ANZCTR search results

This is a prospective study that will recruit surgical patients over the age of 60 who will be in hospital for at least 2 days. The objective of this study is to explore the associations between changes in brain biomarkers following surgery and cognition at 1-year post-operative. The study procedures will include a pre-operative baseline cognitive screen, a quality of life questionnaire and some bloods drawn by the anaesthetic doctor on their day of surgery. Following surgery they will be followed up for up to 4 days post-operatively. Delirium assessments will be conducted and on post-operative day 1 some additional blood will be collected. The blood samples will be analysed for brain biomarker levels following recruitment. Additionally, any participants who experience post-operative delirium will have the option to be referred to the Healthy Brain Aging Clinic for ongoing assessment and care.

This study aims to compare the effectiveness of two body image writing interventions in increasing body appreciation in female cancer populations. Who can participate? You may be eligible to participate in this study if you are a female aged 18 years and older, who has a history of a cancer diagnosis, or a current cancer diagnosis. What will participation involve? The study will be completed online via Qualtrics. Participants will be randomly allocated to one of three writing interventions, which may take up to 30 minutes to complete. Participants may be randomly allocated to either; a) writing about appreciating the functions of your body, b) writing about your cancer experience in a caring and supportive way, or c) writing about different rooms in your house as though you were explaining it to someone who has never seen it before. Measures will be taken directly before the writing session, directly after the writing session, one-week later, and two-weeks later. It is hoped that this study will help diversify the range of interventions available for female cancer survivors. In addition, this study may provide important information regarding which intervention is best tailored to target body image distress.

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.

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.

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.

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.

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.

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.

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.

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