ANZCTR search results

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.

The objectives of the study are: 1) Explore the dose-concentration-response relationship of febuxostat in patients with chronic gout. 2) Gain insights into optimisation of febuxostat therapy to achieve target plasma urate concentrations. 3) Understand inter-patient variations in the pharmacokinetic parameters of the drug and their impact on the serum urate concentration. 4) Explore factors that may affect the pharmacokinetics and/or the response of urate to febuxostat.

The primary purpose of this trial is to evaluate the safety and efficacy of carboplatin plus nab-paclitaxel in comparison with carboplatin plus etoposide chemotherapy for the treatment of gastrointestinal neuroendocrine carcinomas (NECs). Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over, and have been diagnosed with advanced and/or metastatic, unresectable gastrointestinal neuroendocrine carcinoma (NEC). Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either carboplatin plus nab-paclitaxel or carboplatin plus etoposide. Participants receiving carboplatin plus nab-paclitaxel will be required to visit the study site once per week, for weekly administration of nab-paclitaxel plus adminstration of carboplatin once every three weeks. Participants receiving carboplatin plus etoposide will be required to visit the study site for three consecutive days every three weeks for administration of etoposide plus adminstration of carboplatin once every three weeks. Treatment will continue for all participants until disease progression or until side effects become unmanageable. All participants will be reviewed for side effects, outcomes of survival and cancer progression. Blood and tissue samples will also be taken, as well as specialised scans, to identify markers of prognosis and response. It is hoped that the findings of this trial will identify which treatment is the most promising, for further investigation to be undertaken to guide best practice.

This study is designed to evaluate the effects of 8 weeks treatment with the glucagon-like peptide-1 agonist, exenatide (once weekly (QW)), on the rate of stomach emptying, glucose absorption and blood glucose and plasma insulin concentrations in healthy subjects. This is a randomised parallel designed study. Subjects recruited into the study who pass screening criteria will be randomised to receive exenatide QW or matching placebo. they will have a gastric emptying study performed using the gold standard technique (scintigraphy) at baseline and at 8 weeks. Immediately following the first gastric emptying study they will commence treatment with exenatide QW or Placebo, administered subcutaneously at weekly intervals. Glucose absorption, blood glucose and plasma insulin will be assessed during each of the gastric emptying measurements.

The primary purpose of this trial is to evaluate the feasibility and efficacy of using Fitbit devices in combination with an individual exercise counselling session to increase physical activity in women with stage II+ breast cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or older, and have been diagnosed with stage II+ breast cancer for which you are either currently undergoing treatment, or have finished treatment within the previous 24 months. Participants must also reside or work in greater Brisbane and be insufficiently physically active. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either an individual exercise counselling session plus use of a Fitbit device for 12 weeks, or to receive only the individual exercise counselling session. The exercise counselling session will involve a 60 minute appointment at an exercise clinic (Queensland University of Technology, Brisbane) with an accredited exercise physiologist to discuss recommended physical activity levels and methods for increasing physical activity. Individuals in the Fitbit group will then be provided with a Fitbit device to use as much as they choose for the following 12 weeks. All participants will then have their physical activity levels assessed (by wearing a small physical activity monitor on their hip) and report on their levels of physical activity in order for researchers to compare between the two groups. It is hoped that the findings from this study will inform physicians and patients on easily accessible, cost-effective and feasible approaches for maintaining physical activity participation in the absence of supervised exercise in breast cancer patients with a high disease burden.

This study compares two interventions that aim to modify attention (Attention Training Technique: ATT and Attention Bias Modification: ABM) with a placebo. The aim of the study is to determine the relative efficacy of the explicit training (ATT) compared to the implicit training (ABM) in terms of their impact on pain and to examine the likely mechanisms of treatment by assessing changes in attentional control (targeted by ATT) and attentional bias (targeted by ABM).