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Does oral honey decrease the incidence of postoperative pain in children undergoing tonsillectomy procedures? (Bee - pain free)
Expand descriptionTonsillectomy is a very common surgery for children. Post-tonsillectomy there is a high rate of unplanned re-presentation to hospital with many of these visits due to pain. From recent work by our research team we know that despite being given pain medications on discharge, patients can experience insufficient pain management, perhaps in part due to misperceptions of parents regarding the safety of these analgesic medications. In this study we aim to assess the impact of honey on postoperative pain levels through a placebo-controlled trial. If honey is shown to be effective; then children will not only benefit from reduced pain but may also require less additional doses of strong pain killers. Furthermore, better pain control will reduce the number of re-presentations to their general practitioners or hospital benefiting the Health System as a whole.
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Pilot trial assessment of the diagnostic value of Cu64 SAR-Bombesin PET/CT imaging for staging of ER/PR + HER2- breast cancer patients with metastatic disease in comparison with conventional imaging (CT, bone scan and 18F-FDG PET/CT)
Expand descriptionThe purpose of this study is to determine the safety and diagnostic value of 64Cu-Bombesin in PET/CT imaging in patients with progressive metastatic hormone positive (oestrogen/progesterone receptor positive) breast cancer. Who is it for? You may be eligible for this study if you are a female aged 18 or above with oestrogen/progesterone receptor positive metastatic breast cancer. Study details: Participants will undergo a variety of scans over the two study visits. There will be four types of imaging: a Cu64 Bombesin PET scan in addition to conventional imaging in the form of a bone scan, CT scan, 18-FDG PET scan. Prior to the injection of Cu64 Bombesin, patients will be subject to review of their haematological and coagulation assay, ECG and vitals. The patient’s vitals will be monitored before, during and after the scan. Where the scan reveals lesions amenable to biopsy, patients may optionally be recruited for this, and consent for this obtained separately. This will allow for further characterisation of receptors present on tissue samples. The outcome of this study will potentially have important implications for the staging of hormone positive metastatic breast cancer.
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Development, Feasibility, and Efficacy of a Web-Based Intervention to Reduce Psychological Barriers to Insulin Therapy among Adults with Type 2 Diabetes (Stage 2: Pilot Study)
Expand descriptionInsulin therapy is the most effective treatment for diabetes, however, one in four adults with type 2 diabetes (T2D) delay initiation due to negative attitudes towards insulin. Few evidence-based interventions exist to address these issues and none widely available in Australia. The aim of this study is to pilot-test the efficacy of a novel psycho-educational web-based resource for reducing negative attitudes to insulin among adults with non-insulin treated T2D. A two-armed pilot randomised controlled trial will be conducted to assess the feasibility and acceptability of the intervention content and format. Up to 40 adults with non-insulin treated T2D will be recruited through the ACBRD (and affiliated organisations) websites, e-newsletters/blogs and social media. Preliminary evidence for the effectiveness of the web-based resource (intervention) compared to widely available existing resources (control) in reducing negative attitudes towards insulin will also be investigated. Outcomes will be assessed at baseline and 2-week follow-up.
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Validity of retrospective measurement of self-reported health status
Expand descriptionIntroduction: Health-related quality of life (HRQoL) is a commonly used health outcome. For many acute conditions (e.g. fractures), retrospective measurement of HRQoL is necessary to establish pre-morbid health status. However, the validity of retrospective measurement of HRQoL following an intervening significant health event has not been established. The aim of this study was to test the validity of retrospective measurement (recall) of HRQoL by using a test-retest design to measure reliability and agreement between prospective and retrospective patient-reported HRQoL before and after an intervening health event (major elective orthopaedic surgery). Method: Participants were recruited from the pre-admission clinic of a metropolitan hospital. Participants were assessed for their HRQoL using the EQ-5D-5L at two time-points; prospectively at two weeks prior to their date of surgery and then retrospectively (recalling their pre-operative health) following elective hip or knee joint replacement surgery. Prospective measurements were compared with retrospective measurements for the five domain scores (nominal data) using intra-class correlation and for the EQ-Index score and the EQ-Visual Analogue Scale (VAS) score (continuous data), using Pearson’s correlation. Agreement was tested in the continuous variables using Lin’s coefficient of concordance (pc) and inspection of Bland-Altman plots.
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Safety, Tolerability and Pharmacokinetics of ALD1910
Expand descriptionThis is FIH randomized, double-blind, placebo-controlled study in healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.
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Improving adoption of preventive care policy and care provision in community mental health services
Expand descriptionThe aim of this quality improvement project is to implement and examine the effectiveness of strategies to support clinical staff in the provision of the preventive care policy within community mental health services in the Hunter New England LHD. An implementation intervention will be co-developed with the service to support clinicians to provide preventive care for tobacco smoking, harmful alcohol consumption, inadequate fruit and/or vegetable consumption, and inadequate physical activity. Evidence based strategies such as education and training, feedback reports, aids to enable care provision, and a designated support person will be tailored, specifically to overcome the impediments to preventive care provision in community mental health. It is hypothesised that clients from the intervention service will receive higher levels of preventive care compared to a control service who will receive no implementation intervention.
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A Phase I clinical study to evaluate safety, tolerability and biological activity of platelet-derived extracellular vesicles on wound healing in healthy adults
Expand descriptionThis study is primarily intended to investigate the safety and tolerability of platelet-derived extracellular vesicles (PLEXARIS) following intradermal injection around a skin punch biopsy in a healthy participant. PLEXARIS will be directly compared to a matched placebo formulation in each participant. Additionally, the study aims to evaluate the time to wound closure between the treated and control biopsies, and assess the presence of scaring, erythema or infection at the wound site.
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Ultrasonographic evaluation of gastric contents in term pregnant women two hours post consumption of carbohydrate drink who present for elective caesarean section.
Expand descriptionThe study aims to demonstrate that 400 mls of a preop carbohydrate drink is fully cleared from the stomach 2hours after consumption in pregnant patients fasting for a caesarean section. All elective patients are subject to standard fasting guidelines-6h for food and 2h for clear liquid. In an effort to minimise physiological disruption to patients a carbohydrate drink (as opposed to water) has been given to patients fasting for operations. There is minimal data to in the heavily pregnant patient to demonstrate that a carbohydrate drink is cleared from the stomach.
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Impact of NSAIDs on delayed fracture healing
Expand descriptionNon-steroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed following musculoskeletal injuries and fractures as an effective method of pain relief. However, there is inconclusive evidence that these NSAIDs may impair bone formation, and therefore impact upon fracture healing, creating delayed union or non-union. It is essential that we have solid evidence to inform clinical guidelines on the use of safe and appropriate analgesia to improve patient care. In order to conduct a large multi-site randomised-controlled trial (RCT) to draw more definitive conclusions about the effects of NSAIDs on bone healing, it is important to firstly ascertain the safety and feasibility of conducting such a study via a pilot RCT. Therefore, the aim of the current study is to determine the feasibility of using a prescribed treatment regime of NSAIDs versus a placebo in people with tibial shaft or femoral shaft limb fractures, and is expected to inform the design of a large multi-site trial.
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The effect of a neck strengthening exercise program on concussion in high school aged athletes.
Expand descriptionThe primary aim of this intervention research project is to investigate the impact of a neck strengthening exercise program on the incidence of concussion in adolescent (12-18 years) contact sport athletes. A secondary aim will be to investigate whether higher neck strength is associated with reduced head acceleration during purposeful heading in adolescent football (soccer) players. Neck muscle strength data will be collected for all participants at three time points (baseline, 6-week, and 6-months) using a hand-held dynamometer along with weekly completion of a concussion incidence and activity survey. Additionally, for football players only, accelerometry will also be used to capture head acceleration during purposeful heading at three time points (baseline, 6-weeks and 6-months). Anthropometry (neck girth, height and weight) data for all participants will also be collected. If higher neck strength is associated with a lower incidence of concussion this evidence would provide an incentive to include neck strengthening exercise as part of all injury prevention programs within these sports.