ANZCTR search results

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

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32850 results sorted by trial registration date.
  • The influence of orthokeratology contact lens designs on anterior eye shape in young healthy adults with myopia

    Orthokeratology (OK) lenses are rigid contact lenses that are designed to be worn during sleep. Their purpose is to reshape the front surface of the eye (cornea) in order to temporarily correct short-sightedness, also known as myopia. Although their primary aim is to correct myopia and provide clear unaided vision during the day, studies have shown that they also have an effect on slowing or stopping the progression of short-sightedness in children, termed called myopia control. This benefit is likely due to changes in mid-peripheral corneal shape and corresponding changes in peripheral vision induced by OK lenses. It has been proposed that greater changes in peripheral vision may induce better myopia control. Hence this prospective study aims to compare the effect of two different OK lens designs on mid-peripheral corneal shape changes to determine whether corneal shape changes can be predictably made through lens parameter changes. Outcomes of this study can be assist in future studies that investigate myopia control using OK lenses.

  • PneuMatters: maternal immunisation to prevent pneumonia in children

    We plan a parallel, single-blind multicentre RCT (with concealed allocation) to determine the efficacy of maternal PHiD-CV immunisation on infant respiratory outcomes. Our primary question is: Does vaccinating pregnant Indigenous women with PHiD-CV (compared to controls) reduce ALRI in their infants in the first year of life? Our primary hypothesis is that: Infants born to pregnant women who received PCV-HiD have at least 30% less ALRIs in their first year of life, compared to those who did not receive the vaccine

  • Coronary and Peripheral Haemodynamic Studies of Angina with No Obstructive Coronary Artery Disease.

    About 20-30% of patients with angina have no obstructive coronary artery disease on coronary angiogram (NoCAD). Despite no significant obstructive coronary artery disease, most of these patients continue to experience recurrent chest pain without any definitive diagnosis. Main aim of this study is to investigate patients with angina and NoCAD with a comprehensive invasive coronary and peripheral haemodynamic studies at the time of diagnostic coronary angiogram and to evaluate the prevalence of various coronary vasomotor disorders in these patients. Further, we aim to relate the results of testing to outcome by determining the clinical and coronary haemodynamic predictors of recurrent chest pain on 1, 6 and 12 months follow up.

  • The Effect of ‘Recreational Marathon Training’ versus ‘Interval Training’ on Exercise Adherence and Cardiometabolic Health in Apparently Healthy Adults

    Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in the world, imposing a huge financial burden of approximately $7.9 billion of health care cost in Australia alone. Exercise-induced improvement in cardiorespiratory fitness has repeatedly been demonstrated to be a powerful antidote against CVD risk factors including abnormal blood glucose, cholesterol, blood pressure, obesity, and impaired vascular structure and function. However, adherence to regular exercise has proven to be difficult for the majority of the population, primarily due to either lack of time, motivation, or enjoyment. Previous investigations have demonstrated that ‘interval training’, characterized by repeated bouts of high-intensity exercise, interspersed with recovery periods, is a potent exercise strategy to improve cardiorespiratory fitness and cardiometabolic health factors. The popularity of interval training comes from the significantly lower weekly time commitment required relative to the current exercise guideline of moderate-intensity continuous training (MICT). Interval training has also been reported to promote better exercise adherence and enjoyment compared to MICT. However, the long-term adherence of the general population to this type of exercise remains questionable, considering that the majority of studies thus far have only been conducted over a short-term period, usually only up to 6 months and typically in athletes and regular exercisers. Interestingly, participation in sporting activities has recently been reported to be associated with increased long-term exercise adherence, perhaps due to increased motivation to compete in or complete a sporting event. In particular, the popularity of marathon running among the general population has increased steadily over time, specifically in individuals pursuing the reported health benefits of regular exercise. The majority of these recreational marathon runners usually engage in several months of daily aerobic exercise, with the goal of safely completing the race event. This so called ‘recreational marathon training’ has also been demonstrated to have favourable effects on CVD risk factors.The primary aims of this study is to therefore investigate the impact of ‘marathon training’ compared to ‘interval training’ on short- and long-term exercise adherence and compliance.We hypothesise that marathon training will induce better short- and long-term exercise adherence and compliance relative to interval training.

  • Ambulance Clinical Triage For Acute Stroke Treatment (ACT-FAST) Clinical Algorithm Validation Study for Identification of Endovascular-eligible Stroke

    This study aims to validate the 3-step ACT-FAST Algorithm, designed to allow paramedics to recognise stroke patients that require endovascular clot retrieval surgery. Paramedics will assess the algorithm for all suspected stroke and TIA patients prior to arrival in hospital. The study will examine whether the algorithm is accurate in determining need for endovascular clot retrieval, and how much time would have been saved had the patient been taken directly to a hospital capable of endovascular treatment.

  • Does nutrition counselling combined with an education and cooking program improve blood vessel function for patients with vascular disease?

    Patients with peripheral arterial disease are at risk of poor nutritional health. Poor nutritional health can affect the patients’ ability to have ideal clinical outcomes. This project will implement a randomized controlled trial providing a 12-week student nutrition service (consisting of nutrition counselling and 6 fortnightly education and cooking classes) for adults with peripheral arterial disease who attend the Southern Adelaide Local Health Network Vascular Surgery Outpatient Clinic (at Marion GP Plus and Flinders Medical Centre). Through comparing the results of those who are given the intervention with those who are provided with the usual care, the project will enable researchers to observe if this service is associated with any significant improvements in patient's cardiovascular health, nutritional health and quality of life. It will also help researchers to understand if the service can be provided free of charge to patients at an acceptable cost to the government.

  • Assessing the feasibility of microdialysis to monitor vascular endothelial function in paediatric cardiac patients.

    The systemic inflammatory response syndrome (SIRS) characterises up to 80% of critical illness in children. The fundamental pathophysiological features underpinning SIRS are changes to the vascular endothelium, which include: 1) increased permeability to fluid and protein ("leaky") and, 2) increased activation ("sticky"). We recently published data which confirms a direct role for Eph/ephrin signalling in endothelial leakage both in a mouse gut ischaemia/reperfusion injury model of systemic inflammation and in vitro in TNF-induced vascular leakage in human umbilical venous endothelial cells. Based on this data we hypothesise that vascular endothelial function can be monitored in the intensive care unit by: (a) quantifying interstitial protein levels by microdialysis; measuring urinary albumin; and (c) measuring plasma levels of Eph/ephrins a s endothelial activation markers. Positive fluid balance is a poor prognostic sign, but without clear science, opinion on fluid management in the critically-ill patient remains divided. The aim of this project is to determine whether it is feasible to monitor the integrity of the vascular endothelium in critically-ill children by: a) using microdialysis to quantify interstitial protein levels; (b) measuring plasma levels of Eph/ephrin proteins as endothelial activation biomarkers and (c) monitoring urinary albumin (microalbuminuria). This preliminary feasibility study will be undertaken in post-operative paediatric cardiac surgical patients who are routinely admitted to a paediatric intensive care unit for cardiorespiratory support and monitoring. (The control patients undergo an elective cardiac catheterisation without the inflammatory stimulus of cardiopulmonary bypass.) Monitoring the permeability of the vascular endothelium may inform clinicians about the stage and severity of SIRS and assist in clinical decision-making regards fluid resuscitation and fluid balance management. This may improve supportive care in the ICU and result in reduced ventilator days, hospital length of stay and mortality in critically-ill children.

  • The respiratory effect of high-flow nasal oxygen in spontaneously breathing or apnoeic adults during general anaesthesia: a randomised controlled trial.

    The aim of this study is to define the effect that high-flow nasal oxygen has on ventilation and oxygenation in both apnoeic and spontaneously breathing participants during a 30minute period of general anaesthesia. The use of high-flow nasal oxygen is gaining popularity in anaesthesia due to its benefits on oxygenation and ventilation. The precise effect that high-flow nasal oxygen has on oxygen and carbon dioxide levels during general anaesthesia during spontaneous respiration or apnoea is yet to be defined. Therefore it is not clear which technique may be more suitable for particular patient subgroups. No previous studies have directly compared apnoeic and spontaneously breathing techniques using high-flow nasal oxygen during general anaesthesia. We hypothesise that carbon dioxide levels will be different between spontaneously breathing and apnoeic patients while using high-flow nasal oxygen during a 30minute period of general anaesthesia.

  • A Phase I, single centre, open label, escalating dose study to assess the safety, tolerability and immunogenicity of a therapeutic Human Papilloma Virus (HPV) DNA vaccine (AMV002) for HPV-associated head and neck cancer (HNC) after curative treatment.

    The aim of this study is to assess the safety and tolerability of ascending doses of the HPV DNA vaccine, and to see if it has any effect on the immune system. Who is it for? You may be eligible for this study if you have previously been diagnosed with HPV-associated oropharyngeal squamous cell carcinoma, and have completed curative treatment at least 12 weeks ago. Study details Participants in the study will receive three doses of the vaccine over the course of 12 weeks. The vaccine is given via injection just below the skin on the forearm(s) depending which dose of the vaccine you are given. Blood and urine samples will be taken at differnet timepoints to measure safety and efficacy of the vaccine. If we are able to show that the vaccine is safe and that it can induce an immune response, it could be used alone or in combination with other drugs to treat HPV-associated oropharyngeal squamous cell carcinoma.

  • Enhancing rehabilitation services and quality of life for Aboriginal Australians after brain injury: Healing Right Way

    This project involves implementation of the first culturally secure intervention package for Aboriginal survivors of brain impairment in Australia. Aboriginal Australians experience stroke up to three times more frequently than non-Aboriginal Australians, with traumatic brain injury due to assault occurring up to 21 times more often. Yet Aboriginal people remain under-represented in rehabilitation programs. The proposed project follows on from the team's Missing Voices study (NHMRC ID#1046228) that investigated the extent and impact of communication disorders after brain injury in Aboriginal people across Western Australia. Findings suggested significant changes in service delivery are warranted and wanted by Aboriginal brain injury survivors, their families and health service providers. The project aims to improve accessibility to rehabilitation services for all Aboriginal people post brain injury in Western Australia, improve health outcomes for this population, and establish an economic model for the above which will contribute to sustainability and planning of future services. Utilising a stepped wedge cluster randomised control design, the study will involve a complex intervention consisting of a) cultural security training for hospital staff tailored to the delivery of services to Aboriginal people with brain injury, b) use of culturally appropriate educational materials, and c) introduction of a specialist Aboriginal Brain Injury Coordinator to provide an in-reach service to participating hospitals as well as coordination of care and advocacy after hospital discharge. The service and costing models developed in the project will provide a basis for future planning of brain injury services as well as services for a variety of other conditions in WA and nationally.

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