ANZCTR search results

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

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30822 results sorted by trial registration date.
  • 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.

  • Identifying and addressing barriers and enablers to implementing best-practice cardiac rehabilitation: the Quality Improvement in Cardiac Rehabilitation (QUICR) Cluster-Randomised Controlled Trial

    Our primary aim is to determine whether implementation of a data-driven collective approach to best practice cardiac rehabilitation, which addresses shared gaps in quality and access improves CR uptake and completion in CHD patients. The collective approach will be supported by an electronic data platform. Clinical, service and patient-reported outcomes and cost-effectiveness will be assessed. In partnership with CR programs, we will evaluate barriers and enablers to best practice care, develop a framework for scale-up and establish sustainable collaborations. We hypothesise that a collaborative quality improvement approach is feasible, improves outcomes and offers a novel approach that can be replicated in other outpatient health areas.

  • Feasibility and preliminary efficacy of a Hospital Fall Prevention Moments of Care intervention: a pilot trial

    St John of God Health Care (SJGHC) want to develop an innovative solution to prevent falls at Midland hospital as a model for other hospital sites. The incidence of falls is influenced by the complexity of the ward environment and patient characteristics such as age and cognitive status. A common theme of falls that occur in hospital is that many patients do not accurately identify their risk of falling. Studies have identified unwillingness of patients to ask for assistance when mobilizing in hospital, often because they don’t want to be a burden to caregivers. As such, communication between patients and caregivers is a potentially modifiable factor that influences the ‘risk-taking’ behavior of inpatients. Another factor that may be contributing to the risk of falls during the hospital admission, as well as after discharge is that the prevention of falls may have created a disincentive to mobilize patients. Immobility, imposed to prevent falls, may, itself, be an important contributor to falls and subsequent disability. Individualized patient education is an important strategy for falls prevention and will be implemented during the trial to understand what works best for patients and caregivers at Midland hospital. We will use the admission moment of care to engage with the patient and their family and demonstrate how to safely mobilize around their room and take action to prevent their own falls. An additional intervention will address the daily mobilization of inpatients. The first phase will co-design interdisciplinary caregiver training for effective delivery of patient focused falls education during the trial. This project is motivated by the need to impact hospital falls prevention and to understand if the caregiver training and patient education is feasible for consideration in a larger trial.

  • Assessment of extra-renal effects of SGLT2-inhibitors in anuric haemodialysis patients using microneurography

    Sodium Glucose Co-transporter 2 inhibitors (SGLT2i) have been shown to reduce cardiovascular morbidity, mortality and have reno-protective effects. Though their glycosuric effects remain the most studied mechanism, multiple other mechanisms of action have been theorized. This includes extra-renal effects on organs such as the brain, heart, and the sympathetic nervous system (SNS). Increased sympathetic tone is a key feature in various conditions such as chronic kidney disease, type 2 diabetes mellitus, obesity, metabolic syndrome, and heart failure. Limiting the renal effects of SGLT2i by administering them to patients who do not produce urine will allow more accurate assessment of their extra-renal impacts and effectiveness in reducing sympathetic nerve activity. This investigator-led, open-label, prospective, mechanistic study aims to investigate the extra-renal effects of SGLT2i on the SNS, by administering empagliflozin to anuric haemodialysis patients and measuring SNS activity using microneurography of the popliteal nerve, over 6 weeks. We hypothesize that the use of empagliflozin will result in reduced sympathetic drive, which in turn would add mechanistic proof to the extra-renal benefits of SGLT2i.

  • The Combination of Tirzepatide and Resistance EXercise (T-REX) for the Management of Body Composition

    Obesity and physical inactivity are gateway conditions to prevalent and costly cardiovascular (CV) diseases including hypertension, type 2 diabetes, coronary artery disease, stroke and chronic kidney disease. Previous randomised trials have shown promising impacts on weight loss with the use of a self-administered drug called tirzepatide by modifying hormones released from the gastrointestinal tract, as a strategy for the management of obesity. However, an important issue in this and similar studies relates to the type of weight that was lost. In addition to losing fat, participants treated with tirzepatide can lose lean mass, including skeletal muscle. Maintenance of skeletal muscle mass and function are crucial to avoiding frailty, which is linked to cardiovascular diseases and mortality. Resistance exercise training (involving weight lifting type exercises) is known to increase skeletal muscle mass and function in humans, We hypothesise that: -The combination of tirzepatide and a resistance exercise intervention (targeted at reducing fat and increasing skeletal muscle mass), will optimise changes in body composition in our enrolled population, who are at high risk of future cardiovascular diseases. -Combining tirzepatide with exercise training will optimise vascular function and health in older men and women at high risk of future cardiovascular diseases. -Combining tirzepatide with exercise training will optimise heart function in older men and women at high risk of future cardiovascular diseases

  • The ElectroPulse Study: A Safety and Feasibility Study of the ElectroPulse Pulsed Field Ablation (PFA) System to Treat Atrial Fibrillation.

    The purpose of the study is to provide data demonstrating the safety and effectiveness of the ElectroPulse PFA System for the treatment of atrial fibrillation. In particular, the study will provide first in human insights into clinical safety and device function of the ElectroPulse PFA System for pulmonary vein isolation as a treatment for atrial fibrillation.

  • A feasibility study comparing home-based and in-hospital methods of adjusting non-invasive ventilator settings for people with long-term breathing failure

    Non-invasive ventilation (NIV) is a treatment that uses positive pressure delivered via a face or mouthpiece to assist a person to breathe. It can be used as a long-term treatment for people whose breathing has failed – usually due to chronic conditions that produce weakness of the respiratory muscles (i.e. motor neurone disease [MND] or muscular dystrophy), restriction of chest wall movement (i.e. severe obesity or kyphoscoliosis) or in those with severe loss of lung function (i.e. from emphysema or cystic fibrosis). Most people use this treatment at night to improve their breathing during sleep. If a person is unable to use NIV they can be admitted to hospital overnight to undergo a polysomnography (PSG, “sleep study”) in order to adjust ventilator settings and use NIV more effectively. Previous studies have shown that home-based sleep studies or polygraphies, are both safe and feasible, however it is not known whether patient ventilator synchrony can be optimized similarly to a hospital-based PSG. This study will compare the current hospital admission-based model for adjustment of NIV, with two different home-based models for adjusting NIV therapy, with the goals to improve usage and access to this life sustaining treatment for a vulnerable population. Successful model development will likely also reduce use of acute hospital beds and thus costs.

  • A Phase 1 study to Assess Safety and Tolerability of KER-065 in Healthy Adult Volunteers

    The primary purpose of the study is to evaluate the safety and tolerability of escalating doses of KER-065 administered as single and multiple subcutaneous doses in healthy adult volunteers.

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