ANZCTR search results

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

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31295 results sorted by trial registration date.
  • Evaluation of Partnered Pharmacist Medication Charting at Admission: Expansion Project

    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 efficacy of chakra-puncture (CP) in addition to standard treatment for impaired sleep rhythm and disorders of breathing associated with chronic body pains.

    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.

  • A multicentre study of the dose concentration response of febuxostat in patients with chronic gout.

    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.

  • A Randomised Phase II Study Of nab-paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas

    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.

  • Effect of exenatide once weekly on gastric emptying in healthy subjects..

    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 feasibility and effect of using consumer-based physical activity monitors to improve exercise behaviour in women with Stage II+ breast cancer.

    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.

  • A comparison of Attention Bias Modification and the Attention Training Technique on pain: Efficacy and mechanisms

    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).

  • Wear assessment of highly crossed linked (X3) acetabular liners by Radio stereometric analysis (RSA). An analysis of patients with osteoarthritis treatment hip replacement surgery.

    Aseptic loosening, wear and dislocation are complications of primary total hip arthroplasty that have a high cost to society and is unpleasant for the patient to endure. New technology has enabled manufactures to improve the mechanical strength of the bearing surfaces which function well in vitro. Cross-linked polyethylene a second generation polyethylene was introduced into orthopaedic implant designs to address the problems of osteolysis, which is induced by polyethylene wear particles. These implant designs also enable the constructs to accommodate larger femoral heads which create stability and low wear rates which will decrease the amount of osteolysis (Burroughs, Hallstrom et al. 2005) and (Geller, Malchau et al. 2006). X3 'Trademark' represents the third generation of polyethylene, and has been developed in order to address the issues of reduced mechanical properties compared with second generation cross-linked polyethylene, whilst still maintaining the benefits of reduced wear rates. Hip simulator testing shows that the wear rate of X3 polyethylene is significantly less than conventional cross-linked polyethylene (McKellop, Shen et al. 2000). This reduction in wear will result in significantly less wear particles around the joint and therefore less biological reaction, less osteolysis and a lower incidence of osteolysis induced component failure. This Radiostereometry analysis (RSA) study will investigate in vivo wear, migration and performance and the results will be compared to the current standard PE liners study using RSA as the form of analysis (Rohrl, Nivbrant et al. 2005). Hypothesis to be tested Part 1: Annual volumetric wear of the of the highly cross-linked polyethylene (X3 PE) lining used with a 32mm CoCr head is no more than 0.01mm/annum. Part 2: Annual volumetric wear of the of the highly cross-linked polyethylene (X3 PE) lining used with a large (36-40mm) CoCr heads is no more than 0.01mm/annum. Part 3: Annual volumetric wear of the of the highly cross-linked polyethylene (X3 PE) lining used with a Large (36-40mm) CoCr head and thin X3 PE is no more than 0.01mm/annum.

  • Feasibility and effects of inorganic nitrate in acute decompensated heart failure

    Acute decompensated heart failure (ADHF) is the most frequent reason for hospital admission in Australia, requiring improved treatment strategies. Inorganic sodium nitrate (NaNO3) is an indirect dietary means of delivering nitric oxide (NO), which is deficient in ADHF. It is proposed that NaNO3 will improve circulation via vasodilation, without significant hypotension, whilst improving renal blood flow and preserving renal filtration, in ADHF. The aim of this pilot is to evaluate the feasibility and effectiveness of sodium nitrate (NaNO3 8.4mmol administered in 12- hour intervals) over 48 hours as a treatment for ADHF, correlating systemic levels of NO precursors (Nitrate and Nitrite), with measures of cardiovascular and renal function, in 40 patients. We propose a single centre randomized, double-blind, placebo controlled trial, specifically testing the primary hypothesis that supplemental NaNO3 will result in increased systemic nitrate (NO3-) and nitrite (NO2-) levels, in parallel with improved vasorelaxation, as assessed by systemic vascular resistance index (SVRI). Additional surrogate measures relevant to the known pathophysiology of ADHF will be obtained in order to assess clinical effect on dyspnoea, diuretic efficiency and renal function. The results of this novel strategy will be of significant interest to the heart failure community and may help inform a future, larger study.

  • Patterns of artificial kidney failure during continuous renal replacement therapy

    During continuous renal replacement therapy (CRRT), blood is passed through a multi-lumen extracorporeal circuit that includes access, filter, return, effluent and replacement/dialysate components. Although anticoagulants, such as heparin and citrate, are commonly used, clotting of extracorporeal circuit and filter commonly occurs leading to shortened therapy duration or a failure to delivery therapy. In addition, inadequate treatment leads to circuit loss (including increased blood loss), increased costs (of circuits) and a loss of nursing time. The relationship between circuit pressures and artificial kidney failure in CRRT remains unclear. In response, we wish to perform an analysis of CRRT filter and circuit pressures in order to determine the patterns of change associated with artificial kidney failure. Specifically, we wish to evaluate the relative contribution of access circuit, filter, effluent, return circuit and trans-membrane (across the filter) pressures on the lifespan of the artificial kidney. In this pilot investigation we feel that 100 CRRT circuits will provide sufficient quantity of data to aid in the description of patterns of circuit pressure changes occurring during CRRT. Significantly, the findings of this study would provide insight into the dynamic changes of circuit pressures during CRRT, and defined the patterns of artificial kidney failure in CRRT. Such information will inform future prospective investigations aimed at improving the care of critically ill patients requiring CRRT. We plan to publish the audit findings in peer-reviewed critical care or artificial kidney injury journals. Participant anonymity and confidentiality will be preserved as only aggregated findings will be presented or reported.

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