ANZCTR search results

This prospective pilot study will assess various implementation factors associated with integration of a digitally enabled model of care for individuals with type 2 diabetes (T2D) from regional areas into primary care using a digital health intervention. The comprehensive assessment of implementation factors will inform strategies to optimize the implementation process and maximize the effectiveness of future Digital Health interventions.

The main aim will be to test the effectiveness of dance therapy on reducing symptoms of trauma in women with experience of family and domestic violence. The secondary aim will be to investigate the influence of dance movement therapy on overall wellbeing domains on women with an experience of family and domestic violence. Finally, as this is a new trial, the last aim will be to test acceptability and feasibility of implementing this intervention.

The aim of this study is to evaluate the efficacy and long-term safety of modified-release calcium formate to reduce elevated plasma homocysteine (Hcy) levels in adults patients with homocystinuria. The hypothesis, seen in preclinical models, is that modified-release formate can rapidly (within weeks), sustainably, and safely lower plasma homocysteine levels. This outcome would improve long-term outcomes in patients with homocystinuria

The primary aim of this 12-week open-labelled trial is to determine stomach emptying and both small intestinal and colonic transit before and after 1 month and 3 months’ exposure to tirzepatide to evaluate its effect on gastrointestinal function and safety in people with PWS. Secondary outcomes of this study will be the effect of tirzepatide on body weight, food-seeking behaviour, metabolism, and sleep apnoea. This study will quantify transit in the stomach, small intestine and large intestine at baseline and following treatment with tirzepatide. It will improve our understanding of gastrointestinal function, including the prevalence of delayed gastric emptying, small intestinal transit and colorectal transit in PWS and also provide information concerning the safety and tolerability of tirzepatide. A secondary aim is to validate the gas-sensing capsule in measuring gastric emptying and caecal arrival time against scintigraphy. This has not yet been done. If it is shown to be accurate, this capsule is a much less invasive way of assessing gastric emptying and will help to provide data to support its use for this measurement.

Annually, between 10–15 million (3.3–5%) patients will experience an acute perioperative myocardial infarction (PMI) or myocardial injury following non-cardiac surgery. Clinically apparent events only represent <20% of heart injuries, with more patients sustaining subclinical myocardial injuries (MINS). Risk of morbidity and mortality significantly elevate after MINS, yet insufficient evidence exists to inform treatment recommendations. The SHIELD Trial aims to fill this evidence gap, guide MINS management, and improve post-surgical patient outcomes. The SHIELD Pilot will randomise participants to daily dapagliflozin/placebo (SGLT2i) for six months. Pilot data will be used to optimise the protocol for the definitive trial by evaluating of the acceptability and suitability of the intervention and study procedures and expected participant compliance with the study drug.

Adolescent e-cigarette use has drastically increased in recent years, posing several acute and chronic harms, including poisonings, burns, serious lung injury, and - where nicotine e-liquid is used - the potential to impact brain development and lead to dependence. Effective and scalable preventive interventions are urgently needed, and school-based eHealth interventions are an efficient, effective and economical approach. To address this need, we developed the OurFutures Vaping Program. Built on the successful ‘OurFutures’ (formerly ‘Climate Schools’) prevention model, the OurFutures Vaping Program involves 4x40 minute online cartoon-based lessons that are delivered during Year 7/8 health education classes. An initial trial of the intervention began in 2023 among 40 Independent and Catholic schools across NSW, QLD and WA. Due to time constraints for ethical approvals, public schools were unable to be included. To address this limitation, this replication study aims to evaluate the OurFutures Vaping Program among 12 NSW public schools via a cluster randomised controlled trial. It is hypothesized that: • H1 (primary outcome): Students who receive the OurFutures Vaping Program will be less likely to commence e-cigarette use at the 12-month follow-up, compared to students in an active control condition. • H2: The OurFutures Vaping Program will achieve superior outcomes to the control condition on secondary outcomes including: uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes and tobacco smoking,

This is a Phase 1b study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod ±Nivolumab is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. The study consists of four parts (Part A, Part B, Part C and Part D). Part C is an open label study with 3 cohorts. Each cohort will enroll a total of approximately 20 participants.

We previously found that an blood marker called protein C can be measured on admission in burns patients at one hospital to provide information on their injury severity and predict outcomes. This study aims to verify these results still hold true in a new cohort of patients at two hospitals. Additionally the study aims to find if a simple cutoff value can be utilised to incorporate this marker into clinical practice to predict for important complications including sepsis, pneumonia, and death. This study references a previous SCALD study - results published as below: Lang, T. C., Zhao, R., et al. (2019) Plasma protein C levels are directly associated with better outcomes in patients with severe burns. Burns Zhao, R., et al. (2021) Early protein C activation is reflective of burn injury severity and plays a critical role in inflammatory burden and patient outcomes. Burns

To explore the impact of the advanced scope physiotherapy (ASP) service on patient flow in the emergency department fast track stream and determine whether an additional ASP and expansion of hours impacts patient flow. An additional ASP will be rostered in ED over the intervention period and key emergency department (ED) patient flow metrics will be collected and compared to when there is only one ASP (usual care). The primary outcomes of ED patient flow metrics include time for patients to be seen, total length of stay, proportion of patients being seen in the recommended amount of time and proportion of patients meeting the four hour rule in ED.

Muscle weakness is the main cause of slow walking following stroke and strength training is ‘strongly’ recommended by the recent Stroke Foundation and the US stroke guidelines. It is clear that strength training improves muscle weakness after stroke, however, to date, stronger legs have not translated to greater capacity to walk. Our team has identified why previous strength training trials have failed to improve walking speed. We have developed and tested a new ‘power’ training protocol that 1) targets the main muscle groups responsible for power generation, and 2) reflects how the muscles contract during walking (i.e. quickly or ballistically). Our pilot RCT demonstrated that power training was safe and feasible, and associated in significantly faster walking speeds. Therefore, we propose a Phase III prospective, multi-centre, randomised, single-blind trial of a 6-week program, conducted 3 times per week (a total of 18 sessions) during the sub-acute phase of rehabilitation (< 3 months) which is the optimal period for recovery from stroke. The primary outcome measure is walking speed at Week 26 so we can determine 1) is power training efficacious, and 2) if so, is it maintained.