ANZCTR search results

In this randomised, double-blind, placebo-controlled study, 100 adults aged 18 to 60 years experiencing high perceived stress will be randomly assigned to receive an Aframomum melegueta seed extract (Vanizem) or a matching placebo for 28 days. Changes in self-reported perceived stress, anxiety, general mood, sleep quality, and fatigue will be assessed over time. Moreover, to examine potential mechanisms of action, changes in heart rate variability as well as blood and salivary markers associated with stress, mood, sleep, and cognitive function will be evaluated.

Lactose intolerance results from reduced activity of the lactase enzyme, leading to incomplete digestion of lactose and fermentation by gut microbiota, which can produce symptoms such as bloating, pain, and discomfort. While lactose malabsorption is common globally, symptoms occur in only a subset of individuals and self-reported lactose intolerance often does not align with objective clinical diagnosis. Lactose-free milk products have been developed to address lactose malabsorption, however, research shows inconsistent effects on gastrointestinal symptoms. Emerging evidence suggests that intolerance symptoms attributed to lactose may also be influenced by other milk components, particularly the A1 beta-casein protein. This study will investigate the effects of A1-protein-free lactose-free milk compared with conventional lactose-free milk in individuals with self-perceived lactose intolerance. Outcomes will include gastrointestinal symptoms and markers of inflammation and immune response. The study hypothesises that A1-protein-free lactose-free milk will improve tolerance and reduce symptoms compared with conventional lactose-free milk, while maintaining the nutritional benefits of dairy consumption.

The human nervous system exhibits neuroplastic adaptations in response to strength training, which enhance muscle force production. Neuroplasticity refers to the ability of the neuromuscular system to modify its function in response to physical activity, often involving reorganisation within the primary motor cortex that controls movement. Strength training has been shown to induce such plastic changes; however, limited evidence exists regarding how training affects the neural pathways connecting the neuromuscular system and skeletal muscle. Although the corticospinal pathway has been extensively studied in motor control and is considered one of the main sites of neural adaptation following resistance training, the role of other descending motor pathways, such as the reticulospinal pathway, remains largely unexplored in humans. It is also unclear whether strength training can modify the function of this pathway. Therefore, this project will investigate the effects of strength training on the modulation of neural systems, particularly the corticospinal and reticulospinal pathways, as well as motor unit behaviour, using non-invasive neurophysiological techniques. This research will provide new insights into neural adaptations and their contribution to training-induced increases in force output.

The purpose of this study is to assess the acceptability and effectiveness of using a vaginal pessary in post-partum women at high risk of developing prolapse. The study seeks to determine if wearing a vaginal pessary after delivery can reduce the severity and/or the development of prolapse. The pessary will be well tolerated and the support provided to the pelvic organs by a vaginal pessary used in the early post-partum period will facilitate the healing of damaged pelvic organ supporting structures and reduce the prevalence and/or severity of subsequent POP.

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.