ANZCTR search results

Reduced cardiorespiratory fitness is a common secondary impairment for people who have sustained a severe traumatic brain injury (TBI). Gamification including virtual reality (VR) may be one strategy to provide a motivating environment for fitness training. A recent large randomised controlled trial (n=300; including 18 adults with severe TBI) conducted by members of the research team, provided additional rehabilitation using digital devices and demonstrated improvements in mobility and self-reported physical activity at 6-months and cognition at 3 weeks. Fitness training and virtual reality has been investigated in people after TBI by one single group study conducted over 20 years ago. In this study, 13 people with severe TBI underwent 4 weeks of fitness training on a cycle ergometer using VR. This study showed promising results in cognitive changes, but no follow up work was conducted. Given the improved knowledge in dosage and benefits of fitness training in this population, and the growing interest and access to virtual reality systems, a pilot study focused on how best to implement this type of program in practice is warranted. This study will evaluate the efficacy of gamification on outcomes from fitness training using a single-case experimental design protocol with a group of patients from the Liverpool Brain Injury Rehabilitation Unit who require physical rehabilitation after TBI.

Oesophageal soft food bolus obstruction (SFBO) is a common gastroenterological presentation. Mentha piperita, the active component of peppermint oil has been proposed as an adjunct in SFBO. This study is to evaluate the effectiveness of Mentha Piperita in facilitating spontaneous passage of SFBO and improving effectiveness of the endoscopic push technique, via a prospective randomised control trial. To check effectiveness of peppermint oil in relieving blockage from food stuck in the food pipe.

The primary aim of the trial is to investigate if a combination of HMOs and probiotics can improve behavioural outcomes for children with autism spectrum disorder (ASD). This aim will be tested in a two-phase clinical trial. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment. The primary outcome will be measured by the irritability subscale of the Aberrant Behaviour Checklist (I-ABC), Other behavioural measurement tools to support the primary end-point include behavioural changes as measured by the Home Situational Questionnaire – ASD (HSQ-ASD) and the Parent-Targeted Symptom Visual Analogue Scale (PTSVAS), Secondary measures include change in: gastrointestinal symptom severity; stool consistency, quality of life; anxiety; gut (stool) microbial composition; stool short chain fatty acids levels; urinary serotonin concentration; and saliva cortisol levels. It is hypothesised that a combined supplement of HMOs and probiotics will improve behavioural outcomes for children with ASD via mechanisms of the microbiome-gut-brain axis. Evidence of efficacy will support additional research to investigate the gut micorbiome as a therapeutic target for this cohort.

Clinical Islet Transplantation at our center, akin to others internationally, achieves insulin independence rates of ~80% at 1 year in hypoglycemic unaware type 1 diabetics with poorly controlled disease. A major problem with current islet cell transplantation is the delivery of the islets into the portal circulation (via infusion into the liver). Up to 75% of the transplanted islet mass is lost within the first 24 hours due to low oxygen levels in the portal circulation and the instant blood mediated inflammatory reaction (IBMIR). Thus one of the major aims for the field of islet transplantation has been to develop a vascularised alternative site for islet transplantation that avoids the portal circulation. The aim of this application is to change the current paradigm of beta cell replacement with intra-portal islet transplantation, by establishing a clinical protocol to place adult islets in a pre-vascularized “intracutaneous” space. The intracutaneous space represents an attractive site for islet transplantation (ease of access, administration, monitoring, removal or replacement), however, it has been attempted unsuccessfully by groups in the past. The reason for failure of the ‘normal’ intracutaneous site is that the collagen structure produces a low oxygen (hypoxic) environment incapable of supporting islet survival and function. The BTM integrated into the intracutaneous site is much different! Implanting BTM into the intracutaneous site prior to islet transplant enables the formation of a dense vascular bed which is essential for islet survival and function. It is hypothesised that the proposed pilot study will demonstrate that the techniques described result in the successful intracutaneous seeding of human islets capable of secreting insulin to control blood glucose levels.

The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single (Part A) and multiple (Part B) doses of RLYB116 in healthy participants.

Diet has potential to bridge the therapeutic gap in ulcerative colitis (UC). The proposed study evaluates a therapeutic diet for patients with mild-moderately UC. This diet will be tested in an 8-week randomised, placebo-controlled dietary advice study. Patients with mild-moderately active UC on stable therapy will be eligible for inclusion. Those eligible will be invited to provide informed consent then undertake baseline measurements including a 48-h stool collection, blood and urine sampling, clinical questionnaires, 7-day weighed food diary and a flexible sigmoidoscopy to confirm presence of inflammation. Participants will then be enrolled and undergo ingestion of a gas-sensing capsule before being randomised and blinded to receive one of two diets from a research dietitian. Meal plans and recipes will be provided along with a selection of food items. Participants will be reviewed at weeks 4 and 8, with repeating of baseline assessments at week 8.

Net ultrafiltration (NUF) (i.e., fluid removal) during continuous renal replacement therapy (CRRT) enables management of volume status and is supported by international clinical guidelines. Emerging evidence from epidemiologic studies of critically ill patients with acute kidney injury suggests that higher intensities of NUF (i.e., higher NUF rates) impair renal recovery and are associated with increased mortality. However, no randomised studies have compared patient outcomes achieved by targeting a moderate NUF rate to usual care. The primary aim of this study is to determine whether targeting a moderate NUF rate in critically ill patients receiving CRRT affects renal recovery and patient survival compared to usual care. The primary outcome is the time to renal recovery, defined as the number of hours between the initiation and discontinuation of renal replacement therapy (CRRT or intermittent RRT). Death will be considered as a semi-competing risk. Secondary outcomes relate to the feasibility, efficacy, and safety of the intervention.

The Australian Arthritis and Autoimmune Biobank Collaborative (A3BC) was established in 2016 by Australian rheumatologists and researchers to address the urgent need for better prediction of prognosis and treatment outcomes among Australians living with arthritis and autoimmune conditions. The group identified that building a state-of-the-art national resource would not only improve outcomes but also strengthen research capacity in a significantly underfunded National Health Priority Area, given the disproportionate burden and cost of musculoskeletal (MSK) conditions. The A3BC’s vision is to identify the causes and cures of MSK and autoimmune diseases through biobank-enabled, data-linked, collaborative, and multidisciplinary research. Now merged with the Australian Rheumatology Association Database (ARAD), integrated with the Australian Juvenile Arthritis Registry (AJAR), and partnered with the Australian and New Zealand ChiLdhood Arthritis Risk factor Identification sTudY (ANZ CLARITY), the A3BC provides a powerful platform. It combines biological and environmental data with patient and population datasets to reveal new associations that will lead to safer, more effective prevention, diagnosis, treatment, and prognosis strategies. Beyond high-quality biospecimen collection, the most innovative feature of the A3BC is the unprecedented level of integrated data analysis. The A3BC will link biospecimen-derived ‘omic’ data with patient-reported outcomes, cross-jurisdictional electronic medical records (EMR), imaging and pathology data, national datasets (MBS, PBS, AIR), cancer and death registries, and longitudinal studies. This integration offers a comprehensive platform for transformative research. Initially focusing on Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Juvenile Idiopathic Arthritis (JIA), Ankylosing Spondylitis (AS), gout, and vasculitides (including Polymyalgia Rheumatica and Giant Cell Arteritis), the A3BC infrastructure will enable expansion to other significant or rare MSK conditions. These include Sjögren's Syndrome, Low Back Pain, Scleroderma, Systemic Lupus Erythematosus, Myositis, and Osteoarthritis. A broad range of childhood and adolescent MSK conditions, in addition to JIA will gradually be added, including but not limited to, juvenile systemic lupus erythematosus, juvenile scleroderma, juvenile dermatomyositis, juvenile vasculitis (e.g. Kawasaki’s, Henoch-Schonlein), and congenital skeletal dysplasias. Built on a national network of integrated registry, biobank, and research infrastructure, supported by leading clinical and scientific expertise, the A3BC promises a new era of evidence generation. It will deliver a cost-effective, future-focused research platform to drive smarter health policy, better clinical decision-making, and ultimately, new paths to diagnosis, treatment, and prevention.

Adequate analgesia is vital to functional recovery after rib fractures and prevention of respiratory morbidity. Erector spinae catheters provide an alternative regional technique for analgesia by infusion of local anaesthesia to sensory nerves of the posterior rami of the affected spinal level(s). Currently, there is a lack of uniformity and consensus on the best regimen for local anaesthesia infusion: whether using a programmed intermittent bolus, or a continuous infusion, regimen. Theoretical and anatomical considerations, with initial confirmation by in vitro cadaveric and low-quality evidence clinical studies, suggest that PIB provides better local anaesthesia spread. This study will evaluate if the Programmed intermittent bolus is superior to Continous infusion using clinically relevant outcomes of pain scores, opioid consumption, and improved respiratory function.

The Virtual Model of Antenatal Asthma Care (VMAC) study evaluates the suitability of 2 types of asthma care in pregnancy. 1) virtual (tele/video conferencing) and 2) face-to-face (in person). Uncontrolled asthma in pregnancy may harm the mother and the baby. Self-management education and clinical care may help to control asthma throughout pregnancy. Traditionally, it is provided as a face-to-face service which largely depends on the availability of both the mother and the healthcare team. To address this, we have developed a virtual model of care to provide the same service remotely (i.e., via tele or video conferencing). Women can access care at a convenient place and time. In this study, we are testing the suitability of this new approach.