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Observation of Faecal Microbiota Transplantation Use for Restoration of Gut Microbiota in Gastrointestinal Disorders in the Real-World Setting (The REAL-BIOME Study). A Real-World, Prospective, Observational Study.
FMT has been proven to be a safe and effective treatment for recurrent and refractory C. difficile infection and is now available within Australia for this purpose. There is also significant and growing evidence that FMT can effectively treat gastrointestinal disorders such as ulcerative colitis, Crohn’s disease, irritable bowel syndrome, immune checkpoint inhibitor-associated enterocolitis and functional constipation, and practitioners may now request access to FMT for patients with these conditions under the TGA managed Special Access Scheme-B (SAS-B) or authorised prescriber schemes. However, there is a dearth of evidence on the safety and efficacy of FMT in gastrointestinal disorders in a real-world setting. In this a real-world, prospective, observational study, we aim to track the real-world safety and efficacy of FMT treatment in patients with gastrointestinal disorders within Australia. The results of this study may inform standard clinical care for patients with gastrointestinal disorders.
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A Phase 1, Single Centre, Open Label, Single Dose, Pharmacokinetic Study of Erwinaze in Healthy Adult Volunteers
This study will assess the safety and tolerability of a single dose of Erwinaze, and how this drug acts in the body in healthy volunteers. Erwinaze is indicated for use in patients with acute lymphoblastic leukemia (blood cancer), but a trial of the drug in healthy volunteers is needed to obtain additional information to potentially make Erwinase available in more countries. Who is it for? You may be eligible for this study if you are aged 18 to 40 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details All participants who choose to enrol in this study will be screened for eligibility within the 28 days prior to being admitted to a clinical research unit for up to 5 days. Eligibility will be confirmed within the 24 hours prior to participants receiving a single intramuscular (injected) dose of Erwinaze. Participants will then be asked to provide a series of blood and urine samples to assess the effect of the drug on their body. After 5 days, participants will be discharged home and will be asked to attend two further study visits to provide blood samples. It is hoped this research will determine whether Erwinaze can be safely administered without causing severe reactions. Once the safety and tolerability of Erwinaze has been determined, further studies to assess the effect of Erwinaze in people with leukemia may proceed.
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The effect of a high-salt meal on cortisol production in young adults
The current study aimed to demonstrate an acute cortisol response following a single high salt meal. While studies to date show an association between high dietary salt-intake over several days and 24-h urinary cortisol, no studies have investigated the acute relationship between salt-intake and cortisol production. The primary aim of our study was to demonstrate salt-induced cortisol production in an acute setting. Our secondary aim was to demonstrate this cortisol production in the absence of an adrenocorticotropic hormone (ACTH) response. We hypothesized that urinary cortisol but not plasma ACTH will increase following a single high-salt meal. To further characterize the role of high salt intake, we measured salivary cortisol, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and blood glucose.
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Clinical effectiveness of peripheral intravenous device selection and insertion by a vascular access specialist (The SELECT Study)
Peripheral Intravenous Catheters (PIVCs) are the most frequently used vascular access device in Australia, with Queensland Health spending $41 million purchasing over 2.6 million PIVCs in 2016 alone. Currently, peripheral intravenous (IV) device choice consistently defaults to short-PIVCs (<4cms) to meet most patients’ IV treatment needs. This is largely due to the current workforce model in which most PIVC inserters are doctors and nurses (generalist) inserting PIVCs within their existing roles. Over the last decade, PIVC insertion teams made up of Vascular Access Specialists (VAS) have been disbanded in many hospitals due to budgetary constraints. The ‘generalist’ approach has been adopted instead putting pressure on already-stretched frontline clinicians, particularly junior medical officers in the after-hours space. Inherent inefficiencies in the current generalist workforce model are not sustainable. More efficient, innovative service provision is urgently needed. Our research project aims to compare the clinical effectiveness of peripheral intravenous device selection and insertion by (i) VAS compared with (ii) generalist model (standard practice). We will conduct a single-centre, two-arm, parallel, randomised controlled trial recruiting 196 patients who are 18 years of age or older and requiring IV therapy for 24hrs or more. All participants enrolled in this trial will be randomly allocated (by chance) to have their IV device inserted by either a VAS or a generalist inserter. Daily follow up checks will then be carried out by a (blinded) Research Nurse until the time of device removal. We the investigators hypothesise that devices selected and inserted by a VAS, compared to those inserted by a generalist inserter, will result in: • Reduced peripheral IV device failure and complications • Fewer attempts to achieve successful peripheral IV device placement • Fewer devices to complete the prescribed peripheral IV therapy • Improved patient satisfaction and less self-reported pain on insertion
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Does fertility treatment change your vaginal microbiome?
IVF remains a difficult process – physically and emotionally - in part due to the ovarian stimulation protocols that stimulate the ovaries. It has been established that there is crosstalk between female gonadal hormones and the vaginal microbiome. This research aims to look at how the vaginal microbiome will respond when exposed to the physiologically abnormal doses of reproductive hormones introduced during Assisted Reproductive Technology treatment. The purpose of this project is to investigate whether fertility treatment used to stimulate ovulation, changes the amount, or type, of microbes usually present in your vaginal microbiome. This study wants to know what a person's vaginal microbiome looks like prior to commencing gonadotropin fertility treatment, during treatment, and once the person has finished treatment.
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Mechanisms of mindfulness: A longitudinal observational study of the effects of Mindfulness-based Stress Reduction (MBSR) on depression, anxiety, and stress among participants in a MBSR program
This study aimed to identify MBSR-related changes in depression, anxiety, and stress and various subcomponents of mindfulness using a longitudinal design over an 8-week MBSR course.
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An audit of penicillin allergy assessment and outcomes of oral penicillin test-dose challenge in hospitalised patients with a low risk penicillin allergy.
More than two million Australians report an antibiotic or penicillin allergy. Patients’ reports are not always accurate, which may lead to them receiving second-line antibiotic therapies. It has been found that 85% of reported allergies are false and can be removed by testing: in fact, more than 95% of low-risk penicillin allergies. The International Network of Antibiotic Allergy Nations (iNAAN) is a health services program that seeks to improve access to direct oral penicillin challenge for Australian patients. This will reduce the burden and cost of antibiotic allergies in healthcare. At present, many of the patients carrying an antibiotic allergy label remain undiscovered with 50% of these patients not having access to vital testing. We seek to prospectively audit this clinical program to assess safety and the impact on reducing the burden of penicillin allergy in hospitalized patients and the subsequent effects on antibiotic prescribing and patient outcomes.
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The Exercise Right for Active Ageing study
The Exercise Right for Active Ageing (ERAA) program was a 12 weekly exercise program delivered by Accredited Exercise Physiologists and Exercise Scientists to older Australians. This program was supported by the Australian Sports Commission which subsidised a pre-assessment, 12 exercise sessions and provided a free post-assessment for participants. Adherence to participation and outcomes were evaluated during the pandemic. Outcomes of physical activity and sedentary levels, physical and mental functioning were of interest in response to an age-specific exercise program delivered by exercise professionals to older Australians.
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Effect of an Augmented Psychological Treatment on Posttraumatic Stress Disorder (PTSD) in Emergency Service Personnel
People in high-risk occupations, such as those in emergency service organizations, are at high risk of psychological disorders. Posttraumatic stress disorder (PTSD) is the most common psychiatric disorder that develops following exposure to a traumatic event, and emergency service personnel have markedly higher rates of PTSD. PTSD is characterised by severe and persistent stress reactions including: intrusive memories and nightmares of the trauma, hypervigilance, difficulty sleeping, emotional withdrawal, pervasive negative emotions, and avoidance of places, activities, and situations that are reminiscent of their trauma. The treatment of choice for posttraumatic stress disorder (PTSD) is trauma-focused psychotherapy. Trauma-focused psychotherapy typically commences with psychoeducation about the trauma responses, and then focuses on three major strategies: anxiety management, exposure, and cognitive restructuring. Despite support for this therapeutic approach, meta-analyses indicate that at least one-third of patients do not respond to this treatment. This situation is also evidence in treatment of PTSD in emergency service personnel. One recent advance has shown that training people to focus attention in a more controlled way can promote reduction of PTSD symptoms. Accordingly, this trial aims to augment TF-CBT for PTSD by comparing standard TF-CBT with TF-CBT combined with attention training. It is hypothesized that the augmented TF-CBT that includes attention training will result in greater reduction of PTSD than standard TF-CBT.
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Effect of the HIRAID (Trademark) Aged Care Nursing Framework on the Quality and Safety of Residential Aged Care
Australians are aging and have increasingly complex health needs, to which quality nursing care is fundamental. Approximately 191,000 are cared for in residential aged care facilities (RACFs), of which there are ~830 providers and 2,704 facilities across the country.The health issues and needs of the older population are unique in their severity and complexity. Approximately, 54% of permanent RACF residents have comorbid healthcare needs including heart disease, arthritis, dementia, pain and depression. RNs in Australia’s RACFs are need more skills and resources to meet the contemporary complex health and wellbeing needs of residents. This research will implement and evaluate a new aged care nursing assessment framework—HIRAID (Trademark) Aged Care—to improve the quality and safety of person-centred aged care within RACFs, improve RN practice, resident and family satisfaction, and reduce unwarranted hospital burden. HIRAID (Trademark) Aged Care has recently been adapted from the highly successful emergency nursing assessment framework HIRAID (Trademark) – History, Identify Red flags, Assessment, Interventions, Diagnostics, reassessment and communication. This project will introduce and launch the intervention to nurses across 23 participating aged care facilities. This study will use an effectiveness-implementation hybrid design, including a modified Step–Wedge cluster Randomised Control Trial (SW-cRCT). Facilities will first be allocated into one of four clusters. Trial commencement, starting at Step 1, will be rolled out incrementally to each of the 4 clusters at three-month intervals. It is hypothesised that RNs’ use of HIRAID (Trademark) Aged Care for residents will result in a: 1. 20% reduction in preventable deterioration events due to nursing assessment and care. 2. 20% reduction in clinically inappropriate transfer of resident to ED. 3. 20% reduction in National Aged Care Mandatory Quality Indicator Program(15) and other relevant, incoming critical event indicators. 4. 5% increase in satisfaction with care reported by resident or carer and RACF person-centred culture. 5. 10% increase the quantity (completeness) and quality (correctness) of nursing documentation, and nursing and medical satisfaction with clinical handover.