ANZCTR search results

This study is a staged feasibility and pilot RCT evaluating a brief, self-directed, online Earth care intervention designed to support the mental health and well-being (MHWB) of adults experiencing ecological distress. In this study, ecological distress is defined as persistent, negative emotional responses related to climate change and environmental degradation. The intervention is informed by relational values and Tronto's (2013) stages of care, reframes ecological distress as morally important information, and supports participants in translating their distress into adaptive, locally relevant acts of care. The study follows the Medical Research Council's (MRC) framework for designing and evaluating complex interventions and includes pre-pilot testing, a randomised waitlist-controlled trial, and an embedded process evaluation. Outcomes focus on feasibility, acceptability, psychological and ecological distress, self-efficacy for environmental action, mental well-being, and human-nature relationships.

This study aims to improve the healthiness of food and drink options available in sports and recreation settings. Many food outlets in these settings sell unhealthy food and drinks, which can influence people’s food choices and contribute to poor diet and health. The study will test whether providing food retailers with a suite of digital tools can help them make healthier changes. These tools will support retailers to assess their current food offerings, receive tailored recommendations, and monitor progress over time. Food outlets will be randomly assigned to either use the digital tools or continue with their usual practices. The study will compare changes in the availability of healthier drinks and food options, as well as purchasing patterns. It is hypothesised that food outlets using the implementation-supporting digital tools will increase the proportion of healthier food and drink options available and may improve purchasing patterns compared to those continuing standard practice. The findings will help determine whether digital tools can support healthier food environments in community settings and inform future public health strategies.

This study aims to improve the management of patients admitted to the Hospital in the Home (HITH) program with heart failure by integrating lung ultrasound into clinical assessment and treatment decisions. Lung ultrasound is more accurate than physical examination or chest X-ray in detecting pulmonary congestion, which means detecting fluid in the lung that is often missed using conventional methods. Studies have shown that incorporating lung ultrasound significantly improves fluid detection, leading to better-guided therapy. To generate the necessary evidence for implementing this technique, this study will compare standard heart failure management with an approach that incorporates lung ultrasound. A total of 110 participants will be enrolled, with half receiving lung ultrasound and the other half following usual care. Key outcomes, including hospital readmission rates, length of stay in the HITH program, and medication adjustments, will be assessed and compared between groups. This research will provide valuable data on the potential benefits of lung ultrasound in optimising heart failure treatment in home-based care settings.

Brief description of the study purpose This study aims to find out whether the medication olanzapine can help reduce weight loss in people with head and neck cancer receiving combined chemotherapy and radiotherapy given with curative intent. Who is it for? You may be eligible for this study if you are male or female age 18 or over, with head and neck cancer who are planned to receive combined chemoradiotherapy, are able to eat by mouth, and are well enough to take part. Study details Participants in this study will take olanzapine 2.5 mg by mouth once daily for 12 weeks, starting up to two weeks before chemoradiotherapy and continuing during and after treatment. All participants receive active treatment with olanzapine in addition to their standard chemoradiotherapy; there is no randomisation. Outcomes will be compared with past patients who received standard care alone. Participants will have regular clinical assessments, including monitoring of body weight, symptoms, and routine blood tests as part of their cancer treatment. It is hoped that the results from this study will show whether olanzapine is safe and can help reduce weight loss in people with head and neck cancer receiving combined chemotherapy and radiotherapy.

The DExTROCord Study aims to investigate if hormones that control blood sugar levels collected from umbilical cord blood can predict the risk of hypoglycaemia in the first 24 hours of life and hyperglycaemia in the first 7 days of life in preterm infants. Preterm infants are at risk of having dysglycaemia after birth, which can affect their childhood neurodevelopmental outcomes of babies or lead to issues during their admission in the internsive care unit. Being able to predict which babies will eventually have hypoglycaemia and hyperglycaemia will optimise their management and prevent these adverse outcomes. There have been no other studies that have investigated whether hormones collected from the umbilical cord blood of babies are associated with dysglycaemia. Therefore, the results of the DExTROCord Study will advance the knowledge in this research area.

Troponin blood tests are essential for diagnosing heart attacks, but in some people the results can appear falsely elevated because of laboratory interference such as macrotroponin, even when there is no true heart damage. Macrotroponin is an under-recognised condition where troponin binds to other proteins in the blood, leading to persistently high troponin levels that may result in unnecessary hospital admissions, investigations, and anxiety. This study focuses on patients with suspected Myocardial Infarction with Non-Obstructive Coronary Arteries and ongoing elevated troponin levels, where test interference may be mistaken for genuine heart injury. Around 200 participants will undergo additional blood testing using different troponin assays and complete short health questionnaires to determine how often macrotroponin occurs and its clinical impact. The findings may improve recognition of false-positive troponin results and help reduce unnecessary procedures, healthcare costs, and patient distress in the future.

Delirium is a medical condition characterised by abnormal functioning of the brain. Symptoms include confusion, poor attention, sleep disturbances, and agitation. Delirium commonly develops in hospitalised patients, particularly those who are elderly or indigenous. Patients with delirium are more likely to develop dementia, require care in a nursing home or even die. Intranasal insulin is an emerging novel therapy which has been successfully used to reduce the occurrence of delirium in post operative surgical patients. Intranasal insulin produces minimal systematic effect and has been shown not to impact blood glucose levels. It has been previously studied and shown to positively impact delirium duration in older geriatric in-hospital patients. There is currently a trial at the Prince of Wales hospital examining the effect on occurrence of delirium in orthogeriatric population. This study will investigate whether twice daily intranasal insulin reduces the occurrence of delirium in older critically ill patients in intensive care, a group that is known to be at high risk of delirium.

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.