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Management of secondary postpartum haemorrhage
Expand descriptionThe spectrum of illness in secondary PPH is vast. While some patients experience severe bleeding with haemodynamic instability, or even maternal death, more commonly the vaginal bleeding is less than with a primary PPH. However, the morbidity is still considerable, with many women requiring blood transfusion and surgical interventions such as hysterectomy (Hoveyda & MacKenzie, 2003). Breastfeeding, newborn bonding, and peripartum mental health are also impacted when prolonged inpatient care or repeated outpatient reviews are required. There are no randomised controlled trials or other high-quality research data to guide best management for women who present with a secondary PPH (Mavrides et al, 2016). With the exception of certain antibiotic regimes for postnatal endometritis, current management options for secondary PPH are, at best, based on Level 3 and Level 4 evidence. As such, most institutions and professional bodies do not have a specific policy or guideline to assist clinicians managing this relatively common complication, nor are there audit systems in place to assess safety and success of management. This prospective project aims to recruit women attending a single institution for the management of secondary PPH. This women will have baseline antenatal, intrapartum and postnatal data entered and then be invited to participate in a longitudinal study collecting survey-based data every 6months for 36months. A nested cohort study will arise from the patients managed surgically (group managed with traditional suction curette, compared to those managed hysteroscopically).
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Pharmacogenomics guided antiplatelet selection strategy prior to intracranial or carotid stenting.
Expand descriptionFor most endovascular stenting procedures dual antiplatelet therapy is necessary with a combination of antiplatelet medications. The standard medication regime is a trial of the antiplatelet clopidogrel in combination with aspirin, this study pioneers a tailored medication approach to the genetic profile of each patient.
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Medicinal Cannabis for symptom burden in children with advanced cancer
Expand descriptionThis study is aimed at establishing tolerable and potentially effective doses of two medicinal cannabis products in paediatric palliative care. Who is it for? Participants may be eligible for this study if they are aged 6 months to 21 years, have advanced cancer (metastatic or locally advanced solid tumours, brain tumours or advanced hematological malignancies) and have been referred to or are known by the paediatric palliative service. Study details Participants will undergo baseline measurements, before being randomly allocated to either of two cannabis oil treatments which will be delivered daily for a total of 6 weeks. Participants will visit the clinic weekly to have their symptom burden assessed. Results from this study will help determine clinical dosing of medicinal cannabis for relief of symptom burden in children with advanced cancer.
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A longitudinal study of lifestyle health behaviour in emerging adulthood and risk for later symptoms of depression, anxiety, and stress
Expand descriptionThis study is a secondary analysis of longitudinal data from the Western Australian Pregnancy Cohort (Raine) Study. Data will be from participants at age 20- (baseline), 22- and 27-years (follow up). The aims of this study are to 1) investigate latent classes of multiple lifestyle behaviours amongst a sample of Australian emerging adults at age 20-years, and 2) determine whether the emergent latent classes are associated with symptoms of depression, anxiety, and stress at two follow-up time points in emerging adulthood (age 22- and 27-years). It is hypothesised that 1) unhealthy lifestyle behaviours will cluster together, and the same will be true for healthy lifestyle behaviours, and 2) unhealthy lifestyle clusters will predict poorer mental health at later time points compared to healthy lifestyle clusters. Healthy lifestyle is expected to be protective for mental health.
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Examining the impact of techniques and technologies on peripheral intravenous catheter insertion in children
Expand descriptionMost children receiving inpatient care at the Queensland Children's Hospital will require the insertion of a PIVC. Despite their importance, PIVCs can be hard to insert and approximately 50% of PIVCs inserted at QCH fail before treatment is complete. The sequelae to this is a new PIVC is often required to be inserted causing discomfort to the patient and considerable cost to the organisation. Some new techniques and technologies used to insert and care for PIVCs might improve insertion success and post insertion outcomes. Additionally, there may be a number of reasons for catheter failure, some of which may be preventable with appropriate intervention. At present we do not have a clear idea of the causes of catheter failure at QCH. The proposed study will follow a cohort of patients from insertion of PIVC to removal of PIVC and closely monitor PIVC insertion factors and intravenous access events and their associated outcomes. patients with catheter failure will be compared to a group who do not have catheter failure, to identify opportunities for intervention.
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A phase 4, single-arm, open-label treatment, descriptive study of upadacitinib effectiveness assessed by magnetic resonance imaging (MRI) changes in the hand/wrist and clinical response outcomes in participants with rheumatoid arthritis on methotrexate and who are biologic naïve.
Expand descriptionThe aim is to assess at what timepoints any relevant MRI changes are seen with upadacitinib use; which aspects of rheumatoid involvement respond earliest; and if this precedes the timepoints when other clinical RA outcome measures change. Clinical response to treatment will involve assessing response to treatment on MRI of the participant’s most affected hand/wrist (as determined by Investigator assessment by examination at screening). This trial will observe improvements in MRI tenosynovitis, synovitis and osteitis, and evaluate the time to improvement/resolution of these MRI features, as well as clinical outcome measures such as inflammatory markers and joint count assessments. In addition, participant reported outcomes (PROs) will be completed to assess the overall disease activity levels as reported by the participant. The PROs chosen include the conventional PROs EQ-5D, SF-36, FACIT-F and PtGA as these are well-established PROs that have demonstrated validity and reliability in assessing disease state, as well as a specific upper limb function PRO, the DASH. The DASH, which was developed by the Institute for Work & Health4, specifically assesses hand function and is therefore relevant to the objectives of the study. This trial is novel in nature as it looks are earlier MRI timepoints than what has been completed in earlier clinical trials and also compares the MRI findings to PRO data captured at the same timepoint, which has also not been completed in earlier trials.
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Phase I Pilot study of Medicinal Cannabis (MC) in adolescents with Tourette Syndrome (TS).
Expand descriptionThis is an open labeled pilot study of 10 participants that will be treated with medicinal cannabis (THC: CBD 10:15 oil) in reducing tics-related symptoms in adolescents aged 12 - 18 years with Tourette Syndrome. Eligible participants will receive THC:CBD 10:15 oil. This pilot study will assess the feasibility of conducting a large scale, study of the administration of MC (THC:CBD 10:15 oil) in adolescents with TS. This pilot study will also assess the safety and tolerance of the administration of THC:CBD 10:15 oil in adolescents with TS. Clinician and parent symptom ratings will be compared across the conditions to explore for a signal of efficacy.
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Does conservative fluid therapy compared to usual care change the outcomes in critically ill patients with acute kidney injury.
Expand descriptionThe RESPECT trial aims to determine the clinical impact of a conservative fluid protocol (CFP), that is minimizing fluid administered and maximizing urine produced, compared to usual care in patients admitted to the intensive care unit and have an acute impairment in their kidney function. The hypothesis is that a CFP will result is less severe derangement in kidney function and will result in better patient outcomes, such as less need for dialysis. This will be done by randomizing patients to one of the two groups: CFP and usual care. The expected outcomes are divided into feasibility and clinical outcomes. The main feasibility outcome will be a difference in fluid administered after three days between the two groups. This is to ensure that CFP differs sufficiently from usual care. The main clinical outcomes is a reduction in blood levels of creatinine, which is a marker of the severity of kidney injury.
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Effect of a Group Resilience Program on Psychological DIstress in Corrections Officers
Expand descriptionThere is considerable evidence that corrections officers are at higher risk of mental health problems, largely arising from traumatic events and ongoing stressors in prisons. This program aims to trial an innovative Resilience Training program that builds on a program developed by the World Health Organization to teach awareness about identifying stress, stress reduction strategies, problem management, and maintaining productive and social activities. The Resilience Program will also provide participants with an app to download on their phones that will provide them with exercises to practice stress reduction strategies. The trial will randomise 600 NSW Corrective Services personnel to either the Resilience Program or Repeated Assessment conditions. The Resilience Program will provide 2 x 2-hour sessions administered by clinical psychologists one month apart, delivered in groups of 10-15 people. Participants will be assessed for psychological distress and help-seeking at baseline, 2-months, and 6-months, with the 6-month assessment being the primary outcome timepoint. The trial will also for sickness leave from Department of Corrective Service work records.
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The Quality in Acute Stroke Care (QASC) Australasia Trial: Multi-national Translation of Fever, Sugar, Swallow (FeSS) Protocols
Expand descriptionOur landmark trial published in The Lancet in 2011 demonstrated that facilitated implementation of nurse-initiated protocols to manage fever, hyperglycaemia (sugar) and swallowing difficulties (FeSS Protocols) resulted in significantly reduced 90-day death and dependency for stroke patients. However, ten years on, a significant gap remains in translation of the FeSS Protocols into standard stroke care across Australia, particularly notable in rural and remote settings. A program of systematic Australia-wide implementation is urgently needed. To date, systematic implementation of the FeSS Protocols has not occurred in New Zealand. Therefore, the specific aims of this study are: 1) To determine the effectiveness of a large scale intervention with varying intensities of external remote facilitation in enhancing simultaneous multi-site delivery to promote multi-national uptake of the FeSS Protocols to improve management of fever, hyperglycaemia and swallowing difficulties in the first 72 hours of stroke unit/stroke service admission. Specifically, we will compare the effectiveness of: a) low intensity versus high intensity external remote facilitation. b) low intensity versus no external remote facilitation. c) high intensity versus no external remote facilitation. 2) To determine whether post-intervention implementation changes in monitoring and treatment for fever, hyperglycaemia and swallowing differ between metropolitan and rural/remote hospitals. 3) To determine whether post-intervention changes in monitoring and treatment for fever, hyperglycaemia and swallowing differ between stroke units and stroke services. 4) To describe the potential cost-effectiveness of the different facilitation methods (economic evaluation). 5) To identify clinicians’ views regarding factors that influence uptake of the FeSS Protocols in metropolitan and rural/remote hospitals (process evaluation). A three-arm cluster randomised controlled trial, process evaluation and economic evaluation (sub-study) will be undertaken. Hospitals will be randomised to one of two intervention (low and high intensity external remote facilitation) or control (no facilitation) groups. Australian and new Zealand hospitals with a pre-existing stroke unit/service will be eligible. Multi-national implementation of the proven FeSS Protocols into innovative policy and practice will result in better outcomes for survivors of stroke, particularly in rural and remote Australian and New Zealand settings.