ANZCTR search results

This pilot project aims to assess if conducting a study comparing administration of non-steroidal anti-inflammatory drugs, benzodiazapines and no intervention is feasible. The study is being undertaken in patients older than 60 who are having major surgery (not involving the heart or the brain). Study participants will be randomly allocated to one of three treatment groups, non-steroidal anti inflammatory, benzodiazepine or no intervention. Participants will also be asked to undergo delirium assessments for the first 3 post-operative days. If this pilot study is able to be completed with minimal deviations to the protocol and a good participant recruitment rate, a larger study will be undertaken. The larger study will assess the rate and severity of post-operative delirium - a type of temporary confusion and/or agitation that occurs after surgery and is more common in older adults.

This project will evaluate a resilience training program for lawyers. Resilience describes a person’s capacity to “bounce back” from stressful events, such as the workplace stressors experienced by lawyers. Research in some populations indicates that adaptive self-reflection on daily stressors can facilitate the development of resilience. The training program teaches systematic self-reflection, a structured process for examining coping responses to stressful events. The study will involve practising and graduate lawyers across Australia. Participants will attend an initial workshop, complete weekly reflection activities, take part in two short check-in calls, and complete three online surveys over five months. They will be randomly assigned to reflect from either a self-immersed (first-person) or self-distanced (third-person) perspective. The research will test whether reflection perspective influences the development of resilient beliefs and reductions in stress, anxiety, depression, and burnout. Findings are expected to provide evidence for a scalable resilience training approach for the legal profession and advance understanding of how reflective practice can best be utilised to strengthen resilience.

The NEWStitch trial is a cluster randomised controlled pilot study comparing Triclosan-coated sutures with non-coated sutures in adult surgical patients. Conducted across four NSW hospitals, the study uses 8-week cluster blocks to simplify implementation and maintain protocol adherence in high-volume operating settings. The primary aim is to assess feasibility for a larger trial, including recruitment rates, data capture, and adherence to randomisation. Secondary outcomes include surgical site infection rates, wound healing (Bluebelle PROM), cost-effectiveness, adverse skin reactions, complications, and readmissions. This independent, non-industry-funded study responds to growing concern about the routine use of Triclosan sutures without sufficient evidence on safety, effectiveness, or cost.

Obstructive Sleep Apnoea (OSA) is a chronic disorder caused by repetitive upper airway collapse during sleep. One aspect of sleep that is critical for effective cognition is the presence of slow wave sleep; a deep, stable phase of Non-REM sleep. It has been found that that individuals with OSA have less slow wave sleep, poorer cognition and brain atrophy compared to healthy individuals. Existing treatments for OSA have a limited impact on cognition and patient acceptance is poor. Direct enhancement of slow wave activity via acoustic stimulation is a new, non-invasive therapy for improving sleep quality and cognition. Preliminary work showed acoustic stimulation in healthy adults enhanced SWA, improved cognition and reduced next-day sleepiness. The current project will test the hypotheses that acoustic stimulation increases SWA, alters OSA pathophysiology, improves cognition, and reduces sleepiness in individuals with OSA.

The purpose of this sub-study is to assess the impact of radiation therapy on quality of life and patient experience for women with breast cancer. Who is it for? You may be eligible for this sub-study if you are an adult who has been diagnosed with breast cancer and is already participating in the ROSALIE study (NCT05866458 - "Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy"). Study details When you sign consent for the main ROSALIE study, you will have the option to choose to answer some questions about how the cancer diagnosis and treatment affects you. These include: * How you feel about the chance of cancer coming back * How you feel about the results of your surgery, such as how your breast looks, any pain or other feelings, effects on how you can use your arms and shoulders; and * Effects of breast cancer on your physical and mental health. The questionnaires can be completed at home on your computer, tablet or mobile phone, or paper versions can be posted to you. It will take a maximum of 20 minutes to complete all of the questionnaires. You will be asked to complete them 5 times: * When you start ROSALIE (Registration) * 6 months after registration * 1 year after registration * 3 years after registration * 5 years after registration. Your responses will remain confidential. Any concerns should be discussed with your doctor. This part of ROSALIE is optional. You can still take part in the main ROSLAIE study even if you decide not to do the questionnaires. It is hoped that the results of this study will help to inform women with breast cancer when making decisions on the best course of action with their cancer treatment.

This study aims to continue the pursuit of therapy approaches that view the client holistically, and do not just focus on their overt stuttering. This co-designed therapy uses group improv to support clients to positively participate and continuously engage in the activities and social situations that are important to them. Focusing on increasing the awareness of one’s own communication abilities in a risk-free supported environment guided by experts in the field of stuttering has the potential to improve long term outcomes for participants. This project seeks a solution to the lack of affordable, holistic treatment for children and teens who stutter, who are at great risk of inequitable outcomes throughout their lives. An approach that combines group work, improv and acceptance and commitment therapy has great potential to improve their quality of life. We hypothesise that following the improv group, children and teens will have increased social participation, increased communicative confidence, and reduced anxiety levels.

Study aim: To assess the performance of different ultrasound enthesitis scoring systems in assessing disease activity of psoriatic arthritis. Study hypothesis: Ultrasound scores with more sites of examination and inclusion of acute lesions (tendon thickening, hypoechogenicity, and doppler signal) may be more closely associated with global disease activity in psoriatic arthritis.

This study is being done to test the safety, tolerability, and how the body processes a new oral drug called FT2109 in older 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 a single dose in older adults. 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.

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.