ANZCTR search results

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

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33057 results sorted by trial registration date.
  • Very low-energy diet before surgery in obese patients undergoing partial liver excision: a pilot randomised control trial (Very SuPPLE Trial)

    The purpose of this study is to determine if it is possible to use a very low calorie diet in obese patients prior to surgery. Who is it for? You may be eligible for this study if you are an overweight adult who is undergoing surgery to remove all or part of your liver. Study details Participants in this study will be randomly selected to undergo one of the following: Group 1: participants in this group will be required to undergo a very low calorie diet for 2 weeks prior to their surgery, including 3 replacement meals per day. Group 2: participants in this group will continue with routine preoperative care with their physician. All participants will have will have an ultrasound elastography to measure Liver stiffness (steatosis) and liver size, and will have an ICG Clearance test to investigate liver function. It is hoped that this research will help determine if very low calorie diets can be completed by participants in the 2 weeks prior to their surgery, and whether the low calorie diet has any effect on surgery outcomes.

  • The Active Breed randomised controlled trial: A weight loss and lifestyle modification program for male football fans in South-Western Sydney

    Active Breed is a 12-week, gender-tailored men's health program targeting weight loss, physical activity, nutrition, mental health, and violence prevention. The program has been tested as a pilot RCT and will be delivered on a larger scale through this study. The program will be delivered through the Canterbury-Bankstown Bulldogs Rugby League club and will include weekly education and physical activity sessions held at the club's home stadium. Physical activity sessions include gym-based workouts in the first grade gym and touch football games on the sports ground.

  • BEFRIENDAS study: The impact of befriending on depression, anxiety, social support and loneliness in older adults living in residential aged care facilities

    Up to half of people living in residential aged care facilities (RACFs) have significant depression symptoms. Many residents are socially isolated in RACFs even though they are in communal living, and social isolation is a contributor to depression. The literature provides some evidence for ‘befriending’ in alleviating depression, anxiety, social isolation and loneliness as well as improving quality of life and wellbeing, but few studies have been conducted for older adults living in RACFs. Befriending is non-directive emotional and social support generally provided on a regular basis by volunteers. We propose a randomized controlled trial of befriending compared with treatment as usual to improve depression, anxiety, social support and loneliness among residents of RACFs. An economic evaluation will examine the costs and benefits of the program. Volunteers will be trained using beyondblue resources and a manual for befriending already developed but to be further modified by the investigators. If successful the befriending model can be translated to the wider aged care sector to more effectively support residents and to reduce the prevalence of depression, anxiety and loneliness and improve social support in RACFs.

  • The InterACT (Intervention for Appropriate Care and Treatment) study: working with clinical teams in hospitals to trial a feedback loop approach to promoting appropriate care and treatment for elderly patients at the end-of-life.

    This study will work with clinical teams in three acute hospitals to trial a feedback loop approach to promoting appropriate care and treatment for elderly patients at the end-of-life. The feedback loop is intended to provide a ‘flag’ to increase clinician awareness of the risk profile of their patients, and to prompt a tailored care review activity. It is expected that the use of this feedback intervention will improve care outcomes for elderly patients, specifically to increase appropriate care and treatment pathways and reduce the incidence of non-beneficial treatments. the study will report the impact on patients, and the costs and implementation issues of the feedback loop activity.

  • Clinical Study of Synthetic Cannabidiol in Children and Adolescents with 22q11.2 Deletion Syndrome

    This is an open-label single-center study, to assess the safety, tolerability and efficacy of cannabidiol administered as ZYN002, a transdermal gel, for the treatment of child and adolescent patients with 22q11.2 Deletion Syndrome (22qDS). Male and female patients with 22qDS will be treated for 14 weeks. Patients taking Anti Epileptic Drug medications will have an additional one or two week Taper Period after the completion of doing with ZYN002. Approximately 20 male and female patients, ages 6 to < 18 years, will receive ZYN002.

  • The Developmental and Social Benefits of a Classical/Contemporary AllPlay Dance Program for Children with Autism Spectrum Disorder

    Dance is a unique form of physical activity that involves complex movement, emotional expression, and social opportunities. While many avenues of research have suggested that dance offers a wide range of benefits to its participants, children with ASD often face barriers to participating in dance and have fewer opportunities to take part in recreational programs compared to their typically-developing peers. As a consequence, few studies have been able to assess the effects of participating in dance for these individuals and it remains unclear whether this unique activity offers any significant benefits to social, cognitive, emotional/behavioural and motor functioning. The current study aims to deliver a tailored classical/contemporary dance program to children with ASD to begin exploring the potential outcomes of participation. The primary aim will be to determine the feasibility and acceptability of the classical/contemporary AllPlay Dance program. We hypothesise that the program will be feasible, and acceptable to children with ASD, their parents, and the experienced dancers/ buddies acting in a supportive role. Data for this analysis will be collected from all participants within 8 weeks of completing the program. We will also explore the effect of the classical/contemporary AllPlay dance program on social, cognitive, emotional/behavioural and motor functioning for children with ASD. Data for these analyses will be collected from all ASD families regardless of group allocation within 8 weeks of the intervention group commencing (baseline) and completing (primary timepoint 1) the dance program.

  • Are we giving appropriate dose of tranexamic acid in hip replacement surgery?

    According to the annual report from national joint replacement registry, around 32000 primary total hip replacements (THR) have been performed in 2017 in Australia. Reported prevalence of blood transfusion in THR is around 24%. Blood transfusions are associated with infectious risk and complications such as acute lung injury, and acute or delayed immune responses. Tranexamic acid (TXA) has been widely used for its anti- fibrinolytic effect in major joint replacement surgery. It has been shown to prevent excess bleeding and reduce the risk of blood transfusion following lower limb joint replacements. Current dosing of TXA for joint replacement surgery is not based on rigorous scientific evidence and dosing based on bleeding endpoints may be sub-optimal. In this study, we propose investigating the use of biomarkers to describe the extent of fibrinolysis as dosing endpoints for the physiological effect of TXA. From this, we will provide recommendations for effective dosing regimens of TXA in patients undergoing THR.

  • Clonidine at Low dosage postOperatively to Nocturnally Enhance Sleep

    Postoperative delirium is a common surgical complication associated with major long-term morbidity and mortality. No single pharmacological agent has been conclusively shown to reduce or prevent postoperative delirium, but recent trials with dexmedetomidine – a highly selective alpha2- adrenoreceptor agonist – have been promising. A low-dose infusion on the night of surgery appears to have a lasting effect at reducing delirium for the week post infusion, and improved both the quantity and quality of sleep. If these findings could be replicated with clonidine (the prototypical alpha2-adrenoreceptor agonist), this – and subsequent – studies could have substantial implications for future perioperative delirium risk management.

  • The effect of a milk-based oral rinse on satiety

    Acute exposure to fatty acid in the oral cavity leads to a satiety response (both hormonal and behavioural) in rodent models. However, this has never been shown in human studies. In addition, there is a large variation in taste sensitivity to fatty acid among humans. Therefore, it is possible that variation in fatty acid taste sensitivity might influence the efficacy of a fatty acid-mediated satiety response. The primary aim of this study was to assess whether oral exposure to a high concentration fatty acid solution would affect satiety in healthy Australian adults. The secondary aim was to assess whether fatty acid taste sensitivity would modify the aforementioned effect.

  • Using transcranial direct current stimulation to boost the hypoalgesic effects of exercise:: A randomised controlled experimental study

    Exercise is considered a first-line treatment for chronic musculoskeletal pain (Pescatello, 2014). One mechanism contributing to the near-ubiquitous prescription of exercise in chronic pain populations is ‘exercise-induced hypoalgesia’. Exercise-induced hypoalgesia (EIH) is the term used to describe acute reductions in pain sensitivity following exercise (Koltyn, Brellenthin, Cook, Sehgal, & Hillard, 2014). However, in chronic musculoskeletal pain, EIH effects are, at best, small to moderate. Exploration of novel interventions that could bolster EIH effects are therefore warranted. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that provides a promising avenue to boost the EIH response (O'Connell, Marston, Spencer, DeSouza, & Wand, 2018). ’However, the effectiveness of tDCS in enhancing EIH is not known. Therefore, this study will investigate whether tDCS can be used to boost the hypoalgesic effect of isometric exercise .

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