ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Evaluation of the usefulness of a new method for predicting the outcome of critical illness in patients admitted to intensive care.

    It has been postulated that as a result of critical illness, patients leak particular chemicals from their cells with subsequent movement of these chemicals into the blood stream where they may be detected. Disappearance of these chemicals from the blood has been linked to resolution of the process that triggered the episode of critical illness and ultimately, to recovery of the patient. Currently and with few exceptions, direct measurement of these chemicals is not possible and their effect has to be inferred indirectly as part of another commonly performed measurement - the standard base excess (SBE). The SBE also responds to alterations in the concentrations of the major blood chemicals which are normally present in health. The changes in the normal chemistry of the blood occurs as a result of either the underlying critical illness or the fluids used during resuscitation and unfortunately, they also have a major effect on the SBE, The result is that the SBE becomes more of a general indicator of the presence of critical illness rather than a specific and sensitive predictor. It also can remain abnormal even when the patient has returned to health. A recent method for splitting the SBE into its components that permits the estimation of the specific effect of the unmeasured chemicals has been developed, published and experimentally validated - the Unmeasured Ion eXcess (UIX) algorithm. The utility of this algorithm needs to be formally tested in the clinical environment and it is this requirement that drives the need to conduct an audit that involves mapping the results of the routinely collected daily bloods in a population of critically ill patients to their eventual outcome and length of ICU and hospital stay.

  • Does empagliflozin preserve pancreas function in recently-diagnosed type 1 diabetes?

    Empagliflozin is used to treat type 2 diabetes. It works by promoting loss of glucose in the urine. Recent evidence suggests this drug might help preserve pancreas function in people with diabetes. This study will assess the feasibility and safety of this approach in people who are within 100 days of being diagnosed with type 1 diabetes.

  • Consumer Choice of Pre-Packaged Foods that Vary by Nutrition Information and Price

    The non communicable diseases associated with poor diet (e.g., high blood pressure, high blood cholesterol, obesity and poor metabolic outcomes) are increasing in prevalence but are also preventable. Nutrition labels on the front of food packs is one public health intervention designed to assist people to consume a healthy diet. A variety of other information (health related and otherwise) is available on food packs for consumers to incorporate into their purchase decisions. (such as the Nutrition Information Panel, health claims, price, etc). These sources of information often occur together on food packs, yet past research has generally look at the isolated effects of individual forms of nutrition information without consideration of how these pieces of information interact. The primary aim of this study is to investigate how nutrition information format, healthiness and price interact to affect consumer product choice.

  • A pilot study of tongue stimulation to improve balance and gait in stroke survivors

    Many people with stroke have walking and balance dysfunction. Sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) provided through a device called the Portable Neuromodulation Stimulator (PoNS) can stimulate regions in the brain that are important for balance and gait. This study will be a preliminary randomised controlled trial (RCT) of the PoNS combined with a structured task-specific rehabilitation program in stroke survivors undergoing inpatient rehabilitation.The study will be registered with the Therapeutic Goods Administration under the Clinical Trial Notification Scheme (device trial). Ten participants will be randomised to either a 2-week intensive balance and gait training program with a physiotherapist while using the PoNS (intervention), or to a 2-week intensive balance and gait training program with a physiotherapist only (control). Both the intervention and control programs will be conducted at the Royal Park Rehabilitation Centre, and will be additional to the patients' usual rehabilitation program. Training sessions will be tailored to the needs of each participant and comprise five main components: movement control, balance, gait, cognition and breathing and relaxation. Participants will be assessed on a range of outcome measures related to gait and balance, as well as self-perception of performance, depression, cognition and oculomotor function. Assessments will occur at baseline and post-intervention. The primary outcome measures will be the miniBEST Test, which assesses balance. This study will be the first systematic study of the PoNS in Australia, and will establish the safety and preliminary efficacy of the PoNS/training protocol. It will also provide data on which to base a sample size calculation for a future larger RCT.

  • Western Australian Illicit Substance Evaluation

    Recreational drug use is becoming an increasing public health issue in our society. Methamphetamine usage in Australia has been described as an ‘epidemic’ that is ‘tearing our country apart’, and has recently been the subject of a Prime Ministerial National Ice Task Force. The average purity of methamphetamine seized by police in Western Australia has increased from 10% to 75% in just six years. In addition to this, there are a huge new range of synthetic drugs entering circulation, which are collectively termed novel psychoactive substances. These include many novel stimulants and hallucinogens, such as cathinones, NBOMe type drugs, and synthetic cannabinoid receptor antagonists. There were seven unrelated deaths in Australia over the 2015-2016 summer festival season related to synthetic drug use, as publicised in the ABC Four Corners investigation “Dying to Dance” (February 2016). This project is a novel study, based in the emergency department (ED), where patients suspected of being under the influence of recreational drugs have a single blood sample taken to identify the causative agent. The analysis will be undertaken by ChemCentre WA, with whom we have an established collaboration, using liquid chromatography-mass spectrometry analytical techniques. Prior to analysis, the sample is permanently de-identified. We aim to identify the agent (or agents), determine its concentration, and relate it to the clinical picture and complications. We will also compare the analytic result with what the patient believed they had taken. Where novel drugs are identified, repeat analytical work can be undertaken to aim to develop new assays and reference standards for future analysis. Samples will be stored frozen for five years to enable this work. We will be able to identify trends in recreational drug use in patients presenting to the ED, which is vitally important from a public health perspective. Should information of early interest to clinicians or the general public be identified, this would be released in the interest of public safety.

  • A field survey of windfarm and traffic noise effects on sleep

    Increased sustainable “green” energy production has led to rapid expansion of wind farm facilities in Australia and world-wide. This has been associated with community complaints regarding noise emissions that include “infra-sound” (noise below average hearing threshold), and concerns that this may have negative effects on sleep and health. International studies so far remain inconclusive and none have included any direct measurements of sleep so it remains unclear how disturbing wind farm noise is to sleep. Ongoing uncertainty in this area remains a problem for communities close to wind farm facilities, government regulators, wind energy producers and the broader community. This project is specifically designed to address knowledge gaps concerning potential wind farm noise effects on sleep using the most sensitive techniques currently available for assessing sleep disturbance. The results of this study will help to inform the potential need for improved noise regulation and abatement strategies to minimise potential sleep and health impacts. This survey is the first part of a larger project, and is designed to identify people who report being affected by wind farm noise and others who do not, to be invited to participate in a home sleep and noise measurement study, or a later in-laboratory study at Flinders University. This survey is largely based on that developed by Health Canada to study wind farm effects on health and is being used with permission from the Health Canada study team, but has been modified based on input from Australian noise and sleep researchers, and community representatives from areas affected by wind farm or traffic noise. The aim of the survey is to identify 4 groups according to overnight noise exposure type and level of complaints. Individuals within these groups will be sequentially invited to participate in further field measurement and in-laboratory studies.

  • A field survey of windfarm and traffic noise effects on sleep (In-Home Study)

    A strong push towards greener and more sustainable energy production has led to rapid expansion of wind farm facilities in Australia and world-wide. This has been associated with wide-spread complaints from neighbouring communities, particularly regarding noise emissions, including “infra-sound” (noise below average hearing threshold), and concerns that this may negatively impact on sleep and health. International studies so far remain inconclusive, particularly regarding noise effects on sleep. However, no studies so far have used physiological recording techniques necessary to properly investigate sleep. Consequently, this study is specifically designed to investigate windfarm noise effects on sleep using measurements normally used to diagnose sleep problems. This field study is the second part of a large three-part project designed to firmly establish what effect windfarm noise has on sleep compared to quiet sleeping conditions (control) and traffic noise, which is already known to disturb sleep and is therefore a useful condition to compare to (positive control). The overall aim of this study is assess self-reported (subjective) and direct objective measures of sleep quality in the natural home sleep/noise environment to examine relationships between noise, sleep disturbances and other factors.

  • Comparison of computer-based training and compensatory memory rehabilitation in Acquired Brain Injury

    Memory problems are among the most common cognitive difficulties after acquired brain injury (ABI), and can significantly compromise an individual’s ability to perform day-to-day tasks and quality of life. Computer-based training and compensatory approaches are two therapeutic approaches used to improve memory difficulties. The evidence to support the effectiveness of either approach is limited. This study will compare the efficacy of computer-based training versus compensatory memory rehabilitation approaches with regard to improving 1) memory and 2) performance in day-to-day tasks. Participants with ABI will be randomly allocated to participate in either six week of: (A) computer-based memory training, (B) compensatory memory rehabilitation (Memory Skills Group) or C) waitlist control group. This study will establish which approach to memory rehabilitation is most effective and which approach maximises daily functioning and quality of life for individuals with ABI.

  • A supervised walking program to reduce risky wandering in people with severe dementia in residential aged care: A feasibility study

    Dementia-related wandering is very common and has been observed in 100% of ambulant people with dementia in RAC (Algase, Kupferschmid, Beel-Bates, & Beattie, 1997). Anecdotal evidence suggests that, when wandering occurs within safe limits, some benefits may be experienced such as physical activity, stimulation, the provision of meaningful activity and improved quality of life (J Dewing, 2006; Martino-Salzman, Blasch, Morris, & McNeal, 1991). However, evidence suggests that when wandering goes beyond safe limits, adverse outcomes for the person who wanders can be experienced (malnutrition and dehydration, sleep deprivation, increased potential for injury from falls and resident to resident violence, becoming lost, and death) (Algase, Beattie, & Son, 2004). For the person with dementia being cared for in RAC, unique problems associated with wandering are experienced. In the RAC setting the person with dementia who wanders can enter out of bounds areas, such as the bedroom of another resident, which can result in loss of privacy. Due to cognitive impairment, the person with dementia who has had their privacy invaded by a person who wanders may respond to the invasion with verbal and physical abuse, which exposes the person who wanders and their co-resident to increased risk of harm (Shinoda-Tagawa et al., 2004; Talerico, Evans, & Strumpf, 2002). The aspect of wandering resulting in these outcomes is known as boundary transgression (BT), defined as a dimension of wandering that takes the person who wanders to out of bounds or hazardous areas. InRAC when wandering takes the person with dementia into the private space of a co-resident, wandering could result in resident to resident violence, loss of privacy and increased agitation for the recipient of the intrusion, and social isolation for the person who wanders (MacAndrew, 2014). Staff and family members also reported that from their experience, wandering-related BT was very common in RAC, was difficult to manage as carers could not predict where and when a BT would occur and if it would be disruptive to others, and often resulted in physical and verbal abuse. Despite the known asdverse outcomes of wandering in RAC, in the absence of RCTs, there is not strong evidence to support the effectiveness of interventions, and there remains a dearth of evidence-based guidelines for the management of wandering in RAC . The aims of this pilot study are, in people with dementia living in residential aged care, to explore 1. the feasibility of using a supervised walking program delivered before peak ambulation periods 2. to examine if taking a person with severe dementia who wanders for a daily 30 minute walk for 3 weeks will: a. Reduce risky wandering including boundary transgression (BT); b. Improve quality of life (QoL), and sleep quality; c. Reduce agitation, falls and weight loss. A quasi-experimental study design will be used

  • Effectiveness of GAME (Goals Activity Motor Enrichment) for infants at high risk of cerebral palsy

    Each year, 600 Australians are diagnosed with cerebral palsy with a $4 billion annual socioeconomic burden. One third never walk. The National Disability Insurance Scheme ranks early intervention to improve disability as its top priority. We have developed an early training intervention ("GAME" Goals Activity Motor Enrichment) based on the key neuroscience principles of activity dependent plasticity and enriched environments and on successful training interventions known to work in older children with cerebral palsy and adults post stroke. GAME is the only published protocol of an infant friendly early, intense, specific training intervention grounded in contemporary neuroscience, tested for safety and early efficacy, and is acceptable to parents. This new pragmatic, single blind randomised controlled trial (RCT) in 300 infants with cerebral palsy or at high risk of cerebral palsy aims to evaluate the effects of “GAME” versus traditional passive early intervention on gross and fine motor skills at two years of age. We will also evaluate the secondary outcomes of neuroplasticity on MRI, cognitive skills and quality of life. In this pragmatic trial, infants will receive experimental GAME training (once weekly therapist provided+ daily parent provided) versus control (traditional therapy alone). Both groups will be dose matched according to the standard National Disability Insurance Scheme early intervention funding package. Experimental and control treatments will continue until the infant’s 2nd birthday. Assessments will be carried out at baseline, prior to randomisation and at 1 and 2 years of age (corrected for prematurity). The expected clinical outcomes of our trial are that infants who received our intervention will have significant and lasting motor and cognitive gains that lessen the severity of their cerebral palsy and improve their quality of life.

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