ANZCTR search results

This study is a first-in-human, Phase 1 trial designed to test the safety and tolerability of RUNX1 mRNA in patients with primary osteoarthritis who are scheduled for knee replacement surgery. Participants will receive a single dose of RUNX1 mRNA or a placebo via intra-articular injection. The study will include up to three dose levels, with four participants in each group. The effects of RUNX1 mRNA will also be explored. The trial uses a staggered dosing schedule to ensure safety, with the first two participants in each group being dosed before the remaining participants. If no significant safety issues are observed, the remaining participants will receive their doses.

This study aims to evaluate whether a six-week program of psilocybin-assisted psychotherapy can more effectively reduce symptoms of major depressive disorder (MDD) compared to standard psychological care (represented by a waitlist control). Adults with MDD will be randomly assigned to either begin the treatment program immediately or after a 10-week delay. The treatment involves one supervised psilocybin dosing session and six psychotherapy sessions, delivered in a standard clinic setting using a fly-in-fly-out model, where specialist staff attend only for the intervention phase. Participants will also be randomly assigned to use either a virtual reality tool or journaling as an adjunct to support their therapy. Mental health outcomes will be tracked for up to 46 weeks. The study aims to test whether this innovative model can safely and effectively improve depression in real-world care settings.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a lifelong condition that causes fluid-filled cysts to grow in the kidneys and other organs, which can lead to pain and kidney failure. It affects about 25,000 Australians and is responsible for 1 in 10 people starting dialysis each year. People with ADPKD often experience abdominal swelling, pain, poor sleep, and other symptoms that aren't always well understood or addressed in clinical care. Women with ADPKD may face unique challenges related to hormones, pregnancy, and contraception, which are not always discussed with healthcare providers.

This study aims to investigate how gastric surgeries, such as anti-reflux or bariatric surgery, affect stomach function and related symptoms. A non-invasive test called body surface gastric mapping (BSGM) will be used before and after surgery to measure changes in stomach activity. Participants will also complete questionnaires about their symptoms, quality of life, and psychological health. The study will follow participants for 12 months after surgery to assess changes over time. Researchers hope to better understand how these surgeries influence symptoms and identify which patients may benefit most from them.

Extreme weather events attributable to climate change are occurring with increasing frequency and intensity. Whilst extreme temperatures can affect people of all ages and health status, certain populations are more vulnerable, especially older adults (65 years and older). Age is considered the most critical risk factor for morbidity and mortality associated with heatwave exposure. As population exposure to extreme heat rises and our population ages, the associated health burden will continue to grow. The trial purpose is to evaluate whether a tailored text messaging intervention can reduce patient-reported heat symptoms, increase adoption of heat adaptive behaviours and reduce utilisation of health services during and after extreme heat days for older Australians (65 years and older).

This is part a combined cluster randomized controlled trial and individually-randomized controlled trial with embedded clinimetric study. Trial Part 2 is an individually-randomized controlled trial delivering biopsychosocial case management to adolescents with bothersome pain attending Australia secondary schools. The individually-randomized controlled trial (1:1 ratio) will be conducted in adolescents in grades 7-10 attending Australian secondary schools. Adolescents reporting bothersome pain at baseline will be randomized to receive a) biopsychosocial case management and facilitated referral, or 2) no intervention. Participants in Trial Part 2 will be recruited from schools in Trial Part 1.

This is part of a combined cluster randomized controlled trial and individually-randomized controlled trial with embedded clinimetric study. Trial Part 1 is a cluster randomised controlled trial delivering pain education to adolescents attending Australian secondary schools. The cluster randomized controlled trial (1:1 ratio) will be conducted in grades 7-10 in Australian secondary schools. Schools will be randomized to receive 1) a pain education module integrated into the Personal Development, Health and Physical Education (PDHPE) curriculum, or 2) no education. Schools randomized to receive no education will receive the module one year after the study period. A cluster-randomised design, with the school as the unit of randomisation, was chosen to minimise cross-group contamination through staff and student communication.

This study aims to improve treatment for alcohol use disorder (AUD) by matching brain stimulation interventions with brain imaging informed neural network profiles (or subtypes). Using a novel neuroimaging-informed approach, we will identify which brain network is most affected in each individual and provide a subtype-matched brain stimulation intervention targeted to that network. We will assess changes in drinking behaviours through self-report and biological markers (blood and hair samples). We will also measure changes in brain activity, and cognitive, affective, and decision-making skills to better understand how the intervention works. We hypothesise that matching the intervention to the individual’s brain network subtype will lead to better outcomes than a one-size-fits-all approach.

Infants born very preterm have a high mortality rate and are at increased risk of worse neurodevelopmental outcomes and health-related problems. In recent years, convincing evidence has led to improved care and novel interventions for stabilisation of the newborn in the first 10 minutes of life, which may have a long-lasting impact on neonatal outcome. Non-invasive, continuous positive airway pressure (CPAP) immediately after birth of a very preterm infant (“VPTI,” <32 weeks’ gestational age at birth) is currently recommended as the standard of care during the stabilisation of preterm infants following birth. ) After birth, the infant must rapidly transition from a fluid filled lung, and dependence on the placenta for oxygenation and the elimination of carbon dioxide, to an aerated lung that successfully exchanges gases. CPAP supports the transition from fetal to newborn physiology by providing a distending pressure to the lung, thus maintaining a functional residual capacity (FRC) and enabling oxygenation and ventilation. While the rationale of most cord clamping studies has previously been based on the effects of placental transfusion, more recent studies in preterm lambs have demonstrated that delaying cord clamping until after ventilation onset prevents a rapid decrease in cardiac output. The observed large fluctuations in systemic and cerebral haemodynamics, and concomitant bradycardia and hypoxia frequently observed in preterm infants after ICC, could be avoided by delaying cord clamping until after aeration of the lung When a baby stops breathing or fails to establish normal breathing pattern positive pressure ventilation via a face mask is commenced to provide respiratory support while transitioning. The clinician attempts to create an air-tight seal on the infant’s face, with the nose and mouth inside the internal diameter of the mask. An adequate seal is difficult to achieve and the use of a facemask has the additional adverse effect of high compressive forces being applied to the infant’s face and head during resuscitation regardless of which brand of facemask is used, and even with the use of adjunct respiratory monitoring. Studies have shown that the majority of VPTI born less than 32 weeks completed gestation have a good respiratory drive immediately after birth. Ninety percent of VPTIs will initiate spontaneous breathing by 1 minute after birth. In this feasibility study we will recruit 40 very preterm neonates born from 24+0 weeks to 31+6 weeks completed gestation. We will provide nasal respiratory support to the participants at birth prior to umbilical cord clamping. We will provide CPAP (Continuous positive airway pressure) and if they baby is not spontaneously breathing will provide non-invasive ventilation to the baby. The aim of this study is to enable a longer period of delayed umbilical cord clamping (DCC) and improve cardiopulmonary transition in the neonates.

The Royal Hospital for Women (RHW) in Randwick is implementing a new model of maternity care for women with pregnancy complications such as: a diagnosis of gestational hypertension, threatened premature labour (TPL) and/or premature pre-labour rupture of membranes (PPROM) called ‘Virtual Maternity Ward’. Women who have traditionally required inpatient admission, will be offered the opportunity to be care for at home by midwives and obstetricians from the RHW. The ‘Telemonitoring Simulation Study’ will simulate a telehealth clinic within RHW, aiming to establish the usability of a telemonitoring technology with a small cohort of inpatient women, obstetricians and midwives. The purpose of the study is to explore the feasibility and acceptability of a fetal telemonitoring device we may use in the future in the Virtual Maternity Ward. If the device we are evaluating in this study is found to be feasible and acceptable, we can commence work on developing interoperability with RHW technical infrastructures.