ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31435 results sorted by trial registration date.
  • A Pilot study, for mandatory Venous Thromboembolism (VTE) Risk Assessment and Prophylaxis Implementation for cost effectively improving VTE outcomes in hospitalized medical patients

    Venous thromboembolism (VTE) is a condition that hospitalized patients may be susceptible to and which results in blood clots forming in their legs or in their lungs. The study will examine whether less patients develop clots when a medical guideline is strictly adhered to. VTE or blood clots may occur in patients in hospital because they are not moving around as much as usual or perhaps because they have other illnesses that put them at risk. To try and reduce your chance of developing blood clots during your hospital stay your doctors may treat you with a ‘blood thinning’ medication or they may arrange for you to wear special stockings. There is some controversy about which patients are most likely to benefit from these preventative measures and some new guidelines have been proposed to help doctors decide which patients to treat and who it is safe not to treat. The purpose of this study is to test whether these guidelines work better than the system that is currently in place for making this judgment.

  • A study evaluating the efficacy of right unilateral and bilateral repetitive transcranial magnetic stimulation for the treatment of depression.

    The purpose of this project is to help understand the most effective delivery methods for TMS treatment in Major Depression. Previous research suggests that administration of repetitive Transcranial Magnetic Stimulation (rTMS) in the frontal regions of the brain clearly has antidepressant effects (i.e. it helps people with depression) and that the response to rTMS is clinically significant in some patients. Most research conducted has used stimulation to a single side of the brain (left or right) using rTMS that is applied at either high (5-10 pulses per second) or low frequency (1 pulse per second). Recently we have conducted research that has suggested that we can improve the response to rTMS by combining low and high frequency stimulation types. We have done this when the stimulation is applied across both sides of the brain (high frequency on the left and low frequency on the right) and when we have applied both to the right side of the brain. Both seem more effective than stimulation applied in only one way. However, we have not compared these two methods to see if one is better than the other. That is the purpose of the current research trial.

  • Effect of Varying Body Weight on the Pharmacokinetics of Paracetamol in Children

    The most appropriate dosage of the commonly used analgesic and antipyretic medication paracetamol has not been studied in overweight and obese children. Following a dose of paracetamol, we will measure the saliva and blood concentration (obtained from finger-prick or IV cannula) of paracetamol in a group of overweight and obese children, and compare the calculated pharmacokinetic parameters in the overweight/obese population to the normal BMI population, and determine if there are any differences. In addition, we will measure the efficacy of paracetamol in relieving pain and/or fever in each of these patient groups. A subsequant population pharmacokinetic/pharmacodynamic modelling analysis will allow us to simulate what doses are required to maintain overweight and obese children within a target therapeutic range of 10-30mg/L for the longest period of time.

  • Exercise-induced improvement in insulin levels is maintained in obese youth independently of changes in fat mass

    Being overweight is a major risk factor for diabetes. The main purpose of this study is to determine if exercise can reduce this risk for overweight children and adolescents. At entry to the study, participants will be required to complete a 7 day activity record and a 3 day diet history diary. The participant will then be assigned to either an exercise training group, or a control (non-exercise) group. The 8-week exercise program involves attending a gymnasium three days per week for approximately 1 hour each time. The exercise training regime will be fully structured and supervised by experienced exercise physiologists. If a child is initially in the control group, they will be asked to continue with their normal routine for a period of 8 weeks. At the beginning and at the end of each 8 week period subjects will have their blood pressure measured, and will have a test called a glucose tolerance test that involves the insertion of a small intravenous cannula for blood sampling. They will be asked to drink a sugary cola flavoured liquid and following this, blood samples for blood glucose levels, insulin and cardiovascular risk factors will be taken from the cannula. The test takes a total of 3 hours. Other tests will include a special X-ray scan that determines body composition (fat mass and muscle mass) called a DXA scan. A DXA scan requires subjects to lie on their back on a scanning bed for 3-7 minutes and involves a low radiation dose (5% of a standard chest x-ray). This visit will take approximately 1 hour. Following the series of tests outlined above participants will be allocated to the alternate training group for a further 8 week period followed by a series of repeat tests which are identical to the tests outlined above. By comparing the repeat and initial tests, the effect of the training program on fitness, insulin levels and body composition will be determined.

  • A Prospective, Randomized, Controlled, Pilot Clinical Study to Evaluate Graftys(R)HBS or Graftys(R)QUICKSET for the Treatment of Unstable Distal Radius Fractures

    This is a prospective, randomised, controlled pilot study to evaluate the safety and clinical utility (i.e., performance, functional radiographic parameters) of Graftys(R)HBS or Graftys(R)Quickset in the treatment of unstable distal radius fractures, when used with fractures treated by Kirschner wire fixation. The study will enroll a minimum of 10 patients to a maximum of 50 patients per arm requiring treatment of a primary unstable distal radius fracture.

  • Improving opportunities for engagement for hospital inpatients with Huntington's Disease

    This study aims to investigate how the introduction of a Diversional Therapist effects patients with Huntington's Disease, in an inpatient neurological setting. In particular we are interested in how these patients do or do not engage with other people and with activities.

  • Dietary supplements and ocular (eye) comfort

    This study aims to test whether omega oils taken as capsules can help in improving ocular comfort.

  • Trial of an injection to reduce shoulder pain for people with Motor Neurone Disease

    Chronic shoulder pain is a common and distressing symptom for a large number of people with motor neurone disease. Treatments which are sometimes used for this problem include physiotherapy, pain killers and injections into the shoulder. Unfortunately, despite these treatments the pain frequently is not well controlled. Recently, a number of rheumatologists around the world have been using an injection to numb the nerve that supplies pain fibres to the shoulder in. This nerve is the suprascapular nerve. The results of studies to date have proven that this form of therapy is safe and works effectively to reduce pain and improve function. However, more information is required to establish this as a useful additional treatment in people with MND. Researchers at the Repatriation Hospital (Dr Michael Shanahan, Dr Peter Allcroft and Karen Glaetzer) are studying this treatment to see whether it is effective in reducing pain in people with motor neurone disease. In order to establish whether the treatment is effective in this group, we are performing a trial where we inject around the nerve at a point just above the shoulder blade with a mixture of local anaesthetic and anti-inflammatory steroid and then assess whether this helps to reduce the pain. We then compare the result of the injection with a group of people who do not receive the active injection, but rather a placebo injection of sterile normal saline (salt water). Placebo injections are an accepted practice to ascertain if the improvement in pain is due to the medication used or just the process of injecting into the nerve. We are inviting you to be involved

  • The PTSD Program: A randomized controlled trial of an internet based education program for post traumatic stress disorder

    This preliminary project examines the efficacy of an education program for people with PTSD. We expect that people in either immediate or delayed treatment groups will report similar benefit following the active component of their program.

  • STroke imAging Prevention and Treatment (START): PrePARE Prediction and Prevention to Achieve optimal Recovery Endpoints after stroke

    Stroke and depression are two of the highest ranked diseases in the Burden of Disease rankings of the World Health Organisation. Depression is a common sequela of stroke, with recent estimates between 30-60% of all stroke patients. Depression after stroke is often under diagnosed despite the fact that effective treatment exists. Good predictors of depression that could be used to identify ‘at risk’ patients early as part of the clinical care pathway for stroke currently do not exist. This study aims to investigate the association between poststroke depression and 1) novel imaging markers of brain structure and function as identified by specialized MRI, and 2)functional outcomes including cognition, mood, sensorimotor function, and participation in daily activities. START-PrePARE is an observational cohort study that is part of the START program of study. In addition it will be linked as a sub-study of the START-EXTEND study (NTA 0901), which is a randomised, multicentre, double blinded, placebo controlled phase 3 trial within a larger cohort study of ischaemic stroke patients. START-PrePARE will comprise 100 patients. Participants consented onto the START-PrePARE study will be seen at their hospital at baseline, Day 3-7, 3 months and 12 months for collection of bloods and a series of research tests investigating mood, thinking ability (cognition), diet and lifestyle. The patients will also travel to a central site in Melbourne (the Melbourne Brain Centre), at 3 month and 12 month time points. Here advanced MR imaging, plus more advanced clinical measures of mood, cognition, sensori-motor function and participation will be performed. Investigators and patients will remain blinded to START-EXTEND treatment designation. At Baseline a blood sample will be taken, two brief neurological assessments will be conducted and a medical history will be obtained. 3-7 days following stroke, participants will have another blood test, one brief neurological assessment and three questionnaires conducted asking about their diet and lifestyle and their mood and cognition. At the 3 month and 12 month visits participants will have specialised brain MRI scans which will approximately take 40 minutes plus set up time. They will also be given 10 short assessment tasks and three questionnaires to measure functional outcomes including cognition, mood, and movement as well as participation in household, leisure and social activities and quality of life. These assessments will be administered by a qualified therapist, and will take approximately 120 minutes. The blood test and neurological assessments will be conducted at hospital and the 10 short tasks will be conducted at the Melbourne Brain Centre or at the participant's place of residence if more convenient. All information collected will be recorded without any identifying information and kept private and confidential. An independent Data Safety Monitoring Committee has been set up to monitor safety for START-PrePARE patients for the duration of the trial.

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