ANZCTR search results

Regional anaesthesia involves using needles to inject a drug close to target nerves. As this carries risks, doctors must obtain verbal and/or written informed consent from patients, meaning they agree while understanding the procedure and associated risks, benefits, and alternatives. However, clinical practise for this skill is often opportunistic, inconsistent, or informal, leading to generative AI-based virtual patients being considered as an emerging teaching technology. This project aims to explore if a generative AI-based virtual patient can be effective in teaching informed consent for regional anaesthesia. First-year trainee anaesthetists will be assessed for consenting skill before and after a 60-minute AI virtual patient training session to determine this.

This study aims to test whether the PAIR Model, a relationship-focused approach to early childhood intervention, can be successfully used in a hospital infant clinic and improve families’ experiences of care. Health professionals at the Queensland Children’s Hospital will be trained to place greater focus on supporting parent–infant relationships during routine therapy sessions. Families receiving PAIR-informed care will be compared with families receiving usual care. The study hypothesises that families receiving PAIR-informed care will report better engagement with therapy and improved goal attainment. Results will inform whether this approach is suitable for wider use in hospital-based early intervention services.

In brief, the REPAIR-W pilot study is designed to examine the effects of single-session memory reconsolidation blockage (i.e., script driven trauma recall administered under propranolol) in women with probable PTSD/TSRD (IES >33), and to determine whether menstrual cycle–related oestradiol variation moderates symptom response. We hope to categorise n=20 naturally cycling women (aged 18-40 years) into "high" (n=10) versus "low" (n=10) oestradiol groups, corresponding to the late versus early follicular phase of the menstrual cycle, respectively. The aim is not to deliver definitive treatment in a single session, but to isolate the role of oestradiol in modulating reconsolidation effects. Symptom change will be assessed one-week, and one-month post-session, with the a priori expectation that (1) measurable symptom reduction will occur, and (2) oestradiol status will influence the magnitude of this effect.

Current treatment strategies for SSc are targeted towards inflammation and pain relief, however they have a modest impact on addressing exertional intolerance, functional disability and their underlying physiology. On the other hand, there is a lack of defined evidence into other preventative non-pharmacological therapeutics such as exercise training in the clinical management of SSc. Due to its multifactorial effects on organ systems, exercise training has been proposed as an ideal adjunct strategy to address functional impairment, symptomatology and/or organ involvement in patients with SSc. However, the efficacy of exercise training in patients with SSc has primarily been explored in small pilot studies with safety-related or patient-reported endpoints. The impact of exercise to alter the physiologic factors that are contributing to symptom burden and morbidity in SSc has not received sufficient attention. Consequently, we want to evaluate whether a goal-directed exercise approach could be efficacious in addressing functional disability.

This project is testing the safety and pharmacokinetics of a single oral dose of a new drug called GBP-088 when given with and without food. GBP-088 is being developed for the treatment of recurrent kidney stones. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. You will receive a single oral dose of active study drug on Day 1 under fasted conditions. After a 4 day washout period you will receive the same oral dose of active study drug given after eating a high fat, high calorie meal. It is hoped that this research will help determine the safety of GBP-088 when given to healthy men or women so that it can be tested in patients with recurrent kidney stone disease

The study aims to evaluate the performance of the Lubdub AECG device compared with a clinically accepted AECG device used in routine clinical care. Participants who are already referred for AECG monitoring will wear both devices at the same time for 24 to 48 hours. The study will assess the technological performance of the Lubdub AECG device during normal daily activities compared to the comparator AECG device. We expect to evaluate if the Lubdub AECG device will provide ECG recordings, signal quality and technological performance comparable to the clinically accepted AECG device, while maintaining high levels of participant usability and comfort.

Opioid overdose is a major public health issue, causing significant morbidity and mortality. Naloxone is a drug for reversal of opioid overdose and is typically administered through intravenous or intramuscular injection. Intranasal administration of naloxone has several advantages over injection, particularly ease of use and removal of the risk of needle stick injury. This study is a randomised controlled trial to test the hypothesis that naloxone administered intranasally will be non-inferior to naloxone administered intramuscularly in achieving an adequate response (no requirement for a rescue dose of intramuscular naloxone). There is limited quality evidence about intranasal naloxone efficacy. Previous trials used volumes greater than the now-recommended optimal delivery volume for intranasal drug administration, of equal to 0.2ml per nostril, or smaller doses than those typically used in the Australian context. Our trial will evaluate the efficacy of a concentrated naloxone spray (2mg/0.1ml) compared to the 800mcg intramuscular standard in reversing the effects of opioid overdose and the production of any naloxone-associated side-effects.

Prostate cancer recurrences have limited treatment options with current whole gland surgery or systemic therapy associated with significant morbidity. Focal therapy with the Profocal laser may offer men with recurrent prostate cancer post-radiotherapy a safe and efficacious treatment option. This study will assess the safety of the laser focal therapy device in 40 men.

Dizziness is one of the most common and disabling symptoms after an acquired brain injury (ABI), such as concussion or traumatic brain injury. Many people begin to avoid movements, places and activities that bring on their dizziness, which can slow recovery, increase the risk of falls, and affect mood, work and quality of life. Standard vestibular (balance) rehabilitation gradually exposes people to movements and environments that provoke symptoms, but is usually delivered using simple 2D videos that lack real-world realism. This study will recruit participants to take part in a virtual reality (VR) program delivered by trained clinicians during their usual outpatient rehabilitation sessions at the Brain Injury Rehabilitation Service (BIRS) Day Hospital or Concussion Clinic at the Princess Alexandra Hospital. Participants will wear a VR headset and be gradually exposed to virtual environments that vary in visual busyness and movement, chosen and progressed by their treating clinician based on their individual symptoms and goals. The sessions will last for about 30 minutes. Questionnaires and balance assessments will be completed before and after the program, and some participants and clinicians will be invited to a short interview about their experience. It is hoped this study will show that VR-based graded exposure is practical, safe and acceptable in outpatient brain injury rehabilitation. The study will also be used to provide early evidence about its effects on dizziness, avoidance of activity, anxiety and everyday function. The findings will inform a future larger controlled trial.

This research study is an observational, single site study quantifying expression of biomarkers of respiratory disease in nasal fluid using the ABEL microsampler device. The primary objective of this study is to compare biomarker expression between healthy controls and participants with respiratory disorders such as chronic obstructive pulmonary disorder (COPD), hayfever, chronic sinusitis, asthma and rhinitis.