ANZCTR search results

Study purpose: The aim of this study is to determine if a new investigational radiopharmaceutical product used to perform PET scans can distinguish participants who are not responding to immune check point inhibitor (ICI) treatment from those that are responding. Who is it for? Participants with resectable, locally advanced or metastatic solid malignancy intended for immune checkpoint inhibitor therapy either alone or in combination with chemotherapy and/or radiotherapy. Study details: Participants will complete two CDI-DX001 PET imaging tests to assess tumour uptake of CDI-DX001. The first of these tests will be done within 14 days before ICI therapy is started and the second will be done 3-7 days after administration of the second dose of therapy (approximately 3-5 weeks later). Vital signs (heart rate, blood pressure, and temperature), a physical exam, and an ECG will be conducted on the day of each scan. Participants will otherwise undertake standard of care treatment as per their treating oncologist. It is hoped that the findings of this study may contribute to earlier identification of non-response to immune checkpoint inhibitor (ICI) therapy, reduce delays in initiating subsequent treatment strategies, and inform the development of novel therapeutic approaches.

The study examines whether thinking styles in the perinatal period are associated with unwanted thought birthing people commonly experience in this time. The second aim of the study is to examine whether a very brief (15-30 minutes) online training can change these thinking styles.

This study evaluates the feasibility and efficacy of focused ultrasound neuromodulation (SUS) for the treatment of agitation in individuals with Alzheimer's disease. The intervention involves the use of the UltraThera system investigational device. The study hypothesis is that SUS can modulate brain activity to reduce the behavioural and psychological symptoms of dementia by applying low-intensity ultrasound waves to specific areas of the brain involved in emotion and behaviour.

1. This study is an early-stage clinical trial in healthy adults to understand how safe XYL-2499 is and how the body handles it. 2. XYL-2499 is an investigational medicine that affects certain brain pathways and is being developed for possible use in mental health conditions. 3. Participants will receive either a single dose or multiple doses of the study drug or a placebo, with careful monitoring throughout the study. 4. Doctors will closely monitor participants for side effects, changes in mood or perception, and effects on thinking or behavior using standard tests. 5. The study uses small groups, step-by-step dosing, and close medical supervision to help ensure participant safety

Youth depression is a global crisis. One in five young people will suffer from depression by age 25 making it the number one cause of disability in Australia and severely disrupting the social and vocational transition of young people into adulthood. Most burden of depression is caused by recurring or chronic episodes. Although some people only experience transient depressive symptoms, for 50-60% of young people depression becomes a prevailing chronic mental disorder with lifetime recurring episodes. Currently, we have no way of differentiating these groups. Identifying who is at risk for persistent depression, and therefore needs more intensive treatment, monitoring, or relapse prevention during the crucial early stage of illness, is critical to preventing poor outcomes and reducing the exorbitant personal and societal burden and costs associated with depression. In this longitudinal naturalistic clinical cohort study we aim to develop prognostic models for time in depression/ depression relapse in young people. ~1200 young people seeking help primarily for depression at headspace services nationally will be recruited to participate and assessed at baseline and every 2-months during 18 months of follow-up on clinical, demographic, psychosocial and cognitive characteristics. Opt-in components of the study include saliva samples for DNA extraction and daily mobile surveys.

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.”