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VIRGo – Vaccine-induced Immune Responses against Gonorrhoea: A study to investigate immune response induced by the 4CMenB vaccine against gonorrhoea
This study is a prospective observational cohort study in males and females, investigating the immune response in people vaccinated with the Neisseria meningitidis serogroup B (MenB) vaccine 4CMenB. Participants will receive 2 doses of 4CMenB vaccine 2 months apart by intramuscular injection. Gonorrhoea-specific immune responses will be measured to characterise possible mechanisms of vaccine-induced protection against gonorrhoea and to identify immunodominant antigens in 4CMenB and potential future gonorrhoea vaccine-candidates.
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Group therapy for dysarthria following stroke and brain injury compared to individual therapy
Dysarthria occurs in up to 40% of people following stroke and brain injury leading to difficulties participating in daily communication activities, social and work roles and wellbeing. Traditionally, people with dysarthria are treated one on one by a speech pathologist which is relatively costly. This pilot study aims to explore the feasibility of implementing a group therapy model compared to individual therapy in inpatients with nonprogressive dysarthria, to inform the implementation of a larger trial. We aim to recruit 24 inpatients with dysarthria who will randomly receive either group therapy or individual therapy in hospital and be assessed before and after their treatment. The results of this pilot study will give us important information about patient, carer and clinician satisfaction, and costs and practicalities of implementing group therapy which would help develop a larger research trial to run across Australia.
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An open-label, multiple dose study to compare the single-dose and steady-state pharmacokinetics of a 40 mg PHA-022121 extended-release (XR) tablet administered once daily between healthy Japanese, Chinese, and Caucasian volunteers.
This is a Phase 1, open label, multiple oral dose study in healthy adult Japanese, Chinese, and Caucasian volunteers, to compare the single-dose and steady-state pharmacokinetics of a 40 mg PHA-022121 extended-release (XR) tablet administered once daily, and to assess the safety and tolerability of multiple oral doses of PHA-022121.
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Apps and Peer support for a Healthy future and Living Well with Diabetes – Mental Health
Overall, 40-60% of youth with Type 1 or Type 2 diabetes have a mental health condition, affecting their lives, ability to self-manage their diabetes and increasing their risk of complications. Limited access to mental health services aggravates the situation. Our project addresses this through a technology-enabled model of care, leveraging access to peer support and a clinically-validated digital platform. A 6-month randomised controlled trial will rigorously test how well this model works in the ‘real world’ across eight hospitals in improving young people’s mental health (particularly distress), well-being and physical health (eg blood glucose), and reducing health care costs and burden.
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Apps and Peer support for a Healthy future and Living Well with Diabetes – Non-Mental Health
Overall, 40-60% of youth with Type 1 or Type 2 diabetes have a mental health condition, affecting their lives, ability to self-manage their diabetes and increasing their risk of complications. Limited access to mental health services aggravates the situation. Our project addresses this through a technology-enabled model of care, leveraging access to peer support and a clinically-validated digital platform. A 6-month randomised controlled trial will rigorously test how well this model works in the ‘real world’ across eight hospitals in improving young people’s mental health (particularly distress), well-being and physical health (eg blood glucose), and reducing healthcare costs and burden.
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A Phase 1b open label study of the pharmacokinetics and safety of oral OCX063 in adults with chronic kidney disease
This is an open label study to measure the PK of oral OCX063, over 28 days of dosing in participants with chronic kidney disease (CKD). The study will be run in sequential cohorts, with the first 6 participants receiving a 50 mg dose of OCX063 per day and the following 6 participants receiving 100 mg OCX063 per day. An additional dose cohort of 25 mg or 75 mg may be added if PK data indicate that a lower dose may provide adequate exposure levels. Safety will also be assessed.
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A Phase 1, 2-Part, Open-Label, Pilot Trial to Assess the Relative Bioavailability of 3 Formulations of Cannabidiol (CBD) under FASTED (Part A) and FED (Part B) conditions in Healthy Adult Male Subjects.
This is a single-center, Phase 1, randomized, open-label, 3-treatment, 4-period, 3-sequence crossover study designed to compare the relative bioavailability of two novel CBD formulations (SAP-021-T1 and SAP-021-T2) and reference formulation (Epidiolex) under fasting conditions and to evaluate the effect of food on the bioavailability SAP-021-T1 or SAP-021-T2 in healthy male subjects.
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Muscle growth and anabolism in intensive care survivors
Intensive care patients can face significant health issues that extend beyond their Intensive Care Unit (ICU) stay. Despite recent advances it is estimated that one-quarter to one-half of long-stay intensive care survivors live with significant weakness as a consequence of their illness, resulting in impaired mobility and function. The loss of muscle mass in critical illness is related to immobility and a complicated process that causes muscle and nerve dysfunction called critical illness polymyoneuropathy. Another contributory factor is low levels of anabolic (muscle building) hormones such as testosterone – with testosterone levels in critically ill patients are extremely low, even in the recovery phase from acute illness. One potential treatment may be to provide anabolic support in the recovery phase from prolonged critical illness. This project aims to test whether giving a synthetic testosterone (nandrolone), will improve muscle strength in ICU survivors, when compared to placebo. Previous research has already established that early physiotherapy in the ICU can reduce length of stay and improve patients outcomes. In this study, both groups will receive standard care, which includes early physiotherapy. Nandrolone or placebo will be administered intramuscularly weekly for up to 3 weeks. Outcome measures will include hospital length of stay, time until the patient walks with assistance, muscle strength (globally and grip strength) as well as the patient’s physical functioning at 3 months following enrolment. The study design will be a double blinded randomised controlled trial. The teams involved are multi-disciplinary, involving physiotherapy, dietitians, pharmacy as well as medical specialists. The investigators have already successfully conducted a pilot feasibility trial of a nandrolone versus placebo, showing that the intervention is safe and feasible
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A prospective case-control study to develop biomarkers for individualised visual perturbation responses in epilepsy patients
The primary objective of this study is to characterise the response to perturbation in epilepsy patients and healthy controls. This project will develop objective biomarkers to track changes in cortical excitability. These can be used to develop individualised response profiles that could be used in a clinical context to monitor a patient’s state including seizure risk, to evaluate anti-seizure medication (ASM) efficacy, and to predict outcomes like time to seizure freedom.
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Timely post-discharge medication reviews to Improve Continuity – the Transitions Of Care stewardship (TIC TOC) study in rural and regional Australia
After hospital discharge, over 90% of Australians have at least one medication-related problem. Transitions of care are a period when the risk of medication errors and adverse events is high. Improving medication safety at these transitions is one of three flagship areas of the World Health Organisation Global Patient Safety Challenge: Medication Without Harm. In Australia, an estimated 250,000 hospital admissions annually are medication-related, costing $1.4 billion per year. In particular, rural and remote Australians are up to 2.4 times more likely to have a preventable hospitalisation than non-rural Australians. Furthermore, Aboriginal and Torres Strait Islander people, who often live in rural and regional areas, are three times as likely to have a preventable hospitalisation than non-indigenous Australians. Medication-related hospital readmissions in rural and regional Australian hospitals have been shown to be due to inappropriate/suboptimal pharmacological therapy at discharge in 62% of cases and inadequate communication/monitoring in 41% of cases. Due to pharmacists’ expertise in medication management, two systematic reviews have shown that pharmacy-led transitions of care services can successfully reduce hospital readmissions. These systematic reviews showed that the combination of (i) targeting specific patient populations and (ii) utilisation of an effective transition of care stewardship (TOCS) intervention reduced 30-day readmissions with the meta-analysis showing a 32% reduction in odds for readmission. These TOCS interventions included discharge counselling, discharge medication reconciliation and medication reviews. In Australia, the Commonwealth funds pharmacist led HMRs, which have been shown to reduce medication errors and unplanned hospital readmissions if provided promptly. When high-risk patients receive a timely post-discharge HMR, the rates of unplanned readmission reduce (45% vs 28%, P<0.05). Despite this, strategies (i) and (ii) described above are not routinely implemented and the provision of HMRs to high-risk patients after discharge is unacceptably low at 1-2%. A recent study by our team (2022) explored the reasons for low uptake of post-discharge HMRs. We found many implementation issues that are reflected in the Consolidated Framework for Implementation Research (CFIR). These include the (i) outer setting (GPs not remunerated for participating in hospital-initiated medication reviews, HMR numbers capped for pharmacists, pharmacists not funded for case conferences), (ii) inner setting (limited staffing for transitions of care), (iii) processes (lack of streamlined pathways, no risk tools used) and (iv) individuals involved (poor prescriber awareness). To address these concerns, our team developed the SHPA Hospital-initiated Medication Review protocols to support hospital clinicians to facilitate timely post-discharge medication reviews.