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Maintaining the health of people with and without COVID-19 during isolation
Within 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.
This 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)
KER-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
The 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
This 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.
This 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
The 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.
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Comparing the user seal check and fit test between two types of N95 respirators - the Halyard N95 Particulate Filter Respirators and the ProShield® N-95 masks
We are currently facing a global pandemic of COVID-19, caused by the novel coronavirus, SARS-CoV-2. Frontline healthcare workers, especially anaesthetic staff, are particularly vulnerable because of frequent performance of aerosolized-generated procedures, such as bag-mask ventilation and intubation. N95 filtering facepieces are recommended for use by healthcare workers who come into contact with airborne or aerosolized infectious diseases. The protection that is provided by these devices is dependent on the filter’s efficiency and seal quality. According to the recommendations by Standards Australian (AS/NZS 1715-2009), healthcare workers should undergo regular fit testing. Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) recognises that fit testing is a valuable practice, which provides an opportunity to educate healthcare professionals. There are two types of N95 mask examinations — fit check and fit test. Fit checks, also known as the user seal checks, are fast and simple. It is performed by the wearer, who detects if a gross leak is present. Quantitative fit tests are more objective but require the use of specialised equipment by a trained operator. We would like to compare the fit testing results between the two types of N95 masks, namely the Halyard* N95 Particulate Filter Respirators and the ProShield® N-95 masks. There has been no published literature on the performance of these two types of masks. We would also like to compare the fit check with the fit testing results.
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Faster acting insulin aspart (FiASP) vs. insulin aspart using an advanced closed-loop system in type 1 diabetes: 12-month free living study
An advanced hybrid closed-loop (A-HCL) insulin delivery system has shown safety and high time-in-range in a previous study. The use of a faster acting insulin aspart (FiASP) with a more rapid onset and shorter duration of insulin action compared to standard insulin aspart could improve the responsiveness of a HCL system. Limited data is available regarding the use of FiASP in HCL systems, in particular in 'free-living' conditions. The aim is to compare glucose control using A-HCL delivering FiASP vs. insulin aspart in this observational study. All participants will undertake the study over a 12-month study duration in a 'free-living' protocol with A-HCL active. Participants are free to undergo their normal daily activities. There will be no specific interventions from the study team. Participants will be free to utilize insulin aspart or FiAsp with the pump based upon their personal preference. Outcome measures include CGM time-in-range and time in hyperglycaemic and hypoglycaemic ranges; safety and system performance outcomes.
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The iSCREEN study. Developing and evaluating a web-based portal to screen for Patient Reported Outcomes in cancer.
STUDY AIM This study will evaluate the feasibility of a web-based system of patient reported outcomes (PROs) assessment to identify and address unmet needs of cancer patients. WHO IS IT FOR? Patients: You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with any type of cancer for which you are receiving care from Flinders Medical Centre. Staff: You may be eligible to join this study if you are employed by Flinders Medical Centre and provide care for patients with cancer. STUDY DETAILS: Patients and staff participants in this study will provide feedback via a survey and interview or focus group regarding their experience using a web-based portal, called iScreen, to provide PRO data. Patients will be asked to engage in qualitative interviews and complete a survey at least 3 months after their first use of the system to indicate its acceptability. Data on feasibility, cost and safety will also be collected throughout the 16 month implementation period. It is hoped that results from this study will indicate that the iScreen system is feasible, safe and acceptable. It is anticipated that further funding will be sought in order to evaluate the effectiveness of the system and to ultimately roll out the system permanently within Flinders Medical Centre and perhaps across other health institutions.