ANZCTR search results

Cardiac dysfunction is a common complication of cirrhosis, affecting from a third to half of patients with end stage liver disease. The reasons for its development are still unclear, and novel techniques such as metabolite profiling may illuminate new causative pathways and potentially identify targets for treating this condition. Liver transplantation provides a cure for cirrhosis, however its effect on cardiac dysfunction has also not been fully elucidated. Also, the effects of cardiac dysfunction on liver transplant outcomes in also unclear. This study, by combining metabomics and newer cardiac imaging techniques, will be able to study the reversibility of this condition after transplant and allow us to characterise the spectrum of cardiac dysfunction and its effect on liver transplant outcomes.

The aim of this intervention is to provide women with evidence-based advice on exercise during pregnancy that will help them to make informed decisions about their own health and wellbeing. By improving knowledge and awareness about safe and effective exercise during pregnancy, it is hoped that this intervention will contribute to better health outcomes for both mother and baby. Literature suggests that less than 39% of pregnant women meet the current physical activity guidelines. Potentially, this is due to the disregard of the physiological changes in the cardiovascular system as pregnancy progresses, resulting in poor adherence to exercise. This is clinically important as adequate physical activity during pregnancy is associated with lower average gestational weight gain. However, no research has investigated the effect of individualised exercise prescription on maternal weight gain. It is hypothesised that individualised exercise prescription provided during pregnancy will reduce maternal weight gain, and improve maternal and infant health outcomes.

The DETECT-PM study aims to determine the sensitivity and specificity of tumour DNA detection in peritoneal fluid collected at the time of surgery for non-metastatic locally advanced (cT4, N0-2, M0) or perforated colon cancer to predict for peritoneal recurrence. Who is it for? You may be eligible for this study if you are a male or female over the age of 18 and have histologically confirmed colon adenocarcinoma that is amenable to curative intent surgery. Study details: Blood samples will also be collected pre-surgery, 4-6 weeks post surgery, 12 months post surgery and at recurrence (if applicable) for circulating tumour DNA (ctDNA) analysis. Participants with non-metastatic resectable colon cancer who have a high risk of peritoneal recurrence, defined as those with perforation or clinical T4 disease will have peritoneal fluid collected at the time of surgery. It is hoped that findings from this study will provide opportunity for earlier intervention to prevent peritoneal recurrence through the detection of clinically occult peritoneal metastasis.

This study involves healthy participants who will be assessed for driving performance under the influence of alcohol (0.05% BAC) versus placebo. As a sub-arm (Arm 2) of a larger study (CAN-TRACK, ACTRN12624001118594) examining the effects of medical cannabis on real-world driving performance, the primary hypothesis is that THC and alcohol will impair driving performance, with specific focus on lane positioning, speed maintenance, and other critical driving tasks. The findings are expected to provide valuable insights into the influence of alcohol on driving safety, providing as a comparator for a parallel study including medical cannabis patients.

There is no laboratory-based diagnostic test and universally accepted treatment for ME/CFS and Long COVID, instead diagnosis follows fulfilment of a diagnostic criteria. The study aims to determine if treatment with Low Dose Naltrexone (LDN) improves ion channels function, fatigue, cognitive, neurological symptoms, and health-related quality-of-life (HRQoL) in adults with ME/CFS and Long COVID. If this is the case, Low Dose Naltrexone (LDN) may offer a safe and cost-effective treatment for ME/CFS and Long COVID. The investigational production Low Dose Naltrexone (LDN) will be manufactured, packaged, labelled, coded, stored, supplied, and handled in accordance with the requirements of sections 5.13 and 5.14 of the Therapeutic Goods Administration’s Integrated Addendum. Specifically, Low Dose Naltrexone (LDN) will be manufactured in accordance with good manufacturing practices (GMP) and will be coded or labelled by the compounding pharmacy. While Low Dose Naltrexone (LDN) and placebo will be blinded, a coding system will be implemented to enable rapid identification of the product for safety reasons. Specifically, Low Dose Naltrexone (LDN) capsules are to be stored at room temperature in their original container for up to six months. Low Dose Naltrexone (LDN) will be labelled with a specific expiration date by the compounding pharmacy.

Obsessive compulsive disorder (OCD), Body dysmorphic disorder (BDD), and anorexia nervosa (AN) are some of the most debilitating and chronic mental health conditions, sharing overlapping psychopathological determinants in terms of behavioural and cognitive impairments, neurobiological and neurocircuitry mechanisms, and poor response to conventional treatments. This trial aims to investigate the efficacy, safety and tolerability of psilocybin assisted psychotherapy (PAP) for treatment resistant OCD, BDD, and AN. 12 patients from each condition will be recruited in a basket design (multiple conditions) open label trial of 2 dosing sessions with non-directive support, including preparatory and integration therapy, and a 3-month follow up period. It is hypothesised that PAP will lead to statistically significant and clinically significant (35%) improvements in primary symptoms for each condition. Explorative outcomes will be investigated as potential mediators of changes in symptom severity, and lived experience insights will be gained. The outcomes of the trial will enhance scientific understanding and provide rationale for subsequent randomised controlled trials investigating PAP for obsessive-compulsive and body image disorders.

This research will develop, test, and disseminate a multicomponent childhood obesity intervention for primary schools in South-West Victoria. The innovative TransformUs Wellbeing intervention builds on the successfully scaled-up primary school physical activity behaviour intervention in Victoria (TransformUs) and multi-component WHO STOPS community-based childhood obesity intervention. We hypothesise that by embedding capacity in systems thinking and mapping within primary school settings, and extending on the risk behaviours (e.g. diet quality, physical activity, sedentary behaviour, and sleep sufficiency and mental wellbeing) will lead to greater impacts and sustained changes in key behavioural drivers of childhood obesity. Our aim is test the effectiveness of TransformUs Wellbeing on health-related quality of life through a 9-month cluster-RCT among 8 intervention and 8 control primary schools in South-West Victoria in 2024.

With rising mental health strains in the tertiary education sector, it is imperative to promote a supportive, mentally healthy workplace for employees. The current study adapts a skills-based mental health training program, previously successful in training workplace managers to support the mental health of employees, with the aim of upskilling university staff to support their own and their colleagues' mental health. The aim of this study is to ascertain the effectiveness of this training in improving university staff's mental health knowledge, stigmatising attitudes to mental health and mental health management skills.

Mental health problems among university students are extremely common, and university staff frequently report being approached by students for mental health support. Many university staff members feel they do not have the skills or confidence to respond appropriately. The current study adapted a skills-based training program, previously successful in training workplace managers to support the mental health of employees, with the aim of upskilling university staff regarding student mental health. The aim of this study is to ascertain the effectiveness of this training in improving university staff's confidence supporting student mental health, mental health knowledge, stigmatising attitudes to mental health and behavioural responsiveness to students experiencing mental ill-health.

Research suggests that managers play an important role in workplace mental health. Indeed, positive managerial behaviours are a key predictor of employee wellbeing. The current study adapts previously successful manager mental health training programs to upskill managers in the university sector. The primary aim of this research is to evaluate whether this evidence-based training program will improve the confidence of managers in the university sector to support mental health and wellbeing in the workplace. Additional secondary aims include ascertaining the effectiveness of the training in improving managers' knowledge, attitudes and responsive behaviours with regard to employee mental health.