ANZCTR search results

Cardiovascular disease (CVD) is the leading cause of death in Australia . Cardiac rehabilitation (CR) programs assist recovery after a cardiac event and reduce the risk of repeat events. The uptake of CR programs is as low as 10-30% with a variety of barriers to attendance. Using technology via a smart phone app with a specific cardiac rehabilitation format may assist with overcoming some of these barriers and may be used to enhance program uptake and completion .

This is a three-arm, pharmacokinetic, safety, tolerability and immunogenicity study to compare investigational product JHL1188 versus EU and US sourced Herceptin in healthy male participants. Who is it for? You may be eligible to join this study if you are male aged 18 to 55 years old, healthy non-smoker and non-drinker Study details Approximately 159 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1188 (n=53), Herceptin_EU sourced (n=64) or Herceptin_US sourced (n=53). Each subject will receive one intravenous (IV) infusions of the investigational product at the dose of 6 mg/kg on Day 1. Assessments of PK, safety, tolerability, immunogenicity will be collected over the following 70-day period. JHl1188 is developed as a biosimilar of Herceptin, Herceptin is approved for the treatment of adult patients with HER2 positive breast cancer and metastatic gastric cancer. This clinical study is intended to study the similarity between JHL1188 and Herceptin.

The purpose of the study is to identify the presence of inflammation in the brains of boxers if any, by comparing the PET/MRI images of participants from the boxer group to the ones from the non-boxing control group and MS patients (positive control group). To do this, the trial will quantify the uptake of the PET tracer [18F]PBR111 as an indicator of neuroinflammation in the three groups. Having this kind of advanced brain imaging available in Brisbane could become very important for monitoring the brain health not just of boxers, but also players in many other contact sports like rugby union or rugby league. Most importantly, this research may serve as a strong background in future PET studies of brain inflammation in cases of AD, MS and other brain disorders.

The Australian Type 2 Diabetes Prevention Program (AUS 2 Prevent) is a year-long lifestyle change program comprising physical activity and diet sessions. It is a community-based program that aim to prevent or delay diabetes incidence in adults at high risk of developing type 2 diabetes in Australian community. We hope this program will be an effective, feasible and acceptable diabetes prevention program in the Australian community. We are in the process of analysis the data and the final publications should be ready by early 2026.

The purpose of the feasibility study is to examine speech perception outcomes (quiet and noise) and safety (adverse events and adverse device effects) with the cochlear implant in eleven newly implanted adults who meet the eligibility criteria for the study.

Ultrasound assessment has improved the safety and accuracy of pleural procedures. Highly portable handheld ultrasound technology been developed, however has not been validated for this purpose. The aim of this study is to examine the ability of handheld ultrasound to determine a safe site for pleurocentesis. We hypothesize that the handheld ultrasound will be equivalent to the standard ultrasound.

Knee injuries are very prevalent and affect individuals everyday. Some knee injuries, like an anterior cruciate ligament tear (ACL) can result in irreversible damage where only a small portion of the individuals are able to come back to pre-injury level, despite surgery and physical therapy. As a result, injury prevention knee braces emerged as a way of protecting the knees from injuries during high risk activities like sports. The effectiveness of these braces have been controversial and we aim to study the braces in a more realistic environment by using a virtual reality system that can fully immerse our subjects and deliver unanticipated perturbations while the subjects are safely harnessed.

This is a randomised, placebo controlled cross-over study to assess the efficacy and safety of Ziziphus spinosa seeds in people with insomnia compared to placebo. This study aims to determine if Ziziphus spinosa seeds can improve sleep in people with insomnia, in terms of sleep quality, quantity, and associated daytime symptoms; and to determine its safety profile for insomnia. It is expected that Ziziphus spinosa seeds will alleviate some significant symptoms of insomnia and improve sleep quality, quantity, and associated daytime symptoms.The study integrates rigorous clinical trial design and research methodology and will guide the appropriate use of Chinese herbal medicine in clinical practice.

High intake of discretionary food and drinks contribute to the excessive burden of chronic disease experienced by Indigenous Australians living in remote Australia. In collaboration with the Arnhem Land Progress Aboriginal Corporation (ALPA; who manage 25 stores in remote Australia) we will test an intervention to reduce sales of discretionary products in remote Australian communities. Stores randomised to the intervention group will be supported by ALPA to reduce merchandising (i.e., availability and display) of four food categories (sugar, sugar sweetened beverages, sweet biscuits and confectionery) that in total provide 73% of discretionary foods and 90% of free sugars. The remaining stores (50% of total) will serve as controls. Electronic store sales data will be collected over the baseline period, 12-week intervention period and 24-week post intervention to objectively assess change in healthiness of purchases and gross store profit. This research will greatly advance our understanding of how the retail food environment can be used to improve population level dietary intake globally. We hypothesise that intervention stores will have a significant reduction in free sugars from food and drinks purchased (measured using sales data) compared with control stores over the 12 weeks of strategy compared to the baseline and this will be sustained over the 24 weeks post end of the intervention.

The Dizzy PT project is looking at the feasibility of a new model of service, whereby a vestibular trained Physiotherapist is able to assess and treat patients in the ED who are presenting with dizziness, vertigo or imbalance. The feasibility of this will be established by comparing the new model (intervention period) with current practice (control period). We hypothesise that not only will the new model of care be feasible, it will also provide better outcomes for these patients, and improve adherence to evidence-based best practice clinical care.