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This study is designed to test the safety and potential benefit of adding an existing drug used for bone protection (denosumab) to a new immune stimulating drug (pembrolizumab). Who is it for? You may be eligible for this study if you have a confirmed unresectable or metastatic clear cell renal carcinoma, and you have adequate liver and bone function. Study details All participants will receive the two study drugs, along with vitamin D and calcium (mode of administration up to the discretion of the treating clinician). Treatment will continue until disease progression or toxicity. Patients will be monitored for tumour response and skeleton health. It is hoped this combination of medications will be as safe, and provide more benefit than the immune stimulating drug alone in treating kidney cancer.

This is the first in human study to evaluate the safety and tolerability of topical treatment, HXP124 in otherwise healthy patients with mild to moderate fungal toenails infections, onychomycosis. The study also aims to evaluate the effectiveness of HXP124 in treating onychomycosis.

The purpose of this study is determine how the lungs start breathing air immediately after birth. We know that during the pregnancy the baby’s lungs are filled with fluid but that immediately after birth the lungs need to very quickly clear the fluid and replace it with air so normal breathing can begin (this is called ‘aeration’). Some babies struggle to do this and develop breathing problems immediately after birth. This is very common in babies born prematurely but also occurs in at least 10% of healthy term babies. It is known from studies in animals that the process of aeration is very complex and breathing problems are most likely if aeration does not occur equally throughout both lungs at birth. At present we don't know how babies lungs aerate at birth, despite this being something every baby needs to do. This is because measuring aeration is hard to do. Recently, our team have developed a special method of measuring aeration at birth, it uses a simple device called electrical impedance tomography or EIT). EIT does not interfere with the normal behaviour of a baby or their clinical care, and is free from radiation (unlike x-rays), meaning that EIT can measure aeration and breathing in a baby for long periods of time. We would like to use EIT describe, for the first time, how healthy term and preterm lungs aerate immediately after birth. This will assist us in determining how we may be able to better understand how to develop treatments for sick babies who cannot achieve aeration properly.

This study is being conducted to evaluate the safety, tolerability, pharmacokinetics of ascending single doses of XW10172 compared to placebo.

A primary treatment goal of intensive insulin therapy for type 1 diabetes (T1D) is to minimise excessive glucose excursions (hyper- and hypoglycaemia), which exacerbate the risk of chronic vascular complications, disability and premature death. Even with benefits from new technologies such as insulin pumps, achieving optimal glycaemic control in T1D remains a challenge. Those on intensive insulin therapy have several fold higher risk for developing cardiovascular disease compared to those without diabetes. Effective lifestyle-based approaches to improve blood glucose control could further assist in preventing or delaying the onset of the serious vascular complications of T1D. Exercise recommendations for those with T1D have largely been based on studies showing benefits for those with and without type 2 diabetes (T2D). This is because exercise training studies in those with T1D have largely failed to demonstrate improved glycaemic control (HbA1c). Fear of exercise-related hypoglycaemia has been identified as the strongest barrier to exercise in adults with T1D, and epidemiological evidence suggests that those with T1D are just as inactive as their counterparts in the general population. There is now the need to identify practical and feasible lifestyle strategies that can help to optimise glycaemia and reduce the risk of diabetic complications. There are emerging alternatives to the conventional notion of health-enhancing bouts of exercise. Reducing and breaking up sitting time shows promise. Prolonged unbroken sitting time is detrimentally associated with cardiometabolic risk biomarkers, T2D, cardiovascular disease and all-cause mortality. Recent experimental studies, have also shown that prolonged sitting is associated with acute elevations in postprandial glucose and insulin responses, and these adverse effects are attenuated with frequent breaks in sitting. However, these studies have focussed on those who are healthy or overweight without diabetes, or on those with T2D. Although T1D and T2D are distinct conditions, chronic sustained hyperglycaemia is unequivocally associated with increased risk of vascular disease in both forms of diabetes. Consequently, there is a need to evaluate the effect of reducing prolonged sitting on glycaemia and vascular risk factors in T1D, and the associated potential to minimise risk of serious diabetes complications. In a randomised cross-over trial for adults with T1D, we will compare the acute cardiometabolic effects of three controlled experimental conditions: • prolonged uninterrupted sitting • prolonged sitting interrupted with regular short bouts of simple resistance activities Findings from this trial will help to identify new options for the lifestyle management of T1D, which can be examined in more depth in subsequent studies.

The aim of this study is to see whether fructose elevates triglyceride acutely and whether this gets worse after a month of consumption of fructose muffins. Overweight or obese volunteers underwent 2 acute fat tests over 3 hours with 2 muffins sweetened with sucrose or fructose. This was repeated after a month of consumption of 2 low fat muffins/day sweetened with either sucrose or fructose. Endpoints were area under the curve for triglyceride and glucose and weight

Mental illness accounts for significant childhood morbidity and mortality and is an area of national and global importance. Mental health problems are the dominant cause of childhood disability and contribute to 45% of the global disease burden in young people (10-24 years). • The recent Five-Year Youth Mental Health Report reveals alarming figures of one in four young people meeting diagnostic criteria for probable serious mental illness. This has increased from 18.7% (2012) to 22.8% (2016). • Half of all lifetime mental illnesses emerge by age 14, and 75% by age 24. • The negative long-term consequences of childhood mental illness include lower educational attainment, unemployment, substance use and addiction, crime and incarceration, self-harm and suicide. • Suicide is the leading cause of deaths in young people aged 15-24. Key policy recommendations from the report include support for the development of technology that provides an alternative to face-to-face health provider consultations. The prevention, identification and treatment of mental illness is a priority area for national and global health programs. Diagnostic and Management Need: Clinicians have not been able to achieve more than modest agreement in diagnosing mental illness, and the lack of objective measures for evaluating treatment has left long treatment titration cycles and suboptimal management. Indeed, the treatment of adolescent depression remains complicated and controversial because there are no objective measures of treatment effectiveness. New Research and The AutoMHaN Project: Research undertaken in Western Australia (WA) showed that there is a relationship between psychiatric status and 24-hour or ‘circadian’ heart rate (CHR). Broadly, different mental illnesses, such as Generalised Anxiety Disorder and Depression, are associated with distinctly different changes in CHR and this relationship is state-dependent: a change in clinical status is associated with a change in CHR. The autonomic nervous system (ANS) plays a key role in regulating basic body rhythms and activities including heart rate. Under these circumstances, evidence of distinct differences in CHR in different forms of mental illness, especially during sleep when environmental influences on heart rate are minimal, are an objective indication of basic differences between disorders. This suggests that an analysis of CHR can add an objective dimension to diagnostic assessment and the evaluation of treatment. The aim of this study is to see whether similar results can be obtained in children and adolescents. This pilot study will compare CHR from healthy children with CHR from children with different mental health and neurodevelopmental disorders including depression, anxiety, ADHD and autism. The aim is to see whether an analysis of CHR can provide objective indications of these conditions, differentiate between them and provide objective indications of their response to treatment.

The Department of Gastroenterology and Hepatology at the Princess Alexandra Hospital has recently established an Integrated Care Clinic as a strategy to help meet the growing demands for Gastroenterology and Hepatology outpatient services, to reduce waiting times and minimise risks to patients resulting from delayed health care management. The Integrated Care Clinic provides a multi-disciplinary approach by providing outpatient services cooperatively by GPs/specialists and nurses and well as by allied health professionals including psychologists, dieticians and exercise physiologists to manage patients with highly prevalent, but chronic conditions including patients with functional gastrointestinal disorders such as irritable bowel syndrome (IBS) as well as hepatology conditions such as non-alcoholic fatty liver disease (NAFLD). This study aims to compare the effects of standard care and the Integrated Care Clinic on the health outcomes of 500 consecutive patients presenting to an outpatient department with Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, stable Inflammatory Bowel Disease and Irritable Bowel Syndrome (IBS) in relation to psychological, dietary and activity outcome parameters.

This study will be a single-centre, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK of GMA301 (thereafter referred to as getagozumab), in healthy subjects. Four sequential dosing cohorts, each with 6 subjects receiving getagozumab and 2 subjects receiving placebo (total of 32 subjects), will be given increasing single doses of getagozumab. sentinel dosing is proposed for each group. Two sentinel subjects (1:1 active to placebo) will be dosed first and the remaining 6 subjects in the cohort will be dosed 7 days later, followed by at least 12 days prior to the next cohort dosing. After Screening (Screening Period of 28 days), eligible subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized into the study. A computer-generated randomization schedule will be used. The treatment period will last up to 8 weeks, followed by a 2-week follow-up period.

Internationally, the evidence in support of arts programs for participants’ health and wellbeing is rapidly growing. The Mater Young Adults Health Centre (YAHC) arts in health program will offer participants four 6-session options: Vocal Group, Tuned In music program, Art Therapy group, and Podcast Making group. The aim of the project is to evaluate treatment as usual (TAU: individualised medical and allied health consultations) + arts health group; versus TAU; to evaluate the potential effect of the arts health groups on measures of participant wellbeing, identity, social connectedness, and engagement with the health service.