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Topical Dutasteride on Male pattern hairloss.
Expand descriptionThere is some evidence Topical application of dutasteride solution is effective in treating androgenetic alopecia. Local pilot study aims to study the efficacy of topical dutasteride solution to validate this claim.
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Exploring the utility of Indirect Calorimetry to Optimise Nutrition in paediatric Intensive Care (ICONIC)
Expand descriptionSince implementation in 2023, the QNRG+ (COSMED, Italy) indirect calorimetry (IC) device has been used regularly in the paediatric critical care unit (PCC) at Perth Children’s Hospital (PCH) as standard of care to guide nutritional targets on invasively mechanically ventilated (IMV) patients. However, feasibility of this device is yet to be described in paediatrics. This observational cohort study aims to 1) describe the implementation and feasibility of IC in PCC to inform practice / resources for other centres nationally and internationally, 2) determine if correlation exists between measured energy requirements and common PCC factors, such as level of sedation, and 3) determine if correlation exists between proportion of IC-guided energy targets delivered and changes in body composition. To describe IC feasibility, we will screen all invasively mechanically ventilated patients daily for an 18-month data collection period, aiming to recruit and screen a minimum of 250 patients, to assess proportion of patients and PCC days where both technical and stability criteria are met, to be able to perform IC. IC tests will be performed on all eligible participants, with proportion of successful vs unsuccessful rests reported. To describe measured energy expenditure (MEE) variability in invasively mechanically ventilated paediatric patients, we will document factors, such as level of sedation, temperature and nutrition, provided during each IC test. Updates to COSMED firmware in 2026 will allow opportunity for IC testing in children who weigh <10kg, and both feasibility and MEE data in this population will be crucial. To describe changes in body composition, skeletal muscle ultrasound and bio-impedance devices will be utilised, as per current PCC standard of care, and daily nutrition data will be collected. Recruitment will continue for a total of 36-months or more to ensure adequate participant numbers, and to capture data on infants and children who are <10kg.
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The effectiveness of hot-water baths on health and well-being in older adults.
Expand descriptionThis study investigates whether regular heat therapy can enhance heart health and improve the body's ability to manage heat in older adults aged 65 to 90. As climate change leads to more frequent and intense heatwaves, it's crucial to find ways to help older individuals better cope with heat stress. While regular exercise is known to improve heat tolerance, many adults are unable or unwilling to engage in physical activity. Heat therapy, such as sitting in warm water, might offer similar health benefits without the need for exercise. We hypothesize that consistent heat therapy will improve cardiovascular function and increase resilience to heat in older adults.
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A first study in humans to test the safety, tolerability, and how the body processes different single doses of a new imaging agent, KUVA-01, given by intravenous infusion in healthy adult volunteers.
Expand descriptionThis study will assess whether KUVA-01 a novel MRI imaging agent is safe and well tolerated in healthy adults, compared to a placebo agent (5% glucose). KUVA-01 may be indicated for use in patients with any solid cancer, but a trial of KUVA-01 in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged between 18 and 25 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive either an infusion of KUVA-01 or a placebo infusion. Both infusions will be administered once only into a vein over a 30 minute period by a registered nurse. Participants in both groups will then be asked to complete an abdominal MRI 2 hours after their infusion. It is hoped this research will demonstrate that KUVA-01 is a safe imaging agent that can be infused without any serious side effects. If this study shows that KUVA-01 is safe and well tolerated, a further study to investigate the imaging effect of KUVA-01 in cancer patients may be undertaken.
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Zoledronate Early Administration to Limit rebound bone loss
Expand descriptionZEAL is a single-centre, open-label, 1:1 randomised controlled trial at Westmead Hospital enrolling adults with osteoporosis who are stopping denosumab after greater than or equal to 2.5 to less than or equal to 6 years of therapy. It compares early zoledronic acid 5 mg IV at 3 months after the last denosumab dose (second dose 6 months later) versus on-time zoledronic acid at 6 months (second dose 6 months later). The primary endpoint is change in lumbar spine and total hip BMD from baseline to 18 months after the last denosumab dose. Secondary outcomes include bone turnover markers, proportion with >5% BMD loss, incident vertebral and non-vertebral fractures, and safety, with biomarker-guided rescue dosing permitted. Thirty-six participants will be followed for up to 24 months with 3-monthly assessments.
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TRIAD: Trial for Reducing Infection After Arthroplasty with Dilute Povidone-Iodine
Expand descriptionTrial for Reducing Infection After Arthroplasty with Dilute povidone-iodine lavage (TRIAD) is a multi-centre, AOANJRR-nested, cluster randomised trial utilising a hospital-level crossover design that will provide pragmatic low bias world class clinical evidence on the unmet need of surgical site infection (SSI) reduction following hip and knee arthroplasty surgery. It will compare pre-closure lavage with dilute povidone-iodine lavage to normal saline only lavage to reduce bacterial surgical site contamination. This intra-operative bacterial decontamination method if effective, is low cost, low risk and universally available to Australian orthopaedic surgeons. Currently, healthcare professionals have few scientifically validated methods to reduce the risk of SSI following arthroplasty surgery and TRIAD would provide an avenue for establishing this as a standard of care at an international level for reduction of infection following hip/knee arthroplasty. The primary objective of this study is to evaluate the efficacy of dilute betadine lavage in reducing surgical site infections (SSI) occurring within 90 days in adults undergoing primary, elective THA or TKA for osteoarthritis (OA).
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Optical Coherence Tomography Assessment of Radial Artery Injuries Caused by Trans-Radial Access
Expand descriptionThis is an observational study, where we will use a catheter pre- and post-coronary procedures to look for damage to the radial artery caused by trans-radial access. The primary hypothesis is that the radial artery sheath protect the radial artery from spasm and radial artery injuries, and looking at the distribution of injuries along the artery before and after the procedure will allow us to investigate this and guide strategies to protect patients (potential surgical candidates) at higher risk of radial artery injury. We will also study demographic data to help identify these patients that are more susceptible to injury.
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Exercise intervention for people with systemic sclerosis: A randomised waitlist controlled trial
Expand descriptionThis is a randomised two-arm parallel wait-list controlled trial. Participants will be randomised in a 1:1 ratio to either the intervention group (structured exercise) or the wait-list control group (usual care). The primary objective of EXEMPLAR 2 is to determine the between-group difference, from baseline to post-intervention, in peak oxygen uptake (peak VO2) in people with scleroderma receiving either 12 weeks of structure exercise and usual care, or usual are alone. The secondary objectives are to determine the between-group differences, from baseline to post-intervention, in cardiac microcirculation, skeletal muscle volume, muscle strength and endurance, functional capacity, body composition, perceived quality of life, physical function, fatigue, disease activity, and physical activity levels.
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SuPro – Sugammadex and its effect on Progestogens
Expand descriptionThe primary aim of this proposed randomised controlled trial is to determine and compare changes in plasma concentrations of levonorgestrel in women on this drug as part of their oral contraceptive pill after receiving sugammadex or neostigmine.
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Evaluating the Feasibility and Acceptability of a Digital Health Application for Chronic Ulcer Care: A Pilot Randomised Control Trial
Expand descriptionThis pilot RCT involves a new Clinical Decision Support System (CDSS) that will assist community nurses select appropriate ulcer dressings and will be integrated into a mobile application (it is not artificial intelligence). The CDSS, aims to simplify the complex decision-making process of selecting appropriate dressings for various types of ulcers. It has been designed to help community nurses choose the right ulcer dressing by providing an easy-to-use resource. It will suggest evidence-based dressing options. This pilot RCT will test the feasibility and acceptability of using this digital tool in community settings.