable to Neupogen, warranting further investigational trials to evaluate its efficacy in cancer patients.
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Parental and Healthcare Professional Concern in the Diagnosis of Paediatric Sepsis
Expand descriptionThe primary purpose of this study is to determine if the level of concern of parents and healthcare workers, within the emergency setting, can help improve diagnostic accuracy for paediatric sepsis.
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REscuing bone marrow function in patients with aplaStic anaEmia and bone marrow faiLure post allogEneiC Transplantation (RESELECT) Phase I/II single arm with historical control study assessing the efficacy and safety of Atorvastatin and N-Acetyl Cysteine in the treatment of Poor Graft Function post allogeneic transplantation and relapsed/refractory aplastic anaemia
Expand descriptionAllogeneic Stem Cell transplant (alloSCT) is a curative procedure for many blood disorders and involves the transplantation of donor blood cells into a compatible recipient. Engraftment is a key milestone of success of alloSCT and is measured by standard blood tests to ensure normal levels of blood cells as well as a specialised blood test to confirm this blood is being produced by donor tissue. Poor graft function (PGF) is a significant complication of alloSCT and results in poor blood cell production by engrafted donor tissue. Aplastic anaemia(AA) is an autoimmune disease that results in the body's own immune cells attacking the bone marrow (the organ that produces blood cells) resulting in decreased production of blood cells. The mechanisms leading to PGF and AA are similar. There is evidence that the bone marrow microenvironment, the ecosystem in which blood cells reside, is abnormal in both PGF and AA. Atorvastatin is an old drug that has been used to treat high cholestrol and N-acetyl-cysteine (NAC) has been used as an antioxidant to treat paracetamol overdose. There is evidence that atorvastatin and NAC may be able to reverse this microenvironment dysfunction in PGF and AA. This study is aimed at testing the efficacy and safety of atorvastatin and NAC in the treatment of PGF and relapsed/refractory Aplastic anaemia.
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A cluster randomised controlled trial of the impact of a multi-strategy behavioural intervention on the nutritional quality of secondary school student food purchases from online canteens.
Expand descriptionThe aim of this study is to assess the effectiveness of integrating consumer behaviour strategies (including menu labelling, item positioning, tailored feedback & prompts) into an online canteen ordering system, to improve the nutritional quality of foods purchased by secondary school students via online canteens. This study will employ a clustered randomised controlled design. Ten NSW secondary schools currently using an online canteen ordering system will be randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). Intervention effectiveness will be assessed via between group differences in the proportion of online orders classified as ‘Everyday’, ‘Occasional’ or ‘Should Not Be Sold’ according to the NSW Healthy School Canteen Strategy, using purchase data automatically recorded by the online ordering system at baseline (the 2-month period prior to intervention commencement) and follow up (the 2-month period immediately post-intervention commencement).