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Research Hypothesis: In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2NRTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e. non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3NRTIs. Study Design: This is a Phase IIIb/IV, international, randomised, open label study comparing two regimens of combination antiretroviral therapy in people living with HIV with confirmed virological failure of first-line NNRTI/2 NRTI regimens. The study will run for 96-weeks but the primary analysis will take place at the week 48 time point. Eligible participants will be randomised in equal proportions to one of two regimens of combination ART as follows: I. ritonavir boosted lopinavir (LPV/r) + 2-3NRTIs II. ritonavir boosted lopinavir (LPV/r) + raltegravir Number of Subjects per Group: Approximately 275 eligible subjects will be randomly allocated to each of the two treatment arms giving a study total of 550 participants.

The aim for the current trial is to understand how polyphenols affect cognition, brain functioning and blood flow for both acute and chronic doses. We wish to explore the acute (single dose) and four-week (28 doses) neuro-cognitive effects of polyphenols in 72 healthy middle aged volunteers. The cognitive effects will be assessed using the CDR computerised cognitive assessment system and the neurophysiological effects will be measured using high spatial resolution electrical brain recordings measures by the Steady State Topography technique (SST) which has been pioneered at the Brain Sciences Institute and used in over 50 published studies. The cardiovascular effects will be measured using Transcranail Doppler Ultrasound to measure blood flow and the sphygmocor system to measure arterial stiffness

Eligible patients - brain tumour Aim - to develop new, more sensitive Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures for detecting early treatment response Treated as per standard practice with the addition of 3 3,4-dihydroxy-6-fluoro-phenylalanine (FDOPA) PET scans.

Confirmation of correct nasogastric tube (NGT) placement is essential to ensure the safe delivery of nutrition without the risk of morbidity and mortality associated with misplacement in the lung resulting in aspiration, pneumonia, pneumothorax or death. Previous studies indicate a pH < 4 is indicative of gastric aspirate and hence a reliable indicator of correct NGT placement. At the Royal Children’s Hospital (RCH) in Melbourne, the current practice is to use this pH cut-off < 4 based on Metheny’s work, but this is not always clinically practical. The use of antacid medication and/or the presence of enteral feeds due to delayed gastric emptying may be contributing factors in a higher pH result, casting doubt on NGT position. A number of different clinical methods have been reported to determine NGT position including auscultation (listening for air passed down the tube), aspirate colour, administering oral fluids or flushing NGT with oral rehydration solution (ORS), but none are evidence-based methods. Radiography confirmation is the gold standard but has limited application secondary to availability, cost and radiation exposure. This study was undertaken to directly compare pH results of gastric aspirate samples with endotracheal aspirate samples, and particularly to examine potential overlap of pH results between the aspirate samples. This data can then be used to establish a reliable and clinically practical pH cut-off value for gastric aspirate without risking the safety of the patient by not identifying a misplaced NGT in the lung. Whilst undertaking this study, an adverse nasogastric-feeding incident occurred in the UK which led to the formation of a working party to challenge the assumptions and rituals of NGT placement. An NGT algorithm was developed using a risk assessment approach to improve the safety of NGT fed children and increase the awareness of the risks to health care providers. Subsequently, the National Patient Safety Agency (NPSA) published an alert that accepted a pH cut-off <5.5 as being an acceptable risk. This was decided by expert opinion and consensus rather than the result of new clinical research. This current study will provide further evidence for this consensus statement and ensure that our recommendations are based on evidence-based practice and lead to reduced patient risk. We compare the range of pH results between gastric and endotrachael aspirate samples, with particular interest in the area of overlap between the two samples. This data will help to determine a reliable and practical pH value to confirm NGT placement, without increasing the risk of not identifying a misplaced NGT.

Tramadol is increasingly used as an analgesic in newborn infants who require surgery. It is hypothesised that tramadol use promotes decreased exposure to other analgesic agents like morphine, some of which depress respiration. By measuring the effect of tramadol or placebo on duration of mechanical ventilation, we can determine whether or not using tramadol has a significant sparing effect for the use of opioid analgesic agents.

This study is a randomised study that will investigate the safety and effacy of stoss therapy (high dose weekly vitamin D supplementation for 4 weeks) compared to daily vitamin D for 3 months. The hypothesis is that stoss vitamin D therapy is a safe and effective treatment for vitamin D deficency. If proven safe and effective, stoss therapy would have significant advantages where therapy is shortened, thus improving compliance and ultimate recovery from Vitamin D deficiency.

This proposal will provide solutions to a very significant practical clinical question in paediatric brain injury rehabilitation: Can stimulant medication improve disorders of attention and concentration, and other problems including regulation of behaviour and emotions, in children with traumatic brain injury (TBI), and thus facilitate rehabilitation? Few studies have investigated the usefulness of stimulant medication in children with TBI. It is well recognised that there is marked individual variation in response to stimulant medication. Positive effects from stimulants in this population (such as improved attention and concentration and better emotional and behavioural regulation) will allow children to benefit more from rehabilitation interventions, make rehabilitation professionals’ jobs easier and result in more cost-effective rehabilitation. N-of-1 trials (a type of drug trial in which the effect of the drug is examined within each individual patient rather than between groups of patients) will be used to examine the efficacy of stimulants in individual patients with Traumatic Brain Injury, so that the doctor, patient and family can make an objective assessment about the usefulness of this treatment for the patient. The hypotheses we plan to test are: (1) Stimulant therapy with methylphenidate (MPH) or dexamphetamine compared to placebo will significantly improve attention and concentration, and executive dysfunction including disorders of behavioural and emotional regulation, in children with TBI. (2) n-of-1 trials are feasible in paediatric rehabilitation practice for children with TBI. Objectives: A) To determine the efficacy of stimulants in alleviating these symptoms in children with traumatic brain injury. B) To evaluate the feasibility of n-of-1 trials as a means of conducting clinical trials in paediatric rehabilitation.

The study seeks to compare the stability and visual outcomes of patients recieiving 2 commonly used brands of toric intraocular lens implant (TIOL) used to correct corneal based astigmatism at the time of cataract surgery. Accuracy of implantation as well as post operative stability and effectivity of astigmatic correction will be assessed.

This study aims to determine the effectiveness of paracetamol for treating pain relief in people with advanced cancer who are currently taking opioids. Who is it for? You can join this study if you have advanced cancer with chronic cancer-related pain and you are currently taking opioids to control the pain. Trial details Participants will either start treatment with paracetamol in addition to regular opioids or they will start treatment with a non-active compound (*placebo) plus regular opioids. Participants will then cross-over to receive either placebo (if they started by tak! ing paracetamol) or to receive paracetamol (if they started by taking a placebo). Participants will undergo 3 pairs of 3 day treatments (cycles), making a total of 18 days. The drugs being used are paracetamol 500 mg, and placebo, orally, two capsules three times daily. Participants complete a daily diary recording pain scores, side effects, which treatment they prefer, and their estimate of which drug they are taking at the time. The study aims to determine the efficacy of paracetamol in alleviating pain in patients with advanced cancer who are taking routine opioids. It will also allow an evaluation of the study techniques (n-of-1 trial design which is when one patient is randomised from one treatment and then to another to allow comparison) and development of appropriate statistical techniques for the analysis of trial data, and where appropriate, provide a means of adjusting for illness progression.

We will provide a motor and psychosocial intervention to preschool in 6 schools in WA and compare their performance with 6 control schools.