ANZCTR search results

Researchers are investigating how different types of dietary fats affect the way the body processes fats and a protein called amyloid-beta (Aß), which is linked to Alzheimer’s disease. The study will also look at whether these effects differ between people with different APOE genes, specifically APOE e3 and APOE e4. Participants will eat three different meals containing either saturated fat, unsaturated fat, or no added fat on separate days, with blood samples collected before and up to 8 hours after each meal. Based on previous research, the researchers expect that meals high in saturated fat may cause a greater increase in Aß in the blood compared with unsaturated fat. The study will help determine whether dietary fat and APOE type affect how Aß is produced, transported in the blood, and processed by the body after eating.

This study aims to determine whether adding cryo-cuff therapy (a device combining cold application with intermittent pneumatic compression) to standard post-operative care reduces opioid use after arthroscopic rotator cuff repair (aRCR) surgery. Rotator cuff repair is common and often very painful afterwards, usually requiring opioid pain medication. Opioids carry risks including nausea, sedation, dependence and misuse, and these risks can be harder to manage in regional and rural areas where follow-up care is less accessible. Cryo-cuff therapy is a low-cost, low-risk option already used in some clinical practice, but there is not yet good-quality evidence specific to rotator cuff repair to show whether it actually reduces opioid use. This randomised controlled trial will compare opioid consumption in the first 14 days after surgery between patients who use a cryo-cuff device alongside standard care and patients who receive standard care alone. Post-operative pain will be tracked during the first week, patient satisfaction with recovery will be assessed over the first 6 weeks, and shoulder function and return to work will be followed for up to 3 months. Findings will help clarify whether cryo-cuff therapy should be adopted as standard post-operative care, particularly in regional settings where minimising opioid use and supporting recovery with limited follow-up access is especially important.

This study aims to evaluate a new, accessible treatment program designed to help children aged 3 to 12 years overcome specific phobias (such as fears of animals, the dark, or storms). The program, called FAST-CBT, trains parents to support their child in gradually facing fears using evidence-based strategies from cognitive behaviour therapy (CBT), particularly exposure therapy. Families will be randomly allocated to either begin the program immediately or continue with their usual care for 8 weeks before receiving the program. The study will examine whether children whose parents receive FAST-CBT show greater improvements in their fears, daily functioning, and overall wellbeing compared to those receiving usual care. We expect that children in the FAST-CBT group will be more likely to overcome their phobia and show greater improvements in functioning than those in the usual care group.

TOPAS is a parallel 1:1 randomised controlled trial (n=256) that will determine whether adding topical diclofenac gel to self-care advice with a heat pack reduces back and neck pain intensity more than providing self-care advice with a heat pack alone across the first 3 days after initiating treatment in patients with an acute episode of back or neck pain or an acute flare of chronic low back or neck pain. Secondarily, we aim to compare other clinical (e.g. disability, quality of life, use of other pain medicines) and safety outcomes between trial arms.

The aim of this study is to assess the safety and tolerability of BRD-333, an experimental new medicine being developed for the treatment of inflammatory and autoimmune conditions. The study will involve healthy volunteers who will receive either a single or multiple doses of BRD-333 or a placebo. Researchers will monitor participants for any side effects and measure how long BRD-333 stays in the bloodstream.

This study is a fully powered three-arm randomised controlled trial evaluating a consumer co-designed online body image and wellbeing intervention for adults living in Australia with inflammatory bowel disease (IBD). Participants will be randomly allocated to either the digital intervention, the same intervention plus a moderated peer-support group, or a waitlist control condition. The intervention consists of 10 self-guided online modules delivered over approximately three weeks and targets body image and wellbeing using strategies such as psychoeducation, cognitive restructuring, body functionality, self-worth, mindfulness, and self-compassion. Outcomes will include body image, body appreciation, eating disorder psychopathology, depressive symptoms, anxiety, and health-related quality of life, assessed at baseline, post-intervention, and one-month follow-up. The study aims to recruit approximately 420 participants, with around 140 participants allocated to each trial arm.

This study is aiming to evaluate whether exercise during chemotherapy infusion can improve outcomes for people with metastatic colorectal cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with metastatic colorectal cancer and have at least 5 remaining months of prescribed chemotherapy for metastatic colorectal cancer. Study details Participants will be randomly allocated (by chance) to one of two groups to receive either: 1) no exercise during chemotherapy (usual care) or 2) exercise during chemotherapy. The exercise group will complete moderate-intensity aerobic exercise for 20 minutes during each chemotherapy infusion over 6 months, supervised by an exercise physiologist. Participants will continuously wear a provided Fitbit Air to monitor their physical activity, as well as undergo routine imaging and testing and complete questionnaires during their routine appointments at the beginning, middle and end of their prescribed chemotherapy, to determine tumour response, progression-free survival, quality of life and the experience of symptoms and side-effects. At the completion of the 6-months intervention, participants will be invited to optionally attend an interview to share their experience of being involved in the study. It is hoped that this research may transform supportive care for people undergoing chemotherapy for cancer, by providing a new opportunity for exercise that addresses many of the barriers commonly experienced, along with the potential to improve clinical outcomes.

Thirst is the primary mechanism to maintain hydration status in people; a loss of body mass (sweating) should trigger fluid consumption. There is evidence to indicate that age may alter the effect of thirst on fluid consumption. Additionally, there is data to suggest that changing the fluid type with a non-nutritive sweetener may have an impact on thirst; it is unclear how age may impact this. As such, it is hypothesised that fluid consumption of both water and the non-nutritive sweetened beverage will be different between age groups. The study uses a randomised crossover design; participants will serve as their own control as they complete both experimental sessions.

This is an open-label, randomised, two-period crossover trial, testing the impact of Psychedelic Experiential Therapist Training (PETT) on psychedelic therapists’ clinical competencies. Participants will serve in two roles, with each role comprising a 5-week intervention module. After a specified period, participants will switch to the alternate role. Structured individual, co-therapy team and group support is provided throughout the intervention. Experiencer: Receive the psilocybin exposure, which involves one 30mg psilocybin dosing session and 4 non-drug psychological support sessions. Apprentice: Engage in the supervised co-facilitation module for another participant.

This study will be conducted in 2 parts. Part A will examine the safety, and Pharmacokinetics of GE8820 following a single IV or SC administration in sequential dose cohorts of healthy volunteers. Part A is planned to include 5 IV cohorts and 1 SC cohort. Cohorts may be expanded if required by the Safety Review Committee (SRC) to assess safety. Up to 3 additional cohorts may be added, if indicated to meet study objectives. Part B will examine safety and Pharmacokinetics in healthy volunteers. Part B is a multiple dose study with repeated IV and/or SC administration of GE8820 compared to placebo. One cohort is planned with up to 5 additional optional cohorts if required to meet study objectives; the IV and SC doses administered in the additional cohorts will not exceed the planned doses assessed and determined to be below the maximum tolerated dose in Part A.