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COVID-19 prophylaxis with hydroxychloroquine in Front-line Health and Allied-Health Care Workers: The COVID-SHIELD Trial
Expand descriptionAs the world continues to fight the global pandemic of COVID-19, health resources in many Australian hospitals are expected to reach capacity and become overwhelmed. COVID-19 which is caused by the newly identified virus SARS-CoV-2, can result in a severe respiratory illness requiring ventilator support and sometimes lead to death. Front-line health care workers are at an increased risk of becoming infected due to repeated exposure in their occupational role in caring for patients with COVID-19. There is an urgent need for better drug options for COVID-19 as currently there are no known effective therapies above delivering best supportive hospital intensive care. Hydroxychloroquine is a well-known well-tolerated immune-modulatory drug widely used in rheumatological conditions. It has anti-malarial properties but has also exhibited in vitro anti-viral activity against SARS-CoV-2. It is currently in clinical trials as both a treatment option and as prophylaxis (prevention) for COVID-19. This large Australian multi-centre randomised double-blind placebo-controlled study aims to evaluate the efficacy of hydroxychloroquine as prophylaxis against COVID-19 in high-risk health care workers. It will enroll 2250 participants who will be randomised in a 1:1 ratio to take hydroxychloroquine orally daily or placebo for 4 months. The primary endpoint will be incidence of COVID-19.
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A reusable personalised ventilation hood: A phase 1 safety study of a new device (McMonty) in patients with suspected or confirmed COVID-19.
Expand descriptionSince December 2019, the coronavirus disease (COVID-19) pandemic has affected millions of people worldwide. Modern hospital negative pressure rooms have high flow rates and negative pressure to prevent the spread of TB, measles etc. Nevertheless, such negative pressure rooms do not prevent droplet spread of the infectious disease to personnel within the room. Western Health and The University of Melbourne conceived and developed a personalised ventilation hood device (the McMonty) to provide a physical barrier to droplet and aerosol spread. The McMonty hood will provide health care workers with protection from droplets and aerosols during routine care and the administration of specialised oxygen therapies (including high flow oxygen and non-invasive ventilation), and during the conduct of aerosol generating procedures.The hood has a plastic barrier (to prevent droplet spread) and a ventilation system to reduce aerosol spread from a COVID-19 or other infectious patient. The hood relies upon air being drawn from the front near the patient’s legs etc. up to the rear, i.e. away from the healthcare worker who is principally at the front/sides of the patient. The air passes through the fan and on through a High Efficiency Particulate Air (HEPA) filter, thereafter returning to the hospital ward/ICU (similar to that for a patient’s mechanical ICU ventilator). The entire McMonty personal isolation unit is designed to be reusable in order to ensure security of supply during the COVID-19 pandemic. The SARS CoV-2 virus is susceptible, amongst other disinfection treatments to heat (70°C for 10 minutes), and soap/detergent (exposure to soap for 15 minutes). The hood can be thermally disinfected in a standard industrial washing machine (initial studies on the hood prototype have been successful) followed by drying. The remainder (frame, hoops) of the McMonty hood can be readily cleaned down with alcohol wipes. We aim to evaluate the safety of the portable McMonty hood in a clinical setting on use of 20 patients.
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The effect of an acute Methylphenidate (Ritalin®) dose on cognition, behaviour and driving performance in healthy volunteers
Expand descriptionThis research thus aims to address these gaps in knowledge and practice by characterising how acute doses of Methylphenidate (Ritalin) affect ocular parameters and the visual attentional system. Furthermore, we seek to examine how these changes might be indexed to predict impairment in performance during a neurocognitive and driving task.
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The effects of grafting with dental biomaterials on the tooth-supporting tissues surrounding lower second molars following removal of impacted third molars in healthy young adults
Expand descriptionImpacted mandibular third molars can cause extensive damage to the bone and supporting structures (known as the periodontal attachment) surrounding the adjacent second molar. This clinical trial is conducting research on the benefits of ridge preservation, also known as socket grafting, carried out at the time of extraction of an impacted mandibular third molar provides any additional periodontal attachment. In many cases after a tooth extraction, soft tissue and bone grows into the site to facilitate healing and the formation of periodontal tissue to support the adjacent second molar. However, in some cases the healing does not proceed as desired and there are inadequate amounts of periodontal attachment. This means that the bone and tissue support around the adjacent molar is compromised and the tooth has an increased risk of being lost prematurely. Bone substitute materials have been widely used for socket grafting and periodontal regenerate procedures for more than 15 years. Geistlich Bio-Oss Collagen® supports the body’s own bone regenerative processes extremely effectively and help guide hard tissue formation following tooth extraction. Bio-Oss Collagen® consist of 90% Bio-Oss® with 10% porcine collagen. Bio-Oss® is derived from the bone of an Australian bovine herd around Melbourne. The bones are transported to Switzerland for treatment either by heat, chemicals or both to remove all organic components. Porcine collagen is added as part of this process to provide some dimensional stability. Bio-Oss Collagen® is made under a strictly controlled manufacturing process. Due to the great similarity to human tissue, these materials are optimally suited and widely used clinically to promote new bone formation and tissue healing in the human body. Current treatment following an extraction involves healing by blood clot with or without placement of sutures to stabilize the blood clot. Recent evidence suggests that the application of Bio-Oss Collagen® might help assist the healing process to reform the desired levels of bone, gum and periodontal supporting tissue. We are interested in whether socket grafting with Bio-Oss Collagen® will help bone, gum and periodontal tissue formation around the adjacent, remaining tooth compared to standard extraction protocols. This will result in a greater amount of periodontal tissue supporting the adjacent tooth and reduce the risk of premature tooth loss. We are particularly interested in healthy 18 – 35 years old subjects.
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Prehabilitation to Improve outcomes afteR Autologous sTem cEll transplantation (PIRATE) – A randomised controlled trial
Expand descriptionThe purpose of this study is to see if providing rehabilitation (prehabilitation) before stem cell transplant builds physical strength and fitness. Who is it for? You may be eligible for this study if you are aged 18 of older and are on the waitlist for autologous stem cell transplant. Study details Participants will be randomised by chance (like flipping a coin) into two groups. One group will receive a physiotherapy assessment and standardised exercise advice in addition to standard care. The other group will attend 2 x 60 minute exercise classes per week and receive fortnightly phone calls comprising nutrition education for up to 8 weeks before their transplant. As part of this study, participants will also have a fitness and nutrition assessment, answer questionnaires, provide blood samples and consent to medical records being accessed. It is hoped this research will demonstrate that prehabilitation builds physical strength and fitness, and this will to prevent problems after stem cell transplant, leading to faster recovery from treatment.
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Australian and New Zealand Pulmonary Hypertension Patient Registry
Expand descriptionThe primary objective of the Australian and New Zealand Pulmonary Hypertension Patient Registry is to capture all prevalent and incident data on adult and paediatric patients with PH particularly PAH and CTEPH subgroups, presenting to centres of excellence to assist in future service planning, resource allocation and to promote equitable and timely access to life saving therapies and to audit standards of care across Australia and New Zealand. The secondary purpose of the PH registry is to formally characterise this patient population. The study aims to document the history of PH in addition to the current diagnostic and treatment trends in Australia and New Zealand Further, Australian data has previously shown a significant delay in the time to diagnosis. The ANZ Pulmonary Hypertension Patient Registry may serve as a tool to advocate for standardisation in access to skilled clinical care. Importantly it will allow pulmonary hypertension centres in Australia to compare their performance with national (aggregated) benchmarks.
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Study evaluating Front-line health care workers serial blood COVID-19 antibody results in relation to symptom presentation
Expand descriptionThe study will review SARS-CoV-2 IgG, IgA and IgM antibodies in front-line health care workers every month for six months in comparison to symptom presentation.
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A Facebook delivered physical activity focused group lifestyle intervention for older adults during the COVID-19 pandemic
Expand descriptionAs countries are affect by coronavirus disease 2019 (COVID-19), the impact of social isolation and the uncertainty of an epidemic on individuals mental health is concerning. Self-isolation will disproportionately affect older people, particularly those who are living alone with limited opportunities for social contact. Social isolation and loneliness are strongly associated with poor psychological wellbeing and physical health. Promoting physical activity and social connectedness during this time is an evidence-based strategy that can potentially help alleviate symptoms of psychological distress and improve quality of life in older adults. Online technologies provide a novel method of reaching people. This study will recruit 20 older adults (60 years and over) to a 6 week group based physical activity intervention delivered online through a private Facebook group. The group will allow members to receive information and contribute to weekly conversations on pre-specified topics related to physical activity, including goal setting, balance and strength straining. The purpose of the group is to facilitate social support and provide participants with a platform to exchange personal experiences including barriers and facilitators to commencing a physical activity program at home.
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The Carer's Way Ahead: Helping Families Manage with Challenging Behaviour following Traumatic Brain Injury
Expand descriptionManaging challenging behaviour in the home is very difficult for families dealing with an adult relative with a brain injury. It is often difficult to access specialist support, and assistance from a psychologist can be costly and represent a barrier to accessing useful treatment, particularly for those with geographical limitations. In light of this, we recently developed ‘The Carers' Way Ahead’, an internet based program specifically tailored for Australian carers managing adult family members with traumatic brain injury. It is a step by step program, training carers how to implement an treatment approaches to behaviour management. We aim to determine if the program is effective in: 1. Reducing the frequency and intensity of challenging behaviours in the family member with brain injury 2. Improving the well-being of carers compared to families who are not receiving clinical input, including greater social problem solving, decreased strain, increased mood, improved satisfaction with life and improved family relations 3. Yielding health benefits in terms of quality of life and economic benefit Participants will complete a baseline assessment where they will be asked to fill out various questionnaires. They will then be randomly allocated to receive ‘immediate treatment’ or ‘deferred treatment’ (i.e., waitlist control group). Treatment will involve the family member completing 'The Carer's Way Ahead' program. These include two psychoeducational modules, four modules addressing specific challenging behaviours (i.e., apathy, disinhibition, social difficulties, and aggression) and a self-care module to assist carers manage stress, low mood and other emotional states. Participants will complete these modules over a six to eight week period with support by a clinical psychologist (accessed remotely). They will then complete a post-assessment In the waitlist/deferred condition, participants will be asked to wait 10 weeks before gaining access to the online platform. They will attend a second assessment prior to commencement.
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A phase I/II single arm study of combination Belantamab Mafodotin, Carfilzomib, Dexamethasone in patients with early relapsed multiple myeloma
Expand descriptionThe study aims to determine the efficacy of combination therapy with Carfilzomib and Dexamethasone and Belantamab mafodotin (BelaMaf-Kd) for patients with relapsed refractory multiple myeloma. Belantamab mafodotin is a new drug which has not been approved for use by the Therapeutic Goods Administration and so this combination is considered an experimental treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, and have received between 1 to 3 prior lines of therapy for multiple myeloma but have not undergone allogeneic stem cell transplantation. Study Details Eligible participants will receive 6 cycles of combination BelaMafKd with treatment given over a 28 day cycle as tolerated. Belantamab mafodotin and Carfilzomib will be delivered by IV infusion on days 1 and 8 and days 1, 8 and 15 respectively. Dexamethasone will be given orally weekly. Participants will be required to have blood samples taken and medical reviews (including ophthalmic examination) at the beginning of each cycle. An ultrasound test of cardiac function will be performed at screening and within 2 weeks of completion of cycle 6. A bone marrow biopsy will be performed at screening, at cycle 6 and to confirm a complete response or disease progression. These assessments will enable researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. Study treatments will be halted if participants show disease progression, unacceptable toxicity, or upon withdrawal of consent. A final medical assessment and ophthalmic exam will be performed at end of treatment, with follow up to continue every 12 weeks until one year after the final cycle of treatment. Follow up assessments will continue every 12 weeks until one year after the final cycle of treatment. It is hoped that the findings of this trial will establish the benefits of Belantamab mafodotin in combination with Carfilzomib and Dexamethasone for the treatment of patients with early relapsed multiple myeloma.