ANZCTR search results

Pulmonary hypertension affects many people worldwide and can severely reduce quality of life and shorten lifespan. The disease begins in the lung’s tiny blood vessels (the microcirculation), which are invisible on routine tests. The current gold-standard test, right heart catheterisation, cannot measure microcirculatory function and often detects disease only after damage is established. This study will (1) determine whether a new, invasive method to assess lung microcirculation is feasible to use in practice, and (2) establish normal values in healthy adults. By identifying microcirculatory problems in the lungs earlier, we aim to enable earlier, more effective treatment.

We will collect patient data for cardiovascular risk calculator comparisons and CV outcomes, to test whether different risk calculators are roughly equal. Our hypothesis is that cardiovascular risk calculators will give different estimates within the same patients.

Patients with atrial fibrillation may have their treatment path altered due to frailty, yet we do not have guidelines in place to manage frailty if it is diagnosed. The project aims to recruit patients with atrial fibrillation >60 years old who also have some level of frailty and can still participate in exercise. These patients will undergo a multidomain assessment battery establishing multiple aspects of their biopsychosocial health with the primary focus being on physical frailty. Patients will then be randomised to either continuing their medical care as usual or adding an exercise intervention to their treatment for 6-months. At the end of the intervention and 6-montss following (12-months from baseline) patients will undergo the same assessment battery as baseline to determine if exercise is effective in managing frailty in patients with atrial fibrillation.

Our project aims to evaluate the feasibility of a digital self-management App, StudyU, for testing the individual effectiveness of different non-drug treatments in reducing the pain disability associated with chronic non-cancer pain, including but not limited to, pain persisting after Road Traffic Crashes. StudyU is a new, free, mobile phone App, which allows patients to rigorously compare different interventions using gold-standard Single Case Experimental Designs (SCEDs) (personalised single patient behavioural experiments). SCEDs provide a very high level of evidence to evaluate treatment effectiveness in individual patients, empowering them to adopt treatments that help their pain, and discontinue ineffective treatments (even if these are generally recommended). The StudyU App sends patients daily reminders to record pain levels, functional impact and any additional pain medication use. After each trial, it visually displays results (eg pain ratings) for patients. Additionally, sophisticated statistical analyses compare baseline and treatment conditions so doctors can discuss treatment effectiveness with their patient. Testing the effectiveness of different self-management treatment options, such as lifestyle/behavioural interventions, empowers patients to self-manage persistent pain, in partnership with their treating practitioner.

This study includes 4 single ascending dose cohorts (fasted), 1 fasted/fed food effect cohort and 5 fasted multiple ascending dose cohorts. The main purpose is to examine the safety and tolerability of RTR242 following single and multiple ascending doses in healthy adult subjects. Participants will be contacted by telephone 28 days after their last dose of study drug for safety follow up.

The REVIVE Study aims to understand the uptake of RSV prevention products recently introduced to protect newborns from RSV disease. It will assess the uptake of the maternal RSV vaccine amongst pregnant people birthing at Monash Health during 2025-2026. The uptake of RSV monoclonal antibody amongst eligible infants will also be assessed. The study will also evaluate the demographic factors associated with the uptake of these products. Overall, the REVIVE Study will paint a picture of our newborns' current level of protection against RSV and help us understand how to better direct public health messaging in order to maximise the uptake of vaccination programs.

This study is being conducted to find out if the ROMI device can help patients with dizziness to be sent to the right specialist (e.g. vestibular physiotherapist, neurologist) first time rather than a long wait to be assessed by an ENT. This study employs a randomised, controlled trial design to assess both the predictive value and clinical utility of the ROMI test as a triage of those with episodic dizziness. The ROMI is a portable device that allows patients to capture their eye movements during dizziness attacks. Patients referred with undiagnosed vertigo will be prospectively randomised into either a control group which will undergo standard care or into the interventional group which will use the portable diagnostic device and also the standard care pathways. Participants that undertake the ROMI test will do so while on the ENT waitlist and will see the ENT specialist on the date of their allotted appointment with the results of the ROMI test (assessed by an Audiologist) provided to the ENT specialist .

This study will test a new treatment approach for brain cancer treatment before surgery, that involves giving two different drugs - trametinib to target leaky blood vessels within a brain tumour and an immunotherapy drug (pembrolizumab) that aims to activate the immune system. Who is it for? You may be eligible for this study if you are an adult, aged 18 years or older, you have been diagnosed with a malignant glioma (brain tumour) and you have not yet received any treatment for your cancer in the form of surgery, chemotherapy, radiotherapy, immunotherapy and ideally have not received prolonged steroids. Study details Participants who choose to enrol in this study will be assigned to either the intervention group or the standard treatment/control group by the study doctor. Participants who are assigned to the intervention group will be asked to take trametinib tablets daily for two weeks, and have an infusion of pembrolizumab prior to undergoing surgery to remove their tumour. Participants who are assigned to the standard treatment/control group will be asked to take dexamethasone tablets daily prior to undergoing surgery to remove their tumour. All participants will be asked to undergo an MRI scan prior to their surgery and within 48 hours of their surgery to assess the effect of each treatment on their brain. It is hoped this research will demonstrate that combined trametinib and pembrolizumab treatment prior to surgery to remove a brain tumour is safe, able to normalise blood vessels in the brain and increase the activity of the immune system to fight the cancerous cells. If this study is successful, a larger trial involving a greater number of brain cancer patients may go ahead.

This study aims to explore whether taking a short cold-water shower each day can improve mental wellbeing in adults who experience symptoms of anxiety or depression. Participants will be randomly allocated to either continue their usual shower routine or to finish their daily shower with 90 seconds of cold water for 30 consecutive days. The study will measure changes in mood, sleep, fatigue, and overall wellbeing using online questionnaires completed at the start, middle, and end of the study. The researchers hypothesise that daily cold-water showers will lead to small but meaningful improvements in symptoms of anxiety and depression compared with usual showers, and that the approach will be practical, safe, and acceptable for most people. Findings from this pilot study will help determine whether a larger clinical trial should be conducted in the future.

The current study was a pilot trial of the My Toddler and Me program, an 8-week group program adapted from Parent-Child Interaction Therapy for Toddler, delivered to a community sample. The community sample comprised caregiver-toddler dyads who were seeking general caregiving support rather than clinical treatment for specific emotional or behavioral concerns. The current study aimed to (a) assess feasibility of running the My Toddler and Me group program in a community setting; (b) explore caregivers' perceptions of the clinical effectiveness and acceptability of the program and the perceived barriers to attending the program; and (c) conducted an preliminary evaluation of the effectiveness of the My Toddler and Me group program (defined as how well the intervention works in a real-world setting; Rosqvist et al., 2011) by examining caregiver and child outcomes using caregiver-report questionnaires. This pilot assessment of feasibility, acceptability and potential effectiveness of the My Toddler and Me program in a community setting is seen as an important step before conducting a larger randomize control trial to access program efficacy. It was hypothesized that: 1. The program would be deemed feasible based on the facilitator’s ability to successfully deliver the complete My Toddler and Me group program on multiple occasions. 2. Caregivers would be accepting of the program, as evidenced by expressions of positive regard for the program during post-group interviews. 3. There would be preliminary evidence of program effectiveness in improving caregiving variables the program seeks to target, as assessed by caregiver-report questionnaires. Specifically, increases in caregiving self-efficacy, caregiver mentalization (ability to identify and understand child’s mental states), competence in managing negative toddler emotions, caregivers sense of social connectedness, and a decrease in levels of helplessness and caregivers’ perceptions of their child as hostile. 4. There was will be preliminary evidence of program effectiveness in improving child variables, as assessed by caregiver-report questionnaires. Specifically, improvement in child outcomes from pre- to post-intervention including lower levels of social-emotional/behavioral problems (e.g., aggression, defiance, anxiety, and withdrawal) and higher levels of social-emotional abilities (e.g., empathy and compliance), initiative, relationship functioning, and self-control.