ANZCTR search results

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

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32834 results sorted by trial registration date.
  • "What Lies Beneath": Keyhole surgery after previous abdomino-pelvic surgery, and the risk of developing important scar tissue.

  • Does Mycobacterium ulcerans colonise skin prior to clinical Buruli ulcer?

    Buruli ulcer is a destructive disease of the skin and soft tissue that is caused by the bacterium Mycobacterium ulcerans. There is currently a major outbreak of Buruli ulcer in Victoria, specifically in the Mornington and Bellarine Peninsulas. It is unclear how humans acquire the disease. Further information regarding how Buruli ulcer is transmitted may help to prevent the disease and its complications. This study is investigating whether people who live in or visit endemic areas carry the bacteria on their skin. This has implications for how Buruli ulcer is transmitted. Participants will self-collect swabs of their skin (of backs of elbows, wrists, calves and ankles), which will be tested for the presence of Mycobacterium ulcerans DNA by PCR.

  • Early Nutrition Support in Neurosurgical Patients as guided by I-FEED scores

    Early nutrition in spinal surgical patients has been a part of most enhanced recovery protocols but has not been studied independently. Assessment of gastrointestinal function, measurement thereof, and appropriate timing of nutrition initiation have been ambiguous and non-standardized. I-FEED scoring system is a clinical decision making tool devised by the American Society for Enhanced Recovery and Perioperative Quality Initiative.We aim to compare and contrast period of time taken for dietary libertization in the the cohort of patients managed the standard way compared to the cohort having the I-FEED score utilized to assist their early postoperative nutrition. We believe that utilizing the I-FEED score will decrease the time it takes for patients to regain their ability to have full oral intake.

  • The SAINT Trial: Surfactant by supraglottic Airway versus direct laryngoscopy IN late preterm and Term newborns

    A significant number of late preterm and term newborns require respiratory support and surfactant administration in the immediate newborn period for respiratory distress. Although there are many methods for delivery of surfactant, almost all require laryngoscopy. For those infants born outside a hospital with a neonatal intensive care nursery this requires emergency transport and mother-baby separation as the skill of laryngoscopy is mostly held in tertiary care centres. A supraglottic airway device (SAD) is recommended by the American Academy of Pediatrics as an alternative to direct laryngoscopy in later preterm and term newborns requiring resuscitation. It is particularly useful in non-tertiary settings where the skill of laryngoscopy is not available. It is the purpose of this study in late preterm and term newborns with respiratory distress, to determine if this approach is non-inferior in therapeutic effect, presents less risk to the infant and is more user friendly than standard approaches requiring laryngoscopy. If proven effective and safe, the ease of use of a SAD in this population would mean that it could be widely applied in non-tertiary special care nurseries, reducing the need for emergency transfer to a tertiary NICU – reducing costs and keeping mothers and babies together.

  • Social Groups for Australian Children on the Autism Spectrum

    Individuals diagnosed with ASD experience persisting deficits in social communication and social interaction across multiple contexts. They experience high levels of social anxiety, loneliness and isolation, despite a strong desire for friends. It is likely that many of these children have much to gain from social skills training. KONTAKT(c) is a manualized Social Skills Training Group (SSTG) program designed for children and adolescents with ASD which has demonstrated improvements in social skills, behaviour, reduced stress and improved overall functioning as reported by parents immediately following and at three months after the program. However, social skills are at least in part influenced by social cultural contexts so the aim of the current project is to develop and evaluate the effectiveness of a social skills group training intervention, KONTAKT(c), for Australian Children with ASD.

  • The effectiveness of an online multimodal intervention for mental health promotion.

    There is a call to address population-level mental health through the use of integrative approaches that include non-pharmacological strategies such as lifestyle interventions, education programs and psychological therapies. Advances in online technology presents an opportunity to provide mental health promotion and primary prevention strategies that are easily accessible, available population-wide, and that overcome barriers with face-to-face interventions and the stigma of mental health disorders. Online interventions can also provide low-cost solutions for dissemination. This study investigates the effectiveness of a ten-week online multimodal intervention, incorporating both Positive Psychology and Lifestyle Medicine strategies, for improving the mental health and emotional wellness of a community-based cohort. Participants are randomly assigned to an intervention or control group and measures of mental health and wellbeing are assessed at times corresponding to pre-intervention, post-intervention and 12 weeks post-intervention. Comparative changes in the measures of mental health and wellbeing are made between the intervention and control groups.

  • Feasibility of testing the effectiveness of a theory-informed implementation intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial

    Imaging is overused in the management of low back pain, resulting in high healthcare costs and poorer patient outcomes. Previous strategies to reduce imaging have been largely ineffective. In prior work our research team has developed an intervention to reduce non-indicated imaging for low back pain. Prior to future effectiveness testing of the intervention, it is important to assess the feasibility of using the intervention in clinical practice and conducting a large-scale randomised controlled trial (RCT). The overall aim of this study is to perform a pilot cluster RCT to determine the feasibility of a fully powered effectiveness study, and to assess the feasibility of implementing the developed intervention in clinical practice. This is critical to gain funding for future effectiveness testing using a large high-quality cluster RCT.

  • A study to look at the safety and efficacy of Acalabrutinib and Rituximab followed by chemo with or without Autologous stem cell transplant (ASCT) and maintenance Acalabrutinib and Rituximab in fit patients with previously untreated mantle cell lymphoma.

    This purpose of this study to evaluate the efficacy and safety of Acalabrutinib and Rituximab followed by R-DHAOx chemo with or without ASCT and maintenance Aacalabrutinib and Rituximab in fit patients with previously untreated mantle cell lymphoma. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with positive mantle cell lymphoma. Study details All participants in this study will receive the following: 1. Induction phase: one day of Rituximab in the vein and 28 days Acalabrutinib orally for 2 cycles. 2. Chemotherapy phase: 4 cycles of chemotherapy (21 day cycles) 3. Consolidation phase: including stem cell transplant 4. Maintenance phase: Acalabrutinib orally for one year and Rituximab in the vein every 3 months for 2 years. During the trial patients will have blood tests performed and undergo up to 5 PET/CT scans to help determined the progress of the treatment. It is hoped that this research will help determine whether this treatment is safe for patients, and what kinds of side effects/complications may occur with this treatment.

  • An exploration of nurse decision making when managing high risk medications in the intensive care unit.

    It is estimated that 60% of patients admitted to intensive care units receive vasoactive medication to support patient blood pressure and/or heart function. Patients presenting with infection, shock, injury, drug overdose or heart failure are prescribed vasoactive medications by doctors, and nurses are responsible for many aspects of management including preparation, administration, adjustment of doses and weaning. These medications are fast acting and need careful management to prevent harms including stroke and heart attack. Possible problems include rapid administration of the vasoactive medication or incorrect dose adjustments. There has been little research on how nurses manage vasoactive medications and many of the guidelines in current use are not based on research evidence. The aims of this study are to identify the frequency and types of decisions that nurses make in managing vasoactive medications, the immediate impact of these decisions on patients and the underlying decision-making processes in use. The project objectives are to observe how nurses manage vasoactive medications and the decision-making processes they use to assess patients, prepare, initiate and administer the medication and the decisions that prompt dose-adjustments, such as titration and weaning. A systematic review completed by the researcher and PhD supervisors identified few published studies of nurses’ management of vasoactive medications and this lack of attention, coupled with anecdotal clinical experiences, prompted the conceptualisation of this study (Hunter, Manias, & Considine, 2018). These medications are ubiquitous in intensive care settings all over the world and are managed by nurses with little or no evidence based support. The potential for risk associated with the use of vasoactive medications highlights that nurse decision making is fundamental to the safe management of vasoactive medications (Hunter et al., 2018).

  • Improving brain health in at risk populations with aerobic exercise

    Dementia is the second leading cause of death in Australia and its rate is expected to double in the next 20 years. Obesity, physical inactivity, cardiovascular diseases and other chronic diseases can reduce the function of the blood vessels in the brain, which may subsequently decrease cognitive function and mood, which may lead to the development of dementia. Recent evidence suggests that aerobic exercise, such as walking, may improve the health of blood vessels in the brain, potentially also improving cognition and mood. Accordingly, we will undertake a 16 week randomised control trial that will investigate the effects of aerobic exercise training on brain circulatory function, mood and cognition in a physically inactive, middle-age to older (50-80 years old) and overweight/obese (body mass index > 25kg/m2) population, with the hypothesis that exercise training will improve cognition and mood in this cohort by improving cerebrovascular function, as well as improving general health and wellbeing.

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