ANZCTR search results

This project aims to assess the acceptability and feasibility of embedding Physical Healthcare Navigator roles within multidisciplinary community mental health teams. Who is it for? You may be eligible for this study if you are 18 or older already accessing community-based mental health services from participating organisations and able to provide informed consent. Study details Those who are eligible will be provided with a four support sessions delivered by a designated navigator, who may be a peer worker, a carer with lived experience, or a mental health professional, and is embedded within a multidisciplinary community mental health team. Sessions are delivered in-person, online, or by phone according to participant preference and begin with a structured health needs assessment using the Neami Health Prompt. Following this assessment, navigators support participants to identify physical health screening and chronic disease management needs and assist them in navigating and accessing relevant health and preventive services. The navigator’s role is focused on coordination and service navigation rather than clinical care, with all health and mental health–related clinical decisions made by the treating mental health team or the relevant physical health professionals, such as general practitioners. It is hoped that the results from this study will help inform future efforts to increase health literacy with respect to accessing freely available cancer and other health screening checks. These findings will support future research and initiatives to address cancer outcome inequalities for people living with mental health conditions.

This research is likely to provide ‘proof of principle’ for a novel, ‘nutrient-based’ strategy – oral calcium supplementation – to reduce postprandial glycaemia in people with T2D by slowing gastric emptying, known to be integral to reductions in postprandial glycaemic excursions. The outcomes, if positive, will have major implications for the development of a novel, accessible, safe and cost-effective approach to the prevention and management of T2D.

Babies born very prematurely or with brain-related complications at birth are at higher risk of cerebral palsy. A specialised video assessment called the General Movements Assessment (GMA) can help detect cerebral palsy early. This study tests the usability of a smartphone app , Baby Moves VIEW, among 25 parents of high-risk infants. The app allows parents to record their baby's movements at home and securely send the video to a clinician for review.

This is a proof-of-concept study and is not formally powered for hypothesis testing. This is an exploratory, proof-of-concept, open-label study conducted in three independent cohorts (creatine/creatinine, phenylalanine, and tryptophan). Participants will be assigned to a cohort at screening. Participants may be enrolled into any cohort in a non-sequential manner; enrolment is not restricted to a predefined order. This flexible approach allows for parallel recruitment across cohorts based on eligibility and operational readiness. The cohorts consist of: • Cohort 1 = Administration of Creatine for monitoring of Creatinine • Cohort 2= Administration and monitoring of Phenylalanine • Cohort 3 = Administration and monitoring of Tryptophan The primary objective is to evaluate the ability of TDM monitoring patches to detect and continuously track target analytes in interstitial fluid (ISF). Secondary objectives are to assess the relationship between patch-derived signal and blood analyte concentrations and to evaluate device-to-device reproducibility across multiple patches Approximately 12 participants per cohort will be enrolled, with a total sample size of approximately 36 participants across the three cohorts. The sample size is considered sufficient to assess feasibility, signal detection, and variability.

This is Part 1 of a 2-part study to evaluate the safety, tolerability and efficacy of TO-O-1007 IVT implantation in the eye of participants with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). Part 1 of the study will test if it is safe to implant a low dose and then a higher dose of TO-O-1007 IVT in the eye of people with GA which is an advanced form of AMD and explore the effectiveness of the implant on GA progression. Age-related macular degeneration (AMD) is a disease of the macula, an area in the retina found at the back of the eye, needed for sharp, clear vision and activities such as reading and sewing. The advanced form of dry AMD is known as geographic atrophy (GA) (a region of the retina where the cells wither away and die). Sometimes, these regions of GA look like a map to the doctor who is examining the retina, hence the term “geographic atrophy.”

Brief description of the study purpose This is a first in human exploratory imaging study testing two new radioactive imaging agents designed to detect cancers that express a marker called the gastrin releasing peptide receptor (GRPR) in people with advanced or metastatic breast or prostate cancer. The study aims to assess safety, how the agents distribute in the body, radiation dose to organs and tumours, and how well they image cancer lesions. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older with advanced or metastatic breast or prostate cancer that has continued to progress despite standard treatments, who are well enough to take part in imaging scans. Study details Participants will receive one injection of a radioactive imaging tracer followed by multiple PET/CT scans on the same day. If their cancer shows uptake of the tracer, they may also receive a second, very low dose radioactive medicine followed by several SPECT/CT scans over the following days. Blood tests, vital signs checks, ECGs, and medical monitoring will be performed before and after the injections. The results from this study will help guide the future development of a GRPR targeted imaging and treatment approach, with the potential to improve how breast and prostate cancers are identified and treated in the future.

This study investigates how adults with metabolic syndrome respond to fibre-enriched meals. Participants will attend a clinic visit where standardised test meals will be consumed, followed by a home monitoring period. Blood samples and continuous glucose monitoring will be used to assess postprandial metabolic responses, including glucose and triglycerides. Additional data on diet, physical activity, and other individual characteristics will also be collected. The study aims to understand individual variability in metabolic responses to dietary fibre and to support the development of more personalised nutrition strategies.

Peripheral retinal ischaemia is strongly associated with the presence and severity of diabetic macular oedema (DMO), and ultra-widefield fluorescein angiography (UWF-FA) has demonstrated that peripheral non-perfusion is a key feature in eyes at risk of vision loss. Previous work (Hein et al., 2023) found that intravitreal aflibercept 2mg did not reverse or prevent progression of capillary non-perfusion in eyes with DMO. High-dose intravitreal aflibercept 8 mg has recently been approved and funded (TGA-approved and PBS-listed) for treatment of DMO, and is now used as standard-of-care in appropriate patients at our centre. Clinical trial and real-world data indicate that aflibercept 8 mg provides robust efficacy with a safety profile comparable to aflibercept 2 mg in DMO, with the potential to improve disease control and reduce treatment burden through extended dosing intervals. Given the greater pharmacodynamic effect of the 8 mg dose, it is plausible that aflibercept 8 mg may attenuate the natural course of retinal ischaemia progression in patients receiving treatment for DMO; however, its impact on retinal non-perfusion has not yet been systematically characterised.

This study will investigate whether vaginal probiotic supplementation (Amelia V-Spot) improves pregnancy outcomes in women undergoing frozen embryo transfer (FET) treatment as part of in-vitro fertilisation (IVF). Women under 45 years of age with a genetically tested normal (euploid) embryo undergoing FET will be randomly assigned to receive either a vaginal probiotic or placebo treatment. The main objective is to determine whether vaginal probiotics improve clinical pregnancy rates with FET. Secondary outcomes include ongoing pregnancy rates, miscarriage rates, live birth outcomes, changes in the vaginal microbiome, and any treatment-related side effects. The study will be conducted at an IVF centre in Sydney, Australia, with industry funding from Amelia Bio.

This single-site pilot will assess the implementation of a digitally enabled care model for adults with type 2 diabetes delivered through the Brisbane South Community Diabetes Service (BSCDS), Metro South Health. Participants will use a Bluetooth-enabled glucose meter with the Health2Sync app to upload glucose readings for clinician review in a secure dashboard. The model supports timely follow-up, workflow integration and patient self-management. Outcomes focus on feasibility, acceptability and workflow impacts, particularly in a population with higher socioeconomic disadvantage and culturally and linguistically diverse representation.