ANZCTR search results

The primary aim of this parallel group, superiority trial is to determine the effectiveness of PAO surgery + co-designed rehabilitation compared to co-designed rehabilitation on pain at 12 months. We hypothesize that PAO surgery + co-designed rehabilitation with be superior to co-designed rehabilitation at 12 months for pain. In addition, our secondary aims are to explore the effectiveness of PAO surgery + co-designed rehabilitation compared to co-designed rehabilitation on quality of life, sleep, psychological symptoms, hip joint structure, movement patterns and cost-effectiveness.

This is a randomized, placebo-controlled, sequential, multiple ascending dose study conducted at a single site in Australia and comprised of 2 to 3 cohorts (with the third being an optional cohort, at the discretion of the Sponsor). Randomization to either RES-010 or placebo treatment in a ratio of 3 RES-010 to 1 Placebo treatment. An escalating-dose multiple ascending dose study design in overweight and moderately obese participants was chosen to allow careful increase of the study drug RES-010 dose after the assessment of safety, tolerability, and available plasma and urine Pharmacokinetic and Pharmacodynamic results of each preceding dose cohort. A blinded review of all available safety data and plasma and urine Pharmacokinetic and Pharmacodynamic data will be performed by a Safety Review Committee (SRC) after the administration of the fourth study drug dose to identify any potential safety and or tolerability signals. Based on this review the SRC will recommend to either proceed with the study as planned, or indicate if dose escalation or de;-escalation is appropriate. If necessary, recruitment may be paused to await the availability of further safety data to make a recommendation. The minimum number of participants required to decide on a dose escalation is 6 participants (at least four participants on active treatment RES-010).

This prospective cohort study investigates the effect of oral rehabilitation exercises following buccal mucosal graft urethroplasty. It is hypothesised that implementation of these oral exercises will decrease enhance oral rehabilitation and decrease complications following surgery.

The human gut microbiome plays a pivotal role in maintaining gastrointestinal health, immune function, and has been associated with the development and progression of various chronic illnesses. There remains an unmet need for probiotics that provide clinically validated, reproducible, and lasting benefits in broader contexts such as disease prevention and health promotion. In our research, we have developed a bank of isolated microbial strains derived from healthy FMT donors and supported by findings from prior FMT clinical trials conducted by our group and others. These strains have demonstrated consistent clinical and microbiological effects and are being investigated as candidates for a next-generation probiotic formulation. We are examining the impact of administering a combination of these organisms as a probiotic in healthy individuals to assess effects on the gut microbiome.

This study is a pilot and feasibility randomised controlled trial evaluating whether Virtual Reality Exposure Therapy (VRET), when combined with Cognitive Behavioural Therapy (CBT), improves outcomes for individuals experiencing driving anxiety following motor vehicle crashes. A total of 30 participants will be randomly allocated to receive either standard CBT alone or CBT enhanced with immersive VR-based exposure over an eight-week program. The intervention uses personalised, graded exposure scenarios delivered via VR headsets to safely and progressively reduce anxiety related to driving. Outcomes will assess feasibility, safety, acceptability, and preliminary efficacy using validated psychological and quality-of-life measures, alongside qualitative feedback. Findings will inform the design of a future fully powered trial and the potential integration of VR into scalable treatments for driving anxiety.

This study aims to investigate the feasibility of implementing pharmacogenetics in the busulfan dosing method for children undergoing hematopoietic stem-cell transplantation Who is it for? You may be eligible to join this study if you are a male or female paediatric patients aged 0-18 years undergoing Haematopoietic Stem Cell Transplantation (HSCT) with a Busulfan (Bu)-based conditioning regimen. Study details All participants who meet the eligibility criteria in this study will be randomly assigned to one of two groups. The experimental group will receive Bu dosing based on the pharmacogenetics (PG)-based personalised model, the control group will receive dosing according to the traditional McCune model (does not account for genetic factors). The primary outcome measure will be the proportion of first doses that achieve the therapeutic target area under the curve (AUC). Secondary outcomes will include the incidence and severity of treatment-related toxicities, graft failure, relapse rates, overall survival, and event-free survival. An add-on study will investigate the impact Bu metabolites have on Bu clearance and patient outcomes. The study will involve the collection of DNA samples from all enrolled children to determine their GSTA1 haplotypes, which will be used to calculate the personalised Bu doses for the experimental group. It is hoped that this research project will improve the dosing of busulfan in the future with more patients achieving the optimal therapeutic target exposure.

This project will be the first to comprehensively test the hypothesis that oral administration of cannabidiol (CBD) oil modulates brain excitation-inhibition (E-I) using a range of electrophysiological measures (aperiodic activity, gamma band oscillatory activity, mismatch negativity) using electroencephalography (EEG) in neurotypical adults. To that end, we will conduct a randomised, double-blind, placebo-controlled, crossover trial to examine the effect of acute dose 600mg CBD oil on EEG-derived measures of brain E-I.

Study background The WISER Study aims to investigate an educational intervention designed to support sexual health in women with anal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have been newly diagnosed with anal cancer (any stage), and are planned to receive chemoradiotherapy treatment. Study details All participants will receive a Women’s Initiative for Sexual health, Education and Raising awareness of anal cancer (WISER)-developed educational resource. This resource has been designed to address the sexual health, sexual function, and intimacy information needs of women with anal cancer. The resource will be provided by a healthcare professional (HCP) at the beginning of treatment and revisited during a follow-up consultation before the end of treatment. Feasibility and the impact of the information on patient needs, sexual health, and quality of life will be assessed in participants for up to 6 months after treatment begins. The impact of WISER on HCP awareness and confidence in discussing the sexual health effects of anal cancer treatment will also be evaluated at the end of the study. It is anticipated that this research will contribute to improved supportive care by addressing unmet sexual health information needs and enhancing person-centred care for women with anal cancer.

This study is a randomised, open-label, parallel-group trial evaluating the use of the OmniPod 5™ automated insulin delivery system compared with usual diabetes care in adults with type 2 diabetes undergoing elective hip or knee arthroplasty. The primary aim is to determine whether automated insulin delivery improves peri-operative glycaemic control, measured by percentage of time spent in glucose target range (3.9–10.0 mmol/L) during the two weeks immediately prior to surgery. Sixty-four participants will be randomised 1:1 to automated insulin delivery or usual care, with follow-up extending through hospital admission and post-discharge to 10 weeks. Secondary outcomes include additional glycaemic metrics, peri-operative clinical outcomes, device adherence, psychosocial measures, and health service utilisation. The findings will inform the feasibility, safety, and potential clinical benefits of automated insulin delivery in the peri-operative management of type 2 diabetes.

Brief description of the study purpose The COMPRES study aims to test whether wearing compression gloves and stockings during oxaliplatin chemotherapy is feasible, safe, and may help reduce chemotherapy related nerve damage (peripheral neuropathy) in patients with gastrointestinal cancers. Who is it for? You may be eligible for this study if you are male or female, aged 18 years and older with gastrointestinal cancers who are scheduled to receive oxaliplatin based chemotherapy, are well enough to participate, and are willing to provide informed consent. Study details Those who choose to participate will wear compression gloves (two surgical gloves per hand) and lower limb compression stockings starting 30 minutes before chemotherapy, during the infusion, and for 30 minutes after each oxaliplatin treatment, for a minimum of 12 weeks. This is a non randomised study, meaning all participants will receive the compression intervention during their routine chemotherapy care. Participants will complete questionnaires about nerve symptoms, comfort, and quality of life, and clinical information about side effects and any treatment changes will be collected. No additional blood tests are required beyond standard cancer care. It is help the results from this study will help determine whether a simple, low cost intervention can safely reduce oxaliplatin related peripheral neuropathy and support better quality of life for patients receiving chemotherapy.