ANZCTR search results

The single group assignment, open label, clinical trial will enroll up to 30 participants with the goal of at least 20 participants completing the yearlong study implant duration. Enrolled Participants will have the CBGM system implanted via a 20–30-minute procedure. Post procedure, after the initial 14-day post implant assessment, Participants will undergo In-Clinic visits every few months during their yearlong implant duration that include both safety and performance assessments of the CBGM System. Outside of the clinic, Participants will complete a minimum of 3 fingerpicks per day (with a study provided commercially approved BG meter and supplies, carry a study phone to collect investigational sensor data (data is blinded to the participant) and complete a study diary. Removal of the CBGM System will be similar to the implant procedure. A final 14-Day post removal visit will occur to follow-up with the participant to assess the wound. If there are not outstanding safety events or items for follow-up, this will be considered the participants final visit and they can safely exit the study.

This study will use a combined multiple-baseline with reversal single-case experimental design (SCED) to evaluate the efficacy and feasibility of a virutal reality walking intervention. The study will use an ABABC design. A refers to the non-intervention phases, B will be the intervention phases. C phase will be used as an assessment of feasibility. The duration of each phase will be Baseline(~2-3wks), Intervention1 (4wks), Wash out (~3-4wks), Intervention2 (4wks), Follow-up (2wks). . We will measure changes in pain, and wellbeing as well as feasibility through questionnaires before and after the intervention. The results will help us understand whether this type of intervention is effective and feasiblity in the medium to long term for people with SCI-related NP. We hypothesise that VRWalk will have positive long-term effects on NP intensity. Additionally, we hypothesise that VRWalk will be feasible.

The iROAR registry is a prospective, multicentre observational study designed to evaluate the real-world effectiveness of low-dose radiotherapy (LDRT) in adults with symptomatic osteoarthritis across Australia. Participants receiving standard-of-care LDRT will be followed for up to 24 months to assess changes in pain, physical function, and health-related quality of life using validated patient-reported outcome measures. The primary objective is to determine the proportion of treated joints achieving a clinically meaningful response at 6 months based on OMERACT-OARSI criteria. Secondary outcomes include long-term clinical response, safety, retreatment rates, and healthcare utilisation outcomes associated with LDRT. The registry aims to generate the first prospective Australian dataset to inform clinical practice, treatment standardisation, and future research on LDRT for osteoarthritis.

ISLAND hypothesises that a public health approach to dementia prevention can reduce modifiable risk factors in the Tasmanian community. Our novel approach to dementia prevention involves a combination of education with positive lifestyle change. We have shown that our public health approach has efficacy to reduce modifiable risk factors in the Tasmanian community.

Metformin is the first-line glucose-lowering medicine in most clinical guidelines on the management of type 2 diabetes. Standard advice has been to take metformin with meals. However, recent evidence suggests that taking metformin an interval before each meal may work better for lowering blood glucose after the meal. In this study, we will test whether taking metformin 60 min before meals improves glucose-lowering after each meal, compared to taking it with meals in people with type 2 diabetes.

This study is a prospective, multicentre, first-in-human study to evaluate the safety and effectiveness of the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System in subjects with symptomatic, severe calcified mitral stenosis. Eligible participants who meet all inclusion and exclusion criteria and provide informed consent will undergo a transcatheter mitral valve lithotripsy (TMVL) procedure using the VTL II System. The procedure is performed via a trans-vascular approach in a catheterisation laboratory or a hybrid suite, where lithotripsy (soundwaves) pulses are delivered to modify calcified mitral valve tissue. Additional balloon mitral valvuloplasty may be performed at the operator's discretion. Participants will receive standard post-procedural care and be followed during hospitalisation and at discharge. Follow-up assessments will occur at discharge, 30 days, 6 months, and 12 months post procedure. Study exit occurs at 12 months following the index procedure.

This study is being conducted to see if using ultrasound is a reliable way to check for any remaining air around the lung after a chest drain has been removed in people who have been injured. Currently, after a chest drain is taken out, patients usually have a chest x-ray to check for any remaining air or lung collapse. In this study, you will have the usual chest x-ray, but we will also do a quick ultrasound at your bedside to check your lungs. This will help us find out if ultrasound works just as well as an x-ray for spotting any remaining air or lung collapse. If ultrasound works just as well as a chest x-ray, it could mean patients won’t need to be moved to the radiology department for an x-ray and they will also avoid the small amount of radiation that comes with x-rays.

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.”