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TROG 12.02: Positron Emission Tomography (PET) Scans for Locally Advanced Breast Cancer and Diagnostic Magnetic Resonance Imaging (MRI) to Determine the Extent of Operation and Radiotherapy
The primary purpose of this study is to investigate whether breast MRI and a PET-CT scan can accurately predict which women with locally advanced breast cancer (LABC) treated by initial Primary Systemic Treatment (PST), can undergo Breast Conserving Surgery (BCS), without compromising local control or Disease Free Survival. You may be eligible to join this study if you are over 18 years old, female, with Clinical Stage III (non-inflammatory) unilateral breast cancer. All patients receive PST as per local practice before operability is then assessed. MRI and PET-CT scan will be taken up to four times during the study; 1/pre-treatment, 2/between 4 and 5 weeks from start of PST, 3/between 3 and 5 weeks after PST is completed and 4/between 10 and12 weeks after radiotherapy treatment (for participants that are inoperable). Each MRI scan will take 20-40 minutes to complete. Each PET-CT takes 60-90 minutes to complete. * If LABC becomes operable, either mastectomy or BSC is performed as well as Sentinal Node Biopsy (SNB) and axillary node dissection. All patients receive radiotherapy 6-8 weeks post-operatively. * If LABC remains inoperable, radiotherapy is given to the breast and nodes. 5-7 weeks after completion of radiotherapy and the patient is re-assessed. If disease has become operable, mastectomy and axillary node dissection is performed. * All patients with a hormone sensitive tumour commence hormonal therapy 14 days after the completion of treatment to the breast and nodes. This study aims to find out if women with LABC can have BCS instead of mastectomy with a low chance of the cancer returning.
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The Pain Course: A Randomised Controlled Trial assessing the efficacy and acceptability of an Internet Delivered-Treatment Program for Managing Chronic Pain provided with different levels of clinical support.
This project builds on an earlier project and seeks to examine the efficacy and acceptability of the Pain Course when provided with different levels of clinical support. We expect that people in the treatment groups will report similar levels of clinical benefit and acceptability.
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The effect of diet on risk of heart disease in people with diabetes
The aim is to determine the effect of improving diet quality on measures of vascular function in people with type 1 and type 2 diabetes.
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Measurement of dietary intake in people with type 1 and type 2 diabetes
Weighed 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
The 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
This 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
This 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)
Background: 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
This 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.
Inadequate 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.