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Dose-Dense ABVD Study: An accelerated delivery of Adriamycin, Bleomycin, Vinblastin and Dacarbazine for patients with Hodgkin Lymphoma
Expand descriptionThis study will evaluate whether giving standard chemotherapy treatment more quickly can be done safely and will be more effective in treating patients with Hodgkin Lymphoma. Who is it for? You may be eligible to join this study if you are aged between 16-60 years and have been diagnosed with either early stage unfavourable or advanced stage Hodgkin Lymphoma. Trial details The current standard therapy for Hodgkin Lymphoma involves receiving a four drug chemotherapy regimen called 'ABVD' every fourteen days. ABVD is an abbreviation for the four drugs used (A=adriamycin, B=bleomycin, V=vinblastin, D=dacarbazine). This chemotherapy is generally well tolerated. A full cycle of therapy involves ABVD given on days 1 and 15 of a 28 day (=4 week) cycle. In this trial, all participants! will receive the exact same four drug combination (ABVD) but given on days 1 and 12 of a 21 day (=3 week) cycle. A growth factor called Nivestim will be given to accelerate the recovery of the body's normal blood cells from the effects of ABVD and thus allow the chemotherapy to be given more quickly than usual. Participants will undergo between 4 to 8 cycles of treatment depending on response. Participants will be regularly assessed over a period of up to 5 years to determine the safety and efficacy of this accelerated chemotherapy regime.
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Phase I study of RAD001 (Everolimus) in combination with Fluvastatin and Zoledronic acid in patients with solid tumours
Expand descriptionThis study aims to investigate whether the combination of everolimus (RAD001), fluvastatin, and zoledronic acid can be given safely together and to determine the toxicities, if any, of the combination. Who is it for? You may be eligible for this study if you have advanced cancer which has continued to grow despite the use of other therapies. Trial Details In this trial, you will receive an combined treatment of the drugs Everolimus escalating from 2.5mg to 10mg daily, fluvastatin 80mg to 120mg daily, and zoledronic acid 4mg intravenously every 3 weeks until either you experience intolerable side effects or until your cancer grows again. We hope that the combination treatment will ultimately not only be fairly well tolerated, but act synergistically to help slow down the rate of tumour growth.
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A randomised controlled trial of high-normal dose protein compared to standard-normal dose protein intake after cardiac surgery.
Expand descriptionThe purpose of this research study is to investigate whether a treatment involving the delivery of protein supplements into the vein (intravenous) can protect cardiac bypass surgery patients from the onset of a new kidney injury, when compared with standard treatment.
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Randomised Controlled Trial of the Diabetes Self-Management ‘Glucose Buddy’ Smartphone Application.
Expand descriptionIn the study we trialled the effectiveness of a diabetes-related smart phone application to improve self-management and glycemic control in adult patients with T1DM. Specifically the aims of the project were to (i) trial the effectiveness of the ‘Glucose Buddy’ self-management application in improving glycemic control in adults with T1DM, (ii) trial the effectiveness of the ‘Glucose Buddy’ self-management application in producing relevant health behaviour change outcomes in adults with T1DM and, (iii) to examine the relationship of utilisation of the ‘Glucose Buddy’ application, patients engagement with the application and the level of self-care and glycemic control.
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Is amitriptyline effective in the management of chronic low back pain?
Expand descriptionChronic low back pain is a major public health problem. Antidepressants are one commonly prescribed treatment for low back pain, and are used not only to treat depression and insomnia, but chronic pain. Their use is rapidly increasing, despite lack of supportive evidence and conflicting recommendations from clinical guidelines. Aims: In community-based adults with chronic low back pain, we aim to determine: 1. If low dose amitriptyline (tricyclic antidepressant) is more effective than an active placebo in the management of pain 2. If low dose amitriptyline is more effective than an active placebo in improving disability and reducing work absence and hindrance. Methods: A double-blind, randomized, placebo-controlled trial will be conducted. We will recruit 150 subjects with chronic low back pain. Participants will receive low-dose amitriptyline or an active placebo for 6 months. Pain, disability and work absence and hindrance will be assessed at baseline, 3 and 6 months using valid measures. Implications: If antidepressants are found to be effective, it will provide high quality evidence for their use, potentially enabling this treatment option to be considered by more individuals with chronic low back pain. If we do not find antidepressants to be effective, then this trial will provide strong evidence to review international guidelines that recommend their use and to evaluate the extensive use of tricyclic antidepressants for chronic low back pain.
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Atorvastatin for treatment of acute inflammation in newly diagnosed children with Crohn’s disease
Expand descriptionCrohn’s disease is a lifelong condition with symptoms of abdominal pain, diarrhoea, lethargy, vomiting due to an underlying inflammation of the gastrointestinal tract. This is thought to be mediated via elevation of compounds called inflammatory cytokines. There are other health effects not localised to the gut like growth problems and poor bone health (osteoporosis) which may be a consequence of the underlying disease process itself or the use of medication to treat the disease. Often potent steroid medication like Prednisolone are used to control the disease. Whilst this is an effective form of treatment, steroids can have a range of side effects. Growth failure leading to significant short stature, poor bone health with cases of fractures with little or no injury and fracture in the spine have been reported in these groups of children. These of course lead to significant morbidity in the growing years. Statins like atorvastatin have been shown to have a potent effect in lowering cholesterol levels and preventing heart disease from large scale adult studies. Statins have also been used to treat paediatric patients with inherited reason for their high cholesterol. There is some suggestion that statins may have an effect directly at the inflammatory process independent of the level of lowering of cholesterol level. It is thought that statins can lower the level of inflammatory cytokines. As inflammatory cytokine levels are elevated in crohn’s disease and if statins may lower inflammatory cytokine levels, there maybe a role of statins in the treatment of crohn’s disease in children. There are already animal studies and some adult trials that show that statins may help in crohn’s disease and other inflammatory disease like arthritis. In our study, we aim to recruit 60 children with newly diagnosed crohn’s disease (30 in each group) aged between 8-17 years, randomly assigned to either receive atorvastatin or Prednisolone (which is the usual form of treatment in our centre).The study is for a period of 8 weeks. The study aims to show that atorvastatin is no worse than Prednisolone as a medication for induction of remission in reducing actue inflammation in newly diagnosed children with crohn's disease. Patients will attend the study follow-up at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks after diagnosis. At all of those time points, blood tests will be obtained to assess the inflammatory process, growth factors and bone markers. Faeces will be collected to look at the level of inflammation in the gut. At all those time points, the paediatric crohn’s disease activity index will be obtained and also a quality of life score specific for this population of children. IMPACT-III. At baseline and 8 weeks, an assessment of the child’s state of development (puberty) will also be done. Children will also be asked to self assess their development (puberty) based on validated forms. We hypothesis that statin has an effect on the inflammatory process and will be no worse compared with Prednisolone treatment.
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Clinical trial of a Chinese herbal medicine for the treatment of prediabetes and mild diabetes
Expand descriptionThis trial assessed the effectiveness of a Chinese herbal medicine to normalise blood glucose and insulin levels. Participants were randomly divided into two groups. Group 1 received the Chinese Herbal Formula and Group 2 received a placebo which had no treatment effect.
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Preparing culturally competent physical education teachers: Can they increase the physical activity levels of Indigenous students participating in a Sporting Chance Program.
Expand descriptionThe aim of this research project is to create partnerships with Indigenous local community agencies and three local high schools to increase the physical activity levels, educational interests and goals, and life skills of their Indigenous students. Additionally, this will provide University of Sydney preservice physical education teachers with a sociocultural teaching experience that increases and deepens their competence and knowledge of Indigenous youth, their current health, physical inactivity levels and educational goals.
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Naropin vs. Marcaine in Pudendal Nerve Block in Open Haemorroidectomy
Expand descriptionThe study involves double blinded randomised controlled trial, the surgeon is blinded to which local anaesthetic is used and the assessor is also blinded to which agent has been used. Pudendal nerve block is performed by the colorectal surgeon prior to preceeding to perform open haemorrhoidectomy
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Reminder Asthma Management Program
Expand descriptionThis trial has two aims: 1. To determine the characteristics of children who have poorly controlled asthma despite optimal management. 2. Whether using an electronic monitoring device (Smart-inhaler) which includes a reminder function and which can be used to provide feedback on adherenve improves adherence with preventive medication.