ANZCTR search results

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

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31143 results sorted by trial registration date.
  • IMPACT - Intervention to Manage PTSD And Comorbidities after Trauma Study

    After exposure to a traumatic or stressful event, some people develop emotional disorders such as posttraumatic stress disorder (PTSD). Trauma-focussed psychological interventions, such as the gold standard Prolonged Exposure (PE) are empirically supported, first-line treatments for PTSD. However, non-response and drop-out rates are high with PE and many mental health clinicians do not use trauma-focussed treatments to treat PTSD. Using a randomised controlled trial design, this project aims to evaluate the efficacy of a non-trauma focussed transdiagnostic intervention called the Unified Protocol (UP) which targets features associated with PTSD including emotional dysregulation and cognitive distortions, compared to the gold-standard prolonged exposure (PE) therapy for the treatment of PTSD. Eligible participants will be randomly allocated to 10 weekly 90 minute sessions of UP or PE with pre-treatment, post-treatment and 6-month follow-up assessments. We hypothesise that UP and PE will be equally effective in treating PTSD.

  • Evaluation of Eclipse - A support group for people who have attempted suicide

    This is an evaluation of an 8 week support group for people who have previously attempted suicide. The support group teaches specific skills to reduce suicidality, while at the same time increasing resilience and help seeking behaviours. The aim of the evaluation project is to ascertain whether the implementation of the program into the LifeLine service decreases the rate of suicidality and increases the rate of recovery. Self report questionnaires are to be completed pre and post intervention, short term follow up at 1 month (focus group), and a long term follow up at 6 months (interview) to understand the utility and appropriateness of this program for people who have a history of suicide attempt/s.

  • StandingTall-Plus: A 1-year randomised controlled trial of a novel multifactorial intervention for preventing falls in older people

    Falls in older people are often caused by a concomitant decline across three domains: mobility, cognition and affect; or in other words, across moving – thinking – feeling domains. The aim of this trial is to test a program that is individually tailored to physical, cognitive and affective aspects (as opposed to medical pathologies) by taking a multifactorial profile approach to fall prevention. The use of technology will ensure that is easily accessible to do in the home and engaging to continue over a long period. A randomised controlled trial will be conducted in 518 community-dwelling older adults at high-risk of falls. All participants will be assessed using a comprehensive test battery of known falls risk factors across physical, cognitive and affective domains. This will then be used to offer each participant a fully tailored program that is suited to their abilities and circumstances. Our primary aim is to reduce the number of falls over a 12-month follow-up period when compared to a health promotion program. We hypothesise that our program will improve balance, cognitive function and mood, increase physical activity levels and reduce falls in older people, when compared to a health promotion program. This trial addresses a key gap in the understanding of falls interventions and application of personalized medicine and will provide direct evidence about the cost and effectiveness of a tailored multifaceted “best-bet” solution.

  • Heart and lung responses to exercise in adolescents born extremely preterm

    Preterm birth and low birthweight infants have a higher risk of health and developmental problems in childhood and adolescence and some research studies suggest that teenagers and adults who were born preterm may have reduced blood flow, heart function, and lung function compared with individuals born at full term. We believe these differences might lead to an increased risk of heart disease during adulthood and also might make it more difficult to exercise. On the other hand, exercise is known to improve blood flow, heart function and lung function and reduce long term risk of disease. This research study will be conducted in adolescents who were born extremely preterm and/or with an extremely low birth weight, as well as adolescents born at full term and normal birth weight. This study will explore how the heart and lungs respond to exercise and whether a ten-week physical training program might improve exercise capacity, heart and lung function and quality of life.

  • Understanding mechanism of progression of short-sightedness using progressive addition lenses

    Myopia (short-sightedness) is the most common vision problem in children. Higher amounts are associated with vision threatening diseases in later life. Progressive addition spectacle lens designs, used primarily in presbyopia, appear to slow down the development of juvenile myopia but their efficacy tends to weaken after a period of about 12 months. The aim of this project is to further the understanding of the accommodation system (the near focusing mechanism) and drivers of the progression of myopia to ultimately lead to more effective lens designs. This study will improve understanding of eye structure changes during accommodation and provide a fundamental investigation of accommodation mechanisms in myopia. It will potentially contribute to improved designs and use of lenses for the treatment of myopia in children.

  • Non-specific effects and mechanisms of mindfulness meditation for experimental pain

    As many as 1 in 4 Australians experience chronic pain. There is a critical need for the development and evaluation of fast-acting non-pharmaceutical treatments that have the capacity to target the multidimensional nature of chronic pain. This study will investigate how beliefs or expectations about the effects of mindfulness meditation interact with the actual effects of training in the technique, and will further characterise the mechanisms underlying these effects. Results will ultimately lead to targeted interventions that more effectively engage cognitive mechanisms associated with pain attenuation.

  • Instylla Hydrogel Embolic System First In Human Study For Patients Requiring Vascular Embolization Alone or in the Pre-operative Setting for Treatment of Malignant and Benign Hypervascular Tumors, and Select Non-Traumatic End-Organ Infarct

    This study will evaluate the safety and performance of the Instylla Hydrogel Embolic System for patients requiring vascular embolisation alone or vascular embolisation for treatment of Malignant and Benign Hypervascular Tumors or non-traumatic end-organ infarct Who is it for? You may be eligible to join this study if you are aged 18 and above and are requiring vascular embolisation alone or vascular embolisation for treatment of Malignant and, or Benign Hypervascular Tumors, or non-traumatic end-organ infarct. Study details All participants will receive vascular embolisation using the Instylla Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter. Safety and performance of the HES will be assessed using using the grading of the NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0). Severity of complications will be further classified in accordance with Society of Interventional Radiology (SIR) guidelines. for up to 90 days post-embolisation. This study will also allow a greater understanding of whether HES can be used to embolise vascular tumours or organs.

  • S-Check App Trial: To determine the feasibility and efficacy of the S-Check App as a self-administered harm reduction and early intervention tool for those who use methamphetamine.

    The main purpose of this trial is to see whether the S-Check App can motivate behavioural change in those who use methamphetamine. The S-Check App has been developed as a harm reduction and early intervention tool It provides information on methamphetamine use and provides information on support services. One group will be randomised to have immediate access to the App for 28 days. The other group will have have access to the App after 28 days (delayed access). Both group at baseline (Day 0) will be asked to complete the Readiness to Change, General Help-Seeking and Actual Help-Seeking questionnaires. Those given immediate access to the App will repeat the survey at 28 days. Those given delayed access will repeat the survey before access is given. Both groups will also be asked to participate in a telephone interview to capture their experience using the App. App usage metrics will also be collected. The information collected will assist to further develop the App as a self-administered tool for those who use methamphetamine but do not wish seek traditional modes of treatment.

  • Management of Rural Acute Coronary Syndrome (MORACS)- implementing a hub and spoke system to improve identification and management of patients with ACS in Rural hospitals.

    Aims: To improve identification and management of patients with ACS within rural hospitals in a Local Health District by implementing a hub and spoke ACS management system. MORACS clinicians will receive notification of patients presenting to intervention Hospitals with ACS symptoms, review ECG, troponin, clinical information and contact the site to provide advice on evidence based treatment. Research Question: In patients admitted to a rural hospital with suspected Acute Coronary Syndrome (ACS), does a centralised management system improve identification of STEMI and subsequent clinical outcomes in all ACS patients?

  • A Study to Evaluate the Efficacy of Intravenous Magnesium in the Management of Atrial Fibrillation with a Rapid Ventricular Rate in the Emergency Department

    High dose magnesium administered intravenously is often utilized in the management of atrial fibrillation with a fast heart rate. Randomised controlled trials have shown conflicting results in regards to its efficacy. We aim to further examine the relationship between the heart rate and magnesium therapy in patients presenting to a Melbourne based Emergency Department with 'fast' atrial fibrillation. We are primarily interested in finding out whether Magnesium therapy aids the reduction of heart rate and our secondary endpoints include; reversion to sinus (normal) rhythm, time to achieve target heart rate, number of additional treatments required to achieve heart rate target, length of stay in emergency department, rate of inpatient hospital admission and 30 day mortality and readmission rates.

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