ANZCTR search results

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

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33075 results sorted by trial registration date.
  • Comparison of the WarmCloud and Under body Bair Hugger for maintaining core temperature during liver transplantation

    To determine if the Kanmed WarmCloud reduces the incidence of hypothermia in patients when compared with the Bair Hugger warming system in patients undergoing a liver transplant

  • Use of transcranial random noise stimulation (tRNS) as an adjunct to reaching training in chronic stroke survivors with severe arm paresis: An exploratory pilot study.

    Stroke survivors with severe upper limb paresis have the poorest functional prognosis. There is growing evidence of the benefits of repetitive training to promote recovery of upper limb function. In addition, there is accumulating evidence that non-invasive brain stimulation techniques, such as tRNS, can augment activity within the cortical areas that are engaged during various forms of training. The aim of this study is to investigate the therapeutic and neuroplastic effects of combining repetitive training with tRNS in stroke survivors with chronic and severe upper limb paresis. A triple-blind randomised controlled pilot trial will be conducted. Ten stroke survivors will be randomly allocated to 4-weeks of SMART Arm training with active tRNS or sham-tRNS. To determine the clinical benefit, all participants will be assessed pre- and post-training and 2-months follow-up using a range of impairment, activity, participation and quality of life measures. To determine the structural (DTI) and functional (resting state fMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre- and post-training.

  • A randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST)

    The aim of this study is to determine whether an alternating regime of imatinib and regorafenib improves disease control in patients with metastatic gastrointestinal stromal tumours (GIST). Who is it for? You may be eligible to join this study if you aged 18 years or more and have a confirmed diagnosis of metastatic GIST. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive an alternating regime of treatment with the drugs imatinib and regorafenib (administered orally by tablet). One treatment cycle lasts for 8 weeks. Participants in the other group will receive treatment with daily imatinib tablets only. Imatinib is currently used as the initial treatment for incurable GIST. Although many people with metastatic disease initially respond to imatinib, the cancer usually becomes resistant to this drug and starts to grow. The cancer drug called regorafenib works in a similar way to imatinib and has been shown to be effective against GIST after other treatments have stopped working. Participants will be regularly monitored for a minimum of 24 months follow-up in order to determine whether the alternating treatment approach improves disease control. If it is found to have benefit and be tolerable, this alternating approach will be further evaluated in a larger study.

  • Functional electrical stimulation in children with unilateral spastic cerebral palsy: A study of the effects based on the international classification of functioning framework.

    To determine the effects of community applied functional electrical stimulation in ambulant children with unilateral spastic cerebral palsy. A device known as the Walk Aide will be given to the intervention group to wear daily for a period of 8 weeks. This controlled trial will determine the effects of using such a device on a range of outcome measures covering the International Classification of Functioning (child and youth version). The outcome of this trial will deepen our understanding of the effects of functional electrical stimulation in a paediatric population and shape our clinical recommendations based on the available evidence.

  • Kunzea oil for the management of fungal nail infection (toenail onychomycosis), a pilot randomised controlled trial.

    Onychomycosis is a common nail infection. Current topical therapies are largely ineffective, systemic drugs have significant safety risks, and are limited in broader range of patients. A safe, relatively inexpensive, alternative topical treatment is required to minimise treatment failures and relapses, and also as an adjuvant treatment to improve cure rates. The present study compared the efficacy and safety of topical kunzea oil (twice daily) with amorolfine (once weekly) for the management onychomycosis (study duration 40' +/-' 2 weeks). The study recruited patients from single site (Royal Hobart Podiatry).

  • Effectiveness of a weight loss intervention to improve decision-making skills in adults with overweight and obesity.

    The prevalence of obesity has steeply grown in the last decades due to changes in food production, marketing and availability. Food intake largely rests on our ability as an individual to manage to control eating and drinking behaviours within the context of an obesogenic environment. Importantly, it has been found that overweight adults with higher levels of visceral fat have a poorer performance on measurers of risk taking and impulsive behaviours than healthy weight adults with low visceral fat. Those with higher levels of visceral fat are more likely to engage in greater risk taking behaviours and have more unhealthy food choices to those who have less visceral fat stores. It has been shown that visceral fat is more strongly related to cognition than body mass index (BMI). We aim to investigate: (a) the association between visceral fat and cognition, specifically performance as measured by behavioural tests of impulsivity, compulsivity and decision-making; (b) whether reductions in visceral fat are associated with improvement in cognitive control.

  • Chewing gum to relieve thirst in chronic heart failure

    Chronic heart failure is a progressive and burdensome syndrome with thirst as a major reason for non-compliance to self- care practices such as fluid restriction. Due to the life threatening effects of non- compliance to fluid restricted therapy, evidence based interventions are needed to manage thirst. Systematic evaluation of available strategies such as chewing gum is essential in ensuring that the best possible management is provided to CHF patients. The purpose of this study is to test the hypothesis that chewing gum can reduce thirst in people with chronic heart failure.

  • Psychosocial Screening for Burns Patients

    The primary objective of this study is to measure and track the psychosocial consequences of a severe burn injury in terms of its impact of patients’ mental health. Screening all severe burns injury patients admitted to the Severe Burns Injury Unit will offer all patients the opportunity for outcome tracking and collect the necessary extensive cohort data on which to base future treatment, policy and advocacy as well as a targeted study on early intervention for PTSD. Burn patients are at risk of developing this disorder, which is associated with increased rates of medical morbidity, poor health-related quality of life, and functional impairment. It is important to note that primary care, rather than specialty mental health services, has been the point of contact with the health care system for the majority of individuals with PTSD. Improving detection of PTSD, adverse coping styles and depression are important steps in addressing the health and mental health burden experienced by these patients.

  • T3 Trial: Triage, Treatment and Transfer of Patients with Stroke in Emergency Departments

    In 2011, members of our research team published the results of the Quality in Acute Stroke Care (QASC) Trial. This cluster randomised controlled trial evaluated the effectiveness of team-building workshops and education to introduce three clinical protocols to manage fever, sugar and swallowing (the FeSS protocols) in the acute stroke unit. We found that patients cared for in stroke units who received our intervention were 16% more likely to be alive and independent 90 days following their stroke. They also had fewer episodes of fever, lower mean temperatures, lower mean blood glucose levels, and better screening for swallowing difficulties. This landmark trial demonstrated that teamwork and good nursing care can improve patient outcomes. Building on this previous work (1) we will evaluate using a cluster randomised controlled trial, an organisational intervention in EDs. Our evidence-based T3 Trial intervention will comprise: A) evidence-based clinical protocols for triage, treatment and transfer in acute stroke comprised of: (Ai) routine assignment of stroke patients to triage Category 1 or 2; (Aii) time-sensitive ‘trigger’ screening for tPA eligibility; (Aiii) instigation of protocols for prompt management of fever, hyperglycaemia and swallowing; (Aiv) rapid transfer of patients from ED to the stroke unit. To support implementation of the protocols we will use: B) an evidence based implementation strategy consisting of: (Bi) workshops to identify local barriers and enablers and to identify clinical champions; (Bii) didactive and interactive education; (Biii) use of local clinical opinion leaders (site clinical champions); and (Biv) reminders in the form of email, telephone and site visits. This trial will be conducted in the EDs of hospitals with pre-existing dedicated stroke units in NSW, Victoria, Queensland and the ACT. EDs will be randomised to receive either the T3 Trial intervention or no additional support. At 90-days post-admission, we will measure death or dependency (mRS) (primary outcome); health status; and quality of life (secondary outcomes). A separate process analysis will examine contextual factors that may influence successful intervention uptake. Our novel and timely intervention will bridge the theory-practice gap aiming to deliver improvements in 90-day health outcomes for a group of patients currently underserved by evidence-based practice Reference 1. Middleton S, McElduff P, Ward J, Grimshaw J, Dale S, D’Este C, Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D, Levi C. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia and swallowing dysfunction in acute stroke improves 90-day outcomes: QASC, a cluster randomised controlled trial. The Lancet 2011; 378 (9804): 1699-1706.

  • Nutrition and Lifestyle Modifications to an Internet-based Treatment for Alcohol Misuse - Pilot Study

    The current project aims to conduct a Pilot Study, to obtain qualitative and quantitative data on the impact of a combined treatment, comprising an existing online alcohol support program – OnTrack (www.ontrack.org.au), together with emails and newsletters focusing on nutrition and healthy lifestyle "OnTrack to Cutting Down and Feeling Good" emailed newsletters. Approximately fifteen male and female participants, aged over 18 years and drinking more than 14 standard drinks per week will be recruited in to the OnTrack online alcohol program. They will be assessed on their drinking behaviour, physical activity, and diet at the start of the Pilot Study and then again after participating in OnTrack Alcohol and receiving the emailed "OnTrack to Cutting Down and Feeling Good" newsletters. The participants will also be questioned by phone interview about their experiences using OnTrack Alcohol and the "OnTrack to Cutting Down and Feeling Good" emailed newsletters.

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