ANZCTR search results

The purpose of this study is to assess the safety and tolerability (how well a treatment can be tolerated by a patient) of EBC-1013 Gel. This study will be conducted in patients with Venous Leg Ulcers, aged 18 years and above. This study will compare EBC-1013 Gel with placebo. A placebo is a medication with no active ingredients. It looks similar to the real thing, but it is not. Participants enrolled in this study will be placed into one of five different groups. Each group will receive a single treatment with one of five different dose levels of EBC-1013 Gel (0.1, 0.3, 0.6, 1.0 and 1.5 mg/g). One participant in the first three dose concentration groups will receive placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. Each group will involve a minimum of 3 participants. A maximum of 7 participants will be enrolled in each cohort, if any safety signals are observed in that cohort.

The purpose of this trial is to investigate the acute dose-related effects of intraduodenal administration of calcium on gastrointestinal functions, associated with the regulation of appetite and energy intake, in healthy participants.

Stroke affects approximately 1 in 4 people in their lifetime, but is highly preventable through effective management of risk factors such as smoking, inadequate diet, high blood pressure and physical inactivity. Love Your Brain is a digital platform to improve the knowledge of Australians in stroke prevention, by helping people identify and manage their risk factors for stroke. We will determine the feasibility and acceptance of the implementation of the proposed intervention in a sample of attendees of Stroke Foundation StrokeSafe presentations and obtain data to inform the design of a fully powered randomised controlled trial.

Chest pain is the leading cause of Ambulance Victoria attendance and costs $337 million per year. Currently, all patients with chest pain are transported to hospital, but half will be discharged safely from Emergency Departments, at a cost of $135 million every year. We have developed a new Ambulance Victoria clinical practice guideline (CPG) for these low risk patients using risk assessment, point-of-care blood testing by paramedics, and Victorian Virtual Emergency Department consultation with referral for follow-up in the outpatient or general practice setting. We will now conduct a comprehensive evaluation of the new CPG via a randomised trial with safety, effectiveness, quality of care, process, and economic components. The outcomes span from the rapid reduction of ED overcrowding and ambulance ramping in the short term to the development of streamlined follow-up pathways and significant cost savings in the medium and long term. Through this innovative model, we will optimise patient outcomes and contribute to a more efficient and economically sustainable healthcare system for the benefit of all stakeholders.

Humans require sufficient sleep to maintain physical and mental health. Reductions in sleep quantity and quality are associated with reduced cognitive function and productivity and increased absenteeism, along with chronic diseases such as hypertension and cardiovascular disease, dementia, depression and anxiety. Laboratory studies have shown that hot temperatures result in worse sleep, with epidemiological data suggesting that hot overnight conditions are independently related to mortality. To date, nearly all solutions for combatting heat stress are pre-occupied with reducing air temperature – usually using air conditioning (AC). Currently, despite no supporting evidence, all major international public health agencies (including WHO) state that fans should be turned OFF above 32-35°C as they accelerate heat/dehydration risk. A series of recent publications from our research group has shown that fans can mitigate heat stress at temperatures as high as 42°C. However, how these findings translate to overnight fan use at these temperatures remains unknown. Thus, the purpose of this trial is to test the use of electric fans to improve sleep quantity and quality in ambient conditions of 35°C and 40% Relative Humidity.

Apart from topical aminosalicylates and steroids, there is limited local treatment available for ulcerative proctitis, a incurable relapsing inflammatory condition of the bowel. This study aims to assess the safety of using locally injected stem cells derived from healthy placentas to treat ulcerative proctitis. Participants will receive a single injection of cells during routine colonoscopy and undergo assessment using routine colonoscopy, blood tests and stool tests. We hypothesise that these placental-derived stem cells will be safe and well-tolerated and that local injection is feasible.

Identify the feasibility of MI-CBT via telehealth in supporting people with knee/hip osteoarthritis to uptake and adhere to a walking program based on rehabilitation. Hypothesis: Telehealth based on MI-CBT is feasible.

This is a double-blind, randomized, placebo-controlled study which is subdivided in 2 parts, Part 1 (SAD) and Part 2 (MAD). Decisions about how and when to move between cohorts will be based on reviews of the available blinded safety data and available pharmacokinetic (PK) data; this data will be reviewed by a prespecified Safety Review Committee (SRC). In Part 1, healthy volunteers will be enrolled to receive single ascending doses of LTSE-2578 or placebo. In Part 2, healthy volunteers will be enrolled to receive once or twice daily doses of LTSE-2578 or placebo for fourteen consecutive days.

Some people over the age of 65 years experience a substantial fall in BP after eating, so-called, postprandial hypotension. Recent, compelling, evidence indicates that the gut hormones, GLP-1 and GIP, modulate BP after a meal. Unlike GLP-1, GIP does not slow stomach emptying and may accelerate it. While the role of endogenous GIP in the regulation of postprandial blood glucose and BP remains uncertain, due to the lack of a specific GIP antagonist, our recent studies strongly support the concept that GIP regulates BP and gut blood flow. Colleagues in Copenhagen have recently developed an effective GIP antagonist in humans. We will use the GIP antagonist to define the roles of GIP, in the blood glucose, BP, gut blood flow flow and stomach emptying responses to a glucose drink in healthy older people..

Asthma is a common disease and significant public health problem in Australia, affecting one in nine adults. Current asthma management approaches treat all patients the same, using a step up- step down approach, which fails to recognise the complexity and heterogeneity that is evident, particularly in those with more severe disease. While this approach significantly improved asthma outcomes, in the early 21st century its limitations have become apparent, as improvements in asthma outcomes have stalled. Indeed, people continue to die from asthma, have an ongoing burden from acute attacks and symptoms, and suffer severe iatrogenic consequences of treatment, in particular from oral corticosteroids (OCS). Alarmingly, in Australia it has been demonstrated that more than 25% of patients using inhaled corticosteroids reach a cumulative OCS dose of >1000mg which is associated with increased risk of serious adverse side effects and irreversible harm. Management approaches that address the heterogeneity of asthma, including risk factors and comorbidities associated with the prevalence and persistence of the disease, and that incorporate advances in knowledge are urgently needed. “Treatable Traits” have been proposed as a useful concept to implement precision medicine. This approach recommends an assessment of traits or disease characteristics that fall within three domains: pulmonary, extra pulmonary and risk factor/behavioural, and the application of targeted individualised interventions based on the identified traits. This project will test the clinical and cost-effectiveness of a Treatable Traits model-of-care as an OCS-sparing strategy for the management of adults with asthma, while gathering information on its potential for implementation in real-world settings.