ANZCTR search results

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

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32704 results sorted by trial registration date.
  • The effect of new contact lens disinfectant solution on the contact lens discomfort

    The aim of this study is to evaluate the impact of contact lens disinfectant on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. Participants will wear Comfilcon A contact lenses over a 12-week, changing their lenses every four weeks, a commonly recommended wear schedule and use a new contact lens disinfectant made by Ophtecs Corp (Japan). • The primary endpoint is the changes in the ocular surface and tears of contact lens wearer over the first four weeks of lens wear using a new lens care product. • The secondary endpoint is changes in factors that have been reported to be different between comfortable and uncomfortable contact lens wearers.

  • A Multi-centre Observational study of Supportive Ventilation Adjustments and Respiratory Effort Parameters in Adult Patients Admitted to the Intensive Care Unit

    Many patients admitted to the intensive care unit (ICU) for on-going clinical management receive breathing assistance with machines (mechanical ventilation). Mechanical ventilation is the process by which a patient’s breathing is supported by a ventilator. Broadly speaking there are two modes of breathing: i) Mandatory and ii) Supportive. Mandatory ventilation is used when the clinicians deem it necessary to control all aspects of breathing. Supportive ventilation is used when the clinicians aim to help the patient’s spontaneous breathing with some adjusted machine assistance. While receiving mechanical ventilation the patient’s intensive care clinicians make clinical decisions about their patient’s breathing. Such decisions relate to the amount of oxygen to provide, the number and depth of breaths, how much force is needed to adequately inflate the lungs and importantly when it is suitable to wake the patient and remove the breathing tube. All these decisions can be defined as the ventilation management of the critically ill patient receiving mechanical ventilation. For critically ill patients, changes in ventilation support are often made based breathing rate (respiratory rate) and size of breaths (tidal volume). However, the effect these changes have on measurable aspects of breathing effort (which define breathing work) remain unclear. Importantly, such information, which was difficult to get in the past, can now be obtained from modern ventilators just by pushing a button or moving a cursor on the screen. Such information is then displayed on the ventilator screen. In response, we will perform a prospective observational study of supportive ventilation settings in patients who are receiving supportive mechanical ventilation in the intensive care unit. In this multi-centre study, we estimate that the information obtained from 30-35 patients per site (4 sites) will lead to approximately 900 ventilation data-points collected from a cohort of 100 patients.

  • Immune response to a third COVID-19 vaccine dose in people with multiple sclerosis receiving B cell-depleting therapy

    Evaluate immunity provided to people with multiple sclerosis (pwMS) receiving B cell depleting therapy with ocrelizumab by a third mRNA-platform COVID-19 vaccine dose. Immunity was evaluated by comparison with pwMS receiving treatment the non-depleting drug natalizumab and through comparison against a correlate of real-world protection against infection. Peripheral blood immune cells were analysed in order to describe how the altered immune system in pwMS receiving ocrelizumab is associated with vaccine response, and to identify potential predictors of immune response to stratify poor responders for antiviral prophylaxis.

  • Just Say No to the Just in Case Cannula: An Implementation Science Trial

    Background This implementation science trial aims to reduce unnecessary and improve peripheral intravenous catheter (PIVC) insertion in Emergency Department (ED) patients. The intervention is effective locally and recommended by ACSQHC PIVC Clinical Care Standard. This project has received $2.9M funding from the MRFF 2023-2028. Primary Objective To implement best practice for PIVC in Australian ED. Methods 1. Stepped-wedge cluster-controlled trial for clinical effectiveness and safety of the intervention. We will study 9 diverse EDs and implement a package of interventions, three at a time, with 6-monthly steps. We will measure rates of PIVC insertion, use, safety and PIVC-related infections. 2. An adaptive, co-designed intervention based on our previous model/ACSQHC standards, using validated implementation and evaluation frameworks.

  • Testing different ways to explain coronary calcium artery scoring for support of shared decision making in adults who do not have a history of cardiovascular disease

    The aim of this study is to improve knowledge of consumers about new and emerging CVD risk assessment methods, addressing different levels of health literacy; and to improve the uptake of evidence-based risk assessment methods by health professionals by providing them with communication tools that allow them to quickly and automatically apply the evidence to their patients. This project will use a novel approach to: 1) identify the best way to communicate the known benefits/harms and uncertainties of these tests, for patients with varying health literacy levels; and 2) develop novel patient decision aids on these issues to support revised national guidelines before they are implemented.

  • Evaluation of a Virtual, Comprehensive Care Program Before and After Total Hip and Knee Arthroplasty

    This study will assess the outcomes of an integrated program of patient education and exercise before and after total hip or knee arthroplasty. The program will be home-based and remote-monitored, but will include physiotherapy-led home visits, telehealth consultations and tele-messaging. A program of specific muscle strengthening exercises and cycle ergometry will focus on muscle power as the therapeutic target. The cycling program will be fully measured and adjusted based on patient performance and feedback obtained via remote monitoring. Outcomes of the pre-operative phase and early post-operative recovery will be the focus of the study. Specific outcomes will include program completion, hospital length of stay, discharge to hospital rehabilitation and surgery-related readmissions. Physical performance and patient-reported outcomes will be measured at the end of the pre-operative phase and at program completion, six weeks post-surgery.

  • SAFE-HF - tranSlating heArt Failure guidElines into practice in a Nurse Practitioner primary care service

    Current management of HF patients post-discharge is sub-optimal and patients are not receiving the full benefits of evidence-based care simply due to inaccessibility to a heart failure specialist team. The aim of this project is to assess implementation and effectiveness of a HF nurse practitioner primary care service. The HF nurse practitioner service can be integrated within primary care and will reduce hospitalisations and mortality.

  • The effect of manual therapy on ankle dorsiflexion range of motion: A pilot crossover randomised trial

    Ankle stiffness has been identified as a risk factor for lower limb injuries in sport. This randomised crossover control trial will investigate if ankle dorsiflexion can be increased with manual therapy. The participants will be required to attend two sessions of one hour, one week apart. Over the two sessions, participants will receive an intervention to address ankle joint stiffness and one to address calf muscle length. Measurements of ankle dorsiflexion range of motion will be taken before and after each intervention.

  • PROlonged versus Single dose in PEnicillin oral Challenge Testing

    Penicillin allergies are a major burden on patients and health care worldwide. Currently, up to 1 in 4 hospitalised patients admitted to hospital will report an antibiotic allergy, which limits appropriate antibiotic use and leads to poorer health outcomes. In some instances, patients can be given a single or multiple test dose of an antibiotic to determine if a patient is truly allergic. This study will inform whether research to determine if a multiple dose challenge (5-days) elicits more true penicillin allergy than a single dose challenge is feasible. The current Drug Allergy Practice Parameters recommend “against the routine use of multiple-day challenges in the evaluation of penicillin allergy”, providing a “strong recommendation” but with ” low certainty of evidence”. In Europe, a mixture of observational and retrospective studies has suggested that extended challenges ranging from 3 to 10 days may be superior to single dose challenges at excluding delayed immune reactions, however the reported prevalence of delayed reactions is highly variable (5-12% of patients) and many were reliant on patient self-reporting. This is converse to the North American experience where delayed prolonged challenges have been associated with low rates of delayed reactions (0-1.8%). Whilst a study of children demonstrated that delayed reactions may occur <7 days following a single challenge. Therefore, whilst oral challenge is the well-defined gold standard for penicillin allegro-immunological investigation, limited controlled evidence is available regarding the safety and efficacy of single dose versus prolonged oral challenge. Blinded randomized placebo-controlled trials have not been previously used in any drug allergy trials. The aim of this double blinded placebo controlled pilot randomised control trial is to evaluate the feasibility of placebo controlled trial and safety of oral penicillin challenge (5-day) versus single dose challenge penicillin challenge (followed by 5 day placebo) for evaluation of immune-mediated penicillin allergy in the inpatient and outpatient setting to inform the design of a definitive trial.

  • Return to Country: A national platform study to return Aboriginal and Torres Strait Islander renal patients home

    End-stage kidney disease (ESKD), when dialysis or a kidney transplant is required to maintain life, has a devastating impact on Indigenous patients and their families. In remote communities, rates of ESKD are 15 or more times higher than amongst non-Indigenous Australians of the same age and sex, and people need to relocate to distant urban centres to take up dialysis. Community-based dialysis or a kidney transplant allows a patient to return to live in their community. However, Indigenous Australians have very low rates of such community-based treatment. This multicentre prospective interventional study will investigate why this is, and test if interventions to address these identified barriers can get more people home for treatment.

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