ANZCTR search results

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) From pre- to post-intervention (120 days later), 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) From pre- to post-intervention (120 days later), 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 and coaches will find the PiP Kids-Autism program satisfactory, acceptable and feasible to implement.

This study will recruit participants who attend Armadale Hospital (public) Emergency Department (ED) with acute low back pain. They will be randomized into groups, and the intervention group fitted with an abdominal brace. The hypothesis is that in people with mechanical low back pain, wearing a brace will reduce their pain (and increase activity and quality of life [QoL]). The participants will be asked to wear the brace for up to 30 days when in pain during the day and if they feel that the brace is helpful. Low back pain, function, QoL and health care usage will be tracked for 3 months from the date of attendance at ED.

This is a randomised, blinded and controlled Phase I trial to measure the safety, feasibility and efficacy of a combined cell transplantation and intensive rehabilitation intervention to treat spinal cord injury. The trial aims to examine whether transplantation of olfactory cell nerve bridges combined with intensive rehabilitation is safe and feasible for people living with chronic spinal cord injury in Australia, and whether the intervention improves structural integrity of the spinal cord, functional recovery, overall health, and social well-being.

Study approved by bellberry ethics committee K on 19th February 2024. This is a single-centre, single ascending dose study to assess the safety of lanreotide Extended-Release Formulation, and how this drug acts in the body in healthy volunteers. Lanreotide may be indicated for use in patients with neuroendocrine cancer, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Participants who choose to enrol in this study may be enrolled into one of three dose cohorts. Healthy volunteer participants may receive either a single dose of lanreotide ERF administered as a subcutaneous (under the skin) injection or a single dose of lanreotide ERF administered as an intramuscular (into a muscle) injection. All participants will have their vital signs checked and will provide blood samples for testing. It is hoped this research will determine the maximum dose and best injection method for lanreotide ERF that can be administered safely without causing severe reactions. Once the dose of lanreotide ERF has been determined in healthy volunteers, a trial investigating the efficacy of lanreotide ERF as a treatment for neuroendocrine cancer patients may proceed.

Cardiovascular disease is the leading cause of death and disability among adults globally. In Australia it is the lead contributor to health care expenditure and with an ageing population the burden of disease is expected to increase. Cardiac rehab is an effective secondary prevention tool post acute coronary syndrome acute coronary syndrome but is underutilised and inconsistently delivered. The trial will whether early cardiac rehabilitation in high-risk acute coronary syndrome results in greater functional improvement at 6 months when compared to later and standard of care, examine the safety of cardiopulmonary testing to support exercise prescription, and define the metabolic profiles of post acute coronary syndrome.