ANZCTR search results

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

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33563 results sorted by trial registration date.
  • Use of a Novel Mattress Sensor to Assess Breathing During Sleep in People Living with Motor Neurone Disease (MND): A Feasibility Study (MEDBug for MND)

    Motor neurone disease (MND) is a progressive neurological disorder that results in profound disability and eventual death. Respiratory failure is the leading cause of death in MND due to declining respiratory muscle strength. Non-invasive ventilation, to support breathing, is the most effective treatment available for people living with MND. Polysomnography (PSG) is currently the gold standard for diagnosing sleep-disordered breathing and determining when to commence non-invasive ventilation in people living with motor neurone disease (MND) as it offers comprehensive monitoring of cardiac, respiratory, musculoskeletal, and neurological functioning. However, PSGs pose a significant challenge for people with MND as they require significant effort to travel to hospital and stay overnight. Also, as PSGs only collect data on the night they are conducted, they are not able to monitor the deterioration in respiratory status that is synonymous with MND. This study aims to explore the feasibility and acceptability of the use of a minimally invasive on-mattress device capable of recording body position, acoustic, respiratory and cardiac signals to identify breathing issues during sleep by people with MND and carers of people with MND. If feasible and acceptable to people with lived experience of MND, use of this device may simplify and improve the monitoring of sleep-disordered breathing in people living with motor neurone disease.

  • SureStep: Improving mobility in hospitals

    Poor balance and mobility are consistently associated with increased risk of falling among people in hospitals. This study aims to implement and evaluate SureStep, an evidence-based group standing balance exercise program designed to help hospital patients improve their balance, mobility and reduce their risk of falls. The program is delivered by physiotherapists as part of new standard care and involves supervised group exercise sessions held on the recruited wards. Using a stepped wedge type III hybrid design, recruited hospital wards will begin the program at randomly assigned times, allowing comparison between the original usual care and the SureStep program as new standard care primarily on the exercise dose and physical level of patients on ward. The study will assess feasibility, acceptability, cost-effectiveness and sustainability of the program. We hypothesise that SureStep will be feasible, safe and cost-effective to deliver, which will be sustained over time to support better mobility for hospitalised adults.

  • Delivering the Body Project @ Griffith University – an evaluation study among students

    The Body Project is an ED prevention program targeting young females with self-identified body dissatisfaction, aiming to challenge and reduce the unrealistic pursuit of thin idealisation. This study will implement and evaluate the Body Project in the Queensland tertiary environment, by recruiting females aged equal to or greater than 18 years up to 30 years of age enrolled at Griffith University with self-reported body image dissatisfaction (n=80). Participants will be randomised into either 4 sessions of the Body Project or a control group directed to watch a documentary. All participants will be asked to complete online surveys that measure changes in body dissatisfaction, psychosocial functioning, quality of life, service use and dietary intake before and after the intervention, 4 weeks apart for both groups. The groups will be facilitated by trained female peer educators. Following completion of all sessions, participants, peer educators and counsellors will be invited to take part in an individual interview to discuss their participation experiences, perceptions of the Body Project and its value.

  • Redesigning the hospital environment: The effect of removing noise and operational interruptions on patient sleep time and recovery.

    The study hypothesis is that implementation of a nursing program in hospital to reduce noise and interruptions overnight will improve patient's sleep. To investigate the effect of a nursing program to reduce noise and operational interruptions (measurement of vital signs, administration of medications) overnight on a cardiorespiratory ward in an Australian tertiary hospital. Observational study before and after implementation of nursing program. 1. Baseline data collection hospital ward- noise levels overnight, patient sleep duration and quality. 2. Data collection hospital ward after implementation of nursing program- noise levels overnight, patient sleep duration and quality.

  • ALLG AMLM28-A3. A randomised study of ambulatory management compared to standard of care for fever related hospitalisation in patients with AML receiving Venetoclax and Azacitidine – a domain of Achieving Durable remissions via Adaptive Pro-survival Targeting in AML (ADAPT)

  • Feasibility and Acceptability of a Remotely Delivered Physical Activity and Exercise Management Plan for Females in the Menopausal Transition

    This study aims to evaluate whether an online, individualised exercise and physical activity program is practical, feasible and acceptable for females going through menopause. Participants will complete five individual telehealth sessions with an Accredited Exercise Physiologist, including tailored exercise planning and education to support health during this life stage. The study will assess recruitment, retention, and participant satisfaction, as well as explore changes in physical activity, wellbeing, and menopause symptoms. Findings will guide future research and potential integration into routine care.

  • Comparing Unidimensional with Multidimensional Pain Scales on Opioid consumption during Hospitalisation: A Randomised Controlled Trial (COMPASS)

    Effective postoperative pain management is essential for patient recovery, satisfaction, and prevention of complications. Opioid analgesics are routinely used for the management of acute pain following surgery, and pain in practice often has been assessed using unidimensional scales such as the Numeric Rating Scale. The Australian Commission on Safety and Quality in Healthcare has released a Clinical Care Standard for opioid analgesic stewardship in acute pain recommending that clinicians assess a patient’s functional activity using an evidence-based tool before prescribing opioid analgesics, with the Functional Activity Score (FAS) provided as an example. The FAS offers a multidimensional approach by assessing how pain interferes with activity. Despite these recommendations to include functional assessments, evidence supporting the FAS in Australian hospital settings remains limited. Thus, there is a clear need to address this gap by providing data on the utility and impact of the FAS in an Australian hospital population. This trial addresses that gap by assessing whether integrating the FAS into postoperative care reduces opioid use and improves pain related outcomes.

  • Plus one serve: Using what works to increase provision and consumption of vegetables in secondary school canteens

    Consuming adequate amounts of vegetables is crucial for children’s growth, development and long-term health. It is associated with longer life expectancy, better mental health, a healthy heart, reduced risk of cancer, obesity and diabetes, improved gut health and stronger immunity. Yet, in 2022, only 3.5% of Australian adolescents met the Australian Dietary Guidelines target for vegetable intake (5.5 daily serves for girls and 6 for boys) . Around 40% consumed one serve or fewer each day, with vegetable consumption lowest in low socioeconomic areas . Clearly, there is an urgent need to improve adolescent vegetable intake. School food services play a significant role in influencing the foods and drinks students are exposed to and consume. This research aims to evaluate the feasibility of the Chef in Schools Plus program as a strategy to increase sales and consumption of vegetables from secondary school canteens. Tailored to individual secondary schools, the program combines previously successful strategies to increase vegetable consumption, including co-design, professional chef support for canteen staff to improve the availability, appearance, taste and price of vegetable dishes, and an associated co-designed promotion program likely focused on environmental sustainability and planetary health. Six secondary schools will be selected from metropolitan (2 pairs, n=4) and regional (1 pair, n=2) areas. One of each pair of schools will be randomly chosen to try the Chef in Schools Plus Program, while the others will continue with their usual lunch options (to compare results). We’ll gather information about school meals for 2 weeks in one term and for 8 weeks in the next term.

  • Testing the MySurvivorCare website: An online tool to help breast cancer survivors manage hot flushes and night sweats after cancer

    In Australia, many cancer survivors live with bothersome vasomotor symptoms (i.e., hot flushes and night sweats) after cancer treatment. These symptoms can affect daily life. Although supportive treatments exist, barriers such as geographical location, limited specialist clinics hinder accessibility. To address this, efficient models of care to improve access to existing healthcare services are necessary. The MySurvivorCare website, an online health tool designed to help cancer survivors manage hot flushes and night sweats after cancer, was developed to address the unmet. Why this study? This study aims to find out whether it is feasible to conduct a large trial of the MySurvivorCare website before it is launched or made publicly available. Who is it for? You may be eligible for this study if you are a breast cancer survivor and are experiencing hot flushes/night sweats. Study details Participants in this study will be, by chance, allocated to use either the MySurvivorCare website or be provided with access to menopause information from the Australasian Menopause Society website. The MySurvivorCare website will provide users with a self-help guide and information to provide to your GP regarding how to manage symptoms according to the current best practice guidelines. The Australasian Menopause Society website provides educational resources on menopause, including how best to manage symptoms. Participants will be followed up for 6 months via questionnaires. It is hoped that this study will assess how acceptable and easy to use the MySurvivorCare website is, and whether it shows early signs of helping women manage their symptoms over time.

  • A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect of Single Ascending Doses of TRX-100 in Healthy Volunteers

    This is a Phase 1b, randomized, double-blind, placebo-controlled, dose escalation study of TRX-100 tablets evaluating the safety, pharmacokinetics (PK), and food effect of single ascending doses of TRX-100 in healthy volunteers. Participants will be enrolled in three cohorts evaluating two dose levels. Each cohort will assess the effect of food (fed or fasted conditions) on the PK of TRX-100. A total of up to 24 healthy volunteers are planned to be enrolled across 3 cohorts.

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