ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Faecal microbiota transplantation for primary sclerosing cholangitis Sub-study: Profiling the portal vein in primary sclerosing cholangitis

    Primary sclerosing cholangitis (PSC) is a rare and chronic liver disease with no current effective medical treatment options. Patients with PSC are at high risk of bile duct cancer, recurrent sepsis, and many progress to liver transplantation within 10 years. Patients with PSC have an abnormal gut microbiota and current evidence suggests that manipulation of the gut microbiota holds promise as a therapeutic strategy in PSC. The proposed study is investigating whether faecal microbiota transplantation (FMT) from healthy donors, delivered via lyophylised (freeze-dried) capsules, is safe for patients with PSC. The study will also seek signals for efficacy in terms of improving liver function tests and liver duct changes visible on imaging. Participants who choose to enrol in the sub-study will undergo endoscopic-ultrasound guided portal vein sampling at the time of their baseline and week 24 colonoscopies. The sub-study aims to identify the composition and function of the microbiota of the portal venous system and their products, and to explore how this is altered by FMT. This may reveal important pathogenic links between the gut and the liver in PSC, which can be used to develop future therapies.

  • A Seven Day Study of the SynerG Combined Insulin-Delivery and Glucose Sensory System in Persons with Type 1 Diabetes

    This study will evaluate the accuracy of an experimental CGM measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy. Glucose sensory accuracy will be measured over a 7 days period, along with device survival and tolerability over the same period. Accuracy of the device will be tested in both a free living state, as well as over three seperate mixed meal challenges in order to test the device accuracy over a range of glucose levels.

  • The Paediatric Obstructive Sleep Apnoea (OSA) Screening Triple Test (POSTT) Study: Validation of a novel home delivered paediatric OSA screening test.

    Obstructive sleep apnoea (OSA) has serious negative impacts to the physical health, mental health, and cognitive function and development of children. Unfortunately, OSA is quite common and is reported to occur between 1-6% of children. However, currently, the gold standard for OSA assessment (a sleep study or polysomnography (PSG)) is expensive and difficult to access. The limited access to PSG testing leads to unnecessary risk for these children, as it often delays in treatment, and/or results in an incomplete assessment prior to surgeries like adenotonsillectomy. However, a novel postage delivered and home conducted kit may be able to reduce these issues. The Paediatric OSA Screening Triple Test (POSTT) is TGA approved and includes an overnight oximetry device, a validated sleep questionnaire, and video tonsil assessment tool. This proposed research will compare the novel POSTT kit to PSG and determine the diagnostic accuracy, real-world feasibility, and patient satisfaction and preference. We hypothesise that the POSTT kit will demonstrate to be as accurate and more feasible than PSG. If the hypothesise is correct, the novel kit will allow for an increase in access to care, especially for regional and rural patients.

  • Evaluation of the effect of positioning in neonates with Congenital Diaphragmatic Hernia.

    Congenital diaphragmatic hernia (CDH) is a condition requiring immediate medical and multidisciplinary management, including physiotherapy. Positioning is a commonly used physiotherapy technique supported by the literature. However, the extent of its improvement on the respiratory system is unknown due to the limitations of the measuring equipment. Current measuring tools lack the ability to detect regional changes in the lungs. Electrical impedance tomography (EIT) has shown to be safe and effective in other areas of the healthcare system but has not been used for infants with CDH. This study will use EIT to assess the effectiveness of positioning in infants with CDH.

  • Investigating the ability of Systems Thinking with Active Implementation (STAIR) to create healthy school environments: an effectiveness-implementation trial

    Society asks a lot of schools, including that they protect children's health and wellbeing. This trial will work out the best way of supporting schools, teachers and school communities to create and sustain school environments that protect children's physical and mental health. We will measure the impact and return on investment of this support on children's health and education outcomes as well as on the schools themselves.

  • Supporting Mothers in Regional NSW: A Telehealth Intervention for Birth Trauma

    For most women, childbirth is a significant life event that can be associated with a range of emotional responses, from joy and relief for some, but trauma and distress for others. A traumatic childbirth experience, sometimes referred to as ‘birth trauma’ lead to poor mental health outcomes in postpartum women, severely impacting mother-infant attachment, child development, and overall mental health of the family unit. The current project will be the first intervention for postpartum mothers with recent traumatic birth experiences, to decrease serious and persistent mental health concerns. This project will assess the feasibility and acceptability of a highly innovative telehealth group-based early intervention for this vulnerable population group.

  • Embedding digitally enabled, single case experiments in general practice to support self-management and shared decision-making with patients with persistent pain

    This study is exploring how feasible it is for patients with persistent pain to test whether non-drug, self-managed activities are effective for their pain, using an app called StudyU which helps them do single case experiments. The app also produces reports for the patient and their general practitioner (GP), so they can discuss these reports to make shared decisions about the best ways to manage the patient's pain going forward.

  • Vaginal Laser therapy for Treatment of Stress Urinary Incontinence

    The aim of this study is to evaluate the use of Er:YAG laser treatment as a potential treatment for women with slight to severe stress urinary inconctinence. We hypothesize that Er:YAG Laser is superior to sham therapy in women who have slight to severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women, with subjective improvement rates defined as a Minimal Important Difference (MID) of 4 points on the ICIQ-UI-SF questionnaire.

  • Effectiveness of Silver fluoride in managing baby tooth dental decay among Aboriginal children in remote communities

    The study will test the effectiveness and feasibility of applying silver fluoride by an Aboriginal Health Practitioner to decayed baby tooth surfaces to stop the decay process among young Aboriginal children in remote communities. The outcomes will be compared against treatments provided by dental therapists using minimally invasive approaches. the hypothesis tested is that the application of silver fluoride to decayed baby teeth will be as effective as standard minimally invasive restorative treatments in managing baby-tooth decay.

  • Finding the right balance of ‘support’: Testing a new digital model of care for child and adolescent anxiety in regional communities

    Approximately 7% of 4–17-year-olds experience anxiety disorders. Half of these children do not receive help, and waiting times for seeing psychologists extend beyond 12 months, especially in regional areas. During COVID, 1 in 5 children and adolescents experienced clinical-level anxiety. Studies have demonstrated that increasing access to internet-based Cognitive Behavioural Therapy (iCBT) for anxiety can assist with this growing health concern. However, there have been challenges in identifying an optimum digital model of care for effectively addressing anxiety in children and adolescents who reside in regional areas. Studies in iCBT suggest that while some level of therapist support is necessary to enhance motivation, address diagnostic complexity, and personalize treatment for effectively alleviating severe anxiety, it is crucial for treatment to be delivered remotely, at scale, with minimal cost, and without the long waiting times currently experienced with face-to-face services in regional areas. There is a need to develop a new digital model of care that can bridge the gap between self-help and therapist-assisted approaches, effectively reducing anxiety among children and adolescents, and be suitable for dissemination in regional areas. This project will test a new evidence-informed digital model of care for child and adolescent anxiety that combines standard, self-help iCBT program with minimal therapist support at crucial treatment stages and weekly messaging support. To date, no studies have tested such digital model of care for children and adolescent in regional areas. If this model, using self-help iCBT with minimal therapist support is more effective than self-help iCBT alone, we will have identified a scalable, easily disseminated model that is effective for alleviating anxiety among children and adolescents in regional areas. In this project, therapists will offer minimal support (2 x 30 mins sessions at pre- and mid-treatment) via telephone or video conferencing. Additionally, they will send weekly messages to young people, which can be accessed at any location and time. Therefore, this model of care can be readily disseminated and is non-intrusive to young people.

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