ANZCTR search results

MTAI-1025 as a novel agent for the treatment of ulcerative colitis (UC), a debilitating chronic disease caused by inflammation in the colon and rectum. The primary purpose of this study is to test a new oral medication called MTAI-1025 to see if the medication is safe when given as a single dose or when given over 2 weeks of dosing. This study also assesses blood samples to understand how much of the medication is in the blood stream and the impact of food on how much medication is absorbed into the body. The hypothesis is that the new medication will be safe to take.

CRONOS-1 is a prospective, single-arm, single-centre feasibility study evaluating the use of the HybridTherm® cryo-assisted radiofrequency ablation (cryoRFA) system to ablate histologically confirmed malignant pulmonary nodules via a flexible bronchoscopic approach. Five participants with nodules less than or equal to 25 mm, already planned for surgical resection as standard of care, will undergo transbronchial cryoRFA immediately prior to their planned surgery under the same general anaesthetic. The resected specimen is then assessed by histopathology to evaluate ablation effects. The study aims to establish whether the device can be safely and successfully deployed bronchoscopically, and to characterise the immediate histopathological ablation zone in human lung tissue. There are no additional hospital visits; all study activities occur within the index surgical admission. The study is conducted at Macquarie University Hospital, NSW, Australia, and is funded by Erbe Elektromedizin GmbH with Macquarie University as sponsor.

The purpose of this study is to determine whether it is feasible and acceptable to deliver the CALM-Kids program online and to explore its potential to improve anxiety symptoms and healthy lifestyle behaviours in children. The findings will help inform the design of a larger clinical trial. This study is a pilot randomised controlled trial comparing the CALM-Kids lifestyle program with a befriending program delivered via telehealth. Families will be randomly allocated to one of the two programs. Both programs include one individual online session followed by seven weekly small-group online sessions involving the child and a carer, delivered by trained facilitators via Zoom for Education. The CALM-Kids program is a family-based lifestyle intervention designed to support children experiencing anxiety. It focuses on everyday lifestyle habits, including physical activity, healthy eating, sleep, and screen time, using practical activities, goal setting, and parent/carer support to help families make sustainable behaviour changes. The befriending program is a structured group program that provides the same amount of facilitator contact and group interaction but does not include therapeutic or lifestyle advice. Instead, it focuses on social activities and conversation.

This study aims to evaluate a student-led falls prevention program that is delivered as part of routine clinical care at the RMIT Health Clinic. Community-dwelling adults aged 55 years and over will complete an 8-week program including falls risk assessments, group exercise classes, a home exercise program and follow-up support. We expect that the program can be successfully delivered as part of routine student clinical placements while maintaining high participant satisfaction and positive clinical outcomes. The findings will help improve the program and inform its future use in university health clinics.

This pilot study assesses the feasibility and preliminary efficacy of utilising hydrogen-rich water for adults with metabolic syndrome. Participants will be randomised to drink either hydrogen-rich water or a placebo daily for 12 weeks in a double-blind design. The primary objective is to evaluate trial feasibility by measuring participant retention and adherence to dosing. Secondary objectives include evaluating early changes in waist circumference, blood pressure, blood sugar, and cholesterol levels compared to the placebo group. It is hypothesized that the trial design will prove feasible and that preliminary data will show a trend toward reduced waist size, thereby supporting the design of a larger, fully powered future trial.

This study aims to evaluate the usability and clinical effectiveness of the VeinWise device, a portable, ergonomically designed handheld system that displays simplified pathways of veins reconstructed from ultrasound data. The primary objective is to assess the device's performance in facilitating vein visualization during peripheral intravenous cannulation (PIVC), which is one of the most commonly performed medical procedures. The study will not involve direct comparisons with other devices but will focus on assessing the standalone functionality and user experience of the VeinWise prototype in a controlled clinical environment. The novel ultrasound device that will be used for this study will be the VeinWise ultrasound device. This is a portable and handheld prototype that displays simplified pathways of veins reconstructed from continuous wave doppler ultrasound data. The prototype was assembled under ISO13485 Quality Management Systems and safety has been ensured through risk assessment.

This study will evaluate the acceptability, feasibility and possible effectiveness of the Choices model – a novel, fit-for-purpose model for supported and shared decision-making relating to decisions about medication in early psychosis care. This will be compared to standard care (control), which typically does not routinely include all the core elements of supported and shared decision-making. The study will recruit 56 young people aged 12-25 with early psychosis, will utilise rigorous scientific methodology (e.g., pilot cluster randomised controlled trial), and explore initial perspectives from stakeholders that may influence implementation.

We aim to recruit 157 cochlear implant recipients into this observational cohort study. At the time of surgery a small sample of cochlear fluid called perilymph will be collected as well as testing of electrical impedances and the cochlear response (ECochG). Perilymph samples will undergo sequencing of the non-coding RNA fraction (transcriptomes). Participants will be given the option to provide a blood sample for whole exome sequencing. The analysis will be combined with electrophysiological data derived from the implant in the 3 months following surgery as well as clinical outcomes of interest. We expect that expression analysis (miRNA) will correlate with genetic and electrophysiological data. We anticipate that these precision diagnostics will act as predictors of clinical outcomes.

Many children start school with health or developmental needs that are not identified early, particularly in families who experience barriers to accessing services. This study evaluates the Healthy Beginnings model, delivered in early childhood education and care centres, which includes screening, nurse-led care coordination and triage, follow-up support by health professionals, and education for parents and educators. The program will be compared with enhanced usual care, which provides screening, information, and guidance on accessing existing services. The main aim of this pilot study is to determine whether the program is feasible, acceptable, and practical to implement, and to inform a future larger trial. It is expected that the Healthy Beginnings model will improve early identification of children’s needs and help families access appropriate support more quickly compared with usual care.

This study aims to investigate the effects of fat content in a mixed-nutrient meal on muscle and adipose tissue microvascular blood flow (MBF) in healthy humans. We will compare the effects of low-fat vs high-fat content in a mixed-nutrient meal ( a liquid milkshake) on post-meal skeletal muscle and adipose tissue MBF healthy humans in a randomised crossover design.We will also measure gut-derived hormones and perform a correlation analysis with the MBF response. Hypothesis: We hypothesise that the low-fat mixed-nutrient meal will increase muscle and adipose MBF after the meal in healthy individuals, while the high-fat meal mixed-nutrient will not show this increase in MBF responses. We also hypothesise that levels of gut-derived hormones in the plasma will be correlated to MBF responses. Expected outcomes and significance: We aim to show that fat content within a mixed-nutrient meal is an important factor determining tissue MBF response and can affect the risk of cardiometabolic disease.