ANZCTR search results

The EVADE-1 study aims to assess whether a new cancer treatment, evexomostat, shows signs of anti-cancer activity in patients with advanced prostate cancer that has spread to other tissues, and to better understand the safety and tolerability of this treatment in patients with advanced prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with metastatic castration-resistant prostate cancer and your cancer deposits/tumours also show low uptake on PSMA PET scans and/or increased uptake on FDG PET scans. You may need to ask your doctor to confirm whether your cancer meets these requirements. Study details All participants who choose to enrol in this study will be asked to attend the Princess Alexandra Hospital, Brisbane once per fortnight to receive an injection under the skin of evexomostat. If participants don't experience any severe side effects while receiving evexomostat, they will be able to continue attending fortnightly for up to 24 weeks (12 doses). Throughout the study, all participants will be asked to undergo additional PET/CT scans (4 in total), blood tests and clinical assessments to monitor their safety and any response to the treatment. It is hoped this research will determine whether regular doses of evexomostat are safe and tolerated by patients with advanced prostate cancer and to determine the effect of evexomostat on cancer activity. If the study finds that this treatment is safe and has an anti-cancer effect, a larger study to assess the treatment in a greater number of patients with advanced prostate cancer may be undertaken.

This study is testing a new online parenting program called ParentWorks-Unplugged, designed to help parents of preschool-aged children (3–6 years) build healthier technology habits at home and reduce the impact of screens on family life. Families will be randomly assigned to either complete the program straight away or after a short waiting period, allowing researchers to compare outcomes between groups. The study aims to examine whether the program is effective and helpful for parents. We expect that parents who complete the program will report less distraction from devices, reduced interference from technology in family interactions, and healthier technology use for both themselves and their child. We also expect improvements in children’s behaviour and emotional wellbeing, as well as stronger parent–child relationships and overall family functioning.

The SPRAINS (Sports-Related Adolescent Ankle Ligament INjury Surveillance) study is a 5-year prospective cohort study investigating ankle ligament sprains and chronic ankle instability in adolescent athletes at the Maribyrnong Sports Academy, Victoria, Australia. The study aims to determine the prevalence, risk factors, and outcomes associated with ankle ligament sprains in youth sport. Participants will complete annual questionnaires, clinical ankle assessments, and biomechanical testing using VALD ForceDecks. Athletes who sustain an ankle ligament sprain during the study period will complete additional post-injury assessments, including the Ankle-GO assessment tool. Findings from the study aim to improve understanding of ankle injury risk, recovery, and prevention strategies in adolescent athletes.

This study is investigating whether antibiotics that are usually given through a vein can instead be given under the skin (subcutaneously) in children. Giving antibiotics under the skin (subcutaneously) may reduce the need for intravenous lines, reduce complications, and improve comfort. Participants will receive their prescribed antibiotic through both methods in a randomised order. Blood samples will be collected to assess antibiotic blood levels in the body with each method. The study will also assess safety, pain and acceptability of each method.

The aim of this project is to develop, implement, and evaluate a consumer co-designed physical activity promotion program for community-dwelling individuals with moderate-to-profound disability. Through an extensive program of consumer engagement and stakeholder consultation, we will modify our efficacious best practice PA promotion model for people with disability - the Adapted Physical Activity Program (APAP) so it can be applied to support individuals with moderate-to-profound disabilities (APAP-OMNI). For implementation, we will co-design a workforce capacity and capability building training package to enable allied health professionals to deliver APAP-OMNI at scale in their own communities. We will evaluate the impact of the program in an Type 1 hybrid effectiveness-implementation cluster randomised trial and develop training resources to facilitate dissemination of the program to other communities. APAP-OMNI will improve access to safe and effective PA promotion services for people with disabilities who are currently under-served.

A common method of cooling used in endurance sports is additional skin wetting (applying water to the skin), including through water dousing (pouring water over the body). Placing additional water on the skin through dousing effectively acts as non-biological sweat which can increase the skin wettedness (% of skin covered by water) of an individual and potentially improve heat loss through a greater evaporative capacity. There is a need for well-designed controlled experimental studies into the effect of water dousing which mimics the demands (intensity) and features (air velocity) of competitive long-distance cycling.

Patients admitted to General Medicine often have complex health needs, and some are unexpectedly readmitted to hospital soon after going home. This study aims to see whether using an electronic tool that estimates a patient’s risk of re-admission, together with a more consistent approach to discharge planning, can reduce unplanned re-admissions within 28 days. The tool uses information already collected during routine care and supports, but does not replace, clinical judgement. In this trial, both groups receive the same formalised, standardised model of care; the intervention group additionally receives the AI-generated re-admission risk score to support prioritisation. Patients will not be asked to do anything extra as part of the study, and no consent form is required because the study is low risk and part of standard care. All patient information will be handled securely and confidentially.

New blood tests for detection of Alzheimer’s disease (AD), the most common cause of dementia, are becoming available, but are not yet approved for clinical use in Australia. Will they help GPs to diagnose the cause of memory problems? This study, run by the Australian Dementia Network and funded by the Commonwealth Department of Health and Aged Care, aims to answer this question. Participants are invited to take part in this research project because they have presented to their General Practitioner (GP) or practice nurse with concerns about cognition (i.e. memory or thinking). This research project will test if the new blood test for AD trial will help GPs to make a more confident and faster diagnosis of Alzheimer’s disease in patients in the early stages of this disease.

Musculoskeletal conditions such as chronic low back pain and osteoarthritis are leading causes of pain and disability worldwide, and many people also experience poor sleep. This study will investigate whether adding cognitive behavioural therapy for insomnia (CBT-I) to usual physiotherapy care improves pain and sleep outcomes compared with usual physiotherapy care alone. The SLEEP-MSK trial is a two-stage adaptive basket randomised controlled trial involving people with chronic low back pain, hip osteoarthritis or knee osteoarthritis and insomnia. Participants will be randomly allocated to receive either usual physiotherapy care alone or usual physiotherapy care plus CBT-I delivered by trained physiotherapists. Outcomes including pain, insomnia severity, physical function, fatigue and quality of life will be assessed over 12 months.

This study is a staged feasibility and pilot RCT evaluating a brief, self-directed, online Earth care intervention designed to support the mental health and well-being (MHWB) of adults experiencing ecological distress. In this study, ecological distress is defined as persistent, negative emotional responses related to climate change and environmental degradation. The intervention is informed by relational values and Tronto's (2013) stages of care, reframes ecological distress as morally important information, and supports participants in translating their distress into adaptive, locally relevant acts of care. The study follows the Medical Research Council's (MRC) framework for designing and evaluating complex interventions and includes pre-pilot testing, a randomised waitlist-controlled trial, and an embedded process evaluation. Outcomes focus on feasibility, acceptability, psychological and ecological distress, self-efficacy for environmental action, mental well-being, and human-nature relationships.