ANZCTR search results

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

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30938 results sorted by trial registration date.
  • Direct to Psychology Insomnia and Stepped Care Models in a Sleep Disorders Service

    The overarching aim of this project is to develop, refine, implement and report on two concurrent changes in the service model in the Sleep Disorders Centre at TPCH to incorporate a “Direct to Psychology Insomnia” referral pathway, and a “Stepped Care” model of care within the TPCH Sleep Psychology Service, flexibly delivered across the continuum of care. The project will measure the impact of the service change in our target population. The service change will be compared to the current service models for key outcomes.

  • Effect of the Homeless Health Response Bundle on reattendances to an emergency department within 28-days

    There is compelling evidence that people experiencing homelessness are more likely to experience poor health outcomes and die up to 30 years prematurely. Housing status has a substantial impact on a person’s burden of disease and injury, and capacity to access care, yet healthcare professionals do not routinely screen for housing status. Without identifying the level of homelessness, it is not possible to respond appropriately to the often, complex healthcare needs and health-related vulnerability of people experiencing homelessness. For this reason, we have developed an intervention called the ‘Homeless Health Response Bundle’ to improve access to healthcare in the Emergency Department setting. The Homeless Health Response Bundle comprises the Homeless Health Access to Care Tool to assess the level of health-related vulnerability, and a Decision Assistance Guide that facilitates the prioritisation of health needs and streamlines healthcare for people experiencing homelessness. Testing the impact of this tool on access to healthcare is required. Through this randomised controlled trial, we will determine the effect of the Homeless Health Response Bundle on reattendances within 28-days to the St Vincent’s Hospital Melbourne Emergency Department.

  • Measuring airway smooth muscle using optical coherence tomography in patients undergoing bronchoscopy – an observation study.

    In people with asthma, there is more muscle around the airways. The greater the amount of muscle, the more severe the asthma. In this project, we are testing a new method to measure airway smooth muscle around patients' airways during a bronchoscopy using light. Measurements will be made in a number of airways in a number of patients to provide information about the reliability of this technique, particularly how much it varies between airways within the same patient and between patients. It can then be used to improve current treatments and develop new treatments aimed at the increased smooth muscle in asthma. During the bronchoscopy, measurements will be made through the bronchoscope using a laser beam. The bronchoscopists involved will be taking the measurements. This will probably add 10-15min extra to the duration of the procedure. The equipment required for this procedure is a PS-OCT system (packaged in a trolley); a flexible fibre-optic endoscopic probe and a sterile sealed transparent tubing for use during the bronchoscopy.

  • Fit 4 Me After Stroke (Mild)

    Being physically active is important for preventing stroke and other cardiovascular diseases. People who have already suffered a stroke are at a higher risk of future health problems. It can be challenging for stroke survivors to be active. This research aims to test a pathway to personalised physical activity programs that our team has designed together with stroke survivors and clinicians. The aim is to determine what physical activity dose (how much and how intense) is acceptable, feasible and safe for stroke survivors, and is also effective at improving their cardiovascular health. This will ultimately reduce their risk of future stroke and cardiovascular disease. Participants (stroke survivors) will be prescribed a personalised physical activity program. The process will involve a shared decision-making and planning process to develop a personalised physical activity program. The first 2 weeks will involve program set up. Support will be provided by a physiotherapist or exercise physiologist at least weekly over the first 3 months and may be face to face, via videoconference, phone or email–depending on the participants’ preference. Monitoring and support will continue, but decrease in frequency over the following 3 months.

  • TransformUs All Abilities – School-based physical activity and sedentary behaviour interventions for children and adolescents with disability (implementation trial).

    TransformUs All Abilities is a hybrid effectiveness-implementation trial and the outcomes of both trials will contribute to evaluating the roll-out of TransformUs All Abilities. This registration describes the the Implementation component of our hybrid trial. The Effectiveness Trial is registered separately (ACTRN12622001050741). TransformUs All Abilities is a behavioural school-based intervention targeting reducing sedentary behaviour and increasing physical activity in students with additional needs. This is an adaption of a previously registered successful trial "Scalability of the Transform-Us! program to promote children’s physical activity and reduce prolonged sitting in Victorian primary schools" (ACTRN12617000204347). The adapted TransformUs components and supporting resources will be made available in an “All Abilities” section on our website and adaptations to existing activities will be embedded in other sections as well (i.e., Primary, Secondary, Higher Education). Teachers who agree to take part in the Implementation trial will be able to access all the training material via the TransformUs website and will also provide data either online, via text or over the phone interviews. As the program will be available to all Australian primary and secondary schools (mainstream or specialist), an online delivery mode has been deemed the most feasible and sustainable. The focus of this trial will be on investigating the implementation-level outcomes (e.g., acceptability, adoption, feasibility, fidelity, penetration, sustainability, satisfaction) of the TransformUs All Abilities, to understand whether the program is feasible, practical, and sustainable in a real-world environment. School staff involved in the implementation trial will be asked to complete an online survey on two occasions, ecological momentary assessments 3 times per term for up to 6 terms, and a sub-sample will be invited to participate in an interview. In this study, the total number of potential combined primary/secondary schools is 3,440. Based on the uptake of the TransformUs Primary program, we anticipate that approximately 5% of eligible schools and staff may register for the program (i.e., 172 schools).

  • Evaluation of the effects of sugar free chewing gums containing oral care agent on early tooth decay.

    The study is to compare the remineralisation (repair) of early decay-like lesions in tooth treated with sugar free chewing gums containing 0, 5mg and 10mg CPP-ACP (Recaldent) in a randomized, double-blind trial. All participants will wear palatal appliances with attached enamel slabs during each 14 -day treatment period. This study hypothesis is that there is no significant difference between treatments.

  • Stereotactic Body Radiotherapy for Ventricular Tachycardia (CARDIAC SBRT)

    This study aims to investigate whether the use of Cardiac Stereotactic Body Radiotherapy (SBRT) reduces the number of Ventricular Tachycardia (VT) events in patients who are not candidates for, or have failed standard of care therapies The study will use patient reported quality of life assessments, toxicity assessments and compare the use of anti-arrhythmic medications prior to and post treatment to assess effectiveness of the treatment.

  • Food, Move, Sleep (FOMOS) for Postnatal Mental Health

    Background: Home-based health interventions have shown promise in improving some health behaviours (e.g. physical activity) amongst postnatal women, yet little is known regarding the efficacy of home-based interventions that target multiple health behaviours (physical activity, sedentary behaviour, nutrition and sleep) for improving PND symptoms in postnatal women. Intervention description: Food, Move, Sleep (FOMOS) for Postnatal Mental Health is an evidence-based, multi-component and multi-behaviour program which offers a potentially convenient and low-burden solution to improving health behaviours among women at-risk of PND. Study aims: 1) to test the impact of a 6-month home-based program for reducing depressive symptoms by targeting risk factors such as physical activity, nutrition, sleep, and sedentary behaviour in women at-risk of PND; 2) to assess whether the program is efficacious and appealing (e.g., adoption, acceptability, appropriateness, costs, feasibility) at 6 months; and 3) to assess maintenance of behaviour change sustained intervention effects at 12-months follow-up (6-months post-intervention completion). Hypothesis: The FOMOS program will improve depressive symptoms at 6-months, compared to those in the control group.

  • Effect of two probiotic formulations on mental health and mood biomarkers in adults with depressive symptoms

    In this randomised, double-blind, placebo-controlled study, 60 adults presenting with depressive symptoms will be randomly assigned to receive probiotic capsules containing (1) Bifidobacterium adolescentis (5 billion colony-forming units a day), or (2) Lacticaseibacillus rhamnosus LGG and Bifidobacterium BB-12 (1 billion colony-forming units a day), or (3) a placebo for 12 weeks. We will assess changes in mood and sleep using self-report questionnaires. Changes in blood markers associated with inflammation (tumour necrosis factor-alpha, interleukin -1beta, interleukin-6, interferon-gamma, and high-sensitivity C-reactive protein), intestinal barrier integrity (lipopolysaccharide-binding protein and intestinal fatty acid-binding protein), and brain-derived neurotrophic factor (important for the survival of brain cells) will be assessed over time. We will also assess changes in cortisol (blood and hair), heart rate variability, and the gut microbiome over time.

  • A Pharmacokinetic and Safety Comparison of Oxytocin Administered as a Dry Powder by Inhalation and by Intravenous and Intramuscular Injection in Healthy Female Participants

    To evaluate the pharmacokinetics, safety and tolerability of a novel dry powder oxytocin inhaler in comparison to oxytocin intravenous and intramuscular injections. To assess and quantify how effectively oxytocin can be delivered into the human blood stream as a powder from an inhalation device compared with delivery via an intravenous or intramuscular injection. In addition to assess if oxytocin can be delivered as a powder from an inhalation device without causing adverse effects to the recipient

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