ANZCTR search results

This is a 5-year multicenter trial. Children with a history suggestive of OSA and deemed suitable for adenotonsillectomy (T&A) by an otolaryngologist are eligible to participate in an overnight sleep study (PSG). If the PSG demonstrates mild to moderate OSA OAHI< 10/hr), they will be recruited randomised to receive early (treatment group), or routine (control group) adenotonsillectomy (treatment intervention).The outcome sought is a clinically meaningful improvement in the neurocognitive testing scores, which has been defined as an improvement of 4 IQ points. The primary outcome of the study are intelligence quotient (IQ) and behavioural scores. The IQ and behaviour will be assessed after the PSG result but before randomisation. The PSG, IQ and behaviour tests will be repeated at follow-up 12 months later. After follow-up at 12 months, the control group will proceed to T&A and at 24 months, the treatment and the control groups will have PSG, IQ and behaviour tests repeated for the third time. Rationale: Previous studies have demonstrated that children with OSA have lower IQ scores and more disturbed behaviour than age-matched counterparts who do not snore. No randomized trials have been undertaken to evaluate whether the abnormalities improve after treatment. The participants in this study will have overnight sleep studies and neuropsychological testing at three time points. The first is at baseline before T&A. One group will have T&A after randomisation and the first follow-up (12 months after randomisation) will assess changes for treatment (T&A) vs non-treatment (waiting). after 12 months follow-up, the second group will also undergo T&A. The second assessment (24 months after randomisation) whether a 12 month delay to T&A affects outcomes. The first assessment will allow us to determine whether adenotonsillectomy (T&A) improves IQ and behavioural deficits in 3-5 yr-old children compared to no T&A. We hypothesize that T&A produces improvements in IQ and in behaviour. The second assessment will allow us to determine whether there is any difference in the level of improvement achieved after early compared to late (12 month delayed) T&A.

The study aims to evaluate the impact of three linked nutritional interventions on the nutritional care of patients at risk of malnutrition in an acute tertiary hospital setting. This will be achieved by improving the quality of assessment, screening and feeding of patients. Specifically, three linked interventions (the introduction and use of a nutritional screening tool, the provision of food supplements at ward level, and, the introduction of a red tray system to identify those patients requiring help with eating and drinking) will be introduced in a staged way into four groups of randomly allocated wards in the Royal Adelaide Hospital (RAH). Staff will receive facilitated support from members of the research team to assist in implementing the intervention on their wards. By the end of the intervention, all wards of the hospital will have introduced the composite intervention. A stepped wedge design will be utilised to compare outcomes (including: changes in body mass during their hospital visit, length of stay, number of infections, readmission rates) pre-, during and post-intervention.

This study looks at the effectiveness of pure emu oil for treatment of joints pain in postmenopausal women receiving treatment with aromatase inhibitors due to early breast cancer. This is a 2 phase study, where phase 'A ' is blinded and phase 'B' is open labelled (not blinded). In first phase, participants will be randomized to receive either emu oil or placebo for 8 weeks and the arm to which they are randomized will not be known to them or their doctor. During this treatment period, all patients would be required to mainatain daily diary to record treatment compliance. Joint pain and stiffness severity will be assessed before and after treatment using pain questionnaires. In phase B, patients will be asked to continue treatment with open label emu oil for further 8 weeks, if they wish. All patients continuing in phase B, will be assessed for pain and stiffness severity at the end of this phase. Following 16 weeks of treatment, patients will be able to continue with commercial stock of emu oil, and will be assessed for compliance and severity at 6 months. Improvement in joint pain and stiffness will be assessed at baseline and end of 8 weeks of treatment. Adverse events and compliance related to Emu oil will be monitored throughout the study. Overall pain will be assessed at baseline and end of 8 weeks of treatment.

The purpose of this study is investigate effects of fish oil on learning and behaviour of children from predominantly Indigenous schools in the Northern Territory. Children will receive fish oil or placebo on school days for 2 school terms (Phase 1; 10 weeks each with one week's break) and then both treatment and placebo groups will receive fish oil for a further 2 school terms (Phase 2; following a 4 week semester break). The study will be double-blinded for Phase 1 and single-blinded for Phase 2.

This study looks at the safety of using a drug called PG545 in determining its maximum tolerated dose in patients with advanced tumours. In this trial, PG545 will be used for the first time in humans. We will be looking at whether taking PG545 will results in changes to chemicals produced by the body which are linked to cancer growth and spread. Who is it for? You can join this study if you have any advanced (metastatic/widespread), non haematologic, malignant solid tumours, except for primary brain or spinal tumours. Trial details All participants in this study will be assigned to a cohort and will receive PG545 at 50-500 mg once weekly until either their disease progresses, they are removed from study due to a safety concern or the study reaches its end point (estimated to be 12 months). Patients will receive the same dose for the duration of the study. Follow up assessments to determine the optimum dose of PG545, its safety and tolerability, and pharmacokinetic / pharmacodynamic profiles will be measured at the end of the first treatment cycle (28 days) and continuously throughout the treatment duration. The aim of the study is to compare these outcomes amongst all participants, and to determine the possible side effects of PG545.

As the major immune cell types involved in initiating and sustaining the ITP disease are antigent presenting cells (APC), B cells and T cells (Chong 2009, Kuwana 2009), it is reasonable to expect better long-term response rates by using drugs targeting all three cell types: namely an anti-B cell agent (rituximab), an anti-APC drug (high dose dexamethasone) and an anti-T cell treatment (cyclosporine). By combining these drugs together over a short period of time (4 weeks), we hope to maximise the efficacy while minimising anticipated toxicities associated with longer-term use of these drugs.

The purpose of this observational project is to identify patients with a vaginal invagination and report the clinical presentation of a series of 20 patients undergoing prolapse surgery. This observational study is conduced to obtain a better understanding of the pathophysiology of the vagina after repeat gynaecological surgery. The hypothesis of this study is that women undergoing prolapse surgery who have had previous pelvic floor surgery are at high risk to present with a vaginal invagination due to incorrect restoring of the normal anatomy of the vagina. Vaginal invagination are likely to be caused by inappropriate surgical techniques and lack of awareness of this subsequent condition. By identification and in the following surgical releasing of the vaginal invagination this might create a better anatomical setting to perform further prolapse surgery. Furthermore it might have an impact on preexisting pain, dysparunia or shortend vagina.

Recent evidence shows an ethnic variability in tolerance of anticancer drugs between Asian and Caucasian non-small cell lung cancer patients. Pharmacogenetic differences in drug metabolising enzymes have been proposed as the cause of these differences, however they have not been associated with altered cytotoxic drug pharmacokinetics (PK). Other possible explanations include differences in dietary/concomitant medicine intake and inflammatory status. The aim of this study was to investigate inter-ethnic differences in cytotoxic drug metabolism, inflammatory/nutritional status, genotype and outcomes between Asian and Caucasian non-small cell lung cancer patients.

This study seeks to establish whether stem cells can be used to treat patients with poor circlation in their legs.