ANZCTR search results

The purpose of this study is to evaluate the short term effects of selective light filters incorporated into single vision prescription spectacle lenses on short sightedness outcomes. The aim is also to investigate the effect of selective light filter spectacles on vision, colour perception, and comfort and impact on activities of daily living. The resulted will be compared to standard (non-filtering) single vision spectacle lenses in young adults with short-sightedness through a cross-over RCT. We hypothesise that four week exposure will show short term changes to myopia outcomes and have no adverse effects on vision with good safety and minimal interference with activities of daily living.

The research comprises a randomized, placebo-controlled, double-blind trial to evaluate the safety, tolerability, and physiological effects of a hydrogel-encapsulated sodium bicarbonate formulation co-delivered with caffeine and carbohydrates. The study seeks to establish whether this intervention improves exercise tolerance, with minimal adverse effects, in healthy volunteers. Phase 1 will involve 16 healthy adults (8 per group). Participants will complete two test visits. During the first visit participants will undertake a cycling based exercise test (INSCYD lactate test) to define baseline exercise tolerance. During the second visit, 96 hours later, they will ingest either the active hydrogel formulation or a placebo hydrogel before undertaking the same INSCYD lactate test. Physiological responses will be assessed using capillary lactate sampling, venous blood gas (VBG) analysis, and subjective effort ratings. Tolerability will be evaluated using GI symptom questionnaires, palatability scores, and protocol adherence. Performance outcomes will include maximal 4-minute power output, and detailed metabolic profiling via INSCYD software. Statistical analyses will include repeated-measures ANOVA and chi-square tests for tolerability. Both intention-to-treat and per-protocol analyses will be conducted.

Mindfulness training and psilocybin interventions are both promising approaches for supporting mental health and wellbeing, and may have complementary or synergistic effects when used together. The Psil-oMM study aims to examine the combined and independent effects of mindfulness training and psilocybin by comparing three conditions in 45 healthy volunteers: a 4-week mindfulness intervention, a single high-dose psilocybin session with psychological support, and a combined mindfulness plus psilocybin intervention. The primary outcome is wellbeing, assessed using the Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS).

This study will investigate helmet use among riders of e-bikes, pedal bikes, and e-scooters in Canberra and evaluate the impact of safety and legal messaging signage on helmet-wearing behaviour. Helmet use will be observed in public settings using discreet video recording, and de-identified hospital emergency department data will be analysed to assess head injury presentations associated with cycling and e-scooter use. A voluntary survey of adult Canberra residents will explore attitudes toward helmet use and perceptions of deterrent fines. All data will be de-identified, securely stored, and analysed in aggregate to protect participant privacy. The study is expected to provide evidence to inform public safety policy and injury prevention strategies in urban transport settings.

This study aims to implement a clinical transition pathway utilising a collaborative, shared-care model between The Royal Children's Hospital Melbourne (RCH) and Peter MacCallum Cancer Centre (PMCC). Who is it for? You may be eligible to join this study if you are aged 16 years and older, and have a cancer diagnosis or a condition cared for under the RCH Children’s Cancer Centre which is your main medical issue. You need to have finished treatment within the last 2.5 years or be on indefinite, maintenance type treatment. PMCC must be a suitable place to transition to for your ongoing care. Study details All participants who meet the eligibility criteria in this study will begin a clinical pathway for transition from paediatric to adult services for AYA diagnosed with cancer. It will comprise four time points over 3-6 months: Baseline - Orientation and Consent, time points 1, 2, and optional 3 - Transition shared care clinic model. The program will be evaluated throughout intervention period and participants will be assessed for experience of care, client satisfaction, transition readiness, information needs. It is hoped that this research result will help develop and deliver a sustainable model of care that improves the experience of transition for young people with cancer and the skills and systems around transition for adult and paediatric cancer teams.

Exercise is known to support mental well-being during and after pregnancy as well as in times of grief. However, there is very little research on how exercise may support individuals after pregnancy loss. This study will explore the safety and feasibility of a personalised, in-person exercise program aiming to support the mental and physical health of bereaved parents in Australia. Twenty parents who have recently experienced stillbirth will be invited to take part in a 10-week program run by an accredited exercise professional, combining physical activity with education and peer support. The aim of this research is to better understand how exercise and connection with others can help to improve emotional well-being and reduce isolation after pregnancy loss, and to address critical gaps in current research and practice.

This double-blind, placebo-controlled, first-in-human (FIH) study will assess the safety, tolerability, PK, and immunogenicity of TX002100. This study seeks to establish doses of TX002100 that are safe, well tolerated, and exhibit an appropriate PK profile to warrant further clinical investigation. Six cohorts of 8 participants each are planned. Participants will be randomized in a 3:1 ratio to receive a single dose of TX002100 or matching placebo. Planned evaluations will include approximately 48 healthy men or healthy women of non–childbearing potential

Primary objective To quantify pre- to post-season changes in ACL tissue properties using quantitative MRI in youth female rugby league athletes. Hypotheses 1. ACL quantitative MRI indices and morphology will demonstrate measurable changes across the season. 2. The intervention group will show greater favourable changes in ACL morphology and quantitative MRI indices compared with controls. 3. Improvements in strength/power and favourable landing/deceleration mechanics will be associated with favourable ACL MRI changes. 4. Hormonal concentrations will explain inter-individual variability in ACL MRI outcomes and adaptation, consistent with mechanobiological and endocrine influences reported in prior literature .

This research is testing if telling a person their risk of melanoma based on either their clinical risk factors or their genetic risk factors influence their skin screening behaviours. Who is it for? You may be eligible for this study if you are a healthy adult aged between 51 and 75 years old (inclusive) at the time of informed consent with no history of invasive or in situ melanoma. You must have also previously participated QSkin Sun and Health Study. Study details Participants will be randomly allocated to either of the two intervention groups who will receive one of the personal melanoma risk scores along with general skin health education, or the control group who will not be given a risk score and will only receive general education. Data on their screening habits and behaviours will be followed up over a one-year period. It is hoped that findings from this study will help inform potential screening programs for melanoma.

G-DISCOTEQ is testing how well two cancer drugs (Gemcitabine and Docetaxel) work when they are given directly into the bladder at the same time. Who is it for? You may be eligible for this study if you are a male or female age 18 or above with either carcinoma in situ with or without papillary tumours or papillary tumours. Study details Participants will receive intravesical chemotherapy consisting of Gemcitabine (1 g) and Docetaxel (37.5 mg) combined in 50 mL of saline per instillation. Treatment begins with an induction phase of weekly instillations for six weeks, followed by a maintenance phase of monthly instillations for ten months. After the intervention, participants will undergo cystoscopy, cytology, and biopsy. Medical records will be reviewed to evaluate key outcomes, including complete response rate, recurrence-free survival, progression-free survival, cystectomy-free survival, cancer-specific survival, overall survival, and safety. Quality of life will also be assessed through patient-reported outcome measures. It is hoped that the results from this study will contribute to the field of non-muscle-invasive bladder cancer.