ANZCTR search results

Mobile technology, especially tablet computer use, is increasingly common among children. With displacement of other activities and prolonged extreme postures, this use may have harmful effects on physical health including decreased physical activity, increased sedentary time, and increased risk of musculoskeletal discomfort. Yet despite a call from parents and media for best practice guidelines on tablet computer use, there has been no research to date on the physical effects of current tablet computer use on children. This experimental, laboratory study will examine the activity and postures while children use tablet computers, and compare this to two typical sedentary play conditions: watching television (screentime) and “free-play” (non-screen). In a randomized, balanced, within subject design, 24 children (ages 3-5, 12 male and 12 female) will participate in three 15 minute play conditions: tablet computer, television watching, “free play”. The physical environment will be kept constant and only the activity (TV, iPad or freeplay with toys) will vary. Physical activity (using hip and wrist accelerometry), gross postures (systematic video coding), head and trunk angle position and variation (Vicon three-dimensional motion analysis) and upper trapezius and cervical erector spinae muscle activity (surface myoelectric activity), will be measured during each of the three conditions and compared using linear mixed models.

This is an analysis of weight and diabetes outcomes ten years after gastric band surgery to treat obesity. Participants will be identified from a clinical database, which will provide baseline data. Ten-year data will be collected prospectively during routine clinic attendance.

Hydroxycitric acid (HCA), derived from the fruit Garcinia cambogia, reduces the rate of glucose absorption and decreases postprandial glycaemia in rodents, but its effects in humans are unknown. We aim to investigate the effects of small intestinal perfusion with HCA on glucose absorption, incretin (GIP and GLP-1) release and glycaemia in response to a subsequent intraduodenal glucose infusion in both health and type 2 diabetes. Healthy subjects and patients with type 2 diabetes will received an intraduodenal infusion of HCA (2800mg in water) or control (water alone) over 60min, followed by 60g glucose infused over 120min, in a double blind randomized crossover design. In the healthy subjects, 5g 3-O-methylglucose (3-OMG) will be co-infused with glucose as a marker of glucose absorption. Blood will be sampled frequently for subsequent assays.

This study aims to find out how achievable it is to find participants for a trial that involves cancer patients whom despite taking recommended pain relief medications continue to experience problems with pain management, and add either dexamethasone or placebo to their usual medications and evaluate the response. Who is it for? You may be eligible to join this study if you are aged greater than 18 years and continue to experience pain related to cancer or its treatment, despite taking recommended pain relief medications. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive daily injections of a steroid medication known as dexamethasone for 5 days. The injection will either be administered intravenously (i.e. directly into the vein) or subcutaneously (i.e. into the skin). Participants in the other group will receive daily saline injections instead. Saline is an inactive (placebo) treatment. Participants will not know which group they are in until the end of the study. All participants will be asked to complete a number of questionnaires over a period of 14 days in order to evaluate their pain levels and quality of life. Total opioid dose received, overall survival and the occurrence of any adverse events will also be recorded. Data collected from this study will help us determine how achievable it is to proceed to conduct a larger trial.

The 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.

The 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.

The 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.

This 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.

The 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.

The 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.