ANZCTR search results

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

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32757 results sorted by trial registration date.
  • Co-development and end-user testing of a Mobile App to support dementia carers.

    The current project seeks to work with end-users, people caring for a family member or friend with dementia, and a small number of representatives from dementia and carer organisations) to undertake real world testing and co-development of an App, called Carers’ CARE, to assist dementia carers. The project will use participants’ feedback provided in the App and from a small number of interviews, to assess the App’s a) patterns of usage, and end-user feedback about App features, content, user friendliness and acceptability b) dementia and carer related services providers' perceptions of the implementation potential of the App with extant services The study will also examine preliminary information about the App’s potential helpfulness for carers’ coping and psychological well-being.

  • Australian Cerebral Palsy Musculoskeletal Health Network: Bone Quality in Children with Cerebral Palsy

    In children and adolescents with CP, MSK complications are severe and progressive, with life-long impact. Hip displacement, scoliosis and skeletal fragility are often not detected until orthopaedic surgery is required or the child has sustained a pathological fracture. We will collect trans-iliac bone biopsy samples from 30 children with cerebral palsy to evaluate the bone quality and histomorphometry. Having a detailed understanding of the bone phenotype will help us plan targeted therapies to improve bone health.

  • Investigation of community participation outcomes for adults with acquired brain injury after discharge from post-acute rehabilitation: A mixed-methods study

    The primary purpose of this research project is to investigate community participation outcomes for adults with acquired brain injury (ABI) after discharge from post-acute rehabilitation. Community participation refers to the meaningful participation and engagement of an individual in life roles, occupations and activities conducted outside the home environment as well as actively being involved with society. The Brightwater 'Oats Street' Facility is a community-based residential acquired brain injury rehabilitation facility where clients live on-site to receive rehabilitation and support from a multidisciplinary team of health professionals. Rehabilitation at this facility is considered 'post-acute' rehabilitation. Community participation outcomes of Oats Street clients will be measured at discharge and then at 4, 8 and 12 months after discharge. Data from these outcomes will be analysed Phase 3 will then involve data analysis to analyse the changes in community participation outcomes.

  • Comparing Home-Based Digital Treatments for Insomnia.

    The research project is testing two new home-based insomnia treatments. One treatment is a sleep wearable device called THIM, which has been developed to administer a treatment called Intensive Sleep Retraining. The other treatment is an online program called SHUTi (Sleep Health Using The Internet) that administers a brief version of cognitive behavioural therapy for insomnia. Patients who meet diagnostic criteria for insomnia and have sleep onset difficulties will be randomly allocated to one of the four groups: THIM by itself, SHUTi by itself, THIM and SHUTi combined, waitlist control group. The study aims are to investigate: 1) the efficacy of THIM versus a waitlist control group for treating insomnia. 2) the efficacy of the combination versus all other treatments for treating insomnia. 3) the cost-benefits of remote therapies.

  • A randomised placebo-controlled trial examining the efficacy and safety of an adjunct herbal medicine formulation in patients with major depressive disorder and poor response to anti-depressant therapy

    Anti-depressants are a commonly used medication in Australia, with over 15 million prescriptions dispensed in 2018-2019 (Australian Institute of Health and Welfare 2019). However, the response to anti-depressants is varied, and some patients experience flatline emotion, ongoing depression, decreased cognition, changes in sexual function/desire, insomnia, and other symptoms. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed first-line treatment for major depression, however, the rate of treatment response from baseline symptoms following first-line treatment with SSRIs is moderate, varying from 40-60% and lower in subsequent treatment attempts. There is evidence that inflammatory cytokines contribute to the development of depression in both medically ill and medically healthy individuals (Felger and Lotrich 2013), and research supporting anti-inflammatory approaches to depression management has been shown to increase effectiveness of some anti-depressants in clinical trials (Muller, Schwarz et al. 2006, Akhondzadeh, Jafari et al. 2009, Hang, Zhang et al. 2021). Given the large proportion of patients who do not respond adequately to first-line therapy, or experience negative side-effects, incorporating adjunct treatments may need to be considered. Certain herbal medicines may be able to assist treatment response by decreasing inflammation and reducing side effects. It is hypothesised that specific anti-inflammatory and anti-depressant herbs may effect a clinically meaningful improvement when added as an adjunct to existing anti-depressants in patients with poor response to anti-depressant therapy.

  • Feasibility and efficacy of using lung measurements to predict complications during surgery for young children with and without respiratory symptoms.

    Perioperative respiratory adverse events (PRAE) pose a significant risk in paediatric anaesthesia, with the incidence of PRAE being reported between 15 and 50 %. Accurate detection of those at risk for developing PRAE is vital to enable tailoring of their perioperative management. Traditionally, risk of PRAE is assessed using the patient’s past medical history, family medical history and physical examination. However, given the multifactorial nature of the risk of PRAE and children with complex medical backgrounds such as chronic lung disease, obstructive sleep apnoea or obesity, patients may benefit from additional objective preoperative pulmonary function tests. Recently our group published an educational review identifying the clinical utility of preoperative pulmonary function testing in paediatrics which identified that there is little evidence to support the routine use of lung function in preoperative assessment. However, we noted that the measurement of Peak Cough Flow (PCF) is predictive of the need for respiratory support or cough support following surgery suggesting that a higher PCF may reduce the incidence of PRAE; thus far there is no evidence in the role of PCF in preoperative assessment, however this simple, non-invasive and portable test may help identify high-risk subjects. We propose a prospective cross-sectional interventional study to assess if Peak Cough Flow and spirometry in children with and without respiratory symptoms aged 5-10 years is clinically associated with an increased risk of developing PRAE. Monitoring and recording of PRAE (laryngospasm – closure of the vocal cords, bronchospasm – narrowing of the airways, severe and persistent coughing, airway obstruction, oxygen desaturation (<95%) and postoperative stridor-squeaky noises when breathing) will occur throughout the procedure and in the post anaesthesia care unit (PACU). We hypothesise that children with a higher percent of predicted PCF will be at a reduced risk for developing PRAE.

  • The use of MRI guided focused ultrasound for the management of focal hand dystonia

    Current treatments are primarily aimed at short term symptomatic control using oral medications or chemodenervation, with botulinum toxin, to provide relief of the involuntary movements. Physical therapies and rehabilitation, including constraint training and motor training with or without neuromodulation and sensory discriminative training, has shown some improvement but these findings are not definitive. Recently, the use of surgical stereotactic thalamotomy has been shown to provide significant efficacy in the treatment of patients with focal hand dystonia. This is an invasive treatment requiring burr hole and stereotactic probes being passed into the brain with a risk of intracerebral haemorrhage of 1-4%. Advances in minimally invasive surgical techniques using gamma-knife thalamotomy have been shown to be effective in refractory musician’s dystonia. The option of a less invasive neurosurgical technique, using MRI guided focussed ultrasound (MRgFUS), has provided a novel treatment approach for patients with focal dystonia. MRgFUS thalamotomy is a safe and effective treatment modality for essential tremor and other tremor disorders. A recent pilot study of non-invasive thalamotomy using MRgFUS showed promising results with marked improvement in symptoms related to focal hand dystonia with no adverse effects. It is the objective of this research project to establish the efficacy and safety of MRgFUS in an Australian population with focal hand dystonia and establish a database for ongoing research in the use of non-invasive neurosurgical techniques in the treatment of a wide range of movement disorders.

  • Nurse led volunteer support interventions and a technology driven pain assessment for older adults in hospital

    Hospitalisation for older people can result in poor health outcomes, and this is more evident in frail older patients and those with cognitive impairment. Factors such as chronic health conditions, polypharmacy and cognitive and functional decline are associated with increased risk of health care related harm, (such as falls, delirium and poor nutrition) (George, Long, & Vincent, 2013). Pain is also very common in older adults in hospital, however assessment of pain in older patients in hospital can be impacted by the patient’s communication of pain which may be affected by their beliefs about pain as a normal part of ageing, concerns related to use of medications for pain, and cognitive impairment often resulting in under treatment of pain (Schofield et al, 2018). Assessing pain begins with a person’s self-report using pain assessment tools but this can be challenging in older patients, and technology driven pain assessments have been developed for better pain assessment. One such application is PainChek Universal® that enables better assessment of pain at the point of care for those whose ability to communicate fluctuates. PainChek Universal® contains 2 scales 1. Numerical Rating Scale (NRS) for those who can self-report their pain.2. The PainChek scale for those who cannot self-report their pain (using automated facial recognition and analysis to identify pain-related facial micro-expressions, together with a series of user completed checklists of pain behaviours (Atee et al. 2017; Atee et al. 2018a).To minimise the risk of health care-related harm, volunteer programs to support patient care have been established in many hospitals worldwide. Volunteer programs have shown a positive impact on older patients in hospital and have positively upon patient health outcomes related to nutrition, falls and delirium (Naylor et al. 2013; Saunders et al 2019). A non-randomized intervention study will evaluate a model of service delivery for older adults in hospital aged 65 years and older through implementation of technology driven pain assessment and a nurse-led volunteer support program.

  • NSW HEARTS: The NSW Inherited Cardiomyopathy Cohort Study

    The NSW Inherited Cardiomyopathy Cohort or NSW HEARTS is a cohort study that aims to recruit over 2,500 participants from NSW with inherited cardiomyopathies, and prospectively follow them over time . The overarching aim of this study is to create a large, well-characterised cohort of patients with inherited cardiomyopathies in NSW for cross-sectional and longitudinal analysis. This will serve as an invaluable resource for numerous other research projects, as well as an opportunity for future data collection waves, extending follow-up even further. Data collected will include clinical information, cardiac investigations, blood sample, cardiac MRI and NSW Health linked data. All participant samples will undergo whole-genome sequencing (WGS), which will allow us to investigate the impact of genetic variants. The resulting dataset will enable us to perform analyses that have the potential to solve the genetic basis of diseases for many families and will be directly translated to improved variant classification criteria. Moreover, we can also seek to understand this new paradigm of non-familial disease and allow precision-based approaches to the care of families.

  • Evaluation of the performance (accuracy, precision) of a non-contact and non-invasive optical coherence tomography device in imaging and measuring normal eyes and eyes with diseases.

    This clinical investigation is targeted at collecting further clinical effectiveness and safety evidence of HP-OCT (Hyperparallel OCT®) in visualising and measuring anterior and posterior ocular structures/parameters. It is hypothesised that the HP-OCT is not inferior to, or less safe than the current standard devices utilised to measure anterior and posterior ocular structures/parameters. This investigation is composed of two sub-studies. The objective of Sub-study 1 is to (1) determine the precision (repeatability and reproducibility) of HP-OCT in biometric measurements, and (2) investigate the agreement of biometric measurements between the HP-OCT instrument and 3 state-of-the-art comparative devices. Sub-study 2 aims on investigating the reliability of the HP-OCT in generating retinal images to aid qualitative diagnosis. This investigation is a three-site study based on nested design, involving one unit of each of the 4 instruments (HP-OCT and 3 comparative devices) at each of the three sites (12 devices in total). The target enrolment is approximately 150 participants who will be divided into 4 subject/pathological eye populations and go through the non-contact non-invasive ocular scans using the HP-OCT and the comparative devices in a single site visit. All the information, data and images collected are de-identified for communication, analysis, and report. The retinal images obtained for Sub-study 2 will be sent to an image reading centre for qualitative image grading by three independent and masked image graders. The biometric measurements (Sub-study 1) and the retinal image grading results (Sub-study 2) will then be analysed statistically following the pre-specified protocol before the conclusion is drawn and reported in the clinical study report.

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