ANZCTR search results

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.

This is a prospective observational multi-centre registry in which clinical data on consecutive patients with prostate cancer who undergo irreversible electroporation (IRE) procedure is collected. Who is it for? You may be eligible to join this study if you have been diagnosed with histologically confirmed prostate cancer and are scheduled for IRE Nanoknife procedure. Study details Patients with prostate cancer who undergo IRE procedure at participating clinics will have their medical data collected and collated into this clinical registry. Patients’ data to include baseline visit (pre-IRE) and peri-operative data. Participants will then be followed-up at 1, 3, 5, and 10 years after IRE to determine oncological and functional outcomes. Follow up data at each participating treatment site is collected according to the guidelines for focal therapy in prostate cancer and/or by discretion of each treating Urologist. Amendments to the standard of care are not required nor desirable. Deviation from current practices will be by the discretion of the treating urologist only and outcomes will be included in this registry as it is purely observational in nature. It is hoped that this research project will provide a better understanding of patient outcomes undergoing IRE procedure. .

Pregnancy and birth provide a critical window for intervening to improve short- and long-term health and wellbeing for women and their children, yet there is a lack of evidence to guide preventative interventions. Group pregnancy care (where women have care and education in a group of 8-10 women) is very popular among women and midwives but needs further testing for safety. This small pilot study will explore whether we can successfully do a larger study in Victoria, Australia that will provide evidence for the safety of this pregnancy model of care.