ANZCTR search results

Physical inactivity is an independent risk factor for all causes of death in people with heart disease. Thus, accurate measurement of physical activity is essential to ensure optimal physical activity levels are achieved. Wearable activity monitors (accelerometers) offer a method for objective quantification of physical activity frequency, duration and intensity, however, a limitation of the few studies that measure physical activity using accelerometers in this population, is the use of inappropriate accelerometer intensity cut-points derived from healthy populations. Given people with heart disease may have reduced exercise capacity resulting in greater effort for the same activities, this may lead to inaccurate intensity classification (i.e., under-reporting) of physical activity levels. Here we will recruit 164 participants with heart disease to complete a treadmill test and a series of activities-of-daily-living with simultaneous measurement of oxygen uptake and activity counts taken from accelerometers, developing heart disease specific cut-point equations for different physical activity intensities. This project will generate new knowledge, allowing the disease-specific relationship between physical activity and health outcomes to be accurately established. This will guide future physical activity recommendations and interventions, helping more people live longer and healthier after a cardiac event.

Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition causing narrowing of the oesophagus manifesting clinically as dysphagia and food bolus impaction (FBO). Two first line medications, namely proton pump inhibitors (PPI’s) and topical corticosteroids (TC’s) are feasible options. we propose an opened label, randomized controlled trial of PPI (Pantoprazole) vs TCs(Jorveza), with a formalized treatment protocol and the ascertainment of symptom scores (questionnaire), endoscopic appearance, histological findings (biopsy), physiological (manometry) and cross sectional (endoscopic ultrasound) data to determine if PPI or Jorveza are superior treatment.

There is no rigorous evidence on the effects of back pain fact sheets among people seeking care for low back pain from their general practitioner. It is uncertain whether a fact sheet resource that focuses more on listing medical management options (JAMA Patient Page- low back pain), can increase a patient’s preparedness for decision-making, compared with a resource that focuses on self-management (Australian Commission for Healthcare Safety and Quality Information for Patients Fact Sheet). Our primary aim is to compare preparation for decision-making among people seeking care for low back pain who are given one of two currently available fact sheets. Secondary aims are to understand recruitment processes and engagement with research fact sheets, examine management intentions, feelings of reassurance about serious pathology and the acceptability of the fact sheets to people seeking care for low back pain. The study hypothesis is that a fact sheet resource which focuses more on listing medical management options (JAMA Patient Page- low back pain), can increase a patient’s preparedness for decision-making more than a fact sheet that focuses on self-management (Australian Commission for Healthcare Safety and Quality Information for Patients Fact Sheet).

GLX-100 is an investigational medical device containing glycosaminoglycan (GAG) designed to coat the inner lining of the bladder and is believed to reduce irritation and pain. The purpose of this research is to test the safety and tolerability of the device GLX-100 in participants with IC/PBS. This research will also evaluate whether GLX-100 can reduce the amount of pain and other symptoms associated with IC/PBS.

This randomized controlled trial (RCT) aims to evaluate the effectiveness of the Kidney Health for Life (KH4L) program in improving self-management for people living with chronic kidney disease (CKD), at two key stages: after diagnosis and prior to and after commencing dialysis. Participants will be stratified into two groups, (1) people who have been diagnosed with stage 1-4 CKD and (2) people who are preparing to commence or currently receive dialysis. Participants of both groups will then be randomised to receive the intervention (KH4L program) or standard support (control). Participants will be assessed at three time points, at baseline, week 6 and week 18 post randomisation. We hypothesise that (1) participants in intervention groups will show greater self-management behaviours, disease-related knowledge, self-efficacy, and psychological well-being than participants in the control groups and over time, and (2) disease related knowledge, self-efficacy, psychological well-being and selected sociodemographic variables will be predictors of self-management behaviours. We will also ask participants of the intervention groups to provide some general feedback on the intervention. While this will not be a specific outcome of the study, it will be useful to consider their feedback on how they found the intervention so as to provide guidance for future adjustments to the program, post study. Throughout the course of the study, we will monitor adherence to the intervention by monitoring usage of the KH4L online health hub and record attendance at group sessions. The research team will oversee module completion and activate reminders to those who are lagging on module completion.

This multisite prospective study will validate the SERIAS (Seizure-Related Impact Assessment Scale) for use in clinical epilepsy research and practice. 50 adult patients attending the Comprehensive Epilepsy Centres at The Alfred and The Royal Melbourne Hospital in Melbourne, Australia, will be consented and enrolled in the study. Participants will complete the novel SERIAS instrument, and a battery of validated instruments to assist with validation. These questionnaires will be completed at baseline, 3-, and 6-month timepoints. A subgroup will also form a test-retest cohort, repeating the instruments within a 2 week period.

Endometriosis is a chronic condition in which tissue similar to that lining the uterus grows on other organs, leading to scarring and adhesions and causing pain, menstrual irregularities, and infertility. Impacting 11% of Australian women and those assigned female at birth, endometriosis is under-recognised due to the variability in symptoms, reliance on surgery for diagnosis, and stigma of menstruation. Usual care, comprising of hormone and pain medications, has limited efficacy, is associated with adverse effects, and is discontinued by up to 40% of people. Recognising the inadequacy of the current biomedical healthcare approach to treating endometriosis, there is a need to address the complex psychosocial burden of endometriosis, and there are calls for urgent improvements in access to consumer-centred pain management. The current study will refine the structure and content of 'CodeEndo' – an online modular supportive care program for people living with endometriosis. The project will then evaluate the efficacy of the CodeEndo program using a randomised controlled trial, comparing it to waitlist control on quality of life and other important endometriosis-related biopsychosocial outcomes.

The immune system defends us against infection by bacteria, viruses and cancer. An important part of the immune system is white blood cells, which include lymphocytes, neutrophils, macrophages, and dendritic cells. We can identify and classify different white blood cells according to molecules expressed on their surface, their size and function. We have established a substantial programme of research at the Ian Frazer Centre for Children’s Immunotherapy Research (IFCCIR), where we aim to investigate how we can harness the power of the immune system to fight paediatric diseases. To do so, we need to understand what is unique about children’s immune systems, so we can identify the best therapeutic strategies. Thanks to innovative technologies, we are now able to measure up to 20 thousand parameters in a single cell from thousands of individual cells from a single drop of blood. By analysing hundreds of healthy children across all ages, we will build a Paediatric Immune Cell Atlas. This atlas will act as a reference that will help us identify much needed immunotherapy targets for paediatric diseases, including cancer and auto-immune diseases. Who is it for? You might be eligible for this study if you are a child aged 0-18 years old. Children without immune diseases can be consented to the 'Healthy cohort', children with Immune diseases can be consented to the 'Immune disease cohort'. A subset of children who are considered healthy from the immunological point of view, but who are scheduled to have open heart surgery can be consented to the 'Cardiac Surgery cohort'. Additionally, children consented to the 'Healthy cohort' might opt to consent for serial blood collections every 6 months for a period of 2 years. Study details All participants will be requested to provide 1 to 2 teaspoons of blood. The study team will collect discarded thymus tissue from participants in the Cardiac surgery cohort. All participants will be requested to complete a study questionnaire at each collection timepoint.

While many childhood cancers can be treated with standard therapies that have proved to be effective, in some cases, children with cancer might benefit from treatments that match their tumour characteristics. These treatments are known as personalised medicine. Information about personalised medicine for childhood cancer can be found in two main sources: clinical trials and medical literature. The process of determining the best drug, or combination of drugs, for a child can be challenging because there is an ever-growing collection of both of these sources. The process of sorting through hundreds of search results is very time consuming and requires highly specialised knowledge. This means that finding the best treatment can be a complex process, which can make it difficult to choose the best treatment for each child. In this study, we are partnering with researchers in CSIRO to develop Oncology Search Clinical Assistant Registry (OSCAR), a search tool designed to help paediatric oncologist find personalised treatments for childhood cancer. Study Details: What does participation in this research involve for my child? A. Allowing your child’s Molecular Profiling results from ZERO2 to be used to evaluate OSCAR: Your consent will allow ZERO2 clinicians to use your child’s ZERO2 results to evaluate the OSCAR search-engine. Clinicians trying to find adequate treatment for your child will do side-by-side comparisons of results doing manual searches with results obtained using the OSCAR search-engine. There are no costs associated with participating in this research project, nor will you or your child be paid. Who is it for? You may be eligible for this study if you are a child who has been diagnosed with cancer and has been enrolled on one of the studies led by the ZERO Childhood Cancer Program (ZERO2/PRISM). We hope this study will: • Compare the quality of results generated by OSCAR to results obtained by doing manual searches. • Determine if OSCAR can help save time when searching for personalised treatments for childhood cancer.

In this study we want to look at the impact starting on the new treatment for cystic fibrosis (CF) - Elexacaftor/tezacaftor/ivacaftor (ETI – also known as Trikafta) has on children ages 6-11 years in Australia. In the clinical trials conducted before a drug is approved for sale, there are various controls and measures around which children receive the treatment and what is measured. The results of these clinical trials showed that ETI is likely to improve lung function and health related quality of life. This study is about finding out if the same improved lung function and quality of life is seen in the real world, where there are less controls around which children can take the medication. We are adding this study to the BEAT CF project as the data we need to work out the impact of Trikafta in the real world is the same type of data that is being collected in BEAT CF.