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Does inhaled salbutamol decrease the incidence of perioperative respiratory adverse events in children at high risk for respiratory complications?
Expand descriptionDespite the development of anaesthesia management guidelines, perioperative respiratory adverse events (PRAE) remain a major cause of morbidity and mortality during paediatric anaesthesia, causing more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. In a previous large cohort study in over 9000 children, we identified several risk factors (current or recent upper respiratory tract infection, wheezing >3 times in the last 12 months, eczema, nocturnal dry cough, a family history of asthma, eczema, rhinitis or passive smoking) which can help in every day clinical practice to identify the children at a particularly high risk for PRAE. Additionally, we demonstrated in an audit of children with a recent URTI, that inhaled salbutamol reduced the incidence of perioperative bronchospasm (5% vs. 11%, p=0.027) and persistent coughing (5.5% vs. 11.5%, p=0.0314) in the perioperative period. The role of pre-treatment with reliever medications for other PRAE risk factors (such as asthma, present/past eczema) is unknown. We therefore propose a double blinded randomised controlled trial of the use of inhaled salbutamol in children with two or more known risk factors for PRAE on the incidence of PRAE. We will randomise 470 children (6-16 years) to receive either inhaled salbutamol or an inhaled placebo prior to the administration of anaesthesia. We will also assess lung function before and 15 minutes after the administration of salbutamol or placebo. Furthermore, we will monitor and record all respiratory complications (laryngospasm, bronchospasm, severe and persistent coughing, airway obstruction, oxygen desaturation (<95%) and postoperative stridor). We hypothesise that children receiving salbutamol will experience significantly less PRAE when compared with children who did not receive salbutamol preoperatively. This study may help to reduce the health costs associated with respiratory complications (e.g. unplanned hospital admissions, prolonged hospital stay, additional treatment) and may help us to avoid unexpected admissions to the intensive care unit. Additionally, our findings may lead to a reduction in waiting list times and aid us in deciding the best time for the child’s surgery. Finally, this study may increase the availability of preventative strategies that may reduce the numbers of children who have their surgery cancelled due to respiratory issues. Cancellation of surgery has an adverse economic impact for hospitals, causes enormous emotional and financial burdens on the child and his/her family who have made many arrangements to attend hospital. Reducing the number of cancellations will ease the distress experienced by children and their parents when surgery does not go ahead as planned, which will have add on effects for child/parent satisfaction regarding their hospital experience.
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ONTRAC: Effect of oral nicotinamide (vitamin B3) on incidence of nonmelanoma skin cancer and actinic keratoses: a randomised controlled trial (Oral Nicotinamide To Reduce Actinic Cancer)
Expand descriptionThis study aims to assess the effect of nicotinamide (vitamin B3) on incidence of nonmelanoma skin cancer and actinic keratoses. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had at least two confirmed nonmelanoma skin cancers within the previous 5 years. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take two 500mg nicotinamide (vitamin B3) tablets daily for 12 months, whilst those in the other group will take two placebo (inactive) tablets daily instead. Participants will not know which group they are in until the end of the trial. Participants will be regularly assessed over the treatment period and for 6 months after the treatment period to determine the efficacy of nicotinamide in preventing nonmelanoma skin cancer.
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The Neurocognitive Sub Study of Encore1:A Randomised, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus 2N(t)RTI in Antiretroviral-naive HIV-Infected Individuals Over 96 Weeks
Expand descriptionThe purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood http://clinicaltrials.gov/ct2/show/NCT01516060?term=Encore1&rank=4
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DIAMIND: Diabetes SMS text reminders for women who have had gestational diabetes mellitus to test for type 2 diabetes or impaired glucose tolerance in the postpartum period
Expand descriptionGestational diabetes is a form of diabetes, or glucose intolerance, that develops during pregnancy. Women who have had gestational diabetes are many times more likely to develop type 2 diabetes in the future compared with women who have normal blood glucose levels during pregnancy. Thus, it is important to screen these women after they have given birth to see whether they have type 2 diabetes, such that it can be treated, or to see whether they are on the way to developing type 2 diabetes (have impaired glucose tolerance), such that preventative changes can be made. The best way of detecting type 2 diabetes and impaired glucose tolerance is with an oral glucose tolerance test, and this test is recommended by many health organisations, such as the Australasian Diabetes in Pregnancy Society, to be undertaken in the early postpartum period. Despite this, evidence shows that many women who have had gestational diabetes do not receive this follow up testing. The DIAMIND study is aiming to test whether a text message based reminder system (using mobile phone technology) will increase the number of women who have had gestational diabetes who undertake oral glucose tolerance testing in the postpartum period.
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Evaluation of an online support program for Type 2 diabetes self-management and dysphoria (depression, anxiety, and diabetes-specific distress).
Expand descriptionThis study evaluates the efficacy of a novel, online support program that targets Type 2 diabetes self-management and dysphoria symptoms in aiming to improve glycaemic control and emotional well-being. Secondary aims of the program are to improve behavioural outcomes (physical activity, dietary intake, and medication adherence), self-efficacy for diabetes self-care, and quality of life. Program evaluations include cost-effectiveness and qualitative outcomes, for example implementation feasibility, user satisfaction, program usability and acceptability.
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Do blood glucose levels after meals relate to gut hormones, stomach emptying, and nervous system function in young people with type 1 diabetes?
Expand descriptionGut emptying is of central importance to blood glucose levels after meals and is a major determinant of overall blood glucose control in diabetes. Blood glucose levels and insulin release after meals are also influenced by secretion of hormones from the gut in response to a meal. The gut hormones stimulate insulin secretion in response to raised blood glucose levels. However fat, rather than carbohydrate may be the most potent stimulus for gut hormone release. We aim to measure the effect of gut emptying and gut hormone release on high blood glucose levels in youth with type 1 diabetes (T1D). Gut hormone based therapy may normalize gut emptying and/or suppress hormones therefore reducing high blood glucose levels after meals in youth with T1D. Hypothesis: In young people with type 1 diabetes (i) Gut emptying is slower than in controls (ii) Gut hormone secretion is normal in comparison to controls (iii) Nervous system dysfunction relates to gut emptying
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Do blood glucose levels after meals relate to gut hormones and stomach emptying in young people with cystic fibrosis?
Expand descriptionGut emptying is of central importance to blood glucose levels after meals and is a major determinant of overall blood glucose control in diabetes. Blood glucose levels and insulin release after meals are also influenced by secretion of hormones from the gut in response to a meal. The gut hormones stimulate insulin secretion in response to raised blood glucose levels. However fat, rather than carbohydrate may be the most potent stimulus for gut hormone release. We aim to measure the effect of gut emptying and gut hormone release on high blood glucose levels in youth with cystic fibrosis (CF). We will determine whether the adequate replacement of pancreatic enzymes improves blood glucose levels after meals in youth with CF. Our findings for gut hormone release will inform investigation of potential therapies, eg. free fatty acid therapy, to prime gut hormone release to reduce the impact of high blood glucose levels on the complications associated with CF. Hypothesis : In young people with CF i) Gut emptying of a high fat/carbohydrate meal will be abnormally rapid. ii) Abnormal emptying will be associated with high blood glucose levels after a meal and reduced gut hormone secretion and insulin responses. iii) These abnormal responses will be normalised by pancreatic enzyme supplementation.
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The effectiveness of music therapy on preoperative anxiety in day surgery.
Expand descriptionThe primary purpose of the clinical trial is to test the hypothesis that day surgery patients who listen to music during their preoperative wait will have statistically significantly lower levels of anxiety than patients who receive routine care.
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The effect of music on agitated behaviours in older people with dementia.
Expand descriptionThis study investigated the effect that participation in a 40-minute live music program, three times a week for eight weeks, had on agitation, emotions and quality of life in older people with dementia. A randomized cross-over design, with music and reading control groups, was employed.
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The efficacy of MoodGroup, an online group therapy intervention for the treatment of depression in Australian adults.
Expand descriptionThe aim of the proposed research is to evaluate the efficacy of MoodGroup, an online group therapy intervention for the treatment of depression in Australian adults. The study will use a randomised controlled trial design (RCT). MoodGroup is a 9-week intervention that has been adapted from a face-to-face group therapy program for depression. Using cognitive behavioural therapy, participants will learn skills and techniques to reduce their depressive symptoms.