ANZCTR search results

This is a single-centre, randomised, double blind, single and multiple ascending dose study to assess the safety of ZE46-0134, and how this drug acts in the body in healthy volunteers. ZE46-0134 may be indicated for use in patients with leukaemia, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or double dose of ZE46-0134 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of ZE46-0134 or placebo, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of ZE46-0134 that can be administered safely without causing severe reactions. Once the dose of ZE46-0134 has been determined in healthy volunteers, a trial investigating the efficacy of ZE46-0134 as a treatment for patients with leukaemia may proceed.

Perceived cognitive difficulties are prevalent in people with mood and complex trauma. This includes difficulties in concentration, attention, planning and organisation, capacity to multitask, processing speed, and recall. The consequences of cognitive impairment include reduction in self-esteem, capacity to absorb information, and procrastination, as well as increases in the time necessary to complete tasks and avoidance of decision making. Such impairments can consequently impact individuals' performance at work, in relationships and in hobbies, and diminish the benefits of therapy. These circumstances necessitate the development of affordable and accessible interventions that can be offered to individuals experiencing cognitive function deficits associated with mood and trauma disorders. Cognitive training has been shown to be efficacious in aging populations, and populations with mild cognitive impairment, psychosis, and mood disorders. There is clear scope to develop and implement cognitive training for mood and complex trauma disorders in women's mental health. The research activities outlined in this application will specifically address the mental health needs of women with mood and complex trauma disorders. Gender differences in mental ill health are well documented. The proposed project seeks to improve symptoms of mood and complex trauma disorders in women by improving underlying problems in cognitive abilities. The outcomes of this cognitive training research will directly benefit women. The broader benefits of this research activity will help retain females in work and study, including perimenopausal women who often reduce their engagement in the workforce. Hence, this research activity will aid age and gender diversification and expertise in the modern workforce. The aim of this research is to design and implement a cognitive training program (COGtrain) tailored toward women’s mental health. That is, incorporating education about the influence of sex hormones and reproductive life events on mood and cognition. This research activity will employ an open-label feasibility trial design with the aims of (a) examining the feasibility of utilizing COGtrain among women with mood and complex trauma disorders and (b) determining whether COGtrain leads to significant improvements on measures of perceived cognitive impairment; neuropsychological and psychological functioning, and individual goal setting.

Current research indicates there may be an impact of bariatric surgery on patient’s psychological health, including increased rates of depression, suicidal and self-harm behaviours, and drug and alcohol use. However, the actual impact remains unclear due to the variety of procedures being performed, the diverse methods of assessing psychological health, and the amount of time patients are followed. In order to advance our understanding of these relationships, patients must be assessed and followed throughout their experience of bariatric surgery and for an extended amount of time into their recovery. This will facilitate the identification of risk factors so that the most vulnerable patients can be identified and the optimal care provided.

Reduced bone strength and increased fracture risk (osteoporosis) affects millions of older Australians, particularly women after menopause, resulting in massive burdens to society. Innovative research is desperately needed to address this. Exercise improves bone health however effects of combining exercise with bone-building medication are unknown and may lead to more effective collaborative treatment of osteoporosis. We are conducting a study in postmenopausal women with osteoporosis to determine whether a bone-building exercise programme can enhance effects of bone-building medication to improve bone mass over an 8-month period. We will assess whether 8-months combined osteoporosis drug therapy (romosozumab) with high-intensity exercise produces greater improvements in lumbar (lower) spine density compared to drug treatment with low-intensity exercise. The results will help determine whether doctors should prescribe bone-building exercise with drug therapy to enhance effectiveness of treatment in this priority population. This is the first randomised controlled trial initiating and combining drug and exercise treatment for osteoporosis and will provide important insights into the role of exercise in osteoporosis treatment. We will also assess whether romosozumab can improve muscle mass, strength and physical function compared to placebo, which may lead to reduction in falls which is important for people with osteoporosis given majority of fractures occur from falls. We expect that the combination of drug and exercise treatment will be the most effective strategy for improving lumbar spine bone density and that the drug will improve muscle mass, strength and physical function compared to placebo.

This study aims to determine the safety and feasibility of a combination of orally administered medications (naltrexone and bupropion) for people with methamphetamine use disorder in an outpatient drug and alcohol treatment setting. There are currently no approved medications in Australia to help people manage, reduce, or stop their methamphetamine use. It is hoped that this study will help find out if taking naltrexone and bupropion together everyday over a 12-week period is a safe and feasible treatment approach for methamphetamine use disorder .

Summary Our recent work has highlighted that the highest rates of type 2 diabetes are in Central Australia. The increasing numbers of Australian Aboriginal and Torres Strait Islander youth living with overweight, and obesity are contributing to increasing rates and earlier age of onset of type 2 diabetes (T2D) and related conditions. This program was developed in response to requests from NT communities and clinicians (Diabetes across Lifecourse Partnership Aboriginal and Torres Strait Islander Advisory Group, Clinical Reference Group and NT Diabetes Clinical Network) to address the issue of increasing rates of youth-onset obesity and diabetes. A key priority identified was for prevention, early detection and management of obesity and diabetes risk among Aboriginal youth. Australian childhood obesity prevention programs have previously had limited success in adapting to the needs of Aboriginal communities. In partnership with Central Australian Aboriginal Congress- (Congress), formative work in Central Australia was undertaken in 2019-2020 regarding the appropriateness of adapting an international youth diabetes prevention program successfully trialed in First Nations communities of North America (Tribal Turning Point). This work involved extensive consultation with a range of health service providers, family groups and cultural advisors. The next phase of this project involves implementing and evaluating the adapted Tribal Turning Point program (Merne Mwerre Artweye Areye-ke) in remote Australian (NT) communities to raise awareness and to prevent overweight/obesity and improve health among Aboriginal children and families. The cluster randomized trial will assess the clinical effectiveness and implementation of the Merne Mwerre Artweye Areye-ke Program in remote Australia for families with primary school aged children (6-11 years). It will run for 4 years from February 2023 to December 2026.

This prospective multicenter, open-label, randomised clinical trial will be assessing coronary artery bypass grafting (CABG) using two surgical approaches: the novel total arterial revascularization (TAR) versus the conventional use of one or more saphenous vein grafts (SVG) (non-TAR). Participating institutions will include major heart centers in Australia. The eligibility criteria for participants will be primary adult isolated CABG patients with multivessel coronary disease requiring at least two grafts. The primary endpoint is the number of perfectly patent grafts in each arm at 24 months post-surgery, as defined by the absence of atherosclerotic occlusions and lumen irregularities on cardiac imaging. The primary hypothesis of the TA trial is that patients undergoing primary isolated non-emergent bypass surgery with exclusive use of arterial conduits will be associated with an increased rate of perfect patency. The secondary hypothesis is that in these patients, the use of TAR compared to non-TAR is associated with similar survival and freedom from major adverse cardiac events at 24 months. This trial will address a major gap in cardiac surgery research and drive a substantial or transformative shift in international health practice.

Pierre Robin Sequence (PRS) is a rare (1:8500 live births) congenital condition characterized by micrognathia (small jaw)/retrognathia (receding chin), glossoptosis (posterior and upward displacement of the tongue) and upper airway obstruction. Many infants with PRS have a cleft of the soft palate. The main clinical issue for infants with PRS is upper airway obstruction (UAO) leading to obstructive sleep apnoea (OSA, intermittent brief cessations of breathing while asleep), feeding difficulties and failure to thrive (i.e. very slow weight gain). Polysomnography (PSG), also known as the sleep study is the currently approved tool to objectively assess the severity of OSA but is often difficult to obtain in a timely manner. This could lead to suboptimal care, prolonged hospital stays, parental anxiety, and staff dissatisfaction. Two other bedside tools, sleep pulse oximetry and 3D facial photography, are easier and quicker to perform and have the potential to diagnose OSA in these infants. However, there is currently limited evidence on their diagnostic accuracy in comparison to the gold-standard PSG in infants with PRS. Hence, we aim to conduct a prospective diagnostic accuracy study evaluating whether sleep pulse oximetry and 3D facial photography are non-inferior to PSG in detecting upper airway obstruction in infants with PRS. Additionally, we will explore the association between the severity of upper airway obstruction assessed using PSG, sleep pulse oximetry, and 3D facial photography with the neurodevelopmental outcomes of infants with PRS until two years of age. Given rarity of the disease, we aim to recruit for 4 years to reach a sample size of 30 with follow-up of each participant up to 2 years of corrected age. Data from study participants will be collected from birth to 24 months of life. The project is recruiting participants with rare conditions and syndromes.

Urinary tract infections (UTI) pose a significant health concern for women, with as many as 50% being affected, and a quarter developing chronic UTI or interstitial cystitis. There are several herbs with well-established antimicrobial properties, and natural products and supplements have shown promise in supporting overall urinary health, as well as providing protection and prevention against UTIs. This trial aims to examine the efficacy and safety of Urox® for preventing UTIs and cystitis in women experiencing recurrent urinary tract infections.

This phase 1 study is a randomized, placebo-controlled, double-blind, trial of an oral drug called GT 02287 vs. placebo in healthy volunteers. The study will assess the safety, tolerability, Pharmacokinetics, and Food Effect in single and multiple ascending dose cohorts.