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Differential Treatment Effectiveness in Patients with the melancholic sub-type of depression
Expand descriptionThe evidence-based strategies most commonly recommended in treatment guidelines for clinical depression do not distinguish between patients with melancholic depression and those without. This study seeks to demonstrate that a strategy which reflects the different neurobiology of melancholic depression will produce a far better treatment response. Participants will be randomly assigned to one of three groups for 12 weeks of therapy. The first two treatments (an SSRI antidepressant and CBT) are drawn from treatment guidelines, while the third (a Sequencing Drug-based Algorithm [SDA]) has been developed through clinical experience. The principal hypotheses to be tested, which address the comparable effectiveness implied by a sub-typing as against a generic treatment model, are that for individuals with melancholic depression: 1. Those assigned to SDA will show superior remission and responder rates (outcome) to those receiving the SSRI only or CBT only. 2. Those assigned to SSRI only will have a superior outcome to those in CBT only. 3. Differences between treatment arms will not be accounted for by non-specific therapist-based differences.
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Optimisating corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A randomised control trial with placebo comparison.
Expand descriptionA recent systematic review has identified an urgent need to study the long-term effects of corticosteroid injection, especially the possible deleterious ones. We have recently completed a high quality RCT with long term follow up that found poor long-term effects and very high recurrence rates following corticosteroid injection;which clearly highlights the problem to be addressed by this project. The solution to the problem, which we propose to test, is the addition to the injection treatment of a specific physiotherapy program that we have recently shown to have merit for this purpose. As well as evaluating the impact on clinical efficacy and recurrence rates of adding physiotherapy to injection we will also evaluate the economic value of adding the two treatments. In addition the project will help provide insight into the role of medication and non-medication injection related factors (eg placebo) in treatment of tennis elbow. The hypotheses to be tested in this study are: I Addition of physiotherapy to an injection when compared to injection alone will: (a) improve long term efficacy, and (b) reduce the recurrence rate. II The benefits gained by adding physiotherapy to injection outweighs the cost associated with injection alone. III The combined corticosteroid and local anaesthetic medication are superior to that of saline.
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Descriptive study using ultrasound to assess the appropriate needle angle for intramuscular vaccine administration to ensure muscle penetration in adults, adolescents, children, toddlers and infants.
Expand descriptionThis is a descriptive study using ultrasound to assess the appropriate angle of administration for intramuscular vaccinations. The primary aim of this study is to use ultrasound assessment to accurately describe where the vaccine is delivered during vaccine administration for needle administration at a 60° and 90° angle to the arm or thigh. The study will also compare any reactions (such as redness, swelling, pain) for 7 days following immunisation when the vaccine is administered at either 60° or 90° angle.
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Comparison of markers of Oxidative stress, Myocardial structure and function, Inflammation and Vascular structure and function between Incident hemodialysis and peritoneal Dialysis patients (COMIVID) an Observational Study
Expand descriptionCardiovascular disease is very common in patients who require dialysis treatment for kidney failure. There are two main types of dialysis treatment available for patients with kidney failure. Firstly there is peritoneal dialysis where fluids are run into and out of a soft plastic tube inserted into the patients’ abdomen with a minor surgical procedure. Toxins are removed as they diffuse across the membrane in the abdomen and are flushed out in the fluid. The second type is haemodialysis where toxins are removed from the blood stream as the blood is circulated through a filter outside the body. There may be differing effects on the circulation and elements in the blood stream from these two quite different treatments. The aim of this research study is to see which treatment has the best effect on the heart and blood vessels and substances in the blood stream that indicate the degree of stress and inflammation present in the body. The heart and blood vessels will be assessed by a variety of probes outside the body that measure their “stiffness”, thickness and ability to contract and relax. We are aiming to find out whether one or other form of dialysis may be more beneficial over the first year by assessing the heart and blood vessels and substances in the blood. This may lead to recommendations for the initial form of dialysis treatment used.
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A phase III study comparing Sorafenib with placebo in patients who have had kidney cancer removed (SORCE)
Expand descriptionThis study looks at the effectiveness the drug Sorafenib on treating patients who have had kidney cancer removed surgically. Who is it for? You can join this study if you have had primary renal cell carcinoma and this has been removed by surgery, and you are at high or intermediate risk of relapse. Trial details Participants will be randomly divided into three groups. Group 1 will receive a non-active substance (placebo) for 3 years. Group 2 will receive Sorafenib for 1 year followed by placebo for 2 years. Group 3 will receive Sorafenib only for 3 years. Treatment is by tablets taken twice a day. At the moment there are no treatments that have been proven to reduce the risk of kidney cancer returning after it has been removed by an operation. Sorafenib is a drug that acts starving cancers of their blood supply and will often shrink or stop cancer growing for prolonged periods of time. The study aims to see whether Sorafineb reduces the risk of kidney cancer returning and whether it increases survival rate.
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The acceptability and effectiveness of chocolate or tomato extract in reducing blood pressure in people with pre-hypertension: a pilot study.
Expand descriptionThis study will seek to find out whether cocoa (chocolate) or tomato extract are acceptable to take and effective in reducing the blood pressure of people with blood pressure in the prehypertensive range (80-89 /120-139 mm Hg).
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Multivariate analysis of predictors for severity of mucosal lesions in patients with gastro-oesophageal reflux symptoms: a clinical, epidemiological and endoscopic survey
Expand descriptionClinical observations suggest that the endoscopic grade of reflux oesophagitis varies significantly in patients presenting in two different hospitals A and B. These Hospitals are located in socioeconomic diverse areas, which has a big impact in health care utilization and patient’s follow-up. But this difference and a reason have not been studied prospectively so far. This is an epidemiological study using questionnaires for patients with symptoms Gastro-oesophageal Reflux Disease such as heartburn and regurgitation. Symptomatic patients referred for endoscopy will be asked complete the surveys providing information of their gastointestinal symptoms, psychological and emotional status, lifestyle and sociodemographics. Surveys are mailed in the post at time points zero, 2 months and 6 months. The aim is to assess patient’s outcome in a routine clinical care setting in a follow-up over 6 months. We like to determine possible predictors of response/non-response, symptom improvement and efficacy of the common treatment with proton pump inhibitors.
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A Phase II, Double Blind, Placebo-controlled, Randomized, Multi-Center, Parallel Group Study to Evaluate The Efficacy and Safety of T89, drug name: Dantonic 'Registered trade mark' in Patients with Chronic Stable Angina Pectoris
Expand descriptionThis is a phase II clinical trial that will use double blind, placebo-controlled, randomized, multi-center, parallel group study design to evaluate the efficacy and safety of T89 in patients with chronic stable angina pectoris.
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Can Calcium and Vitamin D reduce diabetes risk in people at high risk?
Expand descriptionType 2 diabetes is Australia's fastest growing chronic disease. Simple strategies to prevent this disease at an early stage (pre-diabetes) in people at high risk are urgently needed. Recently, a lack of calcium and vitamin D has been associated with the development of diabetes. This 6-month study will determine if taking vitamin D and calcium supplements could decrease diabetes risk and cardiovascular risk factors in overweight or obese people with pre-diabetes who lack vitamin D. It will also increase our understanding of the mechanisms through which vitamin D and calcium alter diabetes and cardiovascular disease risk.
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Trial of a computer decision support system and structured medical assessment for children with a febrile illness presenting to the Emergency Department of The Children's Hospital at Westmead
Expand descriptionIn Australia every year about 400,000 children become acutely unwell with fever. Some have life-threatening illnesses such as meningitis and blood infection. Accurate and prompt diagnosis is essential so that effective treatment can be given as soon as possible and the likelihood of rapid and complete recovery can be maximised. Routinely, this diagnostic process involves the attending physician taking a history, examining the patient and then ordering relevant tests. For most bacterial diseases in children the definitive test results are only available after a lag phase of at least 24 hours. Thus, it is possible for children who do not have disease to receive unnecessary treatment, and children who do have disease not to be treated. The traditional diagnostic decision making process does not give clinicians the best available information. Ideally, the clinician should know how likely different diseases are in febrile children and how accurate the history taking, examination, and diagnostic test processes are. These questions have been addressed through careful evaluation and follow-up of approximately 17,000 febrile children, less than 5 years old, who attended the Emergency Department of The Children’s Hospital, Westmead, between July 2004 and June 2006 (Phase 1 of the study). These data are currently being completed and analysed and will inform a diagnostic algorithm that calculates the likelihood of serious bacterial infection in individual patients and displays it to the treating physician using interactive software. This new method will be compared with the usual diagnostic process using a cluster randomised controlled trial, in which clinicians will be the unit of randomisation.