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Fit testing of N95 filtering facepieces for anaesthetists and nurses treating COVID-19 patients
Expand descriptionStudy purpose: The purpose of this study is to evaluate the failure rate of this N95 FFP in a group of anaesthetists and anaesthesia nurses. At Austin Health, it is standard practice for the anaesthetist and anaesthesia nurse who are performing tracheal intubation on COVID19 patients to wear a N95 filtering facepiece (FFP). This protects the anaesthetist and nurse from small aerosolized particles and large droplets. To work effectively a N95 FFP must create a tight seal with the user’s face. However due to different facial characteristics, a tight seal may not be achieved with the brand of N95 FFP(BSN Medical Australia ProShield® N95 Medium and Small) that Austin Health is mandating. Fit testing is a rigorous process to ensure that the N95 FFP being used has the ability to form a tight seal. This process is mandatory in the USA and UK and is a requirement specified in Australian Standard AS/NZS 1715-2009. The fit testing method complies with the published protocol of OSHA (Occupational Safety and Health Administration, USA). Who is it for? This research involves fit testing for anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients. This is a small team of highly trained and skilled medical personnel, who are charged with providing this specialised clinical service for all patients at Austin Health who require tracheal intubation. Study details: At a convenient time that does not impact on clinical care commitments; the participant will attend the department for fit testing. As per standard Austin Health guidelines for PPE training, all participants will have already undergone extensive training and education in donning the N95 FFP. Using the BSN Medical ProShield®N95 FFP size that has been assigned to the participant, a fit test will be performed using internationally accepted fit testing protocol. The fit test will be conducted using the TSI Portacount 8038/8048 machine. Participants who do not pass the fit test will be re-educated on how to put on the FFP using the ‘real time’ mode on the TSI Portacount machine. This will allow the user to see how different adjustments to the N95 FFP can affect the seal in real time. The participants who do not pass fit testing will be offered a different sized BSN Medical ProShield®N95 FFP and retested. ' If the participant is unable to be fitted with either of the BSN Medical ProShield®N95 FFP, an alternative FFP or elastometric respirator will be provided. The testing will be conducted in the Department of Anaesthesia. The duration of tetsing will be approximately 15 minutes.
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A Phase Ib study of ZL-1102 in mild-to-moderate psoriasis patients
Expand descriptionThis is a Phase Ib study to investigate the safety, tolerability, efficacy and PK of ZL-1102 in subjects with mild-to-moderate chronic plaque psoriasis (CPP). The study consists of 2 Parts: Part A Part A is open-label. After a 30-day screening period, six (6) subjects with CPP will receive a single topical treatment with ZL-1102 to a suitable psoriatic plaque followed by a 1-week observation period for safety/tolerability. Part B Part B is a double-blind, two-arm comparison of ZL-1102 Gel vs. Vehicle (placebo only). Approximately 44 subjects with CPP will be randomized in a 1:1 ratio to receive study medication of ZL-1102 Gel or Vehicle.
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Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes; - A series of single participant trials.
Expand descriptionFoot ulcers are a common consequence of diabetes due to the development of peripheral neuropathy, peripheral vascular disease, limited joint mobility and foot deformity. Nearly 34% of persons with diabetes will develop a foot ulcer in their lifetime. This can lead to infection and amputation. Diabetes is the main reason for non-traumatic amputation. Reducing plantar pressures is considered a key factor for wound healing and prevention of ulcer recurrence. Footwear and insoles are an important treatment modality for off-loading these pressures. There is no existing, evidence-based recommendation for overall footwear design with all technical specifications to off-load the neuropathic diabetic foot. Hence this study will explore the design and modification features of footwear and insole that can reduce risk of neuropathic plantar forefoot ulceration in people with diabetes.
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Maintaining the health of people with and without COVID-19 during isolation
Expand descriptionWithin Sydney Local Health District (SLHD), stable patients with mild COVID-19 symptoms are being isolated at home or Special Health Accommodation (health hotels) and managed by the Royal Prince Alfred Virtual Hospital. In addition, people without COVID-19 requiring isolation, are being accommodated in health hotels under the care of SLHD staff and services. Both groups experience significant loss of normal routines, lack of exercise, heightened anxiety and reduced opportunities to eat their usual diet. The aim of this study is to evaluate the effects of a Health Package of exercise, anxiety management and nutritional advice on the physical and mental health of those isolated and whether such an intervention can enhance their experience of care. We hypothesise that the Health Package will benefit the participants in terms of physical and mental health and will enhance their experience of care during isolation.
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Evaluation of HXP124 in the treatment of a fungal nail infection, onychomycosis.
Expand descriptionThis is a multi-center, randomized, double-blind, placebo controlled study designed to assess the efficacy, safety and tolerability of HXP124 when administered topically to the great toenail of otherwise healthy participants with mild to moderate Onychomycosis. All participants will be instructed to apply HXP124 topical solution or vehicle to one target great toenail and any other infected toenails, following bathing and towel drying. Up to 132 eligible adult participants will be enrolled to one of three dosing cohorts and will be randomly assigned to receive treatment with either HXP124 topical solution or vehicle (at 3:1
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A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
Expand descriptionKER-050 is being developed by Keros Therapeutics Australia Pty Ltd as a potential treatment for anaemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS). KER-050 is a therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the TGF-ß family of proteins to promote hematopoiesis. The main purpose of this study is to test how safe the study drug is and how well the body can handle taking it (called tolerability). The study will also look at whether the study drug works (called efficacy), the amount of the study drug in the blood (called pharmacokinetics) and how the study drug affects the body (called pharmacodynamics).
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The assessment of experimental artificial intelligence (AI) algorithms for the diagnosis of skin tumours against human performance
Expand descriptionThe purpose of this study is to compare various artificial intelligence algorithms used for the diagnosis and management of skin tumours against clinician diagnosis and management. Who is it for? You may be eligible for this study if you are an adult and either have previously had taken whole body photographs or have been assessed as requiring a biopsy of a skin lesion by your attending specialist.. Study details Following your routine examination by your attending specialist you will be examined by two other doctors and have images taken of some of your skin lesions by a mobile phone. None of this will effect your management and any tests performed will only be related to your attending specialist's requests. It is hoped that this study will help determine if artificial intelligence can accurately be used for the diagnosis and management of skin tumours.
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Microvascular and Macrovascular Disease in Snoring and Obstructive Sleep Apnoea
Expand descriptionThis study examines the hypothesis that the proposed link between obstructive sleep apnea (OSA) and stroke is mediated through abnormalities of: 1) small blood vessels in the brain and 2) the main large artery (carotid) supplying blood to the brain. Retinal blood vessel size (mirrors the cerebral circulation) can be measured via retinal photographs while carotid artery wall thickness (intima media thickness – IMT) can be measured using ultrasound. Patients attending a sleep clinic were recruited and, after retinal photography and ultrasound examination, underwent an overnight sleep study to assess sleep disordered breathing severity. A sub-group then used continuous positive airway pressure (CPAP) at night with repeat vascular examinations at 12 months.
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An interventional study to evaluate the effect and safety of PRN473 topical on skin reactions of otherwise healthy participants with allergies to common allergens.
Expand descriptionThis research project is being conducted to look at the effect and safety of PRN473 topical on skin reactions of otherwise healthy participants with allergies to 2 common allergens - when PRN473 topical is applied to the skin both prior to and following a skin prick with 2 of the allergens.
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Mindful Parenting and Child Emotional Well-being
Expand descriptionThe study is a pilot randomised controlled trial of a mindful parenting program for community-recruited parents who have concerns about their child’s emotional well-being. The study is being conducted to investigate (1) the feasibility of the program, as a way to improve child emotional well-being by assisting parents to manage their own emotions and anxiety-related beliefs and behaviours; and (2) the acceptability of the program to parents.