ANZCTR search results

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

You can narrow down the results using the filters

30938 results sorted by trial registration date.
  • REACH Project: Reducing Alcohol-related harm in General Practice

  • A study testing wafers containing different doses of dexmedetomidine in healthy volunteers.

    This is an open-label, four-way crossover, fasted pharmacokinetic study in healthy volunteers. The screening visit will include a physical exam, vital signs collection, an electrocardiogram, safety laboratory sampling and urinalysis to determine suitability for inclusion into the study. Qualified study participants will be admitted the evening prior (Day -1) to scheduled dosing. Each participant will receive a single dose of study medication per dosing day. There will be a minimum washout of 44 hours between doses. Participants will remain inpatient for the entire dosing/washout period and will be discharged 24 hours after Treatment D.

  • Narrative Discourse Therapy for Patients in Post-Traumatic Amnesia (PTA): A feasibility study

    Post-traumatic Amnesia (PTA) is a state of confusion after someone experiences a TBI. Speech Pathologists (SPs) currently undertake a range of practices for patients with PTA but what they do is under-reported and requires further investigation (Steel et al., 2013). It is common practice that when patients are in PTA, direct therapy is kept to a minimum in case activities lead to agitation. However recent studies have demonstrated that patients in PTA can participate in some therapies such as physiotherapy or occupational therapy. Cognitive-communication deficits are a common sequelae of Traumatic Brain Injury (TBI) with 80–100% experiencing this type of communication impairment (MacDonald & Wiseman-Hakes, 2010). Part of this cognitive-communication profile is the ability to structure verbal narration of an event or a series of events (i.e. narrative discourse). This research project aims to investigate the feasibility of conducting structured narrative discourse therapy with people in PTA in order to improve their cognitive-communication skills. It is hypothesised that patients will tolerate participating in this specialised novel therapy program without any adverse effects and we expect to see improvement in their narrative discourse skills. We also hypothesise that people in PTA will have impaired narrative discourses.

  • BEAT CF: Pulmonary Exacerbations Treatment Platform - Backbone Antibiotics Domain

    BEAT CF is a national, multi-site project which aims to learn and implement , which of the antibiotics commonly used to treat lung infections are best. There is no single standard of care for managing CF pulmonary exacerbations. Standard care comprises a range of interventions and varies across and within CF treatment centres and may evolve over the course of the PEx Treatment Platform. At the time of initiation of the PEx Treatment Platform Protocol, management of pulmonary exacerbations generally involves the use of one or more intravenous (IV) antibiotic therapies. The duration of IV antibiotic therapy is typically 14 days, and generally ranges from 10 days to 21 days. A recent RCT found evidence that 10 days was non-inferior to 14 days of IV antibiotics therapy in those with a rapid treatment response, and found no evidence that 21 days was superior to 14 days of IV antibiotics therapy in those without a rapid treatment response. Most Australian clinicians manage pulmonary exacerbations with an antipseudomonal beta-lactam or carbapenem, combined with a non-beta lactam antibiotic - most typically the aminoglycoside IV tobramycin. Some, but not all, clinicians reserve the use of IV aminoglycoside for patients known to be colonised with Pseudomonas aeruginosa. Some, but not all, clinicians use the results of microbiology and in vitro susceptibilities to guide antibiotic selection. Many centres provide additional antibiotic cover targeted to specific pathogens, but only if identified on sputum microbiology, e.g. for Stenotrophomonas maltophilia or Staphylococcus aureus. CF clinicians prescribe physiotherapy for airway clearance as a core part of the management of CF pulmonary exacerbations, though there is variation in the nature and frequency of this therapy. Some, but not all, CF clinicians all prescribe muco-active or anti-inflammatory therapies. As for the use of antibiotics, there is no evidence to support any of these modes of treatment as a single best standard of care. The primary objectives, outcomes and endpoints for the PEx Cohort were informed by a systematic review of the literature and involvement of key clinical and consumer stakeholders.

  • Health4Me: text messaging to support adolescent physical and mental health and wellbeing in the community

    The current picture of young peoples’ health in Australia is alarming with escalating health risks such as poor diet, physical inactivity, increased screen time and poor mental health becoming widely prevalent. These health risks can lead to chronic health problems such as heart disease in adulthood. Australia’s 3.3 million teenagers have little support to manage these health risks and accessible, engaging programs that support a healthy lifestyle are urgently needed. This innovative Health4Me program will strive to solve this problem. We know that text message healthy lifestyle programs in adults have improved health outcomes and resulted in positive behaviour change. This project will develop and test an engaging healthy lifestyle program for teenagers using text messages, a method through which they communicate every day. We will work with teenagers to co-create theHealth4Me program using an established process, test how effective Health4Me is in a randomised clinical trial (390 teenagers) and evaluate if the program improves physical and mental health outcomes, whether it is acceptable and engaging and if the program can be embedded into the Australian healthcare system. We hypothesise that the Health4Me intervention (with optional health counselling) will improve physical activity or nutrition behaviours more effectively than usual care over 6-months. If it helps, it can be scaled up to deliver to teenagers throughout Australia to improve health outcomes.

  • The effects of non-thermal plasma on burn wounds: a pilot study

    Non-thermal plasma (NTP) is a relatively new technology that generates charged molecules (ions, and reactive oxygen species) at safe working temperatures of 35-40'C. The charged molecules (free electrons and reactive oxygen species such as Ozone) interact with microbial cellular structures such as DNA and proteins causing intracellular deactivation and injury, which induces cellular death. This cellular destruction occurs independently of any antibiotic process, thereby adding to treatment options for multi-drug resistant bacteria. Based on these findings non-thermal plasma has been applied in a variety of commercial fields including water treatment, sterilisation, and healthcare. Terraplasma Medical GmbH has developed and commercialised a hand-held non-thermal plasma device (Plasma care) for use in chronic wounds. The application of this device in burns has yet to be elucidated. The aim of this pilot study is to examine the feasibility, acceptability and initial efficacy of this device in burn wounds. At total of nine inpatients with <10% total body surface area burns will be recruited. A section of the burn will be treated with NTP with the rest treated with standard therapy. Wounds will be assessed and treated daily, with outcomes compared with standard treatment.

  • pRophylactic utErosacral suspension AT Total lAparoscopiC Hysterectomy and the risk of prolapse occurrence – a randomised controlled trial (REATTACH)

    As per the recommendations from American Association of Gynaecologic Laparoscopists (AAGL) practice report, uterosacral ligament suspension may be performed during laparoscopic hysterectomy to reduce the risk of post-hysterectomy vaginal vault prolapse. Hence, ongoing research into the most effective method of preventing prolapse is warranted, this study aims to evaluate the effect of prophylactic uterosacral suspension at time of laparoscopic hysterectomy on reducing the risk of developing prolapse in the future.

  • Early Reintroduction of Nuts for ImmunothErapy (ERNIE)

    This study is a feasibility study designed to establish the safety and tolerability of a food based multi-nut oral immunotherapy (OIT) protocol in children under 5 years of age in WA, We hypothesize that multi-nut OIT will be a practical approach to desensitising children with multiple nut allergies in this age group. Participants with peanut and/or tree nut allergy will receive multi-nut OIT (almond, cashew, hazelnut, walnut and peanut) for 12 months. Children will otherwise avoid those nuts in their diet to which they are confirmed to be allergic at study entry, while those nuts that were tolerated at study entry can be eaten as desired in addition to the OIT doses. Treatment adherence and adverse reactions will be monitored via a daily electronic diary in addition to regular assessment by study clinicians at each visit and monthly telephone calls. Quality of life data will be collected prior to, during and at end of treatment. After 12 months, all participants will undergo an oral food challenge (OFC) to establish whether they are desensitised to the nuts to which they were allergic to at the start of the study.

  • Evaluating a Group Cognitive Behavioural Therapy Program for Adults with Muscle Dysmorphia

    The primary purpose of the study is to investigate the efficacy of a pilot online 8-week cognitive behavioural therapy (CBT) program for adults with muscle dysmorphia. The outcome measures are: primary (changes in muscle dysmorphia symptoms) and secondary (changes in disordered eating, compulsive exercise, depressive symptoms, and psychological distress). There is no prior treatment research on muscle dysmorphia, but we expect participants to experience some benefit in symptoms over the course of the 8-week program.

  • MOVETech: enhancing the coMpetency and confidence of Older drivers in the use of advanced VEhicle TECHnologies

    Older drivers in Australia drive older cars, have increased crash involvement particularly intersection crashes and are more vulnerable to injuries. Autonomous Vehicle Technology (AVT), such as crash avoidance systems, in-vehicle information systems, and comfort-supporting systems, are available in a range of vehicles and are likely to become standard. They have been shown to promote and enhance safe driving whilst potentially mitigating age-related declines. A recent scoping review found <10% of studies examining AVT examined use by older drivers. The limited evidence to date has shown low usage, awareness, confidence, and competency levels in these safety features amongst older drivers. This may be due to a combination of high self-rated driving confidence in older drivers and the fact that many older drivers use older vehicles which do not feature AVT. Little is still known about how older drivers view these technologies, their convenience and the ability of older drivers to use them correctly in order to promote safety. Studies have shown that compared to no training, any type of training in AVT use is beneficial to driving performance. It is hypothesized that road traffic injuries and fatalities can be reduced, among older drivers, by increasing awareness and competence in use of newer cars with available AVT: Level 0 (warnings and alerts) and Level 1 (driver assistance) and Level 2 (adaptive cruise control and lane keeping assist). This trial builds on a successful pilot study (n=8) of a multi-modal training program involving 1) an interactive classroom session, and 2) an on-road (naturalistic) driving session with a trained driving instructor or driver-trained occupational therapist in a dual-controlled vehicle, developed through an expert panel review process led by the research team in 2019-2020. This project will comprehensively investigate AVT for today’s older drivers, with findings of relevance to consumers, insurers, and policy makers and will inform how to position AVTs to enhance the safety older drivers.

Tags:
  • Finding clinical trials