ANZCTR search results

Epidural analgesia is a common choice for women in labour. There is no evidence about how to best manage the positioning of a woman once an epidural has been placed. When no epidural is used, evidence supports upright positioning in labour, but this is not the case for women with an epidural where the opposite is true. We aim to fill an important gap in the literature about the management of a woman’s position when using an epidural to maximise safe and spontaneous vaginal birth. We are proposing a randomised controlled trial comparing usual care with structured position changes from side to side every hour and assessing the effect on spontaneous vaginal birth, as well as other important maternal and neonatal outcomes, and maternal experiences in labour.

Background: Youth aged 14–24 years’ experience more concussions than any age group in Australia, coinciding with a critical neurodevelopmental period. The debilitating signs and symptoms interfere with school, sport, and daily activities. In 30% of cases patients have persistent and intractable effects lasting months to years, affecting mental health and impairing quality of life. Problem: There is a scarcity of effective treatments to mitigate and prevent the effects of a concussion. Australians, The Australian Senate, and international research groups are urging scientific investigations into clinical solutions. Solution: This project seeks to accelerate clinical trials in novel neuroprotective strategies. It will assess the potential and feasibility of an innovative and safe standardised soccer heading model to establish proof-of-concept for neuroprotective strategies in up to 80 male and female youth. This project is informed by a previous clinical pilot trial led by CI Delang. Impact: The clinical research model will facilitate rapid determination of proof-of-concept neuroprotective strategies in future trials, which our team of neurologists, physicians, dietitians, exercise physiologists, physiotherapists, biomedical engineers and statisticians are expertly positioned to conduct.

This study tests a new computer program called "Focal Finder," designed to quickly identify the precise source of certain fast heart rhythms (focal atrial tachycardia). During standard ablation procedures, locating these sources can be time-consuming, and the arrhythmia sometimes stops before a complete map is obtained. Focal Finder may be able to pinpoint the source from only a small number of measurements. To validate accuracy, researchers pace the heart from known locations during procedures that patients are already undergoing for clinical reasons. Because the exact pacing location is known, the team can measure how accurately the algorithm identifies it. The research component (additional pacing sequences) is performed after the clinical procedure is completed, before catheters are removed, and adds approximately 20–40 minutes. No additional procedures, needle insertions, or drugs are involved.

Atrial fibrillation (AF) is the most common heart rhythm problem and a frequent reason for emergency department (ED) visits. Many patients with AF who come to the ED will spontaneously return to a normal heart rhythm on their own — a process called spontaneous cardioversion (SCV) — without needing active treatment. However, because clinicians currently cannot reliably predict which patients will revert naturally, most AF patients are admitted to hospital for monitoring and treatment, which leads to unnecessary hospitalisations. This study, called PREVAIL-AF, tests whether an artificial intelligence (AI) tool that analyses a patient's electrocardiogram (ECG, or heart tracing) can accurately predict which patients are likely to have SCV. The AI tool was previously trained using ECG data from a prior study at the same hospital. In PREVAIL-AF, the AI tool's prediction will be used to guide whether a patient is safely discharged home from the ED under a structured "wait-and-see" plan (with heart rate medications, blood thinners, and a follow-up cardiology appointment within 7 days), or admitted to hospital for standard care. This is a first-in-human pilot study aimed at testing whether this approach is feasible, safe, and accurate. The results will help refine the AI model and design a larger multi-centre study in the future. The study will be conducted at Flinders Medical Centre in Adelaide, South Australia.

This is a two-arm, single-blind, randomised, sham-controlled, parallel-group, superiority trial investigating the immediate effects of a maximal cushioning running shoe (Brooks Ghost Max 2) compared to a sham (Brooks Ghost 16) on patellofemoral joint force and clinical outcomes during running in individuals with patellofemoral pain. Participants will complete pre- and post-intervention biomechanical assessments in a single laboratory session.

This is a two-arm, double-blind, randomised, placebo-controlled, parallel-group, superiority trial investigating the immediate effects of a non-steroidal anti-inflammatory drug (single 400 mg oral dose of ibuprofen) compared to placebo on knee pain, patellofemoral joint force and clinical outcomes during running in individuals with patellofemoral pain. Participants will complete pre- and post-intervention biomechanical assessments in a single laboratory session.

This study aims to assess the feasibility and acceptability of a co-created, family-centred self-management program for Aboriginal women experiencing diabetes in pregnancy (type 1 diabetes, type 2 diabetes and gestational diabetes) and up to six-months post-pregnancy. The program will be offered as part of standard care to all eligible women and their families attending one of two pilot sites; South West Aboriginal Medical Service and Broome Regional Aboriginal Medical Service. We expect to learn whether program implementation is feasible and if the program is acceptable to women, their families and their health care providers, and supports engagement with diabetes self-management and continuous glucose monitoring. The study design is observational. Feasibility of implementation will be evaluated using continuous quality improvement check-in notes and reports for program components. Staff delivering the program and program participants, including their family and community support people, will be invited to participate in surveys, semi-structured interviews and research yarning to explore program acceptability along with engagement with continuous glucose monitors. Findings from this pilot study will inform progression to a large-scale trial.

Cyclopentolate 1% is the recommended drug of choice to induce cycloplegia during paediatric eye examinations. Cycloplegia forms part of the standard of care in the diagnosis and management of refractive error, strabismus, and ocular disease in children. Given this procedure is required for best practice, it is concerning that instillation of cyclopentolate eyedrops can cause significant distress to children during eye examinations due to sting on instillation and discomfort during the administration process. Variables that contribute to sting and discomfort include the low pH of commercially available formulations of cyclopentolate, the size of the eye drop, and the mode of administration. This project aims to assess the effects that these variables have on sting and distress by comparing the sting and discomfort of the two commercially available, TGA approved formulations, Cyclogyl (Alcon) and Cyclopentolate Minims (Bausch and Lomb) (with differing pH levels) administered via alternative delivery methods (micro-drop to reduced drop size and spray to alter administration mode) to study participants. The tolerability and efficacy of a final alternative delivery method (micro-drop or spray) and with which cyclopentolate product (Minims or Cyclogyl) will be determined in adults through Study 1, before being administered to children in Study 2 (to be registered at a later date once data analysis is completed and 'final alternative delivery method' determined from Study 1). Even though cyclopentolate eye drops are the drug of choice for cycloplegia in children, recruiting adults for Study 1 will help to alleviate unnecessary burden of repeated visits and procedural anxiety on children.

To improve health literacy, it is important to develop resources that are easily accessible and simple to understand, that assist adults of all ages to improve their health. Successful Ageing does not occur once a person reaches age 65. To achieve Successful Ageing, it is essential to lead a healthy life throughout adulthood and this MOOC is designed to assist with that. The purpose of this study is to evaluate the effectiveness of the Successful Ageing MOOC in improving health literacy in adults 18 years and over using a wait-list randomised controlled trial. The successful ageing MOOC has 8 modules that will take around an hour each to complete over 8 weeks. At four time points we will measure each participants' health literacy to see if the MOOC helps to improve it or not.

EphA2 Chimeric Antigen Receptor (CAR) T cell Therapy for Children with Bone Tumours: A Phase I Clinical Trial Brief description of the study purpose: This study aims to assess the safety and feasibility of EphA2 CAR-T cell treatment for osteosarcoma and Ewing sarcoma in children where the sarcomas have either not responded to (refractory) or returned after (recurrent) standard treatment and no longer responding to standard treatment and no alternative treatment option exists, or the location of osteosarcoma prevents first time standard treatment. CAR T-cell therapy (Chimeric Antigen Receptor T-cell therapy) is a type of immunotherapy that uses a patient’s own genetically modified immune cells (T-cells) to fight certain cancers. Who is it for: Stage 1: You may be eligible for Stage 1 of this study if you are male or female age less than or equal to 21 years, with documented refractory or recurrent Ewing sarcoma or osteosarcoma no longer responding to standard treatment and no alternative treatment option exists, or osteosarcoma where disease location precludes standard first line treatment and you have enough previously collected tumour previously to testing for the EphA2 protein on your tumour cells. Stages 2 & 3: You may be eligible for Stages 2 & 3 if you have EphA2 protein on your tumour cells, measurable MRI, CT or PET scans, a life expectancy of at least 12 weeks (at least 8 weeks at Stage 3), sufficient heart, kidney, lung, liver and blood function, you have recovered from acute toxicities caused by any previous treatments, and your immune (T) cells have been successfully collected and made into EphA2 CAR-T cells. Study Details: Eligible participant's own immune (T) cells will be collected by filtering the participant's blood (leukapheresis) then genetically modified in a laboratory to a Chimeric Antigen Receptor (CAR) targeting the tumour associated antigen, EphA2. Approximately 14-21 days following leukapheresis, participants will receive lymphodepletion chemotherapy, then 7 days later, a single intravenous infusion of autologous EphA2 CAR T cells according to dose escalation trial design and subject to a maximum 50kg body weight. Cohorts of 3 to 6 participants will be treated at a dose level to determine the maximum tolerated or maximum administered dose. CAR T cell manufacturing feasibility will be determined by whether the manufactured CAR T cells meet quality acceptance criteria. CAR T cell safety will be determined by adverse events occurring after CAR T cell infusion. After CAR T cell infusion, follow-up assessments will include participant clinical assessment, including blood assays to determine anti-tumour efficacy, and to determine the rates of disease response, disease progression, and survival. It is hoped this study will improve treatment outcomes for these patients with otherwise limited treatment options, and increase knowledge of CAR T cell treatment of solid tumours.