ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31202 results sorted by trial registration date.
  • Replication trial of the OurFutures Vaping Program: Evaluation of a school-based eHealth program to prevent e-cigarette use among adolescents in NSW Public Schools

    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,

  • A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection

    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.

  • Validating protein C as a blood marker to predict outcomes in burns patients

    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

  • 'Exploring the impact on Emergency Department (ED) fast track stream patient flow metrics of an Advanced Scope Physiotherapy (ASP) service at St John of God Midland Public and Private Hospital ED'.

    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.

  • Does task-specific strength training improve mobility after stroke?

    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.

  • Effects of calcium on gut functions and blood glucose in healthy humans

    Recent studies have demonstrated that calcium, in the doses of 500 mg and 1000 mg, stimulates gut hormones and pyloric pressures and suppresses energy intake. Given the key role of these GI hormones and pyloric pressures in the regulation of gastric emptying, which in turn is a key determinant of the lowering of blood glucose after a meal, we propose to investigate the dose-related effects of intraduodenal calcium infusion on gastric emptying, glucoregulatory hormones, and blood glucose in response to a mixed-nutrient drink in healthy participants.

  • Supplemental Tackifier to Intravenous Catheter dressings to Keep intact Year-round in Kids (the STICKY Kids trial).

    The objective of this study is to determine if the use of Mastisol Liquid Adhesive in conjunction with standard care reduces dressing disruption prior to scheduled weekly dressing change and is associated with fewer CVAD complications in children receiving in-home care.

  • Feasibility and acceptability of a co-designed self-management program for adults with chronic kidney disease

    Chronic kidney disease (CKD) is a progressive condition associated with reduced quality of life, high mortality, and healthcare costs. The chronicity of this disease necessitates individuals actively self-manage their health care to maximise health outcomes. The term ‘patient activation’ explicitly identifies the skills, knowledge and confidence that underpin a person’s willingness and ability to self-manage their health Our recent survey of South Australian people with CKD stage 5 not receiving dialysis showed that most (73%) patients had low patient activation levels. Low patient activation levels were associated with more hospital emergency department visits and poor medication adherence. Given the current low patient activation levels, we co-designed with renal consumers and clinicians a Self-Management of Kidney Disease Program (S-Manage KD) that will be tested for feasibility and acceptability in this study. This SManage-KD program could significantly increase engagement in positive health behaviours for a more active role in self-management in the CKD population. It is hoped that this newly developed SManage-KD Program will increase patients' ownership of care required to reduce the burden in the transition to dialysis initiation, improve treatment adherence, reduce hospital admissions rate, and ultimately, costs downstream in the CKD population. To assess these outcomes a new study to assess the effectiveness of this program is required.

  • Effects of Transcendental Meditation (TM) on Mental and Cardiometabolic Health among staff at RMIT University, Australia: A Randomised Controlled Trial

    Transcendental Meditation (TM) may help prevent psychological distress while promoting mental and cardiometabolic health, but its effects remain underexplored among university staff in Australia. This two-arm, parallel-group randomised controlled trial at RMIT University will compare the effects of TM with access to the university's wellbeing program on psychological and cardiometabolic outcomes. Over 12 months, data will be collected three to four times through surveys, physical measurements (e.g., blood pressure, anthropometry), tracking using Biostrap Kairos watches (e.g. heart rate, sleep), biochemical assessments (e.g., lipid profiles, salivary cortisol, markers of insulin resistance and inflammation, telomere length), and interviews. The study aims to provide empirical evidence of TM's role in enhancing the mental and cardiometabolic health of university staff.

  • ALMOND ProFIT-PM – Evaluating the effect of almond protein powder on fitness training

    This research project will investigate the effects of daily almond protein supplementation on muscle mass, strength, body composition, and metabolic health in postmenopausal women (aged 50-65) undergoing a 10-week progressive resistance and high-intensity interval training (HIIT) program. The study aims to test the hypothesis that almond protein, a plant-based protein source, can enhance muscle hypertrophy, strength, and improve metabolic outcomes (e.g., glucose tolerance, blood lipids) when combined with resistance training.

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