ANZCTR search results

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

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32694 results sorted by trial registration date.
  • EMVision emu™ Brain Scanner on Acute Stroke and Intracranial Haemorrhage

    This study is a continuous innovation study of the EMVision emu™ brain scanner for patients suspected of suffering from an acute stroke or intracranial haemorrhage for algorithm development purposes and indication expansion to traumatic brain injuries. This study collects EMVision brain scans and radiological scans from patients receiving brain imaging as part of their routine care. Scans are anonymised and enter the EMVision database for advancing and extending software algorithms. This study hypothesises that an expanded acute brain injury dataset can improve the diagnostic performance of the emu™ brain scanner and extend utility to patients suspected of intracranial haemorrhage following traumatic brain injury.

  • PENGUIN Trial: Testing if Glue Can Safely Secure Intravenous (IV) Lines in Newborns

    Peripheral intravenous catheters (PIVCs) are commonly used in neonatal care to deliver fluids and medications. However, due to the fragility of neonatal skin and veins, PIVCs are prone to failure, which may lead to treatment interruptions and additional procedures. Tissue adhesive is a medical-grade glue that has shown promise in improving PIVC securement in adult and paediatric populations, but there is limited high-quality evidence regarding its use in neonates. The PENGUIN trial is a two-arm pilot randomised controlled trial aiming to evaluate the feasibility of a larger effectiveness study on the use of tissue adhesive in neonatal PIVC securement. A total of 100 neonates requiring PIVC insertion will be enrolled and randomised to receive either: (i) standard care with a bordered polyurethane dressing, or (ii) standard care plus tissue adhesive applied at the insertion site. Randomisation will be stratified by age at enrolment (less than 15 days or equal and greater than 15 days of life). This trial will examine whether it is feasible, including the safety, to use tissue adhesive to secure PIVC in neonates. Findings will inform the design and safety of a larger future trial.

  • AI scribe for clinical documentation

    Study aims to evaluate the use of an Artificial Intelligence (AI) Scribe at the Queensland Children’s Hospital (QCH) and Childrens Health Queensland (CHQ) across medical, allied health and nursing professions in a cohort of users who were part of a quality improvement project with AI scribe. The study design is retrospective-prospective cohort design. The retrospective component of the study aims to analyse the data and the outcomes from the CHQ Digital AI Scribe (Quality Improvement) Proof of Concept Project in the clinicians onboarded for the Queensland Children's Hospital AI scribe quality improvement initiative (data upto first 2 months after onboarding as part of the quality improvement project). The prospective component of the study aims to evaluate the ouctomes for the same cohort of health professionals following completion of the Quality Improvement phase of the project beyond 2 months of onboarding (onboarding month is defined as the first month of AI scribe use when the user is learning to use the AI scribe)

  • The effect of BoneBoost Gelato on markers of musculoskeletal health

    Older women are at a much higher risk for osteoporosis (weak bones) and fracture, compared to men. When considering diet, often only calcium, vitamin D and protein are promoted for muscle and bone health. Yet an overall balanced diet is critical to optimise musculoskeletal health. In addition to protein, calcium and vitamin D, key nutrients from vegetables and fruits also play an important role. However, improving dietary habits, such as increasing fruit and vegetable intake, is challenging. To overcome this limitation, BoneBoost Gelato, a nutrient-dense, whole food ice cream containing a variety of key nutrients shown support musculoskeletal health, has been developed. This pilot study seeks to examine the effects of 4-weeks of daily BoneBoost Gelato consumption on markers of bone health in older women.

  • Examining the feasibility and helpfulness of an internet-delivered intervention for adults with medically managed Atrial Fibrillation (AF)

    The current research project aims to examine the preliminary effectiveness and acceptability of an established online psychological intervention (referred to as the Chronic Conditions Course) for people struggling with the impacts of chronic health conditions. This intervention has been evaluated in several previous randomised controlled trials with hundreds of patients with mixed chronic health conditions. This specific trial is focused on Australian adults with atrial fibrillation (AF). The intervention aims to support people to learn psychological and other self-management skills to manage the impacts of chronic health conditions on their day-to-day lives and mental health. We hypothesise that we will observe significant improvements in Atrial Fibrillation related Quality-Of-Life, symptoms of anxiety and symptoms of depression. We hypothesise that the majority of participants (>70%) will be satisfied with the intervention.

  • A Centralized Platform study for Functional High Risk Multiple Myeloma - Master Protocol

    The purpose of this platform study is to assess the efficacy of different novel treatments/ combinations for patients who have functional high-risk disease, defined as relapsing or refractory within 18 months of first-line myeloma treatment. Patients who have functional high-risk disease currently do not have optimal treatments available via the Pharmaceutical Benefits Scheme and have poorer outcomes compared to myeloma patients who are not considered functional high-risk. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older, have a documented diagnosis of multiple myeloma and have relapsed within 18 months following initiation of first-line therapy and require treatment. Study details A platform study is designed to make the process of trialing different treatments for the same disease more efficient by making these treatments under one "platform" and therefore under one ethics approval. With the platform, there are different "domains", analogous to treatment arms. Your treating doctor will decide which domain is potentially suitable for you. Biological samples, such as blood and bone marrow, will be collected to assess how you respond to treatment. These samples will also be used for scientific research to better understand how myeloma changes after using these treatments. It is hoped that findings from this study will provide information on newer treatments that are not yet available in Australia to treatment functional high-risk myeloma.

  • An Ascending, Single and Multiple Dose(s), Double-Blind, Randomized, Placebo Controlled Study Assessing the Safety, Tolerability, and Pharmacokinetics of Intravenous OV350 in Healthy Male and Female Participants

    OV350 is a brain penetrant, small molecule activator of the neuron-specific K+-Cl- co-transporter 2 (KCC2). KCC2 plays a critical role in maintaining chloride homeostasis in neurons through extrusion of chloride ions, thus ensuring the inhibitory function of GABAergic neurotransmission. Dysregulation of KCC2 can lead to an imbalance in excitatory and inhibitory signalling, contributing to disinhibition of neural circuits and downstream neuroinflammation. By directly activating KCC2, OV350 has the potential to restore abnormal neuronal excitatory/inhibitory balance notable in disease states, including psychosis of Neuronal a-Synuclein Disease (NSD). Part A will consist of approximately 5 cohorts, comprising 8 participants each. Dosing will be initiated at 50 mg/day. Subsequent cohorts will be dosed as recommended after the safety, tolerability and PK of IV OV350 from the previous cohort has been assessed. Doses will not increase more than 2x the previous dose tested. It is anticipated that Part B will consist of 4 planned cohorts comprising 8 participants each, using different doses of OV350.Dose levels for Part B (including starting dose) will be determined based on the overall safety and tolerability profile, PK data, and potentially EEG of OV350 after single ascending bolus dose(s). It is anticipated that the starting dose in MAD will be the second SAD dose but will be confirmed once the initial 2 SAD cohort data have been reviewed by the study sponsor, study PI, medical monitor, and pharmacokineticist. Participants will be dosed for a total of 7 days.

  • Motor Neuron Disease Surveillance Unit in New South Wales

    This is an observational study to identify MND incidents over a 3-year period in NSW. A telehealth consultation between the participant, their GP and a neurologist is set up for the neurologist to identify patients with MND. MND cases captured will be used to calculate the incidence and prevalence of MND in NSW.

  • Can use of Artificial Intelligence improve Osteoporosis Detection and Bone Health Assessment?

    The prospective portion of this study will evaluate this deep learning AI system for opportunistic detection of osteoporosis on chest radiographs in a community setting. This study will recruit participants 50 years of age or over, who have undergone a chest x-ray in the preceding 6 weeks. Osteoporosis affects one million Australians and is associated with an increased risk of minimal trauma (“fragility”) fractures. There are effective medications for treating osteoporosis, and timely intervention can reduce the risk of future fractures by up to 70% and mortality by 11%. However, a significant treatment gap in osteoporosis exists, and the majority of patients that present to hospital with a minimal trauma fracture are neither assessed nor appropriately managed for osteoporosis. The gold-standard for diagnosing osteoporosis is by measuring bone mineral density (BMD) using dual energy X-ray absorptiometry (DEXA) or bone densitometry. Access to DEXA scanners depends on the limited availability of equipment and Medicare rebate restrictions. Therefore, opportunistic screening for osteoporosis using Artificial Intelligence (AI) technology represents an approach for identifying patients at higher risk of osteoporosis and more likely to benefit from having a DEXA BMD study. The retrospective portion of this study will continue the development of AI technology for analysing chest X-rays to estimate BMD. The prospective portion of this study will evaluate this deep learning AI system for opportunistic detection of osteoporosis on chest radiographs in a community setting. This study will recruit participants 50 years of age or over, who have undergone a chest x-ray in the preceding 6 weeks.

  • An online program to address tinnitus severity and distress in adults with bothersome tinnitus.

    This study aims to test the benefit of an online tinnitus management program. In this research, adults living with bothersome tinnitus will complete a set of questionnaires measuring tinnitus severity and wellbeing. We will use randomisation to decide who joins the program right away and who waits. By comparing those who start the program immediately with those who wait, we can accurately see if the program really works and how it might help people. Participants in both groups complete follow-up questionnaires at six weeks and three months to what changes occur. It is expected that participants who receive the program in this time will have reduced tinnitus distress following intervention, compared to the control group.

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