ANZCTR search results

This is a first in human (FIH), double blind, placebo- controlled single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous BRB-002 in healthy male volunteers. Up to approximately 48 healthy male participants will be randomised into this study. Participants will be randomised to receive a dose of either BRB-002 or matching placebo. A total of 8 participants are planned for each cohort, with 6 participants receiving BRB-002 and 2 participants receiving placebo. For each cohort, a Safety Review Committee (SRC) will review all emerging safety and tolerability data. The next planned cohort will be initiated only after it is confirmed by the SRC that the latest cohort dose was safe and tolerated.

The EMU program is designed to enhance the health and well-being of children, and their numeracy and literacy levels, through participation in an enjoyable and engaging PA program in the community/at school. The EMU program will specifically target the development of a positive learning environment through positive teaching practices i.e., through Aboriginal/Indigenous games. The overall aim of this study is to evaluate the impact of the EMU program on PA levels, well-being outcomes, and literacy and numeracy attainment in a sample of primary school-aged children. We hypothesise that students may receive various benefits to a variety of health outcomes i.e., resulting from participation in EMU. Phase 1 - pilot (completed) Phase 2 = train the teacher

This study seeks to evaluate the impact of the Kai Fella "Challenging Stereotypes" workshop on transforming the behaviours, attitudes, and perceptions of young adolescent males. Specifically, this study will assess changes to help-seeking behaviours, conformity to normalised masculine traits and ideologies, comfort levels in discussing difficult conversations, and perceptions of surrounding support structures. By investigating the impact of secondary school-based gendered mental health programs, this study hopes to address behaviours linked with the increasing mental health and suicide rates in young males. Lastly, by reflecting on the feedback provided by both teachers and students partaking in the workshops, this study will ensure that future gendered-workshops and the development of such are tailored to the needs and expectations of the core consumers.

Pregnant women, at high risk of developing gestational diabetes and/or hypertensive disorders of pregnancy who receive information about future risk of diabetes and cardiovascular disease, alongside healthy lifestyle coaching from their first trimester antenatally through to 7 months postpartum will be more likely to undergo cardiometabolic screening tests in postpartum, compared with women who receive standard antenatal care. This is a randomised controlled pragmatic implementation trial to optimise lifestyle management and screening of DM2 and CVD in women who are at high risk of developing GDM and HDP during pregnancy. The primary outcome for the RCT component is screening for DM2 or CVD at 12 months postpartum (yes screening occurred; vs not done).

Premature cardiovascular disease (CVD) remains a significant cause of morbidity and mortality despite advances in prevention. Patients with myocardial infarction (MI) at a young age represent a unique cohort, with differences in cardiovascular (CV) risk factor profile, underlying pathophysiology, and coronary plaque compared with their older counterparts. In young patients with MI, genetic predisposition contributes to the development of coronary artery disease (CAD). Indeed, family history of premature CVD is a well-recognised risk factor for MI. It is therefore recommended that family members of patients with premature MI undergo CV risk assessment. There are risk scores available for CV risk assessment, such as the Australian CVD risk calculator, which estimates 5-year CVD risk based on clinical factors. Cardiac imaging has shifted the playing field regarding non-invasive detection and assessment of subclinical atherosclerosis. However, cardiac imaging is not currently recommended for large-scale screening in asymptomatic patients but may improve CV risk-stratification and guide use of preventive medications in certain individuals. Families with premature CAD are a high-risk cohort that remain a neglected target for primary prevention. In 300 adult first-degree relatives of individuals with premature MI, this randomised trial will aim to assess whether addition of computed tomography coronary angiography (CTCA) to routine CV risk factor assessment can lead to superior primary prevention low-density lipoprotein cholesterol (LDL-C) levels

This study aims to evaluate the efficacy of a brief behavioural sleep program (Sleeping sound) in reducing children's sleep problems and emotional behavioural disturbance and parents functioning and wellbeing in a sample of primary school aged autistic children with sleep problems, within a community clinic context.

In our proposed study, all participants will get an exercise program (so all will experience some benefit), but half will get real tDCS to apply at home and half will get sham (‘fake’) tDCS. We will explore whether delivering this intervention at home is feasible and whether it produces any negative or unwanted effects. Critically, we will examine whether home-based tDCS boosts the effects of exercise in treating pain among people with knee OA. If successful, this intervention could lead to further trials and one day provide a more accessible and cost-effective treatment for individuals with knee OA, revolutionising management of this global health concern.

The COVID-19 pandemic has created challenges in the diagnosis and management of colorectal cancer (CRC). It was proposed in regional North Queensland the distance to services could further impact cancer outcomes, leading to delayed diagnosis. We compared the outcomes of patients prior and during the pandemic; with a focus on whether patients were presenting in the emergency setting with more advanced disease (i.e.T4 tumours, locally advanced cancers or stage III/IV CRC). The distance to treatment was also analysed to see if any impact occurred to the management of patients with colorectal cancer.

Reducing tobacco use is an urgent national health priority in Australia, as it is the leading cause of preventable death and disability. The Incentive to Quit (I2Q) pilot aims to reduce harms associated with smoking and vaping by; i) training health professionals on delivering brief smoking cessation advice, ii) providing eligible smokers and vapers with financial incentives, iii) referring participants to the Quitline counselling service, and iv) providing pocket-sized resources with content to facilitate and support quit attempts. For health professionals, four levels of education + training will be available to develop skills, knowledge, and confidence in providing brief advice, and understanding issues specific to priority group support. Participants will be offered several sources of support to increase chances of success in their quit smoking journey at three time-points: baseline, 3-months, and 6-months. Milestone achievements include attempts to quit smoking, participation in Quitline counselling, and successful quitting confirmed through biochemical validation. Feasibility and acceptability of the program will be evaluated through the systematic, rigorous RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework. The primary outcome is to determine potential efficacy of the I2Q program to encourage smoker/vaper abstinence as an adjunct to standard health service delivery, evaluated by the number of smokers with biochemically validated abstinence at 3-month and 6-month follow-up, and the number of smokers that enrolled into the I2Q program. Secondary outcomes are to determine the feasibility and acceptability of the I2Q program to support smoker quit attempts, and potential for up-scale and expansion.

This study aims to evaluate the acceptability, feasibility, and short-term effects of a coach-supported online parenting program for parents of autistic children, to reduce children's symptoms of depression and anxiety. The online intervention is comprised of 2 components; up to 15 online self guided educational modules empowering parents to support their child in the context of reducing anxiety and depression, and up to 8 one-on-one telehealth coaching sessions with a provisional psychologist to support parents in learning, understanding and modifying their parenting practices. It is hypothesised that from pre to post intervention (120 days later): (1) There will be a parent reported increase in preventive parenting practices and parental self-efficacy, as well as a reduction in parent psychological distress (2) There will be a reduction in parent reported child anxiety, depressive symptoms, sleep problems, and emotion dysregulation. Additionally there will be an increase in child participation; At post intervention (120 days later): (3) Parents will find the PiP Kids-Autism program satisfactory, acceptable and feasible to implement.