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An alternative model of care for liver health care for First Nations patients living in remote communities
Colonisation has, and continues to, negatively impact the health and wellbeing of First Nations peoples, which is further exacerbated by unequal access to health services especially in rural and remote communities. Liver disease and liver cancer are growing concerns for First Nations peoples due to increasing incidence rates. Disparities in liver disease outcomes, especially for those residing in rural and remote communities, are exacerbated by key barriers such as the lack of access to specialist care and the need to travel substantial distances Off-Country to access testing and treatment. This project aims to address these health inequities by exploring new ways of diagnosing and managing liver disease in rural and remote communities using non-invasive technologies On-Country. Who is it for? You may be eligible to participate in the liver check phase of this study if you are an Aboriginal and/or Torres Strait Islander person aged 25 or older and has at least one risk factor for liver disease. You will be eligible to participate in the liver monitoring phase if you have been identified during the screening phase of having compensated advanced chronic liver disease. Study details In the liver check phase, eligible participants will have a liver health assessment alongside their routine annual health check. This phase will include simple fibrosis tests that will help identify anyone at potential risk of liver disease complications. This risk will be confirmed by an On-Country scan (using a FibroScan) that will enable diagnosis of advanced liver disease. Participants identified to be at risk of liver cancer in Phase 2 will be invited to take part in Phase 3, the liver monitoring phase. This phase of the project will be a stepped-wedge randomised trial to compare two models of liver cancer surveillance — the current model of care and the study On-Country model of care. The new model of care will allow participants to have 6 monthly ultrasounds On-Country (performed by an experienced ultrasonographer) in conjunction with serum biomarker tests for liver cancer. Yarning circles will be incorporated at the end of Phase 2 and Phase 3 to explore participant experiences in the study, their knowledge of liver disease and views on the different models of care. It is hoped that the result from this study will help to demonstrate the feasibility of providing quality liver health care On-Country to First Nations peoples living in remote communities.
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Type 1 Diabetes National Screening Pilot: General Practice Feasibility and Acceptability Study
DESCRIPTION: This is a follow-on study from the Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study (ACTRN12622000381785). In this study we will explore the feasibility and acceptability of embedding general population screening for type 1 diabetes into primary care in Australia, by pairing it with routine immunisation +/- health check appointments (6 weeks to 6 months of age). Participating children will be screened for their genetic rick of developing type 1 diabetes in childhood (using a polygenic risk scrore (GRS2)), and those at increased risk will be monitored for type 1 diabetes autoantibodies annually from ages 1 to 5 years. The primary outcome is uptake rate, and recruitment will be capped at 300 children. HYPOTHESIS: General population screening for type 1 diabetes in primary care is feasible and acceptable, without causing significant parental distress.
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Investigating the impact of normal tissue objectives in treatment planning for stereotactic body radiation therapy
This study aims to provide a dosimetric comparison between plans using the Stereotactic Body Radiation Therapy Normal Tissue Objective (SBRT NTO) feature in Eclipse version 18 (v18.0) planning system and those using the standard NTO settings currently utilised in our department. Who is it for? Ten lung and ten nodal/bone metastasis stereotactic body radiation therapy (SBRT) plans that were previously treated at our institution from July 2022 until December 2024. The study may include patients with one or two targets. Study details: Once the participants are deemed eligible they will be randomly selected and anonymised. The de-identified datasets of the selected patients and corresponding plans will be sent to an Eclipse v18.0 test system where they will be replanned using the SBRT normal tissue objective (NTO) feature by the PI. After replanning, the impact of SBRT NTO on plan metrics for lung and nodal/bone metastasis SBRT plans and the effectiveness of Eclipse 18 will be compared to previously clinically accepted plan. It is hope that the results from this study will provide a solution to automate the process of enforcing sharp dose fall-off around the target and eliminates the need for time-consuming manual contouring of optimisation structures.
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Omega-3 supplementation on behaviour, mental health and cardiovascular health
The purpose of this research study is to see if omega-3 fats (the healthy fats) can improve on various health conditions, including depression, anxiety, stress, impulsive behaviour, as well as risk factors for heart disease, which will be measured in a blood sample. Study participants that have volunteered for this study will be provided with the omega-3 supplements which they will take daily for up to 16 weeks. They will attend 2 clinic visits before and after omega-3 supplementation, provide blood samples and answer various questionnaires at both clinic visits, so we (the researchers) can see what potential improvements have been made to the various health conditions.
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EMPOWERED-GP: Evaluating the Effectiveness of Education through online Media around Pregnancy planning and cOntraception for Women's EmpoweRmEnt in Diabetes in General Practice: a feasibility, acceptability and efficacy study.
This project aims to improve the engagement of general practitioners (GPs) in discussions with women of reproductive age with pre-existing diabetes mellitus, regarding preconception care (PCC) and effective contraception to address the risks associated with elevated HbA1c levels. The research includes an audit of eMRs from the past 5 years, and a knowledge assessment questionnaire, pre- and post-implementation. The implementation phase involves an eMR alert system to assist GPs in assessing participants' pregnancy intentions within the next 12 months, while educational resources will be provided to participants. The results of this study will inform clinical practice and public health measures at NBMLHD and around Australia on improving PCC and effective contraception among women of reproductive age with pre-existing diabetes in GP setting. A specific Medicare item for these consultations could also facilitate audit and incentivize GP.
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Short term haemodynamic effects of high flow humidified nasal oxygen in pregnant people with hypertension – a pilot study
This is a single arm interventional study investigating the effect of short duration high flow nasal oxygen on blood pressure in pregnant people with a hypertensive disorder of pregnancy. Our hypothesis is that this therapy will either lower or not significantly alter systolic and diastolic blood pressure levels in this population. We are also collecting important consumer feedback data around therapy comfort. These findings are key feasibility challenges if larger trials examining high flow nasal oxygen during sleep in pregnant people are to be considered.
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Safety and Tolerability of CLB-4000 in Subjects with Chronic Hepatitis B: Randomised cohort
Summary A Phase 1b Study Evaluating the Safety and Tolerability of CLB-4000 with or without Peg-IFNa-2a in Subjects with Chronic Hepatitis B Who is it for? You may be eligible for this study if you are an adult aged between 18 and 60 years old with chronic hepatitis B. Participants in this study will be randomly allocated (by chance) to one of two treatments: - Arm 1: CLB-4000 (250 µg CLB-405 and 250 µg CLB-505 adjuvanted with 400 µg TQL-1055), or - Arm 2: CLB-4000 (250 µg CLB-405 and 250 µg CLB-505 adjuvanted with 200 µg TQL-1055) with 180 µg Peg-IFNa-2a Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-4000 on Days 1, 30, 60, 90, and 120. Subjects participating in arm 2 will self-administer or have a caregiver administer a weekly subcutaneous injection of Peg-IFNa-2a 180 mcg for 8 weeks during a run-in period and then for 16 weeks during the CLB-4000 treatment phase following injection training and instructions on proper storage and disposal by a clinician. The end of the study is defined as the last subject last visit at Day 300. The estimated duration of the study is approximately 11 months or, for subjects participating in Peg-IFNa-2a arms, 13 months.
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Driver Sleepiness Detection Device – Optimising Road Safety by Targeting Sleepiness on Australian Roads
A laboratory-based study will recruit adults 18-75 years (healthy sleepers, shift workers, and individuals with sleep apnoea). Participants will be exposed to a 29-hour extended wakefulness protocol as part of the intervention. During this time, participants will complete cognitive testing, vestibular and ocular motor (VOM) assessments, and driving simulators. The study will determine whether changes in VOM reflexes, measured objectively by the NeuroFlex device, can identify those who are sleepy and at risk of a motor vehicle accident during an extended wakefulness protocol.
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An examination into the safety and efficacy of Khapregesic®, a Khaya senegalensis preparation, on vasomotor, physical, and psychological wellbeing in women experiencing perimenopause and menopause
In this randomised, double-blind, placebo-controlled study, 140 women aged 42 to 62 years experiencing menopausal symptoms will be randomly assigned to receive 2 grams daily of a proprietary preparation of pure Khaya Senegalensis Dry Stem Bark (Khapregesic) or a placebo for 28 days. Changes in menopausal symptoms, sleep, and fatigue will be assessed before, during, and after the intake of the investigational product. It is hypothesised that compared to the placebo, Khaya Senegalensis will be associated with greater improvements in menopausal symptoms, sleep and fatigue.
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An Open-Label Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
The purpose of this protocol is to allow for subjects who have previously been enrolled in and completed an Avalyn Pharma Sponsored study of an inhaled antifibrotic, such as AP01, to continue therapy until drug approval, study termination, or withdrawal of the subject from the study.