ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Visual images to assist in positioning for spinal and epidural anaesthesia

    Traditionally, anaesthetists have always been verbally instructing patients how to position themselves for spinal or epidural anaesthesia. This project is based on our hypothesis that if we use images in addition to verbal instructions, the patients could understand easily what is expected of them and therefore they can position themselves appropriately and quickly. We believe this will increase the satisfaction of both anaesthetists and patients with the whole procedure. This project involves randomising patients into two groups, one group gets the standard verbal instructions and the other group gets to see images of the correct position as well. We note the time taken to do a successful procedure, the number of skin punctures made and the satisfaction scores of patients and anaesthetists. The two groups are compared and analysed if showing visual images is any beneficial as opposed to mere verbal instructions.

  • Assessing management practices and residents' eye health in residential aged care facilities to develop a new model of eye care.

    The overall aim of this project is to improve and preserve optimal visual function of residents in Australian residential aged care facilities (RACFs), in order to improve or optimise this critical sensory input in their already restricted environment. There is clear evidence that people living in RACFs have more vision issues which are not adequately managed, when compared to similarly aged people living in their own home. Vision issues include macular degeneration (the main cause of blindness and major vision loss in people over 50), glaucoma, diabetic retinopathy, untreated cataract, uncorrected refractive error and many other conditions. Eye testing of residents will be conducted to quantify the extent of vision issues in these facilities, and to test the practicality of onsite testing, or alternate means when necessary. After gaining a detailed knowledge base of the current landscape, legislative requirements and issues through consultation with an expert reference group, the project will identify the existing eye health practices in eight different RACFs from four different providers (Estia Health, Presbyterian Aged Care, BaptistCare, Allambie Heights Village) using a detailed audit. The facilities to be audited will have varying levels of additional services provided. The audit will focus on existing policies and procedures to determine: a) whether appropriate baseline records of a resident's vision are obtained; b) whether residents obtain regular ongoing eye tests, and if so, how; c) whether resident care (including treatment and rehabilitation) is modified as a result of vision issues; d) the extent of communication regarding eye health with the residents' healthcare providers (eg GP and relevant specialists) and family. Using input from the expert reference group, a draft 'minimum standard of care' model will be developed. A manual will then be produced to provide a practical/workable guide for use in RACFs. In addition, an audio-visual education tool will be developed for use by RACF management and staff, as well as an educational publication for families. The manual and video will then be tested within the RACFs prior to final production and distribution to all RACFs across Australia.

  • VERBATIM: A randomised controlled trial of aripiprazole for the treatment of auditory verbal hallucinations in borderline personality disorder

    Borderline personality disorder (BPD) affects over 95,000 15-24 year-old Australians and is a leading cause disability and mortality in this age group. Up to half of patients with BPD experience distressing and disabling auditory verbal hallucinations (AVHs) but opinion about their veracity and their treatment is polarised. Second generation antipsychotic medications (SGAs) are prescribed frequently ‘off label’ for BPD, despite limited supporting evidence. Recent studies show that AVHs in BPD and schizophrenia are phenomenologically indistinguishable. However, no randomised controlled trial (RCT) has ever tested whether conventional pharmacotherapy for AVHs in schizophrenia is applicable to AVHs in BPD. This study is a 12-week, single-centre, RCT of aripiprazole versus placebo, with a 27-week follow-up period, for 15-25 year-olds with BPD and AVH. The primary outcome is AVH severity, measured using a standardised scale. Secondary outcomes include BPD severity, general psychopathology, functioning, experience of psychotic symptoms and changes in neurobiological mechanisms underlying AVHs that are associated with treatment. Currently, the NHMRC clinical practice guidelines for BPD recommend against the use of antipsychotic medications as first-line treatment for BPD, which places them in direct conflict with NHMRC clinical practice guidelines for psychotic disorders. This novel study will advance knowledge about treatment for BPD by providing information about the efficacy of antipsychotics in the treatment of AVHs when they co-occur with BPD. It will also extend knowledge about the phenomenology of AVHs, whether AVHs should be considered as part of the symptom profile of BPD and the neurobiological basis of this symptom.

  • Efficacy of the Zap and Run defibrillator skills training program for health care workers.

    ‘Zap and Run’ is a ten minute one on one training workshop focused on developing and maintaining skills in use of a cardiac defibrillator for rhythm recognition, defibrillation, cardioversion and external pacing. It utilises the portable ALSi simulator. This project aims to evaluate the skills of participants while undertaking the workshop. Participants will be asked to rate their training experience and time to treat will be measured using the logging features of the simulator. This evaluation will be used to determine the skills gap and need for training. The workshop consists of testing the skills of participants using a simulated defibrillator over seven scenarios. The simulator logs the times and actions of the participant. The instructor then explains and corrects any errors and the scenario is run again if necessary to confirm learning before moving to the next scenario. At the beginning and end of the workshop the participant will fill out a workshop evaluation questionnaire.

  • Managing menopausal symptoms and reducing chronic disease risk factors in midlife women: The Women's Wellness Program Study.

    This project aims to bring to proof of concept an evidence-based, flexibly delivered, information technology driven (interactive website) program of structured health promotion and risk reduction (the Women's Wellness Program), which aims to decrease menopausal symptoms and instill sustained and positive health behaviours in midlife women.

  • Molecular Profiling and Matched Targeted Therapy for Patients with Metastatic Melanoma (MatchMel)

    The primary purpose of this study is to evaluate the efficacy of cancer therapy which is matched specifically to the genetic profile of each individual's tumour in patients with metastatic melanoma. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and are newly diagnosed with stage IIIB, IIIC or IV melanoma. Study details: All participants in this study will first undergo standard testing to establish whether a certain type of genetic mutation (BRAF/NRAS mutation) is present in their tumour cells. This is carried out using an existing or fresh tumour tissue sample. All participants will then begin standard care therapy for the melanoma. In participants with tumours testing negative for BRAF/NRAS mutations in the initial test, and who show disease progression or who are unable to continue standard care therapy, further testing on their tumour tissue sample will be carried out. This will provide further information regarding the genetic profile of the tumour. Researchers will then match this genetic profile to a specific therapy which targets it. Researchers will measure disease progression and survival to evaluate the efficacy of the matched targeted treatment in comparison to standard care only. The matched targeted therapies which may be used will be continuously updated as other research provides more information on which drugs may target which genetic profiles. It is hoped that the findings of this study will provide valuable information regarding the efficacy of therapies which target the specific genetic profile of metastatic melanoma tumours, in comparison to the current standard care.

  • PlaTFORM: PrevenTing Falls in a high risk, vision impaired population through specialist ORientation and Mobility services: a randomised trial

    Visually impaired older people are increasing in number and have significant ongoing morbidity including risk of falls, but are neglected in regard to falls prevention programs. We aim to evaluate the effectiveness of the Lifestyle approach to reducing Falls through Exercise (LiFE) program to prevent falls and improve function in older people with vision impairment compared to usual care, delivered through specialist Orientation and Mobility Instructors. Secondary aims are to establish the cost-effectiveness of the LiFE program compared to usual care and to identify determinants of the success of the LiFE program and implementation issues in the vision impaired population. We will conduct a randomized controlled trial evaluating the LiFE program in older people with visual impairment in NSW and ACT in collaboration with Guide Dogs NSW/ACT, a leading community service organisation for people with vision impairment. A total of 588 participants will be recruited through Guide Dogs client database, and randomized to receive either the LiFE intervention or usual care (control group). Guide Dogs' Orientation and Mobility Instructors will receive training in delivering the LiFE program, which will be delivered to those in the intervention group. Social and demographic characteristics and visual and physical status and will be assessed at baseline, and physical status reassessed at 12 months to characterise the study cohort.. Falls will be self-reported on a monthly basis. Physical activity will be measured using actigraphy at baseline, 3 and 12 months. A sample of 30 participants in the intervention group will be interviewed after completing the program to determine how well the LiFE program concepts are integrated into daily activity. An economic evaluation will be modeled from a health service provider perspective, with data collected on costs to deliver the LiFE program, in-patient hospital admissions, emergency department presentations and other health and community service contact, The primary outcome measures will be the rate of falls over the 12 months following randomization and the Late Life Disability and Function Index.. The secondary outcomes will be falls requiring medical care and the rate of falls per steps taken.

  • First Human Use of an Investigational Bronchoscope System - Assessing Safety and Performance

    First human use clinical trial of an investigational (not-approved) study device used to facilitate the biopsy of pulmonary nodules with unknown etiology. The purpose of this study is to evaluate the safety and feasibility/performance of the investigational device - up to 30 subjects will be enrolled, and will be followed-up for up to 6 months post-procedure. For non-malignant subjects, data may be collected from a standard of care follow-up visit at 12 months post-procedure

  • Evaluating transcatheter arterial embolisation for improvement of pain in osteoarthritis (OA) of the knee

    Knee osteoarthritis (OA) is a leading cause of pain and disability around the world. OA involves the breakdown of joint cartilage, but it also appears to include the proliferation of blood vessels and nerves about the joint. It is suggested that these blood vessels and nerves contribute to the experience of pain. One pilot study found that embolising abnormal vessels about the knee substantially improved individual's pain. The primary aim of the current study is to determine whether transcatheter arterial embolisation of abnormal neovasculature about the knee improves pain. Secondary aims include whether embolisation improves physical function, quality of life, joint stiffness, and medication usage. The study is a randomised controlled trial. People are eligible if they have knee OA that is not yet ready for knee replacement surgery and have tried other forms of traditional management such as medications and physiotherapy. Participants will be randomly allocated to one of two groups: intervention or placebo. Participants in the intervention group will receive embolisation of abnormal vessels about the knee. Participants in the control group will receive a placebo intervention that looks and feels like the real intervention but does not include embolisation of abnormal blood vessels. All participants will be assessed shortly before the intervention (real or placebo) and then 1, 6 and 12 months after the intervention. Participants in the intervention group will also be assessed 24 months following the intervention. Assessment includes a variety of questionnaires and physical tests.

  • Ultrasound for endotracheal tube position in neonates.

    This is a single-blinded study. The ultrasound and x-ray images will be stored as a study number only. They will be analysed later after completion of enrolment. The x- rays will be evaluated by paediatric radiologist (AL) blinded to the ultrasound measurements and clinical management. The x-rays will be reported as the distance from ET tip to carina and Position of ET tip in relation to vertebral body. The ultrasound images will be analysed by investigators separately, blinded to the x-ray results and clinical management. The results will be used to compare correlation and reliability of two methods. The distance between ET tip and carina on x-ray will be correlated with ultrasound measurements of - 1. Distance between aortic arch and ETT 2. Distance between RPA and ETT

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