ANZCTR search results

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

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31070 results sorted by trial registration date.
  • A Feasibility Study of Adjunct Transcutaneous Electric Stimulation in Post-stroke Incontinence Rehabilitation

    Certain Transcutaneous Electric Nerve Stimulation (TENS) machines are approved to be used in Australia to treat incontinence, however, it is not known if it is useful for people who have just had a stroke. In this study, the investigators aim to see if it is feasible and acceptable to use TENS in addition to standard treatments for incontinence after a stroke. Participation will involve trying two TENS treatment protocols and one sham TENS protocol. Participants are to learn one protocol on one day and then given a chance to perform the protocol while being observed by the investigator on the following day. The investigators hypothesise that adults can learn and safely perform TENS protocols for post-stroke incontinence.

  • Is metformin better taken before or with meals? An acute evaluation of the impact of timing of metformin administration on intestinal glucose absorption, gut hormone secretion and the blood glucose response to an intraduodenal glucose infusion in type 2 diabetes

    Metformin is the first-line oral glucose-lowering medicine in almost all clinical guidelines on the management of type 2 diabetes (T2D). Standard advice has been to ingest metformin with meals to minimise any gastrointestinal adverse effects. It was long thought that metformin’s main action relates to suppression of glucose output from the liver. However, newer evidence suggests that the gastrointestinal tract is a key site of metformin action, and that administration of metformin at an interval before the meal may be more effective than ingestion with the meal, for lowering postprandial blood glucose levels. We have recently shown that the lowering of postprandial glucose by metformin in patients with T2D is associated with stimulation of the incretin hormone, glucagon-like peptide-1 (GLP-1), and inhibition of intestinal glucose absorption. We now propose to evaluate whether the timing of metformin administration affects glucose absorption, GLP-1 secretion, and the glycaemic response to intraduodenal glucose infusion in metformin-treated patients with T2D.

  • More or less? Bile acids and glycaemic control in type 2 diabetes

    Bile acids (BAs) are now recognised as pivotal signalling molecules that orchestrate metabolic homeostasis through interacting with specific intestinal regions to induce the secretion of gastrointestinal (GI) hormones. Indeed, BAs trigger the release of glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) from enteroendocrine L-cells (which are abundant in the distal small and large intestine), to slow gastric emptying, suppress energy intake, stimulate insulin, and inhibit glucagon in both health and type 2 diabetes (T2D) 1. The proposed project will determine whether reducing intestinal exposure to BAs (using BA sequestrants) enhances subsequent GI sensitivity to BAs subsequently to augment GI hormone secretion and thereby diminish the magnitude of postprandial glycaemic excursion in T2D. Specifically, we will evaluate the hypothesis that depletion of intestinal BAs by two weeks treatment with colesevelam increases GI sensitivity to BAs, thereby enhancing the GLP-1 response to intrajejunal BA infusion and diminishing the glycaemic in response to an intrajejunal glucose infusion in patients with T2D.

  • The effect of enhanced messaging on COVID-19 testing intentions and behaviour.

    COVID-19 response in Australia relies on people getting tested should they experience symptoms; however, national data indicate suboptimal uptake. This study aims to improve the uptake of COVID-19 testing by addressing peoples’ specific reasons for not getting tested. We will be testing whether we can increase people's intention to get tested for COVID-19 if they symptoms using an animation, as compared to the government's written information. We will also be testing whether an animation based on a narrative will be more effective than one based on facts.

  • A clinical audit of opioid reduction in patients undergoing treatment with medicinal cannabis for chronic non-cancer pain

    Patients referred to the chief investigator’s chronic pain management clinic where appropriate are treated with medicinal cannabis. Many of these patients are already taking opioid drugs (morphine-like drugs), which seldom control their pain and in many cases are deleterious to their health. This study will evaluate outcomes in a group taking both opioids and cannabinoids in comparison to a group taking opioids but not taking cannabinoids.

  • Clinical study of cannabidiol in children, adolescents and young adults with Fragile X syndrome (RECONNECT)

    This study is evaluating the efficacy and safety of ZYN002, a pharmaceutically manufactured form of Cannabidiol (CBD) that is a clear gel that can be applied to the skin (called transdermal application). It is applied twice a day for treatment of symptoms of Fragile X Syndrome (FXS) Who is it for? Patients who have been diagnosed with Fragile X Syndrome with full mutation of FMR1 gene and are aged between 3 and less than 30 years old. Study details All participants will undergo a screening process. Eligible participants will be randomized 1:1 to drug or placebo and will undergo up to a 18-week treatment period. Participants who are taking anti-epileptic drugs may undergo an additional 1-3 weeks of blinded treatment to taper off study drug treatment. During the treatment period, all participants may be either assigned to ZYN002 or placebo. All participants may receive placebo during the trial. The assignment will be done by a computer generated system and neither the study doctor or the participant or their caregivers will know which treatment is being given to them. The dose of the treatment will depend on the weight of the participants. If the participants weigh less than or equal to 30kg, they will receive 2 sachets of the gel through the day (1 sachet approximately every 12 hours), if they weigh more than 30kg but less than 50 kg they will receive 4 sachets of gel per day (2 sachets approximately every 12 hours) and if they weigh more than 50kg, they will receive 6 sachets of gel per day (3 sachets approximately every 12 hours). Parents/ caregivers will be instructed on proper application of the gel. The gel will be applied to clean, dry, intact skin of the upper arms/ shoulders. Blood samples will be collected for safety analysis of ZYN002. An independent analytical laboratory will also perform CGG repeat and methylation status analyses. Additionally, the parents/caregivers will be asked to complete some questionnaires. There will be other questionnaires and scales that will be completed at the site by the study doctor and/or with the participant and their parents/caregivers. Participation in this study may help the child’s/adolescent’s FXS symptoms; however, we cannot guarantee that he/she will get any benefits from this study. The results of this study may benefit future patients.

  • Understanding if mental health and wellbeing coordinators in primary schools can help improve student mental health support

    Half of mental health condition present before the age of 14, making schools an important platform for supporting student mental health. However most of the research has focussed on secondary schools with little attention on the effectiveness of mental health support in primary schools. Therefore, the current study will train a qualified teacher in a new role of Mental Health and Wellbeing Coordinator (MHWC) in primary schools across Victoria, Australia to build the capacity of schools to support student mental health. Our hypothesis is that the MHWC role and associated training (ie. the 'MHWC model') is effective in improving teacher and student outcomes using objective and self-reported measures, when compared to business as usual schools. The primary objective of this study is to assess whether the MHWC model leads to changes in classroom teachers’ self-reported confidence to support student mental health and wellbeing. Our hypothesis is that teacher's self-reported confidence to support student mental health and wellbeing will increase following the implementation of the MHWC model.

  • Immunomodulatory effects of Fucoidan (seaweed extract) in recreationally active adults

    There is strong interest in the use of naturally occurring supplements to promote immune competence and prevent illness in daily living, as well as in response to periods of increased stress, including intensified physical activity. In a pilot study we observed substantial increases in faecal lysozyme concentrations in high performance athletes following 7 days of seven days of supplementation with Fucoidan (Fucus vesiculosus / Undaria pinnatifida extract, 1 g/day). We now wish to extend this study to investigate a longer period of intensified training. We propose to recruit a small group of recreationally active individuals to undertake two three-week training intervention of repeated sprint intervals with a cross-over design. Supervised training will involve 45 min of interval cycling at pre-determined workloads corresponding to a proportion of VO2max and a series of short repeated 6 sec sprints. We have already developed and validated this repeated-sprint training study for use with recreationally active individuals. Hypothesis: To determine whether daily Fucoidan supplementation is able to positively modulate immune biomarkers during a period of intensified exercise training in healthy recreationally active adults.

  • Enhancing Pharmacist Involvement in Care - Medication Assisted Treatment for Opioid Dependence (EPIC-MATOD) Implementation Study

    Medication Assisted Treatment for Opioid Dependence (MATOD) is effective for opioid dependence, yet a lack of prescribers in the community limits access to this treatment, particularly in regional and rural areas. The Enhancing Pharmacists Involvement in Care (EPIC)-MATOD study aims to evaluate clinical and implementation outcomes among people with opioid dependence receiving MATOD through a collaborative pharmacist-prescriber model of care across multiple sites in a regional-rural area of Melbourne, Australia.

  • The effect of Heart Rate Variability Feedback to improve heart-brain function after spinal cord injury - The Spinal cord injury, Mind and HeART or (SMART) study

    Spinal cord injury (SCI) is associated with significant secondary conditions that impact health and wellbeing adversely. Our randomised controlled trial involves evaluating the effectiveness (intention-to-treat) of an innovative neuro-cardiac self-regulation therapy to improve autonomic and neural activity dysfunction increasing risk of secondary conditions in adults with SCI living in the community. The therapy involves heart rate variability feedback (HRV-F). Evidence that autonomic activity changes after SCI suggests autonomic modulation may be a new frontier for improving neuro-cardiac function in spinal patients and mitigate maladaptive plasticity. Because the autonomic nervous system is paramount in system regulation, HRV-F has potential to improve life-threatening cardiovascular dysfunction like orthostatic instability and autonomic dysreflexia, as well as improve mental health, vitality, and sleep. This trial involves research not ever attempted in a SCI population anywhere and it will build substantial capacity in SCI research in NSW/Australia. The trial will follow a feasibility and dosage pilot study. A two-arm parallel randomised controlled trial where patients will be randomly assigned to a HRV-F or a control group. Dependent on the pilot study findings, there will be feedback learning sessions each week over at least 10 weeks with homework and follow-up training. Provided effectiveness of the HRV-F intervention, the trial will be followed by an implementation study involving mixed methods with SCI stakeholders to determine facilitators and barriers to translating the HRV-F intervention into existing health services in NSW for adults with SCI.

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