ANZCTR search results

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

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31144 results sorted by trial registration date.
  • Stem cell transplant influenza vaccination strategies

    This study will compare the level of protection afforded by two different influenza vaccination strategies in patients who have undergone autologous haematopoietic stem cell transplantation. Who is it for? You may be eligible to join this study if you are aged at least 18 years, have received an autologous haematopoietic stem cell transplantation (autoHSCT) within the last 12 months, and have not received an influenza vaccine for the 2019 season following your transplant. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive a new two dose strategy, which consists of the trivalent high dose influenza vaccine followed by a second dose of quadrivalent standard dose influenza vaccine one month later. Participants in the other group will receive the current standard two dose strategy of quadrivalent influenza vaccine one month apart. All vaccines will be administered by injection into the muscle. All participants will be required to provide blood samples at four time points: 1) before first influenza vaccination, 2) before second influenza vaccination; 3) 21-28 days post-second-vaccination; and 4) approximately 6 months post-vaccination. They will also be asked to provide information on vaccination history, side effects and occurrence of influenza-like illnesses (ILI). Participants who develop respiratory symptoms during the study period will be asked to provide a nasal swab. Findings may assist in improving vaccine responses and protection from influenza in a highly vulnerable patient group

  • Prebiotic supplement use, the gut microbiome and behaviour change in children with autism spectrum disorder (ASD).

    This intervention study will assess the effect of prebiotic supplementation ßGOS on Quality of life, basal cortisol levels, social and mealtime behaviours, GI symptoms and sleep patterns in children aged 4 to 10 years with a clinical diagnosis of Autism Spectrum Disorder (ASD).

  • One-Needle Approach to Paediatric Procedural Sedation using Ketamine: A Randomised Control Trial.

    Procedural sedation in children is a commonly performed task in mixed emergency departments around Australia. Ketamine has gained significant acceptance as the drug of choice to conduct this sedation. The preferred route of ketamine administration is an ongoing debate. Historically intravenous ketamine sedation has been favoured, however the evidence is not strong and mostly based on anecdotes. Further, the initial intravenous cannulation required has the negative consequence of inducing significant pain and distress. Aim To demonstrate in a randomised control trial that intramuscular ketamine, given in one needle, can achieve successful procedural sedation in children. Research Design This is an open label multicentre randomised control trial investigating whether paediatric procedural sedation can be achieved with just one needle. Study sites include Gold Coast University Hospital and Logan Hospital - 537 participants will be enrolled. Patients 1-12 yrs of age presenting to emergency department and requiring procedural sedation with ketamine (as determined by the senior treating clinician) will be eligible for inclusion into the study. Exclusion criteria will include the lack of informed consent and intravenous cannulation being required for another aspect of their management. The study has two intervention arms, one arm will receive 3mg/kg and the other arm will receive 4mg/mg via intramuscular injection. Participants will be randomised in a 1:1:1 ratio between the two intervention arms and control. Intramuscular injections will be administered by the treating doctor or nurse. Where adequate sedation to undertake the required procedure is not achieved with the initial intramuscular dose, additional intramuscular or intravenous doses of ketamine will be administered at treating clinician discretion.. Patients in the control group will be intravenously cannulated and ketamine given initially at 1mg/kg and then dose titrated to effect at the treating clinician’s discretion. The primary outcome will be success of paediatric procedural sedation with only one needle. Secondary outcomes include length of stay in the emergency department, length of sedation and adverse effects in the intramuscular versus intravenous groups. Significance This multicentre randomised trial will allow definitive assessment of the efficacy of a one needle approach giving intramuscular ketamine to achieve paediatric procedural sedation in children, with the goal of minimising unnecessary distress.

  • Lyophilised Oral Faecal Microbiota Transplantation in the Management of Ulcerative Colitis -(LOTUS Study)

    Ulcerative colitis (UC) is a chronic, disabling immune mediated inflammatory condition affecting the large bowel, which is thought to be caused by an aberrant interaction between the immune system and a dysbiotic intestinal microbiome. There is emerging evidence that faecal microbiota transplantation (FMT) is effective in treating UC. This is a multi-centre double blind, randomised, placebo-controlled trial of orally administered FMT in patients with chronic active UC over an 8 week period.

  • Effectiveness and safety of LM011 in treating subjects diagnosed with non-alcoholic steatohepatitis (NASH).

    This open-label, 16-week, 20-subject study is to assess if LM011 is safe and efficacious in treating subjects diagnosed with non-alcoholic steatohepatitis (NASH).

  • A trial of computerised brain training to improve cognitive function in adults with cochlear implants

    Cochlear implant surgery is used to treat moderately-severe to profound hearing loss, but there are currently no treatments for cognitive impairment associated with hearing loss. The current clinical trial will examine and compare different types of computer-based brain training activities to determine which type of training will improve memory and thinking skills, hearing abilities, mood, and quality of life in adults with cochlear implants. We hypothesise that cochlear implant recipients will experience significant improvement in memory and thinking skills, hearing abilities, mood, and quality of life in response to auditory training combined with cognitive training. Considering that dementia is now the second leading cause of death in Australia and mid-life hearing loss may predict the development of dementia in later-life, findings from this study have the potential to inform the broader community of steps they can take to potentially limit and prevent the onset of dementia associated with their hearing loss.

  • Combined endurance and resistance exercise training for physical and mental health in the academic workplace; significance for both employer and employee.

    Full-time desk-based workers may be at greater risk of mental (e.g. depression and anxiety) and physical (e.g. diabetes and cardiovascular disease) disease due to low levels of physical activity and/or chronic stress. There is preliminary evidence that increasing physical activity through a combined resistance and endurance exercise training intervention (CT) could provide significant mental and physical health benefits to employees within this workplace. The academic workplace is unique in that academics have higher psychological strain and lower job satisfaction compared to other university staff, who already present with greater symptoms of anxiety and depression than the general population. Considering the paucity of health research within academia, this high-risk cohort lends itself to an investigation of the impact of CT on mental and physical health within the workplace. In turn, this study will determine the effects of a 14-week CT intervention on the mental and physical health of inactive full-time academics.

  • Should we CHECK it? Assessing interrogation of cardiac implantable electronic devices in the Emergency Department

    The purpose of this study is to investigate the outcomes of Cardiac Implantable Electronic Device (CIED) interrogations performed in the Emergency Department (ED). Patients who present to the Royal Adelaide Hospital’s (RAH) ED whom have an Implanted Cardiac Electronic Device (CIED) currently have their device interrogated upon request by the attending ED physician. These device interrogations are performed by Cardiac Physiologists, often requiring call-backs at the expense of the hospital, who use specialised computer systems which can interact with the device by telemetry. The performance of the CIED can be assessed during these interrogations to exclude device malfunction as a contributing factor to the patient’s clinical presentation. Furthermore, clinical data trends stored in the device can assist in diagnostics for the ED physician. It is not known how frequently significant issues are detected from these device checks. We hypothesize that there is a low yield of significant issues identified by CIED checks performed in the ED. The outcomes of this study can be used to develop evidence-based triaging methods to reduce the number of unnecessary checks and call-backs being performed.

  • Assessing the effect of changing a women's diet during breastfeeding on the levels of nutrients and hormones in their breast milk.

    Breast milk is the optimal form of infant feeding, and it is recommended that all infants should be exclusively breastfeed for the first 6 months after birth. Breast milk contains the essential nutrients, immune factors and hormones to support infant growth and development. However, it is becoming increasingly clear that the levels of these factors vary considerably between mothers, and that these differences may affect the short and longer-term health of the child. Maternal diet is thought to be an important determinant of the breast milk composition, however there is very little known about how changes to the maternal diet while breastfeeding can impact on breast milk composition. Many women in Australia currently consume poor quality Western diets that contain excess amounts of fat and added sugars, and there are suggestions that this might be having a negative effect on the quality of the mother’s milk. However, no studies have determined whether and to what extent improving dietary quality during breastfeeding can affect the composition of human milk. The aim of this research study is to determine the effect of improving dietary quality during breastfeeding on the concentrations of macronutrients (fat, sugar, lactose) and metabolic hormones (leptin, adiponectin, insulin, ghrelin) in breast milk.

  • Brain Oxygenation changes during Heart Surgery

    The aim of this pilot study is to evaluate the relationship between intraoperative blood pressure and brain metabolism during heart surgery using an advanced non-invasive optical imaging technique . We hypothesise that drops in perfusion pressure (below the limit of cerebral autoregulation) which are frequently encountered in heart surgery, not only impair cerebral haemodynamics, but also affect brain metabolism. This research will extend this extensive programme of research for the first time to the cardiac surgical population. This pilot study will inform the feasibility of future studies comparing [oxCCO] with clinical outcomes following cardiac surgery.

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