ANZCTR search results

Osteochondral lesion in talus can be challenging to treat leading to ongoing pain and loss of function. This study aims to investigate the efficacy of viable cartilage allograft for osteochondral talar dome lesions. The study hypothesis is: In patients with talus osteochondral lesions, viable cartilage allograft can improve patient pain and function.

• We are studying patients with anaemia who have had trauma surgery. • Anaemia is a deficiency in the number or quality of red blood cells. • Red blood cells carry oxygen around the body, using a protein called haemoglobin. • Anaemia exists when either the level of red blood cells or haemoglobin is lower than normal. • A treatment, involving a single intravenous (IV) injection of iron medication in hospital prior to discharge, is expected to improve the body’s ability to better correct anaemia. • This could result in a faster recovery, but we don’t not know if the IV iron injection truly works in people following trauma – this is why we are doing this trial.

This study aims to assess the effectiveness of a culturally adapted avatar-based education app in improving coronary heart disease knowledge and uptake of cardiac rehabilitation among Chinese-speaking patients with acute coronary syndrome (ACS) admitted to hospitals. We will conduct a randomised, controlled trial to compare an avatar-based education app to usual care. Adults admitted to Westmead, Royal Prince Alfred, and St George Hospitals with a diagnosis of ACS in the current admission will be invited to participate. Participants randomised to the intervention group will be given a link to download the app to their smartphone or tablet. During the study period, participants will independently work through the app's six modules, which are based on the Heart Foundation’s Six Steps to Cardiac Recovery. We hypothesize that the application will improve Chinese-speaking ACS patients disease-related knowledge, self-management behaviours and health-related outcomes such as disease recurrence, mortality, and quality of life.

The purpose of this research is to investigate the effectiveness of a brief mindfulness meditation (MM) vs clinical hypnosis (HYP) training for improving pain in injured competitive athletes. Additionally, the study aims to investigate potential psychological factors underlying the effects of these mind-body therapies. It is hypothesised that mindfulness meditation and clinical hypnosis will be effective via changes in unique mechanisms.

Physically active play is critical during the early years of life for facilitating children’s health and development. Just one in three Australian children aged 2 to 5 years achieve the recommended three hours of daily physical activity. Early childhood education and care (ECEC) services are a key setting to intervene to improve physical activity levels. Our prior research addressed the need for an ECEC specific physical activity policy. We successfully developed, implemented, and evaluated an evidence-informed ‘Play Active’ program (a Play Active policy with accompanying implementation support strategies) in a pilot trial of 79 ECEC services. With our partners, we are now investigating how best to scale-up Play Active to ensure its effective and fit for purpose. This scale-up research will reach more than 700 ECEC services and 100,000 children across Australia.

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