ANZCTR search results

This study is a pilot randomised, placebo-controlled clinical trial to determine the effects of a single dose of two amino acids L-theanine and L-Glycine (The-Gly) on resting cardiovascular responses in postmenopausal women. This study involves two visits, one for the measurement of baseline parameters and second visit for the intervention and 60 minutes and 120 minutes follow up.

Initial treatment of snake bite involves early first aid with the application of a pressure bandage and immobilisation (PBI) of the limb. There is limited data to support the basis of this technique and emerging evidence of harm when applied incorrectly. This project sets out to evaluate PBI compared to another technique involving the application of a pressure pad (PP) at the bite site (which is easier to do, and used in most countries outside of Australia), The project aims to determine whether each technique is effective, and whether the PP technique is at least as effective as PBI. To do this 24 participants will be recruited to undergo study with mock venom injected into their hand or foot and having either PBI or PP applied. The mock venom will then be traced with a gamma camera to determine rate of flow through the lymphatic system, which is how venom travels in the body. It is expected that the project will demonstrate the efficacy of both techniques, and that the PP will be at least as effective as PBI. This will provide a basis for change in the current first aid recommendations for snake bite first aid in Australia, and improve the care provided.

This study will explore the efficacy of the mobile health app, cpThrive. Families of children with CP will participate in the study, using cpThrive for 12 months to explore whether this improves health knowledge and impacts function. cpThrive is a mobile app that has been co-designed with people with lived experience, to provide people with cerebral palsy and their families with up to date information on intervention options. cpThrive allows users to search interventions that are relevant to their age, functional ability and current goals and priorities. It includes fact sheets and real-life video examples of interventions. cpThrive aims to improve access to health information, which may in turn lead to improvements in function and participation.

The research questions will be addressed using a small, carefully controlled clinical study administered to adult contact lens wearers. This research aims to find out whether a new contact lens packaging solution improves comfort for people who wear contact lenses compared to the current solution and to two other commercially available contact lenses on the market. The study will explore how comfortable the lenses feel after six hours of wear and whether the new packaging helps reduce the build-up of natural deposits on the lenses. Each participant will try four different types of daily disposable contact lenses over several weeks at UNSW Sydney’s Eye Research Group clinic. Participants will be fitted with each lens type in a randomised order (like flipping a coin). Participants will insert the allocated study lens in the morning on Day 1 and return on the same day after 6 hours of lens wear. Participants will provide feedback on comfort and vision, their eyes will be assessed and the worn contact lenses collected. Participants will then be dispensed with a 7-day supply of that same lens type and asked to wear the lenses during the week and return for follow-up assessment after wearing the lenses for 6 hours at the 7-day follow-up visit. Simple eye tests and questionnaires will be used to collect information, and lenses will be examined after wear to understand how well they stay clean. These methodologies and target populations are appropriate to meet the research aims because the study design allows direct comparison between lenses under real-world conditions. Experienced contact lens users can reliably describe comfort differences and follow the required routines safely. This approach will help determine whether the new packaging solution offers practical improvements for everyday lens wearers.

Burnout and poor wellbeing are commonly experienced by healthcare workers. Patient safety may be affected by healthcare workers' level of burnout and wellbeing. The ‘ACT in the Workplace’ program is based on an evidence-based workplace intervention. This project aims to determine if the ‘ACT in the Workplace’ program and its evaluation are feasible and acceptable to Australian healthcare workers to help design a future, larger study. Additional aims include exploring if the program changes levels of burnout and wellbeing, psychological flexibility, perceptions of the organisation, and sleep quality. The program is a group training for healthcare workers, involving three 2-hour meetings and a follow-up 2-hour meeting scheduled over 4 consecutive weeks. For healthcare workers attending the program who consent to participate in the study, participation will involve completing questionnaires using REDCap taking 7 minutes three times: before the program starts, just after completing the program, and 3 months after completing the program. We expect the program will be feasible and acceptable to Australian healthcare workers, and will improve wellbeing and reduce burnout. This is the first study to evaluate the program implementation among Australian healthcare workers.

Patient-reported antibiotic allergy labels are a major public health concern with an estimated 18% of all hospitalised Australians reporting an antibiotic allergy. In one study, the prevalence of paediatric antibiotic allergy labels was 5.3%, with an increasing incidence of reported antibiotic allergy labels with age. Paediatric inpatients with an antibiotic allergy are more likely to receive inferior antibiotics and those reporting a beta-lactam allergy are more likely to have a prolonged hospital length of stay. In the paediatric population, penicillin direct oral challenge has been demonstrated to be a safe delabelling strategy in the outpatient setting, however the safety and effectiveness of paediatric inpatient direct oral challenge and its subsequent impact on antibiotic prescribing and antimicrobial resistance is ill-defined. Furthermore, a national implementation strategy for an effective paediatric antibiotic allergy toolkit has not been previously published. We seek to prospectively audit implementation of paediatric clinical antibiotic allergy delabelling programs, via the International Network of Antibiotic Allergy Nations (iNAAN) platform, to assess safety and the subsequent effects of antibiotic allergy delabelling on antibiotic prescribing and patient outcomes.

This study aims to find out how safe and well-tolerated a new oral form of esketamine, called GM-28K, is when taken by healthy adults. Esketamine is a medicine that affects certain brain pathways involved in mood regulation and is already used in other forms to treat depression. GM-28K has been developed as a capsule taken by mouth, which may provide a simpler and more comfortable way to deliver the medicine compared to the existing nasal spray or injection forms. In this study, participants will receive a single dose of GM-28K or a placebo capsule (which does not contain active medicine). The main goal is to check for any side effects and to understand how the body processes the medicine by measuring its levels in the blood and urine over time. The results will help determine a safe dose range for future studies in people with depression or other conditions that may benefit from this treatment.

This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous CBP-4888-101 in hospitalised participants with preterm preeclampsia receiving standard of care, expectant management. Eligible participants are between 26 +0/7 and 35 +6/7 weeks gestational age and clinically appropriate for inpatient expectant management. Eligible participants will receive standard of care expectant management for their pregnancy with the only study intervention being one subcutaneous dose of CBP-4888.

The study aims to assess the feasibility of referring emergency department patients with chronic conditions to a telehealth exercise physiology consultation. Secondary aims will compare the exercise physiology consult with control (exercise advice via written information) exploring the feasibility of collecting patient reported outcomes on health service use, hospital reattendance, and projected financial costs. Participants will include emergency department patients with chronic conditions (present for at least two months, with a need for ongoing management) who are expected to be discharged to the community. Participants will complete a brief electronic survey at baseline and at one- and two-month post-discharge follow-up. The anticipated outcomes include enhanced continuity of post-emergency department care, improved health outcomes for individuals with chronic conditions, and a reduced burden on emergency departments. These findings will inform the feasibility and value of scaling this model within other emergency departments, with potential for application to a broad range of patients and allied health services.

This study aims to investigate the absorption of quercetin, a naturally occurring flavonoid antioxidant abundant in onions, apples, and tea, in healthy adults. Participants will receive low and high doses of quercetin, provided in both food and capsule forms, equivalent to the amount naturally found in two to three onions. Researchers will assess quercetin bioavailability using urine measurements to determine how dietary components such as soluble fibre and fat influence absorption. The goal is to compare the effects of dose and food matrix on quercetin uptake. The findings will provide valuable insights into how food composition affects quercetin bioavailability in humans.