ANZCTR search results

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

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31212 results sorted by trial registration date.
  • Remote Alexa-based care versus telehealth (via zoom) and active control for rotator cuff tendinopathy: a pilot and feasibility randomised controlled trial

    Shoulder pain affects 15-27% of adults and is the 3rd most common musculoskeletal complaint seen by general practitioners in Australia. Rotator cuff (RC) tendinopathy is the most common cause of shoulder pain and people affected have impairments in work and self-care activities, with 40% having ongoing disability beyond 12 months. Clinical practice guidelines and consensus statements suggest 12 weeks of first line management (activity modification, medication advice, clinician guided exercise) for RC tendinopathy prior to considering imaging or surgical referral. In contrast, our team and others have shown high rates of non-guideline indicated (‘low-value’) imaging (up to 80%) and surgical referral (about 20%). Video conferencing-delivered care is cost effective, convenient, and able to reach people in rural and remote regions. However, video conferencing rely on synchronous contact with a health professional, which is both time and labour intensive, and costly. Providing first line care directly to patients in their homes is now possible via digital voice assistant (DVA) or voice-controlled intelligent personal assistants (VIPAs) like Amazon Alexa (“Alexa”). Our group pioneered this technology for delivering exercise interventions for elderly people. We have now developed an Alexa program that delivers high-quality first-line exercise and education to people with RC tendinopathy. Our program includes behaviour change strategies as well as asynchronous interaction with a health professional via the user’s voice responses. The proposed study aims to test the feasibility of a randomized trial comparing DVA care (via Alexa) to telehealth (via Zoom video conferencing) and active control. If successful, this will lead to a full-scale randomized trial in Australian primary care that has the potential to develop evidence for a high quality and efficient internet-delivered intervention that could benefit millions of Australians who suffer with shoulder pain.

  • Efficacy of a 3D Printed Device to facilitate Intracytoplasmic Sperm Injection (ICSI): Achieving Comparable Fertilisation Rates to Conventional Methods

    This clinical investigation aims to evaluate the performance and safety of the microICSI device, an investigational product designed to improve the specialised in vitro fertilization (IVF) process of intracytoplasmic sperm injection (ICSI) by reducing physical trauma to oocytes during insemination. The microICSI device uses cutting-edge micro-3D printing technology (2-photon polymerization) to create a micron-level resolution 3D receptacle, minimizing the need for the conventional (glass) holding pipette and suction, which often causes distortion to the oocyte’s shape. This innovation seeks to enhance fertilisation and embryo development outcomes, while also reducing variability associated with traditional ICSI procedures. The primary hypothesis is that microICSI will demonstrate non-inferior performance to cICSI regarding fertilization outcomes.

  • A therapeutic movement program for adolescents engaged in gender diversity services

    Trans and gender diverse adolescents face heightened physical and mental health challenges, with elevated rates of depression, self-harm, and suicide attempts (Strauss et al., 2020). Potential risks to cardiometabolic health also exist due to gender affirming medical therapy and unhealthy behaviors (Spanos et al., 2020). Given the well acknowledged benefits of physical activity for physical and mental health (Biddle & Asare., 2011), exercise presents a novel but underexplored strategy to mitigate some of the adverse mental and physical health symptoms and contribute to improve overall health and wellbeing of trans adolescents (Storr et al., 2021). The WA Gender Diversity Service is an outpatient service located at Perth Children’s Hospital that provides adolescents with a multidisciplinary approach to the assessment, care, and management of gender diversity. Currently there are no exercise services part of standard care within the WA service, nor is exercise incorporated as standard care in any gender services across Australia. The "Movement Program" is a twelve-week exercise intervention for adolescents within the GENder identiTy Longitudinal Experience Cohort (GENTLE cohort; RGS320). In collaboration with stakeholders, we aim to create and assess an evidence-based exercise intervention for bettering health, physical activity, and well-being of trans adolescents. The study will enable us to understand the impact exercise can have on trans adolescents’ health and wellbeing and whether providing such support during key developmental stages will also support trans adolescents in developing healthy (or healthier) physical activity behaviours. We propose to deliver the program over 2025 and anticipate up to 20 GENTLE adolescents participating in the intervention. We aim to enhance service delivery and address a significant gap in international research by developing this project within the GENTLE Cohort. Our goal is to determine whether this evidence-based exercise service can complement the current health services of the WA Gender Diversity Service.

  • Evaluating the feasibility of a new brief psychological intervention for people living with chronic pain who use prescription opioid medications

    To evaluate the feasibility of a brief psychological intervention, OMED Assist in practice for patients with chronic non-cancer pain who may be at risk of potentially harmful prescription opioid use in a prospective non-randomised pilot study.

  • TIPS: Trans-Tasman Internet-delivered Prevention of (youth) Suicide

    We need to answer key questions about the efficacy of apps that have been based on proven therapeutic approaches (can they reduce suicidal ideation and improve wellbeing compared with a control, are effects portable from one country to another?), and to understand if these apps are acceptable (are these apps engaging for youth, including rangatahi Maori), and safe (do they cause unintended harms). Answering these questions is the aim of this world-first international trial. We hypothesise that the use of all of the test apps (but not the control app) will result in reduced suicidal ideation. We also hypothesise that apps developed in NZ will be better for NZ young people and the same for Australian apps for Australian young people.

  • Can a Heart Ultrasound Help Predict the Need for Major Vein Replacement in Cancer Surgery?

    This study is evaluating a new technology called intracardiac echocardiography (ICE) to assess if tumours are compressing, or invading the major abdominal blood vessel, the inferior vena cava (IVC). Who is it for? You may be eligible for this study if you are an adult with a retroperitoneal sarcoma who has radiological evidence (CT/MRI) demonstrating compression or involvement of the IVC, and are scheduled for tumour resection at Sir Charles Gairdner Hospital in Perth, Western Australia. Study details Participants will undergo ICE which is a day case procedure performed under local anaesthetic, involving passing a small catheter into the IVC to assess the degree of involvement of the tumour. It is hoped that by accurately distinguishing between patients with true IVC invasion and those with compression preoperatively will allow us to reduce unnecessary additional invasive procedures in patients that they do not ultimately need. This approach will allow for more effective scheduling of the operative lists and improve efficient use of theatre resources, including staff.

  • Australian Football League Brain Health Initiative: monitoring player brain health.

    The AFL Brain Health Initiative is a prospective, longitudinal clinical research program designed to monitor player brain health across the lifespan, and explore both protective contributors and risk factors for long-term brain health. The research design therefore aims to answer key questions regarding the prevention, diagnosis and management of sport-related concussion (SRC) and repetitive head impacts, and potentially enable identification of players at risk of poorer outcomes following retirement to inform education and intervention to reduce risks.

  • The effect of ethnicity on Meal Induced Thermogenesis (MIT study)

    The aim of this study is to look at how much energy the body uses to digest, process and store the food that is eaten after a meal (referred to as meal -induced thermogenesis) and if there are differences between ethnicities. Understanding how the body uses energy may help us towards explaining observed differences in body composition (fat and lean mass) between people of Asian and Caucasian ethnicities and susceptibility of developing chronic diseases. The hypothesis is Asians will have a lower meal induced thermogenesis compared with Caucasians.

  • Effect of exercise training intensity on vascular health during late perimenopause

    This study aims to compare the effects of a 12-week high-intensity interval training (4x4 HIIT: 4 x 4min at 85%-95% max HR with 3 min of rest) on brain and systemic vascular function in healthy late perimenopausal women against an energy matched moderate-intensity interval training ( 6.5x4 MIIT: 4 x 6.5min at 65%-75% max HR with 3 min of rest)) and non-exercising time control group. This will be investigated as a randomized controlled trial at the University of Queensland. In total we hope to recruit 36 participants to be randomized into either a HIIT, MIIT or a time-control group. Measures of brain and peripheral vascular function, arterial stiffness, hormone levels, vasomotor symptoms (hot flushes), cardiorespiratory fitness and body composition, will be taken prior, during, and following the intervention. We hypothesize that the HIIT group will produce the greatest improvements in cerebrovascular and peripheral vascular measures, when compared to the MIIT and time control group. The findings from this investigation will inform practitioners about how to optimise targeted exercise therapies for vascular disease prevention in women undergoing menopausal transition.

  • Evaluating the short and long-term changes experienced by people with physical impairments who undertake supervised sports training

    This study is a single-case experimental design (SCED) study with longitudinal follow-up aiming to evaluate the therepeutic benefits for individuals with neuromusculoskeletal impairments participating in a self-selected, performance-focused Para-sports training program. Participants involved in this project are currently enrolled in the ParaSTART (service) program and will undertake structured training in the sport of their choice and will be closely monitored in relation to sport-specific performance, psychosocial responses, fitness, health, independence and well-being. In SCEDs, each participant serves as their own control, with responses monitored during active training periods and recovery periods. SCED outcomes will demonstrate how self-selected sports participation affects health, functional independence and quality of life. Following the SCED, participants will be encouraged to continue training and monitoring for as long as they wish (ongoing service). This longitudinal follow-up is consistent with the current ParaSTART ( model which has run continuously since 2016. It is believed that participating in a performance-focused sports training program for a long period of time will improve not only the participant's ability and sporting performance, but also have benefits to their health, fitness, functional independence and mobility and psychological health and wellbeing.

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