ANZCTR search results

This study aims to test whether a short, supervised exercise program called integrative neuromuscular training (INT) is safe, achievable, and enjoyable for children, and whether it may improve strength, movement skills, and overall physical and mental wellbeing. Who is it for? You may be eligible if you are aged 6–12 years who were diagnosed with acute lymphoblastic leukaemia, have been in remission for at least 6 months, and are within 5 years of completing treatment. Study details All participants who are eligible will take part in an individualised, supervised integrative neuromuscular training (INT) exercise program. The program involves 16 one on one exercise sessions delivered over about 8 weeks (two sessions per week), with each session lasting around 60 minutes. Sessions include a warm-up, strength and movement skill exercises, fun circuit-based activities targeting speed, balance, and core strength, and a cool down with stretching. Exercise sessions are led by a qualified exercise professional experienced in working with children and can be delivered in person or via telehealth if needed. The program is tailored to each child and adjusted over time based on their ability and comfort level, with exercise intensity monitored throughout. Participants will complete physical assessments to measure muscle strength, physical function, body composition, as well as questionnaires about physical activity and wellbeing. It is hoped that the results from this study will help develop safe and effective exercise programs that support long term health, physical function, and quality of life for children who have survived leukaemia.

This study aims to evaluate the feasibility of RISE, a clinician-supported SMS text message intervention designed to support recovery following whiplash-associated disorder after a road traffic crash. Participants (n=50) within 12 weeks of injury and at medium to high risk of poor recovery will be randomised (1:1) to receive either the RISE intervention or an active control condition consisting of generic health messages and access to online resources. The RISE intervention delivers tailored messages focused on recovery, information, support, and empowerment to promote self-efficacy and informed recovery. Feasibility outcomes include recruitment, retention, engagement, and acceptability, with preliminary effectiveness and feasibility of integrating multimodal data also explored. Findings will inform the design of a future definitive trial and the potential implementation of scalable early interventions for people with whiplash injury.

Brief description of the study purpose This Phase 1 study is testing the safety of a new targeted radioactive treatment, [¹77Lu]Lu FAP 2286, given together with standard immunotherapy (nivolumab and ipilimumab), to find the safest dose and understand how the combination behaves in patients with malignant pleural mesothelioma. Who is it for? You may be eligible for this study if you are male or female aged 18 or over with advanced or unresectable malignant pleural mesothelioma whose cancer shows uptake on a specialised FAP PET scan and who are eligible to receive immunotherapy. Study details All participants will receive an intravenous dose of the investigational radioligand [¹77Lu]Lu FAP 2286 every 6 weeks for up to 4 cycles, alongside standard nivolumab and ipilimumab immunotherapy. The early part of the study tests increasing dose levels of the radioligand to identify the safest dose, followed by an expansion group treated at the selected dose. Participants will undergo regular blood tests, imaging (including specialised FAP PET scans), and clinical assessments to monitor safety and response. The results from this study will help determine whether combining targeted radiotherapy with immunotherapy is safe and feasible, and may inform future studies aiming to improve outcomes for people with mesothelioma.

The aim of this research study is to assess the feasibility of conducting a future randomised controlled trial using a continuous glucose monitor paired with an Australian mobile app that provides diet and lifestyle education, recommendations for reducing glucose spikes and support from a dietitian coach in a cohort of postmenopausal women at risk of type 2 diabetes (T2D). Empowering women with real-time glucose insights and personalised tools may enable sustainable lifestyle change. If feasible and acceptable, this model could support scalable, cost-effective interventions to reduce T2D risk in this vulnerable population.

The purpose of this study is to determine whether providing personalised melanoma (skin cancer) risk information based on genetic and other lifestyle factors has any influence on sun protection and skin cancer prevention behaviours in Australian adults. Who is it for? You may be eligible for this study if you are aged 18 or over and have previously enrolled in the Australasian Centre of Excellence in Melanoma Imaging and Diagnosis study (ACTRN12619001706167). Note, that you do not need to have been diagnosed with skin cancer or be at risk of skin cancer to participate in this study. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will receive personalised melanoma risk information as an electronic booklet, based on a genetic sample and additional information provided as part of the Australasian Centre of Excellence in Melanoma Imaging and Diagnosis study. Participants allocated to the second group will receive standard melanoma prevention information, based on the available guidance from the Cancer Council. Participants in both groups will be asked to complete online questionnaires at the time they enrol, and then at 3 months and 12 months after enrolment. Participants who are allocated to the second group will then be offered the option to receive a personalised melanoma risk booklet after they have completed their final questionnaires at 12 months. It is hoped this research will improve participants' willingness to engage in melanoma prevention and sun protection behaviours, which could reduce their risk of melanoma.

The study tests the hypothesis that people do not differentiate hope from expectation when completing surveys about their expectations from surgery. By randomising the order of distribution of the survey (A or B) for people attending the waitlist management clinic, we can test whether people who complete the survey which differentiates hope from expectation report lower (more realistic) expectations compared to those who complete the survey which does not have any explanation.

The EQUAL-AF study is a randomized clinical trial designed to investigate whether treatment outcomes for atrial fibrillation differ between women and men. The study compares catheter ablation for rhythm control versus guideline-directed medical therapy in patients with atrial fibrillation and heart failure. Although catheter ablation has shown benefits in previous trials, women have been underrepresented, leaving uncertainty about whether treatment effects are similar across sexes. EQUAL-AF therefore randomizes women and men separately to evaluate treatment response within each sex and to assess whether outcomes differ between them. The study aims to generate evidence to guide more equitable and personalized treatment strategies for patients with atrial fibrillation.

This study will assess the feasibility of giving methoxyflurane to patients with advanced cancer during a single episode of incidental cancer pain (IcP) in the palliative care setting, with a particular focus on regional and rural populations. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced cancer, you have used a palliative care service previously and you are scheduled to undergo a procedure/event considered likely by clinical staff to induce IcP. Potential examples include radiotherapy, malignant wound dressing, or personal hygiene activities. Study details All participants who choose to enrol in this study will be asked to undergo a procedure/event considered likely by clinical staff to induce IcP at a palliative care centre. Immediately following the event, participants will be given a methoxyflurane inhaler (also known as the 'green whistle') and asked to breathe in and out using the inhaler as needed to achieve adequate analgesia, using the minimum effective dose. Participants will be asked to rate their pain levels before they use the inhaler and will be assessed at 20 and 60 minutes after using the inhaler and within 60-90 minutes post procedure completion. Participants will also be asked to report any side effects that they experience after using the inhaler, for up to 90 minutes post procedure completion. It is hoped this research will demonstrate that use of a methoxyflurane inhaler can provide effective immediate pain relief to patients with advanced cancer who experience incidental cancer-related pain episodes. If this initial study is successful, a larger study involving a greater number of patients with advanced cancer may be conducted.

Pelvic organ prolapse (POP) is a common condition affecting women, with vaginal childbirth. Sacral colpopexy is considered the gold standard operation for prolapse of the vaginal apex and can be performed via open, laparoscopic, or robot-assisted approaches, with comparable efficacy across access methods. A graft is used to suspend the vaginal apex from the sacral promontory. Graft options for the treatment of Pelvic Organ Prolapse have been Synthetic mesh - no longer approved for use by the TGA and Autologous fascia lata. Autologous Fascia Lata harvest requires an additional operative site, which may be associated with donor site morbidity such as pain, scarring, and delayed wound healing. Posterior rectus sheath (PRS) represents a novel alternative autologous graft that may mitigate these limitations. As a local abdominal fascial tissue, PRS can be harvested from the same operative field used for sacrocolpopexy, This study will describe the surgical techniques of robotic autologous posterior rectus sheath sacral colpopexy (PRS-AC) for bothersome apical prolapse and report 1-year anatomic and functional outcome

The widespread availability of heavily processed, energy-dense foods, combined with increasingly inactive lifestyles, is contributing to growing rates of obesity and related health conditions across Western societies. These foods, typically high in fat, sugar, and artificial ingredients, have been linked to a range of adverse health outcomes, including poor blood sugar regulation, liver dysfunction, and increased levels of lipids in the blood, such as elevated triglycerides. These effects appear to occur regardless of total calorie intake, suggesting that the quality of one's diet plays an important and independent role in overall health. Regular physical activity remains one of the most effective non-pharmacological strategies for counteracting the negative health consequences of a prolonged poor diet. Engagement in structured exercise is associated with improvements in cardiovascular and cardiorespiratory fitness, which is among the strongest known indicators of long-term health outcomes and reduced risk of premature mortality, as well as beneficial effects on blood lipid levels. Despite this, the majority of the general population continue to fall short of recommended physical activity guidelines. Endurance athletes are a unique population that demonstrate exceptional cardiovascular fitness but also possess improved blood sugar regulation and more favourable blood lipid profiles compared to the general population. Highly trained triathletes typically accumulate > 14 hours of training/week and expend considerable amounts of energy daily. The physiological adaptations resulting from this level of training are known to support many of the same biological processes that are disrupted by a diet high in ultra-processed foods (UPF). What remains unclear, however, is whether these adaptations are sufficient to protect metabolic health during consumption of an UPF diet. Therefore, this study aims to determine whether highly trained endurance athletes are able to offset the associated negative metabolic health consequences of an UPF diet. We hypothesise that; (1) athletes will be able to offset elevations blood lipid levels, including triglycerides and total cholesterol, despite consuming an UPF diet, relative to their habitual diet; and (2) athletes consuming an UPF diet will not experience meaningful changes to their body composition.