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Evaluation of comfort and surface properties of various soft contact lenses
Expand descriptionThe 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.
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Acceptance and Commitment in the Workplace: Feasibility Trial for Australian Healthcare Workers
Expand descriptionBurnout 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.
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An audit of antibiotic allergy assessment and test-dose challenge in hospitalised paediatric patients using a patient registry.
Expand descriptionPatient-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.
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GM-28K in Healthy Adult Participants
Expand descriptionThis 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.
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A study to investigate the safety, pharmacodynamic and pharmacokinetic characteristics of CBP-4888 in hospitalized participants with preterm preeclampsia and the safety and tolerability of CBP-4888 on their children.
Expand descriptionThis 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.
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Evaluating Pathways to Integrate Care using Exercise in the Emergency Department: A hybrid implementation effectiveness pilot study in patients with chronic conditions (EPIC-ED)
Expand descriptionThe 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.
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Determining the absorption of natural flavonoids from food in healthy subjects
Expand descriptionThis 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.
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How accurate are smartphone apps that use artificial intelligence to detect skin cancer in Australian adults?
Expand descriptionThis study aims to determine whether the artificial intelligence smartphone applications for skin screening are effective at providing an accurate diagnosis of melanoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a suspected melanoma and/or clinically benign skin lesion. Study details. The accuracy of smartphone applications will be tested by taking photos of the skin lesions and comparing the smartphone applications evaluation against the histological gold standard diagnosis by a dermatologist. If the study shows that these applications are accurate, this will allow greater acceptance of them for medical use. If inaccurate, it will raise concerns about the need for more regulation of these applications due to the health risk posed.
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Collaborative Response for Overlapping Symptoms of Somatic and Mental Illness in Neurological Disorders
Expand descriptionThis study aims to provide comprehensive insights into the clinical course, relapse rate, treatment outcomes, and potential adverse events experienced during immunosuppressive therapy for participants presenting with neuropsychiatric symptoms related to autoimmune or inflammatory processes. The information obtained through this project is intended to provide information to guide clinicians' decision-making process, particularly in relation to selecting appropriate therapeutic approaches for managing these varied and complex neuropsychiatric syndromes. By elucidating the effectiveness and potential risks associated with immunosuppressive therapy in our cohort, we aspire to make a substantial contribution to the enhancement of participant care and the optimization of treatment strategies for this challenging and multifaceted medical condition. Adult participants over the age of 18 with a diagnosis of autoimmune encephalitis made by the treating neurologist/immunologist and who received a trial of immunosuppressive therapy (e.g. corticosteroids, intravenous immunoglobulins, plasmapheresis, cyclophosphamide, rituximab, mycophenolate) will be included in an analysis of clinical data collected from eMR records. Research samples and data will be collected only after participant consent is obtained, up to November 30, 2030. Data will be collected from the Western Sydney Local Health District (WSLHD) eMR and will include information readily available in the clinical notes and letters, discharge and admission summaries, pathology results, or any other forms of documentation available on eMR. Data will be re-identifiable at time of collection but will be de-identified at time of analysis. Blood samples for biobanking for future research will be collected after receiving participant consent, by drawing additional tubes for research purposes during routine blood draws in clinic at Westmead Hospital. This study will be storing participant blood and tissue samples via the SWIFT Biobank: Sydney West Immunology Forum for Translational Research: Clinical Database and Biobank (2019/ETH02568) study, which has ethics approval to establish biobanks for various immunological conditions.
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Living well with chronic kidney disease (CKD): Effect of a revised model of care (group-based education and skills based workshops) on quality of life in people with chronic kidney disease (CKD)
Expand descriptionChronic Kidney Disease (CKD) affects 1 in 10 adults in Australia and, if unmanaged, can lead to heart disease and kidney failure. This clinical trial aims to compare the effectiveness of a structured, group-based multidisciplinary education program for people with CKD Stage 3a and 3b against usual care. The program includes five group sessions focused on managing blood pressure, diabetes, weight, smoking, diet, exercise, medications, and personal health planning. Key outcomes include changes in kidney function, lifestyle behaviours, quality of life, and cost-effectiveness, with additional evaluation of patient and carer experiences and feasibility for routine implementation. The study also seeks to determine the cost utility of the revised model from the perspective of the Australian healthcare system.