ANZCTR search results

Semaglutide is a long-acting GLP-1 analogue used in the treatment of patients with type 2 diabetes (T2D), and has shown to improve glycaemic control and result in meaningful weight loss. The drug has a well described safety profile including a low risk of hypoglycaemia. Tirzepatide is a glucagon-like peptide 1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, and has robust glucose-lowering and weight loss effects. This short duration pilot study will compare the biological activity of a single dose of 4 mg of oral semaglutide with 25 mg oral tirzepatide, both in Diabetology’s Axcess formulation. Five healthy volunteers will receive 4 mg of the encapsulated semaglutide on an empty stomach with a glass of 100 mL of water, on Day 0. Five additional healthy volunteers will receive 25 mg of the encapsulated tirzepatide on an empty stomach with a glass of 100 mL of water, on Day 0. Each participant would also receive a placebo 2 days prior to this (Day -2). Both the placebo and the semaglutide or tirzepatide will be administered at the same time of day, in a fasting state. An intravenous glucose tolerance test (IVGTT) will be conducted two hours after placebo and treatment, before any food is consumed. The IVGTT will also be performed at approximately the same time on days 1, 4 and 6 post-treatment. The primary aim of the study is to determine whether a single dose of orally delivered encapsulated semaglutide or tirzepatide is associated with a difference in plasma blood glucose levels during an intravenous glucose tolerance test (IVGTT). The secondary aims are to 1) explore changes in serum insulin during an IVGTT, and 2) to explore the duration of action over a span of 7 days.

A single-case experimental design with multiple baselines across participants will be conducted to evaluate the effects of self mobilisation exercises on pain-related grip measures in individuals with lateral elbow tendinopathy. In this study, participants will be assigned to a randomised baseline monitoring period (7, 10 or 13 days) before commencing the intervention. Staggering the introduction of the intervention across participants at different timepoints allows the treatment effect to be distinguished from natural symptom fluctuation or spontaneous recovery. The primary and secondary outcome measures will be measured daily throughout the baseline (7-13 days) and intervention (14 days) periods and at a single 2-week follow-up timepoint. In this study, it is hypothesised that the self mobilisation intervention will improve pain-free grip strength and reduce pain ratings at different grip loads across participants when comparing the baseline phase to the intervention and follow-up phases.

The utilization of advanced 3D planning and patient specific instrumentation is rapidly increasing in the total hip arthroplasty (THA) market in Australia. Accuracy and precision are expected for these tools, yet is not well documented. This research is required to guide surgeon decision-making in the selection of appropriate THA preoperative planning methods. This study is designed to provide an objective assessment of the accuracy and precision of FORMUS LABS Pre-op Planning and OSSIS Patient Specific Instrumentation (PSI) for primary THA.

This prospective pilot study aims to evaluate the sleep staging and sleep apnoea detection capability of the Somfit device in children. Twenty children will undergo simultaneous in-hospital polysomnography and Somfit overnight sleep assessment. Children less than four years of age will be excluded. Additionally, patient/parent feedback will be sought. This is a single centre study.

This study aims to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 to detect known tumour deposits in patients with locally advanced or metastatic epithelial cancers, including ovarian cancer, breast cancer, bladder cancer and pancreatic cancer. Who is it for? You may be eligible for this study if you are an adult with locally advanced or metastatic (cancer that has spread to other organs) ovarian, breast, bladder or pancreatic cancer with a visible tumour on diagnostic imaging. You may also be asked to provide a tumour sample for testing to ensure that you are eligible for this study as it is targeting tumours that express a specific cell surface receptor (CUB domain-containing protein 1). Study Details All participants who meet the eligibility criteria in this study will receive a single dose of 89Zr-hu/mo-10D7 as an intravenous infusion over 30 minutes to deliver a maximum dose of 37 MBq of 89Zr-labelled antibody. During and after completion of the treatment participants will be assessed for safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 via vital signs, blood tests, ECG, urinalysis and PET/CT scans. Participants will be asked to attend a minimum of 5 study visits, with the imaging and tests described above to be completed at each visit. It is hoped that this research project will demonstrate 89Zr-hu/mo-10D7 targets locally advanced and metastatic ovarian, breast, bladder or pancreatic cancers in humans and therefore prove its potential utility as a theranostic in these cancers.

This research study aims to examine the effects of a multi-level school-based sleep health intervention: ‘Sleep Ninja for Schools’, designed to improve sleep knowledge and behaviours among students in Years 5 to 8. Implementation factors including the acceptability, appropriateness and feasibility of delivering the stepped support model in schools will also be explored. The intervention includes three main components: (1) Delivery of a universal sleep health education program to students in Years 5 to 8 by their regular class teacher, with accompanying educational resources provided to parents. (2) Training of school wellbeing staff in assessment, support, and referral options for students with significant sleep disturbances. (3) Screening for sleep disturbances in students, with stepped support provided for students who report subthreshold or significant sleep disturbances. Hypotheses: (1) Students who participate in the sleep education program will demonstrate improvements in sleep knowledge relative to a control group; (2) The classroom program will be rated as acceptable by students and teachers. All other outcomes are exploratory and no specific hypotheses are proposed.

CIRCA DIEM KIDS is a prospective observational follow-up at 5-8 years of children born before 32 weeks of gestation who were enrolled in the CIRCA DIEM Study (ACTRN12618000371291) during their initial hospitalisation after birth. The CIRCA DIEM study (ACTRN12618000371291) aimed to determine whether cycling light and noise during initial hospital care improve brain development and overall well-being compared with routine care with constant levels of light and noise during both daytime and nighttime. This follow-up study aims to establish if exposure to this cycled environmental care in the neonatal period has longer term benefits including improved intellectual performance at 5-7 years, and improved vision, hearing, breathing, sleep, school performance and general quality of life.

This study aims to evaluate a new, accessible treatment approach for children with obsessive–compulsive disorder (OCD). The program, called FAST-ERP, supports parents to learn practical skills through online modules and telehealth sessions so they can help their child manage OCD symptoms at home. FAST-ERP will be compared to the current gold-standard treatment, where children receive individual cognitive behavioural therapy (CBT) with a clinician via telehealth. The study will assess whether FAST-ERP is as effective (non-inferior) as standard CBT in reducing OCD symptoms and improving children’s daily functioning.

To characterise current ventilatory practices and adherence to low tidal volume ventilation (LTVV) in the management of patients with acute hypoxaemic respiratory failure (AHRF) receiving invasive ventilation in intensive care units in Australia and New Zealand.

The purpose of this study is to assess how safe and effective elranatamab is in treating newly diagnosed systemic AL amyloidosis. You may be eligible to participate if you are 18 years of age or older, have been recently diagnosed with this condition, and have not yet received any treatment. If you join the study, you will be given elranatamab as an injection under the skin for up to 6 treatment cycles, with each cycle lasting approximately 28 days. Throughout the study, your health will be carefully monitored to assess how you respond to the treatment and to identify any potential side effects. Following completion of treatment, you will attend follow-up visits every three months for up to five years. The purpose of this study is to determine whether elranatamab can slow or stop the progression of the disease, and whether it's safe to have it.