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A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CLD-423 in Healthy Participants
Expand descriptionThis is a FIH randomized, double-blind, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple intravenously or subcutaneous doses of CLD-423 in healthy adult participants
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Evaluating the effectiveness of the Gro Health mobile app to improve cardiometabolic health in people with type 2 diabetes in Australia.
Expand descriptionThis study is investigating whether a mobile app called Gro Health can help people with type 2 diabetes improve their health. The app provides education and support to help users make changes to their diet, physical activity, sleep, and mental wellbeing. Adults with type 2 diabetes will be randomly assigned to receive access to the Gro Health app for 6 months in addition to their usual care, or to continue with usual care alone. After 6 months, the control group will be offered access to the app. The main outcome is to see whether using the app improves blood glucose levels (HbA1c) over 6 months, as well as other health measures like cholesterol, weight, and blood pressure.
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Parenting to Prevent: testing a web-based parents’ intervention to prevent adolescent self-harm in Australia
Expand descriptionThe Black Dog Institute has co-developed a youth-focused self-harm prevention program, Bridge to Better (B2B), along with a complementary parent/carer intervention, Parenting to Prevent (P2P), to address rising rates of adolescent self-harm in Australia. The primary aim of this pilot trial is to test the efficacy of the P2P web-based intervention in improving parent knowledge of emotion regulation strategies and skills in autonomy-supportive parenting. Secondary aims include assessing the impact of P2P on self-harm literacy and stigma, program implementation outcomes (acceptability, feasibility, credibility, expectancy, engagement), and the effectiveness of digital recruitment strategies compared to traditional flyer distribution. The trial uses a three-arm cluster randomised design with 264 parents of NSW primary school students (grades 3–6) enrolled in the B2B trial, randomised at the school level into one of three recruitment pathways: physical flyer, digital flyer, or trial link embedded in child B2B consent form. All parents receive the same P2P program, consisting of eight YouTube videos and weekly activities delivered via a website over 8 weeks. Outcomes will be assessed at baseline and post-intervention, with qualitative interviews conducted with a subsample of parents to explore integration of P2P into routine parenting.
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Physical activity, goals and outcomes for older Australians in the Transition Care Program: a cluster randomised controlled trial
Expand descriptionPeople coming into the Transition Care Program (TCP) are invited to participate in a research project. In collaboration with Metro South Health in Queensland, and the University of Queensland, we are conducting a study to understand goals, activity patterns and other health data relevant to older people who enter the TCP following their stay in hospital. We will use Fitbits to collect activity and health data. You will also be asked to do some additional health assessments when you first start TCP and when you exit TCP. The purpose of this study is to examine how much TCP clients’ move around each day and to see how this is related to their goals, health and quality of life outcomes throughout the program. Future benefits for TCP clients’ may include improved clinical monitoring and patient care, as well as better goal attainment and health outcomes.
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Evaluating circuit haemodynamics and filter life during extracorporeal carbon dioxide removal and continuous renal replacement therapy
Expand descriptionBoth hypercapnic respiratory failure and acute kidney injury (AKI) are common problems in Intensive Care Units (ICUs). When either or both are severe, organ support in the form of non-invasive ventilation (NIV), mechanical ventilation (MV) and continuous renal replacement therapy (CRRT) are sometimes required. In some of these patients, extracorporeal carbon dioxide (CO2) removal (ECCO2R) may also be required. Although there has been detailed description of circuit pressures and filter life in CRRT, there is no published clinical data affecting the adequacy of treatment with ECCO2R and circuit haemodynamics and filter life when ECCO2R is combined with CRRT or used as standalone without CRRT. Our group have published a case series of patients where ECCO2R was used in conjunction with CRRT. The main complication noted in this study was circuit clotting within 72 hours of initiation of ECC02R. Circuit clotting can lead to poorer delivered treatment doses, requirement of red cell transfusion due to blood loss and increased resource requirement for re-commencement of therapy. It is unclear if the circuit haemodynamics and filter life, is impacted by the way ECCO2R is delivered i.e. ECCO2R in conjunction with CRRT compared to standalone ECCO2R or conventional CRRT. This research investigates the circuit haemodynamics and filter life and its clinical effects
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Optimal Timing for Adolescent Meningococcal B vaccination schedule (BOOST MenB study)
Expand descriptionThe BOOST MenB Study is a randomised controlled trial investigating the best timing of the Meningococcal B (Bexsero®) vaccine in adolescents. Currently, two doses are given approximately 2-3 months apart, around age 15-16. This study aims to determine if spacing the doses several years apart would provide longer-lasting protection. It will also explore whether Bexsero® offers cross-protection against gonorrhoea.
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Determining the exercise dose required to reduce endometriosis symptoms in regional, rural and remote women.
Expand descriptionThe aim of this study is to examine the critical threshold of differing exercise doses on symptoms, quality of life and biomarkers of endometriosis. It is hypothesized; a larger dose of exercise will result in reductions in symptoms and improvements in quality of life for women with endometriosis in regional, rural and remote Australia,
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Investigating Effects of Estrogen Blockade on Androgenic Steroid Profile in Healthy Women
Expand descriptionThis research study is looking at understanding how estrogen blockade in women, with either estrogen antagonist or aromatase inhibitor drugs, influence circulating levels of testosterone or pro-androgens (precursor steroids that can be converted to testosterone). The aim of the study is to investigate serum and urine androgen profiles in healthy women undertaking typical 5-day treatments with estrogen blockade using an anti-estrogen (Clomifene) or an aromatase inhibitor (letrozole) compared to a placebo (a treatment with no active medicine).
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Empagliflozin in cystic fibrosis related diabetes
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Scaling up an evidence-based physical activity telephone coaching program through rural Allied Health services: a hybrid Type 3 implementation–effectiveness trial
Expand descriptionThis project will test whether the Healthy4U telephone-based physical activity coaching program can be successfully integrated into routine Allied Health care across three rural Victorian health services. Adults who are insufficiently physically active will be referred by their treating Allied Health clinician and receive five coaching sessions over 12 weeks. The study will examine key implementation outcomes—such as reach, adoption, fidelity, and sustainability—using the RE-AIM framework. Changes in participants’ physical activity, self-efficacy, and wellbeing will also be measured at baseline, 3 months, and 6 months. Findings will inform scalable, sustainable approaches to delivering evidence-based physical activity support in rural and regional communities.