ANZCTR search results

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

You can narrow down the results using the filters

31378 results sorted by trial registration date.
  • Assessing the impact of blood pressure targets and surgical approach (laparoscopic or open) on continuous urinary oxygenation in patients undergoing general surgical procedures

    The impact of blood pressure targets and surgical approach (laparoscopic or open) on continuous urinary oxygenation (PuO2), a validated surrogate of renal medullary PO2, during general surgery is unclear. We aimed to assess the effects of different blood pressure targets and surgical procedures on PuO2. In this pilot, single centre, randomised controlled physiological study, patients were allocated to usual mean arterial pressure target management or a slightly higher mean arterial blood pressure target as managed by the treating anesthetists during the operation. The primary outcome was the mean urinary oxygen value during the operation. In doing so, our trial has explored the complex relationship between blood pressure targets, surgical procedures, and renal oxygenation and guide future investigations aiming to personalise renal protective perioperative management stratagies.

  • The effects of exercise training on small blood vessel health in individuals with type 2 diabetes and in overweight and obese older participants.

    Microvessels are the smallest type of blood vessels inside every organ of the human body. They are approximately the size of a human hair, or smaller. There are approximately 100,000 km of these microvessels in humans and they are crucial for human health and wellbeing, as they are responsible for maintaining tissue nutrition including the delivery and exchange of oxygen. Microvessels are capable of undergoing structural and functional change during growth and development and they respond and/or adapt to stimuli including heating and exercise. Microvessels may become dysfunctional, causing symptoms that affect the skin, kidneys, eyes, muscles, nerves, heart and brain. These microvessel diseases are particularly common in people with cardiovascular diseases, obesity and diabetes. However, at present, we know very little about microvessel function and health in humans due to the lack of direct and reliable imaging methods. The aim of this study is to use optical coherence tomography (OCT) techniques to quantify and compare the effect of exercise training and repeated body heating on the health and function of skin microvessels in individuals with T2D, and in older overweight and obese persons. We will also measure artery function in large arteries in the limbs and the brain, alongside heart function, to determine which of these factors impact on microvessel function. The exercise training will consist of 3x per week aerobic training (i.e. cycling/fast-paced walking) for 40 minutes during 12 weeks. There will be two centre-based and one home-based exercise session per week. Centre-based sessions will consist of cycling at range from 60 to 75% of individuals' maximum heart rate, depending on the exercise block, with less intense warm-up and cool down periods. Home-based sessions will consist of a fast-paced walking also meeting the desired heart rate training zone (60-75% of maximum hear rate). The heat therapy will be fully centre-based and will consist of 3 session per week, with a duration of 40 minutes each session, for 12 weeks. Individuals will remain in a hot tube at 40°C for 40 minutes.

  • Live student-actor simulation versus video-based learning for Situational Awareness in Primary and allied Health care: Integration, Research and Education (SAPHIRE)

    Teaching of clinical decision-making skills is a complex task undertaken by educators of health professional degrees. Simulated learning approaches are now commonplace, but it is unclear how they can best be delivered. They can be conducted “live” using professional actors or students as role-playing actors, or be video-taped for non-live learning. It is unclear both whether how live versus non-live simulated learning approaches generate the same benefits for student learning, nor how much of each approach is needed to generate measurable improvements. In this research we will compare live delivery of simulated learning using students as role-playing actors with video-taped versions of the same simulated scenarios. We will also compare providing varying amounts of each form of training to determine how much is required to generate a measurable improvement. The clinical skill context area that we will conduct this investigation in is “Situational Awareness”. This is a relatively new concept that has been drawn from fields such as aeroplane pilot training. It relates to the concepts of being aware of specific cues in the environment, comprehending the meaning of these cues for the patient, and then being able to project into patient management relevant strategies based on this information. Currently, situational awareness is only being taught in one professional discipline within the School of Primary and Allied Health Care. We hypothesise that greater amounts of exposure to situational awareness training will result in higher performance in the situational awareness testing, and that the live, student-actor teaching approach will be more effective than the video-based education approach.

  • Removing smAll BaBies from Incubators to coT (RABBIT) - A pilot study

    This pilot study would be implemented at Nepean Hospital on low birth weight babies born at less than 34 weeks or weighing less than 1400g at birth and to assess whether there is sufficient evidence for justification for weaning them more rapidly into a cot from a humidicrib once they reach 34 weeks gestation and or 1400g weight. There is a need to further investigate these outcomes in Australia as neonatal intensive care nurses and medical staff use their own judgement on an ad hoc basis to determine when premature and small for gestational age babies can be weaned into a cot and may be arbitrarily delaying their progress. Currently there is no evidence pertaining to this practice with babies weighing between 1400g to 1600g and this project addresses this gap. The hypothesis is that stable low birth weight babies who qualify for the enrolment criteria can successfully tolerate weaning once they consistently demonstrate a stable body temperature at the lowest incubator air temperature and this will have no impact on their temperature stability, weight gain and facilitate faster discharge from hospital.

  • Heel lift inserts for insertional Achilles tendinopathy

    Primary aim is to evaluate the feasibility of conducting a randomised trial comparing heel lifts to a sham heel lift for reducing pain associated with insertional Achilles tendinopathy. Secondary aim is to obtain statistical parameters to inform the main trial sample size calculation and provide a signal of efficacy to justify the future main trial. Hypothesis: Heel lifts will lead to superior outcomes to a sham innersoles for insertional Achilles tendinopathy and a full-powered trial will be feasible.

  • Trial of the DRIVing my own mental health Recovery (Driv-R) app - efficacy of a mobile app to support individuals' control over their own mental health recovery

    Consumer advocates, growing evidence, national guidelines and practice frameworks all emphasise the need for mental health consumers to participate more and have greater control over their mental health recovery planning. However, research indicates that services struggle to translate these empowerment principles into practice. Goal setting and action planning continue to be staff rather than consumer driven. Our project will support consumers to attain greater control over their recovery assessment, goal setting and action planning. Our project will co-design and test the impact of the DRIVing my own mental health Recovery App (Driv-R). This App will build upon a widely adopted, well-validated, recovery-focused mental health self-assessment (RAS-DS – Recovery Assessment Scale – Domains and Stages). Extensive previous work and the co-design process will ensure consumer- and staff-prioritised features are embedded. In Phase One we will co-develop and co-produce the App. We will use Human Centred Design to deeply engage consumer expertise within and beyond the research team. Iterative cycles will include deep-dive design labs, co-development, user-exploration and feedback processes. In Phase Two (this trial), we will evaluate the App using a multi-methods approach. First, a pragmatic trial will be conducted with consumer-staff dyads implementing Driv-R compared to practice as usual during a “waitlist” period. The primary outcome measured is mental health self-efficacy. Secondary outcomes include self-rated mental health recovery and “mastery of illness”. Second, feasibility analyses will examine consumers’ and workers’ perspectives on App usefulness, relevance and helpfulness. Third, data analytics from Driv-R will be examined for uptake, use and accessibility of the platform. Fourth, qualitative interviews will facilitate nuanced interpretation of findings. The outcome will be a freely available App that promotes consumers’ control over their mental health recovery journey.

  • Exploring how to support regional and rural communities with delivering obesity prevention interventions to improve child health.

    Despite the promise of whole of systems community-based obesity prevention interventions to improve the health of the population, there has been challenges with the implementation of such initiatives. Such interventions are inherently complex in nature and present unique implementation challenges that require targeted implementation support. This pilot RCT and feasibility study therefore seeks to assess the i) potential usefulness of strategies to support the implementation of evidence-based and locally appropriate solutions generated via systems mapping approaches in rural or regional communities, and to pilot certain elements of the research to inform the conduct of a fully powered RCT . Implementations team in the intervention arm will receive support to prioritise local and evidence-based actions for implementation, use a systems mapping lens to identify key determinants to implementation and generate suitable solutions and support from an experienced facilitators to troubleshoot any implementation challenges for approximately 6 months. The key outcomes of the study include describing potential changes in implementation fidelity and intention, as well as describing the process of recruiting, data collection and any adaptations to delivery protocol. This study address an important gap in the literature, and provide important data to inform the development of future studies supporting community-based implementation of obesity prevention programs.

  • Using Virtual Reality to manage patient anxiety during painful procedures in Emergency Department (VR-ED)

    The pilot randomised controlled trial aims to test the feasibility of a large trial. The trial will evaluate the effectiveness of virtual reality headset in managing emergency department (ED) patients' painful procedure related anxiety. Clinical outcomes includes anxiety, stress, pain, procedural sedation and anaesethics, procedure time, ED length of stay, patient and staff satisfaction and acceptability, and adverse events.

  • Artificial intelligence Steering Testosterone deprivation Treatments in prostate cancer External-beam radiotherapy (ASTuTE)

    This study aims to assess how a new test (ArteraAI) that uses artificial intelligence to analyse prostate tumour samples to predict patient outcomes and suitable treatment options impacts the treatment recommendations that doctors make for their patients with prostate cancer. Who is it for? You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with a localised intermediate risk prostate cancer (one or more tumours) and you are scheduled to undergo initial curative radiotherapy treatment for your cancer. Study details All participants who choose to enrol in this study will have a sample of their prostate cancer assessed using a new test, ArteraAI, that uses artificial intelligence and a specialised computer algorithm to analyse the characteristics of their specific cancer. The ArteraAI test will use previously collected tumour samples so that participants will not need to provide further tissue for this study. Depending upon the results of the ArteraAI test, participants may have their cancer treatment plan changed to include or stop use of ADT (testosterone blocking drugs). A subgroup of participants will also be followed up at five years after they have undergone the ArteraAI test to check their Prostate Specific Antigen (PSA) levels noted in their medical records . PSA is collected as part of normal care follow-up for prostate cancer, therefore participants won’t need an additional blood test for this. It is hoped this research will determine whether use of the ArteraAI test helps doctors to make more informed treatment recommendations for patients with prostate cancer. If the ArteraAI test is found to be useful and the costs associated are not prohibitive to publicly-funded medical care, use of the test may be expanded to a greater number of cancer treatment clinics to assist a greater number of patients with prostate cancer.

  • Relaxation for Anxiety in healthy adults

    The aim of the proposed research is to investigate the feasibility of conducting a clinical trial of relaxation practice for outcomes of subclinical anxiety, stress, and worry in a healthy adult population via a smaller feasibility trial. A secondary aim is to determine the preliminary efficacy of two different relaxation practices when compared to each other practice across these outcomes. Lastly, the aim of the proposed research is to further understand the neurological mechanisms involved in relaxation practice and whether they may be associated with any clinical outcomes found.

Tags:
  • Finding clinical trials