ANZCTR search results

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 formed in 2016 by a group of Australian rheumatologists and researchers in response to a clear need to enable better prediction of prognosis and treatment outcomes among Australian men, women and children living with arthritis and autoimmune conditions. It was agreed that the best way to achieve this was to build a state-of-the-art national resource that would also enhance rheumatology and related research capacity, thereby addressing the disproportionate support for research into the National Health Priority Area of 'Arthritis and musculoskeletal (MSK) conditions' compared to its high health burden and expenditure. The A3BC vision is to identify causes and cures for a wide range of musculoskeletal and autoimmune conditions using biobank-enabled, data-linked, collaborative, and multidisciplinary research. Now merged with the Australian Rheumatology Association Database (ARAD) and joining forces with the Australian and New Zealand ChiLdhood Arthritis Risk factor Identification sTudY (ANZ CLARITY), Australian Paediatric Rheumatology Group (APRG) and Juvenile Arthritis Foundation Australia (JAFA), the A3BC will identify the biological/environmental causes and phenotypic consequences of musculoskeletal conditions and combine these with a broad range of patient and population health datasets, to uncover unknown patterns and associations for safer, more effective and evidence-based prevention, diagnosis, treatment and prognosis strategies. Aside from the collection of high-quality, diverse-use biospecimens, the most innovative element in the A3BC vision is the establishment of a level of data analysis and integration not seen before in Australia. The A3BC will link broad biospecimen-derived biological (‘omic’) data, patient-reported outcome data, cross-jurisdictional electronic medical records, pathology and medical imaging data, Commonwealth health datasets (MBS, PBS, AIR), national cancer and death registries, and longitudinal studies, into a comprehensive platform for discovery and change. Initially focused on Rheumatoid Arthritis, Psoriatic Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis and Vasculitis (including Polymyalgia Rheumatica, the network and infrastructure of the A3BC, once established, will provide a platform to expand biospecimen and data collection to other key high-burden MSK conditions, such as Sjogren's Syndrome, Lower Back Pain, Gout, Scleroderma, Systemic Lupus Erythematosus, Myositis and Osteoarthritis. Built upon a national network of consolidated biobank/research infrastructure and leading research/clinical expertise, the A3BC promises a new paradigm in evidence generation for more responsive policy and practice decision-making, and a cost-effective research platform to efficiently uncover vital patient and population data associations to drive a new era in disease diagnosis, therapy, prognosis and hopefully - prevention and cure.

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.

The purpose of this study is to determine whether feeding into the small bowel after combined CRS and HIPEC is feasible and can promote post-operative return to bowel function Who is it for? You may be eligible for this study if you are an adult who is going to have cytoreductive surgery and hyperthermic intraperitoneal chemotherapy to treat your cancer. Study details Participants in this study will undergo their surgery as normal. During the surgery, study participants will receive a nasojejunal gastric decompression tube and receive enteral feeds (formula) into the small bowel within 24 hours from the end of the surgery up until the participant commences a solid oral diet. Tolerance and delivery of nutrition will be monitored. It is hoped that this research will help determine if it is possible to commence feeding patients after their CRS and HIPEC and therefore reduce gut-related side effects