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Evaluating the effects of metronidazole ointment for non-healing pilonidal sinus wounds in adults
The goal of this study is to determine whether topical metronidazole ointment works to improve healing rates and achieve complete healing without causing discomfort or side effects for non-healing pilonidal wounds. Based on a previous pilot study, we hypothesize that 10% topical metronidazole will be better than placebo in achieving these outcomes
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Diabetes Management Errors in Australia: A Factorial Randomised Controlled Trial of a Health Workforce Educational Platform (The WDEP.AI RCT) for Rehabilitation Wards
The primary purpose of this study is to evaluate the effectiveness of the WDEP.AI digital platform in enhancing healthcare professionals’ knowledge and skills in diabetes management. This platform provides structured and systematic learning to address knowledge gaps, aiming to reduce errors in care and improve patient outcomes. We hypothesise that healthcare professionals who use the WDEP.AI platform will demonstrate improved competencies, leading to safer and more effective diabetes care.
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Video Informed DEcisiOn-Making (VIDEO-2) for Patients Undergoing Incisional Glaucoma Surgery: A Randomised Control Trial to evaluate if the addition of a targeted patient information video improves the shared decision-making process when compared to standard processes for patients considering incisional glaucoma surgery.
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Feasibility of randomization to different flow targets for cardiopulmonary bypass.
Worsening kidney function is common after cardiac surgery. During cardiac surgery, cardiopulmonary bypass (CPB) is commonly utilised to deliver blood around the body However, the use of CPB is known to decrease blood flow to the kidneys compared to normal, putting the kidneys at risk of harm. Increasing overall CPB blood flow to the whole body has minimised kidney harm in small studies. However, the benefit of routinely increased CPB blood flow has not been tested in real-world settings. In order to work towards a large trial that applies high CPB blood flow routinely, we aim to demonstrate the feasibility of targeting different CPB blood flow targets in two different hospitals. Adult non-female patients having cardiac surgery who: require normal temperatures to manage their surgery; have normal oxygen-carrying capacity and without severe kidney disease will randomly receive blood flows at the highest range of acceptable CPB flow or blood flows at the middle of that range. Afterwards, routinely collected data related to kidney outcomes and other outcomes will be collected. An extra blood test will be collected comparing red cell breakdown in both groups. This trial is expected to demonstrate feasibility for a larger trial.
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Randomized trial of medical therapy versus conduction system pacing with atrioventricular (AV) node ablation in persistent atrial fibrillation (AF) and heart failure with preserved ejection fraction
In patients with permanent AF and HFpEF the beneficial effects of conduction system pacing with left bundle branch area pacing (LBBAP) and AV node ablation remains unclear. In particular, there is a lack of data on invasive haemodynamic profiling, exercise capacity and natriuretic peptide changes in patients who undergo conduction system pacing with AV node ablation compared to medical therapy alone. Therefore the aim of this research project is to conduct a single centre, randomized controlled trial of conduction system pacing with AV node ablation, versus medical therapy, in an AF and HFpEF cohort. We will compare the structural and functional cardiac remodelling changes that occur over time in both groups utilizing exercise haemodynamic measurements.
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The role of pharmacological heart failure therapy in LV recovery following INDEX catheter ablation for patients with atrial fibrillation (AF) induced cardiomyopathy - the INDEX-AF Study
We propose a randomised control clinical trial to explore whether patients with AF-induced cardiomyopathy undergoing catheter ablation can avoid anti-heart failure pharmacotherapy. Patients will be randomised to recieve anti-heart failure pharmacotherapy (control) versus monitoring without anti-heart failure pharmacotherapy (intervention). The primary outcome will be change in left ventricular ejection fraction from baseline.
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Triggered Acute Risk Prevention (TARP): Effect of a Novel Model of Care on Cardiovascular and Mental Health Outcomes.
Cardiovascular disease (CVD) remains Australia’s leading cause of death. Current prevention strategies focusing on chronic risk factors and daily treatment fail to fully explain the risk of CVD. We and others have identified acute triggers in almost half of heart attacks, yet until now, this information has not been used for prevention. In a placebo-controlled double-blind study of 120 participants with cardiovascular disease (CVD) or >=2 risk factors, we will evaluate a Triggered Acute Risk Prevention (TARP) strategy for the triggers of acute emotional stress (anger and anxiety), physical exertion, heavy/fatty meals, respiratory infection and pollution. The TARP strategy will empower individuals to recognise these triggers and respond appropriately by taking preventative medication and/or accessing app-based trigger-related educational resources. The goal is to lower acute psychological stress responses and to reduce cardiovascular risk.
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Is Achilles tendinopathy pain education with or without exercise, more effective than usual care, in improving pain cognitions in those with midportion Achilles tendinopathy? A pilot and feasibility study
Achilles tendinopathy is a common injury amongst both athletic and non-sporting populations. (1-3). Despite the best efforts of various rehabilitation approaches. there is evidence to suggest that 1 in 5 of those with Achilles tendinopathy will remain symptomatic after 10 years.(4). There is emerging literature supporting cognitive-based interventions in chronic pain conditions. (5, 6) It is thought that pain neuroscience education can assist patients in reconceptualizing their pain by improving knowledge regarding their condition.(5, 6, 7). However, whilst there is support for the use of education in other chronic pain conditions it is yet to be applied as a stand-alone intervention in Achilles tendinopathy. There is evidence to suggest that the psychological profile of those with Achilles tendinopathy resembles those with chronic lower back pain, with both conditions presenting with a similar prevalence of kinesiophobia. (6) Therefore, we wish to determine the feasibility of conducting a randomized controlled clinical trial that evaluates whether the addition of a previously developed Achilles Tendinopathy Pain Education (ATPE) (7) to usual care has added benefit in improving maladpative pain-related cognitions in Achilles tendinopathy. References: 1. Lopes AD, Hespanhol Júnior LC, Yeung SS, Costa LO. What are the main running-related musculoskeletal injuries? A Systematic Review. Sports Med. 2012 Oct 1;42(10):891-905. 2. Malliaras P. Physiotherapy management of Achilles tendinopathy. Journal of Physiotherapy 2022;68:17. 3. Visser ST, van der Vlist A, van Oosterom R, van Veldhoven P, Verhaar J, de Vos R. Impact of chronic Achilles tendinopathy on health-related quality of life, work performance, healthcare utilisation and costs. BMJ open sport & exercise medicine. 2021;7(1). 4. Lagas IF, Tol JL, Weir A, de Jonge S, van Veldhoven PLJ, Bierma-Zeinstra SMA, et al. One fifth of patients with Achilles tendinopathy have symptoms after 10 years: A prospective cohort study. Journal of Sports Sciences. 2022;40(22):2475-83. 5. Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016;32(5):332-55. 6. Smitheman HP, Lundberg M, Härnesand M, Gelfgren S, Grävare Silbernagel K. Putting the fear-avoidance model into practice – what can patients with chronic low back pain learn from patients with Achilles tendinopathy and vice versa? Brazilian Journal of Physical Therapy. 2023;27(5):100557. 7. Post AA, Rio EK, Sluka KA, Lorimer Moseley G, Bayman EO, Hall MM, et al. Effect of pain education and exercise on pain and function in chronic achilles tendinopathy: Protocol for a double-blind, placebo-controlled randomized trial. JMIR Research Protocols. 2020;9(11).
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Improving Access to Hernia Surgery: A Study of Same-Day Procedures in Public Hospitals
This study aims to evaluate the effectiveness of a dedicated short-stay hernia surgery service for adults undergoing elective repair of abdominal wall or groin hernias. The intervention involves performing laparoscopic or open surgical hernia repairs as same-day procedures, focusing on minimally invasive techniques and intraoperative nerve blocks to support early recovery. The study will assess postoperative outcomes, including complications and quality of life, through structured follow-up at 4 weeks and 12 months. The hypothesis is that same-day hernia surgery will improve access to care and patient outcomes in the public healthcare setting.
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A comprehensive DIGITAL solution To Empower Asthma and comorbidity self-Management. The DIGITAL TEAM study.
To improve education, medication adherence, and symptom monitoring in people with asthma, a comprehensive digital program To Empower Asthma and comorbidity self-Management (DIGITAL TEAM) has been developed, to be implemented by Asthma Australia. This randomised controlled tele-trial aims to explore how effective this program is in improving asthma outcomes for Australians with Asthma, compared to enhanced usual care. 1100 adults with asthma will be recruited and randomised into one of two arms. Control arm participants will be provided with educational materials about asthma and a recommendation to see their GP. Intervention arm participants will be referred to Asthma Australia, who will provide access to the DIGITAL TEAM program, which includes 2+ telehealth sessions, a smartphone application, text messages and a website. Follow-up interviews will be conducted at 3-, 6-, and 12-months post-randomisation. The primary outcome of this study is Asthma Control over 6-months.