ANZCTR search results

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

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31379 results sorted by trial registration date.
  • Using CLEAR SPEECH to improve speech disorders following stroke or traumatic brain injury

    Overall this research aims to determine whether or not CLEAR SPEECH is a viable treatment option for patients with non-progressive dysarthria. Specifically, this research project aims to: 1. Determine the efficacy of CLEAR SPEECH as a treatment for non-progressive dysarthria following stroke and TBI across a range of perceptual, acoustic and everyday communication outcome measures. 2. To compare the effects of CLEAR SPEECH with the outcomes of traditional dysarthria therapy (TRAD) in individuals with non- progressive dysarthria. It is hypothesized that CLEAR SPEECH will result in short and long term improvements to perceptual and acoustic measures of speech function, and ratings of everyday communication in individuals with non-progressive dysarthria. Also, the degree of improvement in speech and communication parameters will be greater following CLEAR SPEECH compared to the effects achieved following TRAD.

  • Does reducing intra-abdominal scar tissue formation after removal of a gastric band make subsequent obesity surgery quicker and safer?

    A randomised trial to determine whether using a sprayable adhesion barrier onto the operative field during removal of a gastric band will make a future laparoscopic sleeve gastrectomy quicker and safer due to reduced scar formation where the gastric band used to be.

  • An evaluation of the effectiveness of an internet-based treatment program for psychotic like experiences.

    To determine if a purpose built evidenced-based internet-based program called Getreal is effective in reducing the frequency and distress associated with psychotic like experinces in young people.

  • Omega-3s, learning and behaviour in primary school children

    Omega-3s in fish oil are important for brain function and Australian children are not consuming enough in their diet. The purpose of this study is to give primary school children fish oil capsules or placebo capsules to determine whether the fish oil capsules assist them with their learning and behaviour, specifically literacy, attention, cognitive development, and parent/teacher reports of learning and behaviour as well as quality of life.

  • Does deep neuromuscular block reduce intra-abdominal pressure requirements during laparoscopic surgery? A prospective observational pilot study

    Laparoscopic surgery continues to cause specific pathophysiological changes particularly due to intraabdominal pressure (IAP) and positioning. Cardiovascular changes include hyperand hypotension, prolonged QT dispersion, arrhythmias and rarely cardiac arrest. Splanchnic perfusion changes with changes in organ function are mainly due to the increased intraabdominal pressures and the resultant reduction in abdominal perfusion pressure. Pulmonary changes like hypercarbia, hypoxemia and barotraumas are usually avoided through adaptations in ventilation settings. Although other causes like CO2 absorption, ventilation strategy, surgical technique, the nature and duration of the procedure, and intrinsic patient factors (intravascular volume, preexisting cardiopulmonary status and neurohormonal status) have been identified, the intraabdominal pressure caused by the CO2 pneumoperitoneum combined with the patient’s position remain the main drivers behind these pathophysiological change. Commonly IAP is around 12 mm Hg for most laparoscopic procedures. Pressures above 15 mm Hg lead to increased systemic and pulmonary vascular resistance and a reduction in cardiac index. Lowering insufflation pressures even more leads to a further reduction in postoperative pain and a better quality of life 5 days after surgery. The primary reason for insufflation is to create good view of the surgical field and enough room to manoeuvre with the surgical instrumentation. Determining factors will be the proceduretype dependent extent of the relevant surgical field, the patient habitus, and the abdominal wall elasticity. One would assume that a neuromuscular block (NMB) would facilitate the extension of the abdominal wall and produce more space at lower insufflation pressures. However, only very limited evidence exists, both suggesting that ongoing NMB may or may not provide any benefit. Clinical practice varies between ongoing NMB, intermittent NMB or no NMB at all after induction. With the advent of the reliable NMB reversal agent Sugammadex, we are now in a position to offer continuous deep NMB (CDNMB) until the end of the procedure without compromising our ability to timely and fully reverse the NMB. This enabled us to design this prospective observational pilot study to investigate if the IAP can be reduced to lower values with a CDNMB with Rocuronium compared to no ongoing neuromuscular block under a standardized anaesthetic technique. The outcome of this study will help us determine the power and study size requirements for a randomized controlled trial looking at the lowest IAP in patients with and without continuous deep NMB.

  • Dosing Study of the V501 Product - Protocol 503: An Efficacy Study comparing two Doses of the V501 Product in Patients with certain Anterior Segment Eye Diseases

    Dosing study of sustained release Ocular System for treatment of Anterior Segment Eye Disease to determine Safety and Efficacy of the ForSight V501 Product.

  • Sitting Time AfteR Stroke (STARS). A phase II safety and feasibility trial of counselling sessions aimed at encouraging stroke survivors to 'move more and sit less'.

    Sitting for long periods of time each day is detrimental to health and has been linked with increased risk of cardiovascular disease and death. Stroke survivors are among the most sedentary members of society and face significant barriers to maintaining recommended levels of physical activity. This project aims to investigate the safety and feasibility of an intervention aimed at encouraging stroke survivors to 'sit less and move more' each day.

  • Exenatide in acute ischemic stroke- a randomised controlled trial

    This study will investigate the use of a drug called Exenatide in patients with acute ischaemic stroke. Exenatide is a drug currently approved for use in patients with type 2 diabetes to help control glucose levels. Research in animals and other laboratory studies suggests that exenatide may have a protective effect on brain cells by protecting cells that are at risk of dying in ischaemic stroke, as well as controlling glucose levels. Exenatide has also been shown to reduce the area of brain damaged by stroke. In this study we aim to have two groups of 25 patients – an exenatide treatment group and a control group. One group will receive an exenatide injection twice daily for 5 days after stroke, with the first dose given within 9 hours of the onset of stroke symptoms. These patients will also receive either metoclopramide 10 mg or ondansetron 4 mg twice daily intravenously to prevent nausea and vomiting for the first 3 days. The control group will have standard stroke care without exenatide treatment. Patients in both groups are also eligible to receive tPA therapy. Blood tests will be taken on days 0,1, 3, 5, 7 and 14 to assess glucose levels and other blood markers. Standard imaging for stroke patients will be done for participants in the study, including a CT scan before starting the trial and CT or MRI 3-5 days after the stroke. All the patients will also have continuous glucose monitoring done in the first 72 hours. This will be done by equipment called Guardian real-time CGM system (Medtronic), which has a sensor with a subcutaneous needle. We aim to look for any significant differences between the two groups for blood sugar control, clinical outcome and size of stroke on CT/MRI. We will also monitor participants closely for adverse events that may be linked to exenatide treatment.

  • Effects of protein on gastric emptying and hormones, and appetite and energy intake in undernourished compared with healthy older individuals

    Ageing is associated with a physiological reduction of appetite and energy intake, which has been called the “anorexia of ageing”. Dietary supplementation with liquid protein preparations is now used frequently to increase energy and protein intake in older adults in both institutionalized and community-dwelling populations. Although the latter would appear a logical approach, evidence for success of increased energy intake in older individuals is limited. It is well established that the ingestion of nutrients induce a number of changes in gastrointestinal (GI) function, which are associated with the modulation of appetite and energy intake. These changes include the slowing of gastric emptying, which sustains gastric distension and is associated with proximal gastric relaxation. In addition to the effects of healthy ageing, there is evidence of differences between undernourished and well-nourished older people, which may potentially result from being undernourished and/or contribute to the undernourished state. Urgent investigation is warranted to determine the effects of oral protein intake, so that protein can be incorporated into their diet to assist in sparing muscle mass without reducing their appetite. The study aims to characterise in older individuals, the effect of undernutrition on energy intake, appetite, antral area, gastric emptying, plasma concentrations of amino acids, hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose.

  • A trial to determine the benefits of the UniWellbeing Course for consumers of Macquarie University Campus Wellbeing with symptoms of anxiety or low mood

    This study tests the short and medium term efficacy of the online UniWellbeing Course with students with symptoms of anxiety or low mood, when administered by staff from the Macquarie University Campus Wellbeing Service.

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