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GATOR: Development of a detailed database for collection of clinical data in patients with newly diagnosed GAstro-oesophageal Cancer
Expand descriptionThe purpose of this study is to create a database of early and late stage gastro-oesophageal cancer patients. Who is it for? You may be eligible for this study if you are aged 18 or over, have gastro-oesophageal cancer and are a patient at one of the participating sites. Study details All enrolled patients will contribute data to the development of the web database. Data captured will include presentation and disease characteristics, patient characteristics, surgical and/or drug treatments administered, survival and treatment outcomes. Data will be collected for up to 10 years and will be updated regularly by study personnel throughout the patient’s treatment and follow-up from their medical record. It is hoped this research will contribute important information about all patients with gastro-oesophageal cancer and help to inform future treatment decision-making for clinicians.
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Testing safety and efficacy of a live bacterial therapy for the treatment of Helicobacter pylori infection
Expand descriptionThe aim of this study is to evaluate safety and efficacy of SVT-1C4610 as a monotherapy treatment for eradicating H. pylori infection. The treatment consists of carefully selected bacterial species that have demonstrated bactericidal activity against H. pylori in vitro. Bacteria are part of a healthy gut microbiome, including the stomach. An altered balance of bacteria in the gut is observed in people with H. pylori infection. When H. pylori is eradicate from the stomach, the gastric microbiota is observed to rebalance to a more healthy state. Proposed mechanisms for the bacterial species in eradicating H. pylori infection include competition for adhesion sites on the gastric epithelium, improved gastric mucosal barrier function, production of antimicrobial peptides against H. pylori, down regulation of inflammatory cytokines that are induced by H. pylori and by binding to H. pylori forming complexes that can be removed from the stomach via the gastrointestinal tract. There is evidence that monotherapy with high doses of beneficial bacteria is successful in eradicating H. pylori in a certain number of cases and several studies have found a greater response to eradicating H. pylori when standard treatment is given together with beneficial bacteria. This study will help determine how effective a high dose of SVT-1C4610 is as a stand-alone therapy in eradicating H. pylori and reducing symptoms.
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DETECT Schools Study: Understanding the impact of COVID-19 in Western Australian Schools
Expand descriptionThe State Government is partnering with Telethon Kids Institute in a study (the DETECT School Study) to learn more about undetected SARS-CoV-2 infection among school students and staff without symptoms.It is hoped that this study will provide a greater understanding of any role that schools play in the transmission of the disease and help us to understand how students, parents and staff are coping in this challenging environment. Three study Modules will be used to address these overarching objective and the specific module aims and intended outcomes are as follows. Module 1 - SARS-CoV-2 asymptomatic testing Aim: Document the prevalence of SARS-CoV-2 infection in a cohort of randomly selected school students/staff for testing who are not reporting any clinical symptoms of SARS-CoV-29 (asymptomatic). Module 2 – SARS-CoV-2 index case response Aim: To determine the secondary attack rate of SARS-CoV-2 when detected in a school setting. Case detection includes asymptomatic cases detected in Module 1 and symptomatic cases from Module 1 schools (after presenting to a community testing facility for symptomatic testing). Module 3 – Psychosocial impact of COVID-19 Aim: Document the psychological and social circumstances and their prevalence in a cohort of students aged 9-18 (Years 4-12), school staff and parents of children aged 3-18 (Years K-12).
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Sources of a Resilient Mindset in Health Professionals During COVID-19: The SOAR Study
Expand descriptionHealth professionals around the world face unprecedented uncertainty during the COVID-19 pandemic, and a resilient mindset is needed to both ameliorate stress and facilitate growth experiences during this difficult time. Resilience involves responding to a potentially highly disruptive event adaptively such that psychological and physical functioning is relatively preserved, and there is capacity for positive growth. The purpose of this study is to interview frontline health professionals to explore lived experiences of resilience during the COVID-19 pandemic. Specifically, we will focus on exploring modifiable sources of resilience, including psychological and lifestyle factors that Australian healthcare workers are drawing on to navigate the challenges of working through the COVID-19 pandemic.
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The effects of 12 weeks of resistance training combined with 5:2 intermittent fasting or continuous energy restriction on body composition, strength, compliance and gut microbiome.
Expand descriptionEnergy restricted diets are commonly undertaken with the aim of losing weight, specifically body fat. However, weight loss commonly leads to the loss of lean body mass as well. The primary purpose of this study is to compare the effects resistance training with either continuous energy restriction or 5:2 intermittent fasting on lean body mass in healthy individuals, when overall energy deficit and protein intake is similar. Our hypothesis was that 5:2 intermittent fasting would result in better preservation of lean body mass during weight loss.
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Comparing traditional Placement With placement using electrocArdiography for central Vascular access dEvices trial (P Wave Trial)
Expand descriptionIt is hypothesised that inserting a central venous access devices (CVAD) using intra-cavitary electrocardiography (IC ECG) compared to traditional anthropometric guided insertion is more accurate resulting in shorter procedure times, less catheter malpositions and cost savings. CVAD malposition can lead to significant patient injury including heart rhythm disturbances, vessel or heart wall erosion or significant thrombosis. The aim of this study was to compare the IC ECG method for CVAD insertion with traditional CVAD placement in a broad patients population.
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Cancer Molecular Screening and Therapeutics (MoST) Program Substudy Addendum 7: Tremelimumab
Expand descriptionThis study will determine if an immunotherapy drug (called tremelimumab) has an effect on progression-free survival in patients with rare or neglected cancers. This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. Who is it for? You may be eligible for this study if you are an adult with and advanced and/or metastatic solid cancer. Study details Participants will receive the study drug (Tremelimumab) via intravenous infusion every 4 weeks for 6 cycles. Participants will complete imaging, clinical and safety assessments throughout the study. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that tremelimumab will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study
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The effect of continuous versus intermittent delivery of enteral feeding on glycaemic control and gastrointestinal response in critically ill patients (CGM-ICU)
Expand descriptionThis study aims to compare the effect of nutritional feeding pattern of standard feeding (continuous delivery of feeding over 24 hours) or intermittent feeding (4 boluses of feed every 6 hours) on blood glucose levels, the rate of stomach emptying and clinical outcomes. When patients are sedated and on a breathing machine in the intensive care unit (ICU) they are fed via a tube with liquid feed. Delivery of feed to critically ill patients is often provided continuously over the day as it is believed that this pattern may help control blood glucose levels and is easier logistically. However, intermittent feeding, by providing several larger boluses at 4-6 hourly intervals, follows more of a meal-like pattern, and is thought to have benefits on gut function and prevention of muscle loss. At this time, little is currently known about which pattern of feeding has the most benefit on blood glucose control, gut function and muscle mass.
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Proof of concept study on the combined effect of dronabinol and acetazolamide on apnoea hypopnoea index (AHI) in adults with obstructive sleep apnoea
Expand descriptionThis is a randomised crossover study to determine the therapeutic benefit of a combination of dronabinol and acetazolamide in subjects with suspected or diagnosed mild to moderate Obstructive Sleep Apnoea (OSA). Subjects will be required to undergo five sleep tests. Prior to each sleep test the Subjects will complete questionnaires to assess daytime somnolence, mood and quality of life. The first sleep test will confirm OSA and establish baseline levels for AHI, daytime somnolence, mood and quality of life. Once OSA is confirmed Subjects will be randomised into one of six treatment arms. All Subjects will undergo four treatment periods where they will receive treatment one of placebo or low, medium or high dose combination of dronabinol with acetazolamide. All subjects will receive all treatments over the course of the study but the order or treatment periods will be random. Each treatment will last for seven nights with a seven-night washout period between treatments. On night 7 of each treatment period the Subjects will undergo a sleep study using a polysomnography (PSG) machine at the sleep clinic. Sleepiness, mood and quality of life questionnaires with completed prior to PSG set up on night 7. AHI, daytime somnolence, mood and quality of life scores will be compared to baseline across the 4 treatments to establish the optimal dose for the therapeutic benefit for the combination of dronabinol with acetazolamide for treatment of OSA.
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The Prediction modelling for Risk-Stratified care for women with Gestational Diabetes (PeRSonal GDM) study: Calculating the individualised risk of adverse outcomes for women with gestational diabetes.
Expand descriptionBackground Gestational diabetes (GDM) is a common yet highly heterogeneous condition. The ability to calculate the absolute risk of adverse pregnancy outcomes for an individual woman would allow preventative and therapeutic interventions to be delivered to women at high-risk, sparing women at low-risk from unnecessary care. Research Aims 1. To examine the outcomes of GDM in the context of current care. 2. To develop a prediction model for adverse pregnancy outcomes in women with GDM. Participants All pregnancies within the existing Monash Health maternity outcomes database with a birth recorded from 1 January 2016 to 31 December 2018. All analysis will be conducted using non-identifiable data. Methods Epidemiologic questions will be examined with logistic regression analysis. A multivariable prediction model will be developed using clinical characteristics routinely available at the time of GDM diagnosis. Recent methodologic advances aimed at developing clinical meaningful and implementable models will be utilised. Expected Outcomes Obesity, excess gestational weight gain and ethnicity are significant contributors to adverse pregnancy outcome in women with GDM in this real-world population-based dataset. A method for stratifying women with GDM by risk of adverse pregnancy outcomes will be developed.