ANZCTR search results

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.

This pilot study evaluates the feasibility, acceptability and appropriateness of a brief, structured intervention modelled on Good Psychiatric Management (GPM) for adults diagnosed with borderline personality disorder (BPD) who present to Eastern Health (EH) emergency departments (EDs) in crisis. Up to fifteen patients will be recruited through referrals from EH clinicians at EDs or Crisis Assessment and Treatment Teams (CATT) or Psychiatric Assessment and Planning Units (PAPU) to receive GPM from a trained clinician at an EH site. Each patient will receive 10 individualised GPM sessions focused on psychoeducation, crisis management, and the development of alternative help-seeking strategies. Survey data on patients’ treatment acceptability and engagement will be collected. Up to fifteen Eastern Health ED staff members – clinicians, nurses, and administrative staff – involved in implementing the assessment, recruitment and/or referral steps will be surveyed to provide quantitative and qualitative data on the intervention’s feasibility, acceptability and appropriateness as a post-crisis support for patients diagnosed with BPD. Data on fidelity and preliminary clinical outcomes will also be collected.

The purpose of this study is to investigate the feasibility, safety and acceptability of a Pilates exercise intervention for adults living with advanced cancer. Additionally, the aim is to also understand the impact of a Pilates exercise intervention on the strength, balance, physical activity, quality of life and sleep quality of adults living with advanced cancer. Who is it for? This study is for adults aged 18 years and older living with a confirmed diagnosis of an advanced cancer who are able to attend and perform Pilates in-person and on-line (telehealth) across 8 weeks. Participants must not currently be engaging in structured exercise for more than 2x per week over the previous 3 months. Study details Participants will be randomised to either attend Pilates intervention or to continue to receive usual care. Participants allocated to the Pilates intervention will undertake 2x 60 minute supervised mat-based Pilates sessions per week for 8-weeks, delivered by a certified Pilates instructor who is also an accredited exercise physiologist. Sessions are in a small group format of up to 3 participants per class, and each week one of the two sessions will be delivered in-person (face-to-face) while the second session will be delivered on-line (telehealth). Participants in this study will completed a variety of physical tests, including but not limited to: grip strength test, sit-to-stand test, up-and-go test, balance. Participants will also be asked to complete questionnaires to assess quality of life, sleep, and physical activity. It is hoped that the findings from this study will help determine whether Pilates could become a practical component of cancer rehabilitation programs and inform the design of a larger clinical trial.

Mobile phones are ubiquitous in healthcare settings as patients, visitors and healthcare workers use them frequently. Mobile phones can carry harmful microbes in healthcare settings, especially in the intensive care unit, and may potentially be putting patients at risk of contracting healthcare-associated infections. Therefore, mobile phone sanitisation solutions are required for healthcare settings, and ultraviolet-C (UV-C) devices offer a promising solution to this problem. However, it is yet to be investigated whether healthcare workers will be willing to use UV-C devices frequently to disinfect their phones at work. Hence, this study aims to implement a UV-C device in a real-world intensive care unit, and evaluate whether it is accepted and utilised by healthcare workers.

The aim of this study is to investigate the dentoskeletal effects of Align Technology™ Invisalign treatment with Mandibular Advancement with Occlusal Blocks (MA-OB) in comparison with historical data on a traditional functional appliance, the Twin-block, in growing adolescents with a small jaw. The study hypothesis is that there is a significant difference in dental and skeletal effects from the Invisalign MA-OB orthodontic appliance, compared to effects from using conventional functional appliances. There are no studies to date which have investigated the efficacy of the updated Invisalign MA-OB appliance. Therefore, the aim of the present investigation is to evaluate the effects of Invisalign MA-OB and compare it with the conventionally used functional appliance, the Twin-block.