ANZCTR search results

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).

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.

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.

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.

Critically ill patients often require prolonged mechanical ventilation for periods greater than 48 hours. It has been identified that skeletal muscle wasting occurs early and rapidly during the first week of critical illness. Despite international recommendations to commence activity as early as possible with critically ill patients it has been identified that exercise interventions are rarely initiated when a patient is on mechanical ventilation. This leads to prolonged immobility and may contribute to the development of ICU Acquired Weakness (ICUAW). A randomised controlled trial (RCT) will compare outcomes of critically ill patients who receive standard physiotherapy (control group) and those who complete additional in-bed cycling intervention sessions. This will enable comparison of outcomes to assist clinicians to determine if additional in-bed cycling sessions may be beneficial with critically ill patients. Objectives: To determine: (1) if in-bed cycling in addition to standard care is effective in reducing the rate of rectus femoris (RF) cross-sectional area (CSA) atrophy and intensive care unit acquired weakness (ICUAW) in patients requiring > 48 hrs of mechanical ventilation compared to standard care; (2) whether in-bed cycling in addition to standard care improved functional and cognitive outcomes in patients requiring > 48 hours of mechanical ventilation compared to standard care. Trial Design: Two (parallel) arm, preliminary randomised control trial with assessor blinding. In summary, this study aims to examine if addition of an in-bed cycling intervention with critically ill patients reduces the loss of thigh muscle mass. Also to examine if in-bed cycling improves functional and cognitive outcomes post intensive care discharge.

Tulsi or Holy Basil is an Indian herb used for centuries for coping with stress as well as for the treatment of Type 2 Diabetes (T2D) and other cardiometabolic disorders. Tulsi tea is widely available throughout the world as a caffeine free herbal tea with no reported side effects in literature associated with regular consumption of tulsi tea. Considerable evidence in animal models shows that tulsi improves cognition, immunity, stress and cardiometabolic disorders. Also accumulating evidence from human trials indicate that long-term tulsi ingestion improves mood, cognition and cardiometabolic function. However, there are no published reports on short term effects of tulsi on these pathways in humans. In addition, only a few of the clinical trials have looked at the effect of tulsi consumption in healthy adults who are infact the majority of the tea drinker population. Potential outcomes of this clinical trial are not only to support traditional effectiveness and safety of tulsi but also to stimulate further research into the numerous healing potentials of this Ayurvedic sacred herb. This project aims to explore time course of mood, cognition and cardiovascular functional changes after the consumption of a single cup of tulsi tea in healthy people. In addition, since cortisol is a well-established biomarker of mental stress, known to control blood pressure (Kelly et al., 1998) and high cortisol levels found to be associated with reduced cognitive function such as memory (Shirbin et al., 2013), therefore acute change in cortisol activity was also assessed.