ANZCTR search results

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

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31373 results sorted by trial registration date.
  • First time in human study of GPV381 in healthy volunteers with Porphyromonas gingivalis bacteria

    This study will assess the safety and immune response to GPV381. Participants will be admitted as day patients to the unit and receive a dose of IP on Day 1 and remain in the unit for 4 hours post dose for tests and observations. They will be discharged following assessments and return for an outpatient visit on Day 8. They will be readmitted as a day patient for a second and third dose on Day 28 and Day 56, respectively, and return for outpatient safety assessments on Days 35 and 63, and for longer-term safety and immunogenicity follow up visits on Day 90 and Day 120.

  • Schema therapy for people with binge eating disorders

    This study will provide a course of schema therapy to adults with eating disorders featuring binge-eating. The treatment will be tailored to certain aspects of personality: early maladaptive schemas, perceived parenting style and temperament. The aim of the study is to determine whether this treatment reduces eating disorder symptoms and behaviours and whether there is a relationship between change in early maladaptive schemas and eating disorder symptoms. People aged 18 or older with eating disorders featuring binge eating (e.g., bulimia nervosa, binge eating disorder) will be eligible to participate in the study. The study will be conducted at multiple sites, including two eating disorder services in the UK and three private practice centres in Australia. The treatment includes 25 x 1-hour sessions over approximately 30 weeks. Participants will complete questionnaire measures before starting treatment, halfway through treatment, at the end of treatment and at 3- and 6-months after treatment is complete. To understand participants' perspective of the treatment, an optional qualitative interview will be conducted after treatment is complete.

  • The Lily: Eating Disorder Clinical Registry

    The Lily Registry will aim to: a. collect data about inpatients with medical complications of eating disorders b. define the practice and improve outcomes for patients with medical complications of eating disorders c. encourage translational research, innovation, and clinical leadership in best practice care across South Australia for this important and challenging patient cohort d. enable excellence in inpatient care of people with medical complications of eating disorders by supporting best-practice multidisciplinary care and continuous quality improvement

  • Getting to the heart of healthy ageing: a behaviour change program targeting adherence to a healthy dietary pattern in postmenopausal women. The Wise & Well Study

    Blood vessel disease is linked with risk of dementia, cardiovascular disease and falls. A large clinical trial will determine if a novel, low-cost, behaviour change program (knowledge of level of blood vessel disease, its links with risk of dementia, cardiovascular disease and falls, and the benefits of and how to follow a Mediterranean diet) will motivate an individual to make healthy lifestyle changes and will improve measures of risk for dementia, cardiovascular disease and falls. The study hypothesis is that adherence to the MedDiet will be improved after provision of the behaviour change program.

  • Courage Quest Plus: Testing an optimal way of conducting exposure treatment for children with anxiety

    The overarching goal of this research is to improve the efficacy of exposure by optimising a digital exposure-focused intervention (the Courage Quest intervention). This intervention (named Courage Quest Plus) is for children aged 8 to 12 years with one or more anxiety disorders. We are aiming to answer the following research question: Testing Courage Quest Plus. What is the optimal method of delivery of exposure? More specifically, what are the key features that optimise outcomes of exposure, i.e., lead to greatest reductions in anxiety symptoms and remission of anxiety and related disorders, as conducted via the Courage Quest Plus intervention, in children aged 8 to 12 years. We aim to evaluate this through using a fractional factorial design. Although we cannot test all optimization features in one study, we will test 5 features based on the literature in a fractional factorial design, i.e., i) expectancy violation, ii) positive affect, iii) parent training, iv) relaxation, and v) rewards. We hypothesise that the optimal intervention includes expectancy violation, positive affect, parent training, and attachment-based rewards, and does not include relaxation.

  • The effects of alcohol on eye movement behaviour during driving

    This project investigates how low and moderate doses of alcohol affects eye movement patterns during driving. It will also examine how these doses of alcohol affects cognition, visual information processing, and subjective intoxication. It is hypothesised that eye tracking methods will show good sensitivity and reliability for detecting impairment due to alcohol usage during actual driving.

  • The effect of new contact lens disinfectant solution on the contact lens discomfort

    The aim of this study is to evaluate the impact of contact lens disinfectant on ocular physiology, tear film characteristics, and symptomatology that might occur during contact lens wear. Participants will wear Comfilcon A contact lenses over a 12-week, changing their lenses every four weeks, a commonly recommended wear schedule and use a new contact lens disinfectant made by Ophtecs Corp (Japan). • The primary endpoint is the changes in the ocular surface and tears of contact lens wearer over the first four weeks of lens wear using a new lens care product. • The secondary endpoint is changes in factors that have been reported to be different between comfortable and uncomfortable contact lens wearers.

  • A Multi-centre Observational study of Supportive Ventilation Adjustments and Respiratory Effort Parameters in Adult Patients Admitted to the Intensive Care Unit

    Many patients admitted to the intensive care unit (ICU) for on-going clinical management receive breathing assistance with machines (mechanical ventilation). Mechanical ventilation is the process by which a patient’s breathing is supported by a ventilator. Broadly speaking there are two modes of breathing: i) Mandatory and ii) Supportive. Mandatory ventilation is used when the clinicians deem it necessary to control all aspects of breathing. Supportive ventilation is used when the clinicians aim to help the patient’s spontaneous breathing with some adjusted machine assistance. While receiving mechanical ventilation the patient’s intensive care clinicians make clinical decisions about their patient’s breathing. Such decisions relate to the amount of oxygen to provide, the number and depth of breaths, how much force is needed to adequately inflate the lungs and importantly when it is suitable to wake the patient and remove the breathing tube. All these decisions can be defined as the ventilation management of the critically ill patient receiving mechanical ventilation. For critically ill patients, changes in ventilation support are often made based breathing rate (respiratory rate) and size of breaths (tidal volume). However, the effect these changes have on measurable aspects of breathing effort (which define breathing work) remain unclear. Importantly, such information, which was difficult to get in the past, can now be obtained from modern ventilators just by pushing a button or moving a cursor on the screen. Such information is then displayed on the ventilator screen. In response, we will perform a prospective observational study of supportive ventilation settings in patients who are receiving supportive mechanical ventilation in the intensive care unit. In this multi-centre study, we estimate that the information obtained from 30-35 patients per site (4 sites) will lead to approximately 900 ventilation data-points collected from a cohort of 100 patients.

  • Immune response to a third COVID-19 vaccine dose in people with multiple sclerosis receiving B cell-depleting therapy

    Evaluate immunity provided to people with multiple sclerosis (pwMS) receiving B cell depleting therapy with ocrelizumab by a third mRNA-platform COVID-19 vaccine dose. Immunity was evaluated by comparison with pwMS receiving treatment the non-depleting drug natalizumab and through comparison against a correlate of real-world protection against infection. Peripheral blood immune cells were analysed in order to describe how the altered immune system in pwMS receiving ocrelizumab is associated with vaccine response, and to identify potential predictors of immune response to stratify poor responders for antiviral prophylaxis.

  • Just Say No to the Just in Case Cannula: An Implementation Science Trial

    Background This implementation science trial aims to reduce unnecessary and improve peripheral intravenous catheter (PIVC) insertion in Emergency Department (ED) patients. The intervention is effective locally and recommended by ACSQHC PIVC Clinical Care Standard. This project has received $2.9M funding from the MRFF 2023-2028. Primary Objective To implement best practice for PIVC in Australian ED. Methods 1. Stepped-wedge cluster-controlled trial for clinical effectiveness and safety of the intervention. We will study 9 diverse EDs and implement a package of interventions, three at a time, with 6-monthly steps. We will measure rates of PIVC insertion, use, safety and PIVC-related infections. 2. An adaptive, co-designed intervention based on our previous model/ACSQHC standards, using validated implementation and evaluation frameworks.

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