ANZCTR search results

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

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31611 results sorted by trial registration date.
  • The role of middle meningeal artery embolisation as primary treatment for chronic subdural haematoma in adult patients

    Chronic subdural haematoma (cSDH) is one of the most common neurosurgical conditions and its frequency continues to rise as a result of the aging population and the increasing use of anticoagulation and antiplatelet medications. While there are no established guidelines for its management, symptomatic cSDHs are usually treated with surgical evacuation. The reported recurrence rates following surgical evacuation in the literature vary widely from 2% to 37%, with most estimates ranging between 20% and 30%. Recent studies have suggested middle meningeal artery (MMA) embolisation to be a potential alternative treatment for cSDH. Numerous case reports and series have demonstrated MMA embolisation as a safe primary treatment for cSDHs or as an adjunct treatment following surgical evacuation. We aim to conduct the first randomised controlled trial to further confirm the efficacy of MMA embolisation. -Stable cSDH patients who do not require urgent surgical evacuation will be randomly allocated to observation or to receive MMA embolisation. -We aim to demonstrate that MMA embolisation can reduce the need for surgical evacuation in stable patients

  • Active WeAR Everyday (AWARE): The effect of wearing a sports uniform everyday on student fitness and physical activity at school.

    The overall objective of this study is to assess the effectiveness of a simple, scalable intervention (an ‘activity supporting’ school uniform) in reducing cardiovascular risks in children attending primary school. The primary aim is to compare the difference between the intervention and control group in their mean cardio-respiratory fitness at 9 months (primary end-point) and 18 months follow up, as measured by a multistage fitness test. It is hypothesised that the intervention group will report a higher mean cardiovascular fitness compared to the control group.

  • A Multicentre, Qualitative Evaluation of Australian and New Zealand Emergency Doctors’ Attitudes Towards Artificial Intelligence in Emergency Medicine

    Background Artificial intelligence (AI) has become increasingly capable over the last decade. AI technologies are approaching or surpassing human abilities at complex tasks. Specifically, in healthcare, AI is approaching or surpassing human clinician ability in multiple narrow domains. Research on AI in medicine has been increasing worldwide and across almost all specialties. General public opinion has seen to be positive in a number of surveys, with the public expressing high hopes that AI could be used to improve healthcare. Interaction with AI technologies is likely to become an increasingly common aspect of healthcare for both patients and physicians. Despite these trends, there is no data regarding Australian and New Zealand emergency doctors’ knowledge, attitudes, and opinions towards AI in general and the use of AI in emergency medicine. Aim Assess Australian and New Zealand emergency doctors’ attitudes and knowledge towards AI in general and the use of AI in emergency medicine. Plan We will conduct voluntary semi-structured interviews with a representative sample of Australian and New Zealand emergency medicine doctors until thematic saturation is achieved. Participants will be recruited through the research teams’ personal networks, and through recruitment advertising through ACEM. We will continue interviews as required until we achieve appropriate representation of the emergency medicine workforce. We will undertake qualitative analysis on transcribed interviews to uncover attitudes and themes.

  • Role of EMT (epithelial mesenchymal transition) in metastatic breast cancer: Association with eribulin and cyclin dependent kinase inhibitor treatment and disease recurrence

    The EMT study is investigating a molecular process (epithelial-mesenchymal transition) which can occur in the breast cancer cells of some patients, which can make the cancer more aggressive and might reflect how well the cancer cells will respond to treatment. Who is it for? Eligible patients in this study are aged 18 years or older, have been diagnosed with hormone receptor positive, HER2 negative breast cancer and have received a cyclin D kinase inhibitor in the adjuvant setting and have experienced a breast cancer recurrent event, or have received a cyclin D kinase inhibitor for treatment of metastatic cancer. Any metastatic breast cancer patient who has received at least one dose of eribulin in the course of their treatment may also be eligible. Study details All participants enrolled in this study will be asked to provide 1-2 tumour biopsies (tissue samples) that will be used to perform the molecular tests to determine EMT activity. Samples from previous surgeries and/or biopsies may be used to perform the molecular tests. Some eligible participants may be asked to undergo a maximum of two new biopsies if tissue from prior procedures is not available. No other patient procedures will be performed. It is hoped this research will provide more information regarding the EMT process which may allow doctors to better select treatment for their patients whose breast cancer has this feature, and potentially allow the development of new drugs which can target the EMT process to increase cancer cell kill.

  • The Australian Emergency Procedural Sedation Database; A multi-centre observational study of the practice of Procedural Sedation in Australian Emergency Departments (ED)

    Procedural sedation to facilitate painful and non-painful procedures is a core skill of specialist emergency physicians (EPs) in Australasia. Our goal is to establish a national procedural sedation dataset to monitor practice for trends in techniques and safety on a large scale over time. This will collect data on current practices around procedural sedation, including patient selection and optimisation, staffing, medication use, monitoring modalities and rates of procedural success and sedation complications. We hope that this database will form fertile ground for the exploration of future research hypotheses.

  • Electrical stimulation combined with strength training to increase the strength of very weak muscles in people with recent spinal cord injury. A randomised controlled trial

    Weakness is a debilitating problem for people with spinal cord injury (SCI) and while we know a lot about how to strengthen fully innervated muscles, we know very little about how to strengthen the very weak muscles of people with SCI. It is believed that the addition of ES to strength training might further enhance the neural and muscular adaptations required to increase strength in the very weak muscles of people with SCI. The underlying mechanisms are not well understood but are thought to be due to enhanced neural plasticity in combination with hypertrophy of the muscle. Increasing the strength in very weak muscles is crucial to the future independence of people with SCI. Even small changes in strength can have a big impact on function. This study will be a pragmatic multi-centre, single-blind between-participant randomised controlled trial. The aim is to compare the effectiveness of strength training combined with ES and usual care, versus usual care alone for increasing voluntary strength in very weak muscles of people with recent SCI. One target muscle for each participant will be selected from the following groups of muscles: the elbow flexors, elbow extensors, wrist flexors, wrist extensors, knee flexors, knee extensor muscles, ankle dorsiflexors or ankle plantarflexors. Eligible participants will be randomised to one of two groups, either the Treatment group or the Control group. Participants allocated to the Treatment group will receive ES and voluntary strength training to the target muscle, three times a week for 8 weeks in combination with usual care. Participants in the Treatment Group will aim to perform a total of 120 repetitions of isolated contractions of the target muscle during each session, as well as usual care. Participants allocated to the Control group will receive usual care alone. The intervention will be provided for 8 weeks. All outcomes will be collected at baseline and at 8 weeks.

  • Effect of Ivabradine use on exercise capacity in patients with transposition of the great arteries (TGA) post atrial switch repair

    This is a single centre, randomized, double blind, cross over study designed to assess the effect of Ivabradine (as a heart rate lowering drug) on the exercise capacity of adults with transposition of the great arteries who have had a previous atrial switch repair. Subjects will be randomised to Ivabradine or placebo after undergoing a baseline cardiopulmonary stress test. Repeat testing will be performed after 4 weeks of treatment then at 8 weeks after a crossover at 4 weeks. We hypothesise that heart rate lowering on exercise with improve exercise capacity (VO2 max) in these adults owing to improved blood flow through the heart (ie. improved atrio-ventricular transport).

  • A study to determine the feasibility of a trial investigating the effect of angiotensin II infusion on kidney damage in cardiac surgical patients

    Each year more than 25,000 Australians have cardiac surgery. While the mortality rate is relatively low (around 1-2%), the rate of problems afterwards such as kidney injury is higher (up to 40%). Acute kidney injury (AKI) is a reduction in kidney function over a short period of time. In many cases it resolves, but patients who have had AKI have higher rates of long-term kidney problems and mortality rates. A few will need dialysis. Maintaining blood flow and pressure for the kidney may help prevent injury. Angiotensin II is produced by the body naturally but can also be given as a drug. It has effects that increase blood pressure. Studies in patients with infection have shown that angiotensin II may improve kidney injury. Animal experiments suggest it may be superior to another drug, known as noradrenaline. Our hypothesis is that angiotensin II may reduce kidney injury. In this pilot study we will determine the feasibility of a definitive study comparing angiotensin II to noradrenaline.

  • The implementation and effectiveness of Brief Physical Activity Counselling by Physiotherapists (BEHAVIOUR) on levels of patient physical activity.

    Physical activity counselling increases physical activity when delivered in healthcare settings; however, implementation efforts have been sub-optimal. The BEHAVIOUR trial aims to address this important evidence-practice gap by delivering implementation strategies (education, training, tailored strategies to address community referral barriers, creation of a learning collaborative, and facilitation and audit and feedback) to enable physiotherapists working in South Western Sydney Local Health District to provide physical activity counselling within routine care. It is hypothesised that physical activity counselling will be implemented into practice and that patients receiving treatment from physiotherapists who receive the implementation strategies will be more likely to participate in greater amounts of self-reported planned physical activity at 6-months after baseline assessment compared to patients whose physiotherapist have not received the implementation strategies.

  • Meta-Emotion Therapy for Bulimia Nervosa

    The aim is to build on previous findings and gain some preliminary evidence to the effectiveness of MET within the BN population. Furthermore, it is important to gain feedback on therapy content, process and dosage in order to prepare for future clinical studies. It is hypothesised that the MET intervention will improve participants’ BN as evidenced by primary measure scores, as well as the secondary measure scores. This study employed a single-case multiple baseline design with commencement of the intervention staggered for each participant. Participants intend to include six adults. Following pre-treatment telephone screening, participants will be screened in an initial assessment interview and to ensure a diagnosis of BN consistent with DSM-5 criteria. Participants will also be administered a Structured Clinical Interview for DSM-5 (SCID) (First, 2015) to ascertain that inclusion and exclusion criteria were met. Participants will be referred to another service for treatment if exclusion criteria is met. Following the initial interview, participants will then complete the outcome measures. Participants will also need to be assessed by a general practitioner to identify any physical conditions that precluded full participation and to ensure that their electrolyte levels are all within a safe range. Participants will complete 16 sessions of MET treatment on a weekly basis with each session lasting approximately one hour in duration. The therapist will be a registered provisional psychologist currently undertaking a Masters of Clinical Psychology at QUT. All sessions will be video/audio recorded and discussed during clinical supervision with a supervisor who is an experienced clinical psychologist (20 years).

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