ANZCTR search results

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

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31212 results sorted by trial registration date.
  • Abdominal Functional Electrical Stimulation to reduce respiratory complications in spinal cord injury

    The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can reduce the rate of respiratory complications in acute tetraplegia. The secondary objectives of this study are to analyse whether this intervention also affects: (1) respiratory function, (2) quality of life and (3) mortality.

  • The Lewy Body Study - an observational study that will assess the changes that occur in memory and thinking skills and changes that occur in the body of 100 participants with dementia with Lewy bodies over a 3 year period.

    Lewy body diseases are a common form of neurodegenerative disorders which includes Parkinson’s disease (PD), Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB). DLB and PDD are both termed Lewy body dementias, with many overlaps clinically and pathologically. Lewy body dementias also share many features with Alzheimer’s disease (AD). Dementia with Lewy bodies is a common form of dementia in older age (approximately 1 in 6 of all dementia cases), However there are very few longitudinal studies that investigate the changes that occur in the brain and in the body of people with DLB. People with DLB have an abnormal accumulation of the protein alpha-synuclein in their brain which may affect memory, thinking, behaviour, mood and movement. Many cases of DLB have multiple changes in brain pathology, such as vascular disease changes, or the accumulation of other proteins, such as amyloid and tau, that are found in Alzheimer’s disease. However it is not known what effect these changes have when there are also Lewy bodies present. In order to understand the disease process and offer potentially effective treatments in the future, these changes need to be investigated. The Lewy Body Study will establish an Australian cohort of 100 individuals diagnosed with DLB and follow them over the course of 3 years to investigate factors which may help to predict disease outcomes, and which may lead to effective treatments being available in the future. As comparison groups, 20 people diagnosed with PDD, 20 people diagnosed with AD and 20 healthy control participants will also be enrolled. So that the rate of disease changes can be monitored DLB participants will undergo clinical and cognitive (memory and thinking) assessments and health related questionnaires, a blood test and brain MRI scans every 12 months; and optional brain PET imaging scans. There is also an opportunity for participants to undergo cerebrospinal fluid collection (optional). DLB is currently widely under-diagnosed. The Lewy Body Study will provide the largest depository of DLB disease related data in Australia that will be made available to approved researchers both nationally and internationally to help further dementia research. We aim to establish whether there are any disease biomarkers (genetic, blood, imaging, cognitive) which may help improve the diagnosis rate of DLB which may in turn improve the treatments and outcomes for those diagnosed with this disease.

  • Compare the efficiency of two treatments used to remove unhealthy tissue from non-healing leg ulcers

    Chronic venous leg ulcers are a major health problem affecting approximately 1.1/1000 of the Western Australian population and previous community studies have shown that venous leg ulcers contribute to 50% of all wounds managed by community nurses. Although most leg ulcers will heal with compression bandages, approximately 20% fail to respond to this treatment possibly due to the presence of unhealthy tissue. Therefore this study is looking at two different types of debridement treatments used to breakdown the unhealthy tissue to encourage the dressings and compression bandaging to be more effective at healing the venous leg ulcers. Participants who have had a leg ulcer for more than 4 weeks but less than 5 years that have failed to respond to dressings and compression bandaging because of the presence of unhealthy tissue would be eligible to participate in the study. The participants after consent with be randomly assigned to either low frequency ultrasonic debridment or sharp debridement treatment on a weekly basis for a maximum of 12 weeks or less (if healing occurs before the 12 weeks) carried out by an experienced wound Nurse Practitoner and then have a silver dressing and compression bandaging applied. The wounds will be measured on a weekly basis using 3-dimensional laser digital planimetry system which is uploaded on a secured computer to allow automatic calculation of wound tissue volume including the percentage of reduction or increase. In addition the wound assessment and care plan will be completed using an electronic on-line secured platform (Comcare Wound Module) to analyse healing outcomes and costs for all treatments of all participants. Each participant will complete a quality of life assessment prior to commencement of treatment and on completion of the study. The study will analyse the healing rates for both debridement treatments, compare the healing rates of the two treatments to determine which treatment was more effective and analyse the cost of healing for the two treatments.

  • Nasal High Flow therapy for Children with Acute Hypoxemic Respiratory Failure

    This study aims to develop a multi-centre trial and to assess which children with acute respiratory failure benefit using Nasal High Flow Therapy (NHF). For this purpose we will perform a randomised controlled trial comparing current best practice (standard oxygen delivery via subnasal prongs, facemask, venturi mask) versus NHF therapy. With the introduction of this simple to use respiratory system in regional and tertiary centres we aim to investigate if NHF therapy has a lower treatment failure rate in comparison to standard oxygen delivery reducing the hospital length of stay.

  • Abdominal Functional Electrical Stimulation To Assist Ventilator Weaning In Critically Ill Patients: a randomised controlled trial

    The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can reduce mechanical ventilation duration in critically ill patients. The secondary objectives of this study are to analyse whether this intervention also affects: (1) the thickness of respiratory muscles, (2) respiratory function, (3) Intensive Care Unit (ICU) length of stay, (4) ICU and hospital representations, (5) re-intubations and (6) mortality.

  • Mouthguard and positional trainer( vibrating collar) in supine sleep apnoea..

    In this study, we propose to study the effects of 2 types of treatment for positional sleep apnoea. Positional sleep apnoea is when you have more sleep apnoea, when you sleep on your back. The first treatment is called MAS or a mouthguard which is like a denture worn during sleep to improve sleep apnoea. the second treatment is called night shift, this is a vibrating collar, which will vibrate when you sleep on your back. We are hoping to try these two treatments in a controlled fashion by adding the collar in different time periods of the trial. Our study hypothesis is that adding the vibrating collar will improve the treatment efficacy. We are hoping to look at the benefits of treatments by looking at the treatment compliance which will be assessed by a chip inserted in the outhguard and by llong at the data obtained by the vibrating collar. We will also look at how your sleepiness scores have improved.

  • PARTICIPATE-CP: Optimising participation in physically active leisure for children with Cerebral Palsy

    In Australia, 35,000 people are living with cerebral palsy (CP). People with CP have poorer health outcomes, are less active and have a 1.2 to 1.6 greater risk of chronic health conditions such as diabetes, hypertension and stroke compared with those without a disability. We have promising data about a new intervention called Participate-CP, which is a therapy that improves children’s participation in physical activity goals that are meaningful to them. In this trial for 100 children with CP, we will compare Participate-CP to Standard Care to see whether or not the intervention delivers additional benefits over Standard Care.

  • A healthy volunteer study to test the safety and tolerability of a single dose of the Dexmedetomidine Transdermal System as well as how your body takes it in and disposes and breaks it down.

    The DMTS has been evaluated in 3 completed clinical studies. This study was designed to evaluate the safety and pharmacokinetics of a 4-day application of DMTS as well as to identify an appropriate oral water/liquid hydration volume to be administered starting 2 hours before DMTS application through 6 to 12 hours after DMTS application.

  • Angiotensin-Converting Enzyme (ACE) inhibitor cessation in the setting of well-functioning Fontan hearts

    This study will look at the impact of angiotensin receptor inhibitors (ACEI) cessation in children and adults with a Fontan circulation and normal heart contraction. Many children born with a single cardiac pumping chamber undergo a Fontan operation. Due to concerns about potential late heart failure, many are prescribed ACEI although they have good heart function, possibly exposing them to unnecessary risk of adverse drug reactions and the burden of lifelong medication. Evidence has shown ACEI are of benefit in a failing 2-ventricle heart, but there is no literature to suggest they are of benefit in the Fontan circulation. This project aims to demonstrate that cessation of ACEI, or closely related angiotensin receptor blockers (ARB), is safe and non-inferior to ACEI/ARB continuation in children and adults with a Fontan circulation with good cardiac systolic function and without other indications for continuation such as moderate or greater valvar regurgitation and/or hypertension. We hypothesise that: 1. Cessation of ACEI or ARB does not result in a significant decline in peak exercise capacity or cardiac function over a 12-month follow-up period. 2. Cessation of ACEI or ARB results in improved quality of life and reduced medical expenses over 12 months. If the hypotheses hold true it will dispel a historical concern that will relieve a large number of Fontan patients and their families of an unnecessary burden, improving quality of life and sense of well-being. It will improve the futures and the lives of people affected by childhood heart disease. Lifelong medication carries with it an important psychological burden because of the effects on one’s sense of well-being and “normalness”. This can be especially burdensome for children and their families. Medications also impose a risk of adverse reactions, and may also be costly, for example an adult on a standard dose of ACEI without a Healthcare Card could expect to pay $265 per year. Although, in this current era, we strive for evidence-based medical practice, there is little evidence to guide us in many areas of congenital heart medicine. Some practices, that have been routine for many years, may actually be useless or even cause harm. The implementation of ACEI as a routine for people with the unique single-ventricle Fontan circulation is practiced in many centres, although there is virtually no evidence to support their use. Future implications of this trial would include reduced morbidity related to unnecessary medication administration, insight into the disease processes that may or may not contribute to late Fontan failure, a better understanding of the consequences of ACEI use including the social and psychological impact, improved quality of life, and streamlined and improved management strategies for people living with a Fontan heart.

  • A study of initial total hip replacement using a cementless hip implant that has been coated with a bio-active material.

    This is a prospective, multi-centre, clinical study using a product that has been registered for use in Australia by the TGA. The primary purpose of the study is to measure micro-movement of a cementless total hip replacement implant within the bone at timepoints up to three years. The micro-movement (if any) will be measured using X-Rays. 222 participants will be recruited and will be followed up for a period of three years. Quality of Life will also be analysed using two questionnaires.

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