ANZCTR search results

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

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31070 results sorted by trial registration date.
  • A randomised trial of detailed written consent compared to standard verbal consent in adults with routine orthopaedic trauma

  • Intralesional triamcinolone acetonide for squamous cell carcinoma of the lower limbs

    This study aims to determine whether injection of a corticosteroid (triamcinolone acetonide) directly into squamous cell carcinoma (SCC) lesions of elderly patients (older than 70) is safe and whether this drug has any effect on the size of the lesions. Who is it for? You may be eligible for this study if you are aged 70 or older, you have at least one lesion on either of your legs clinically consistent with low-grade SCC, and you have been deemed to be at high risk of surgical complications because of pre-existing lower limbs conditions (such as diabetes mellitus, chronic venous disease affecting the lower limbs, previous lower leg cellulitis, previous poor wound healing at the legs, lower limb oedema). Study details All participants who choose to enrol in this study will undergo a biopsy of one of their SCC lesions to determine the severity of the lesion and whether they are eligible to enrol in this study. Two weeks after this biopsy, eligible participants will be randomly allocated by chance (similar to flipping a coin) to have their SCC lesion injected with either the corticosteroid drug or a placebo (sterile injection solution). A maximum of one injection will be made over a 5 week period. Prior to this injection and after the last review at 5 weeks, all participants will be asked to complete two questionnaires about their lower limb function and quality of life. These questionnaires are anticipated to take 20 minutes. No further study visits will be required after the 5 weeks. It is hoped this research will demonstrate that corticosteroid injection into SCC lesions is safe and able to reduce the size of the lesions, which may then be used to improve health outcomes for future patients with SCC.

  • Sneezing under intravenous sedation during nasal local anaesthetic injection for plastic surgery procedures

    Local anaesthetic injections to the nose may be painful and patients often require intravenous sedation. At the same time, local anaesthetics injections to the nose may lead to sneezing especially when performed in a sedated state. Sneezing during these injections however poses potential patient safety concern, potential infectious spread via aerosol generation and an occupational health hazard. We hypothesise that administering intravenous fentanyl (a strong opioid) as part of intravenous sedation may lessen the incidence of sneezing in these circumstances. The primary aim of the study therefore is to determine whether administration of intravenous fentanyl as part of propofol-based intravenous sedation given prior to nasal injection of local anaesthetics will reduce the rate of sneezing compared to propofol-only intravenous sedation in adults undergoing plastic surgery to the nose.

  • A Proof Of Concept study to evaluate the sensitivity and specificity of Wearable and Artificial Intelligence Technology for Chronic Heart Disease used in detecting irregular heart rhythm of patients with Atrial Fibrillation, The “POC WATCH AF” study

    The purpose of this trial is to test the specificity and sensitivity of two types of sensors, used in the Saiiv device, in detecting AF when compared to ECG. Other vital signs including blood pressure (and related arterial stiffness) as well as mechanical performance of the heart will also be measured and compared with standard measurement techniques.

  • Artificial Intelligence for Sperm Selection in Artificial Reproductive Technology

    Sperm selection for ICSI is a highly subjective process based on the embryologist’s perception of what looks like the best sperm. There are currently no evidenced-based methods to select high quality sperm during the ICSI process. Given the huge body of evidence showing that sperm quality impacts both fertilization and child health, we predict the development of artificial intelligence (AI) assisted sperm selection will have positive impacts for infertile couples and their children. This study aims to capture images of sperm shape and movement using a video imaging system during ICSI. This information from each sperm that is injected will be matched with each embryo outcome, as well as the clinical information and reproductive outcomes from the IVF cycle to create a machine learning tool to choose the best sperm for ICSI. Machine learning is a type of AI, where a computer uses mathematical models based on sample data, known as training data, to make predictions or decisions without being explicitly programmed to do so i.e., without human bias. The information collected will be used to develop a machine learning sperm selection tool to aid the scientist in selecting the sperm during ICSI with best potential for fertility.

  • Comparison of a Physiotherapy versus Extracorporeal Shockwave Therapy (ESWT) for treatment of Hamstring Tendon pain.

    Proximal hamstring tendinopathy (PHT) is a common condition in the active and sporting population. It can also occur in less active individuals. There is limited research regarding the efficacy of various treatment options for this condition. One study has shown improved pain and function from shockwave therapy, however the comparison group in this trial were provided with non-specific treatments as well as treatments mechanistically hypothesisied to be detrimental to this condition. A research trial is planned to compare individualised physiotherapy to shockwave therapy for PHT.

  • Fundus EDucation: Analysing the utility of an online education tool in improving the diagnostic accuracy of fundus image interpretation amongst Emergency Doctors and Medical Students

    Non-mydriatic fundus photography (NMFP) has been demonstrated to improve detection of fundus abnormalities in patients presenting to the emergency department (ED). Despite this, there is limited knowledge and education amongst ED doctors and medical students on how to interpret fundus images. This study aims to create an online e-learning program that will improve the diagnostic accuracy of fundus interpretation.

  • The Efficacy and Acceptability of a Remotely Delivered Transdiagnostic Cognitive Behavioural Therapy (CBT) Treatment for Perinatal Anxiety: A Case Series

    The purpose of this project is to assess the efficacy and acceptability of a remotely delivered transdiagnostic cognitive behavioural treatment for perinatal anxiety in an Australian sample. Participants are asked to complete standardised questionnaire measures at pre-treatment, post-treatment, and 3 month follow up, and brief weekly questionnaires throughout treatment to monitor participants’ symptoms and safety throughout treatment. Treatment will consist of 5 x 50-minute weekly sessions, which will be conducted via the secure online platform, Zoom. It is hypothesised that participants self-reported symptoms of perinatal anxiety will reduce from pre-treatment to post-treatment and that participants will no longer meet diagnostic criteria for anxiety.

  • Evaluating a website to help Australians better manage stress, adapt to change and optimise their mental health

    We will test whether an interactive, self-guided, online intervention based on Acceptance and Commitment Therapy (ACT), developed in consultation with mental health professionals and consumers, is perceived as acceptable and helpful by Australian adults (aged 18 years and older), optimises their mental health and wellbeing, and leads to effective coping when faced with future challenges. The icanactnow website contains five short, interactive modules designed to teach users new tools to better manage stress, adapt to change and strengthen their mental wellbeing by fostering the key ACT processes of defusion, acceptance, values, connecting with the present moment and psychological flexibility. Modules are designed to be completed over 10 weeks, with subsequent modules becoming available two weeks after completion of the previous module. We will establish the safety and efficacy of the website using the data that users input as they go through the modules. Users will also be able to opt-in to help us to evaluate the website by completing additional questionnaires. These users will complete questionnaires when they create an account, at the end of the intervention, and 6 months post-intervention so we can examine changes in their mental health and wellbeing over time. We hypothesise that the intervention will lead to a decrease in distress and increase in levels of mental wellbeing and that changes in distress and mental wellbeing will be mediated by the key ACT processes of defusion, acceptance, values, connecting with the present moment and psychological flexibility.

  • Topical magnesium oil for the treatment of neuropathic symptoms in stage IV and V chronic kidney disease

    Neuropathic pain and symptoms are chronic debilitating problems that commonly affect people with advanced kidney disease. Most currently available treatments are taken orally, and may be associated with significant side effects. Also, people with advanced kidney disease are on many medications, and adding additional medications increases the risk of drug interactions. Topical magnesium may represent an alternative treatment for these bothersome symptoms and due to local application, the risk of side effects and drug interactions may be lower. The objective of this study is to determine the effectiveness of daily application of topical magnesium oil for the treatment of neuropathic symptoms (pain, numbness, cramping) in people with stage IV or V chronic kidney disease. The study will also examine the impact of using magnesium oil on quality of life, blood magnesium concentrations and any adverse effects from using magnesium oil. This study will run for a period of 12 weeks, with follow up scheduled every 4 weeks.

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