ANZCTR search results

The ZenZone Trial will test whether an eight-week dairy study is practical, safe, and acceptable for 14-year-old girls experiencing elevated depressive symptoms. Participants will be randomly assigned to consume either a yoghurt containing added BB-12, conventional yoghurt, or flavoured milk each day. The main aim is to assess recruitment, retention, adherence, completion of study activities, protocol compliance, and safety. The study will also explore changes in mood, sleep, thinking, gastrointestinal symptoms, diet, the gut microbiome, saliva biomarkers, and, for some participants, brain imaging measures. We expect the study procedures to be workable and acceptable, and will examine whether probiotic yoghurt shows more promising changes than conventional yoghurt or milk to inform a larger future trial.

This pilot study aims to compare a new wound closure technique — called boot-lace assisted tissue expansion — against standard reconstructive surgery (skin grafts or flaps) for closing skin wounds on the arms, legs, and trunk in adults following skin cancer removal or trauma. Who is it for? You may be eligible for this study if you are an adult presenting for elective excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) or post-traumatic event. Study details Participants will be randomly allocated to either boot-lace assisted wound tissue expansion, or conventional techniques including local or regional flap, full-thickness skin graft or split-thickness skin graft. Participants assigned to the boot-lace technique group may be further randomly allocated to undergo the Khouri technique, which involves small needle perforations made in the surrounding skin to further improve its elasticity. Outcomes assessed will include scar quality, wound healing time, pain, complications, cost effectiveness, and patient satisfaction. It is hoped that findings from this study inform future surgical practice for skin cancer removal and post-trauma events.

This pilot study aims to assess the feasibility and acceptability of a structured breathwork exercise program delivered through the Physitrack mobile application for patients preparing to undergo Deep Inspiration Breath Hold (DIBH) radiation therapy. The study will investigate whether the program may help improve breathing control and breath-hold performance in patients who have difficulty performing DIBH because of respiratory limitations. Who is it for? You may be eligible for this study if you are male or female with a cancer diagnosis who have been offered DIBH radiation therapy but are unable to achieve or maintain adequate breath holds during initial assessment due to respiratory-related limitations. Participants must be able to provide informed consent and commence the program at least one week before their radiation therapy planning appointment. Study details Those who are eligible will be randomly assigned to one of two groups. One group will receive a structured breathwork exercise program delivered through the Physitrack mobile application, while the other group will receive the standard breath-hold exercises currently provided as part of routine departmental education. Participants in both groups will complete breathing exercises twice daily for approximately two weeks before their CT simulation/planning appointment, with each session taking less than 10 minutes. The intervention group will receive video-guided exercises, reminders, and adherence tracking through the Physitrack app, while the control group will receive written instructions and record exercise completion in a paper diary. Participants will undergo assessments of inspiratory capacity, breath-hold stability, and DIBH capability. Exercise adherence will also be monitored through app-recorded data or participant diaries, depending on group allocation. It is hoped that this research will determine whether a digital breathwork program is practical and acceptable for patients and provide information to support a larger trial aimed at improving access to and effectiveness of DIBH radiation therapy.

People with traumatic brain injury can experience mental health and behavioural difficulties, but access to specialist psychiatric care is often limited, particularly for people living in rural and regional areas. This study will evaluate a telepsychiatry service that provides specialist psychiatric advice and support through videoconferencing to people with acquired brain injury and the clinicians involved in their care. The purpose of this study is to understand whether this model of care is practical, acceptable, and helpful for improving access to specialist mental health support. We expect to learn about changes in participants’ mental health, wellbeing, and everyday functioning after receiving telepsychiatry support, as well as the experiences of patients, clinicians, and psychiatry trainees involved in the service. The study will also identify the benefits, challenges, and opportunities for improving the delivery of telepsychiatry for people with brain injury.

Brief description of the study purpose This study aims to investigate whether adding a targeted internal radiation treatment called OncoSil™ to standard chemotherapy, with or without immunotherapy, can improve outcomes for people with metastatic pancreatic cancer. Who is it for? You may be eligible for this study if you are male or female aged 18 or older, have confirmed pancreatic ductal adenocarcinoma that has spread to a limited number of sites (oligo-metastatic disease), who are well enough to receive standard chemotherapy and meet the study's health and laboratory requirements. Study details All those who are eligible will be randomly allocated to one of three treatment groups: (1) OncoSil™ plus chemotherapy, (2) OncoSil™ plus chemotherapy and immunotherapy (nivolumab), or (3) chemotherapy standard care. Participants receiving OncoSil™ will undergo a single endoscopic ultrasound (EUS)-guided implantation of phosphorus-32 microparticles into the primary pancreatic tumour approximately four weeks after starting chemotherapy. All participants will attend regular follow-up visits, which include clinical reviews, imaging scans, blood sample collection, and completion of quality of life and pain questionnaires. Researchers will also analyse blood and, where available, tumour samples to better understand how OncoSil™ affects the immune system and response to treatment. The findings may help determine whether this treatment approach could improve future care for people with metastatic pancreatic cancer.

This study will compare how much SOR102 is found in the blood and stool and look at the safety of both a tablet and capsule dose formulation of SOR102. The capsule formulation has been tested in healthy volunteers before, with the tablet formulation being given for the first time in humans in this study. SOR102 is being developed as a potential treatment for inflammatory bowel disease. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 65 years old.

The authors aim to perform thyroid artery embolisation (TAE) for a pilot cohort of 5 patients with symptomatic benign thyroid nodules and/or thyroid goitre to determine the safety, feasibility, efficacy and outcomes in the local setting.

The purpose of this study is to determine if circadian informed light therapy will improve outcomes for the treatment of circadian misalignment, relative to treatment as usual, for adults presenting for treatment of circadian misalignment. Effective and accurate light administration depends on accurate assessment of the circadian system which has a very narrow time-window of sensitivity to blue-enriched light, so large phase delays and advances (shifts in our sleep timing) can occur with only a relatively small difference in light administration timing. At present circadian timing is estimated by sleep wake timing alone which is highly variable and inaccurate. Therefore this project will assess the efficacy of personalised advice on the use of the retimer light device from information provided by wearable light pin to estimate the circadian rhythm more precisely.

This study will investigate the effects of hydrogen-rich water (HRW) supplementation in adults with excess body weight through a randomised, double-blind, placebo-controlled clinical trial. Participants will consume either HRW or placebo water daily for six months. The study will evaluate changes in body composition, cardiometabolic health, glycaemic control, oxidative stress, inflammation, and gut microbiota composition. In addition, mechanistic analyses will explore the effects of HRW on immune cell function and redox-related pathways. The findings will contribute to understanding the potential role of hydrogen-rich water as a nutritional intervention for improving metabolic health in adults with overweight and obesity.

This study is a prospective, multicentre, first-in-human study to evaluate the safety and effectiveness of the Shockwave Medical VTL II System with VTL II Catheter and Aortic Steerable Sheath to treat participants with symptomatic, severe calcified aortic stenosis. Eligible participants who meet all inclusion and exclusion criteria and provide informed consent will undergo transcatheter aortic valve lithotripsy (TAVL) procedure using the VTL II System. The procedure is performed via a trans-vascular approach in a catheterisation laboratory or a hybrid suite, where lithotripsy (soundwaves) pulses are delivered to modify calcified aortic valve tissue. Additional balloon aortic valvuloplasty and transcatheter aortic valve implantation may be performed at the operators discretion. Participants will receive standard post-procedural care and be followed during hospitalisation and at discharge. Follow-up assessments will occur at discharge, 30 days, 6 months, 12 months and 24 months post procedure. Study exit will occur between 12 and 24 months following the index procedure.