ANZCTR search results

This study aims to examine the effect of THC (active component in cannabis) on driving performance along with various measures of cognition and decision-making, fatigue, vigilance (attention) and stress during both the acute and residual phases of cannabis consumption. A double-blind, placebo-controlled, counterbalanced cross-over design means that 20 healthy participants will will attend 2 experimental conditions and smoke either 2* THC cigarettes or 2* Placebo cigarettes at each testing session.

This study compares the safety and efficacy of two different treatment strategies (active surveillance with selective intervention versus radical treatment) in patients with favourable risk prostate cancer. Who is it for? You can join this study if you have been recently diagnosed with favourable risk prostate cancer and are a suitable candidate for radical prostatectomy or radiotherapy. Trial Details: Participants in this study will be randomly allocated to one of two treatment groups. Patients allocated to Group 1 will undergo either radical prostatectomy or radiotherapy based on you and your treating doctor’s preferences. Patients allocated to Group 2 will not undergo any immediate treatment. Rather, a ‘watchful waiting’ approach will be taken whereby your cancer is monitored closely and treatment (surgery or radiotherapy) is only undertaken if progression occurs. The results of this study will be useful to help guide patients and physicians in choosing the best treatment strategies to manage their cancer.

This project proposes to compare two methods of measuring women’s blood pressure during elective Caesarean sections. The safest and most common type of anaesthetic for a Caesarean section is a spinal anaesthetic. This abolishes painful sensation from the surgery and allows the woman to stay awake while her baby is delivered. However, a common side effect of a spinal anaesthetic is low blood pressure which can cause nausea and vomiting for the mother and may be harmful to the foetus. The pH (acidity) of blood from the umbilical cord taken immediately after delivery is lower (more acidic) if there has been low maternal blood pressure during the Caesarean. Blood pressure is closely monitored by the anaesthetist immediately after the spinal anaesthetic and a drug called metaraminol is given to increase the blood pressure if it is low. Metaraminol works by constricting blood vessels. The most common way of measuring blood pressure is with an automatic cuff on the arm called a noninvasive blood pressure (NIBP) device. This may be set to inflate every one, two or three minutes. However, the reliability of NIBP devices is poor and sometimes they fail to provide a blood pressure reading when required. This is a problem when the blood pressure is so variable in a short time period. An alternative device can provide continuous noninvasive arterial pressure (CNAP) measurement. It measures blood pressure using small cuffs on the finger. This study proposes to compare the reliability of the NIBP device with the CNAP device. Reliability is defined as the ability to provide a blood pressure reading every one minute during a Caesarean section. The main aim is not to compare the accuracy of these two devices. This is already well described in other research. The CNAP device often needs to recalibrate (at least every 15 minutes) and during this period, lasting between 40 and 180 seconds, no blood pressure readings are provided. It is therefore unknown which device is more reliable.

Observational study of 5 body temperature sites on critically ill neonates. Hypothesis: that rectal temperature would be slower to respond to changes in environmental temperature than oesophageal temperature.

Compartment syndrome occurs when swelling in a muscle interferes with the blood supply to that muscle. The syndrome happens most often in fractures, and after bone operations, and can lead to damage to the muscle and nerves of the limb affected. We are interested in using a new technology that is designed to look at the blood oxygen levels in tissue (in this case muscle). The technology uses probes attached to a machine. The probes are placed on the skin, and shine light into the muscle. The light is not damaging to the tissue. We would like to know more about the oxygen levels of muscles in compartment syndrome in children. All children 0 to 18 years of age can participate. They cannot participate if they have jaundice, or broken skin where the probes may be placed. For those presenting with suspected compartment syndrome, when the child comes to theatre, once they are asleep, we will place a probe on the skin over the muscle. We will do this on the affected and the unaffected side. We will also do a standard compartment pressure measurement simultaneously. The probe will be left on for 2 minutes in theatre, and then removed. For those presenting with a supracondylar fracture, the probes will be placed on the injured, and uninjured sides and left on for 48 hours or until hospital discharge. The monitor has not yet been shown to help in this problem, and we will not use the values to alter treatment in any way. We hope that the results of this study will help us to detect compartment syndrome early on, and allow quicker treatment, in those children who develop it.

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.