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Therapeutic drug monitoring guided dose optimization of beta-lactam antibiotics in haematology/oncology patients with febrile neutropenia
Expand descriptionThe aim of this study is to evaluate a dose optimisation strategy to improve exposure of beta-lactam antibiotics in haematology/oncology patients with febrile neutropenia. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of febrile neutropenia and cancer/haematological malignancy, for which you have been prescribed to receive beta-lactam antibiotics. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will continue to receive standard dosing of beta-lactam antibiotics at the discretion of their treating clinician. Participants in the other group will have their beta-lactam antibiotics dosed according to a new dose optimisation strategy guided by measurements of antibiotic concentration in the blood. All participants will be regularly monitored to determine how well the antibiotic dosing target is met and how long it takes for their fever to subside. It is hoped that the new dose optimisation strategy will help avoid the likelihood of inadequate antibiotic exposure, thereby improving treatment of infections and reducing antibiotic resistance.
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Randomised Controlled Clinical Trial of a Supervised EXErcise Program in Patients with Lymphoma treated with Chemotherapy
Expand descriptionThe EXEL study will look at the effects of combining a structured exercise program with chemotherapy in patients with lymphoma to see whether adding exercise to a chemotherapy treatment schedule can be accomplished safely and practically. Who is it for? You may be eligible to join this study if you are aged between 18 and 80 years and have a biopsy-proven diagnosis of lymphoma, both Hodgkin and non-Hodgkin. You should also be recommended to have systemic chemotherapy with or without external beam radiotherapy, with curative intent. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard care which includes general health education materials regarding nutrition and physical activity, in conjunction with their prescribed chemotherapy/radiotherapy treatment. Participants in the other group will undergo a structured exercise program. All participants will be asked to complete a number of questionnaires at the beginning of the study, then at the 6 week, 12 week, 6 month and 12 month (completion of the study) time points. This information will help us evaluate whether regular supervised exercise in addition to chemotherapy improves the quality of life and sense of wellbeing during and after chemotherapy. This study will also look at whether adding an exercise program to chemotherapy helps increase the ability of patients to receive the prescribed dose of chemotherapy treatment in the required treatment time frame. A number of study procedures will be performed when you start your participation in the study. These include: Health status assessment – your doctor will collect clinical information about your medical history and your current level of exercise. You will also be asked to complete a number of written questionnaires that look at different aspects of your wellbeing and quality of life. This will take approximately 15 minutes. Physical examination – your blood pressure and heart rate will be checked. Your weight, height and waistline will also be measured. You will also perform three short walking, strength and balance tests. This will take approximately 15 minutes to complete. Blood tests – this is to check the levels of different blood cells and important vitamins and minerals in your body. Your liver and kidney function, markers of inflammation and lymphoma activity and levels of immune proteins will also be assessed. This test is done only at the beginning of the study. ECG (electrocardiogram) – this test records the electrical activity of your heart to ensure that you have a normal heart rhythm. This procedure takes about 15 minutes and is painless. This test is done only at the beginning of the study. Bone mineral density assessment (DEXA scan) – this is a specialised X-ray scan that tests overall bone strength and risk of fractures. X-rays of two different strengths are passed through the tissues of the body and depending on the density of the tissues. This scan takes 5-10 minutes to complete and is painless. This test is done at the beginning and the end of the study. The exercise program includes: Aerobic Aerobic exercises primarily consist of treadmill or upright/recumbent cycling. Aerobic activities are usually 5 – 15 min duration depending on Rating of Perceived Exertion (RPE) or fatigue levels. Intensity is gradually progressed i.e. speed or resistance to support cardio- respiratory improvements. Rowing or Elliptical trainers are also available and may be considered as an alternative. Resistance Training All major muscle groups are exercised and we utilise pin loaded weights machines to ensure safe and effective technique. The participants commence at 75% or their 1 RM score and the resistance is gradually increased and capacity/strength improves. Typically 2 – 3 sets or 10 – 12 repetitions, although can be modified by Exercise Physiologist to suit individual.
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The effect of mild changes in temperature on metabolic rates before and after a glucose load: a study of European Australians
Expand descriptionThe aim of the study is to understand how the body’s metabolism changes in response to mild cold. In general, people with obesity, insulin resistance or diabetes do not increase their metabolic rate as much as those who are insulin sensitive.
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Sexual Well Being After Breast cancer study - SWAB study
Expand descriptionThis study will determine the effectiveness of intravaginal testosterone cream therapy for the treatment of sexual dysfunction due to Genitourinary Syndrome of Menopause (GSM) in women with breast cancer being treated with an aromatase inhibitor (AI). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with invasive breast cancer, currently being treated with an AI and experiencing at least one symptom of vaginal dryness, itch, or pain with sexual activity for which you are seeking treatment Study details -participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will apply the intravaginal testosterone cream, whilst participants in the other group will apply the intravaginal placebo cream. Both groups will apply the creams nightly for the first two weeks and then nightly 3 times a week for the remaining 24 weeks. Circulating levels of hormones will be checked before, during and at the end of the treatment period and participants will be asked to answer questionnaires related to sexual function.
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Impact of risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in young high-risk women: A multicentre prospective study
Expand descriptionThe study is evaluating the impact of risk-reducing bilateral salpingo-oophorectomy (RRBSO) on sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function in high-risk, pre-menopausal women. Who is it for? You may be eligible to join this study if you are aged between 18 years old (inclusive) and 50 years old (inclusive), at a high risk of developing breast and/or ovarian cancer, have regular menstrual periods if your uterus is intact, no current vasomotor symptoms (e.g. hot flushes and night sweats), early follicular follicle-stimulation hormone (FSH) of equal to or less than 15 IU/L, Estradiol > 100pmol/L, and are planning to have RRBSO. Women who are not planning to have RRBSO or become pregnant in the next 2 years, and fit the same eligibility criteria are also asked to participate. They will form an age matched control. Trial design. Participants in this study will be required to undergo blood tests and bone mineral density scanning at baseline and then repeated on an annual basis for 2 years. Participants will also need to complete questionnaires relating to sexual function, menopause, depression/anxiety, and sleep quality at baseline, 3 months, 6 months, 12 months and 24 months. Participants will also have tests to measure cognitive function at baseline, 3 months, 12 months and 24 months.
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Cuffed Versus Uncuffed Endotracheal Tubes for Ventilation of Neonates and Infants in the Neonatal and Paediatric Intensive Care Unit: A Pilot RCT
Expand descriptionThe purpose of this pilot study is to show the efficacy of using cuffed endotracheal tubes (ETT) for longer term ventilation in neonates >3kg and infants <3 months in the neonatal and paediatric intensive care setting. Cuffed ETTs potentially offer the advantage of a less or more manageable air leak and therefore improved ventilation. This is extremely relevant in theatre and in the intensive care unit (ICU) where inflammation, fluid shifts and changes in lung compliance result in dynamic changes. There has been much debate in recent years over the use of cuffed versus uncuffed ETTs for the ventilation of neonates, infants and children. Traditionally, uncuffed ETTs have been used due to historical, unsubstantiated concerns over the safety of using cuffed ETTs in small children. However, over the last few years with the advent of the newer high-volume low-pressure cuffed tubes (HVLP), there has been an increase in the use of cuffed tubes in children from birth (>3kg) particularly during anaesthesia for surgical procedures. There has also been an increase in use for longer term ventilation in the PICU. Our hospital is now using cuffed ETTs in small children from birth for anaesthesia in theatre and they are also commonly used in PICU. They are sometimes being used in term neonates in the NICU when they come back from theatre with one in place. Most of the data available in the literature concerns short term use of cuffed ETTs in the anaesthetic setting, but data supporting the use of cuffed or uncuffed tubes for longer term ventilation in neonates and infants is poorly studied. It is an important question as complications with regard to inadequate ventilation contribute to prolonged hospital stay and inappropriate tube selection and multiple tube changes contribute to airway trauma potentially requiring airway reconstruction inferring a high cost to the patient and health care system. This is a pilot RCT to begin the process of bringing some proper scientific rigor to the subject. It will take place at PMH in 6B (NICU) and PICU with the involvement of anaesthetics when the tube is placed in theatre. It will include neonates >3kg and infants up to 3 months of age. Patients will be randomised to receive a cuffed or uncuffed ETT and then data will be collected to look at the primary outcome of tube leak. The secondary objective is to show comparable or improved safety and improvement in the ability to ventilate with cuffed ETTs when compared with uncuffed ETTs. With this initial study, we hope to show that safety and efficacy is at least on a par with the traditional uncuffed ETTs and maybe a trend towards improved ventilation. With these initial results, we will go on to set up a larger multi-centre RCT to look at the outcomes in more detail.
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Cognitive control training for treatment resistant depression: application, evaluation and augmentation
Expand descriptionThe purpose of this project is to explore whether cognitive control training can help alleviate some of the symptoms of depression. Depression is associated with changes in both emotions and cognition (i.e. thinking skills). Research has shown that the emotional and cognitive symptoms of depression interact with each other, and these interactions can contribute to the severity and length of depressive episodes. Examples of these interactions include preferential memory for negative memories and paying greater attention to negative thoughts or negative environmental stimuli. We are interested in whether targeting the cognitive symptoms of depression may also help to improve the emotional symptoms. We are exploring this using cognitive control training (CCT). CCT involves practicing a thinking activity that has been designed to improve attentional processing. The type of attention that CCT is designed to improve is subsumed by activity in a frontal area of the brain called the dorsolateral prefrontal cortex (DLPFC). Research has shown that a mild form of brain stimulation called transcranial direct current stimulation (tDCS) administered to this brain region can enhance cognitive processing. tDCS involves the application of gentle electrical currents to the scalp though electrodes, and can increase activity in various parts of the brain, depending on where it is applied. We are also interested in whether tDCS may be a useful means of augmenting CCT in depression.
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Early detection of lung disease in smokers with normal spirometry
Expand descriptionIn chronic obstructive pulmonary disease (COPD), commonly associated with long term smoking, the earliest abnormality occurs in the very small airways. However, these changes to the small airways are unable to be detected by common lung function tests used in clinical practice and therefore early detection of COPD at present is impossible. In our laboratory we have two easy-to-perform lung function tests that are sensitive to abnormalities in the small airways and we want to determine whether these tests are able to detect abnormalities when common lung function tests remain normal and if they can be treated with administration of bronchodilators. If either of these tests are sensitive to small airway abnormalities it will mean that they have the potential to be used for the early detection of COPD in smokers. We hypothesise that IOS parameters will be sensitive to alterations in small airway function, as defined by abnormal ventilation heterogeneity measured by MBNW, in smokers with normal spirometry. Also, these abnormalities may be partially of completely reversed with bronchodilators.
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The Effects of One Month of Therapy with the Long-acting Bronchodilator Tiotropium on Small Airway Physiology in Chronic Obstructive Pulmonary Disease
Expand descriptionInhaled “bronchodilator” medications (found in puffers/inhalers) are used for the treatment of COPD at all stages of the disease. Large clinical trials have proven the benefits of these medications in patients with COPD. However, we still do not fully understand the effects of these medications on lung function. Our research team has access to advanced methods of measuring lung function, and by using these techniques we hope to understand more about the lungs respond to bronchodilator treatment. By improving our understanding of the effects of these medications on lung function, we may be able to improve future treatments for patients with COPD.
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Vulnerability to alertness failure in response to sleep deprivation in people with obstructive sleep apnoea
Expand descriptionThe objective of this study is to determine relative vulnerability to alertness failure using a sleep loss (extended wakefulness) challenge in people with obstructive sleep apnoea, and to collect data on related markers of biological function (biomarkers) for comparision. By examining the biomarkers in people who are more vulnerable to alertness failure compared with those who are more resistant, it may be possible to develop new, readily usable measures to predict vulnerability to alertness failure, to allow better tailored care and advice for those individuals.