ANZCTR search results

This study is a clinical audit of patients undergoing implantation of a commercially-available and TGA-approved high frequency stimulator (TGA certificate DV-2011-MC-00182-3) between 1st January 2013 and 1st February 2017 for the clinical management of pain. The study will be a two-year audit of pain scores, disability index, analgesic drug consumption and patient satisfaction after implantation of a high frequency electrical nerve stimulator. Each patient will provide their informed consent for their data to be included in the clinical audit.

Stroke and dementia are two of the most common and disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment and dementia common after stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on the contribution of vascular risk factors to Alzheimer’s disease. Yet we still know very little about whether brain volume loss – a hallmark of dementia – occurs after stroke, and whether such atrophy is related to cognitive decline. The aim of this research is to establish whether stroke patients have reductions in brain volume in the first three years post-stroke compared to control subjects, and whether regional and global brain volume change is associated with post-stroke dementia in order to elucidate potential causal mechanisms (including genetic markers, amyloid deposition and vascular risk factors). We hypothesise that stroke patients will exhibit greater brain volume loss than comparable cohorts of stroke-free controls, and further, that stroke patients who develop dementia will exhibit greater global and regional brain volume loss than those who do not dement. An understanding of whether stroke is neurodegenerative, and in which patients, may be used to help guide the early delivery of disease-modifying therapies.

Fractures of the distal radius are the most common fractures presenting to emergency departments and orthopaedic surgeons. These fractures are more common in the elderly (due to osteoporosis and increased risk of falls) and the incidence in this age group is increasing. Considerable practice variation exists in the management of distal radius fractures in the elderly in Australia, ranging from closed reduction (manipulation of the arm to realign the fracture) with cast immobilisation, to open reduction (surgical exposure and realignment of the fracture) with plate fixation. Open reduction and (volar locking) plate fixation is currently the most common treatment provided. While there is evidence showing no significant advantage for some forms of surgical fixation over closed treatment, and no difference between different surgical techniques, there is a lack of evidence comparing the two most common treatments used in Australia: volar locked plate fixation versus cast immobilisation. Surgical management of these fractures involves significant costs (implant costs, medical costs, hospital costs) and risks (infection, implant failure, general surgical risks) compared to non-operative management (closed reduction and cast immobilisation in the emergency department). Therefore, high level evidence comparing the current treatment alternatives (plate fixation versus casting) is required in order to address practice variation, justify or avoid costs, and to provide the best clinical outcome for patients with these common fractures. This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether (volar locking) plate fixation leads to better pain and function and is more cost-effective than closed reduction with cast immobilisation in displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques, but will also follow patients that are unwilling to be randomised (but consent to follow up) in a separate, observational arm. Inclusion of non-randomised patients provides a more complete spectrum of fracture presentation, provides practice and outcome insights about standard care, and improves the generalisation of the results from the randomised arms. Given that plate fixation requires hospital admission and surgery, and that closed reduction with cast immobilisation is usually performed in the emergency department without admission, the findings have important implications for use of resources (theatre time, bed days, staff and implant costs) and may also reduce harms associated with plate fixation (infection, implant mal-positioning, tendon rupture and reoperation for implant removal). This trial will have significance in Australia, New Zealand and internationally, as it will address an important need for evidence supporting surgical practice.

The focus of this program of research is on carers of young people (aged 15-27 years) diagnosed with a first episode of psychosis. The proposed research program is a randomised controlled trial (RCT) which will examine the effectiveness of a novel online intervention for improving carer stress. The key research question is: can an innovative web-based intervention entitled “Altitudes”, which utilises moderated online social networking therapy (MOST), lead to improvements in stress at 6 month follow up in carers with a relative receiving treatment for a first episode psychosis, when added to specialist first-episode family work? The primary hypothesis is that carers randomised to the Altitudes online application+STAU will report significantly less stress at 6 months follow up compared with carers randomised to specialist family treatment as usual (STAU). The secondary hypothesis is that carers randomised to Altitudes will experience reduced objective stress, improved positive coping, self-efficacy, depression and perceived social support compared with carers randomised to STAU at 6-months follow up.

The glycocalyx is a particle that is important in maintaining blood vessel health. Patients with kidney disease have impaired blood vessel function, and previous studies have indicated that the glycocalyx is affected in those who have kidney disease. Laboratory studies indicate that the use of spironolactone, a common medication used for blood pressure, heart failure and to reduce protein in the urine, can have beneficial effects on the glycocalyx. The purpose of this study is to assess if the glycocalyx is affected in people who have kidney transplants, and whether spironolactone has any additional protective benefits on the glycocalyx.

Chronic obstructive pulmonary disease (COPD) is characterised by chronic inflammation of the airways and obstruction to airflow in the lungs, resulting in dyspnoea, chronic cough, and sputum production. The GOLD guidelines define mild COPD as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio less than 0.7 and an FEV1 greater than of equal to 80% predicted. With COPD being a progressive and irreversible disease, disease management in the earlier stages is of great importance in order to optimise long term outcomes. People with mild COPD already have dynamic hyperinflation, impaired gas exchange and increased dead space ventilation which are associated with exercise limitation and fatigue. Also, a reduction in physical activity levels develops early in COPD, even before patients are diagnosed with the disease. According to a study exploring physical inactivity in patients with COPD, people with mild COPD were found to have 13% reduction in step counts and 47% reduction in time spent in moderate physical activity compared to healthy subjects. This is significant because lower physical activity levels are associated with increased mortality and increased hospitalisation in people with COPD. Pulmonary rehabilitation (PR) is an eight-week program involving exercise training, education and support. In our previous research, we developed a home-based model of PR for people with moderate to severe COPD. Our findings suggested promising results in improving physical activity levels and enhancing health related quality of life. People with even the mildest forms of COPD have been shown to have markedly reduced levels of physical activity. We believe that the benefits attained in our home based program for patients with more severe disease may also be achieved in people in the early-stages of COPD. As most individuals with early-stage COPD are managed in primary care (and many are still working), a home-based PR program may be more acceptable for this patient group. We hypothesise that a. pulmonary rehabilitation will result in clinically important improvement in six minute walk distance in people with GOLD stage I COPD; b. PR will improve dyspnoea, quality of life, and physical activity in GOLD stage I COPD. In this RCT we will recruit 58 people diagnosed with early stage, mild COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines. Participants will be randomised to receive either usual care or home-based pulmonary rehabilitation program. Clinical measures will be recorded at baseline, 8 weeks-time point and 6 months. Outcome measures will include exercise capacity using change in 6 minutes walk distance, physical activity levels objectively measured by the sense wear armband (SWA), health related quality of life measured by change in the Chronic Respiratory Questionnaire and change in dyspnoea measured by the Modified Research Council Scale.

Survivors of the intensive care unit (ICU) can suffer long standing impairments in physical function. Rehabilitation provided in the ICU has been shown to improve physical function outcomes at both hospital discharge and 12-months. Early rehabilitation has been shown to be safe and feasible and may help prevent the long term sequelae. However, early rehabilitation is not routinely implemented in ICU due to cultural barriers and a lack of well-defined safety parameters, it currently relies on the discretion of the clinicians caring for the patient. Clinician's decisions can be influenced by conventional wisdom, personal experience, intuition and knowledge. The factors that clinicians consider to be important in the decision to provide rehabilitation, particularly out of bed functional activities in the ICU, are currently unknown. Therefore we aim to identify the factors that influence the initiation of early rehabilitation and develop a decision making support tree that includes safety parameters to assist clinicians in the provision of early rehabilitation for patients in ICU.

This is a Phase IIa study, testing a new medication for chronic pancreatitis. The new medication is called MS1819-SD which is a modified version of a naturally occurring enzyme made in the pancreas. The primary purpose of this study is to investigate the safety of escalating doses of study drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss. The design of the study is open-label, meaning that all eligible participants will receive the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of four treatment periods that ranges from low, medium, to higher doses. The total duration of the MS1819-SD treatment phase is of 48-60 days, Participants will be required to complete five day stool collections following high fat meals at the end of the washout period and at the end of each treatment phase. The total duration of patient participation in the study is of 74-93 days. Safety will be assessed at throughout the study that will include physical examinations and pathology testing to determine immunoallergic effects, Digestive symptoms will also be assessed and evaluated throughout the study. This study is being sponsored by AzurRx (the Sponsor). The Sponsor will fund researchers who conduct this research for the use of their facilities and to conduct this study.

A Partnered Pharmacist Medication Charting (PPMC) model has been in place at Alfred Health in the General Medical Unit since 2012. A randomised trial conducted in 2015 demonstrated that PPMC significantly reduced medication errors on admission compared to the standard medical model. From the 1st of August 2016, the PPMC will be implemented as a new standard of care in the General Medical units of 6 health services across Victoria. The purpose of this study is to evaluate this new standard of care. This pre/post study is not seeking participants. All patients admitted to the General Medical units of these services will be enrolled. Ethics approval and a waiver of consent has been granted by the Alfred HREC.

The primary objective of the study is to collect ‘real-world’ data on patients undergoing medical treatments with chakra-puncture (CP) or medical treatments alone in impaired sleep rhythm and/or sleep-disordered breathing (SDB) with chronic body pains. There are two main hypotheses assessed by the study: firstly, the experimental treatment with CP and medical treatments result in 20% or greater reduction in perceived body pains, and objective improvement in self-perception of quality of sleep over a six-months of follow up as compared to the medical treatments alone. Secondly, the improvements in chronic body pains and quality of sleep correspond to a significant reduction in abnormal body movements during sleep, which is associated with objective changes in sleep-related and daytime physiological markers. The study is a crossover-randomised study which will be completed over a period of 16 weeks, which is inclusive of participant recruitment, stratification, central randomisation, treatment and follow up. All relevant baseline physiological and demographic data will be collected at the time of randomisation. All participant-specific data will be de-identified to protect participant confidentiality and maintained in a safe data storage facility. Up to 80 participants will be randomly allocated to either consecutive generic CP treatments at 2-weekly intervals along with their medical treatment or medical treatment alone. After the initial treatments over a period of 6 weeks, a ‘wash-out’ period of four weeks will be given before the treatment sequence is reversed for each participant. Upon the study completion, a comparative analysis will be performed for clinical and statistical significance. Significant changes in impaired sleep rhythm and body pain will be summarised both by the percentage proportion (%) of participants experiencing at least 20% or more change in baseline sleep rhythm, pain scores and physiological markers at Week 1, 3, 5, 7, 10 and 17 of the study. Additional outcome analysis will be performed for adverse events, regional EEG patterns, quantitative core body temperature changes in localised areas of pain, participant satisfaction survey and QOL questionnaires, serial actigraphy and polysomnographic parameters, and nocturnal sleep-related movement data. To date, there is no published literature on the application of CP in neurocognitive research and treatment of impaired sleep rhythm associated with or without chronic body pains through a well-designed clinical study. The minimally invasive nature of the CP offers a potentially important avenue of non-pharmacological treatments.