ANZCTR search results

This clinical trial is a critical step in the development of the Vaxxas HD-MAP vaccine delivery system and will verify the safety and consistency of device performance in paediatric subjects at several potential anatomical application sites. The paediatric population represents a significant segment of the vaccination market; therefore, it is vital to know if the performance of the HD-MAP delivery system differs in this population and whether it presents any additional safety risks. Furthermore, the opinions of guardian/child dyads on the acceptability of the delivery system will be collected.

The program will evaluate the feasibility of the intervention, its delivery and its effectiveness in partnership with Maori & Pasifika community organisations and key stakeholders in Southeast Queensland. It will examine intervention efficacy (i.e. improved HbA1c levels, diabetes self-care, waist circumference and BMI) aimed at reducing risks in MPI women with type 2 diabetes and prevent late hospital presentations from diabetes-related complications. Objectives 1. Primary objective: to examine efficacy where intervention women with type 2 diabetes have improved HbA1c clinical levels than those in control group from baseline to 24 weeks. 2.Secondary objectives: to determine whether, compared to controls, the intervention group achieves: •Change to bring body-composition measurements closer to recommended healthy range for specific cultural groups (e.g. BMI is less than or equal to 30 kg/m2; waist circumference <80cm based on WHO Criteria). • Improved diabetes self-care scores on diet, physical activity, routine health checks, diabetes distress and medication assessed using summary of diabetes self-care activities (SDSCA) (Toobert et al 2000) Hypothesis H1: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management report improved HbA1c levels at 12 weeks (end of intervention) and 24 weeks (post-intervention sustainability) H2: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management will have reduced waist circumference and BMI at 12 weeks and 24 weeks H3: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management have improved diabetes self-care at 12 weeks (end of intervention) and 24 weeks Expected Outcomes The primary outcome measure is HbA1c. Secondary outcome are changes in BMI, waist circumference, diabetes self-care, diet and physical activity and stress will be assessed. That is all endpoints will be measured at baseline (T0), 12 weeks (T1) and 24 weeks (T2) to assess program sustainability.

The study aims to assess the feasibility and effectiveness of guided self-help CPT (CPT-GSH) in a stepped care model in treating PTSD using a randomised controlled trial. It is hypothesized that those who have successful outcomes with CPT-GSH will improve PTSD (primary outcome) and depression symptoms and quality of life similar to that of standard CPT delivered via video call. The study will also assess other factors contributing to treatment outcomes in stepped-care condition (e.g. client's response to low-intensity versus high-intensity treatment approach). Stepped care is predicted to be a cost-effective treatment modality for participants because of minimal therapist input and sessions compared to a standard CPT.

Writing is a cost-efficient intervention that has been shown to help people cope with negative life events by expressively writing about that particular experience. This study investigates if a self-compassionate attitude influences the way in which we provide self-advice regarding our experiences, and to understand if this approach is more helpful than a relaxed mindset. Despite the growing evidence regarding self-compassion, there is a paucity of research on our understanding of the perceived usefulness of self-compassionate writing, and the likelihood of participants engaging in this treatment. The present study aims to examine the acceptability and effectiveness of self-compassionate writing to cope with personal problems. A randomised controlled design with longitudinal follow up was adopted for this study. Participants will be randomly assigned into either the self-compassion writing condition or the relaxation breathing control writing condition, with outcome measures administered at three intervals (pretest, post-test, and 1-week follow-up). In the initial phase, participants will be encouraged to write about a personal problem which caused them to feel failure, humiliation, or rejection. They will then be directed to listen to a 10 minute audio recording, either a self-compassionate or relaxation breathing recording dependant on random group assignment. and provide self-advice related to the problem previously described. All participants will be administered the Positive and Negative Affect Scale, the Compassion Motivation and Action Scale, and other questionnaires related to problem intensity, helpfulness of their self-advice, and the likelihood that would use this approach to address future personal problems.

Malaria volunteer infection studies, particularly the IBSM model, play a key role in accelerating antimalarial drug development. We recently manufactured a new, in vitro expanded malaria cell bank, P. falciparum 3D7-MBE008, and conducted a small pilot study (ACTRN12619001079134) that showed that the 3D7-MBE008 parasites were safe and infective in healthy participants. The next step is to evaluate the ability of the 3D7-MBE008 parasites to be transmitted from humans to mosquitoes. This is a randomised study that will use the IBSM model to evaluate the transmission of P. falciparum 3D7-MBE008 parasites from participants to mosquitoes. The study will be conducted in four participants. This study will be essential for determining whether this new parasite bank can be used in future studies testing novel transmission blocking antimalarial drugs.

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.