ANZCTR search results

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

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31330 results sorted by trial registration date.
  • REACH: Multisite randomised trial of Rehabilitation very EArly in Congenital Hemiplegia

    This multisite study will compare infant friendly modified constraint induced movement therapy to infant friendly bimanual therapy for infants with asymmetric brain injuries.

  • Nerve transfer surgery in the upper limb of patients with tetraplegia

    The aims of this project are to: 1) conduct a prospective case series of nerve transfer surgery in eligible patients with tetraplegia; 2) implement and refine a standardised protocol for clinical and neurophysiological assessment and post-operative therapy; 3) evaluate the outcomes and cost-benefit of nerve transfers. Fifteen patients with complete or incomplete SCI between C5 and C7, who are deemed suitable for surgery by the Upper Limb Program Team, will be evaluated. Participants will undergo thorough clinical and neurophysiological assessment pre- and up to 24 months post-operatively. Donor and recipient nerve and muscle tissue samples will be examined histologically, and functional tests of upper limb performance will also be conducted. Expected outcomes include evidence of the functional effectiveness of nerve transfer surgery, refinement of selection criteria and post-operative management, cost-benefit of nerve transfer surgery , and histological information about the health of the donor and recipient nerves and muscles.

  • Assessing nutritional status in patients with spinal cord injury

    Nutritional management of patients after spinal cord injury is complex and challenging. Dietitians currently estimate a patient’s nutritional requirements using standard equations of normal resting metabolism, adjusted for activity and stress levels. These equations have never been validated in the spinal cord injured population. To do this, metabolic activity will be measured using a technique called doubly labelled water. Patients are given a single dose of water labelled with a stable isotope. The elimination of the isotope over time directly measures metabolic activity. Weight loss, commonly used to detect malnutrition, cannot distinguish between muscle wasting associated with paralysis and wasting from malnutrition. This study will therefore validate the use of an objective and non-invasive technique called bioelectrical impedance analysis (BIA) to measure segmental body composition (muscle, fat and water) in acute spinal cord injury. With segmental BIA, muscle wasting due to paralysis can be distinguished from wasting due to malnutrition. BIA measures will be validated by dual energy x-ray absorptiometry (DEXA), the gold standard for analysing body composition. BIA can be conducted at bedside and is therefore more clinically feasible and cost-effective for on-going assessment in this population where nutritional needs change through different phases of recovery.

  • A study for participants with cancer who experience ongoing nausea, not related to their treatment, despite taking standard and usual medications, that studies the effectiveness of oral methotrimeprazine versus oral haloperidol.

  • Do suction assisted negative pressure dressings reduce the incidence of surgical site infections after abdominal surgery: a randomized controlled trial.

    The aim of this project is to assess a new kind of dressing, to see whether it reduces the rate of wound infections after abdominal surgery. The dressing is attached to a small, portable device that creates suction or negative pressure on the wound, to help suck away any fluid that leaks from the wound. These dressings have been assessed as being safe, and are already in use in the hospital. However, there is no conclusive evidence that they provide a benefit to patients by reducing wound infections. We will hopefully answer that question, and help to provide better outcomes to future patients undergoing abdominal surgery. This study is in part funded by the company that makes the dressing used. However, they do not provide any direct payment to the investigators, and do not have any role in collecting information or deciding what the results of the study are. This research is being conducted by doctors and nurses working in Dandenong Hospital, under the auspices of the Monash School of Medicine.

  • Measuring the increase in exhaled carbon dioxide in spontaneously breathing infants at birth, the RISE study

    When we breathe, we take in oxygen and get rid of carbon dioxide. Based on previous studies, many done at the Royal Women’s Hospital, we believe that monitoring carbon dioxide that the baby breathes out may be a useful tool to improve our ability to help babies breathe at birth. The purpose of this study is to measure and define the common values of carbon dioxide that a healthy baby breathes out during the first ten minutes of life. Carbon dioxide will be measured whilst the newborn baby breathes into a mask, intermittently, during the first ten minutes of life, with repeated measurements at 1-2 hours and 12-72 hours of life. With the knowledge gained about how much carbon dioxide is breathed out in the first minutes after birth, more effective ways of helping babies breathe at birth can be developed.

  • Anti-inflammatory treatments for contact lens discomfort

    Contact lens discomfort is a multifactorial condition that is “characterised by episodic or persistent adverse ocular sensations related to contact lens wear, which can lead to decreased wearing time and discontinuation.” Currently, the main form of treatment for contact lens discomfort is the use of artificial tears (lubrication drops), which can assist in reducing these symptoms by supplementing the deficient tear fluid. However, as artificial tears fail to address the underlying cause of the condition, for many patients they are inadequate in completely relieving symptoms. New and enhanced therapeutic treatments are therefore needed. Inflammation has been implicated in the pathogenesis of contact lens discomfort. The aim of this ‘proof-of-concept’, single site clinical trial is to evaluate the benefit of different formulations of omega-3 supplements for treating contact lens discomfort.

  • Speech Discrimination and Early Acquisition of Language in Infants with Hearing Loss

    Now that newborn hearing checks are available, hearing loss is often picked up soon after birth and hearing aids are fitted shortly after. There are standard procedures for checking that the hearing aids make sounds audible to a child, but no one knows how effective the hearing aids are for supporting discrimination between sounds because there are no clinical tools to do so. Further, no one knows whether this early discrimination ability may relate to later language development of children with hearing loss. The IDEAL study aims to 1) develop new clinical tools for assessing whether an infant with hearing loss can hear the differences between sounds after they are fitted with hearing aids; and 2) determine the relationship between early auditory discrimination and spoken language skills at 3 years of age for children with hearing loss. The findings will provide the much-needed evidence to guide best-practice management of children with hearing loss.

  • A randomised controlled trial comparing a brief and standard parenting intervention for toddler externalising and aggressive behaviours

    This randomized controlled trial compared the efficacy of a brief parenting intervention with a standard parenting intervention and a waitlist control group, for reducing toddler aggressive behaviour, dysfunctional parenting and related aspects of family functioning. It was hypothesized that both interventions would show superior improvements relative to the control group in child aggressive behaviours and other child and family outcomes, but that the brief and standard interventions would not differ significantly from one another at post-assessment or 6-month follow-up.

  • A stepped wedge cluster randomised controlled trial of a healthy lifestyle intervention for people attending residential substance abuse treatment

    This study will determine whether administering a healthy lifestyle intervention targeting multiple cancer risk factors, namely smoking, poor diet and physical inactivity, will change behaviours among people attending residential substance abuse treatment. The study will be conducted with people who are attending The Salvation Army Recovery Service Centres located in New South Wales and the Australian Capital Territory, Australia. You may be eligible to join this study if you are aged 18 years or above, have an alcohol or other substance abuse dependence disorder and are attending The Salvation Army Recovery Service Centre. Study details: Cardiovascular disease and cancer are leading causes of mortality for people with a history of substance abuse problems and it requires prevention strategies that address primary risk factors such as smoking, poor diet, and physical inactivity. The current project will trial the Healthy Recovery Program, a group based intervention that targets multiple cancer risk factors. Each service centre will be randomly allocated (by chance) to one of two programs: a Healthy Recovery program or the usual residential substance abuse treatment program provided by the Salvation Army. The Healthy Recovery program focuses on helping participants to reduce their smoking, improve their diet and increase their level of physical activity in a group setting. The intervention involves a combination of health focused psycho-education, goal setting, monitoring, motivational interviewing, and cognitive behavioural therapy. Participants will be asked to complete a number of questionnaires at 8-weeks, 3-months and 6 months post-intervention to assess frequency of smoking, fruit and vegetable consumption, physical activity, alcohol and substance use, quality of life and mental health. Results from this study will inform the development and implementation of multiple health behaviour change interventions for other marginalised populations.

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