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Can intravenous high dose zinc improve clinical outcomes in patients with COVID-19 infection?
Expand descriptionAn outbreak of a new virus called novel coronavirus (COVID-19 or 2019-CoV) infection has posed significant threats to the health of people worldwide and the global economy. There are no vaccines for this virus, and there is no specific treatment for people infected with the virus. In severe cases, COVID-19 virus can spread to the lungs and cause extreme difficulty with their breathing. We call this acute respiratory distress syndrome (ARDS). Zinc is a naturally occurring essential metal required for the normal function of the body. Numerous studies have been done showing the potential of zinc to inhibit viral infections (including the common cold) in clinical trials and experiments. It is our study hypothesis that zinc will reduce the severity of COVID-19 infection and improve the clinical outcomes of patients with COVID-19 infection. Therefore, we plan to perform a study to test whether zinc (given as Zn chloride) is effective and safe in subjects with COVID-19 infection and to work out whether giving zinc to patients can make them get better quicker.
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Effects of time restricted eating compared to diet modification in people with type 2 diabetes
Expand descriptionThe proposed study will be the first to compare the benefits of TRE for improving glycaemic control compared with standard dietetic advice, in individuals with T2D in a chronic (6 months) randomised controlled trial. Evidence-based findings for the improvement of blood glucose control and longer term outcomes need to be developed in order for this information to be available for the design of larger studies, prior to being incorporated into current dietary guidelines and inform best practice. The combination of physiological and psychosocial measures will allow us to demonstrate the efficacy and safety of using TRE in a real-world setting to reduce the psychological burden of dietary modifications, whilst improving glycaemic control, for individuals with type 2 diabetes.
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Nanofat: a novel therapeutic approach for vocal cord paralysis
Expand descriptionGlottic insufficiency can have negative effects on patient quality of life. This condition mainly affects the quality and strength of voice. Glottic insufficiency can be due to vocal cord paralysis. Autologous fat injection is a well-known technique used to manage paralysis, and has been utilised for many years as a valid technique. A new method of processing fat has been described whereby harvested fat can be processed and filtered quickly and efficiently, leaving behind an easily injectable liquid with a high number of stem cells, without requiring long processing times and highly specialised equipment. It is potentially a modern refinement and improvement of a long-standing technique. The proposed benefit of nanofat supplementation is that the volume of the injected cord is maintained for longer compared to fat grafting alone. due to increased adipocyte survival. Patients will be recruited to undergo nanofat injection for vocal fold paralysis. Prior to the surgery, patients will fill out questionnaires and have their vocal cords examined via stroboscopy and undergo objective acoustic and aerodynamic assessment. They will then undergo treatment with follow up assessments occurring at multiple timepoints thereafter, as described in our protocol. The effect of nanofat treatment will be compared with standard of care treatment.
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Nanofat: a novel therapeutic approach for vocal cord scar
Expand descriptionGlottic insufficiency can have negative effects on patient quality of life. This condition mainly affects the quality and strength of voice. Glottic insufficiency can be due to vocal fold scar. Autologous fat and steroid injections have been described to manage vocal fold scar, and have been utilised for many years as a valid technique. A new method of processing fat has been described whereby harvested fat can be processed and filtered quickly and efficiently, leaving behind an easily injectable liquid with a high number of stem cells, without requiring long processing times and highly specialised equipment. It is potentially a modern refinement and improvement of a long-standing technique. The proposed benefit of nanofat supplementation is that the volume of the injected cord is maintained for longer compared to fat grafting alone. due to increased adipocyte survival. It also has anti-fibrotic effects that are favourable in the treatment of vocal fold scar. Patients will be recruited to undergo nanofat injection for both vocal fold scar. Prior to the surgery, patients will fill out questionnaires and have their vocal cords examined via stroboscopy and undergo objective acoustic and aerodynamic assessment. They will then undergo treatment with follow up assessments occurring at multiple timepoints thereafter, as described in our protocol. The effect of nanofat injection will be compared with steroid injections.
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Maternal and neonatal outcomes from women infected with SARS-COV2 (COVID-19) during pregnancy
Expand descriptionThis is a national study of women with confirmed COVID-19 in pregnancy in Australia. The study will collect information about all pregnant women who are confirmed to have SARS- CoV2 infection. The information will be analysed on a continuous basis to inform ongoing guidance for women and maternity staff as we respond to the pandemic. Specifically, the study will describe incidence, management and outcomes of COVID-19 in pregnancy and identify factors associated with better outcomes for women and their babies. Anonymous information will be collected by clinicians or clinical researchers who are based in maternity units in the Australia. Data collectors will have been sent a live link to a RedCap database to allow them to notify cases and complete an anonymous data collection form. SARs-COV-2 is a new strain of coronavirus that has not previously been identified in humans. which causes a respiratory illness, but it is not known what impact it will have on pregnant women and their babies. In order to investigate risk factors, management and outcomes, the researchers plan to extend data collection to include data on all pregnant women with SARS-CoV-2. The aim of this study is to learn more about the effects of SARS-COV-2 and its treatment on pregnant women and their babies. Pregnant women, are known to be at increased risk of developing more serious problems from respiratory viral infections, as was shown in the MERs, SARS and H1N1 'swine flu' epidemics. But little is currently known about this virus. This study will collect and report contemporary data to inform ongoing pregnancy and neonatal management in order to optimise modifiable outcomes.
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Expressive Writing To Combat Distress Associated With The COVID-19 Pandemic In People With Inflammatory Bowel Disease
Expand descriptionThe COVID-19 pandemic presents significant risks to the health of people living with chronic conditions. Inflammatory bowel disease (IBD) is a chronic and life-limiting illness affecting 85,000 Australians and up to 7 million people worldwide, with symptoms involving chronic diarrhea (up to 20-30 times a day), pain, and fatigue. A large proportion of patients with IBD receive immunosuppressive medication and are at a particular risk of COVID-19. Further, given the recent COVID-19 related product shortages, toilet paper, heavily used by patients, has become difficult to purchase. This has resulted in significant distress expressed by the members of the IBD community. This project will provide timely information on the effectiveness of a simple, brief, evidence-based, online, group-based expressive writing intervention targeting COVID-19-related distress in people with IBD.
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Use of therapeutic drug monitoring (TDM) to optimise oral/enteral hydroxychloroquine dosing in critically ill patients with COVID-19
Expand descriptionTo date, COVID-19 has resulted in nearly 721,000 infections and almost 33,000 deaths globally, with no proven effective therapeutic options to reduce mortality. Hydroxychloroquine (HCQ) is a widely used anti-malarial drug showing great promise in treating COVID-19 in preclinical studies. The intensive care physicians at the Royal Brisbane and Women's Hospital (RBWH) have chosen to treat all COVID-19 patients admitted to the ICU with HCQ. The dose of HCQ used in virtually every other hospital is the same as used for malaria. However, critically ill patients with renal failure and other problems commonly require different doses of many drugs. The aim of this study is to investigate whether the dosing of HCQ for critically ill COVID-19 patients requires adjustment, in order to ensure the safety of practice at RBWH, Inclusion criteria is suspected or proven severe COVID-19 infections admitted to the RBWH ICU. Data will be routinely collected as part of standard ICU practice. The outcome of this study will potentially be of critical importance in the interpretation of results of the large randomised comparative trials of HCT using fixed dosing currently underway.
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Childhood outcomes of fetal genomic variants: the PrenatAL Microarray (PALM) cohort
Expand descriptionTo establish and follow up a Victorian cohort of children who had a prenatal diagnosis of a genomic copy number variant from 2013-2019. Children aged 12 months to 7 years will be assessed for developmental, social-emotional and health outcomes using validated, age-appropriate measures. Objectives: 1. To compare the developmental, social-emotional and health status of children with prenatal CNVs to children with normal prenatal CMA results. 2. To measure the impact of a prenatal diagnosis of a VUS on parental perceptions of their child. 3. To determine the proportion of prenatally-ascertained VUS that are reclassified as benign or pathogenic after 2 or more years.
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Australasian COVID-19 Trial (ASCOT): A multi-centre randomised adaptive platform clinical trial to assess clinical, virological and immunological outcomes in patients with SARS-CoV-2 infection (COVID-19)
Expand descriptionASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled Bayesian adaptive platform trial. The aim of the trial is to identify the best regimen (combination of interventions) to treat adults hospitalised with COVID-19.
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COVID-19 Research Response (ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections COVID-19 Research Response Trial)
Expand description- This clinical trial aims at describing the clinical features of COVID-19, the response to treatment, as well as pathogen replication, excretion and evolution within the host, determinants of severity and transmission using high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood and stool. - Characterise the host responses to infection and therapy over time, including innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood - Identify host genetic variants associated with disease progression or severity - Understand transmissibility and probabilities of different clinical outcomes following exposure and infection