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Neonatal CoVID-19 Study to evaluate the population health impacts of COVID-19 in mothers and their newborn infants cared for in tertiary and non-tertiary hospitals in Australia.
In the midst of an unfolding global pandemic, there is a dearth of information about how COVID 19 infection affects neonates born to women with suspected or proven COVID 19. This study will contribute to an emerging and global body of information about COVID 19 in the perinatal period, enabling timely reporting and appropriate health service planning to ensure optimal outcomes for neonates, mothers and families. The aim of this project is to investigate the population health impacts of COVID -19 in mothers and their newborn infants cared for in tertiary and non-tertiary neonatal facilities. The research questions/hypothesis this study seeks to address include: 1. Incidence of COVID-19 in pregnant women and their newborn infants 2. Describe the outcomes for mothers and their newborn infants with COVID-19 3. Identify incidence of SARS-CoV-2 infection in the neonatal period and describe clinical course and outcomes for newborn infants with COVID-19 4. Collaborate with international COVID-19 registries to inform global variations and outcomes in care of newborn infants
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Evaluating new, rapid point of care testing for hepatitis C in injecting drug users visiting a medically supervised injecting room.
The aims of this study are to evalute the uptake and acceptability of point fo care testing for hepatitis C using the Xpert Hepatitis C (HCV) Viral Load (VL) Fingerstick test, as compared to standard of care HCV testing in persons who inject drugs presenting to the medically supervised injecting room in Richmond, Victoria. We also seek to evaluate if point of care testing increases the rates of initiation of HCV treatment. Participants will be those persons over the age of 18 years who inject drugs that visit the medically supervised injecting room in Richmond, Victoria. The study will be a time series design, with two arms, conducted over ten months. The recruitment phase will be a total of four months, with each arm (standard of care, point of care) recruiting for a consecutive period of two months. Participants recruited in the first two months (months 1-2) will undergo standard of care testing for HCV. Participants recruited in the subsequent two months (months 3-4) will undergo point of care testing with Xpert HCV VL Fingerstick. Participants who return a positive HCV RNA result, suggestive of chronic hepatitis C infection, will be offered treatment with direct acting antiviral therapy. Participants will be followed up throughout the treatment course at four-weekly intervals, at end of treatment and at 12 weeks post treatment completion to assess for sustained virological response (SVR12). Participants will also complete questionnaires at enrolment, following HCV testing and at each follow up visit to assess acceptability of point of care testing, as compared to standard of care testing.
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Inflammatory responses to meals with varying levels of anti-inflammatory potential: a randomised control pilot study in adults above a healthy weight
Reduction in subclinical inflammation is a potential target for chronic disease prevention, and pro-inflammatory effects of foods are observed following consumption of a single high fat meal. However, there is no consensus regarding inflammatory mediators that best characterise postprandial inflammatory responses. There are also few studies which account for the complex nutritional matrix that exists at mealtimes. Therefore, this study aims to identify whether plasma IL-6, IL-1ß, TNF-a and IL-10, the most commonly measured inflammatory mediators in postprandial research, are appropriate outcomes measures in postprandial protocols comparing acute inflammatory effects of mixed meals. In a randomised controlled, crossover design, 12 adults aged between 50 and 75 years, who are above a healthy weight, will consume three isocaloric (2.2 MJ) meals designed to have a low (-6.24), moderate (-2.76) or high (+9.36) Dietary Inflammatory Index (DII) score, after an overnight fast. Fasting and postprandial blood samples will be collected over five hours and analysed for plasma IL-6, IL-1ß, TNF-a and IL-10. Post-hoc power calculations will be used for future research, to identify appropriate outcome measures, that can be used to perform sample size calculations for larger fully-powered studies. To aid the interpretation of inflammatory responses, this study will also assess differences on postprandial glucose, insulin, lipids and subjective measures of appetite between the three test meals.
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Evaluation of a remote monitoring smartphone application and care model of COVID-19 patients in the community (ReCOVER)
This is a multi-site, prospective, non-randomised trial assessing the implementation of a smartphone application-based model of care for patients with COVID-19 infection managed in community isolation. We will recruit 2000 COVID +ve patients aged 18 years and over who are managed at home. The objective will be to describe the rates of avoidable presentations to ED and 30 day all case mortality per diagnosed COVID-19 case and to compare these to a propensity matched and synthetic control group.
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A Trial in Healthy Participants to Evaluate the Pharmacokinetics, Safety, Tolerability and Food Effects of Multiple Forms of PRAX-114.
This clinical trial is to evaluate the PK, safety, tolerability and food effects of oral suspension and solid dosage formulations of PRAX-114 in healthy participants aged 18 to 55 years inclusive.
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Investigating Complications in Men who have Undergone Surgical Reconstruction of the Urethra using Oral Grafts
1. Background Urethral strictures are a common cause of urinary issues for men worldwide. Repair of the urethra with a tissue graft taken from inside the cheek is currently the best treatment for long urethral strictures. Whilst the use of an oral graft to repair urethral strictures is well studied, there has been less research into mouth problems (e.g. pain, infection) after the graft is taken. 2. Aims This study aims to determine the rate of post-operative mouth problems in men who had an oral graft taken from inside their cheek and used to repair their urethral stricture. This study will also investigate if certain patient's features (e.g. age, medical conditions) or operative details (e.g. size of oral graft, length of urethral stricture) are more likely to result in complications after the surgery. 3. Hypothesis Patients who have an oral graft surgically removed are at risk of developing mouth problems. Some patient features or operative details may increase the likelihood of complications.
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Efficacy and Safety Outcomes of Drainage of Intensive Care Pleural Effusions
The ESODICE trial is a Phase 2 open label randomised trial of drainage of pleural effusion in patients admitted to an intensive care unit. Coprimary endpoints are: a) safety, determined by rates of pleural effusion related serious adverse events at the earlier of 90 days or hospital discharge; b) efficacy, defined as statistically significant improvement in P:F ratio at 48 hours compared to randomisation.
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Feasibility of thin disposable endoscopes for screening and surveillance of gastro-oesophageal varices performed in outpatient liver clinic
Patients with liver cirrhosis are at risk of having varices (dilated vessels) in their oesophagus and stomach. These varices can bleed and bleeding is associated with serious complications. It is recommended that all patients have their oesophagus examined with an endoscopy (flexible telescope / camera) to detect these varices. Currently these endoscopies are performed in the Gastrointestinal Investigation Unit using sedation (medication to make you drowsy). The purpose of this study is to evaluate the feasibility of performing this procedure in the outpatient clinic, using a new endoscope. The newer scope is very thin, disposable and can be used in a consultation room. The thinness of the scope allows the examination to be performed without sedation, using only local anaesthesia with lignocaine gargle or spray. The scope has already been shown to be as effective in the detection of large varices as standard endoscopy; this study aims to assess the viability of its use in the outpatient setting.
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COVID-19: Can Nebulised HepArin Reduce Time to Extubation in SARS-CoV-2 patients requiring mechanical ventilation (CHARTER Study)
The search for an effective treatment for COVID-19 is underway around the world. A trial of nebulised heparin is warranted. A recent (not yet published; still under journal review) pre-pandemic double-blind multi-centre randomised study of 256 mechanically ventilated patients with or at risk of developing the Acute Respiratory Distress Syndrome (ARDS) of which 47% had ARDS, led by our group, found important pre-specified secondary outcomes were significantly improved with nebulised heparin. There was no evidence of harm. COVID-19 is associated with the development of ARDS displaying the typical features of diffuse alveolar damage with extensive pulmonary coagulation activation resulting in fibrin deposition in the microvasculature and formation of hyaline membranes in the air sacs. The anticoagulant actions of nebulised heparin limit fibrin deposition. Serendipitously, unfractionated heparin also inactivates the SARS-CoV-2 virus and prevents its entry into mammalian cells. Nebulisation of heparin may therefore limit fibrin-mediated lung injury and inhibit pulmonary infection by SARS-CoV-2. For these reasons we believe a trial of nebulised heparin in patients with COVID-19 is warranted. Our hypothesis is that nebulised heparin will reduce the time to separation from invasive ventilation at Day 28. Nebulised heparin sodium 25,000 Units, will be administered 6-hourly with a vibrating mesh nebuliser while patients are receiving invasive mechanical ventilation up to Day 10. The dose and methodology of nebulisation were established in previous clinical trials by our group. The intervention is given in addition to standard care.
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Larger dose Rocuronium (2mg/kg) versus standard dose (1mg/kg) Rocuronium for speed of onset of paralysis and quality of intubating conditions in Rapid Sequence Intubation (RSI) in adults having surgery.
Many patients undergo emergency intubations, also called Rapid Sequence Intubations (RSI), where a breathing tube is placed into their windpipe to provide oxygen to their lungs, both in hospital and at the roadside. To place a breathing tube requires the muscles of the voice box to be paralysed. Which drug and dose is best for this paralysis has undergone much debate and many studies. Rocuronium manufacturers suggest 1mg/kg will suffice to paralyse patients for RSI and this has become current anaesthetic and emergency department standard practice. Studies reveal 1mg/kg Rocuronium paralysis at 60seconds to be ‘adequate’ rather than ‘excellent’ however, as judged by those doing the intubations. Mathematical calculations based on patient data revealed that a dose of 1.8 – 2.3 mg/kg Rocuronium may be needed to achieve ‘excellent’ intubating conditions at 60 seconds in at least 90-95% of people. This study will ask how quickly 2mg/kg Rocuronium works compared to 1mg/kg and if that is better for Rapid Sequence Intubations. The time taken for paralysis effect in muscles can be measured in seconds, and anaesthetists can rate the quality of intubating conditions at 60s. If Rocuronium 2mg/kg proves to be reasonably faster and more effective than 1mg/kg, then this information could change the dose of Rocuronium given not only at prehospital emergency intubations but also in any operating theatre or intensive care unit when speed of action matters.