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Study Of Neck Injuries In Children (SONIC)
This study aims to externally validate existing international adult and paediatric clinical decision rules (CDRs) designed to guide emergency clinician imaging decisions in a large cohort of Australian and New Zealand children presenting with suspected cervical spine injury. It aims to assess (i) their accuracy in detecting cervical spine injury (CSI) (ii) their ability to accurately identify children who do not need cervical spine imaging and (iii) their cost-effectiveness. An exploratory analysis of the data will also be conducted to determine whether a new paediatric CDR can be derived and validated to improve accurate detection of CSI and/or risk stratification of children with suspected CSI into those who do and do not require imaging. This study is expected to identify the most child appropriate CDR. The epidemiology and outcomes of CSI in this cohort of children will also be described.
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Tablet-based documentation during neonatal resuscitation
In newborns requiring resuscitation in the delivery room, we will investigate if an application (app)-based electronic documentation using an iPad (Tablet) is more accurate than conventional paper-based documentation for recording neonatal resuscitation interventions, compared with video recording as the gold standard. We hypothesise that app-based documentation will be a more accurate method for recording events during neonatal resuscitation when compared to paper-based recording, regarding time error, numerical error, omission error and commission error. Three types of documentation records will be available after each resuscitation: Video recording, Tablet report, and paper report. The Tablet and paper report will be recorded simultaneously and independently by two researchers. Data recorded on the tablet and paper form will be compared with the timing of events noted from the video recording. Primary outcomes will be to analyse errors regarding precision and accuracy of events and intervention times (time discrepancy): time to face-mask application, time to start and stop positive pressure ventilation (PPV), time to start and stop chest compressions, time of endotracheal intubation attempts and when the concentration of supplemental oxygen altered. Secondary outcomes are to describe types of documentation errors in the following parameters: SpO2 (oxygen saturation,(%)); concentration of supplemental oxygen (%) and heart rate (beats per minute) at 3, 5 and 10 minutes after birth .
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Does fibrinolytic capacity influence stroke outcomes?
Stroke is commonly caused by blockage of arteries which carry blood and oxygen to the brain. Thrombolysis, a process of unblocking or recanalizing blood vessels with an injection of tissue plasminogen activator (tPA), has become a standard of care in acute stroke treatment however, only ~40% patients will respond to treatment. This study looks at the variation in blood protein biomarkers involved in thrombolysis including plasmin levels and its relation to the recanalization effect. Adult patients arriving at The Alfred with acute ischemic stroke will be recruited for the study. Informed consent will be obtained from the patient or from the patient’s Medical Treatment Decision Maker (MTDM). Consent will be gained for gaining research blood samples and to use clinical information contained in the hospital electronic patient record for comparative analysis. We aim to recruit at least 40 patients in total. One blood sample, ~10 mL (or 2 teaspoons), will be collected from patients, prior to thrombolysis treatment or on arrival, another one at 1 or 2 hours from the time of thrombolysis or from the time of arrival, then again at 24 hours and 72 hours. Plasmin levels and other immunological parameters will be analysed in these samples, and also in patient’s routine clinical bloods, at the Australian Centre of Blood Diseases on the Alfred campus. The results of this study are expected to expand our understanding on the mechanisms of thrombolysis and potentially improve future stroke therapeutics.
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Automatic detection of abnormal heart sounds in a paediatric cardiac population using a wireless electronic stethoscope
The primary objective of this study is to train an algorithm to accurately classify abnormal paediatric heart sounds using a digital stethoscope. Our hypothesis is that once trained, a digital stethoscope can identify abnormal paediatric heart sounds with similar accuracy to an experienced paediatric cardiologist using a standard stethoscope.
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Muscle strength, gait analysis and function following three different types of total hip replacements
Hip replacement is the most commonly recommended intervention in Australia for people with severe hip arthritis, pain or fractures of hip. There are 3 different surgical approaches to replace the hip & based on the side of the hip is cut . These are from the front (anterior), back (posterior) & side (lateral). Although all 3 approaches have been proven to improve pain & function after surgery, it is still not know which approach has better muscle strength & better performance results in functional tasks like walking, stair , sit to stand etc after the surgery. Additionally some studies still report abnormalities in these functional activities regardless of which approach is used. Currently the evidence suggests the approach based on surgeon's experience & comfort. The proposed research will study patient’s muscle strength and mobility outcomes at 5 timepoints including - before surgery and after surgery at 3, 6, 12, & 24 months. The strength testing for all hip and knee muscle groups along with performance of functional tasks like walking , sit to stand , step up and down etc will be analysed using a 3D gait analysis setup. The study will also compare these outcomes between the 3 different hip replacement approaches at different mentioned at these timepoints. As a secondary outcome measure the study will compare the results of strength and functional assessment with patient reported outcome measures routinely collected as a part of normal care at the same timepoints. The results of the study will assist future clinical decisions before and after hip replacement. It may help optimising the rehabilitation and management and thus the economic costs of patients undergoing hip replacement by informing the clinicians better about muscle strength changes and its affect on functional performance at different stages following hip replacement.
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Acute Renal effects of Angiotensin II Management In Shock (ARAMIS-2)
Angiotensin II is an endogenous peptide that causes potent vasoconstriction and promotes the release of aldosterone from the zona granulosa of the adrenal gland. The ATHOS-3 study demonstrated that continuous infusion of angiotensin II could effectively augment mean arterial pressure compared to placebo in patients with catecholamine refractory shock. Secondary analyses suggested that angiotensin II may be of particular benefit in patients with acute kidney injury, especially in those with a high ratio of angiotensin I to II. This randomised controlled trial will examine the renal outcomes of critically ill patients with vasodilatory shock who receive angiotensin II compared to noradrenaline. Patients who meet all of the inclusion criteria and none of the exclusion criteria will receive a continuous intravenous infusion of angiotensin II or noradrenaline until resolution of their shock. The renal outcomes and survival of patients receiving angiotensin II will be compared to those of control patients who received noradrenaline.
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Examining the role of faecal microbiota transplantation (FMT) to induce remission in resistant ulcerative proctitis (UP): A pilot study
This single-centre single arm prospective pilot clinical study aims to demonstrate the safety of donor FMT in patients with UP resistant to 5-ASA therapy. Participants who meet study inclusion criteria and provide informed consent will receive an induction course of 6 single donor FMT enemas over 8 weeks in addition to their standard therapy. All participants will receive a 1-week course of oral vancomycin pre-conditioning prior to FMT induction. Flexible sigmoidoscopy, 3-day diet diary, stool and blood panels will be performed prior to and upon completion of FMT enema induction course. This study will primarily assess the safety of FMT enemas in patients with UP. Our study will also assess the impact of FMT induction therapy on UP disease activity utilising clinical, endoscopic, histological and patient reported outcome measures. Changes in colonic microbial composition, diversity and function post FMT therapy will be analysed.
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The Western Australian COVID-19 Immunity Collaborative (WACIC) Biobank
The WA COVID-19 Immunity Collaborative (WACIC) Biobank will establish a biobank of high-quality samples from well characterised cohorts of convalescent COVID-19 cases, their close contacts, SARS-CoV-2-negative controls, immunised people, and other populations,, to support future basic science, translational and applied research, and development, optimisation and validation of diagnostic laboratory assays relevant to assessment of SARS-CoV-2 immunity.
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Evaluation of a Digital Health Promotion Resource for Children about Ergonomic Ways of Using Information and Communication Technologies (ICT)
The purpose of this study is to evaluate the effectiveness of a digital health promotion resource in promoting ergonomic ways of using technology to children aged 12 to 13 years in Australia. Specifically, it aims to determine if the resource can be effective in improving children's knowledge, attitude, subjective norms, perceived behavioural control, and behaviours relating to ergonomic use of technology. A cluster group, two-arm trial will be conducted to determine the effectiveness of the resource. Study hypothesis: The use of a digital health promotion resource can improve children's ergonomic behaviours when using technologies.
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An immune-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab, and Dexamethasone (Iber-IsaDex) – the IBIS study
The purpose of this study is to determine whether the combination of Iberdomide, Isatuximab and Dexamethasone combined improves response to treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, you have been diagnosed with multiple myeloma and you have demonstrated disease progression within 12 months of commencing first-line therapy. Study Details Eligible participants will receive Iberdomide, Isatuximab and Dexamethasone. Treatment (each cycle is 28 days) will be given until disease progression, unacceptable toxicity, or withdrawal of consent. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of this combination of treatment of multiple myeloma patients early in the course of their disease.