ANZCTR search results

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.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-203 in Healthy Volunteers

Despite the prevalence of insomnia among psychiatric hospital inpatients, few studies have investigated the effectiveness of CBT-I for this population. Furthermore, no known studies have selected a psychiatric inpatient population when examining the impact of CBT-I on suicidality. The current study aims to implement a program of CBT-I adapted for suitability with mental health hospital inpatients, evaluating the effectiveness of this intervention in both the reduction of insomnia symptom severity and suicidal ideation. Participants will be randomly allocated to one of two conditions: i) adapted CBT-I, or ii) treatment as usual at the hospital. The adapted CBT-I will be delivered in group-therapy format across four sessions (twice a week, for two weeks). It is hypothesised that inpatients who receive the sleep intervention will show a larger reduction in their insomnia symptoms and suicidal ideation, compared to patients in the control group. Assessment time points for self-report questionnaires will be at baseline (admission), end of treatment, and a 1-month follow-up.

This study is testing whether a new hormone-based therapy called HAV-088 (a combination of testosterone and an aromatase inhibitor) can help reduce breast cancer risk in premenopausal women. Who is it for? You may be eligible for this study if you are aged between 25 and 50, you are not currently going through menopause or peri-menopause, and you are at-risk of developing breast cancer - defined as meeting one of the following: history of abnormal cell growth in the breasts, known BRCA1/2 or other high-risk gene mutation, or extremely dense breasts. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two treatment groups. Participants allocated to the first group will be asked to take an oral dose of tamoxifen each day for 1 year. Participants allocated to the second group will be asked to have a slow-release HAV-088 pellet injected into soft tissue (with local anaesthetic) near their hips once every 3 months for 1 year. All participants will be asked to attend two MRI scans and will also be asked to provide blood samples and fill out questionnaires about their symptoms and quality of life throughout the study. It is hoped this research will determine that HAV-088 is a safe treatment for women at high-risk of developing breast cancer, while preserving ovarian function and causing fewer side effects than tamoxifen. If this small study is positive, a larger study enrolling a greater number of women at high-risk of developing breast cancer may be undertaken.

P. gingivalis is associated with diseases including periodontitis, cardiovascular disease, diabetes, and AD. This study will assess the safety and immune response to GPV381 in patients who have mild AD.

The REPURPOSE Trial aims to assess the efficacy and safety of oral efavirenz in high grade serous ovarian, fallopian tube and primary peritoneal cancer. Who is it for? You may be eligible for this study if you are an adult female with platinum resistant or potentially platinum sensitive high grade serous ovarian, fallopian tube and primary peritoneal cancer. Study details All participants will receive daily oral efavirenz (600mg) for 24 months or until disease progression by RECIST 1.1 or CA125 GCIG criteria unless the clinician believes that there is a clinical benefit to continue treatment beyond progression and there is no unacceptable toxicity resulting from the treatment. Data will be collected on clinical response and incidence of adverse events. It is hoped that findings from this study will inform researchers and clinicians of the role of efavirenz in the landscape of gynaecological cancer treatment.