ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Stroke Self-Management Rehabilitation Trial (SMART)

    Stroke is a major health problem in New Zealand and internationally. Current educational tools for stroke survivors and their caregivers remain inadequate and there are major gaps in the ability of the existing educational tools to transfer knowledge about stroke risk factors, warning symptoms, treatment, caregiving and rehabilitation. New technology allows more personal, engaging educational strategies that can be delivered interactively. This randomised controlled trial is to assess the feasibility of a novel observational learning DVD-based educational intervention in stroke survivors and their caregivers as a potentially applicable strategy to improve the function of stroke survivors as well as the health and well-being of both survivors and informal carers. Should this unique role model DVD-based observational learning tool be effective in improving outcomes in stroke patients and their caregivers, it will be a significant advance in stroke care.

  • Management of patients with mild head injury in Australian Emergency Departments: The Neurotrauma Evidence Translation (NET) Trial

    Head injury is a very common presentation to emergency departments (EDs). Up to 15% of patients with mild head injury experience persistent disabling problems (e.g. reduced cognitive and functional ability, heightened emotional distress, and delayed return to work or school). As the ED is the main, and often only, point of medical contact for these patients, the care they receive in the ED can impact on these patients’ outcomes. The NET-Trial is a cluster randomised trial which aims to test the effectiveness of a targeted, theory and evidence-informed implementation intervention regarding the management of adult mild head injured patients in the ED in Australia. Three recommendations from clinical practice guidelines have been selected as the focus of the study and they are 1) prospective assessment for post traumatic amnesia (PTA) using a validated tool; 2) appropriate computed tomography (CT) scanning based on risk criteria; and 3) the provision of patient information upon discharge from the ED. The 3 key evidence-based recommendations have been decided after a systematic review of the evidence and available clinical guidelines, and consultation with the ED community. EDs will be randomised to receive either the intervention or to a control group who will have access to the clinical practice guideline alone. The control group will be offered to receive the intervention component of the study following data collection. In addition, EDs will be invited to participate in the “NET-Plus” trial that also includes patient outcomes to investigate whether improved management as a result of our intervention is translated into improved patient outcomes.

  • Traditional Chinese Medicine (TCM) Constitution in patients with obstructive sleep apnea syndrome (OSAS) treated with continuous positive airway pressure (CPAP).

    Obstructive sleep apnea syndrome (OSAS) is composed of sleeping apnea and hypopnea. It also accompanied with fatigue, daytime sleepiness and poor concentration and memory in such patients. The standard treatment for it is usage of continuous positive airway pressure during sleeping. In this study, we want to know condition of Traditional Chinese Medicine (TCM) constitution in patients with OSAS, and to see if treatment of CPAP improves patients' TCM constitution.

  • The Fear Reduction Exercised Early (FREE) approach to acute low back pain - an acceptability and utility study

    People with LBP are often anxious, catastrophise about the consequences of LBP, and are fearful of movement and re-injury. Increased fear is associated with more time off work, and the progression of an acute episode of LBP to chronic disability. Health Care Practitioner (HCP) attitudes and beliefs are associated with the attitudes and beliefs of their patients. Numerous guidelines have been developed to try and improve the management of LBP and prevent progression to disability. When these guidelines are followed patients have better outcomes at lower cost. However, the development and implementation of these guidelines has not decreased the financial and social burden of LBP. Although this may be due to a number of factors, the attitudes and beliefs of both HCPs and their patients, and the interaction between these two groups, are important contributors. The Fear Reduction Exercised Early (FREE) approach will communicate current best practice to GPs and their patients by using a novel information package. This aims to influence the attitudes and beliefs of both GPs and their patients, providing them with a consistent framework upon which to achieve optimal management of LBP. This trial will test the acceptability and utility of the FREE approach amongst a cohort of General Practitioners.

  • Viewing of a song-based videotape by pre-school aged children to reduce their anxiety before anaesthesia is commenced using a face mask.

    70% of children experience significant pre-operative anxiety and their anxiety levels peak at the time of mask induction. This study aims to familiarise children with the anaesthesia face mask prior to induction of anaesthesia with a cheap and readily available intervention: a playful, song based video that children will enjoy watching.

  • Youth Depression Alleviation: A Randomised Controlled Trial of Cognitive Behavioural Therapy with Fluoxetine or Placebo (YoDA-C)

    The aim of this NHMRC-funded study is to answer an important question in the treatment of moderate-to-severe youth depression: should antidepressant treatment be started as a first-line treatment, concurrent with psychotherapy? The question has taken on increased clinical importance in the wake of recent evidence questioning the efficacy and safety of antidepressants in young people, and the subsequent development of treatment guidelines for youth depression that provide only qualified support for their use. This proposal aims to address the need for studies of effective treatments for youth with moderate to severe major depressive disorder (MDD). Patients between the ages of 15 and 25 will be randomised to receive either (i) cognitive behavioural therapy (CBT) and fluoxetine, or (ii) CBT and placebo, for 12 weeks in a double-blind, randomised controlled trial (RCT), with followup to 26 weeks. This will be the first placebo-controlled study that has examined whether the addition of medication to CBT is a more effective strategy than the provision of CBT alone for the treatment of youth depression. The primary hypothesis is that young people with moderate to severe MDD will show greater improvement after 12 weeks of treatment with CBT and fluoxetine (CBT+FLX) compared to treatment with CBT and placebo (CBT+PBO). The primary outcome measure is change in the MontgomeryAsberg Depression Rating Scale (MADRS), an observerrated depression scale that is widely used in depression treatment trials, being both easy to administer and psychometrically sound (Montgomery & Asberg, 1979). Our secondary hypotheses are that the CBT+FLX group will show greater improvement compared to the CBT+PBO group on efficacy, functioning, quality of life, and safety measures at 12 weeks, but that the differences between groups will not be sustained at 26 weeks.

  • Traditional Chinese Medicine (TCM) constitution and the cardiovascular risks in patients with obstructive sleep apnea syndrome (OSAS).

    Obstructive sleep apnea syndrome (OSAS) is composed of sleeping apnea and hypopnea. It also accompanied with fatigue, daytime sleepiness and poor concentration and memory in such patients. It was known that OSAS is associated with higher occurrence of cardiovascular disease. In traditional Chinese medicine aspect, OSAS has three major subtypes and has corresponding treatment. In this study we will observe on their TCM constitution and their cardiovascular complications in patients with OSAS.

  • A Feasibility Study Of The Role Of Sentinel Lymph Node Detection In The Management Of Patients With Apparent Early Stage Endometrial Cancer

    The aim of this pilot study is to assess the feasibility of sentinel lymph node detection in patients with apparent early stage endometrial carcinoma in the Australia setting. The hypothesis is that carrying out SLN detection in women with presumed early stage endometrial cancer, would prevent the morbidity associated with a formal pelvic lymph node dissection while attempting to identify the cohort that will be upstaged on final pathology. This will help to identify the women who could potentially benefit from adjuvant radiotherapy in preventing a loco-regional recurrence following the management of endometrial cancer. This feasibility study will help us determine if SLN detection is feasible in women with low risk endometrial cancer.

  • Metformin and dietary advice to improve insulin sensitivity and promote gestational restriction of weight in pregnant women who are overweight or obese: the GroW Randomised trial.

    There are a number of complications that women who are obese during pregnancy may develop and can impact on their health an don the health of their baby. There are also longer term risk for infants born including being overweight or obese in childhood and an increased risk of diabetes and heart disease in later life. Metformin lowers blood glucose by improving insulin sensitivity and is commonly used to treat diabetes and gestational diabetes. Women who are obese are more likely to be insulin resistant and in pregnancy this increases the risk of developing gestational diabetes. Insulin resistance raises blood glucose levels and provides excess nutrients to the baby increasing the chance that they will be born large for gestational age. Metformin may modify this risk. This study is a double blind placebo controlled trial; women will be randomly allocated to receive metformin or an identical placebo. All women in the study will receive dietary and exercise advice from a qualified dietitian throughout their pregnancy to help them adopt a healthy diet and lifestyle. Information about the woman’s pregnancy, birth and postnatal admission and the baby’s postnatal hospital stay will be obtained from case notes.

  • Does glycosylated haemoglobin (HbA1c) feedback from a Chronic Disease Management Register to treating General Practitioners have an impact on the management of diabetes and increase the proportion of patients with poorly controlled diabetes who achieve good control?

    To assess whether providing General Practitioners with reminders about their patients’ HbA1c results from a Chronic Disease Management Register leads to better diabetes control. This will be determined via GP Practice Visits and HbA1c levels.

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