ANZCTR search results

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

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33687 results sorted by trial registration date.
  • 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.

  • A novel exercise regime to reduce cardiometabolic risk in overweight sedentary individuals

    To investigate whether interval execise training reduces cardiovascular risk factors (including improving cardiorespiratory fitness) and how this compares with traditional continuous exercise training.

  • A phase 1 study to evaluate the potential role of mesenchymal stem cells in the treatment of chronic refractory tendinopathy

    The purpose of this study is to assess if mesenchymal stem cells are a safe and effective therapeutic treatment option for people suffering from chronic disabling tendinopathy, who have no other effective treatment options

  • A pilot trial assessing the effect of fish oil on leptin and adiponectin levels in overweight/obese individuals.

    Obesity is a global epidemic. It is associated with a high burden of chronic diseases such as type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD) and some cancers. Obesity and CVD progression have been associated with altered levels of biologically active proteins secreted by adipocytes, including the hormones adiponectin and leptin. This study aims to assess the effect of a high dose marine lipid supplement [dose: 4000mg per day for 8 weeks] on plasma adiponectin and leptin levels in overweight and obese individuals.

  • Using ultrasound to measure the flow of eye blood vessel (Central Retinal Vein) to assess hydration status

    The primary purpose of this study is to test a simple and non-invasive method for estimating intravascular volume status. Estimation of intravascular volume status (hydration status) is of crucial importance in treating patients in various specialties including intensive care. The current methods available are mostly invasive. The non-invasive methods currently in vogue are resource intensive. Hence, there is a need for a simple, consistent and reliable measure for assessment of intravascular volume status. With this view, this study proposes the use of Central Retinal Venous blood flow velocity as an index of intravascular volume status.

  • The Effect of Intensive Home Based Speech Pathology Intervention on Speech, Swallowing and Quality of Life for Stroke Survivors.

    Communication and swallowing difficulties are a common sequelae for people who have suffered a stroke. These difficulties can affect interpersonal relationships, self image and community reintegration. This project is designed to evaluate the effect of a treatment program on the speech, swallowing and quality of life of stroke survivors when delivered by a therapy assistant in a home based setting. The intensive treatment program will include education, behavioural intervention and oral motor rehabilitation, with functional speech or swallowing practice. It is anticipated that patients who have intensive treatment will achieve improved outcomes in swallowing status and speech intelligibility as well as self-confidence and independence. Stroke survivor details will be collected and analysed with frequency of treatment and home practice to determine any barriers to treatment delivery and ability to practice on their own.

  • Exercise or advice after ankle fracture

    This study will determine if rehabilitation programs for people with ankle pain and stiffness following immobilisation for ankle fracture produce clinically worthwhile effects and are cost-effective.

  • The effects of a naturally occurring combination of omega-3s on children and adolescents with hyperactivity and inattention

    The objective of this trial is to examine whether 14 week administration of lyprinol(registered trademark) improves a range of cognitive, mood, behavioural and psychophysiological measures in children aged 6-14 years with symptoms of inattention and hyperactivity relative to placebo. Children will be enrolled into the study if they have elevated inattention or hyperactivity whether or not they have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and whether or not they are currently medicated for their ADHD. As there is no evidence that Omega 3 intake interferes with current ADHD medications, providing children or adolescents who are currently taking ADHD medication with Lyprinol should be safe and well tolerated (Whitehouse et al, 1997). Their inclusion in the trial will be based on their level of hyperactivity and impulsiveness. If participants are included in the trial and are currently taking stimulant or other medications then this indicates that their current medication is not efficacious, as they are still presenting with high levels of inattention and hyperactivity. We will not include participants who have started stimulant medication for ADHD within the past two weeks as the medication may not have had sufficient time to reach maximum effectiveness. As this is a randomized trial there will be equal probability of the control (placebo) and active (Lyprinol) groups to have the same numbers of participants who are currently on medication. All participants will receive a 14 week supply of Lyprinol(registered trademark) once they finish the study. This is to ensure participants who are allocated to the placebo group also have the opportunity to take the Lyprinol for the same duration as the study.

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