ANZCTR search results

This study will look at how people with ulcerative colitis (UC) respond to treatment with the medicine vedolizumab. It will take place across several centres and follow people in a real-world setting. The focus is on whether vedolizumab can help achieve “transmural response” or “transmural healing,” which means improvement and healing throughout the full thickness of the bowel wall, not just the inner lining. Participants will first receive vedolizumab through intravenous (IV) infusions to induce remission, and then continue with ongoing maintenance therapy. Ultrasound scans of the bowel (intestinal ultrasound, or IUS) will be used to measure changes and healing over time. The main aim is to understand how effective vedolizumab is at achieving deeper levels of healing in people with ulcerative colitis.

In residential aged care, up to 70% of residents will receive an antibiotic annually. However, there are high rates of inappropriate antibiotic use, including the inappropriate commencement of an antibiotic for infections where there is likely to be little or no benefit, and inappropriate choice of an antibiotic, its dose and duration. Behavioural science informed interventions have been shown to successfully reduce antibiotic prescribing in primary care. The primary purpose of this study is to test a bundled intervention consisting of social norm feedback, public commitment and consumer information to support improved antibiotic use.

Hypoglossal nerve stimulation (HNS) has been shown to be a safe and effective treatment option for patients with moderate to severe obstructive sleep apnea (OSA). However, since the introduction of HNS in clinical practice, approximately one third of the implanted patients do not demonstrate clinically meaningful improvement. This study will evaluate whether chronic ansa cerivalis stimulation (ACS) in combination with HNS during natural sleep will yield a clinical meaningful improvement for OSA patients.

This study aims to find out how the body absorbs, processes, and removes a new investigational drug called IRX616a (Cannabidiol) when given as a single inhaled dose in healthy adult volunteers, and to check the safety and tolerability of this treatment. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 65 years with no significant medical conditions. You will need to undergo screening tests, including blood tests, heart monitoring, and a physical examination, to confirm you meet all the health requirements before enrolling. Study details All participants who choose to enrol in this study will be randomly allocated to receive a single inhaled dose of either IRX616a (Cannabidiol) or a placebo (a treatment with no active drug). The study drug will be given using a pressurised metered dose inhaler under the supervision of trained study staff. Participants will stay in the clinical research unit for at least 24 hours after dosing so that blood samples can be collected at multiple timepoints to measure levels of the drug in the body. Safety assessments, including monitoring for side effects, vital signs, heart tracings (electrocardiograms), laboratory tests, and questionnaires on mental health, will be performed before and after dosing, and again at a follow-up visit on Day 8. Higher doses of IRX616a may be studied in later groups if no safety concerns are identified in earlier groups. It is hoped this research will help determine the safety and tolerability of IRX616a and provide important information about how the drug behaves in the body to support the design of future studies.

Cognitive Processing Therapy (CPT) is a first-line psychological treatment for posttraumatic stress disorder (PTSD). The original, standard form of CPT consisted of 12 one-hour sessions, typically delivered once or twice per week. Research shows that variants in its delivery (e.g., guided self-help, massed or intensive therapy over 1-2 weeks, or longer duration) can also be efficacious. Research in psychotherapy shows that when clients have choice over therapy options, this can improve adherence and possibly engagement. In an uncontrolled design, the project will test the outcomes of CPT when clients are given the choice of a range of formats of CPT, including self-help, guided self-help (i.e., with clinician support), abbreviated CPT (less than 12 sessions), and standard and flexible length CPT. Primary outcomes are PTSD and depression symptoms, and treatment adherence. The project uses a pretreatment, posttreatment, and 3-month follow-up design.

Body image concerns are common in children and increase risk for eating disorders and mental health problems. Butterfly Body Bright (BBB) is a whole-school program designed to promote body confidence and healthy attitudes in primary school students. This study will test whether BBB improves children’s body image and related outcomes, while also examining how schools can best implement the program in real-world conditions. Sixteen Victorian primary schools will be randomly allocated to either receive BBB during the study or continue usual practice and receive access later. Students in Years 5–6, along with parents and teachers, will complete surveys before and after the program and at follow-up. Some parents and teachers will also take part in interviews, and school community workshops will help identify barriers and strategies to improve delivery. The study will also test whether the program is cost-effective. Findings will guide future implementation of body image programs in schools and support national prevention efforts.

The impact of climate change upon sport and exercise participation has underscored the importance of cooling intervention strategies, but many are underpinned by limited empirical evidence or lack translatable and relevant designs. One cooling method that appears in the research literature is the placement of multiple cold, wet-towels on an individual during or after exercise. The American College of Sports Medicine (ACSM) recommend using the intervention, but with limited underpinning empirical evidence (Roberts et al. 2021; Casa et al. 2015). The intervention is feasible and low-cost, highlighting the relevance across all sport and exercise contexts.

Stroke is a serious health condition that can affect people of all ages, often leading to long-term challenges. One concern after a stroke is the risk of falling. In Australia, falls are the leading cause of hospital stay due to injuries resulting from falls and not only are costly to the healthcare system but can impact on people’s independence and participation in meaningful life activities. For people with stroke, the risk of falling is even higher—about 75 percent will experience a fall, usually at home, within the first year after their stroke. This can lead to injuries, hospital visits, and a loss of confidence in daily life. We need strong evidence on the best ways to prevent falls after stroke. A program called Action Falls has been shown to reduce falls by 43 percent in older adults living in nursing homes. FISS - Australia trial will test whether Stroke Action Falls (Action Falls adapted for people who have had a stroke) along with usual care reduces falls in people living in the community following their stroke. The trial will evaluate the clinical and cost-effectiveness of the Stroke Action Falls intervention from the perspective of patients and their carers (clinicians and significant others) via participant reported questionnaires as well as interview data for a sample of participants who have received the Stroke Action Falls intervention.

This study is a prospective, three-arm, randomized controlled trial investigating the clinical outcomes of standard, intermediate, and high doses of intravenous dexamethasone administered during total knee replacement surgery for knee osteoarthritis. We hypothesise that higher doses of dexamethasone will reduce pain, lower opioid use, and improve early functional recovery compared with the standard dose.

Mild traumatic brain injury (mTBI) or concussion results in persistent post-concussion symptoms (pPCS) in 31% of cases, contributing to lasting disability and significant cost burden. Evidence of efficacy of treatments for pPCS is scant and most individuals do not have access to evidence-based and timely treatment. There is a growing awareness that physical (e.g., vestibular, cervical), psychological (anxiety, fear avoidance) and medical factors interact in a variable fashion to perpetuate pPCS and need to be addressed in treatment. Mild TBI Guidelines recommend multidisciplinary treatment for pPCS. Evidence for the efficacy of such interventions remains limited. Our team co-designed and piloted an Interdisciplinary Rehabilitation program for Concussion Recovery (i-RECOveR), modifying it in response to consumer feedback. This led to a current randomised controlled trial funded by MRF2016112 (Ponsford CIC) (ACTRN12622000702718) of co-ordinated interdisciplinary treatment (neuropsychology, physiotherapy, medical) delivered in person. However, access to specialised interdisciplinary treatments is limited in rural/remote areas and public sector hospitals. Telehealth can increase access to such treatments for rural/remote residents, although evidence for telehealth concussion interventions is not established. With the aim of improving long-term outcomes after mTBI we will evaluate the efficacy of the i-RECOveR interdisciplinary intervention delivered to individuals with pPCS across Australia via telehealth, extending our pilot telehealth trial (ACTRN12624000924550) and its comparative effectiveness with our existing in-person delivery (ACTRN12622000702718). Our team will partner with individuals with pPCS including those in rural/remote areas, to evaluate the experience of receiving the intervention in-person and via telehealth and experiences of clinicians delivering it. The project will assess outcomes including symptom reduction, functional goal attainment of daily activities and quality of life, providing robust evidence of the effectiveness of this interdisciplinary model in addressing pPCS. A process evaluation will assess treatment integrity and content, participant experience, and cost effectiveness.