ANZCTR search results

Non-alcoholic fatty liver disease (NAFLD) is rapidly rising in prevalence worldwide and is responsible for growing numbers of cases of hepatocellular carcinoma and end-stage liver disease. There is currently no PBS-listed therapy for NAFLD in Australia. Low testosterone (T) is common in men with NAFLD and may contribute to disease prevalence and severity by increasing visceral fat, insulin resistance and altering hepatic metabolism. The impact of T therapy in men with NAFLD and low T levels remains unknown, but it is biological plausible that T will reduce hepatic fat content both via direct actions on hepatic sex steroid receptor signalling as well as indirectly, via promoting metabolically favourable changes in body composition and whole body glucose metabolism. Our aim is to conduct a randomized, placebo-controlled trial of intramuscular T therapy for 12 months in 120 men with NAFLD and low T levels to investigate its impact on hepatic steatosis. Our hypothesis is that T therapy will reduce hepatic steatosis and our primary endpoint is a 15% relative reduction in hepatic steatosis as measured by MRI fat fraction. Our secondary hypotheses are that T therapy will lead to improved liver enzymes, reduced insulin resistance, reduced visceral fat, increased lean mass and muscle strength and a reduction in liver fibrosis, as measured by MRI, Fibroscan and non-invasive blood markers.

The aim of this study is to explore the interaction between obstructive sleep apnoea (OSA) and other known cardiovascular disease (CVD) risk factors (e.g., diabetes) in the pathogenesis of CVD. Using baseline data collected between 2005 and 2010 we will describe and assess current cardiovascular status in approximately 2000 participants, 500 of which will be assessed in greater detail. With the primary aim of determining whether OSA predisposes to the development of CVD, or early markers of CVD (n=500), independently of other known CVD risk factors.

Hypothesis We hypothesise that nut butter supplementation of 30 grams/day for 12-weeks will be a practical strategy that will improve the overall nutritional intake, health and wellbeing of older adults living in an aged care facility. Study aims The aim of this study is to investigate the efficacy and feasibility of supplementing the habitual diet of older adults living at the Barwon Health’s Percy Baxter Lodge at McKeller Centre with 30 grams/day of mixed almond, Brazil nut and cashew nut butter for 12-weeks on their nutritional status, health and wellbeing.

This study will evaluate the feasibility and efficacy of pilocarpine on xerostomia for patients with cancer Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with cancer and xerostomia Study details Participants in this study will receive both the interventional drug and placebo drug but in a random sequence. At the beginning of the study, Participants will receive 6 bottles of drug. 3 bottles contain placebo and 3 contain the drug pilocarpine. The 6 bottles will be taken randomly as instructed by the pharmacy over 18 days. Participants will not know which bottle has what drug. The drug will be taken three times a day for the 18 day trial. All participants will complete a diary which will provide information around dry mouth symptoms, and document any adverse events/side effects experienced. We hope that this drug and formulation will be able to help cancer patients in the future who suffer from the debilitating symptom of chronic dry mouth.

The study focuses on applying a new assessment technology to better detect and monitor pain in older people with dementia living in the community. Elderly people, particularly those with dementia frequently suffer from painful conditions that are poorly treated. This is usually because dementia makes it difficult for people to remember and tell their doctors or family carers of how bad their pain is or in some cases when or where pain exists. Although, tools exit to assess pain in people with dementia, they are often subjective, manually based and subsequently underutilised. For this reason, this study aims to introduce PainChek® as an App for smart devices to assist family carers in assessing and monitoring pain of their relatives with moderate-severe dementia. It is hoped that the findings of this study will contribute to better pain management among this community-dwelling vulnerable population.

Pain often goes unrecognised and under-treated in people with communication difficulties such as those with dementia. Although, tools exit to assess pain in people with dementia, they are often subjective, manually based and subsequently underutilised. PainChek® is an approved medical device in the form of a smart device App, which combines artificial intelligence and smart automation to identify and quantify pain in real time. The App has been validated and used for assessing pain in people with moderate to severe dementia. PainChek® works by using facial recognition technology and analysis to detect pain through facial muscle movements which indicate the presence of pain. A number of studies have reported that PainChek® (formerly known as ePAT) is valid, reliable and accurate in identifying pain in people with moderate to severe dementia living in aged care facilities. It has also been used to assess pain in community-dwelling people with dementia referred to Dementia Support Australia. However, to date its use by family carers of people with dementia, and by people with mild dementia as an aide- memoire have not been studied. The study will therefore focus on investigating the views of stakeholders (family caregivers, people suffering from dementia and healthcare professionals) about applying PainChek® to better detect and measure pain in older people with dementia and those living in the community. The results of this study will be used to adapt strategies to facilitate family carers of people with dementia to use PainChek® to assess and monitor the pain of their loved ones, and for people with dementia who may wish to use the application as a way to document their pain experience.

ISU305 is being developed by ISU Abxis as a proposed biosimilar to eculizumab (Soliris® marketed by Alexion in the European Union [Soliris]). Soliris is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) or atypical haemolytic uraemic syndrome (aHUS), disorders associated with dysregulated complement activation.

This study aims to investigate ‘guideline based antimicrobial dosing’ in terms of pharmacodynamic target attainment and clinical outcomes and compare these findings to a matched cohort of patients receiving Therapeutic Drug Monitoring (TDM) based dosing. A sample size of 150 ICU patients meeting the inclusion criteria is required. This study is a single centred, prospective, observational study in critically ill patients admitted to the ICU with infections treated with the study antibiotics. All patients admitted into the ICU over a 12 month period who meet the inclusion criteria are consider for inclusion. This research will fill a gap in contemporary studies in terms of describing the achievement of pharmacodynamic targets of guideline based antibiotic dosing compared to a matched cohort of TDM-based dosing.

IBS is a functional GI disorder that causes long-term GI symptoms that reduce quality of life. Dietary management of IBS using the low FODMAP approach can effectively manage symptoms, but may indirectly compromise other aspects of gut health, including bowel habit and the gut bacteria. We have identified two types of dietary fibre whose functional properties may address these potential consequences and optimise dietary management of this condition. The aim of this clinical is to provide the low FODMAP diet to participants with IBS, with or without these fibres, in order to investigate their effects on GI symptoms, GI function and the gut bacteria.

Currently transplant during organ procurement specially trained theatre technicians take photos of the potential donor liver prior to aortic cross clamp and following reperfusion. These pictures are then sent to the transplant surgeon, transplant coordinator, liver pathologist via secure communication and stored on the liver database. In addition a biopsy is sent to the lab to confirm viability. On the basis of these pictures the surgeon either decides to go ahead with surgery or wait for the biopsy. An operating theatre is placed on hold from the time the team leave for organ retrieval until the biopsy results come back at which point they either proceed with the transplant or cancel it. This process can take several hours during which time each person who has seen the photo claims to be as accurate as the eventual laboratory result in predicting organ viability, organ age and organ fat content. We would like to create user response curves to see if there is a correlation between health care provider groups and their ability to predict organ viability in liver transplant