ANZCTR search results

This randomised controlled trial will evaluate a 12-week intervention providing two eggs per day to older adults in retirement living (retirement villages, community living) , with outcomes assessed at baseline, week 6, week 12, and 6 months from the beginning of the intervention. The primary hypothesis is that participants in villages allocated to the increased egg intake intervention will have greater improvements in Mini Nutritional Assessment total scores at 12 weeks compared with control villages continuing usual intake (less than one egg per day). Key secondary hypotheses are that, at 12 weeks, intervention participants will have greater gains in physical function, assessed by the Short Physical Performance Battery and additional physical function tests (HGS, TUG, ADLs), than controls, and will report better health-related quality of life measured by the SF-36 Physical Component Summary. Additionally, it's hypothesised that all blood markers (total cholesterol, HDL, LDL, triglycerides and glucose) will have no significant difference between groups. The trial will also assess implementation outcomes, with the hypothesis that intervention participants will achieve high adherence, defined as consuming at least 80 percent of prescribed eggs over 12 weeks. A further hypothesis is that intervention participants will report high acceptability of incorporating eggs into their regular diet, including favourable ratings of taste, ease of preparation, frequency tolerance, and perceived health effects, and that trial data will identify practical strategies to support sustained egg consumption in this population.

The study aims to evaluate the adverse events and quality of life outcomes associated with prostate stereotactic ablative radiotherapy (SABR) for newly diagnosed metastatic prostate cancer, Who is it for? You may be eligible to join this study if you are aged 18 years or above and have newly diagnosed metastatic prostate cancer. Study details: Traditional radiotherapy for de novo metastatic prostate cancer typically involves four weeks (20 sessions) of daily treatment to the prostate, on top of standard care systemic therapy. In this study, all participants in this study will receive SABR to the prostate delivered in five fractions, one fraction per week over 5 weeks, for a total of 35 Gy, in addition to standard care systemic therapy. Participants will complete questionnaires, and blood tests during regular follow-up visits up to 5 years post-SABR completion to determine quality of life and efficacy outcomes, and adverse events. It is hoped this study may provide evidence for a safe and effective, and more convenient radiation therapy schedule in the form of prostate SABR, for patients with metastatic prostate cancer.

This study will evaluate the safety of the HYPNOS System, a novel implantable hypoglossal nerve stimulation device designed to keep the airway open during sleep. Participants with moderate to severe OSA who cannot tolerate CPAP will be implanted with the system and followed for 24 months to assess safety and sleep outcomes.

This project aims to determine the acceptability, feasibility, and preliminary effectiveness of an occupation-based, virtual reality intervention (VR-Brain Aware) for improving health outcomes including executive function (including self-awareness), confidence and preparedness for home of people with acquired brain injury (ABI). Eligible people with ABI will be identified by treating occupational therapists. After informed consent is obtained, patients will be randomised into either either the usual care only group or the usual care plus VR-BrainAware group. Patients in the VR-BrainAware group will be provided with training to use VR and they will receive two additional VR-BrainAware treatment sessions per week over a three-week period by a trained, qualified occupational therapist. This study will explore the acceptability and feasibility of VR-BrainAware and the results will inform the feasibility of a larger, adequately powered RCT. We will describe and explore the clinical outcomes from this pilot RCT with due caution to not extrapolate results beyond the feasibility and pilot nature of the study.

This study aims to evaluate the feasibility of Phase 2 of the Falls Prevention and Education Program (Falls-EDU), a student-led, semi-individualised falls prevention program delivered in a university health clinic. Community-dwelling adults aged 55 years and older will receive a structured falls risk assessment, tailored falls prevention education, and exercise strategies delivered by supervised osteopathy and physiotherapy students. Participants will attend individual consultations and may also choose to participate in small supervised Falls and Balance (FAB) group exercise classes based on the Otago Exercise Programme. The study will assess feasibility and implementation outcomes including recruitment, retention, attendance, engagement with group classes, protocol adherence, and participant satisfaction measured using the Client Satisfaction Questionnaire (CSQ-8). Evaluating both phase 1 and phase 2 program feasibility and implementation metrics, with analysis of preliminary clinical data results, will inform future program refinement and scalability.

Brief description of the study purpose: This study aims to evaluate the safety and feasibility of belzupacap sarotalocan (bel-sar / AU-011) when used to treat conjunctival melanoma, melanocytic lesions, or conjunctival squamous cell carcinoma (SCC). Who is it for? You may be eligible for this study if you are a male or female, aged 18 years or older with a confirmed biopsy diagnosis of elevated or flat conjunctival melanoma, melanocytic lesions, or conjunctival squamous cell carcinoma, who hasve a tumour suitable for bel-sar injection and planned tumour excision. Study details Participants will receive one or multiple injections of bel-sar depending on their assigned cohort, with each injection followed by laser application. All participants who are eligible will receive treatment. Safety monitoring includes assessment of adverse events, vital signs, laboratory test (complete blood count and metabolic panel), and visual acuity. Blood samples will also be collected to measure serum concentrations of bel-sar. It is hoped that this research will determine provide information as to whether bel-sar, combined with laser activation, can be safely used as a new treatment approach for conjunctival tumours and ultimately contribute to improved options and patient outcomes.

The primary aim of this study is to examine the feasibility of recruiting patients into the trial, the implementability of the prescribed treatments and whether the study treatments are followed. This feasibility study will test whether we can conduct a future, larger trial asking: In patients with early postoperative heart complications, does an early intervention bundle reduce short-term and long-term cardiovascular complications and death? Adults aged 65 years and over, experiencing heart complications after surgery, will be eligible. Recruited individuals will be randomly assigned to receive current standard treatments, or a bundle of care, comprising i) medical therapy (such as aspirin, blood pressure-reducing therapy, diabetes treatment and cholesterol-lowering therapy) and ii) aggressive lifestyle interventions, including smoking cessation, physical activity, dietary modifications and weight management. Barriers and enablers to treatment adherence will be explored individually for each patient, with subsequent recommendations to improve compliance with therapy. All individuals in the study will be followed up for 1 year after surgery, to find out whether they experience further heart complications or do not survive.

In this study, each participant completes four sessions, with a minimum 48-hour washout period, in a randomized and counterbalanced order. In each session, participants receive one of four LA conditions: stimulation of pain-related acupoints LI4, LI11, or ST36, or a sham acupoint. Before the intervention, participants undergo a standardized battery of assessments, including EEG signal, pressure, and electrical pain thresholds and tolerance, followed by a Go/No-Go cognitive control task. LA is then administered for 5 minutes in continuous-wave mode, during which EEG is recorded to capture real-time changes in oscillatory activity and functional connectivity. Immediately after stimulation, all pre-intervention assessments are repeated to evaluate changes. We aim to determine the effects of laser acupuncture of pain-related acupoints on pain sensitivity, cognitive function, EEG band amplitude, and intracortical connectivity in healthy young participants.

Extracorporeal membrane oxygenation (ECMO) is an advanced life support machine used to support critically ill people with severe heart and/or lung disease. While ECMO can be lifesaving, death during ECMO is common and recovery after this treatment is often slow and difficult, with people facing serious problems with their physical health, memory, mental well-being, and day-to-day functioning. It can also be hard for them and their families to find the right support to help with these issues after hospital discharge. The ECMO-RECOVERY study will test a new intervention to support patients after they leave the hospital following ECMO treatment. This intervention includes use of digital platform (similar to an app) on a mobile phone, tablet or computer and access to a specialised recovery coordinator for regular check-ins through video or phone. Patients will set recovery goals, track their symptoms, and access health information through the app. Their general practitioner (GP) will also receive updates to guide ongoing care. This study will include 227 adult patients who have received ECMO from several hospitals in Australia. Of these patients, roughly half will receive standard care following ECMO, while the other half will receive the ECMO-RECOVERY intervention. We will compare the two groups to see if the intervention helps reduce disability, and improve quality of life, functional status, psychological well-being and cognitive function after ECMO.

The National Which Way? Quit Pack is a program designed by and for Aboriginal and Torres Strait Islander people to support quitting smoking and vaping. Tobacco use causes significant harm in communities. While many people want to quit, they face barriers such as cost, access, and lack of tailored support. Building on successful pilot studies, this national trial will mail Quit Packs to people who sign up. Each pack includes health information, culturally relevant resources, free nicotine replacement therapy (patches, gum, mouth spray or lozenges), and options for phone counselling and an online support forum. The study will follow participants over 12 months to understand how effective the Quit Pack is in helping people quit, how widely it is used, and how it can be made sustainable as a national program.