ANZCTR search results

The primary aim of the study is to determine whether providing EGDT, compared to standard care, reduces 90-day mortality in patients presenting to the ED of hospitals in Australasia with severe sepsis. Each patient meeting all of the exclusion criteria and none of the exclusion criteria will be randomised in the ED to receive either EGDT for a total of 6 hours post-randomisation, or standard care. Patients assigned to receive EGDT will be cared for by the dedicated ARISE study team. The patient will receive treatment as per the study protocol for 6 hours with central blood oxygen levels as the target end-point, then receive standard care. Patients assigned to receive standard care will continue to be cared for by the hospital team in accordance with current best practice. Patients in both groups will also receive any additional treatment needed, such as antibiotics or surgery. The study will be conducted in 32 hospitals in Australasia with 1600 patients enrolled in the study over a 2.5 year period.

The primary purpose of this study is to access the results of using laser acupuncture to assist long term smoking cessation. Long term smoking cessation is assessed at 26 weeks after treatment commences. This trial has attempted to remedy the deficiencies of a previous laser acupuncture trials. It has been designed to address several questions: 1. Does true [verum] laser acupuncture have better outcomes of smoking cessation than sham laser acupuncture ? This style of laser acupuncture treatment has been chosen because there is not enough evidence from trials of this type of treatment to assess its validity. The Cochrane Library Review, Acupuncture and Related Interventions for Smoking Cessation [White, Rampes et al, 2007] was updated in 2007 and stated that “there is no consistent evidence that acupuncture, acupressure, laser therapy or electro-stimulation are effective for smoking cessation, but methodological problems mean that no firm conclusions can be drawn.” Research has shown acupuncture is a safe therapy with few side effects. Using the drug therapy of nicotine replacement therapy and Bupropion therapy as aids to assist smoking cessation is not suitable for everybody. The outcome of this trial will be clearer information about the role of true [verum] laser acupuncture This will inform recommendations for interventions that will assist smokers wishing to quit. It will add worthwhile information to the debate concerning the use of acupuncture and may influence future meta-analysis and reviews concerning the efficacy of laser acupuncture treatment and its role in assisting people to cease smoking.

Prior case-control studies on selected samples showed highly promising levels of sensitivity and specificity for uRNA. The next phase in the evaluation of the uRNA tests is to carry out a nested case-control study in a clinical population in which uRNA could potentially be useful. This would enable more accurate estimations of sensitivity and specificity as well as estimations of positive and negative predictive values for this population. This study would also enable a formal comparison of sensitivity and specificity for uRNA and each of the FDA-approved NMP22 tests. The clinical population chosen for this phase is patients with no history of TCC who present with a history of gross haematuria. This is the most common presentation for TCC and forms a relatively well defined population. In this study’s patient population, the potential use of uRNA is in conjunction with cystoscopy, where it would aim to identify TCCs which were missed during initial cystoscopy. Currently cytology is routinely used for this purpose and an alternative non-invasive assay NMP22 (Matritech) is also FDA approved for use, although it is not in routine use. The nested case control study described here will explore the value of uRNA as an adjunct to cystoscopy and in particular compare the performance of uRNA to that of cytology and the NMP22 tests for the detection of primary TCC in patients with a history of gross haematuria. Of particular interest are the relative sensitivity, specificity, positive and negative predictive values, the variation in sensitivity and specificity by grade and stage of disease, and the ability of the tests to identify invasive TCC.

This project will compare the growth rates and nutritional status of infants who are exclusively fed formulae either based on goat milk or cow milk. Growth will be assessed regularly (2 weeks, 1, 2, 3, 4, 6 and 12 months). Blood biochemical profile of infants, including plasma amino acids, will be assessed at 4 months. Formula tolerance and stool frequency will be assessed through to 4 months of age and stool microbiota will be assessed through to 2 months of age. A gold standard reference group of breastfed infants will also be included.

The objective of the proposed research is to establish a clinical program to test novel therapeutic interventions for TBI patients with fatigue and/or sleep disturbance. Specifically, the proposed four-year study aims to evaluate, in a randomized controlled trial, the effectiveness of two interventions, cognitive-behavioral therapy (CBT) and light therapy, administered for 8 weeks alone and in combination, in alleviating fatigue, sleep complaints, and cognitive performance following TBI. These innovative interventions will be evaluated in a TBI civilian population, with the aim of translating the program to military populations. Our primary hypotheses are that participants receiving CBT will show reduced self-reported fatigue, reduced daytime sleepiness, and improved sleep (assessed subjectively and objectively) and improved cognitive performance, 4 and 8 weeks after commencement of the CBT program and at one-and six-month follow-up compared to those receiving the current standard of care. In addition, that participants receiving blue light therapy daily will show reduced self-reported fatigue, reduced daytime sleepiness, improved sleep (assessed subjectively and objectively) and improved cognitive performance 4 and 8 weeks after commencement of therapy compared to those receiving the current standard of care. And finally, that patients receiving CBT and blue light therapy (combined) will show greater reductions in self-reported fatigue, reduction in daytime sleepiness, improvement in sleep (assessed subjectively and objectively) and in cognitive performance, after 4 and 8 weeks of the combined treatment and at one- and six-month follow-up compared to those receiving the current standard of care.

The primary objectives of this trial are to determine if a program of stretching before and after vigorous physical activity reduces risk of experiencing soreness after physical activity or reduces the risk of incurring an injury while participating in vigorous physical activity. The trial is internet-based and open to the whole world of English and Norwegian speakers.

The aim of the study is to compare diagnostic accuracy of emergency department ultrasound diagnosis with eventual ophthalmological diagnosis in patients with suspected posterior ocular pathology e.g vitreous haemorrhage, vitreous detachment, retinal detachment.

Despite an acknowledgement of the significance of carer support and consumer involvement in recovery, to date there is a lack of empirical evidence regarding their impact on the outcome of rehabilitation programs for stroke patients. The aim of this study is to develop a consumer and carer centred model to assist with recovery and community reintegration in the first year after the onset of stroke.