ANZCTR search results

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

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32815 results sorted by trial registration date.
  • Investigating heat tolerance in females

    Heat tolerance testing is used to establish if a Defence member is fit for return to duty following heat illness. The most frequently utilized heat tolerance test was developed by the Israeli Defence Force in the late 1970s with male participants. To our knowledge, the appropriateness of this protocol for females has not yet been established. Therefore, this study aims to investigate female heat tolerance responses using the current standard heat tolerance test protocol and to develop an alternative protocol if the current protocol is inappropriate.

  • Effects of transcranial direct current stimulation for improving attention after traumatic brain injury

    This study evaluates the efficacy of brain stimulation, i.e. Transcranial Direct Current Stimulation (tDCS) to improve attention skills and working memory in people with traumatic brain injury. The study involves placing electrodes on the scalp and passing a weak direct electrical current through the brain that can increase neuronal excitability. The stimulation is non-invasive and painless with few reported side effects such as skin irritation or a mild headache. Individuals received one active/actual tDCS sessions and one sham or placebo session. During both sessions they also completed two computer-based task in which they responded to symbols appearing on the computer monitor. Participants were fully awake and alert during these sessions. Test sessions were approximately an hour in duration and took place approximately 1 week apart. The order of session (active or sham) was unknown to participants and, indeed, people find it very difficult to guess.

  • INTEGRATE: An integrated treatment for young people with psychological distress.

    The aim of the study is to test whether a new integrated psychological treatment (INTEGRATE) improves mental health difficulties and decreases the risk of problematic substance use in young people, compared with usual treatment. Young people between the ages of 12 and 25 (inclusive) will be randomised to receive either i) the INTEGRATE therapy, or ii) treatment as usual (TAU), for 16 weeks in a double-blind, randomised controlled trial (RCT), with followup to 12 months. The primary hypothesis is that young people who are randomised to receive the INTEGRATE intervention will decrease their alcohol and other drug use compared to participants in the TAU group.

  • Lignocaine versus opioids in myocardial infarction (AVOID-2)

    There is some concern that medications called opioids, which are used to treat pain, may delay the onset of blood thinning medications that are vital to improving patient outcomes after a heart attack. This study seeks to enrol patients suspected of having a heart attack to compare the safety and effectiveness of a different type of painkiller called lignocaine (which does not appear to interact with blood thinners) to fentanyl which is the current standard of care opioid used. We hypothesise that use of lignocaine will be safe and effective for pain related to a heart attack. Ambulance Victoria paramedics will randomise patients with suspected heart attacks to receive either intravenous lignocaine or intravenous fentanyl and assess its effectiveness as pain relief and also side effects (safety) in each group. We will also assess size of the heart attack based on blood testing as well as clinical outcomes during follow-up.

  • How effective are anti-bacterial contact lens storage cases?

    The study aims to examine the rate and type of microbial contamination rate of silver impregnated and non-silver contact lens storage cases. This study is a prospective, randomized, single-masked, crossover clinical trial with five scheduled visits. A total 40 soft contact lens wearers will be recruited to use the silver impregnated lens cases and non-silver lens case (each for three month) along with a multipurpose disinfecting solution. Participants will be allowed to use their existing lens brand. There will be total 5 visits within 6 months (baseline, 1 month, 3 months, 4 month and 6 month). Routine assessment of contact lens fit and anterior eye health will be conducted at each visit and lens cases will be collected for microbial analysis at the 1, 3, 4 and 6 month visits. At each visit, participants will be requested to complete two questionnaires relating to their contact lens use. The contact lens storage cases and multi-purpose disinfecting solutions will be provided free of charge during the duration of the study. Participants will be provided with a $10 vouchers at the end of each study visit to compensate for their costs incurred in attending the study visits.

  • Investigating alternative treatment methods for Mal de Debarquement Syndrome

    Mal de Debarquement Syndrome (MdDS) is a rare neurological condition that affects the vestibular system and currently has no cure. Symptoms of MdDS include a continuous swaying, rocking, or motion-like feeling that typically arises following a motion experience such as traveling on sea, which leaves patients with a feeling of chronic “sea legs” or “sea sickness” though they are on stable ground. The underlying cause is currently unknown, and thus treatments for this condition are often ineffective. This project seeks to investigate the efficacy of a combination of Theta Burst Stimulation (a form of Transcranial Magnetic Stimulation) and the Vestibular Ocular Reflex Protocol (a manual therapy) in reducing objective and subjective measures of the condition. It is hypothesized that MdDS patients will report an improvement of symptoms after the combined therapy, which will significantly affect their quality of life, compared to the sham treatment.

  • Nitric Oxide on ExtraCorporeal Membrane Oxygenation – a randomised Trial in neonates and children (NECTAR trial).

    This pilot pragmatic open label randomized controlled Trial (RCT) compares the use of Nitric Oxide (NO) treatment blended into the oxygenator of the Extracorporeal Membrane Oxygenation (ECMO) circuit in comparison to standard care defined as no treatment with NO into the ECMO circuit. We hypothesize that in children treated with ECMO, a randomized trial investigating the use of NO during ECMO is feasible. We hypothesize that neonates and children on ECMO exposed to NO on ECMO have a reduced rate of clotting and bleeding complication and reduced inflammatory response measured by various clotting markers as well as serum cytokine levels in comparison to controls, leading to shorter ECMO run duration and reduced health care costs. The findings could have major potential to improve patient-centered outcomes and reduce health care costs.

  • Cradle to Kinder: A Qualitative and Quantitative Evaluation of a Maternal and Child Health Intervention for Disadvantaged Young Mothers

    Young disadvantaged mothers are at a higher likelihood of having their child/children removed from their care, which results in poor psychosocial outcomes for the mother and the infant. Therefore, a prospective cohort study will be conducted to evaluate the efficacy of the Cradle to Kinder program on psychosocial outcomes among young and vulnerable families. An anticipated sample of 50 young at-risk women and their families will receive the Cradle to Kinder program, commencing from pregnancy up until the child turns four years old, Cradle to Kinder is a targeted, intensive and long-term ante- and postnatal support service for vulnerable young mothers (aged less than 25 years with one or more risk factors) and their families. Cradle to Kinder practitioners will conduct weekly to fortnightly home visits and engage families in a range of different interventions to support and facilitate health outcomes. Assessments will be conducted by the practitioner at baseline and then every six months over the four years of the intervention. Maternal health outcomes (i.e., mental health, parenting capacity) will be measured using the North Carolina Family Assessment Scale, and infant outcomes (i.e., attachment style, social and emotional development) will be assessed by the Brigance. It is expected that families who engage in the program for its entire duration will demonstrate better psychosocial outcomes at the conclusion of the program compared to the beginning.

  • Effect of breaking up sitting on health and cognition in sleep-restricted and non-sleep restricted individuals

    Our modern 24h society means that sleep and waking activities are changing. Ten million Australian workers sit at work, eleven million Australians are sleep restricted and 1.9 million Australians are shiftworkers. This is problematic, as prolonged sitting and sleep restriction have negative impacts on health and safety at work and contribute to a huge burden on public health. Although sleep restriction and prolonged sitting have been investigated separately, to date, no study has investigated how these factors jointly impact health and safety. To investigate the combined effects of prolonged sitting and sleep restriction in different shiftwork types, this study measures cardiometabolic outcomes and cognitive performance in healthy adults doing dayshifts or nightshifts under different levels of sleep restriction and in conditions of prolonged sitting and conditions of breaking up sitting. We propose that breaking up sitting will improve cardiometabolic health and cognitive performance compared to prolonged sitting, but this effect will be lessened under conditions of sleep restriction. These results inform the development of workplace policy and public health guidelines targeting prolonged sitting at work and the impacts on health and safety.

  • Lung function, quality of life and handgrip strength in adults with heart disease

    Previous research has showed a reduced lung function after cardiac surgery and this has been associated with increased mortality and morbidity. The aim of this prospective, observational study is to determine if a cheap and simple tool like HGS could be an indicator of lung function and health-related quality of life after cardiac surgery. It is hypothesized that HGS will be a simple and valid method to monitor lung function and health-related quality of life during post-hospital recovery in cardiac patients.

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