ANZCTR search results

A randomised within-subject feasibility crossover study investigating the immediate effects of footwear designed to reduce toe walking on gait characteristics, heel contact, comfort and acceptability in children with idiopathic toe walking and toe walking associated with Autism Spectrum Disorder

Brief description of the study purpose: This pilot study aims to identify whether a two-step risk screening pathway can accurately detect early, often symptom-free heart dysfunction that may occur after cancer treatment. Who is it for? You may be eligible for this study if you are male or female age 40 years or older, who have completed cancer treatment that may affect the heart (such as chemotherapy, radiotherapy to the chest, or targeted therapies) and are eligible for Medicare. Study details: Participants will attend a single study visit. No treatment is given as part of this study. At the visit, participants will first complete a clinical risk questionnaire (CHERISH) that estimates their risk of heart failure. They will then undergo a standard 12-lead electrocardiogram (ECG), which is analysed using an artificial intelligence program to estimate the chance of early heart dysfunction. All participants will also undergo a standard heart ultrasound, which measures heart function and is used as the reference test. There is no therapeutic intervention, and the screening results are not used to guide clinical care during the study. It is hoped that the findings will help design a larger multicentre study and could support scalable, low-cost heart screening for cancer survivors and other high-risk groups.

This is Part 2 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 2 of the study is randomised to provide either a sham/ placebo or one of two dose levels of TO-O-1007 IVT to study participants. This will provide data on the safety and effectiveness of implanting a 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 summary Bronchiolitis is a common chest infection in infants and some babies need short-term hospital observation in an Emergency Department Short-Stay Unit. This study will test whether selected infants with mild bronchiolitis who need short-stay observation can be safely cared for at home through a virtual Emergency Department Short-Stay Unit model. Infants in the virtual care group will receive hospital-level care at home using wearable monitoring devices that continuously measure oxygen levels, heart rate and breathing rate. They will also receive regular virtual nursing observations, daily paediatrician-led virtual ward rounds and 24-hour access to the virtualKIDS clinical support line. This will be compared with usual care in a physical hospital Emergency Department Short-Stay Unit. The main purpose of the study is to determine whether virtual short-stay care at home is not worse than hospital short-stay care in terms of the need for oxygen treatment within 7 days. The study will also look at safety, hospital re-presentations, length of stay, family and clinician experience, and costs. Study hypothesis We hypothesise that, for carefully selected infants with mild bronchiolitis, virtual Emergency Department Short-Stay Unit care at home with wearable monitoring and regular clinical review will be non-inferior to physical Emergency Department Short-Stay Unit admission, as measured by the need for oxygen therapy within 7 days of randomisation.

People with anorexia nervosa often restrict food even when it causes serious harm, but current treatments help fewer than half of those affected. This project aims to understand why the drive to avoid eating becomes so strong. Instead of assuming people with anorexia nervosa simply don’t find food rewarding, the study explores whether avoiding calories may itself feel rewarding. To investigate this, researchers will use a device that delivers tiny amounts of real food during brain scans, allowing them to study how the brain responds during actual eating rather than just looking at pictures. The study will also examine hormones and gut bacteria, which may influence appetite, stress, and decision-making around food. People with lived experience have helped shape the study to ensure it is safe and acceptable. Ultimately, the goal is to uncover the biological mechanisms that sustain self-starvation and identify different subgroups who may benefit from tailored treatments.

Tinnitus can severely affect a person’s quality of life, and although there are ways to manage it, clinicians are not sure how well treatments work and which treatment an individual would respond to best. This is because tinnitus and how it affects individuals are sometimes very subjective and difficult to describe reliably. Our research group has previously demonstrated that a non-invasive brain imaging technique called functional near-infrared spectroscopy (fNIRS) can detect tinnitus-related changes in brain activity. This research project now aims to perform fNIRS measurements on people with tinnitus before and after starting a new treatment. This would allow us to assess how changes in our measurements compare with changes in individuals’ subjective ratings of their tinnitus. The treatment is a digital therapeutic for tinnitus management, accessed via a smartphone app called Oto. Oto aims to assist people to adjust to their tinnitus and therefore reduce tinnitus associated distress.

This randomised controlled trial aims to determine the efficacy of a coach-supported online cognitive training program for preventing PTSD and depression in early career Defence personnel. The study involves an active, experiential preventative intervention that develops practical evidence-based skills through exercises and videos, with opportunities to apply and test acquired strategies across six weekly modules. The study includes a standard practice condition in which participants can access standard support services as needed. Participants will complete questionnaires at baseline, post-intervention, and at one-year follow-up to measure PTSD and depression symptom severity and track rates of probable PTSD and depression.

This study will use a single-case experimental design (SCED) to investigate the feasibility and preliminary effectiveness of ENVIRO, a co-designed environmental cognitive rehabilitation intervention for adults with traumatic brain injury (TBI). A multiple-baseline A-B design across behaviours will be used, with up to three tiers, staggering the introduction of the intervention across three target behaviours of each participant. Prior to baseline, participants will undergo a brief cognitive assessment and clinical interview. Participants will then collaboratively establish up to three rehabilitation goals with a clinician. Goals will be operationalised using Goal Attainment Scaling (GAS) and associated target behaviours will be identified. Baseline will involve repeated measurement of each target behaviour, with baseline durations staggered across behaviours (two, three, or four weeks). The intervention phase will involve the sequential introduction of the ENVIRO intervention framework to each target behaviour over six weeks. An up to eight-week maintenance phase will follow, including a one-hour booster session. It is hypothesised that using the ENVIRO intervention will assist participants to make progress towards their goals, and will be a feasible and acceptable approach for people with TBI and their close others.

This is a Phase II, prospective, randomised, double blind, placebo controlled, parallel group study. Approximately 40–60 participants will be randomised 1:1 to receive either: • E2Spine (autologous SVF) suspended in Plasma Lyte, or • Plasma Lyte placebo. All participants undergo adipose tissue harvest and SVF processing to maintain blinding. Treatment consists of combined image guided intradiscal and ipsilateral facet joint injections at the symptomatic lumbar level(s). Participants are followed for 12 months, with an optional descriptive extension to 24 months. The study hypothesis, in plain language: We believe that a single treatment using a person’s own fat-derived cells, injected into the affected areas of the lower spine, may reduce long-term low back pain and improve daily function more than placebo treatment, while remaining safe and well tolerated.

This multi-site randomised controlled trial will test whether adding an online stoma-specific core-strengthening exercise program, Convatec Me+Recovery®, to standard stoma support garment use helps prevent parastomal hernia or delays the time to parastomal hernia after stoma formation. The study will recruit 450 adults with a new stoma across Australian hospitals/services. Participants will be randomly allocated 1:1 to either stoma support garment alone or stoma support garment plus the Convatec Me+Recovery® program. Participants will complete monthly online surveys and attend routine Stomal Therapy Nurse reviews for up to 24 months. The main outcome is time to diagnosis of parastomal hernia.