ANZCTR search results

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

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31604 results sorted by trial registration date.
  • 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.

  • Evaluating the safety, tolerability and anti-parasitic immunity boosting activity of ruxolitinib when co-administered with artemether-lumefantrine in adults with Plasmodium falciparum Induced Blood Stage Malaria

    This is a, randomised, double-blind, placebo-controlled, phase 1b trial to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic (malaria parasitaemia 18S qPCR, pSTAT3, and immune responses) of artemether-lumefantrine (AL)+ Ruxolitinib (Rux) in healthy adults with P. falciparum IBSM. Twenty-six malaria-naïve, healthy males or females, aged between 18-55 years old, who meet all of the inclusion criteria and none of the exclusion criteria, are planned to be enrolled. Volunteers will be randomised in a 1:1 ratio to receive oral twice daily doses of AL+Rux or AL+placebo on Days 9, 10 and 11.. A sentinel dosing strategy will be used whereby two volunteers (one randomised to AL+Rux and one randomised to AL+placebo) will be dosed initially. The Safety Data Review Team will review safety and tolerability data up to and including Day 15 before dosing of the remaining 24 volunteers. As part of the informed consent process, volunteers will be asked if they agree to be contacted at approximately 3, 6 and 12 months after their end of study visit for blood sampling to investigate anti-parasitic immune response longevity.

  • 3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)

    This Phase 2 open label trial seeks to investigate whether a novel therapy named 3K3A-APC is safe and potentially effective in patients with Amyotrophic Lateral Sclerosis (ALS). A total of 16 patients with ALS will be enrolled into 2 dose cohorts with five doses of 15mg or 30mg doses given 12 hours apart in each cohort. The primary study outcomes are to ensure the safety and tolerability of 3K3AAPC in ALS patients, and to determine whether 3K3A-APC is able to reduce the pathological changes that might possibly cause ALS.

  • Smart Wars II: Withings ScanWatch versus Implantable Loop Recorder for Diagnosing Atrial Fibrillation after Unexplained Stroke

    Atrial fibrillation (AF) is one of the leading preventable causes of ischemic strokes worldwide. Screening for AF in post-stroke populations is widely recognised as standard care, however given the paroxysmal and often asymptomatic nature of the disease it can be easily missed using standard 24 hour Holter monitoring. A higher rate of diagnosis can be achieved using longer-term implantable loop recorders (ILRs), but these are invasive and resource-intensive. Withings ScanWatches have the ability, via photoplethysmography (PPG), to continuously monitor heart rate and rhythm and may be a potentially useful diagnostic tool for detecting AF on a larger scale. Furthermore, Withings watches’ new built-in ECG promises to significantly improve accuracy of diagnosis when used in conjunction with PPG. Some previous studies have investigated the usefulness of Withings Watches in diagnosing AF, however no studies have investigating their usefulness utilising this new ECG feature in a post stroke population. Our study hypothesis is to investigate whether the Withings ScanWatch detects atrial fibrillation (an abnormal rhythm which can cause stroke) as effectively as an implantable loop recorder.

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