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Measurement of dietary intake in people with type 1 and type 2 diabetes
Expand descriptionWeighed food records are considered the gold standard for determining dietary intake. Twenty hour urine samples are the gold standard for measuring sodium and potassium intake. However, these methods are burdensome to complete. The DQES (V2) food frequency questionnaire, a much less burdensome method of measuring dietary intake, has been previously validated in non-diabetic populations, however there has been no validation in people with diabetes.
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The 2-hour effects of whole-grain wheat in women with overweight or obesity
Expand descriptionThe aim of this study is to measure the acute (2-hour) effects following consumption of wheat whole-grain foods differing in processing treatment on obesity-related measures. This study hypothesises that the grain products that have undergone selected additional processing will contain greater nutrients and bioactive compounds and have favourable outcomes on postprandial measures compared with regular whole-grain products.
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Caffeine/Glucose and Multi-tasking
Expand descriptionThis investigation is a single centre, double blind, parallel groups design assessing the effects of two doses of glucose alone and a dose of caffeine- glucose combination on cognitive performance, fatigue, stress and mood associated with extended multi-tasking. Using a randomised double blind crossover design, up to 160 healthy frequent caffeine consumers will attend 2 sessions (1 practice and 1 test session). During the practice session participants will complete a battery of cognitive tasks, mood and fatigue ratings. During the test session they will complete a battery of cognitive tasks, mood and fatigue ratings once before and once after receiving one drink corresponding to: 1. Placebo - Britvic Tango Orange Sparkling Drink, Diet sugar free fizzy orange drink 2. 25g Glucose - Lucozade energy (International) diluted with Tango orange 3. 60g Glucose - Lucozade energy (International i.e. outside UK) 4. 60g Glucose/40mg Caffeine - Lucozade energy (UK)
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Self-management and Multiple Sclerosis: The impact of a community-based exercise and education program
Expand descriptionThis pilot study will investigate if an exercise and education program is useful to help keep persons with Multiple Sclerosis exercising in the community by themselves. We hypothesise that the program will improve walking speed and be a feasible and safe program.
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Antenatal Asthma Management Service (AAMS)
Expand descriptionBackground: Pregnancy presents a unique situation for the management of asthma as it can alter the course of asthma severity and its treatment, which in turn can affect pregnancy outcomes. Despite awareness of the substantial adverse effects associated with asthma during pregnancy, little has been done to improve its management and reduce associated perinatal morbidity and mortality. The aim of this randomized controlled trial is to evaluate the clinical and cost effectiveness of an Antenatal Asthma Management Service (AAMS). Methods/design: Design: Multicentre, randomized controlled trial Inclusion criteria: Women with physician diagnosed asthma, which is not currently in remission, who are less than 18 weeks gestation with a singleton pregnancy and do not have a chronic medical condition. Trial entry and randomization: Eligible women with asthma, stratified by disease severity, will be randomized into one of two study groups: either the ‘Standard Care Group’ or the ‘Intervention Group’ Study groups: Both groups will be followed prospectively throughout pregnancy. Women in the ‘Standard Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive additional care through the nurse-led Antenatal Asthma Management Service, based in the antenatal outpatient clinic. Women will receive asthma education with a full assessment of their asthma at 18, 24, 30 and 36 weeks gestation. Each antenatal visit will include a 60-90 min session where asthma management skills are assessed including: medication adherence and knowledge, inhaler device technique, recognition of asthma deterioration and possession of a written asthma action plan. In addition, subjects will receive education about asthma control and management skills including trigger avoidance and smoking cessation counseling when appropriate. Primary study outcome: Asthma exacerbations during pregnancy. Sample size: A sample size of 378 women will be sufficient to show an absolute reduction in asthma exacerbations during pregnancy of 20% (alpha 0.05 two-tailed, 90% power, 5% loss to follow-up). Discussion: The integration of an adapted model of an asthma education program within the antenatal clinic setting has the significant potential to improve the participation rate of pregnant women in the self-management of their asthma, reduce asthma exacerbations and improve perinatal health outcomes.
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Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial
Expand descriptionThis research is comparing two clot dissolving medications tenecteplase and alteplase. Tenecteplase is not currently licensed and approved for use in acute stroke care, but has shown very promising results in recent stroke studies. Alteplase is the approved medication for ischaemic stroke. Despite the clear benefits of alteplase at reducing brain damage and disability, we would like to find a medication that has similar clot-dissolving effects with a lower risk of brain bleeding. This would result in an even greater reduction in long-term stroke disability. The aim of this study is to compare alteplase with tenecteplase for stroke treatment to determine which will help more patients have less disability at 3 months following their stroke.
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Sampling Antibiotics in Renal Replacement Therapy, A Multinational Prospective Pharmacokinetic Study.
Expand descriptionInadequate antibiotic therapy is a critical determinant of survival in patients admitted to an Intensive Care Unit (ICU) with overwhelming infection requiring renal replacement therapy (RRT). Guidelines for effective dosing are not available because RRT can be vastly different between ICUs, resulting in significantly different antibiotic pharmacokinetics. Developing an evidence-based antibiotic dosing guideline is of global significance and should be considered a priority to improving clinical outcomes for patients requiring RRT that have infections.
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Prevention of Deep Vein Thrombosis (DVT) in Patients undergoing Total Knee Replacement (TKR)Surgery with Low Molecular Weight Heparin (LMWH) or outpatient Calf Compression Device (CCD) after a short course of LMWH: a randomized prospective study
Expand descriptionThis study hypothesises that shorter duration low molecular weight therpay is as effective as standard therapy in post operative orthopaedic DVT prophylaxis. There will be no significant difference in the incidence of post operative thrombotic events such as DVTs and PE. There mat be added advantages of reduced leg swelling and hence pain with the use of mobile calf compressor device as an outpatient.
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Phase II Feasibility Study of Lipidiol Markers for Radiation Therapy Localisation and Response Assessment in the Multi-Disciplinary Team Management of Oesophageal-Gastric Cancer
Expand descriptionPatients involved: Those patients with oesophageal-gastric cancer. Intervention: Insertion of lipiodol markers under endoscopic guidance that will allow improved response assessment with imaging such as CT, surgical resection and pathological assessment of the tumour in the surgical specimen. Intervention will also allow image guided radiotherapy for candidates who are suitable for radiotherapy. Outcomes of this study: The outcomes include success of lipiodol marker insertion which will be classified endoscopically and or radiologically on follow up imaging. Visibility of markers for radiotherapy planning Cost analysis of lipiodol markers in comparison to alternative methods such as fiducial/endoclip placement. The rate of successful anatomical correlation of both pre and post neoadjuvant therapy lipiodol images. The rate of successful (RECIST) assessment of tumour response post neoadjuvant therapy. The quantitative improvement in RECIST reporting with lipiodol. The quantitative improvement in correlating metabolic response with pathologic response rate with lipiodol. The rate of successful spatial correlation of pathologic margin (macro and micro) correlation with conventional imaging. (CT, EUS and FDG-PET/CT) Spatial correlation of CT, EUS and FDG-PET/CT and oesophagectomy specimens with radiotherapy volumes in definitive and postoperative settings
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Effect of Transfusion of Washed Reed Blood Cells on Neonatal Outcome: A Pilot Randomised Controlled Trial
Expand descriptionExtremely low gestational age newborns represent the smallest and most immature newborns and are at greatest risk of dying or surviving with significant morbidity particularly neurodevelopmental disability. Over 90% of these newborns receive at least one packed red blood cell (PRBC) transfusion whilst in neonatal intensive care with the majority receiving between 3 and 5 transfusions during their primary hospital admission. There is increasing evidence that PRBC transfusions are independently associated with more frequent and severe cardiopulmonary, gastrointestinal and neurodevelopmental morbidities. Indeed, in comparison to other populations, these transfusion associated adverse events are more common in the preterm newborn. Packed red blood cells are biologically active. We have shown that PRBC transfusion results in endothelial activation, inflammation and oxidative stress in preterm neonates. This transfusion related immunomodulation (TRIM) might contribute to the recognised association between allogeneic PRBC transfusion and adverse clinical outcomes. It is unclear if TRIM is a response to red blood cells themselves, the time-dependent accumulation of bioactive substances in the supernatant (storage lesion), or both. However, in adult and childhood populations significant benefit is gained from modifications in blood product processing such as PRBC washing, though this has never been studied in the preterm neonate. Any reduction in PRBC transfusion related harm would be of substantial clinical benefit in this at risk population. This pragmatic clinical trial aims to identify if transfusion with washed PRBCs reduces harm from transfusion in high-risk newborns.