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How does Flash Glucose Monitoring affect Blood Glucose Levels of Indigenous Australians with type 2 diabetes?- A Pilot Study.
Expand descriptionDiabetes is a major contributor to the mortality gap between Indigenous and non-Indigenous Australians. High blood glucose levels in Indigenous Australians are a major driver of diabetes complications. In non-Indigenous populations, knowledge gained from continuously monitoring blood glucose levels has led to behavioural change and a reduction in blood glucose levels in individuals with diabetes. Continuous monitoring of blood glucose levels has never been studied in Indigenous Australians. There is an urgent need to find effective ways of improving blood glucose control in this population. The aim of this pilot study is to compare to usual care (SMBG), continuous use of real-time flash glucose monitoring in Indigenous Australians with type 2 diabetes, to determine if flash glucose monitoring will improve HbA1c, achieve blood glucose targets and reduce hypoglycaemic episodes. This study will also evaluate whether flash glucose monitoring is effective, feasible, acceptable and cost-effective in this population. Participants will be randomly assigned to blood glucose monitoring by flash glucose monitoring (Abbott Freestyle Libre) or conventional SMBG. 40 volunteers will be recruited to participate in the pilot study. Participants’ involvement in the study will last 6 months.
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A feasibility study to determine the efficacy of using an actively managed discharge care plan for promoting enhanced communication for patients with diabetes.
Expand descriptionStudy Title: A project that aims to determine the efficacy of using an actively managed discharge care plan for promoting enhanced communication. Study Population: Participants will be male or female with diabetes coming from priority populations (but are not limited to): • People experiencing homelessness • Aboriginal and Torres Strait Islander peoples • Culturally and linguistically diverse people Participants will be recruited through the Diabetes outpatient clinics at the lead site: Royal Prince Alfred Hospital and recruitment from partner sites, Prince of Wales Hospital and St Vincent’s Hospital. Study tool: Actively managed discharge care plan with calling criteria for Primary Care Physician (PCP) to ensure continuity of care and care coordination. Sample size: 100 participants Lead study site: Royal Prince Alfred Hospital Study duration: 2 years Study Start: 25JAN2021 (recruitment) Study Endpoints: This program aims to assess the feasibility of enhancing communication with the PCP across the CESPHN region for improved health outcomes to decrease patient’s hospital readmission and follow-up.
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Comparison of fibreoptic-guided intubation through an i-gel versus hyperangulated video laryngoscopy by emergency physicians: a prospective randomised study in cadavers.
Expand descriptionIn this study we have chosen to compare a standard approach to the intubation of a difficulty airway, using hyperangulated video laryngoscopy (HAVL), with a novel method where the endoscope is guided into the trachea through a supraglottic airway device (SGA). We feel this is a scenario likely to be encountered by emergency physicians as these devices are commonly used in this setting as a ‘rescue device’, which can temporarily allow ventilation when traditional laryngoscopy has failed to secure a definitive airway. Our hypothesis is that intubation facilitated by a fiberoptic airway scope inserted via an SGA will allow an emergency physician to rapidly achieve a secure airway, when compared with HAVL, as these devices are designed to open directly at the laryngeal inlet and so may be an ideal conduit for endoscopic intubation of the trachea.
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Effect of Palmitoylethanolamide (PEA) and Oleoylethanolamide (OEA) Compared to a Placebo on the Gut Microbiome in an Adult Population – A double blind, randomised controlled trial.
Expand descriptionEffect of Palmitoylethanolamide (PEA) and Oleoylethanolamide (OEA) Compared to a Placebo on the Gut Microbiome in an Adult Population – A double blind, randomised controlled trial. The aim of this study is to assess the effectiveness of PEA and OEA for altering the gut microbiome diversity and population compared to a placebo in overweight but otherwise healthy adults aged 18-65 years old.
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Effect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Population – A double blind, randomised controlled trial.
Expand descriptionEffect of Palmitoylethanolamide (PEA) and Resveratrol compared to a placebo on menstrual pain symptoms in an Adult Population – A double blind, randomised controlled trial. The aim of this study is to assess the effectiveness of a combination of PEA and resveratrol on alleviating menstrual pain symptoms in otherwise healthy women.
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Does the delivery of an online intervention for eating disorder symptoms impact outcome?
Expand descriptionAlthough internet interventions can effectively address key eating disorder symptoms, it is not yet known whether the mode of content delivery impact engagement, outcomes, and dropout. This randomized controlled trial will compare a static (i.e., written text content online) versus interactive (i.e., multimedia content with embedded activities) internet intervention on eating disorder symptoms. This trial is nested within a larger RCT (ACTRN12619001437156), in which participants originally randomized to the wait-list arm of that trial will be subsequently randomized to either the static or interactive intervention at post-test (once the wait-list period ends). The two interventions are identical in content, with the only difference being the mode of delivery.
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A 2-part, randomised, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of FTP 637 in healthy volunteers.
Expand descriptionThe purpose of this study is to test the safety and tolerability of a new medication (called FTP-637) in healthy volunteers. FTP-637, an investigational drug, is a small molecule inhibitor of tyrosine kinase 2 (TYK2) being developed for the treatment of psoriasis and other autoimmune diseases. The study will consist of 2 parts; Part A - multi-cohort Single Ascending Dose (SAD), and Part B – multi-cohort Multiple Ascending Dose (MAD).
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mMaLeS: Markers in Male Lichen Sclerosus
Expand descriptionLichen sclerosus (LS), also known as balanitis xerotica obliterans (BXO), is a chronic relapsing inflammatory dermatosis of cryptic aetiology. LS, which usually occurs in the anogenital region of men or women, may cause destructive scarring that can lead to devastating urinary and sexual problems. Clinically it presents as symptoms of itching, pain, dysuria, urinary retention and sexual dysfunction. Specifically, in males, lichen sclerosus may present as phimosis or urethral stricture disease, requiring the involvement of urologists in their care. One third of men were found to have signs of lichen sclerosis without symptoms on examination for other conditions. Lichen sclerosus is a clinically and histologically diagnosed pathological condition with very little understanding of the underlying genetic and proteomic changes that lead to the development and progression of this condition. Skin samples of affected and normal skin will be taken from affected men undergoing circumcision for the treatment of lichen sclersus and analysed to determine the genetic and proteomic profile. The purpose of this study is to investigate the gene and protein expression profile changes in skins affected by LS as compared to normal skin in order to discover the mechanism of the LS, and to further develop targets for diagnosis and effective drugs to treat the condition.
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Effect of Polygenic Risk Modification on breast cancer risk management and prevention: The PRiMo Trial
Expand descriptionThis trial is investigating the efficacy and feasibility of a personalised risk assessment for breast and ovarian cancer, through offering a polygenic risk score. Who is it for? You may be eligible for this trial if you are a woman aged 18 years and above undergoing a predictive test for a known familial mutation in a gene associated with increased risk of breast cancer - BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51C or RAD51D at a participating Familial Cancer Clinic. You may also be eligible if you have previously completed predictive testing that detected PALB2, CHEK2, ATM, RAD51C, or RAD51D at a participating Familial Cancer Clinic. Study details Participants will be randomly allocated to either the intervention arm, or a waitlist control that will be eligible to receive the personalised risk assessment after 1 year. The intervention arm will receive an integrated, personalised risk assessment and risk management advice, whereas the control arm will receive risk management advice based on the standard risk assessment incorporating the results of single gene testing and family cancer history. Information from this trial will be used to optimise targeted risk management of breast and ovarian cancer, whilst minimising the burden and cost to the health system
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Measured energy expenditure in critically ill adult patients
Expand descriptionIndirect calorimetry is a device used to measure energy requirements by measuring oxygen use and carbon dioxide production. Indirect calorimetry is the recommended method of guiding energy provision in critically ill patients in key nutrition guidelines. However, indirect calorimetry is not widely available in Australia and there is minimal data describing measured energy expenditure during Intensive Care Unit (ICU) admission in a modern setting. The primary aim of this study is to describe measured energy expenditure in adult mechanically ventilated critically ill patients in a modern Australian ICU.