ANZCTR search results

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.

Post-operative ice block consumption offers potential to reduce adverse symptoms of post-operative nausea and vomiting (PONV) and thus optimise patient recovery, patient experience, as well as decrease costs to healthcare systems through decreased antiemetic use and hospital length of stay. Therefore, in people who have undergone surgery requiring general anaesthesia, the objectives of this study are to examine the effect of post-operative consumption of a lemonade ice block compared to 1). unflavoured ice chips or 2). standard care (no ice block or ice chips) on postoperative recovery; specifically, PONV incidence and severity, rescue antiemetic use, and PONV-related outcomes (blood glucose level, quality of recovery, gastrointestinal recovery, post-anaesthesia recovery unit length of stay, patient experience). Outcome data will be collected at four time points: T0 (pre-surgery, within 24-hours of scheduled surgery), T1 (post-surgery, on waking in recovery unit; medical records only), T2 (post-surgery, on discharge from recovery unit), and T3 (24 hours post-surgery).

Asthma is the most common chronic illness in children. Yet, identifying wheeze is challenging for parents (disagreement rate between doctors and parents are >50%) and indeed many cultures (including Indigenous Aus) do not have a word for wheeze. Our multicentre study addresses the need to define wheeze accurately using digital technology. We will use WheezeScan (WzS) digital technology during face-to-face clinics as well as remotely (child’s home) in Queensland (including outreach clinics), Darwin and Sydney. In 125 children aged <12 years with asthma, we aim to evaluate the impact of using WzS impacts upon asthma control assessment, PROs, self-efficacy scale and health cost. WzS’s dependable accuracy will provide parents/caregivers and doctors the ability to discern if a child is wheezing-subsequently providing the confidence and clarity over the next steps that need actioning. Our study will lead to more accurate assessment of asthma control, thus resulting in improved management. Asthma guidelines identify that the primary goal of management is achieving good asthma control, thus reducing the risk of exacerbations.

This is a multi-centre, prospective, cohort study to evaluate epileptic encephalogram abnormalities and seizures in relation to sleep measures using polysomnography in patients diagnosed with an epileptic encephalopathy (Dravet syndrome and LGS) during video-EEG monitoring admission and are undergoing treatment with cannabidiol (EPIDYOLEX) as part of their routine clinical care. A total of 26 patients will be recruited from The Alfred and The Austin hospitals who are newly prescribed with EPIDYOLEX but have not yet commenced. The study will consist of a 4-week baseline period prior to drug initiation, during which time participants will keep a seizure diary and undergo actigraphy (GENEActiv accelerometer wristwatch) measurements. Participants will subsequently undergo two hospital admissions consisting of 24-hour EEG and polysomnography assessments at baseline, and the end of the study (16-weeks following drug initiation), respectively; actigraphy will be measured throughout the study period. All medications or interventions for epilepsy will remain unchanged the 4-weeks during the screening period and throughout the study period.

Adult community participants with a diagnosis of either bipolar disorder, schizophrenia, or schizoaffective disorder will be randomized to a dietary intervention alongside their treatment as usual. Participants will be assessed for their metabolic health, and social and mental functioning and supported with education and assistance in ensuring adherence to the allocated dietary protocol.