ANZCTR search results

ZEAL is a single-centre, open-label, 1:1 randomised controlled trial at Westmead Hospital enrolling adults with osteoporosis who are stopping denosumab after greater than or equal to 2.5 to less than or equal to 6 years of therapy. It compares early zoledronic acid 5 mg IV at 3 months after the last denosumab dose (second dose 6 months later) versus on-time zoledronic acid at 6 months (second dose 6 months later). The primary endpoint is change in lumbar spine and total hip BMD from baseline to 18 months after the last denosumab dose. Secondary outcomes include bone turnover markers, proportion with >5% BMD loss, incident vertebral and non-vertebral fractures, and safety, with biomarker-guided rescue dosing permitted. Thirty-six participants will be followed for up to 24 months with 3-monthly assessments.

Trial for Reducing Infection After Arthroplasty with Dilute povidone-iodine lavage (TRIAD) is a multi-centre, AOANJRR-nested, cluster randomised trial utilising a hospital-level crossover design that will provide pragmatic low bias world class clinical evidence on the unmet need of surgical site infection (SSI) reduction following hip and knee arthroplasty surgery. It will compare pre-closure lavage with dilute povidone-iodine lavage to normal saline only lavage to reduce bacterial surgical site contamination. This intra-operative bacterial decontamination method if effective, is low cost, low risk and universally available to Australian orthopaedic surgeons. Currently, healthcare professionals have few scientifically validated methods to reduce the risk of SSI following arthroplasty surgery and TRIAD would provide an avenue for establishing this as a standard of care at an international level for reduction of infection following hip/knee arthroplasty. The primary objective of this study is to evaluate the efficacy of dilute betadine lavage in reducing surgical site infections (SSI) occurring within 90 days in adults undergoing primary, elective THA or TKA for osteoarthritis (OA).

This is an observational study, where we will use a catheter pre- and post-coronary procedures to look for damage to the radial artery caused by trans-radial access. The primary hypothesis is that the radial artery sheath protect the radial artery from spasm and radial artery injuries, and looking at the distribution of injuries along the artery before and after the procedure will allow us to investigate this and guide strategies to protect patients (potential surgical candidates) at higher risk of radial artery injury. We will also study demographic data to help identify these patients that are more susceptible to injury.

This is a randomised two-arm parallel wait-list controlled trial. Participants will be randomised in a 1:1 ratio to either the intervention group (structured exercise) or the wait-list control group (usual care). The primary objective of EXEMPLAR 2 is to determine the between-group difference, from baseline to post-intervention, in peak oxygen uptake (peak VO2) in people with scleroderma receiving either 12 weeks of structure exercise and usual care, or usual are alone. The secondary objectives are to determine the between-group differences, from baseline to post-intervention, in cardiac microcirculation, skeletal muscle volume, muscle strength and endurance, functional capacity, body composition, perceived quality of life, physical function, fatigue, disease activity, and physical activity levels.

The primary aim of this proposed randomised controlled trial is to determine and compare changes in plasma concentrations of levonorgestrel in women on this drug as part of their oral contraceptive pill after receiving sugammadex or neostigmine.

This pilot RCT involves a new Clinical Decision Support System (CDSS) that will assist community nurses select appropriate ulcer dressings and will be integrated into a mobile application (it is not artificial intelligence). The CDSS, aims to simplify the complex decision-making process of selecting appropriate dressings for various types of ulcers. It has been designed to help community nurses choose the right ulcer dressing by providing an easy-to-use resource. It will suggest evidence-based dressing options. This pilot RCT will test the feasibility and acceptability of using this digital tool in community settings.

Post-operative pulmonary complications occur in approximately 10–25% of patients following cardiac surgery, contributing to delayed mobilisation, prolonged ICU and hospital length of stay, and poorer recovery outcomes. Early identification of patients at higher risk of complications and objective monitoring of deconditioning during recovery remain unmet clinical needs. Skeletal muscle status reflects physiological reserve and vulnerability to critical illness. Emerging evidence suggests that rectus femoris muscle cross-sectional area and echogenicity, measured using real-time ultrasound, may predict adverse outcomes in hospitalised populations. Ultrasound is non-invasive, low-cost, portable, and increasingly feasible for use by allied health clinicians in acute and ICU settings. This study evaluates whether cross sectional area of the rectus femoris muscle can be reliably implemented in cardiac surgery pathways and whether these measures predict clinically meaningful outcomes.

This pilot RCT study aims to assess the preliminary effectiveness, feasibility and acceptability of a telehealth Medical Nutrition Therapy (MNT) model of care (Diabeating Nutrition) delivered by dietitians for adults with type 2 diabetes (T2D) using GLP-1 RAs medication over 6-months, within the Hunter, NSW. Adults with T2D that are about to commence, currently using or previously used GLP-1 RA medication of primary care practices participating in the Diabetes Alliance Program Plus or registered in the NDSS will be invited to participate. Adults will be randomised to either: 1) Diabeating Nutrition: personalised MNT plus usual care (intervention), 2) Usual care without MNT (wait-list control). Preliminary effectiveness will be evaluated using the primary outcome measure HbA1c. Feasibility and acceptability will be assessed by MNT appointment attendance rates and process evaluation survey responses respectively. Study findings will be used for the development of fully powered RCT.

Cardiac catheter ablation using radiofrequency (heating energy) is a common treatment for heart rhythm disorders. Catheters are long flexible tubes with electrodes at the tip placed in the heart and deliver heating or cooling thermal injury to disrupt abnormal electrical circuits in the heart (ablation). Radiofrequency ablation can be performed using catheters which are flushed continuously with water (irrigated) or with non-irrigated catheters which are dry. The benefits of irrigated catheters are that they can create larger and deeper injury to the abnormal circuits which may be more effective as the water prevents overheating. Importantly, irrigated catheters also have technology which determines if the catheter has adequate contact or pressure with the cardiac tissue it is ablating, known as contact force. This is vital in achieving a stable position to facilitate effective ablation. Failure to apply enough pressure or energy to the heart tissue consistently can result in poor quality ablation lesions and recurrence of the abnormal heart rhythm. Non-irrigated catheters do not have contact-force sensing capabilities. Catheter ablation is an effective treatment for a fast heart rhythm condition called atrioventricular nodal reentrant tachycardia (AVNRT). Traditionally, ablation has been performed with non-irrigated non-contact force-sensing catheters but more recently due to the benefits of irrigated and contact force-sensing catheters, more operators have been using them. Whilst initially there was concern larger lesions could potentially lead to higher risk of damaging the atrioventricular node, a vital electrical structure in the heart, multiple studies have shown irrigated contact force-sensing catheters are safe to use for this condition and may be even safer than non-irrigated non-contact force-sensing catheters. However, the benefits of contact force-sensing catheter ablation for AVNRT have not been evaluated in high-level evidence studies. A randomised control study is the gold-standard in comparing 2 treatments in research. We will be conducting a randomised trial comparing the effect contact force-sensing catheter ablation has during AVNRT ablation to non-contact force-sensing ablation. There will be 2 treatment groups of equal size with 51 in each for total of 102 patients. All patients will undergo AVNRT ablation using an irrigated contact force-sensing catheter. In half the group, the operator will not know the contact force and perform the procedure as per conventional standard practice. In the other half, the operator will know the contact force during ablation. This is to assess if contact force can make procedures faster, safer and more effective in treating AVNRT which will benefit future patients. Another goal is also to see if junctional rhythm (a finding suggestive of successful ablation) correlates with adequate pressure or contact force during ablation.

This study is testing a new, more convenient way to administer rabies pre-exposure vaccination in adults at risk. Instead of needing two visits to complete the vaccine course, three of the study schedules give the vaccine doses in a single visit: (1) one dose into the skin (intradermal), (2) two doses into the skin (in two injections sites), and (3) one dose into the muscle (intramuscular) in a single-visit, and this is compared with the current standard two-visit schedule: (4) two dosis into the muscle (one dose in each visit). The main aim is to determine whether this single-visit schedule “primes” the immune system sufficiently so that, when people later receive a booster dose, they quickly develop high levels of protective antibodies (“boostability”). To assess the "boostability" of the pre-exposure schedules, all participants will undergo a standard simulated post-exposure prophylaxis regimen with two doses administered intramuscularly (one dose per visit), approximately 56 days after receiving their initial pre-exposure vaccination. The study will also closely monitor and compare any side effects between the different schedules. The researchers hypothesise that the single-visit intradermal schedule will be as effective as the standard schedule in preparing the immune system, while being easier to complete and potentially reducing costs and barriers to protection.