ANZCTR search results

The VIBE study aims to investigate the effect of Voyant Versus Diathermy for Haemostasis on post-surgical drainage and seroma in Breast Cancer Surgery Who is it for? You may be eligible to join this study if you are aged 18 years or above, diagnosed with breast cancer and undergoing unilateral or bilateral mastectomy Study details Participants in this study will randomly be allocated (by chance) to one of two groups: one group will be allocated the Voyant™ Intelligent Energy System for tissue dissection and vessel sealing during surgery while the other group will be allocated standard surgical care with conventional diathermy for tissue dissection and vessel sealing during surgery. Outcomes assessed up to 30 days post-surgery include time to drain removal, total drain output, seroma, and other recovery measures such as pain, complications, and quality of life. This research may help identify the most effective surgical device for reducing post-operative drainage and seroma after breast cancer surgery, with the potential to improve recovery and patient outcomes.

Body dysmorphic disorder (BDD) is a disorder that is characterized by a significantly disturbed perception of one’s own appearance. We propose to conduct a randomised within-group mixed-methods study on individuals with BDD to determine the feasibility and acceptability of VR-based mindfulness training. This study will be conducted at Swinburne University of Technology, Melbourne, Australia. The feasibility and acceptability of VR-based mindfulness training will be achieved in a number of ways: 1) qualitative semi-structured interviews; 2) self-report measures; 3) physiological measures (i.e. heart rate variability and galvanic skin response). This comprehensive, multimodal assessment of these experiences will be integral in refining our mindfulness training for this complex disorder. The effects of receiving VR-based mindfulness training will be assessed through comparing pre- and post-intervention state mindfulness, body image concerns and emotional regulation variables.

International guidelines now recommend screening for primary aldosteronism (PA) in people with chronic hypertension, however this is often not done. Unlike essential hypertension, PA has specific treatments, some of which can even provide a cure. Pregnancy and the postpartum provides a window of opportunity to screen women and improve their longterm health outcomes. However we don't know the prevalence of PA in this population. We aim to determine the prevalence of PA in women who have chronic hypertension after pregnancy. With a pragmatic design, we also aim to provide both quantitative and qualitative data on performing initial screening on medications commonly used in the postpartum period.

The CogCoach Brain project aims to evaluate an online, evidence-based lifestyle intervention designed to promote healthy brain ageing and reduce dementia risk in older adults with subjective cognitive decline (SCD) or mild cognitive impairment (MCI). Building on the CogCoach-Health framework, the program delivers a 12-week multidomain intervention targeting physical activity, cognitive engagement, diet, social connection, sleep, and mood through interactive e-learning modules and personalised behavioural support. The randomised controlled trial follows participants for 12 and 24 months to assess long-term changes in cognitive function, lifestyle behaviours, and wellbeing. Optional biomarker testing will explore how lifestyle modification may influence biological indicators of brain health. The overarching goal is to provide an accessible, scalable program that supports healthy brain ageing and reduces dementia risk in older Australians

The primary aim of this parallel group, superiority trial is to determine the effectiveness of PAO surgery + co-designed rehabilitation compared to co-designed rehabilitation on pain at 12 months. We hypothesize that PAO surgery + co-designed rehabilitation with be superior to co-designed rehabilitation at 12 months for pain. In addition, our secondary aims are to explore the effectiveness of PAO surgery + co-designed rehabilitation compared to co-designed rehabilitation on quality of life, sleep, psychological symptoms, hip joint structure, movement patterns and cost-effectiveness.

This is a randomized, placebo-controlled, sequential, multiple ascending dose study conducted at a single site in Australia and comprised of 2 to 3 cohorts (with the third being an optional cohort, at the discretion of the Sponsor). Randomization to either RES-010 or placebo treatment in a ratio of 3 RES-010 to 1 Placebo treatment. An escalating-dose multiple ascending dose study design in overweight and moderately obese participants was chosen to allow careful increase of the study drug RES-010 dose after the assessment of safety, tolerability, and available plasma and urine Pharmacokinetic and Pharmacodynamic results of each preceding dose cohort. A blinded review of all available safety data and plasma and urine Pharmacokinetic and Pharmacodynamic data will be performed by a Safety Review Committee (SRC) after the administration of the fourth study drug dose to identify any potential safety and or tolerability signals. Based on this review the SRC will recommend to either proceed with the study as planned, or indicate if dose escalation or de;-escalation is appropriate. If necessary, recruitment may be paused to await the availability of further safety data to make a recommendation. The minimum number of participants required to decide on a dose escalation is 6 participants (at least four participants on active treatment RES-010).

This prospective cohort study investigates the effect of oral rehabilitation exercises following buccal mucosal graft urethroplasty. It is hypothesised that implementation of these oral exercises will decrease enhance oral rehabilitation and decrease complications following surgery.

The human gut microbiome plays a pivotal role in maintaining gastrointestinal health, immune function, and has been associated with the development and progression of various chronic illnesses. There remains an unmet need for probiotics that provide clinically validated, reproducible, and lasting benefits in broader contexts such as disease prevention and health promotion. In our research, we have developed a bank of isolated microbial strains derived from healthy FMT donors and supported by findings from prior FMT clinical trials conducted by our group and others. These strains have demonstrated consistent clinical and microbiological effects and are being investigated as candidates for a next-generation probiotic formulation. We are examining the impact of administering a combination of these organisms as a probiotic in healthy individuals to assess effects on the gut microbiome.

This study is a pilot and feasibility randomised controlled trial evaluating whether Virtual Reality Exposure Therapy (VRET), when combined with Cognitive Behavioural Therapy (CBT), improves outcomes for individuals experiencing driving anxiety following motor vehicle crashes. A total of 30 participants will be randomly allocated to receive either standard CBT alone or CBT enhanced with immersive VR-based exposure over an eight-week program. The intervention uses personalised, graded exposure scenarios delivered via VR headsets to safely and progressively reduce anxiety related to driving. Outcomes will assess feasibility, safety, acceptability, and preliminary efficacy using validated psychological and quality-of-life measures, alongside qualitative feedback. Findings will inform the design of a future fully powered trial and the potential integration of VR into scalable treatments for driving anxiety.

This study aims to investigate the feasibility of implementing pharmacogenetics in the busulfan dosing method for children undergoing hematopoietic stem-cell transplantation Who is it for? You may be eligible to join this study if you are a male or female paediatric patients aged 0-18 years undergoing Haematopoietic Stem Cell Transplantation (HSCT) with a Busulfan (Bu)-based conditioning regimen. Study details All participants who meet the eligibility criteria in this study will be randomly assigned to one of two groups. The experimental group will receive Bu dosing based on the pharmacogenetics (PG)-based personalised model, the control group will receive dosing according to the traditional McCune model (does not account for genetic factors). The primary outcome measure will be the proportion of first doses that achieve the therapeutic target area under the curve (AUC). Secondary outcomes will include the incidence and severity of treatment-related toxicities, graft failure, relapse rates, overall survival, and event-free survival. An add-on study will investigate the impact Bu metabolites have on Bu clearance and patient outcomes. The study will involve the collection of DNA samples from all enrolled children to determine their GSTA1 haplotypes, which will be used to calculate the personalised Bu doses for the experimental group. It is hoped that this research project will improve the dosing of busulfan in the future with more patients achieving the optimal therapeutic target exposure.