ANZCTR search results

This study will compare the chemotherapy drug, Pacritinib, against the best available treatment for Thrombocytopenia and Myelofibrosis. You may be eligible to join this study if you aged 18 years or above and have been diagnosed with thrombocytopenia and/or myelofibrosis. Participants in this study are randomly allocated (by chance) to one of three groups. Participants in the first group will receive one dose of 400mg of oral Pacritinib for 24 weeks or until progression has occurred. Participants in the second group will receive two doses of 200mg of oral Pacritinib daily for up to 24 weeks or until progression occurs. Participants in the third group will receive best available treatment - which will be chosen by your treating physician. Participants will undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans to determine spleen volume and will be assessed for total symptom score using the Myeloproliferative Neoplasm Symptom Assessment Form 2.0. These assessments will occur 12 weekly. Patients may crossover from the BAT (Best available treatment) arm to Pacritinib at the discretion of the Investigator.

Despite the development of anaesthesia management guidelines, PRAE remain a major cause of morbidity and mortality during paediatric anaesthesia, accounting for more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. It is known that the rate of PRAE is approximately 2-folds higher in children undergoing tonsillectomy procedures compared to adults and that the rate of complications is also inversely proportional to age. Younger children are at a higher risk for PRAE compared with older children with a decrease in PRAE of 11% with each yearly increase in age. In recent studies and audits in our institution looking at children undergoing tonsillectomies, we found that approximately half the patients suffer from PRAE. Such a high rate of complications inevitably generates a cascade of linked events such as delays in theatre, with the potential for cancellation of other children due to the lack of theatre time and consecutive increases in waitlist time, unplanned hospital admissions, prolonged hospital stay and additional treatment. Even though most PRAE are not associated with long-term sequelae, it also creates more stress for the child and parents. Furthermore, data from closed malpractice claims in the United States of America (USA) show that nearly half of all claims were due to PRAE with higher incidents of death and brain damage as well as higher compensation payments in children as compared with adults. The development of preventative strategies, incorporated into an optimised anaesthesia management, would help reduce the occurrence of PRAE and address the previously cited issues. Salbutamol is a commonly used drug in the treatment of asthma which is available as an over the counter medication in Australia. A previous observational trial showed that premedication with inhaled salbutamol reduced the incidence of respiratory adverse events and in particular reduced bronchospasm and persistent cough by up to 50% in children with a recent upper respiratory tract infection. This current study aims to test the efficacy of inhaled salbutamol to prevent PRAE in young children undergoing tonsillectomies, who are at a particularly high risk for PRAE in a randomised controlled setting. The secondary objectives are to reduce the delays in theatre and the time spent in PACU due to PRAE, the number of unplanned admissions, prolonged hospital stays and delays in the waiting lists due to sequelae following PRAE. Hypothesis We hypothesise that, in children undergoing tonsillectomy (+/- adenoidectomy, +/- grommets) procedures, the incidence of overall PRAE will be significantly reduced by the preoperative treatment with inhaled salbutamol as compared with placebo.

There is now a substantial evidence base for a range of treatment strategies that target the core features of autism spectrum disorders (ASD). Educational and behavioural interventions in particular have been the focus of several well-designed studies that have reported benefits of intense and sustained therapy. However, the effectiveness of these interventions depends on significant therapy time with trained clinicians, and come at considerable financial cost. Thus, a significant proportion of families are unable to access these therapies. Any activities that can improve the time- and cost-effectiveness of early intervention, and are proven to enhance the longer-term outcomes among individuals with ASD, will provide enormous benefit to the community. TOBY (Therapy Outcomes By You) Playpad, an iPad App developed by a team of computer scientists, psychologists and speech pathologists, is one such tool that may enable a more cost-effective way to provide therapy to children with ASD. The TOBY curriculum covers social skills, language, sensory discrimination, and cognitive skills, using Applied behavioural analysis (ABA) principles. While TOBY was not designed to replace one-on-one therapy with clinicians, it may provide an affordable (RRP: $27.99AUD) and easily accessible intervention method to complement existing therapy. Anecdotal reports suggest that TOBY may be an effective intervention method for children with ASD, and also a means of positively empowering parents by giving them greater control over their child’s therapy. However TOBY is yet to be subjected to a randomized controlled trial. 1.To determine the effectiveness of the TOBY Playpad app as a complement to early behavioural intervention using a multi-site single-blind, randomized controlled design. 2.To examine whether the use of TOBY influences parental empowerment in relation to therapy. Further information on TOBY Playpad, can be found at: http://tobyplaypad.com/

In recent years the, role of physical activity in healthy brain ageing has also been a major topic of investigation. Observational studies have shown that adults who are physically active are more likely to have better performance on several cognitive test tasks, including those involving higher order executive functions. Regular physical activity during midlife has also been associated with a significantly slower rate of cognitive decline and reduced risk of developing dementia in later adulthood. Such evidence has prompted calls to investigate the potential role of regular exercise as a protective factor against cognitive decline and dementia. Traditionally, the physical activity public health focus has been directed at purposeful exercise for health benefits, at a moderate to vigorous-intensity. Emerging evidence suggests that targeting the adoption of moderate to vigorous exercise in the population should not be the only consideration; a focus on reducing sedentary behaviour may be equally important for health outcomes. Previous work has provided epidemiological and experimental evidence on the independent associations of sedentary behaviour with metabolic health. Together, with The University of Western Australia, we propose to undertake a randomised cross-over trial in 48 older overweight adults involving three experimental conditions. All participants will complete each of the three (one-day) experimental conditions, separated by a 7-day washout period to account residual physiological effects of the acute exercise. We will examine whether, compared to uninterrupted sitting, there are acute effects of a single bout of moderate-intensity exercise, with or without intermittent (3 min) light-intensity activity breaks from prolonged sitting, on cognitive function and metabolic function in overweight adults aged between 55 and 80 years of age. We hypothesise that (1) a continuous 30 minute bout of moderate-intensity exercise will lead to improvements in cognitive function relative to uninterrupted sitting, and (2) that the magnitude of the improvement in cognitive function resulting from the exercise bout, compared to uninterrupted sitting, will be greater when an exercise bout is combined with a series of brief intermittent light-intensity breaks from prolonged sitting. Furthermore, we aim to examine an exploratory hypothesis that the improvement in cognitive function associated with both the continuous 30 minute bout of exercise and the brief intermittent breaks from prolonged sitting will be associated with mechanisms which increase cerebral blood flow and glucose uptake.

This study is investigating the ability of a means of gentle electrical stimulation to the abdomen in improving bowel function in patients with constipation. This is called trans abdominal electrical stimulation (TES). It is used successfully in the treatment of urinary incontinence, but a side effect is diarrhoea. It has been used in a study on children with constipation where it improved bowel function and quality of life. We believe it will also improve bowel function in adults with constipation. This stimulation is administered through 4 sticky electrodes where 2 are on the front of the abdomen and 2 on the back. The current passes diagonally through from front to back on both sides. We will split participants into two groups where one receives the stimulation the correct way, and the other where the current does not go diagonally, but from right front to right back, the same on the left. It is believed this is not therapeutic. Participants will not know which way is the correct way, so we hope that those who do receive it the correct way will show an improvement over those that don’t. The study will run for 6 weeks for each participant. Participants will keep a diary and answer a questionnaire before, halfway through and at the end of the study. Further contact for this information will also be at 3 months and one year after the study. Before and after the study tests on the function of the rectum and anus will be done, as will a colon transit time study, which looks at how quickly the colon works.

Heart disease is the single biggest cause of death for Aboriginal and Torres Strait Islander people and the main reason for the difference in life expectancy between Indigenous and non-Indigenous Australians. Indigenous Australians are 3 times more likely to suffer “heart attacks” than non-Indigenous Australians and are 1.5 times more likely to die as a result. Recent studies suggest that Omega 3 polyunsaturated fatty acids (PUFAs) may help prevent “heart attacks” in people who already have coronary artery disease. Coronary artery disease is caused by plaque building up along the inner walls of the arteries of the heart, which narrows the arteries and reduces the blood flow to the heart. Omega 3 oil is a polyunsaturated fatty acid (PUFA) found in some plants, seafood, and, to a lesser extent, eggs and meat. Omega-3 is seen as "essential" because the human body can't produce it and so we must get it from foods or supplements. Several studies around the world have shown a decrease in the risk of sudden cardiac death (SCD) associated with increased consumption of fish or fish oils. This study is likely to be very important for understanding the main cause of death and life expectancy gap for Aboriginal people, as well as providing evidence to guide policy and clinical practice. The purpose of this study is to test the effectiveness of Omega-3 Long Chain Polyunsaturated Fatty Acid supplementation in Aboriginal adults with established coronary artery disease (CAD) to determine effects on factors implicated in adverse cardiovascular (CV) events including: atherogenic and protective lipid factors, Inflammatory factors, factors associated with thrombus formation, arrhythmic risk as measured by heart rate variability, and major adverse cardiovascular events (MACE). The Aboriginal Cardiovascular Omega 3 (AC Omega 3) trial aims to find out if Aboriginal patients who have coronary artery disease will be better protected from having “heart attacks” by taking an Omega 3 oil supplement and if so how does it help do this.

Hypothesis: MSCs are safe in COPD. Aims of trial ; To track MSCs post-infusion in the lung To ensure safety of MSCs We will infuse labelled MSCs and track them with nuclear imaging. We will then do a second infusion of MSCs to monitor safety

Aim of pilot study: To evaluate the impact of an 8-week school-based intervention examining High Intensity Interval Training (HIIT) vs. a Body Weight Exercise Program (BWEP) on various physical and psycho-social outcomes for low active year 9-10 students from the Newcastle region. i. Can an 8-week school-based HIIT program improve cardio-respiratory fitness (primary outcome) in comparison to a BWEP for low active students? ii. Can an 8-week school-based HIIT program improve secondary outcomes (e.g., Body composition, BMI, Muscular fitness, physical self-description, executive function) in comparison to a BWEP for low active students? iii. Will a school-based HIIT program be a feasible and acceptable method to improve fitness outcomes and psycho-social outcomes of students? Implementation of Pilot Study: Implementation of the 3-arm 8-week HIIT vs. BWEP intervention will occur during term 3, 2014. After randomisation has occurred: *Group A (n=20 participants) will proceed as the HIIT intervention group; *Group B (n=20 participants) will proceed as the BWEP intervention group; and, *Group C (n=20 participants) will act as the comparison (‘wait-list control’) group. The program will be replicated for group C once the intervention and all follow-up assessments have been completed by all groups. The intervention and wait-list control groups will receive the program at school, during school hours (i.e., sessions will be conducted during recess and lunch breaks, using school-based facilities, three days per week during term 3). Setting and Participants: The program will be held during school hours (i.e., recess and lunch breaks) utilising facilities available at the school. Equipment for the activity sessions will be sourced from the school and the University of Newcastle PE store room, if required. This pilot study will involve three separate groups within one secondary college in the Newcastle region, aiming to recruit a total of 60 participants (Intervention condition A (N=20 participants); Intervention condition B (N=20 participants); Wait list control (N=20 participants)). Intervention: This intervention is designed for year 9-10 students from a secondary college in the Newcastle region. The intervention will involve delivery of an 8-week school-based program conducted within school hours (e.g., recess and lunch breaks). The program will consist of: *Each week students randomised to the intervention conditions will participate in 3 x 8 minute HIIT or BWTP sessions, which will include a combination of core, upper body and lower body exercises. Sessions will be conducted by trained facilitators (e.g., qualified physical education teachers). *Sessions will be held in the school gym or another appropriate area within the school campus during recess/lunch breaks on three days per week. *All sessions will be delivered in a comfortable environment (e.g., indoors, air-conditioned, sufficient space, motivational music, basic equipment) to ensure continued participation and engagement of students. Physiological and psycho-social assessments will be conducted at baseline and post-intervention.

Babies who have deprived of oxygen during birth can be at risk of brain damage because the blood rushes to the brain to compensate for the lack of oxygen. Cooling has been show to help prevent brain damage. Currently all babies are cooled for 72 hours but it is thought that some babies may benefit from being cooled for longer. Babies in this study will have more frequent ultrasound scans through the soft spot on the head (fontanelle) to monitor blood flow to the brain. Ultrasound scans will occur before cooling, daily whilst cooled, and every hour during rewarming (this takes around 12 hours). Whilst being treated the baby will be monitored by a patient monitor that monitors blood pressure, heart rate and respiration rate and an electroencephalograph (EEG) monitor which records electrical brain activity. The data from the patient monitor and EEG will be collected and analysed for the research. Pathology results and MRI’s may also be included in the research. When the baby is 2, it is normal practice to invite parents of HIE babies to an interview with a Paediatrician to discuss their developmental progress and this study will use the information from this developmental review.

Invasively measure haemodynamics (right heart catheterization and arterial line) at rest and during exercise (Ex 1) in patients with presumed HFPEF and to repeat these measures after random allocation to milrinone or placebo