ANZCTR search results

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

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32101 results sorted by trial registration date.
  • A 2-part Phase I study to evaluate the safety, tolerability, pharmacokinetics and food effects of AXN-027

    This study in healthy volunteers aims to identify the range of safe single and multiple doses of AXN-027 Salt administered by mouth; to assess how the body handles AXN-027 Salt; how AXN-027 Salt contained in capsules compares to AXN-027 Salt contained in a tablet, what effect a high fat meal has on how the body handles AXN-027 absorption and to evaluate the safety of AXN-027 Salt compared to placebo. The results of this study will help identify appropriate doses of AXN-027 Salt to evaluate in future clinical trials.

  • A randomised controlled trial of online self-reported clinical information followed by clinical interview in mental health triaging via phone.

    The study aimed to test whether the online mental health self-report by patients at home (or anywhere with internet and phone access) without necessarily presenting to an emergency department, to inform subsequent clinical triage contributed to reduction in the time required to complete triaging e and whether this novel approach was acceptable. Study hypotheses: 1) The intervention (online mental health self-report by patients prior to triage phone interview) reduces triage time compared to the usual triaging process; 2) The intervention is acceptable to clinicians and clients.

  • Dads Tuning in to Kids: Real-world evaluation

    Dads Tuning in to Kids (Dads TIK) is an evidence-based parenting program that helps fathers to understand and regulate their own emotions and to use emotion coaching with their children to promote children’s competence. Dads TIK has been selected as one of several programs to be delivered as part of the Movember 'Scaling What Works' project, with a focus on improving men's mental health outcomes. As part of the ‘Scaling What Works’ project, 40 facilitators are trained to deliver Dads TIK to approximately 800 ‘hard to reach’ fathers. This research specifically aims to explore the acceptability, effectiveness, and adaptability of Dads TIK in this ‘real world’ context. Outcomes of interest include the impact of Dads TIK on men’s health by strengthening connections between fathers and their children, supporting emotional competence, improving fathers' responses to their children's emotions and improving father’s wellbeing in order to reduce mental health problems. More broadly, the project aims to contribute to cultural change where emotions become more acceptable for men.

  • A phase 1 safety trial of CANN001, a hydrogel patch containing 2-deoxy-D-Ribose, in diabetic foot ulcers

    Diabetic foot ulcers are a chronic wound and the pathophysiology is linked to neuropathy, infection and peripheral vascular disease. This peripheral vascular disease, linked to diabetes, prevents ulcer closure and leads to susceptibility to infection. 2-deoxy-D-ribose (2dDr) is known to promote vascularisation and may therefore increase angiogenesis when administered to a DFU and through this mechanism promote wound closure. The planned study will investigate if CANN001 (2dDr containing hydrogel) is safe in patients with diabetic foot ulcers and whether 2dDr may promote DFU healing and localised wound angiogenesis/neovascularisation through increasing local expression of VEGF.

  • Helping Women Overcome Infertility Distress: The Impact of Eye Movement Desensitization and Reprocessing (EMDR) Therapy

    This study aims to investigate the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy in reducing infertility-related distress in women undergoing infertility treatments. The research will compare the emotional and psychological outcomes of women receiving EMDR therapy with those on a waitlist control group. It is hypothesised there will be differences between the groups in terms of distress, anxiety, depression, trauma-related symptoms, psychological well-being, and coping strategies. Participants will be assessed before, after, and three months post-treatment. The study hopes to provide insights into how EMDR can help women cope with the emotional challenges of infertility.

  • Clinical outcomes following prescription of Vosoritide in children with Achondroplasia 0-2 years of age

    An observational study in children 0-2 years of age with ACH who initiate vosoritide treatment, receiving daily subcutaneous injections of vosoritide, followed up in accordance with the Australian achondroplasia management guidelines. Outcomes in treated children will be compared retrospective data of untreated children. A retrospective study (2000-2023) will be undertaken to collect data on children 0-7 years of age who have not had any therapeutic treatment for ACH. It is hypothesised that children receiving vosoritide will have better growth and developmental outcomes compared to historical controls.

  • Resilience and wellbeing in the era of climate change: an acceptability and feasibility pilot of the Bee Well program for treating eco-anxiety in rural children exposed to natural hazards

    This project aims to fill a gap in existing services by helping young people living in rural areas who are feeling distressed about climate change. Specifically, the project aims to support the mental health and resilience of young people aged 10-14 in rural NSW who have been affected by natural disasters such as fire, drought, or flooding. The program will take place outdoors using an interactive workshop. It will draw on the best-available evidence in the field of eco-therapy for mental health resilience in the era of climate change. It is hypothesised that participation in an interactive intervention, designed as a workshop with 5 inter-related modules, will lead to a beneficial change in psychological distress, resilience and emotions related to climate change.

  • The womens Wellness Intrauterine Neuroimmune modulation Study Expansion Group: The effect of a new intrauterine device on pelvic pain in women.

    Alyra Biotech Pty Ltd is an Australian-owned biopharma company that wishes to develop an optimal intrauterine contraceptive device (IUD) for people with period or pelvic pain. The use of IUDs globally is increasing, however some people experience increased pelvic pain in the 3-6 months following insertion, causing them to have the device removed. They then miss out on the benefits that IUDs can provide, such as; reducing your lifetime exposure to synthetic hormones; decreasing the amount of blood loss at each period; as well as decreasing intense period pain, over time with continual use. Alyra Biotech Pty Ltd has developed and patented a novel IUD designed to reduce the severity of post-insertion pain in those that experience it, giving them access to the benefits of IUD use. The objectives of this study are: 1. To determine how the device performs at releasing the appropriate medicinal drugs (pharmacokinetics). 2. To compare the tolerability of the new Alyra device with the currently approved for use in Australia, the Mirena 'Trademark" device. 3. To establish the expected number of days of bleeding following insertion 4. To determine the number of days and intensity of pain experienced following insertion

  • Targeted treatment for people with dysfunctional breathing and difficult asthma

    This project aims to test a multi-dimensional physiotherapy intervention for dysfunctional breathing in people with difficult asthma. The intervention involves breathing exercises and education, and may involve manual therapy, relaxation therapy and physical exercise depending on the individual assessment findings. We believe a targeted, individualised program will be feasible and acceptable to people with difficult asthma.

  • Functional Neurological Disorder (FND)- Informed Physiotherapy for organic tremor disorder - A Feasibility Study

    Tremors are uncontrollable shaking movements. Organic tremors are usually the result of structural damage to the parts of the brain that coordinate muscular movement. Current treatments for organic tremors are mainly medication based. Up to 30% of tremor patients do not respond to medication and therefore need alternative treatment options. For some of these patients surgical treatment options can be considered. These treatments are invasive (with significant risks of complications), expensive and difficult to access for many patients. Also, many patients cannot undergo surgery for treatment of their tremors due to age or unacceptably high surgical risk. Functional Neurological Disorder (FND) is one of the most common diagnoses in general neurology clinic. Functional tremors are not caused by structural damage to the brain, but are due to a problem with communication between different brain areas. Functional tremors can often be treated by teaching patients strategies to retrain control over their movements. In this study we want to test if this approach can also work for patients with organic tremor disorders. Acute flares of organic tremors share many features with functional tremors. We hypothesized that it will be possible to use the physiotherapy-based treatment approaches that have been shown to be beneficial in patients with functional tremors to help patients with organic tremors to manage their acute tremor flares.

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