ANZCTR search results

The effects of a chronic curcumin supplementation on team sport athletes performance and recovery. The study involves team sport athletes, aged 18-35. This is a randomized, double-blinded, cross-over study where participants will consume either a curcumin supplement or a placebo at a time, without knowing which one they were given. They will be tested on their athletic performance and recovery over five sessions, with a break between the supplements to ensure any effects of the supplements have worn off. The study will measure performance through a battery of field tests and recovery through blood sample collection and questionnaires. The hypothesis of this study an acute dose of curcumin supplementation will reduce the detriment in exercise performance post-fatiguing exercise. Additionally, muscle damage markers and inflammation will be reduced, and the participants’ perceived recovery will be improved.

The aim of this study is to explore the effects of an online quality improvement tool developed for service providers and educators in family day care to promote healthier nutrition and physical activity practices. it is hypothesised that using the online tool will improve the quality of the service provider's revised quality improvement plan (QIP) compared to the service provider's previous QIP.

Provision of psychotherapy to children with T1D has been associated with improved mental health and improved management of diabetes symptoms. These promising findings for the role of psychological interventions in the management of diabetes have led to international guidelines which recommend that they be easily accessible for children and young people with T1D and their families. Despite this international consensus, there is not yet a widely accepted and employed psychosocial intervention for management of diabetes distress and other mental health symptoms. Further, there are no trauma-informed interventions that address traumatic stress in this population. Thus, we intend to address these gaps by co-designing an intervention with community stake holders to support the psychological needs of children and young people with T1D using a trauma-informed framework. We hypothesise that the Wellbeing project will show efficacy in improving the wellbeing, resilience and coping skills of adolescents with T1D.

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.