ANZCTR search results

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.

Charcot-Marie-Tooth (CMT) is the most frequently inherited peripheral neuropathy affecting around 1 in 2500 persons. CMT causes slow degeneration of the nerves in the extremities including feet, legs, arms and hands. Typically muscles weaken and atrophy due to the loss of activation by the affected nerves. In the past, persons with CMT have been discouraged from performing exercise and physical activity because clinicians believed that such activity might hasten the disease; these beliefs have never been validated by studies. However, it is now known that regular exercise or activity helps maintain good health and function in most populations. Inactivity and a poor muscle mass can also lead to metabolic syndrome, increasing morbidity and the risk of developing diabetes and cardiovascular disease. These metabolic diseases may even worsen the symptoms of Charcot-Marie-Tooth disease, for example diabetes can worsen CMT symptoms. More evidence is required on exercise for persons with CMT, especially at moderate to high intensities. Recent research has shown that light and moderate intensity exercise is not detrimental to persons with CMT and offers many of the same benefits to persons with CMT as it does to the general population . The few previous studies have used home-based low intensity training (i.e. 20-30% maximum lift) for the upper limbs and moderate intensity for the legs (i.e. 40-50% maximum lift). In the neurologically normal population, muscle and strength gains are correlated with the intensity of exercise, i.e. high intensity training develops greater strength and muscle mass. A considerable amount of weakness and muscle atrophy in persons with CMT may be due to secondary disuse due inactivity. Higher intensity training could be beneficial for those with CMT to improve muscle mass, power and strength. The benefits of intense training might also provide persons with CMT from developing secondary metabolic disease or lead to improve functional ability in daily activities. We propose to conduct a study investigating the benefits of a high intensity training gym-based program (i.e. power training) for individuals with CMT. The proposed project is an eight-week resistance training randomized controlled pilot trial. This pilot study will provide information on the effectiveness of progressive resistance training (PRT) for people with CMT. We expect power training may benefit individuals with CMT by increasing muscle mass (strength and metabolic benefits) and muscle power (increased function). This research will provide data for a larger National Health and Medical Research Council funding application that will have the statistical power to answer more specific questions about CMT and exercise. Recently, many people with CMT have become aware that exercise might be beneficial for them, but do not understand how to accommodate exercise in their lives. Therefore, the results of this pilot study will be promoted to educate Exercise Sports Science Australia (ESSA) and Australian Accredited Exercise Physiologists (AEP) on the benefits of exercise for CMT. In time, we hope that people with CMT will be able to easily contact AEPs in the community for advice on exercise.

The purpose of the study is to identify the key determinants of under-vaccination among infants and children in Western Australia (WA). This study will compare socio-demographic characteristics of parents of under-vaccinated compared with fully-vaccinated children, and stated beliefs/attitudes held by parents towards vaccination and toward vaccine preventable diseases. In addition, we will survey parents about perceived barriers to vaccination and potential solutions to improve confidence in or accessibility to vaccination. Through the identification of determinants of direct relevance to WA families, we expect to inform effective strategies to improve vaccine coverage in WA.

The study is evaluating the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged over 18 years, have a histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists, a life expectancy greater than 12 weeks, and your disease is measurable or evaluable by the Response Evaluation Criteria In Solid Tumours (RECIST). Trial details: Participants in this study will be administered DEP(TM) Docetaxel (DTX-SPL8783) via intravenous infusion in escalating doses once every 3 weeks. The number of doses and dosage amounts administered to participants are dependent on any toxicities occurring at each dose level. The starting dose is 10mg/m2, increased by 1.4 – 2 times at each dose level. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.

The Food Insulin Index (FII) is a novel algorithm for ranking foods based on insulin responses in healthy subjects relative to an isoenergetic reference food. Our aim was to compare postprandial glycemic responses in adults with type 1 diabetes who used both carbohydrate counting and the FII algorithm to estimate the insulin dosage for a variety of protein-containing foods. Subjects/Methods: 11 adults on insulin pump therapy consumed 6 individual foods (steak, battered fish, poached eggs, low fat yoghurt, baked beans and peanuts) on two occasions in random order, with the insulin dose determined once by the FII algorithm, and once with carbohydrate counting. Postprandial glycemia was measured in capillary blood glucose samples at 30 min intervals over 3 h. Researchers and participants were blinded to treatment.

The proposed study aims to evaluate Analgesia Nociception Index (ANI) titrated analgesia in patients undergoing spinal surgery. This clinical utility study is designed to investigate the effect of ANI guided fentanyl administration on post-operative events, including self-reported post-operative pain scores, analgesia administration, recovery times, and opioid-related side effects. The study will also record the incidence of unwanted intra-operative events such as tachycardia, hypertension, and the consumption of fentanyl under constant hypnotic level balanced general anaesthesia.

This is a prospective, blinded, randomised controlled feasibility trial of critically ill tube fed ICU patients looking at the effectiveness of diabetes specific nutritional formula in managing stress hyperglycaemia. The primary aim of this study is to determine whether the administration of a diabetes specific formula, when compared to standard enteral formula, reduces insulin use over a 48 hour period. Secondary outcomes include both clinical endpoints and assessment of the feasibility of study processes to inform a potential multi-site RCT. A sub-study will also be incorporated to determine if altered carbohydrate, is associated with a change in oxidative stress markers, as well acute and chronic inflammatory biomarkers.

The primary aim of this group randomised control trial is to evaluate the impact of an innovative multi-component intervention to reduce sedentary behaviour (i.e. time spent sitting) on health and psychological well-being in adolescents. The project will address the following research questions: i) What is the impact of the intervention on the primary outcome of recreational screen-time? ii) What is the impact of the intervention on the secondary outcomes of psychological wellbeing, obesity, physical activity and sleep time? iii) What are the factors responsible (i.e., mediators) for sedentary behaviour change? iv) What is the feasibility and acceptability of the intervention among students, parents and teachers? The study will include a range of different strategies including: (a) e-Health delivered intervention messages and an, (b) Information session. The intervention will also include a range of strategies for parents to manage their children’s screen-time: (c) screen-time behavioural contract, and (d) newsletters focusing on household screen-time rules, consequences of excessive screen-time, strategies to manage parent/child conflict arising from screen-time rules and home challenges to reduce screen-time. Recreational screen-time will be the primary outcome of the study. Secondary outcomes include: psychological well-being, physical self-concept, psychological distress, weight, height and physical activity. Social cognitive and environmental mediators of sedentary behaviour change will be also be assessed. Assessments will be conducted at baseline and 6-months.

Participants will be provided with placebo film (equivalent in number to their usual Suboxone film dose denomination) and will be asked to try to remove the film following its administration sublingually. This will be repeated at various time points following administration (ie. 15 seconds, 30 seconds and 1 minute), under 2 different conditions. That is, the adherence of the film in the mouth (and subsequently ability to remove the film(s)) will be explored when multiple films are stacked as well as when spaced.