ANZCTR search results

Ulcerative colitis (UC) is an immune mediated disease that causes sores in the large bowel and symptoms such as diarrhoea, passage of blood and abdominal pain. Acute severe ulcerative colitis (ASUC) is the most severe form of this condition, which requires admission to the hospital for treatment with intravenous steroids as their first line of treatment. In this randomised open label trial, we will aim to explore whether the addition of Upadacitinib, a medication belonging to family of drugs known as janus kinase (JAK) inhibitors, to intravenous steroids is effective, feasible and safe. The primary aims of this pilot study are to determine if, in patients admitted to hospital with ASUC, upadacitinib in addition to steroids is more effective than steroid treatment alone in inducing clinical response and reducing the need for rescue therapy by Day 5 of admission, and whether this strategy is feasible, and safe. The secondary aims include evaluation of efficacy of upadacitinib in improving symptomatic and biochemical response at day 5; likelihood of colectomy during index hospitalisation; cost and duration of index hospitalisation. We hypothesise that upadacitinib in addition to corticosteroids will be more effective that corticosteroid treatment alone in inducing response and reduce need for rescue therapy, and will be a feasible and safe strategy.

This study is aiming to evaluate safety, tolerability and immune cell profile of one dose of Activated Immune Cells with Anti-Cancer Phenotype in healthy volunteers Who is it for? You may be eligible to join this study if you are aged 18 to 70 years, are in good general health medically without a clinically significant medical history. This study is only for healthy volunteers. People who have been diagnosed with cancer will not be eligible for this study. Study details All participants will go through screening, peripheral blood mononuclear cell (PBMC) harvest, treatment and follow-up over a 20 week-period. Participants will receive a single intravenous infusion of Activated Immune Cells with Anti-Cancer Phenotype prepared using their own blood during the PBMC harvest period. Participants will then undergo physical examinations, clinical monitoring and laboratory assessments at regular follow-up visits to determine safety, tolerability and immune cell profile of the treatment. This research aims to advance the clinical development of Activated Immune cells with Anti-cancer phenotype, an autologous immune cell therapy initially focused on treating non-small cell lung cancer, with the hope of expanding its application to other cancers and immune-related conditions, ultimately contributing to improved treatment options and health outcomes for patients with limited current therapies.

This project aims to evaluate whether the “Ballet for Brain Injury” program can be effectively delivered online to people living with acquired brain injury in regional and rural Queensland. People with brain injury often experience social isolation and reduced wellbeing and access to supportive community programs can be limited outside metropolitan areas. The study will recruit adults living with brain injury who are medically stable and living in the community. Participants will take part in a 10-week ballet-based movement program delivered either online via telehealth or in person in Brisbane. Weekly group classes will be led by trained dance instructors. We will measure quality of life, participation in meaningful activities, safety, and participants’ perspectives of the program. The expected outcome is to determine whether the telehealth version of the program is safe, acceptable, and practical to deliver, helping inform future expansion of accessible wellbeing programs.

Older people living in long-term care facilities (LTCFs) often experience medication-related problems. With the introduction of clinical pharmacists working on-site in Australian LTCFs, there is a need to support interprofessional collaboration and communication, and pharmacists’ impact on quality use of medicines. Medication Safety Needs Rounds build on the evidence-based principles of palliative care needs rounds. They involve an iterative monthly cycle to proactively identify residents at risk of medication-related harm, discuss these residents at an interprofessional triage meeting and implement follow-up actions to support quality use of medicines. This study aims to examine the feasibility and scalability of Medication Safety Need Rounds in LTCFs. Monthly Medication Safety Needs Rounds will be conducted in six LTCFs over six months. We will conduct a non-randomised mixed-methods feasibility study, guided by the Consolidated Framework for Implementation Research and key principles of feasibility studies, to answer the overarching question: ‘Can it work?’. Using a mixed-methods implementation and evaluation design, we will assess the feasibility of Medication Safety Needs Rounds on a small scale across multiple LTCFs, with a particular focus on the intervention acceptability, practicality, adaptation, integration into routine practice, implementation processes, demand, and associated resource requirements. We will also examine preliminary impacts on medication safety knowledge and skills, interprofessional communication/collaboration, and quality use of medicines indicators, while assessing the suitability of proposed outcome measures for future evaluation. A further objective is to evaluate the scalability of Medication Safety Needs Rounds across diverse LTCF contexts. Qualitative and quantitative data will be collected before, during and after implementation to evaluate the feasibility and scalability of the Medication Safety Needs Rounds. Study findings will be disseminated through a forum, plain language summaries, conference presentations and peer-reviewed publications.

This randomised split-mouth clinical trial will compare the effectiveness of three naturally capped silver nanoparticle formulations (casein-capped Ag1 and citrate-capped AgL1) with conventional silver fluoride/iodide therapy (AgF/KI; Riva Star Aqua™, SDI) for arresting dentinal caries in primary molars. Children aged 2–10 years presenting with bilateral, comparable active lesions will receive different agents on contralateral teeth, minimising inter-subject variability and reducing sample size while limiting cross-contamination. Following standardised plaque removal and isolation, baseline clinical measures, DIAGNOdent readings, and calibrated photographs will be recorded before topical application of each agent. Primary outcomes include caries-arrest rates at 3, 6, and 12 months and tooth colour change. Secondary outcomes assess lesion activity, retreatment need, pulpal symptoms, adverse events, microbial load reduction, patient/caregiver acceptability, and cost effectiveness. This study aims to identify aesthetic, antimicrobial alternatives to silver fluoride that maintain clinical efficacy while improving patient acceptance in managing early childhood caries.

We are conducting a research study to evaluate the feasibility and acceptability of 'Healthy Mum, Healthy Bub', a psychologist-supported digital support program designed for mothers who experience anxiety and who have concerns about their alcohol use during the first three years of motherhood. The program combines six weekly audio modules combined with two telehealth sessions delivered by a registered psychologist. We also want to test whether participation in the Healthy Mum, Healthy Bub program leads to greater reductions in anxiety and risky alcohol use, compared to a waitlist control group. Those assigned to the waitlist group will be offered access to the program and psychologist support after completion of the trial period (i.e., 4-month follow-up).

Neck pain is an important issue in primary headache with recent research suggests up to 40% of patients demonstrate signs of cervical musculoskeletal dysfunction. The clinical trial will use assessments prior to 4 weeks of treatment as usual, Day 1 of the 4 week treatment period, Day 1 post treatment and 3 / 6* and 12* months post treatment (*= 6 and 12 month post treatment assessments will only be completed if results at earlier timepoints indicate continued analysis is warranted) to examine whether multimodal physiotherapy targeted (manual therapy, exercises and education) influences frequency, severity, functional impact and characteristics of migraine events with neck pain and identified upper cervical rotation impairment. A second study will be an embedded pilot study with a minimum of 10 additional participants in individuals with no identified cervical upper cervical rotation impairment. We hypothesise that cervical treatment is more relevant and effective in the participants with identified cervical dysfunction. A third study involves interviews to explore patient experiences and opinions on the interventions 3 months following the completion of the treatment period.

The study aims to evaluate the adverse events, quality of life and oncological outcomes associated with stereotactic ablative radiotherapy (SABR) to the prostate and all metastatic sites for newly diagnosed metastatic prostate cancer, Who is it for? You may be eligible to join this study if you are aged 18 years or above and have newly diagnosed metastatic prostate cancer. Study details: Traditional radiotherapy for newly diagnosed metastatic prostate cancer typically involves four weeks (20 sessions) of daily treatment to the prostate (without radiotherapy treatment to the metastatic sites), on top of standard care systemic therapy. In this study, all participants in this study will receive SABR to the prostate and all metastatic sites delivered in two fractions, one fraction per week over 2 weeks, for a total of 24 Gy, in addition to standard care systemic therapy. Participants will complete questionnaires, blood tests during regular follow-up visits up to 5 years post-SABR completion to determine quality of life and efficacy outcomes, and adverse events. There will also be one PSMA PET scan at 3 months post completion of SABR treatment. It is hoped this study may provide evidence for a safe and effective, and more convenient radiation therapy schedule in the form of SABR, for patients with metastatic prostate cancer.

Every Australian deserves to age well. Dementia is a considerable threat to quality of life and is set to become the leading cause of death in Australia, yet we are not harnessing existing evidence for dementia risk reduction effectively. There is substantial evidence that 40% of dementia cases can be prevented by addressing modifiable risk factors and that individuals respond stronger to personal information than aggregated evidence. We know that individuals in longitudinal research projects benefit from receiving personal information, such as digital and biological markers that are indicators of dementia risk, yet we still don’t know if knowledge of this information will drive positive behaviour change. This project aims to bridge the gap between knowledge and practice by understanding how people respond to their digital and biological markers of dementia. We will co-design an online dashboard in which to present personal information, alongside personalized evidence-based recommendations to empower individuals to take steps toward positive behavior change. We will run co-design sessions with clinicians, participants, researchers, people living with dementia and their caregivers to ensure the messaging is presented in a safe, user-friendly and ergonomic fashion. We will then pilot test the impact of communicating this information on modifiable risk factors for dementia over time. We will also investigate how wellbeing, self-efficacy and quality of life change as a result of receiving this information. By harnessing personal resonance, we can enact positive behaviour change, improve quality of life and ultimately reduce dementia risk, ensuring Australians can live better for longer.

A healthy volunteer study testing a new oral insulin, EA-Ins-IQ-100.. This study will assess the safety, tolerability, and pharmacokinetics of different doses of EA-Ins-IQ-100 after single oral administrations.