ANZCTR search results

The receptor-binding domain (RBD) in SARS-CoV-2 S protein has been identified as the component required for coronaviruses to enter the human cells using the human receptor angiotensin converting enzyme 2 (ACE2). The investigational vaccine, RBD SARS-CoV-2 HBsAg VLP vaccine, is a subunit vaccine where the RBD antigen is conjugated to the hepatitis B surface antigen to allow the stimulation of the immune system to produce anti-RBD (CoV2 Receptor binding domain) antibodies. The study will be conducted in two stages: phase I and phase II. Phase I will include healthy adults aged 18 - 45 years and evaluate the safety and immunogenicity outcomes following administration of different formulations of the vaccine when compared with placebo. Phase II will include a separate group of healthy adults participants aged 18 - 79 years and evaluate the safety and immunogenicity outcomes following dosing of different formulations of vaccine and different dose strengths 28 days apart when compared with placebo.

Plaque psoriasis is a multifaceted immunological condition primarily resulting from a dysfunctional immune response with T-cells at the center of immunogenesis. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with moderate to severe plaque psoriasis and your treating physician has prescribed you Tildrakizumab. Your treating physician will have prescribed two loading doses of Tildrakizumab 4 weeks apart. Study details: This is an observational study that uses high quality photography and investigator assessments to determine changes to plaque psoriasis over a period of 64 weeks (Study visits will be conducted at week 0,4,8,16,28,40,52 and 64.). The aim of the study is to evaluate the efficacy of Tildrakizumab in the resolution/treatment of psoriasis.

Collaborative depression care in chronic disease populations is established in the USA and UK, however this model of care is not widely implemented in Australia, and the effectiveness and cost-effectiveness is unknown within our healthcare system. This quality improvement initiative, embedded within an implementation-science trial, aims to evaluate whether standardised depression screening performed by site-specific nurse coordinators, improves the uptake of collaborative depression care in Australian coronary heart disease populations, with concomitant reductions in depressive symptoms and major adverse cardiac events, with cost-utility.

Patients who survive ICU stay often develop important muscle weakness and rapid reduction in muscle mass. Furthermore, they often have notable deficits in nutritional intake. These changes in body composition and nutritional shortfalls may negatively impact long term outcomes and recovery. Therefore, ward based interventions or therapeutic agents which may slow muscle loss or aid in recovery from critical illness associated muscle loss have the potential to deliver clinical benefits. This study aims to determine the feasibility of providing a nutrition intervention to critically ill multi-trauma populations throughout hospital admission at the Royal Melbourne Hospital. Secondly, we aim to describe nutrition related patient outcomes (including anthropometric changes, nutritional intake, muscle strength and physical function) in this group.

This study aims to answer the question: Does proactive (early intervention) specialist care for hospital inpatients with diabetes or new hyperglycaemia improve glucometric and clinical outcomes? All patients admitted to The Royal Melbourne Hospital during the trial period who have diabetes or hyperglycaemia will be randomised to usual care or proactive specialist care. Proactive specialist care involves the inpatient diabetes service (IDS) identifying patients with diabetes or hyperglycaemia proactively without the team looking after the patient necessarily referring to the IDS for their input. The IDS will then make management suggestions with the effect of these suggestions on outcomes such as glucose levels, in-hospital complications, and length of stay assessed.

The aim of the study is to determine if Palmitoylethanolamide can reduce diabetic induced neuropathic pain and inflammation over a 8 week period. The study is a randomised clinical trial comparing Palmitoylethanolamide (active treatment) with a control (placeb0). The active treatment is a 350mg capsule taken twice daily (total 700mg/day) for 8 weeks. The outcomes being evaluated in the study are: the severity of neuropathic pain and the characteristics of the neuropathic pain, the effect of the neuropathic pain on quality of life, the use of rescue medications used during the study and the effect of the active treatment on general health pathology and inflammation markers.

The first five years of life is an important period for establishing children’s liking and intake of vegetables. About half of Australian children aged 2-5 years attend formal early childhood education and care, where they consume 40-60% of their daily food intake. Therefore, early care and education settings can play a pivotal role in shaping young children’s dietary intake and there is a need to better support early care settings to provide supportive environments for promoting vegetable intake. The aim of this study is to develop and evaluate a package of initiatives for use in long day care to increase children’s vegetable intake in care. Three initiatives will be developed which support cooks to provide more vegetables on the menu, provide training for educators to encourage children to taste and enjoy vegetables at mealtimes, and support educators to teach a sensory and experiential vegetable-focused curriculum. A factorial experiment will be conducted, which will test all possible combinations of the three initiatives to determine the optimum initiative package for increasing children’s vegetable intake in care. The effectiveness of the initiative package for increasing children’s vegetable intake will be tested in a future randomised controlled trial (reported in separate trial registration).

The purpose of this research project is to identify which factors are important in explaining the benefit obtained after implantation. The ability to understand words and sentences in noise varies across people who have been implanted with the cochlear implant. This study is particularly interested in understanding differences in the way in which cochlear implant recipients can discriminate the important cues of pitch and timing in speech sounds. The discrimination of these cues is essential for speech understanding. The study will investigate the influence of a range of factors on the ability to discriminate these cues; factors such as the anatomy of the cochlea, the health of the nerve fibres in the cochlea and the sound processor MAP settings.

We aim to assess the effectiveness of a new model of care (SC4C) compared to standard GP care in: (a) reducing GP referrals to hospital emergency departments (EDs) and outpatient (OP) clinics for children and young people < 18-years; (b) increasing GP quality of care and (c) confidence in paediatric care, and (d) family trust in primary care, whilst reducing family preference for paediatrician referral; (e) cost-effectiveness and cost-benefit of SC4C; (f) the factors that help or hinder the implementation of SC4C, and; (g) the sustainability and enduring effects of SC4C on our outcomes of interest. Participants include GP practices, GPs, families that choose to participate, practice managers, administrative staff, and the study paediatricians. The trial will be implemented in a stepped-wedge design, with a new practice adopting SC4C month-by-month for the duration of 12 months in total per practice. We expect to find a 4% absolute decrease in GP referrals to ED/OP clinics, increased provision of GP care that is adherent to guidelines for 5 common exemplar conditions, a 10% improvement in GP confidence in paediatric care, and parent confidence in GP care, and a 10% reduction in family preference for paediatrician care.

We aim to compare the efficacy of two novel prevention programs aimed at building resilience to manage worry, anxiety and depression in children, namely an Emotion Regulation-based (ER) program, and a Behaviour Activation-based (BA) program. The Emotion Regulation-based program has a main focus on identifying and understanding emotions, and developing positive emotion regulation strategies to manage these emotions. Developing healthy emotion regulation has been shown to improve wellbeing and successfully reduce anxiety and depression in children. The Behavioural Activation-based program aims to teach children about worry and what behaviours might be helpful to deal with these situations. Students will learn to problem solve ways to manage their worry and increase their engagement in activities that they enjoy and that are important to them. These in turn, will improve their resilience and increase resources for dealing with emotional difficulties. South Australian students between the ages of 8-13 are eligible to participate in this study. Participating schools will be randomly selected to receive one of the two programs, or into a control group whereby students will complete lessons as normal. All participating students are requested to complete questionnaires measuring worry, resilience, anxiety, depression, emotion regulation, behavioural activation, and working memory at pre-program, post-program, and at 6-, 12-, and 24-month follow-up periods. It is expected that participants in the ER and BA programs would report fewer symptoms of worry, anxiety and depression, and greater levels of resilience and working memory at post-program and at 6-, 12- and 24-month follow-up periods, compared to those in the control condition.