ANZCTR search results

In Australia and New Zealand, blunt splenic injury is common and splenic artery embolisation (SAE) has been shown to be an effective method of controlling bleeding and preventing splenectomy. There is now short- and long-term data on splenic function after SAE. However, recent studies show that management of patients remains heterogenous, with many not undergoing any form of splenic function testing. This study aims to use a modified Delphi process to standardise post-SAE governance in the Australia and New Zealand region. The study investigators wish to form a team to undertake a 2-4 round modified Delphi process (online via email surveys) to focus on the following key areas: • Patient preparation • Treatment governance • Post-care • Follow-up • Vaccinations and antibiotics • Quality and research The study will include a balance of different specialists who are experts in the field. Societies to be invited include: IRSA, Spleen Australia, ANZAST, and ANZTS. This group will then determine relevant questions and answers relating to post-SAE governance and follow-up. The results will inform a guideline which is aimed to be endorsed by the involved societies, and will inform and standardise future practice in the region.

A Phase 1 study, multiple dosing to evaluate the safety, tolerability and pharmacokinetics of oral administration of RTX-101 and RTX-111 in participants with C9orf72 ALS. The study is the first clinical administration of combinations of RTX-101 and RTX-111 to be conducted in participants with C9orf72 ALS. This study includes Part 1C: open-label treatment for participants with C9orf72 ALS.

DietAR is a novel dietary assessment tool, developed by researchers at the University of Melbourne, that uses advanced image analysis and 3-dimensional reconstruction techniques to assist with estimating food portions and nutritional information. This pilot study will recruit 25 adults with type 1 diabetes in a randomised crossover study to evaluate how accurately DietAR estimates food portions and carbohydrate content, and how users experience the app in a real-world setting. Participants will attend three visits to the university, consume standardised test meals, and provide feedback on their experience using the app. The primary outcome is the accuracy of carbohydrate estimation, while secondary outcomes include user experience and app usability assessed through validated scales. By incorporating co-design principles, this study aims to evaluate how well DietAR works in real-world settings and gather insights to improve the app for regular use by people with type 1 diabetes.

Trial to explore depth of anaesthetic and quality of recovery through randomising patients to a low or standard bispectral index (measurement in theatres to determine how "deeply" unconscious a patient it using EEG electrodes). Patients will be followed up for quality of recovery pain, nausea and vomiting as well as post-anaesthetic surveys at 24 hours and 7 days. Additionally, blood samples will be collected and analysed for hormone levels.

This study is investigating whether the medicine exenatide (MTF-3110) can help preserve the body’s natural insulin production in people with latent autoimmune diabetes in adults (LADA). LADA is a form of diabetes in which the immune system gradually damages the insulin-producing cells of the pancreas. Over time, this leads to reduced insulin production and the need for insulin therapy. Exenatide is a medication that mimics a natural hormone called GLP-1, which helps regulate blood sugar levels by increasing insulin release when glucose levels are high, slowing stomach emptying, and reducing appetite. Researchers believe that treatment with exenatide may help protect or preserve the remaining insulin-producing cells in people with LADA. In this study, participants will receive exenatide injections twice daily for 26 weeks. Researchers will measure how well the pancreas produces insulin using a mixed meal tolerance test, as well as monitor blood glucose levels, diabetes control, and safety outcomes during the study. The main hypothesis is that treatment with exenatide for 26 weeks will preserve insulin-producing beta-cell function, as measured by stimulated C-peptide levels, in adults with LADA. The findings from this study may help determine whether exenatide could be a useful treatment to slow the progression of LADA and delay the need for insulin therapy.

This project aims to examine whether a 12-week combined Pilates & Progressive Resistance Training (PRT) plus education intervention for adults with osteoporosis (OP) improves quality of life, mental health, pain and other health outcomes. The research questions that this study seeks to address are: 1. In people living with OP, a combined Pilates & PRT plus education intervention will improve quality of life, mental health and pain when compared to a Pilates and education and waitlist-control group over 12 weeks. 2. In people living with OP, a Pilates plus education intervention will improve quality of life, mental health and pain when compared to a waitlist-control group over 12 weeks.

This is a global, prospective, longitudinal, non-interventional, multi-center study to collect participant and physician satisfaction, and treatment experience with Relfydess in routine clinical practice. The primary objective of the study is to evaluate participant satisfaction after three treatment cycles with Relfydess in the GL and/or LCL..

This is a double-blind, placebo-controlled, First-In-Human Study of the safety, tolerability, pharmacokinetics of LW-1017 in Healthy Volunteers. Who is it for? You may be eligible for this study if you are aged between 18 to 55 years old and are in good general health without a clinically significant medical history. Study details Healthy volunteers will be randomly assigned to receive single oral doses of LW-1017 or matching placebo under three separate conditions starting on Day 1 (Period 1; under Regimen A fed condition), Day 8 (Period 2; under fasted conditions), and Day 15 (Period 3; under Regimen B fed condition) (3 doses total). Participants will undergo regular safety assessments, including vital signs, blood and urine tests, and other clinical evaluations. The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics of LW-1017 and to identify dose levels suitable for future clinical studies. If results are acceptable, subsequent studies may evaluate LW-1017 in patients with Alzheimer’s disease or Parkinson’s disease.

This trial aims to improve care for young people with obsessive–compulsive disorder (OCD) in community mental health services. It compares two evidence-based models of cognitive-behavioural therapy with exposure and response prevention (CBT-ERP): a standard approach and a stronger, more intensive approach that includes additional parent training and longer ERP sessions. Both models are expected to reduce OCD symptoms, with the stronger model leading to greater improvements for some young people. The study will also evaluate how well clinicians can learn, deliver, and sustain high-quality CBT-ERP after receiving tailored training and supervision. By improving the detection, assessment, and treatment of OCD, this project aims to increase access to effective care for young people and their families.

This feasibility study is aimed at testing the feasibility and acceptability of the ‘You-can-do-it: Successful Ageing’ Massive Open Online Course (MOOC). The MOOC has been developed at Curtin University in collaborations with researchers from Monash University, City University of New York and Boise State University. It was co-designed with partner organisations and consumers (including older adults and allied health students from Curtin University). This feasibility study will be followed by a wait-list randomised controlled trial where health literacy and ageism will be evaluated pre and post MOOC completion.