ANZCTR search results

COBAT aims to help alleviate the chronic, severe disability experienced by people with treatment-resistant depression. Approximately 30% of people with depression don't respond to standard treatments. Ketamine has emerged as a novel treatment for this difficult-to-treat population, but approximately 50% don't respond and many relapse after ketamine treatment ends. This COBAT pilot is Phase 3 of broader COBAT study and aims to evaluate whether the co-adapted Behaviour Activation therapy manual can be feasibly delivered alongside ketamine treatment as a part of routine care, whether it is acceptable to patients, and whether it shows preliminary marginal effectiveness for future large-scale RCTs

We are conducting this online randomised trial to evaluate the effect of providing an additional explanatory imaging infographic alongside standard imaging reports to adults aged 18-50 years' understanding, treatment beliefs and intentions, information-seeking intentions, concern for symptom progression and confidence in managing hip pain conservatively. It is unclear how the way imaging findings are communicated influences patient understanding, worry, and willingness to engage with first-line physiotherapy treatment. Previous qualitative research suggests that focusing on structural patholoy alone may increase the perception that surgery is necessary course of treatment, potentially reducing engagement with conservative care, but this has not yet been tested experimentally. This study will compare two groups: both groups receive the same hypothetical hip pain scenario, then one group receives standard x-ray and MRI reports and the other receives the same reports plus an infographic explaining the imaging findings in clear, lay language that contextualises structural changes and emphasises the role of physiotherapy. Participants will then complete a nine-item purpose-built outcome survey assessing understanding, treatment beliefs and intentions, information-seeking intentions, concern about symptom progression and confidence in managing hip pain conservatively. The findings will provide insight into the effects of adding an infographic to standard imaging reports on patient understanding, treatment beliefs and intentions.

Open heart surgery is performed more than 2 million times each year worldwide. During and after surgery, doctors often use invasive devices to monitor the heart and blood vessels. One of these devices, the pulmonary artery catheter, provides detailed information about how the heart is functioning. Despite being widely used, it is still unclear whether this device actually helps patients recover better, because it has never been properly tested in a high-quality randomised trial. The PUMA study will address this question by randomly assigning adults undergoing open heart surgery to receive either a pulmonary artery catheter or standard care without one. We will compare outcomes that matter most to patients, including measures chosen with input from people with lived experience. This study will help determine whether routine use of this device improves recovery, safety, and overall outcomes after open heart surgery.

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.