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A safety and efficacy trial of the SureflO2™ oxygen mask which incorporates a visual gas flow indicator into a standard oxygen mask.
This research aims to demonstrate safe function of SureflO2 device and efficacy of the device in alerting staff to adequacy of oxygen flow through a standard face mask. The SureflO2 indicator is incorporated into a standard oxygen mask and reveals a bright orange indicator to carers when oxygen flow is present which changes to white when oxygen flow is inadequate. The developers of the SureflO2 indicator contend that this extra alert as to absence of adequate oxygen flow will prompt healthcare workers to carry out further checks to the oxygen provision system when oxygen flow is inadequate.
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Transfusion of fresh platelets or frozen alternatives in patients with severe thrombocytopenia
The purpose of this study is to evaluate the potential for different blood transfusion strategies to assist with the treatment of thrombocytopenia that has occurred as a result of blood-related cancers, chemotherapy or bone marrow failure. Who is it for? This study is for adults with either a blood related cancer or has been diagnosed with aplastic anaemia and who has low pletelets which would usually be treated with platelet transfusion. Study details Participants will take part in one of two treatment options: 1. The transfusion of cryoprecipitate (a frozen product derived from healthy blood donors), followed by a platelet transfusion, or 2. A frozen platelet transfusion In each case, participants will receive these transfusions in lieu of an expected platelet transfusion, but will be able to continue on with all other therapies. Blood tests will be measured before each transfusion and for up to two days afterwards. Blood tests will be repeated if participants require additional regular platelet transfusions as part of their standard of care. This study is non-randomised. Potential participants will be able to choose a strategy provided that arm remains open. This study will provide information on the effect of these alternative transfusion strategies in this patient group. It is hoped that this may provide a basis for treatment in regions where fresh platelets are not available to treat or reduce the risk of bleeding and enhance our understanding of how this might be best measured.
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The effectiveness and safety of a herbal formulation for the management of osteoarthritis of the knee
This study is a 12-week, randomised, double-blind, placebo controlled, clinical trial to assess the effectiveness and safety of a novel herbal formulation, consisting of Curcuma longa (Turmeric), Boswellia serrata (Indian Frankincense) and Zingiber officinale (Ginger) for the management of osteoarthritis of the knee. The study will assess if taking this formulation helps reduce knee pain and improves function and wellbeing from osteoarthritis of the knee. It is expected that the herbal formulation will reduce pain from osteoarthritis of the knee over the course of 12 weeks compared to placebo medication.
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Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KER-047 Administered to Healthy Male Volunteers and Postmenopausal Female Volunteers
KER-047 is being developed by Keros Therapeutics Australia Pty Ltd as a potential treatment for Fibrodysplasia ossificans progressive (FOP). FOP is a rare genetic condition where the muscles, tendons and ligaments of the body slowly turn into bone. There are no approved treatments for FOP; This study aims to recruit healthy volunteers to determine the safety and pharmacokinetics of single and multiple dose of KER-047.
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Randomized, Double-Blind, Placebo-Controlled, Two-Part, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of KER-050 Administered to Healthy, Postmenopausal Women.
KER-050 is a muscle anabolic agent proposed to increase muscle mass and strength and is in development for the treatment of Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Duchenne muscular dystrophy is the most common form of muscular dystrophy and is estimated to affect 1 in every 3500 males globally. FSHD is one of the most prevalent adult forms of muscular dystrophy and can also affect children. The study hypothesis is that Ker-050 is safe to administer to participants and provides an indication that has an effect on the growth of adipose tissue and bone.
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Could "Gazefinder" Eye-Tracking Technology Support the Earlier Identification and Diagnosis of Autism in Young Children?
This is a clinical trial of the accuracy of “Gazefinder” eye-tracking technology to support the identification and diagnosis of autism in young children aged 2- to 4-years, funded by JVCKENWOOD Corporation, Japan (developers and manufacturers of “Gazefinder”) and run by researchers at two Australian sites (Melbourne, Perth). Children in two groups – those with a diagnosis of autism and those with no developmental difficulties or close family members with autism – will view the 2½-minute animation, with preferential attention to more vs. less ‘social’ Regions of Interest (ROIs) automatically determined by Gazefinder software. The hypothesis is that “Gazefinder” will accurately differentiate children with and without autism on the basis of gaze patterns whilst watching the animation sequence.
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Does group physiotherapy improve outcomes for women with chronic pelvic pain?
Female chronic pelvic pain is a debilitating condition that significantly impacts women’s’ health and quality of life. WCH Physiotherapy referrals for chronic pelvic pain are rising in an unsustainable way for the current individualised care approach. A revised, coordinated approach to care is required, in response to growing demand. This project plans to determine if outcomes are improved when women with chronic pelvic pain have group education sessions included in care pathways. There will be 3 treatment arms: treatment arm 1 – individualised care; treatment arm 2 - an introductory group education session followed by individual care; treatment arm 3 – group education, individual care and an 8 week group therapy program. Group sessions will provide information about chronic pain, introduce relevant therapeutic concepts, promote treatment adherence and maintain motivation through regular contact and message reinforcement. Pelvic pain scores and pain impact are the primary outcomes assessed. Other secondary outcomes include patient satisfaction surveys, time off work/school, use of medications to manage pain, physical activity engagement, and time to discharge from physiotherapy.
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Assessing hypercoagulability after total hip arthroplasty
This retrospective observational study will be conducted by the Department of anaesthesia. Total hip arthroplasty (THA) can result in a significant surgical stress, which in turn can trigger a hypercoagulable state. These patients are at significant risk for the development of thromboembolic complications. Despite venous thromboembolism (VTE) chemoprophylaxis being administered to all patients who undergo THA at Austin Health, VTE remains a common cause of preventable death and a well recognised complication after total THA. Despite combining extended VTE chemoprophylaxis with early mobilization, compression stockings and intermittent pneumatic compression devices, many patients at Austin Health who undergo THA remain at high risk for VTE because of advanced age, extensive surgical procedures, and greater medical comorbidities. Furthermore, a large multicenter study showed that most VTE’s occur due to prophylaxis failure rather than failure to provide prophylaxis. Although several agents have been shown to reduce the risk of thromboembolic disease, there is no clear preference for thromboembolic chemoprophylaxis for patients undergoing elective total hip arthroplasty. Thromboelastography (TEG) measures whole blood coagulation and fibrinolysis providing a global view of the interaction between all components of clot formation, retraction and lysis. TEG is one of the most sensitive methods currently available for the assessment of a perioperative hypercoagulable state with numerous reports in surgical patients demonstrating an association between TEG measured variables, anaesthetic techniques, and postoperative thrombotic events. Studies have demonstrated that major joint arthroplasty is associated with activation of coagulation (hypercoagulable state) as measured by TEG, however there have been few comparisons of the effects of general and regional anaesthesia techniques on coagulation. Therefore, we propose to perform a retrospective audit of patients who underwent THA at Austin Health, who received a TEG as part of routine care. The primary aims of this retrospective review are to determine if VTE chemoprophylaxis with low molecular weight heparin prevents hypercoagulability after THA (as assessed by TEG) and if general or spinal anaesthesia had similar effects on perioperative coagulability as measured by TEG. Notably, there will be NO CLINICAL or patient contact at any point. All data collected has already been collected as part of routine clinical care according to standard anaesthesia and surgical processes. No new data will be collected.
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Using routine pulse oximetry to estimate severity of lung problems in very premature infants.
The project aims to investigate the longitudinal trajectory of ventilation-perfusion mismatch measured using the Lockwood method in preterm infants less than 32 weeks of age at the end of first week, first month and 36 weeks postmenstrual age. This will be novel non-invasive data which may help to identify those infants at risk of developing bronchopulmonary dysplasia.
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Non-invasive assessment of pulmonary shunt and ventilation-perfusion status in newborn infants during minimally invasive surfactant therapy
We aim to utilise a novel method for non-invasively estimating the ventilation-perfusion mismatch, a measure of the severity of lung disease of preterm babies with respiratory distress syndrome. The Lockwood algorithm uses routinely measure oxygen saturation levels paired with the amount of oxygen needed in order to calculate how much the oxygen dissociation curve has been "shifted" to provide a measure of the right-left shunt. This study aims to use measures of oxygen levels before and after surfactant treatment and the corresponding ventilation-perfusion levels in order to gauge response of the infant's lungs to surfactant treatment. The hypothesis is that the Lockwood measure will provide robust measure of ventilation-perfusion status in preterm infants with respiratory distress,