ANZCTR search results

Headache is a common reason for seeking emergency care in Australia. The sphenopalatine ganglion represents a promising anatomical target for analgesic intervention among patients with headache. Findings from the seven studies conducted to date support that a sphenopalatine ganglion block may be effective among emergency department patients with headache. This multicentre (Angliss Hospital, Box Hill Hospital, and Maroondah Hospital), individually randomised, double-blind, placebo-controlled, two-group parallel (1:1), superiority trial will examine the effectiveness of an adjunct sphenopalatine ganglion block in adult emergency department patients with headache. We hypothesise that an adjunct sphenopalatine ganglion block will be superior to placebo for all outcomes.

Critically ill patients in the ICU are commonly observed to have low serum electrolyte concentration of magnesium and/or phosphate. Prompt treatment must be administered to avoid serious harm. The intravenous (IV) route is most commonly administered in the ICU. This is important for very unwell patients in the ICU where electrolyte levels are dangerously low. However, most patients in the ICU have electrolyte levels that are only slightly or moderately low and we are exploring if the enteral route could be used more often. The enteral route has potential benefits - it costs less and produces less waste, therefore producing less carbon which makes it a more environmentally friendly alternative. There is little information known about how effective the enteral route is compared to IV for patients in the ICU, and whether the enteral route would be acceptable to staff and patients to use more often. This study is extending the work from two small clinical trials comparing enteral to IV route of magnesium and phosphate in the ICU. Both studies showed that enteral route didn’t cause harm, cost significantly less than the IV route and had less waste. However, there were mixed results on clinical effectiveness and wider testing in other ICUs is needed. In particular, staff perceptions of effectiveness, attitudes toward cost and environmental impact in decision making and beliefs on which route is “easier” to give have not been explored. The aim of this study is to test effectiveness of the enteral route compared to the IV route in a larger group of patients across multiple ICU settings. Each ICU will first use the IV route for all patients in the ICU that require electrolyte replacement for mild and moderately low electrolyte levels. We will then gradually ‘switch’ the ICUs across to using the enteral route. We will conduct staff surveys and group discussions to explore the factors that may influence staff in use of enteral or IV route.

The VIBE study aims to investigate the effect of Voyant Versus Diathermy for Haemostasis on post-surgical drainage and seroma in Breast Cancer Surgery Who is it for? You may be eligible to join this study if you are aged 18 years or above, diagnosed with breast cancer and undergoing unilateral or bilateral mastectomy Study details Participants in this study will randomly be allocated (by chance) to one of two groups: one group will be allocated the Voyant™ Intelligent Energy System for tissue dissection and vessel sealing during surgery while the other group will be allocated standard surgical care with conventional diathermy for tissue dissection and vessel sealing during surgery. Outcomes assessed up to 30 days post-surgery include time to drain removal, total drain output, seroma, and other recovery measures such as pain, complications, and quality of life. This research may help identify the most effective surgical device for reducing post-operative drainage and seroma after breast cancer surgery, with the potential to improve recovery and patient outcomes.

Body dysmorphic disorder (BDD) is a disorder that is characterized by a significantly disturbed perception of one’s own appearance. We propose to conduct a randomised within-group mixed-methods study on individuals with BDD to determine the feasibility and acceptability of VR-based mindfulness training. This study will be conducted at Swinburne University of Technology, Melbourne, Australia. The feasibility and acceptability of VR-based mindfulness training will be achieved in a number of ways: 1) qualitative semi-structured interviews; 2) self-report measures; 3) physiological measures (i.e. heart rate variability and galvanic skin response). This comprehensive, multimodal assessment of these experiences will be integral in refining our mindfulness training for this complex disorder. The effects of receiving VR-based mindfulness training will be assessed through comparing pre- and post-intervention state mindfulness, body image concerns and emotional regulation variables.

International guidelines now recommend screening for primary aldosteronism (PA) in people with chronic hypertension, however this is often not done. Unlike essential hypertension, PA has specific treatments, some of which can even provide a cure. Pregnancy and the postpartum provides a window of opportunity to screen women and improve their longterm health outcomes. However we don't know the prevalence of PA in this population. We aim to determine the prevalence of PA in women who have chronic hypertension after pregnancy. With a pragmatic design, we also aim to provide both quantitative and qualitative data on performing initial screening on medications commonly used in the postpartum period.

The CogCoach Brain project aims to evaluate an online, evidence-based lifestyle intervention designed to promote healthy brain ageing and reduce dementia risk in older adults with subjective cognitive decline (SCD) or mild cognitive impairment (MCI). Building on the CogCoach-Health framework, the program delivers a 12-week multidomain intervention targeting physical activity, cognitive engagement, diet, social connection, sleep, and mood through interactive e-learning modules and personalised behavioural support. The randomised controlled trial follows participants for 12 and 24 months to assess long-term changes in cognitive function, lifestyle behaviours, and wellbeing. Optional biomarker testing will explore how lifestyle modification may influence biological indicators of brain health. The overarching goal is to provide an accessible, scalable program that supports healthy brain ageing and reduces dementia risk in older Australians

The primary aim of this parallel group, superiority trial is to determine the effectiveness of PAO surgery + co-designed rehabilitation compared to co-designed rehabilitation on pain at 12 months. We hypothesize that PAO surgery + co-designed rehabilitation with be superior to co-designed rehabilitation at 12 months for pain. In addition, our secondary aims are to explore the effectiveness of PAO surgery + co-designed rehabilitation compared to co-designed rehabilitation on quality of life, sleep, psychological symptoms, hip joint structure, movement patterns and cost-effectiveness.

This is a randomized, placebo-controlled, sequential, multiple ascending dose study conducted at a single site in Australia and comprised of 2 to 3 cohorts (with the third being an optional cohort, at the discretion of the Sponsor). Randomization to either RES-010 or placebo treatment in a ratio of 3 RES-010 to 1 Placebo treatment. An escalating-dose multiple ascending dose study design in overweight and moderately obese participants was chosen to allow careful increase of the study drug RES-010 dose after the assessment of safety, tolerability, and available plasma and urine Pharmacokinetic and Pharmacodynamic results of each preceding dose cohort. A blinded review of all available safety data and plasma and urine Pharmacokinetic and Pharmacodynamic data will be performed by a Safety Review Committee (SRC) after the administration of the fourth study drug dose to identify any potential safety and or tolerability signals. Based on this review the SRC will recommend to either proceed with the study as planned, or indicate if dose escalation or de;-escalation is appropriate. If necessary, recruitment may be paused to await the availability of further safety data to make a recommendation. The minimum number of participants required to decide on a dose escalation is 6 participants (at least four participants on active treatment RES-010).

This prospective cohort study investigates the effect of oral rehabilitation exercises following buccal mucosal graft urethroplasty. It is hypothesised that implementation of these oral exercises will decrease enhance oral rehabilitation and decrease complications following surgery.

The human gut microbiome plays a pivotal role in maintaining gastrointestinal health, immune function, and has been associated with the development and progression of various chronic illnesses. There remains an unmet need for probiotics that provide clinically validated, reproducible, and lasting benefits in broader contexts such as disease prevention and health promotion. In our research, we have developed a bank of isolated microbial strains derived from healthy FMT donors and supported by findings from prior FMT clinical trials conducted by our group and others. These strains have demonstrated consistent clinical and microbiological effects and are being investigated as candidates for a next-generation probiotic formulation. We are examining the impact of administering a combination of these organisms as a probiotic in healthy individuals to assess effects on the gut microbiome.