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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
This 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?
Type 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
In 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.
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A study of the EpiSure syringe vs conventional epidural syringe
We intend to evaluate the EpiSure, a new epidural syringe that uses a novel spring-loaded mechanism to locate the correct place in the back for epidural insertion. Early data regarding this device suggests that it may ease the process of inserting an epidural and reduce complications, particularly in anaesthetists who are relatively new to the procedure of epidural insertion. We will compare effectiveness of pain relief and outcomes in patients whose epidurals are inserted with the EpiSure with those whose epidurals are inserted with traditional syringes.
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Assessment of the generation of respiratory pressure by high flow nasal prongs using pressure measuring and lung imaging techniques
After cardiac surgery the lungs may suffer from a small amount of collapse and may require extra assistance to re-expand. If this occurs nasal high flow therapy may be applied (delivery of warmed and humidified medical gas via the nose at flow rates up to 50 L/min). It is believed that this flow generates a degree of positive pressure in the lungs which is beneficial to patients with some degree of lung collapse. Assessment of the physiological effect by two different methods (pressure measurement in the upper airway and by a lung imaging technique called electrical impedence tomography) will help doctors understand the effects of this therapy better and will form the basis for future research in this area.
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Randomised controlled trial of paper, online and text message diaries for sexual health data collection from young people
This randomised controlled trial compared SMS, paper and online diaries on response rate, timeliness, completeness of data, and acceptability. The correlation between behaviour reported in diaries and a retrospective questionnaire was also determined.
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TOP GEAR: Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma A randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer
This study aims to evaluate whether the addition of pre-operative chemoradiotherapy to chemotherapy is superior to chemotherapy alone in patients undergoing surgery for resectable gastric cancer. You may be eligible to join this study if you are aged 18 years or over and have a diagnosis of stomach cancer that is suitable for removal with surgery. If you join the study, you will be expected to attend the following visits over a period of approximately 28 weeks: • 1 set of screening visits over a period of 3 weeks • Up to 20 chemotherapy visits (once a week during chemotherapy) • 25 radiotherapy visits if being treated with chemoradiation (daily, Monday to Friday, for 5 weeks) • 1 set of pre-surgery visits over a period of 3 weeks • 1 surgery Following treatment, you will be expected to attend approximately 14 follow-up visits over a period of 5 years (one visit every 3-6 months). You will be asked to fill in Quality of Life questionnaires before you start treatment, twice during preoperative treatment, before surgery, around 1, 4, 6, 9 and 12 months after surgery and at each subsequent follow-up appointment until 5 years. This is so we can find out how you are feeling in yourself and the effect treatment has upon you and your daily activities. The study aims to further medical knowledge and may improve future treatment of stomach cancer.
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A randomised clinical trial to determine the relative benefits of botulinum toxin injections, ankle foot orthosis or a combination of both on knee hyperextension during walking in people with chronic stroke.
This is a pilot study to investigate the effects of Botulinum toxin (BoNT-A) and ankle foot orthosis (AFO) on controlling knee hyperextension during walking, in people who have had a stroke. It is hypothesised that a combination of BoNT-A and AFO will result in 5 degrees or more decrease in knee hyperextension, and improved ankle dorsiflexion, during walking, than BoNT-A or AFO alone. It is also hyptohesised that a combination of BoNT-A and AFO will increase walking speed by 10cm/sec or more, than either BoNT-A or AFO alone. The results of this study will provide information to calculate power and sample size requirements for a more comprehensive study.
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Evaluation of the Youth Mental Health First Aid Course
Orygen YOUTH Health Research Centre, Department of Psychiatry, The University of Melbourne is conducting an evaluation of its 14-hour Youth Mental Health First Aid Course via face-to-face training, which aims to teach adults how to better assist adolescents who are developing a mental health problem or in a mental health crisis. Participants will be asked to complete 3 surveys - prior to commencing the course, immediately upon completion and at 6-month followup. The surveys ask questions to determine changes in adult's knowledge, attitudes and helping behaviour towards adolescents with mental helath problems or in a crisis.
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A comparison of the use of different types of continous positive airway pressure (CPAP) masks to control leaks and improve patient comfort
Continuous positive airway pressure (CPAP) is the treatment of choice for OSA. The CPAP pressure is delivered via a mask worn over the nose or the nose and mouth. If air leaks from the mouth or around the mask whilst being used, the treatment is not as effective and the patient may find it uncomfortable and not use it. We have two options to control mouth leaks , add a chinstrap to a nasal mask or change to a full face mask.We do not know which is the best option. The full face mask may leak more and is more expensive but the chin strap may not work. Also patients may find that one option is easier to use and more comfortable.