ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32210 results sorted by trial registration date.
  • A First-in-Human Feasibility Study of the Lycovent Portable Mechanical Ventilator

    This study aims to see if a new portable ventilator can safely and effectively support patients who need help breathing during surgery. We will compare this smaller “Lycovent” device to a standard hospital ventilator, focusing on breathing measures and patient safety. Our hypothesis is that the Lycovent will work at least as well as the larger, conventional machine. If shown to be reliable, this portable option could offer more flexibility in operating rooms and potentially lower costs. Ultimately, we want to confirm that the Lycovent meets essential safety and effectiveness standards for use during surgical procedures.

  • A Pilot Evaluation of Urine Albumin-to-Creatinine Ratio as a Predictive Biomarker for the Development or Progression of Acute Kidney Injury in Patients Undergoing Cardiac Surgery: A Prospective Cohort Study

    Acute kidney injury (AKI) is a frequent and serious complication after cardiac surgery. Current diagnostic methods rely on blood tests and urine output, which often detect AKI only after significant kidney damage has occurred. This prospective cohort study will assess whether the urine albumin-to-creatinine ratio (uACR), a simple and inexpensive urine test, can predict AKI earlier. We will enroll 200 adult patients undergoing cardiac surgery at Austin Hospital. Urine samples will be collected at three time points: before surgery, at admission to the intensive care unit, and the following morning. Our hypothesis is that patients with rising uACR after surgery will have a higher risk of developing acute kidney injury. Early identification could allow timely preventive strategies and improve patient outcomes.

  • Silent Thief of Sight Study

    Glaucoma is one of the most heritable of all complex diseases, and when untreated causes irreversible blindness. Despite advances in imaging technology, approximately half of all cases in our community are undiagnosed, and many people with glaucoma continue to present at advanced stages of the disease. We have recently developed a polygenic risk score, which in retrospective cohorts robustly identifies people at risk of disease. We now aim to conduct a randomized, single-blinded, parallel-controlled trial, to investigate the utility of polygenic risk profiling as the key intervention to identify people at high-risk of developing glaucoma and requiring clinical screening. We will recruit people who are aged between 64 and 68 years old, and have not had a clinical examination by an optometrist or ophthalmologist within the preceding 3 years. Services Australia will contact approximately 132,000 people across 320 postal regions in Australia. Participants will be randomly allocated to a) direct optometry examination regardless of genetic risk (control) or b) polygenic risk score-based prioritised (top 5% of population) clinical profiling (case). As such, we will be able to determine, and directly compare the prevalence rates of definite or probable glaucoma between screening groups.

  • Assessing implementation outcomes of Occupational Therapist (OT) led falls hazard reduction at home (FRH@Home).

    Cochrane level evidence indicates that Occupational Therapist led falls hazard reduction at home is clinically effective. The new national falls prevention guidelines for community care recommend that all older people at high falls risk receive this intervention (ACSQHC, 2025). A national team, of Occupational Therapy researchers (two team members authored the Cochrane Review), is leading an implementation study to support Occupational Therapy services to adopt and embed this evidence-based intervention. Our project will implement and evaluate the roll out of Occupational Therapy led FHR@Home to prevent falls in older people. Focus group discussions and in-depth interviews will explore implementation barriers and enablers for each health setting. We will co-design implementation strategies with consumers (patients and carers) and end users (Occupational Therapists) to support routine adoption of FHR@Home in Occupational Therapy clinical practice, using the Knowledge to Action model and the Expert Recommendations for Implementing Change (ERIC). We will provide tailored training materials and a range of implementation strategies, including resources and managerial support for Occupational Therapy services to embed this evidence-based intervention in a variety of practice and geographical contexts. This design will enable investigation of implementation strategies across public, private and non-government health services of an already established clinically effective intervention. We will provide this intervention to sites that meet a pre-defined organisational readiness for change score.

  • Assessment of Adjunctive Acetazolamide for Furosemide Treated Critically Ill Patients

    Furosemide (a loop diuretic) and Acetazolamide (a carbonic anhydrase inhibitor) are two commonly used diuretic drugs in the intensive care unit. Evidence suggests that giving Acetazolamide together with Furosemide has beneficial physiological effects. This multi-centre, cluster, crossover trial will assess a two-dose Acetazolamide regimen over 48 hours and focus on its physiological effects and evaluate patient outcomes, such as time spent in ICU and hospital. The trial will enrol approximately 144 patients from approximately 3 intensive care units in Australia and Japan. Each hospital will be randomly allocated to ‘Adjunctive acetazolamide’ arm or ‘Furosemide only’ arm. Each hospital will follow each Arm for a period of 6 months before swapping to the alternative regimen for 6 months. This is a crossover design. The trial will be complete in 12-months. Findings from this study will be used to improve diuretic management in the ICU and inform the design of future trials.

  • A randomised controlled trial evaluating a mental health training refresher module for managers in the ambulance service

    This randomised controlled trial is embedded into a parent controlled trial aimed at investigating the effectiveness of MindWise Leadership, an evidence-based mental health training program for people-leaders in the ambulance service. The parent controlled trial will be used to measure whether the MindWise Leadership training program, compared to a control group, will improve managers' and leaders' responsive behaviours, preventative behaviours, confidence, knowledge and stigma regarding employee mental health. It also aims to investigate whether any changes are sustained over a 12-month period. The current embedded randomised controlled trial will investigate the effectiveness of providing a short 15-minute online refresher training module at 6-months post-intervention for half of the intervention group. This refresher training will be delivered immediately following the 6-month data collection for the parent controlled trial to a random selection of the intervention of the parent-controlled study. This forms the intervention group for the embedded RCT described here. The other half randomly assigned to not receive the refresher module will form the control group for this embedded RCT. Outcomes measured 6-months after the refresher module (captured in the 12-month data of the parent-controlled trial) will be compared to evaluate whether this top-up training module will promote participants outcomes at 12-months post-intervention. The research questions that this research seeks to address are: 1. Does this refresher training module at 6-months post-intervention improve leaders’ responsive and preventative behaviours at 12-months post-intervention? 2. Does this refresher training module at 6-months post-intervention improve leaders’ confidence addressing mental health matters in the workplace at 12-months post-intervention? 3. Does this refresher training module at 6-months post-intervention reduce mental health stigma among leaders in the ambulance service at 12-months post-intervention? 4. Does this refresher training module at 6-months post-intervention improve workplace mental health knowledge among leaders at 12-months post-intervention?

  • COMparative Pharmacotherapy And peRsonalised stratEgy in the management of Coronary Microvascular Dysfunction double blind randomised controlled Trial - Part 1

    Coronary artery disease(CAD) is the leading cause of death in Australia, with 10 - 15% of the patients suffering from debilitating angina(chest pain), a prominent CAD symptom. While obstructive CAD is well understood, coronary microvascular dysfunction(CMD), a disorder of the small coronary vessels is under recognised, but now acknowledged as a major contributor to patient’s symptoms. It disproportionately affects women & is linked to impaired quality of life, high healthcare utilisation($1.5 billion/year) & worse outcomes. Despite its significant burden, CMD remains undertreated, with international guidelines highlighting major evidence gaps, with no consensus on 1st & 2nd-line therapies. With no established treatment framework & limited clinician guidance, many patients receive sub optimal management - often empirical with a one-size-fits-all approach leading to debilitating symptoms, polypharmacy, financial strain & rehospitalisations. This represents a critical failure in equitable cardiovascular care. Part 1 will compare the acute effects of commonly prescribed cardiovascular drugs on microvascular function using invasive, gold-standard physiological indices to identify optimal therapies, thereby identifying 1st/2nd line therapies.

  • COMparative Pharmacotherapy And peRsonalised stratEgy in the management of Coronary Microvascular Dysfunction double blind randomised controlled Trial - Part II

    Coronary artery disease(CAD) is the leading cause of death in Australia, with 10 - 15% of the patients suffering from debilitating angina(chest pain), a prominent CAD symptom. While obstructive CAD is well understood, coronary microvascular dysfunction(CMD), a disorder of the small coronary vessels is under recognised, but now acknowledged as a major contributor to patient’s symptoms. It disproportionately affects women & is linked to impaired quality of life, high healthcare utilisation($1.5 billion/year) & worse outcomes. Despite its significant burden, CMD remains undertreated, with international guidelines highlighting major evidence gaps, with no consensus on 1st & 2nd-line therapies. With no established treatment framework & limited clinician guidance, many patients receive sub optimal management - often empirical with a one-size-fits-all approach leading to debilitating symptoms, polypharmacy, financial strain & rehospitalisations. This represents a critical failure in equitable cardiovascular care. PART II will assess if personalised treatment based on coronary function testing will improve patient symptoms compared to physician directed care.

  • A pilot study evaluating whether the Growing Minds Check-In for Young People (GMCI-Y) is acceptable and improves help-seeking behaviour, intentions & efficacy in adolescents

    This research will conduct a pilot randomized controlled trial (RCT) of the Growing Minds Check-In for Young People (GMCI-Y), a universal online mental health check-in and referral tool that involves young people answering questions about their mental health and wellbeing, receiving automated feedback based on their responses and recommendations for evidence-based programs, services, and information matched to their need. It is expected that the pilot RCT will show that the GMCI-Y is acceptable as an intervention, based on responses to satisfaction and usefulness questions, and that at one-month follow-up the intervention group, relative to the waitlist control group, will be more likely to show an increase in mental health help-seeking intentions, have actively sought help for their mental health (i.e., help-seeking behaviour), and show an increase in mental health help-seeking efficacy (i.e., knowledge and ability to seek help).

  • The FAME 2 Kidney trial is a study of whether fenofibrate is able to slow kidney disease progression in adults with type 2 diabetes with moderate kidney damage

    The FAME 2 Kidney study is a large international clinical trial testing whether a low-cost, once-daily medication called fenofibrate can slow kidney damage in people with type 2 diabetes and moderate chronic kidney disease. Researchers believe fenofibrate may help protect kidney function and reduce other diabetes-related complications, compared to a placebo.

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