ANZCTR search results

Children who are supported on mechanical ventilation for a prolonged period of critical illness are at risk of developing respiratory muscle weakness which may lead to dependence on ventilatory support. Inspiratory muscle training (IMT) is a technique which has been proven in adults to help strengthen weakened respiratory muscles (such as the diaphragm and intercostal muscles) and may improve the success of liberating critically ill patients from mechanical ventilation (MV). This weakness can significantly impact the ability to wean from MV support and may subsequently lead to prolonged admissions to the intensive care unit, at a significant cost to the healthcare system (approximate cost per patient is in excess of $4000/day). Adult publications using IMT in prolonged ventilated patients have demonstrated several benefits, including increased inspiratory muscle strength, reduced weaning time from MV, and improved weaning success rates. It may also contribute to shorter ICU stays, as well as patient centered outcome measures such as reduced dyspnoea, physical function and improved quality of life (Bissett et.al, 2016, 2020, 2024). There are no published studies using IMT in children who are ventilated (non-invasive and invasive ventilation) despite the potential benefits of IMT in this patient group. This pilot trial aims to demonstrate that inspiratory muscle training (IMT) is safe and feasible for use in children who are ventilated (non-invasive or invasive ventilation).

This study is testing a new type of treatment called ARI0002h, which is a Chimeric Antigen Receptor T-cell (CAR-T) therapy. The purpose is to see whether ARI0002h is safe and effective for people with multiple myeloma whose cancer has come back or not responded after standard treatments. Who is it for? This study may be suitable for adults aged 18 to 80 years who have multiple myeloma that has returned or is not responding to treatment after at least two prior lines of therapy, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody. Participants need to have a reasonable general health (ECOG 0–2) and a life expectancy greater than 3 months. Study details All participants in this study will receive the investigational treatment ARI0002h. To create this therapy, a participant’s own T-cells (a type of immune cell) will be collected from the blood and modified in a laboratory to specifically target BCMA, a protein found on myeloma cells. Before receiving the therapy, participants will be given chemotherapy to prepare their body (lymphodepletion). Treatment with ARI0002h will then be given in three step-up doses over the course of one week. A second infusion may be given 3–4 months later if participants have shown at least some response, the disease has not progressed, and severe side effects such as high-grade cytokine release syndrome are not present. Blood tests and other assessments will be performed regularly to monitor safety and response. It is hoped that this study will show whether ARI0002h can help control multiple myeloma that has not responded to other treatments, and contribute to developing new treatment options for patients in the future.

The critical environmental thresholds that constitute the level of risk (i.e. low, moderate, high, extreme) for heat illness in popular extreme heat policies for long-distance running do not differentiate between distance categories (i.e. 5 km, 10 km, half marathon, marathon). The project aims to observe the physiological response of individuals competing across a 5 km, 10 km, and half marathon in a crossover study design. This will inform the evolution of these policies by contributing data to help decision makers determine if the environmental thresholds that determine risk should be adjusted across the various distances. We hypothesise that the difference in the core temperature response between the 5 km and 10 km trials, and the 5 km and 21.1 km trials will be statistically different.

To determine the effectiveness of the EPIK model of care versus usual care alone, for adults with persistent pain at 3 months following Total Knee Replacement (TKR) surgery, in improving knee-specific function and pain at 12 months post intervention. To determine the safety, cost-effectiveness, influence of treatment adherence on treatment effects, and potential for national implementation of the EPIK model of care versus usual care alone, for adults with persistent pain following TKR.

This research project is testing whether NTA-476, labelled with a radioisotope called Lutetium-177 (177Lu) can be safely given to patients with prostate cancer and to find out where it goes in the body once it is injected into a person. NTA-476 labelled with Lutetium-177 is called Lu-NTA-476. Who is it for? You may be eligible for this study if you are a prostate cancer patient at GenesisCare Murdoch in Australia. Study details Participants will receive a single intravenous injection of 177Lu-NTA-476 and then undergo 3 single-photo emission computed tomography (SPECT)/CT scans at 2-4 hours, 20-28 hours and 72-96 hours after the injection of 177Lu-NTA-476. These scans will be compared to the standard of care prostate specific membrane antigen (PSMA) PET/CT scans used for diagnosing prostate cancer. It is hoped that findings from this study will assist researchers with developing novel, more accurate modalities of imaging for the diagnosis and staging of prostate cancer which could be used for treatment of future prostate cancer patients.

PROFASTA-2 is a sub study of the randomised, controlled, crossover the original PROFASTA trial. This study (PROFASTA-2) will compare two short fasting methods in healthy adults: a strict water-only fast and a vegetable-based fasting diet that provides very few calories from vegetables. By testing both approaches in the same group of participants, researchers hope to understand how each type of fasting affects the body at a physiological and cellular level. The proposed study hypothesis is that both fasting methods will trigger similar beneficial biological responses.

This study aims to evaluate the feasibility and acceptability of delivering a food-based very-low-energy diet (VLED) as a strategy to support weight loss in adults with obesity. VLEDs provide fewer than 800 calories per day and are widely used to achieve rapid weight loss, such as before surgery or to manage weight-related health conditions. Traditionally, VLEDs rely on specially formulated meal replacement products (e.g., shakes, soups, bars). While effective, these products can present challenges for some individuals, including taste fatigue, limited variety, and difficulty maintaining adherence in social settings. This study will investigate whether an alternative approach - using everyday, conventional foods to deliver a nutritionally balanced VLED over 8 weeks - can be practical and acceptable. By using real foods, this intervention may improve adherence and satisfaction, while still achieving clinically meaningful weight loss in the long term. Importantly, this approach could broaden the use of VLEDs beyond formula-based products, offering a flexible option that can be integrated with other weight loss strategies, such as medications or bariatric surgery, while maximising nutritional adequacy under low energy intakes.

This randomized controlled trial evaluated the effect of the number of appropriate care alternatives in a choice set on clinical decision-making. Specifically, we investigated whether providing two or more alternatives influenced the odds that primary care physicians would shift from an existing management plan to an alternative or remain with the status-quo.

This study is being done to test the safety, tolerability, and how the body processes a new oral drug called FT2109 in healthy adults. FT2109 is being developed as a potential treatment for inflammatory diseases. The study will look at how the drug behaves in the body after taking different single and multiple doses, including the effect of food. The information from this study will help researchers decide if FT2109 is safe enough to be tested in future studies involving people with inflammatory conditions.

One in four strokes in Australia are repeat events. These repeat strokes are more likely to result in death and are costly, for both individuals and the healthcare system. Cardiac rehabilitation is a well-established, evidenced-based and widely available secondary prevention program that reduces disease risk and death from heart disease and could help prevent repeat strokes as both share similar risk factors. This 2-year pilot implementation trial will uses a pre-post trial design, conducted within the Canberra Health Service (Canberra and North Canberra Hospitals). The multi-component implementation strategy intervention will first be developed using implementation frameworks, data from our randomized trial and in consultation with stakeholders (stroke and cardiac rehabilitation clinicians, managers, patients). We will then assess the effectiveness of the implementation strategies (e.g., Digital Health Record (DHR) referral, clinician training) for improving clinician referral and delivery of cardiac rehabilitation to people who have had a TIA or mild stroke over 12-months. Implementation outcome (i.e., number people with TIA or mild stroke referred, commenced and completed the program) and process measures will be collected using hospital administrative data, clinician interviews, surveys, and observations of the clinical context. Results will guide the implementation of this novel program on a larger scale, identifying solutions to address the research-to-practice gap, rarely included in efficacy or effectiveness trials.