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A prospective pilot study of the safety and efficacy of thyroid artery embolisation (TAE) for the treatment of symptomatic thyroid nodular goitre
Expand descriptionThe authors aim to perform thyroid artery embolisation (TAE) for a pilot cohort of 5 patients with symptomatic benign thyroid nodules and/or thyroid goitre to determine the safety, feasibility, efficacy and outcomes in the local setting.
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The RESET Study: Circadian Rhythm Enhancement through Smart, Evidence Based Wearable Technology and Personalised Intervention
Expand descriptionThe purpose of this study is to determine if circadian informed light therapy will improve outcomes for the treatment of circadian misalignment, relative to treatment as usual, for adults presenting for treatment of circadian misalignment. Effective and accurate light administration depends on accurate assessment of the circadian system which has a very narrow time-window of sensitivity to blue-enriched light, so large phase delays and advances (shifts in our sleep timing) can occur with only a relatively small difference in light administration timing. At present circadian timing is estimated by sleep wake timing alone which is highly variable and inaccurate. Therefore this project will assess the efficacy of personalised advice on the use of the retimer light device from information provided by wearable light pin to estimate the circadian rhythm more precisely.
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Hydrogen-Rich Water Supplementation for Adults with Excess Weight
Expand descriptionThis study will investigate the effects of hydrogen-rich water (HRW) supplementation in adults with excess body weight through a randomised, double-blind, placebo-controlled clinical trial. Participants will consume either HRW or placebo water daily for six months. The study will evaluate changes in body composition, cardiometabolic health, glycaemic control, oxidative stress, inflammation, and gut microbiota composition. In addition, mechanistic analyses will explore the effects of HRW on immune cell function and redox-related pathways. The findings will contribute to understanding the potential role of hydrogen-rich water as a nutritional intervention for improving metabolic health in adults with overweight and obesity.
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Shockwave Medical Aortic First in Human Study utilising the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System for subjects with severe, calcified aortic stenosis
Expand descriptionThis study is a prospective, multicentre, first-in-human study to evaluate the safety and effectiveness of the Shockwave Medical VTL II System with VTL II Catheter and Aortic Steerable Sheath to treat participants with symptomatic, severe calcified aortic stenosis. Eligible participants who meet all inclusion and exclusion criteria and provide informed consent will undergo transcatheter aortic valve lithotripsy (TAVL) procedure using the VTL II System. The procedure is performed via a trans-vascular approach in a catheterisation laboratory or a hybrid suite, where lithotripsy (soundwaves) pulses are delivered to modify calcified aortic valve tissue. Additional balloon aortic valvuloplasty and transcatheter aortic valve implantation may be performed at the operators discretion. Participants will receive standard post-procedural care and be followed during hospitalisation and at discharge. Follow-up assessments will occur at discharge, 30 days, 6 months, 12 months and 24 months post procedure. Study exit will occur between 12 and 24 months following the index procedure.
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A study comparing two intravenous treatments, magnesium sulfate and aminophylline, to see which works better for children experiencing a severe asthma attack.
Expand descriptionAsthma attacks are a common reason children come to the Emergency Department. When inhaled treatments and steroids are not enough, doctors give stronger medicines through a drip. The two medicines used most often are magnesium and aminophylline, but despite their frequent use, we still don’t know which one helps children recover faster or reduces the need for extra breathing support. The MAGIC study will compare these two treatments in more than 1,000 children aged 2 to 15 years with severe asthma across leading hospitals in Australia and Aotearoa New Zealand. Each child will be randomly assigned to receive one of the medicines first; if their asthma remains severe, they may also receive the other. We will measure whether the first medicine works within four hours without needing more IV treatment or increased breathing support, and which treatment pathway leads to shorter hospital stays. We will also assess side effects, need for intensive care, satisfaction with care, quality of life and costs. The aim is to provide clear evidence to guide emergency doctors and update national guidelines in both countries, helping children recover more quickly and return home sooner.
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Optimising evidence-based perioperative nutrition care in patients undergoing reconstruction surgery for head and neck cancer (HNC)
Expand descriptionBrief description of the study purpose: This study aims to assess the feasibility of implementing a digital, patient-led malnutrition screening tool for people undergoing jaw reconstruction surgery for head and neck cancer at Chris O'Brien Lifehouse. The study will also involve co-designing the tool with consumers, healthcare professionals, and information technology specialists. Who is it for? You may be eligible for the co-design phase of this study if you are a consumer advisory panel members with experience of head and neck cancer. You may be eligible for the implementation phase of this study if you are aged 18 years or older who are undergoing jaw reconstruction surgery for head and neck cancer at Chris O'Brien Lifehouse, are English-speaking, and have access to a mobile device and the internet. Study details: The study will be conducted in two phases. In Phase 1, consumer advisory panel members, including people with lived experience of head and neck cancer, will take part in a single online or in-person focus group lasting approximately 1 to 1.5 hours to help co-design the digital malnutrition screening tool. In Phase 2, patients undergoing jaw reconstruction surgery for head and neck cancer will test the digital screening tool before surgery. Participants will complete a short survey (by phone or SMS), use the screening tool, and complete a final online survey. Participation is expected to take approximately 30 minutes in total. All participants will receive the study intervention relevant to their phase of participation. The study involves completion of surveys and testing of the digital malnutrition screening tool. No additional blood tests or cancer treatments are required as part of the study. It is hoped that this research will support the development and implementation of an effective patient-led screening approach to identify malnutrition earlier and improve nutritional care for people with head and neck cancer.
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Running with Osteoarthritis: A physiotherapy-supported exercise, education and running program to increase physical activity for people with knee osteoarthritis
Expand descriptionThis project aims to investigate whether physiotherapists can support people to return to run after stopping due to knee osteoarthritis. Twenty participants will be recruited and prescribed a running program along with fortnightly physiotherapy sessions (conducted in-person or using telehealth) to guide progression of running distance over 9-12 weeks, increasing toward 5km distance. Physiotherapists will offer advice and exercise to help support running. Pain and symptoms will be monitored and if needed treatment offered to participants. Running distance and number of runs completed will also be recorded. At the end of the project, participants will be invited to complete an interview with a researcher to understand their experiences taking part. Insights from these interviews and the success of recruitment and participation will form the results of this project to guide further research and inform the real-world use of physiotherapy-supported running programs in Australia.
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A randomised trial of an intervention to sustain the implementation of a healthy lunchbox initiative in primary schools
Expand descriptionThis study will evaluate whether low-intensity support helps schools sustain the implementation of the SWAP IT healthy lunchbox program. The SWAP IT program is integrated within an app-based communication platform used by schools to communicate with parents and consists of text-messages sent to parents targeting barriers to packing healthier lunchboxes. SWAP IT has proven to be effective in improving child nutrition and weight outcomes, is acceptable to parents and principals, is cost effective and has been scaled-up to >900 primary schools across Australia. We will compare schools receiving sustainment support to those receiving usual care, assessing the proportion implementing the ongoing SWAP IT program as recommended at 6 month follow-up.
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FIDAA - Understanding the Experience of People Receiving Escalating Financial Incentives for the Testing and Uptake of Direct Acting Antivirals for Hepatitis C - A Feasibility Study.
Expand descriptionHepatitis C remains a major public health issue, particularly for people who inject drugs, where staying engaged in care can be challenging. This study aims to assess whether offering small financial incentives can improve engagement with hepatitis C testing, treatment, and follow-up care. Using a single-site, non-randomised, single-arm design, participants receive incentives for collecting point-of-care test results. Those who test positive may receive further incentives for attending a pre-treatment clinic visit; collecting direct-acting antiviral medication; attending follow-up testing to confirm cure. The study hypothesises that this incentive-based approach is feasible, acceptable, and can support improved engagement across the hepatitis C care pathway.
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A randomised controlled trial evaluating the efficacy of multi-wavelength photobiomodulation for providing anaesthesia in intradermal injections
Expand descriptionThis study is testing whether a hand-held light device can reduce the pain of needle injections into the skin. Each participant will have the light device placed briefly on one forearm, and a different, inactive-looking light device placed on the other forearm, before receiving a small injection on each arm. We expect that the arm treated with the active device will feel less pain during the needle insertion and injection than the arm treated with the inactive device. Pain will be measured straight after each injection using a simple 0–10 pain rating scale, and participants will also be asked about any side effects up to one week later. We hope this study will show whether this light-based device is a safe and effective way to reduce pain from injections.