ANZCTR search results

The aim of the study seeks to determine if the histological, immunochemistry, microbiological and scanning electron microscopy analysis of explanted pelvic mesh in women with complications of mesh is pathological or physiological. This will be determined by comparing the explanted meshes from women with symptoms (cases) and women who have mesh opportunistically explanted (controls). To date, conclusions evaluating mesh responses in situ of explanted meshes have not been compared to asymptomatic controls to determine if the described changes are pathological or physiological.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), is a debilitating illness affecting up to 24 million people worldwide but concerningly there is no known mechanism for ME/CFS and no objective test for diagnosis. A series of our neuroimaging findings in ME/CFS, including functional MRI (fMRI) signal characteristics and structural changes in brain regions particularly sensitive to hypoxia, has informed the hypothesis that abnormal neurovascular coupling (NVC) may be the neurobiological origin of ME/CFS. NVC is a critical process for normal brain function, in which glutamate from an active neuron stimulates Ca2+ influx in adjacent neurons and astrocytes. In turn, increased Ca2+ concentrations in both astrocytes and neurons trigger the synthesis of vascular dilator factors to increase local blood flow assuring activated neurons are supplied with their energy needs. This study will investigate NVC using multimodal MRIs: 1) hemodynamic response function (HRF) that represents regional brain blood flow changes in response to neural activities and will be modelled from a cognitive task fMRI; 2) respiration response function (RRF) that represents autoregulation of regional blood flow due to carbon dioxide and will be modelled from breath holding fMRI; 3) neural activity associated glutamate changes that will be modelled from a cognitive task functional magnetic resonance spectroscopy. We also aim to develop a neuromarker for ME/CFS diagnosis by integrating the multimodal MRIs with a deep machine learning framework. This cross-sectional study will recruit 288 participants (91 ME/CFS, 61 individuals with chronic fatigue, 91 healthy controls with sedentary lifestyles, 45 fibromyalgia). The ME/CFS will be diagnosed by an agreed diagnosis made by two clinicians using the Canadian Consensus Criteria. Symptoms, vital signs, and activity measures will be collected alongside multimodal MRI. The HRF, RRF, and glutamate changes will be compared among four groups using one-way analysis of covariance (ANCOVA). Equivalent non-parametric methods will be used for measures that do not exhibit a normal distribution. The activity measure, body mass index, age, depression, and anxiety will be included as covariates for all statistical analyses with the false discovery rate used to correct for multiple comparisons. The data will be randomly divided into a training (N = 188) and a validation (N = 100) group. Each MRI measure will be entered as input for a least absolute shrinkage and selection operator - regularized principal components regression to generate a brain pattern of distributed clusters that predict disease severity. The identified brain pattern will be integrated using multimodal deep Boltzmann machines as a neuromarker for predicting ME/CFS fatigue conditions. The receiver operating characteristic curve of the identified neuromarker will be determined using data from the validation group.

Metabolic, immune and gut health are commonly compromised in the general population as people age, are exposed to stress and exercise less than that recommended for health. Plant based extracts have increased significantly in popularity in recent years due to health promoting effects. Whilst some of these claims are substantiated, many claims on the effect of these products on gut and immune function remain unexplored. This study aims to investigate a powdered nutritional product to determine its effect on immune, metabolic and gut health over an 8-week period. It is hypothesised that the supplement will improve markers of gastrointestinal, immune and metabolic health compared with the placebo.

Chronic Kidney Disease affects 1 in 10 Australian adults, with almost 15,000 Australians relying on dialysis to survive. Kidney transplantation provides better quality of life and long-term survival, in addition to being more cost effective when compared to dialysis. However, transplantation requires major surgery, which is associated with a number of serious risks and adverse events. One such adverse event is hypotension, or low blood pressure, after the operation, which may starve the newly transplanted kidney of oxygen and nutrients in the critical post-transplant period. The effect of this low blood pressure on short, medium and long term kidney transplant function is unknown. The best way to prevent, monitor and treat low blood pressure during this period is also unknown. The care of a new kidney transplant in the first 24 hours of the operation is very important. Parameters such as blood pressure, the amount of fluid delivered and the amount of urine produced make all have an impact on how well a new transplant kidney works in the immediate post operative period. Optimisation of these parameters may have an impact on long-term kidney transplant function. This is a pilot study looking at different way that patients can be monitored after kidney transplant. The study would aim to compare current protocols against additional methods of monitoring blood pressure and fluid status, to see if this leads to better outcomes. This study is a randomised trial. Participants will be randomised to 1 of 2 post operative care models. One model is the current standard Royal Adelaide Hospital post transplantation management protocol, which will involve being managed on the kidney ward with a team of kidney doctors and nurses after time spent in recovery. The second model will involve participants being admitted to a specialised advanced recovery area for 24 hours after kidney transplantation. Participants will have regular observations and occasional blood tests. The study may require the placement of an arterial line, which is a line that can be used for intensive blood pressure monitoring and blood taking without the need for additional venepuncture. After the operation, participants will be monitored carefully by a team consisting of kidney doctors, recovery nurses and kidney nurses trained in post-transplant care. After 24 hours, participants will move to the kidney ward.

Dementia is a condition that is in the top 5 leading causes of death for Australians. Informal carers report high levels of mental health concerns such as stress, anxiety, depression, social isolation, and poor quality of life (QoL). They are known to face significant strain associated with caregiving responsibilities. Maintaining the health and wellbeing of carers is essential to enable the continuation of care of family members as well as to prevent poor mental and physical health in carers. Despite the well-recognised need to support carers, limited programs have been delivered in Australia to promote their mental health and coping strategies. This aim of this study is to evaluate the effectiveness of an online psychosocial intervention on family carers’ coping skills, psychological wellbeing and QoL. The study hypotheses include: Hypothesis 1: Participants in the intervention group will demonstrate significantly greater improvements in appraisals of coping at post-intervention than the control group. Hypothesis 2: Participants in the intervention group will demonstrate a significantly greater reduction in depression at post-intervention than the control group. Hypothesis 3: Participants in the intervention group will demonstrate significantly greater improvements in quality-of-life at post-intervention than the control group. Hypothesis 4: Participants in the intervention group will demonstrate a significantly greater reduction in perceived burden at post-intervention than the control group.

Young people who have been diagnosed with cancer may experience long term adverse effects on their emotional and mental wellbeing. This study aims to determine whether it is feasible to deliver an online age and cancer-specific mindfulness intervention, and to investigate the potential for this intervention to impact these patients' quality of life and wellbeing. Who is it for? You may be eligible for this study if you are aged between 15 and 30 years and you have been diagnosed with cancer. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either receive the intervention immediately, or to receive the intervention at the end of the study (waitlist group). Participants who are allocated to the immediate intervention group will be given access to the web-based mindfulness program by an email and participants in the waitlist group will receive access on completion of the post- survey (after 6 weeks). The online intervention will involve completion of one 60 minute module each week for 6 weeks. After the 6 weeks both groups will complete the post-test questionnaires of the same quantitative measures and in addition the immediate intervention group receives a post program survey with open-ended questions to assess the feasibility of the mindfulness program. It is hoped this research will demonstrate whether it is possible to recruit and deliver a mindfulness-based intervention online. If the mindfulness program shows a positive impact on the quality of life and wellbeing of participants in this pilot study, a larger study enrolling a greater number of patients may go ahead and could lead to future benefits for more young cancer patients.

This fixed size, single-blind, randomised control trial is the first step in the development and optimisation of a community-based intervention for children struggling from Central Auditory Processing Disorder (CAPD) or 'Listening Difficulties'. There are limited effective interventions to improve these children's listening and associated developmental impacts. Current treatment options, such as assistive listening devices or speech training, have high costs, do not treat co-occurring challenges such as mental health, and often require cognitive functioning at a level beyond many children. Hence, CAPD is often left unresolved and issues persist into adulthood causing social, emotional, health and economic burdens on individuals. These challenges highlight the urgent need to develop and implement treatment that is easily accessible, engaging and beneficial for children. This study will investigate the feasibility and effectiveness of exercise, rhythm and music in remediating CAPD or 'Listening Difficulty', as well as its effects on physical literacy, fitness and quality of life. It is hypothesized that incorporating aspects of rhythm and music into exercise will be more effective in remediating CAPD or 'Listening Difficulty' than exercise alone.

Early Childhood Education and Care (ECEC) settings are a particularly important setting to reach young children with physical activity (PA) promotion efforts. As children aged 3-5 years spend an average of 25-35 hours a week in ECEC services, these settings provide a broad reach for intervention delivery to increase child activity at a population level. In light of the lack of sustained implementation documented following the introduction of outdoor free play public health policies, the aim of this study is to assess the feasibility, acceptability, and potential impact of a sustainability strategy to increase the sustainment of recent indoor-outdoor free play practice in ECEC services. The 6-month intervention will target ECEC service Nominated Supervisors (NS), and an educator responsible for supporting the implementation of physical activity programs in the ECEC service. Specifically, services will be supported to continue to deliver the evidence-based intervention; indoor-outdoor free play through the development of eight sustainability strategies. This will be compared to a control group that does not receive the sustainability strategy. It is hypothesised that the sustainability strategy will be feasible to implement, acceptable to ECEC services, and will produce sustained implementation of indoor-outdoor free play compared to the control group.

The phenomenon of ambulance ramping is a significant challenge to healthcare systems. Reducing the burden on emergency departments (ED) is imperative. In Australia, suspected cardiac chest pain represents nearly 1 million ED presentations annually, yet approximately 85% of these patients do not have acute coronary syndrome (ACS). The clinical work-up for these patients is laborious and inefficient, especially in low-risk individuals. This study will investigate whether we can safely reduce ED presentations by shifting the initial assessment of chest pain to an out-of-hospital setting. Making it possible for paramedics and general practitioners to assess chest pain with portable blood test devices and digital algorithms, which accurately categorise a patient’s risk of ACS, means low-risk patients can be directed to a Priority Care Centre instead of ED. Priority Care Centres provide community-based health care for patients with urgent but non-life-threatening conditions, who would otherwise be seeking a service from an Emergency Department. The objectives of the study are two-fold: 1. Evaluate the non-inferiority of a model of care initiated pre-hospital using point of care High-Sensitivity Troponin I and artificial intelligence (AI)-based decision-support compared with standard ED care. 2. Establish the cost effectiveness and define the funding approaches to support the sustainable implementation of a prehospital model of care for the effective assessment of chest pain and suspected ACS.

This pilot study will recruit 75 adolescents and ask them to use the Health4Life app – an evidence-based healthy lifestyles mobile phone app developed by the research team, for one month. During the month, participants will receive text messages to remind them to access the app. The timing and content of these text messages will be randomised with participants receiving, on average, one message a day. The purpose of the study is to assess the acceptability of these text messages and their timing as well as the feasibility and acceptability of the Health4Life app as a whole.