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The current provisional or emergency use approvals of COVID-19 vaccines are based on interim phase 3 clinical trial results indicating that these vaccines have an acceptable safety profile, are immunogenic and protect against symptomatic COVID-19. To date, it has not been possible to obtain robust safety and immunogenicity data for pregnant women or the very elderly; two groups at increased risk of developing severe COVID-19, because the initial trials focused on healthy adults. It is probable that the elderly will have less robust responses to COVID-19 vaccination, whereas pregnant women may or may not respond similarly to non-pregnant adults. We propose to conduct COVID-19 vaccination studies in these vulnerable groups and compare vaccine-specific antibody and T cell responses to those induced in young healthy non-pregnant individuals. The COVID-19 pandemic has seen the rapid development of multiple candidate COVID-19 vaccines, many using new platforms never before used for licensed human vaccines, including mRNA and viral vectors vaccines. While we know that they elicit SARS-CoV-2 specific antibody and T cell responses, we have no information about their broad effects on the immune system. Systems vaccinology is a newly emerging approach to studying vaccine effects by utilising various ‘omics’ platforms such as transcriptomics and metabolomics to provide unique insights into mechanisms of adverse events, reactogenicity and immunogenicity of vaccines. We will therefore use an exploratory systems vaccinology approach to interrogate the broad immunological effects of COVID-19 vaccination on the immune system of participants, providing important data for their future deployment and development. The interrogation of responses in those more vulnerable to the serious outcomes of COVID-19, and also more likely to have suboptimal immune responses, may identify mechanisms and strategies to optimise COVID-19 vaccines for vulnerable populations. Given the well-established links between nutrition, microbiome, mood and the immune system, there is a strong rationale and urgent need to conduct multidisciplinary studies that include both molecular and lifestyle factors. Standard questionnaires will therefore be administered prior to each blood collection (pre- and post-vaccination) to assess mood, nutrition and lifestyle. The results will be correlated with the key molecular findings from the immunological analyses.

ABI can be defined as damage to the brain sustained after birth which is not of a congenital or genetic nature. It is a leading cause of death and disability in children and adolescents, with a global incidence rate of ~ 47-280 per 100,000 children. In Victoria alone, more than 1000 children a year present with an ABI, with the most common causes including traumatic brain injury (TBI) (from falls, sports, vehicular accidents), child stroke and cancer, infection and hypoxicischaemic events. Bierbaum et al reported that, in Australia over a 10-year period, ABI related hospitalisations of children aged 16 years or younger have cost the health system close to half a billion dollars, with life-long health implications for the child and their family. Injury to the brain in childhood has significant consequences, primarily impaired cognition, communication, behaviour, social skills and overall quality of life. Despite the consequences of childhood ABI, implementation of robust childhood ABI treatments to improve social skills is currently hindered by imprecise understanding of the mechanisms underpinning the social domain, a lack of high quality evidence and a focus on generic approaches, treating only a single domain, despite children‘s varied behavioural impairment profiles. Disappointingly, the exciting potential for applying a targeted approach addressing modifiable factors unique to the individual‘s social profile has not been attempted. ITSS will address this gap and improve child outcomes after ABI by delivering evidence-based individualised treatment (ITSS), tailored to the child’s needs. Cognition. The Amsterdam Memory and Attention Training for Children (AMAT-C) is a treatment for deficits in children‘s attention, memory and executive skills commonly associated with impaired social skills following ABI. Social cognition. The Program for the Education and Enrichment of Relational Skills (PEERS) is an evidence-based treatment that has shown efficacy in improving social cognition and social competence in children with neurodevelopmental and socio-emotional disorders, with improvements observed in social knowledge, peer-engagement, and friendships. Mental Health: Anxiety/depression. The Cool Kids Anxiety Program (COOL KIDS is an evidence based structured Cognitive Behavioural Therapy (CBT) treatment, with a focus on anxiety. Parenting. The Signposts Program for Building Better Behaviour (Signposts) is an evidence-based parent education CBT treatment program that assists parents to identify and manage their child‘s challenging behaviours. Parental mental health. Take a Breath is a treatment on Acceptance Commitment Therapy aimed to reduce persisting parent anxiety and stress in the context of child illness/injury.

Neurological Impairment (NI) in children is often caused by conditions such as cerebral palsy and other neuromuscular conditions. Many children with NI are prone to chest infections which can lead to long stays in hospital, additional impairment and even premature death. Despite the suffering caused to children and their families by these infections and the high cost to health services, there is very little information on how best to prevent them. Some doctors prescribe long-term antibiotics but we don't really know whether this treatment makes any difference to the numbers of chest infections children suffer from, or whether these antibiotics can cause long term harm. The trial (PARROT-Junior) is a sub-study of a parent study (PARROT). In PARROT-Junior, we will recruit children aged 0.3-3 years, with NI who are at risk of chest infections, along with their parents/primary care giver to take part. Children included in the trial will be given either azithromycin or a placebo for 6 months to evaluate whether regular azithromycin reduces the frequency of chest infections. For the analysis, results from PARROT-Junior will be combined with data from the children recruited from Brisbane/Darwin in the parent study (PARROT). Our target sample size thus includes the subset of Brisbane/Darwin-enrolled children from PARROT.

The purpose of this study is to evaluate the effectiveness of an 8-week intervention program on mental health and wellbeing of Year 6 students transitioning to Year 7. The project will involve 300 Year 6 students; from primary schools located within 2 km radius from the ACU Strathfield Psychology Clinic, who will participate in an 8 week, school based transition program "I'll be Ok in Year 7" and 300 Year 6 students, who will attend a one-off information session. This project is being conducted by Ms Ewa Geba MAPS and will form the basis for her Doctor of Philosophy degree (PhD) at the Institute for Positive Psychology and Education, Australian Catholic University, under the supervision of Dr Baljinder K. Sahdra and Dr. Philip Parker. The results will inform future research and service delivery of ACU Strathfield Psychology Clinic; and will be published in a scientific journal.

An intensive care unit (ICU) stay is associated with significant muscle wasting in up to 80% of critically ill patients. This muscle wasting results in ‘ICU-acquired weakness’ that is associated with slower weaning from ventilator support, longer time to discharge alive from ICU and hospital, higher in-hospital costs which persist well after discharge from the acute care setting. Nutrition therapy, delivered as liquid nutrition via a tube into the stomach, forms usual care for critically ill patients. The provision of additional protein has the potential to attenuate muscle atrophy, and hence improve outcomes following critical illness. Current international guidelines recommend delivery of protein prescription of 1.2 - 2.0 g/kg/day or higher, but this is based on very low quality of evidence, and there is observational evidence to support both benefit and harm of augmented protein prescription. Therefore, there is a need for a high-quality randomised controlled trial of differing protein prescriptions. We propose a cluster randomised clinical trial with the aim of evaluating the effect of higher dietary protein delivery on outcomes of critically ill adult patients when compared to usual care. In this study each ICU will be randomised to one of the two study formulae for 3 months and then crosses over to the other study formulae for 3 months, which is then repeated, with each site participating for 12 months. Each eligible patient admitted to the ICU during these 3-month periods will receive the same study formula.

People with Parkinson’s disease (PD) experience cognitive dysfunction, limiting their occupational performance. Establishing an effective intervention to address the impact of cognition on daily life is a research priority. Interventions that comprehensively address cognitive and physical performance skills in people with PD have not previously been explored. The Cognitive Orientation to Daily Occupational Performance (CO-OP) treatment approach is effective for improving occupational performance, improving self-efficacy and participation in other adult populations. The proposed clinical trial will evaluate the efficacy of a CO-OP approach for people with PD. This study has four research questions: 1. Is the CO-OP approach feasible for people with PD? 2. Do people with PD benefit from CO-OP? 3. What CO-OP intervention intensity achieves optimum outcomes? 4. What do people with PD think and feel about the CO-OP approach? A parallel-group assessor blinded randomized controlled feasibility trial with long term follow-up will investigate the effectiveness of the CO-OP treatment approach for adults with PD. This will be the first study to evaluate the impact of CO-OP with people with Parkinson’s disease. This research aims to improve quality of life, confidence and reduce the impact of cognitive decline on the lives of people with PD. Significantly, this research will empower older people with PD to manage their symptoms and rate of progression. This research will lead to new, evidence-based services for older people with PD, based on their preferences and priorities and wide dissemination of findings to clinicians will increase access to new treatment options.

Metastatic breast cancer impairs quality of life (QOL), causes distress, and has a high health-system burden, yet few studies have examined interventions to address this. Our research group recently developed an online psychosocial program for women with metastatic breast cancer “Finding My Way-Advanced”. The purpose of this study is to test whether, compared to a control group, Finding My Way-Advanced leads to improved QOL, distress and health care use for women with metastatic breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older who has recently been diagnosed with metastatic breast cancer (MBC). Study details Participants in this study will be randomly allocated (i.e. allocated by chance) to one of two groups: Group 1: Participants in this group will be provided with an online intervention consisting of 6 modules which focus on improving the psychological well-being and quality of life of women diagnosed with metastatic breast cancer. Topics addressed by the modules include (1) Navigating healthcare (making decisions and communicating with my health care team), (2) Living well with a progressing illness: Managing fear of progression and coping with uncertainty; (3) Managing physical symptoms (particularly fatigue and pain); (4) Managing emotional distress; (5) Managing identity and role-changes; and (6) Social support: receiving support and supporting family. Participants will be able to access all modules immediately, and use them as much as needed during the intervention. They will receive weekly reminders to log in and use the program, over the 6 week study period. Group 2: Participants in this group will receive links to Breast Cancer Network Australia's 'gold standard' resource for women with metastatic breast cancer: “My Journey Online Tool”. This key resource will be supplemented with the static digital downloadable “Hope & Hurdles” kit specific to MBC which includes (a) an introductory booklet about MBC; (b) an information guide (which provides detailed information about diagnosis, treatments, support options, practical issues, and further contacts and resources), and (c) videos from a woman living with MBC and a health care provider. Links to optional online resources will also be provided. Participants in both groups will complete self-report measures of quality of life, distress, unmet needs and health service use, before they receive access to their program. They will then be followed up by researchers 6-weeks after receiving access to their program, and asked to complete the same online questionnaire assessing quality of life, distress, and health service use. Participants will be asked to complete these same research surveys 3 and 6 months later. It is hoped that this research will demonstrate that the Finding My Way-Advanced program improves quality of life, distress and health service use in women with MBC.

Nuclear medicine myocardial perfusion imaging is currently indicated in patients with symptoms of cardiac ischaemia, who have either failed a stress echocardiogram, are unable to exercise to the extent required to provide an adequate stress echocardiogram or have a body habitus or other physical condition that would prevent an adequate stress echocardiogram. A nuclear medicine myocardial perfusion scan consists of an intravenously administered radioisotope, which can then be assessed with either single photon emission computer tomography (SPECT) or positron emission tomography (PET). This allows the assessment of the underlying myocardium and the underlying coronary arteries. More recently coronary artery calcium (CAC) scoring has been developed to assess patients without known coronary artery disease who present with symptoms of acute ischaemia and are of low or intermediate risk, without electrocardiograph changes or elevation in cardiac biomarkers. As both investigations utilise computed tomography (CT), our aim is to assess the value of coronary artery calcium scoring on nuclear medicine myocardial perfusion scans, in order to improve the diagnosis and outcomes in patients with low to intermediate risk cardiac ischaemia. Currently there is no research available on the utility of coronary artery calcium scoring in myocardial perfusion scans. The investigators aim to show a correlation of the coronary artery calcium score between the computed tomography conducted for myocardial perfusion imaging and dedicated computed tomography imaging. This will then allow the assessment of the coronary artery calcium score retrospectively in participants who underwent myocardial perfusion imaging to assess the change in predefined outcomes when utilising the additional measure.

Critically ill patients are often unconscious and require airway support via a mechanical ventilator. This renders them able to eat, with nutrition most commonly provided by a gastric feeding tube (termed enteral nutrition [EN]) in the Intensive Care Unit (ICU). EN feeding interruptions are common in the ICU and may significantly impact nutrition delivery, with approximately 50-60% of energy and protein targets delivered in practice. Reasons for EN feeding interruptions are varied and may include fasting for airway procedures, including tracheal extubation (i.e. removal of the breathing tube used for ventilation). There is limited contemporary information on reasons for EN feeding interruptions in Australian ICUs, including the number of hours fasted prior to tracheal extubation. We are conducting an observational study (NUTRIENT-Fasting) using a pre-existing dataset from NUTRIENT (Nutrition practice in critically ill adults – an observational study; ACTRN12620001025921) to assist to better understand the current reasons for EN interruptions over the first seven days of ICU admission in critically ill patients that received mechanical ventilation and EN across 35 of the Australian ICU sites included in NUTRIENT.

The study hypothesis is that migraines are caused by the constriction of small blood vessels (capillaries) in the brain and that the use of natural, vessel-widening supplements will cause these small blood vessels to dilate and therefore reduce the frequency and severity of migraines. The aim of this study is to investigate whether oral treatment with L-arginine and/or aged garlic extract prevents/decreases migraines in Australian adults. The trial is specifically designed to provide evidence that treatment with these nutraceuticals dilates the small vessels of the brain, thereby improving blood flow and preventing the onset of migraines. This is a double-blind trial, meaning the participant and investigator will not be aware which group the participant has been randomised to. Approximately 240 men and women who have been diagnosed with migraines, will receive 1500 mg/day L-arginine and/or 1000 mg/day aged garlic extract and/or placebo for 14 weeks. Each participant will be required to take 5 capsules a day over the 14 weeks, and will be asked to monitor their migraine frequency and severity. At visit 1, participants will complete a series of daily diaries and questionnaires that will capture information about their pain experience, light-sensitivity and quality of life. We also complete anthropometric measurements. Participants will also receive a 2-week supply of study capsules and two weeks of migraine diaries to be completed daily. At visit 2 (2 weeks after visit 1), participants will provide a blood sample, complete a light-sensitivity test, and an OCTA (optical coherence tomography angiography) scan. Participants will then receive a 12-week supply of the study capsules and migraine diaries to be completed daily. At visit 3 (12 weeks after visit 2), participants will recomplete the questionnaires from visit 1, and will recomplete the measures from visit 2, After the 14 weeks (visits 1-3), we will compare each participant’s baseline (visits 1 & 2) and post-intervention (visit 3) results to examine the impact of L-arginine and aged garlic extract on migraine symptoms, and whether this corresponds with dilation of the small cerebral blood vessels.