ANZCTR search results

This study employs a single-site, multiphase, mixed-methods pre-post evaluation of a co-designed model of care for Aboriginal and/or Torres Strait Islander children and families accessing a public tertiary hospital outpatient paediatric service. The model of care implementation will be evaluated using the Ngaa-bi-nya Aboriginal and Torres Strait Islander program evaluation framework, as well as Implementation and Evaluation Outcomes to evaluate implementation, service, and consumer outcomes. A full service evaluation, including economic analysis using a cost-utility approach to determine the cost-effectiveness of the new model of care will be undertaken. By sharing learnings, processes, and outcomes from this study, this methodology can inform future co-design studies, empowering Aboriginal and Torres Strait Islander peoples and enhancing access to care.

This is a two-stage trial to: -develop, implement and evaluate polygenic scores (PGS) that describe the inherited risk of four common cancers: breast, prostate, bowel and ovarian. - investigate the efficacy and feasibility of a personalised risk assessment for cancer that includes PGS alongside current clinical genetic testing. Who is it for? Individuals aged between 18 and 74 years who have been referred to a participating clinical genetics service for testing of rare high- and moderate-risk cancer susceptibility genes. Study details: In the first phase existing genomic data from current cohort studies will be used to operationalise clinical PGS testing adapted to the Australian healthcare setting. At the same time a control arm of 1000 patients undergoing current standard genetic testing will be enrolled through specialist cancer genetics services. In the second phase an intervention arm of 1000 patients will be enrolled and offered a personalised risk assessment, that includes PGS based testing, for up to 3 common cancers. It is hoped that findings from this study will help inform researchers and clinicians of the impact of personalised risk assessments on cancer risk management behaviour in individuals.

To determine the effectiveness and clinical utility of the fear conditioning and extinction task (CON-EXT) Predictive Marker Task and targeted Cognitive Behavioural Therapy (CBT) for children with anxiety disorders with 62 anxious children between 7-12 years. Additionally, to examine clinician and consumer feasibility and acceptability of the CON-EXT Predictive Marker Task. Following evidence-based multi-modal assessment, including delivery of the CON-EXT Predictive Marker Task, all children will receive standard CBT (10 weekly sessions) with the child and treating clinician remaining masked to CON-EXT Marker status. The post-treatment assessment and a one-month post-treatment follow-up assessment will be conducted by independent clinicians masked to children’s prior assessments and CON-EXT Marker status. The post-CBT assessment at primary end-point addresses the key question of whether CBT produces greater clinical benefits in Marker (+) than Marker (-) anxious children. The follow-up assessment addresses the question of whether greater clinical benefits of CBT for Marker (+) than Marker (-) anxious children persist after treatment. It is expected that participants who had a positive score in the CON-EXT task, will respond better to cognitive behavioural treatment than those participants who had a negative score in the CON-EXT task.

An open label trial evaluating the feasibility of a medicinal cannabis product for the symptoms associated with adult autism such as anxiety. The participants will complete a 3-week titration then stay on that dose for 12 weeks thereafter. There will be four weekly follow up visits in person and safety bloods will be taken. The trial is assessing if it is feasible to conduct a trial using medicinal cannabis in an adult Autism population. It is assumed that it will be feasible, and that medicinal cannabis will help reduce anxiety and improve quality of life.

This pilot randomised controlled trial aims to assess the effectiveness, feasibility, and acceptability of nine single-session interventions (SSIs) compared to a waitlist control for the early intervention of eating disorders in young people aged 14–25. The findings will identify the most effective SSIs based on changes in disordered eating and secondary mental health outcomes, guiding their refinement and development. The top-performing SSIs will undergo further evaluation in a subsequent RCT. Ultimately, the final SSIs will be made freely and widely available to support early intervention efforts for eating disorders in young people. We anticipate that participants receive one of nine SSIs will have lower depression, anxiety and disordered eating scores at 1-month follow-up compared to participants in the waitlist condition.

Postural orthostatic tachycardia syndrome (POTS) is a multisystem, autonomic disorder that culminates in extensive morbidity for those affected. POTS is currently diagnosed on the basis of strict heart rate response to a standing test in addition to the presence of orthostatic symptoms for greater than 3 months unexplained by another condition. However, the heart rate criterion is confounded by multiple factors and has not previously been well validated to correlate with symptoms. Additionally, little is known about whether individuals with postural symptoms without tachycardia (PSWT) have similar symptom burden and health related quality of life impairment to those with POTS. As such, we will explore the symptom burden of PSWT patients and compare this to a POTS cohort.

This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109. A total of 72 healthy volunteers are expected to be enrolled into this study. Study consists of 2 parts- Part A- Single Ascending dose (SAD) and part B- Multiple ascending dose (MAD). The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study. MWN109 is believed to be a novel recombinant fatty acid chain-modified peptide with GLP-1/GIP/GCG biological activity and a good safety profile. This proposed Phase 1 study of MWN109 will provide preliminary evidence of safety, tolerability, PK, and PD in a healthy volunteer population. These preliminary results will pave the way to quickly enter into Phase 2 proof of concept studies, where it is intended to treat patients with Type 2 Diabetes Mellitus, overweight or obese

This trial aims to test whether a Prebiotic Fibre Supplement (PFS) is tolerable and feasible in a CAR T treatment context. Who is it for? You may be eligible for this study if you are aged 18 or older and planned to receive CAR T therapy as part of standard of care. You would need to be able to take a twice daily PFS for up to 90 days. Study details Participants who choose to enrol in this study will receive standard of care CAR T and be randomly assigned to either standard supportive care or receive an oral prebiotic fibre supplement in addition to supportive care. Participants will be followed up for up to 6 months to assess for feasibility and safety, and documented for clinical response, adverse events, and gastrointestinal symptoms to CAR T therapy. It is hoped the outcomes from this study will provide insights into the relationship between diet, the microbiome and response to CAR T therapy. Ultimately, the goal is identify strategies to positively influence the gastrointestinal microbiome to improve outcomes for patients having CAR T therapy.

This study will use a RCT design to evaluate the efficacy of an online education intervention on the characteristics of healthy sleep and contributing factors in improving sleep health and negative emotional states among young adults in Australia. At the 1 week post baseline follow-up assessment, it is hypothesised that participants in the intervention group will exhibit a significantly greater improvement in sleep health, including sleep satisfaction, and negative emotional states compared to participants in the control group,

The aim of this study is to compare the use of an iPad-based app (YoDoc®, Version 2.2) to the use of conventional communication devices in communication by nonverbal post-head and neck cancer surgical patients in a crossover design. Who is it for? You may be eligible for this study if you are a male or female aged 18 to 80 years old, planned for HNC surgery, and have a strong likelihood of being nonverbal post-procedure. You must also be admitted to ICU after surgery and without any mental or physical disability which prevent the use of iPad based app. Study details The participants will use conventional communication devices (e.g., pen & paper) during one study period, and an iPad-based app (YoDoc®, Version 2.2) during the other period. The comparison will be made using a modified QUEST 2.0 survey and an exit survey. It is hoped that information provided by this study will further medical knowledge and may improve future treatment of patients after head and neck surgery who are unable to speak after head and neck surgery. It is also likely that the iPad® based app may be of use to other group of patients who are unable to speak, e.g. those who require breathing tube & breathing machine; after a stroke, etc.