ANZCTR search results

Within a 1:1 randomised trial, this study will compare the effect of an antiplatelet approach with Ticagrelor versus placebo on 3, 6, and 12 month high-sensitivity troponin levels. It will also explore the frequency of late cardiovascular events, and the impact of P2Y12 platelet inhibition versus placebo on late cardiovascular events, among patients with elevations in high-sensitivity troponin not attributable to other acute clinical diagnoses.

We established that triheptanoin (triglyceride of heptanoate), a stable, edible tasteless oil that has been used in the clinic in patients with metabolic disorders, is an anticonvulsant in four mouse seizure models. This Phase I clinical trial aims to establish the feasibility, safety and tolerability of triheptanoin as add-on treatment in children with treatment-resistant epilepsy, and obtain indications for its efficacy against medically refractory seizures. We propose to initiate a pilot phase I clinical trial of 50 children (3-18 yr of age) with treatment-resistant epilepsy at the Royal and Mater Children’s Hospitals in Brisbane. Eligible patients without contraindications to triheptanoin will count seizures during a baseline period of two months. Subjects with more than two seizures per fortnight will be enrolled and receive slowly increasing doses of triheptanoin (max 35% of caloric intake) during meals until the maximum tolerable dose is reached. All patients will be counselled and monitored by a dietitian before, during and after the treatment to ensure that they receive adequate nutrition. This treatment would be ideal for patients with epilepsy in the developed and developing world, because: 1) triheptanoin does not require refrigeration and is straightforward to add to meals and 2) it is not expected to change metabolism of other drugs and require “drug monitoring” nor to have significant side effects.

People who have experienced for the first time an episode of inflammation within the brain, spinal cord or optic nerves (called a first demyelinating event) are at risk of developing Multiple Sclerosis. In this study, we will test whether a course of narrow band UVB phototherapy decreases their risk of developing Multiple Sclerosis.

Funded by the Australian Research Council, this study will test the effect of a professional development program targeting physical education teachers that is designed to increase students’ opportunities for physical activity during physical education lessons and to enhance their motivation towards physical activity. This research is important because many Australian youth do not participate in sufficient physical activity and there is a large decline in physical activity associated with adolescence. As a result, there is an urgent need to develop strategies to engage adolescents in physical activity. If adolescent physical activity levels can be increased, a variety of benefits are expected, including engagement during academic classes, greater self-concept, and better overall well-being.

There is an increasing body of evidence that the adoption of point of care (POC) guided coagulation and haemostatic management algorithms in the cardiac surgical patient population results in improved outcomes. We aim to critically evaluate our POC programme at the Gold Coast University Hospital (GCUH). In addition, we aim to evaluate the prognostic importance of baseline and perioperative humeral factors relating to haem catabolism (bilirubin/carboxy haemoglobin) in modulating haemostatic function and predicting post-operative outcomes in patients undergoing cardiac surgery

One of the commonest complications of an ileostomy is the potential loss of a large amount of fluids and salts from the ileostomy, and this is called a high output ileostomy. A high output ileostomy can cause a person to become dehydrated and when the losses are large enough, it can lead to kidney failure, and re-presentation to hospital, with admission to hospital with long hospital stay The purpose of this study is to see if large ileostomy output can be prevented from occurring, rather than waiting for it to happen and then treating it.

The Alcoholic Chlorhexidine or Alcoholic Iodine Skin Antisepsis (ACAISA) Study is a cluster randomised controlled trial comparing alcoholic chlorhexidine to alcoholic iodine skin antisepsis at the time of surgery for prevention of superficial wound complications in patients undergoing elective prosthetic hip and knee replacement surgery. Skin antisepsis is a simple and effective strategy to remove soil and microorganisms from the patient’s skin prior to surgical incision. The three main agents commonly used for skin antisepsis are chlorhexidine, iodophors (such as iodine) or alcohol. Despite their use for over a century, no studies have adequately assessed the comparative effects of these agents on wound complication risk, particular in patients undergoing orthopaedic surgery. Joint replacement surgery is a national healthcare priority and represents high volume, high cost surgery. In 2011, 90 000 Australian patients underwent prosthetic joint surgery and this rate will double by 2020. The conservative estimate of direct medical costs for prosthetic joint surgery in Australia is $2 billion annually. Superficial wound complications are a major cause of morbidity for patients following prosthetic joint replacement surgery and are associated with increased risk of deep prosthetic joint infection. In addition, treatment of superficial wound complications are estimated to add a further $34 million annually to the direct cost of prosthetic joint surgery. Prevention of superficial wound complications will substantially decrease morbidity and mortality, improve patient outcomes and reduce the economic burden to the healthcare system. The ACAISA study represents an international first. In addition, this study is a unique collaboration between orthopaedic surgeons, infectious diseases clinicians and infection control practitioners in both the public and private healthcare sector.

Our research team has identified dietary triggers that might be responsible for the induction of symptoms in the majority of patients with IBS. These triggers involve a group of small carbohydrates that are commonly found in a wide variety of foods. These carbohydrates can be poorly absorbed in the small intestine and include; fructose (in apples, pears and fruit juice), lactose (milk), fructans (onions), galacto-oligosaccharides (legumes) and sugar alcohols (stone fruits and artificial sweeteners). We have named this group of compounds FODMAPs - Fermentable Oligo- Di- and Mono-saccharides And Polyols. There is already good evidence that the absorption of one of these FODMAPS; fructose, is greatly enhanced in the presence of glucose. However there is no data investigating this absorption method in IBS sufferers, specifically whether the addition of glucose to fructose eliminates symptoms. We hypothesize that the addition of glucose will reduce breath hydrogen production and reduce gastrointestinal symptoms.

This randomised, within subject, longitudinal trial will determine the efficacy of Functional Remediation as an early intervention in young people with mood disorder/psychosis who have increased Cardio Metabolic Syndrome risk factors and cognitive difficulties, as determined by their referring clinician. Specifically this trial aims to demonstrate that Functional Remediation will: aim 1: improve quality of life in young outpatients with a mood disorder/psychoses aim 2: improve mental health by delaying progression of illness and promote longer periods between lapse/relapse aim 3: modify sleep-wake behaviour, mood and general health (targeting cardio-metabolic outcomes) to improve social educational and functional skills, educational/employment/retention/return aim 4: to examine the role of change in cardio-metabolic characteristics with the cohort and following the intervention

In Australia, about one in twelve babies are born prematurely. Compared to those born at term gestation these babies, particularly those born very or extremely preterm, are at increased risk of life-threatening conditions such as bronchopulmonary dysplasia. This condition represents a major challenge because, not only is it life-threatening, but also there is no specific directed treatment. Current management is essentially limited to supportive care. As such, the mortality and morbidity toll exacted by bronchopulmonary dysplasia remains challenging, to say the least. We have recently shown that stem-like cells can be isolated from the amniotic membrane. These cells, term human amnion epithelial cells (hAECs), bear many characteristics of traditional stem cells such as pluripotency, ability to self-renew and are able to escape immune surveillance, thus avoiding immune rejection even when administered xenogeneically. In our preclinical studies, we showed that hAECs were able to prevent and rescue lung injury in animal models of adult and neonatal lung disease. In this clinical trial, we aim to evaluate the safety of hAECs delivered intravenously to preterm babies with established bronchopulmonary dysplasia. In this trial, we will determine the following: 1. Safety of hAECs administered intravenously to premature babies with established bronchopulmonary dysplasia. 2. Effect of hAECs administration on the infant’s short term respiratory parameters.