ANZCTR search results

This study is being conducted to assess the safety of a novel health supplement (PMB676) in healthy volunteers. The supplement is an extract of green-lipped mussels containing an ingredient called plasmalogens, which are a type of lipid naturally present in the cells of our bodies. Preliminary research has shown potential for a plasmalogen supplement to support cognitive decline in aging. The present study will not be investigating the effectiveness of the supplement but aims to investigate if it is safe to take and if changes in the lipid levels within the blood and blood cells can be seen after taking the supplement for 12 weeks.

Mobile phones are ubiquitous in healthcare settings as patients, visitors and healthcare workers use them frequently. Mobile phones act as significant fomites in healthcare settings, especially in ICU, and may potentially be putting patients at risk of contracting healthcare-associated infections. Therefore, mobile phone sanitisation solutions are required for healthcare settings, and Ultraviolet-C (UV-C) devices offer a promising solution to this problem. However, it is yet to be investigated whether healthcare workers will be willing to use UV-C devices frequently to disinfect their phones at work. Hence, this study aims to investigate the perceptions of healthcare workers regarding mobile phone contamination, and their beliefs regarding the viability and utility of UV-C mobile phone sanitisation in the intensive care unit.

This study will test whether GameGear Nodal Impact Attenuation soft padded headgear can reduce the risk and severity of concussion in collision-sport athletes. Players from participating teams in Victoria, Queensland and the ACT will take part in a randomised crossover trial, in which they will wear the headgear during some matches and not wear it during others. We will compare concussion rates and concussion severity between these two conditions. If a participating player sustains a suspected concussion during a match, they will undergo specialist clinical review and provide a blood sample to measure biomarkers of brain injury. A smaller subgroup of players will also wear instrumented mouthguards during selected matches to measure head impacts, and will provide additional blood samples after non-injury matches to help assess the biological effects of head impacts when playing with and without headgear. The study aims to improve understanding of whether this headgear provides meaningful protection in real-world sport and to help guide safer sporting practices.

This project aims to support the mental health of children aged 7–12 by helping them manage perfectionism. High perfectionism in childhood is linked to anxiety, depression, eating issues, and school-related stress. Teaching children healthier thinking habits early can improve their wellbeing now and protect their mental health in the future. Growing Strong Minds is a program designed to reduce perfectionism in children. It is delivered in a new way: instead of being run by teachers or clinicians, parents learn how to guide their children through the program at home. This approach increases access to support and helps parents model positive behaviours in everyday life. Our pilot study, supported by a Channel 7 grant, showed promising early results. In this project, we will refine the program based on our pilot findings and test the updated version in a larger study. Families will be randomly assigned either to the intervention or to a control group, where parents receive general information about perfectionism. All families will complete online surveys. Parents in the intervention group will join five online guidance sessions, and both parents and children will complete home activities to practise new skills. We expect that children who take part in Growing Strong Minds will show better mental health and academic outcomes compared with the control group, and that the updated program will have higher completion rates than our pilot.

Prospective parallel randomised controlled feasibility trial. The study aims to adapt the existing evidence-based Take Charge intervention (in partnership with people with lived experience of stroke) to tailor it to the needs of younger adults (18 to 55 years) with chronic stroke (> 6 months post-stroke), and to investigate the feasibility of delivering it via telehealth in a randomised pilot study. We hypothesize that it will be feasible to deliver the adapted Take Charge intervention to younger adults with chronic stroke via telehealth, with at least 85% of randomised participants completing the trial at 3 months post-randomisation.

Shoulder pain is the third most common musculoskeletal complaint managed by general practitioners (GPs) in Australia, with rotator cuff–related shoulder pain (RCRSP) being the most frequent presentation. Despite clinical practice guidelines recommending education and exercise for the management of RCRSP, these approaches are poorly implemented in routine care. This problem is further exacerbated in rural and remote communities, where access to care is limited. There is therefore a need to develop convenient, low-cost, and accessible strategies to support people with RCRSP. The INTEL trial aims to determine the effectiveness of adding internet-delivered care, with or without telehealth, to usual care for reducing pain and disability at 12 months post-randomisation in people with RCRSP. The trial will also compare the cost effectiveness of each treatment from a healthcare perspective and societal perspective (including absenteeism) over 12 months.

This study will compare the bioavailability and biological effects of generic oral rapamycin with a sublingual (under-the-tongue) rapamycin formulation in healthy adults aged 30–60 years. Participants will be randomised to receive a single 6 mg dose of either oral or sublingual rapamycin. Blood samples will be collected at multiple time points over 72 hours to assess the bioavailability of rapamycin. Sirolimus blood concentrations and changes in immune-related gene expression, including pathways related to mTOR signalling, will be measured. The findings will determine whether sublingual administration improves rapamycin bioavailability and molecular response compared with standard oral dosing, informing future clinical research on rapamycin use for healthspan and longevity.

The primary purpose of this study is to determine the safety and immunogenicity of one and two doses of DCO1 at different adjuvant and alum doses. This will be a phase 2 randomised observer blinded trial which aims to help be better prepared for a potential influenza pandemic.

The primary purpose of this study is to determine the safety and immunogenicity of one and two doses of DCO1 at different adjuvant and alum doses. This will be a phase 1 randomised observer blinded trial which aims to help be better prepared for a potential influenza pandemic.

This project aims to evaluate the efficacy of a parent-supervised app-based assessment and intervention program for delivery speech pathology services to children with speech sound disorder (SSD) while they are waiting for standard pathology services. The innovation is in using the program with children on a waiting list. It has been found efficacious in previous studies with children already receiving standard speech pathology services. Primary expected outcome is a new effective approach to managing the chronic shortage of speech pathology services in Australia for children with SSD. Significant benefits will be realised through children accessing low cost speech therapy earlier. The study has two secondary aims. First, we will also test the robustness of our automated speech analysis algorithms for assessment of children’s speech, which has the potential to reduce the time/cost burden of manual speech assessment by speech pathologists. Second, we will explore whether videos of upper body (including face and hand movement) provide insights into how motor control of face and hands changes as speech accuracy increases with treatment.