ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31173 results sorted by trial registration date.
  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • Assessing the impact of blood pressure targets and surgical approach (laparoscopic or open) on continuous urinary oxygenation in patients undergoing general surgical procedures

    The impact of blood pressure targets and surgical approach (laparoscopic or open) on continuous urinary oxygenation (PuO2), a validated surrogate of renal medullary PO2, during general surgery is unclear. We aimed to assess the effects of different blood pressure targets and surgical procedures on PuO2. In this pilot, single centre, randomised controlled physiological study, patients were allocated to usual mean arterial pressure target management or a slightly higher mean arterial blood pressure target as managed by the treating anesthetists during the operation. The primary outcome was the mean urinary oxygen value during the operation. In doing so, our trial has explored the complex relationship between blood pressure targets, surgical procedures, and renal oxygenation and guide future investigations aiming to personalise renal protective perioperative management stratagies.

  • The effects of exercise training on small blood vessel health in individuals with type 2 diabetes and in overweight and obese older participants.

    Microvessels are the smallest type of blood vessels inside every organ of the human body. They are approximately the size of a human hair, or smaller. There are approximately 100,000 km of these microvessels in humans and they are crucial for human health and wellbeing, as they are responsible for maintaining tissue nutrition including the delivery and exchange of oxygen. Microvessels are capable of undergoing structural and functional change during growth and development and they respond and/or adapt to stimuli including heating and exercise. Microvessels may become dysfunctional, causing symptoms that affect the skin, kidneys, eyes, muscles, nerves, heart and brain. These microvessel diseases are particularly common in people with cardiovascular diseases, obesity and diabetes. However, at present, we know very little about microvessel function and health in humans due to the lack of direct and reliable imaging methods. The aim of this study is to use optical coherence tomography (OCT) techniques to quantify and compare the effect of exercise training and repeated body heating on the health and function of skin microvessels in individuals with T2D, and in older overweight and obese persons. We will also measure artery function in large arteries in the limbs and the brain, alongside heart function, to determine which of these factors impact on microvessel function. The exercise training will consist of 3x per week aerobic training (i.e. cycling/fast-paced walking) for 40 minutes during 12 weeks. There will be two centre-based and one home-based exercise session per week. Centre-based sessions will consist of cycling at range from 60 to 75% of individuals' maximum heart rate, depending on the exercise block, with less intense warm-up and cool down periods. Home-based sessions will consist of a fast-paced walking also meeting the desired heart rate training zone (60-75% of maximum hear rate). The heat therapy will be fully centre-based and will consist of 3 session per week, with a duration of 40 minutes each session, for 12 weeks. Individuals will remain in a hot tube at 40°C for 40 minutes.

  • Live student-actor simulation versus video-based learning for Situational Awareness in Primary and allied Health care: Integration, Research and Education (SAPHIRE)

    Teaching of clinical decision-making skills is a complex task undertaken by educators of health professional degrees. Simulated learning approaches are now commonplace, but it is unclear how they can best be delivered. They can be conducted “live” using professional actors or students as role-playing actors, or be video-taped for non-live learning. It is unclear both whether how live versus non-live simulated learning approaches generate the same benefits for student learning, nor how much of each approach is needed to generate measurable improvements. In this research we will compare live delivery of simulated learning using students as role-playing actors with video-taped versions of the same simulated scenarios. We will also compare providing varying amounts of each form of training to determine how much is required to generate a measurable improvement. The clinical skill context area that we will conduct this investigation in is “Situational Awareness”. This is a relatively new concept that has been drawn from fields such as aeroplane pilot training. It relates to the concepts of being aware of specific cues in the environment, comprehending the meaning of these cues for the patient, and then being able to project into patient management relevant strategies based on this information. Currently, situational awareness is only being taught in one professional discipline within the School of Primary and Allied Health Care. We hypothesise that greater amounts of exposure to situational awareness training will result in higher performance in the situational awareness testing, and that the live, student-actor teaching approach will be more effective than the video-based education approach.

  • Removing smAll BaBies from Incubators to coT (RABBIT) - A pilot study

    This pilot study would be implemented at Nepean Hospital on low birth weight babies born at less than 34 weeks or weighing less than 1400g at birth and to assess whether there is sufficient evidence for justification for weaning them more rapidly into a cot from a humidicrib once they reach 34 weeks gestation and or 1400g weight. There is a need to further investigate these outcomes in Australia as neonatal intensive care nurses and medical staff use their own judgement on an ad hoc basis to determine when premature and small for gestational age babies can be weaned into a cot and may be arbitrarily delaying their progress. Currently there is no evidence pertaining to this practice with babies weighing between 1400g to 1600g and this project addresses this gap. The hypothesis is that stable low birth weight babies who qualify for the enrolment criteria can successfully tolerate weaning once they consistently demonstrate a stable body temperature at the lowest incubator air temperature and this will have no impact on their temperature stability, weight gain and facilitate faster discharge from hospital.

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