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Can Flash Glucose Monitoring (FlashGM) improve glucose management in Indigenous Australians with type 2 diabetes?
Diabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians, and the risk and severity of diabetes complications (cardiovascular disease, kidney failure, blindness) are far greater in this population than in non-Indigenous Australians. We address this problem, targeting Goal 5 of the National Diabetes Strategy. We urgently need effective and convenient ways of improving glycaemic management in Indigenous Australians. New technologies that continuously monitor blood glucose are effective in assisting patients to improve their blood glucose levels through driving changes in behaviour (increasing physical activity), lifestyle (healthier eating habits), and therapy. The devices are worn on the arm and provide continuous, real-time feedback on blood glucose levels, but have not been tested in Indigenous Australians. We will assess the effects of one of these technologies (flash glucose monitoring) on glycaemic control (glycated haemoglobin [HbA1c] levels, achieving blood glucose targets, reducing hypoglycaemic episodes) through a randomised clinical trial in this high-risk population. We will also perform a cost-effectiveness analysis. Indigenous Australians with type 2 diabetes on injectable therapy, and with persistent high blood glucose levels, as indicated by HbA1c >7.5% (n=350), will be equally randomised to use a flash glucose monitor or receive standard care (glucose tested by finger-prick) for 6 months. Anticipated primary outcomes will be a lower, clinically significant HbA1c level with flash glucose monitoring. Anticipated secondary outcomes include achieving blood glucose targets, fewer hypoglycaemic episodes, reduced costs, and improved quality of life. The research will likely lead to major, cost-effective health gains for Indigenous Australians, and significantly improved health-service delivery for Indigenous and other high-risk Australians.
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The effects of morphine on breathlessness and sleep in chronic obstructive pulmonary disease: A randomised, double-blind, placebo controlled cross-over study
The purpose of this study is to determine the effects of sustained-release oral morphine (20mg) on sleep efficiency, breathlessness, and daytime alertness in breathless people with chronic obstructive pulmonary disease. We hypothesize that low dose morphine will improve sleep efficiency.
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Controlled Human Infection for Penicillin Against Streptococcus Pyogenes
The CHIPS Trial is a double-blinded, randomised dose-ranging trial designed to determine the minimum effective steady-state penicillin concentrations required to prevent pharyngitis caused by Strep A. This trial will use a world-first fully validated human challenge model for Strep A infection which has been developed in Australia by members of our team as a tool to test different interventions in the fight against acute rheumatic fever (ARF) and rheumatic heart disease (RHD). If the CHIPS Trial determines that the minimum concentration required to prevent Strep A pharyngitis is lower than the currently accepted target of 20 ng/mL, this will transform the penicillin reformulation landscape toward a new long acting penicillin implant and provide opportunities to make data-driven changes to recommendations of currently available penicillin preparations used for secondary prophylaxis of ARF and RHD.
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Magnetic and Indocyanine Green (ICG) Sentinel Lymph Node Mapping in Colorectal Cancer: A Feasibility and Validity Clinical Trial
The purpose of this study is to evaluate the safety of a new magnetic tracer (FerroTrace) and an infrared dye (Indocyanine Green - ICG) to be used together in colorectal cancer surgery to find the lymph nodes the cancer is most likely to have spread to (the sentinel lymph nodes). This study will also evaluate the feasibility and accuracy of the new magnetic tracer (FerroTrace) and infrared dye (ICG) for finding the sentinel lymph nodes. If the sentinel nodes are clear of cancer, there is a very high probability the cancer has not spread. Finally, the study will also investigate whether the new tracer enables better detection of cancer cells in lymph nodes on Magnetic Resonance Imaging (MRI) before surgery. Who is it for? You may be eligible to join this study if you are aged between 18 and 75 years, have a confirmed diagnosis of primary colorectal cancer and are scheduled for surgery to remove the primary tumour. Study details All participants will undergo their surgery to remove the primary tumour as originally scheduled, with the addition of receiving the new magnetic tracer (Ferrotrace) and the infrared dye (ICG) during the surgery. Participants will then be monitored for 14 days after the surgery for complications. It is hoped that this research project will demonstrate the new method is safe and feasible, and can enable larger follow on trials to determine if the new method improves staging accuracy and can improve patient outcomes.
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TaxAdapt: A clinical trial testing the feasibility, acceptability, and safety of docetaxel in men with prostate cancer that has spread
The purpose of this study is to test the idea of a new way of using an old drug in men with prostate cancer that has spread. Who is it for? You may be eligible for this study if you have prostate cancer that has spread and you are offered to take a chemotherapy infusion called docetaxel by your oncologist. Study details If a man about to take docetaxel chooses to take part in the study, their oncologist will advise them to pause taking their medication if their PSA blood test falls by over half. If their PSA blood test returns to pre-treatment levels, participants will then be advised to recommence taking the tablets again until again, the PSA blood test has decreased by more than 50%. The idea is to take breaks from the chemotherapy, using it for long enough to control the cancer, but then stopping and saving it up until later to treat the cancer again. The blood tests, scans, and doctors appointments in the trial are almost identical to normal treatments; men on the trial will be asked to complete short questionnaires, and have an extra blood test every three months. It is hoped this study will demonstrate this strategy of treatment will reduce side-effects, and may improve the lives and survival of men with prostate cancer.
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Does targeted dietary advice via telecommunications (video, phone and text) reduce blood phosphate levels in patients with kidney failure on dialysis?
Compared to participants who are randomised to the normal care group participants randomised to the intensive telenutrition phosphate control strategy will have lower serum phosphate and reduced intake of high phosphate dietary sources.
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Preliminary Efficacy of SIR1-365 in Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome
SIR1-365 is a potent and selective allosteric kinase inhibitor of RIP1 with favorable drug-like properties in vitro and in vivo. RIP1 inhibitors may be beneficial for the treatments of degenerative diseases including neurodegenerative and systemic inflammatory diseases. The primary objective is to assess the overall safety and tolerability of SIR1-365 administered orally at 200 mg, two times per day (BID) for 28 days relative to the placebo group. The secondary objectives are to assess the effects of SIR1-365 on clinical efficacy endpoints, and the biomarkers indicative of inflammation, and target engagement as well as the plasma SIR1-365 levels.
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Lower limb rehabilitation for patients with peripheral artery disease.
Peripheral artery disease (PAD) is a disease that leads to a reduction in blood flow to the legs. This study looks at the feasibility of using heart rehabilitation, which is well established in Australia, to help patients with PAD. We will conduct an 8-week supervised exercise program for patients with PAD and provide a medical risk assessment, education and counselling, and address lifestyle factors (diet, exercise, medication use), and how you’re feeling. After 8 weeks of supervised exercise, you will be prescribed a home exercise program. After 6 months, we will re-assess your ability to walk, as well as your symptoms, strength, and overall state of health and well-being. The exercise program will be tailored to your ability. We believe using the heart model for exercise, education and counselling will help to improve physical activity, symptoms, and quality of life in patients with PAD, similar to those with heart problems.
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Investigating the Effect of Plant Based Diets on Cardiovascular Disease Risk
The switch to plant-based diets (PBD) is not only an emerging societal trend but a global movement. Diets with an emphasis on higher intakes of plant foods and lower intakes of animal foods (i.e. plant-based) have been associated with a lower risk of cardiovascular morbidity and mortality as well reduced risk of major risk factors such as obesity, type 2 diabetes mellitus and hypertension. This cross-sectional cohort study aims to investigate the dietary profile and nutritional adequacy of current plant-based dietary patterns followed by middle-aged Australians and compare the risk of cardiovascular disease across plant-based dietary patterns and omnivorous diet (regular meat eaters). It is hypothesised that individuals following a PBD will have significantly different food group and nutrient intakes to individuals who regularly eat animal flesh. Moreover, the cardio-metabolic risk profile will differ between individuals following a PBD and individuals who are regular meat eaters. It is also hypothesised that the dietary profile and indicators of cardio-metabolic disease will differ across various types of PBDs and some PBDs may even be nutritionally inadequate when compared against the Australian Dietary Guidelines and/or Nutrient Reference Values. Unlike other studies where PBD are often categorised under the same category (e.g vegetarian) findings from this study will provide more specific information across the difference PBD categories and therefore more comprehensive evidence to potentially support future dietary guidelines around PBD.
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A randomised control trial investigating the effect of temazepam on sleep in critically ill patients
The DREAM study aims to compare a single dose of temazepam to a placebo, to investigate whether this will improve sleep in patients in the intensive care unit (ICU) of a tertiary hospital. Currently, there is no evidence on whether temazepam, a commonly prescribed sleep aid in the ICU, is effective in promoting sleep for critically ill patients. Patients will be given a weight adjusted dose of temazepam, or a blinded placebo, on a single night during their stay in the ICU. Both subjective measures of sleep (bedside nurse assessment), and objective measures (polysomnography) where available will be collected.