ANZCTR search results

Achieving optimal glucose control in type 1 diabetes requires frequent monitoring of glucose which can be burdensome for many patients. The most common methods for self-monitoring glucose involve frequent "finger-pricking" or continuous glucose monitors inserted under the skin which last up to 1-2 weeks and require at least daily calibration with finger-pricks. The device under investigation is an implantable long-term glucose sensor that measures an individual’s glucose every 3 minutes and sends data to a receiver outside the body. Following implantation, the sensor requires no user interaction, and the receiver only needs to be kept close by. The only maintenance required of the receiver is battery changes and data downloading.  This study aims to collect glucose information from the implanted sensor to optimise sensor signal processing and improve sensor performance.

There has been an increasing concern on the possible negative effects of excessive sugar intake, particularly added sugar, on the quality of diet and health status. Added sugar was found to be associated with poorer nutrient intake. A similar impact on micronutrient dilution was expected from free sugar as an estimation of approximately 10 g difference between added sugar and free sugar intake was found in the Australian population. The hypotheses of the current analysis include: a) the WHO cut-offs were not suitable for assessing micronutrient dilution; and b) micronutrient dilution is not evident until %energy from free sugars reaches 25% or above.

This study aims to assess the efficacy of single lumen needle compared to the double lumen needle which has been routinely used at Fertility North. Each ovary of patients undertaking oocyte collection as part of their IVF/ICSI treatment is aspirated by either a single lumen or double lumen needle after randomisation in randomised order. Subsequent oocytes and resulting embryos are tracked according to their origin, and fertilisation and time-lapse embryology parameters are compared between 2 groups..

This project aims to evaluate a virtual clinic (the Uni Virtual Clinic, or UVC) to improve mental health in university students. We want to know whether the UVC is feasible, acceptable, useful, and effective at helping students with their mental health, specifically symptoms of depression. To do this, we will ask university students attending the Australian National University in Canberra, Australia to participate in a pilot trial, which will involve using the UVC website and completing three brief surveys comprising demographic measures (pre-intervention only), depression symptoms, anxiety symptoms (generalised anxiety, panic, social anxiety), quality of life, disability/days out of role, alcohol use, help-seeking, and adherence and satisfaction (post-intervention only).

Childhood peanut allergy is increasing, affecting 3% of Australian children. It is the food allergy that persists into adult life, and the most likely to be associated with death due to accidental exposure. It involves the allergy antibody, IgE, which stimulates allergy cells to release chemicals that cause allergic symptoms. There is no current cure. Management is by avoidance with emergency plans and medication in case of accidental exposure. Immunotherapy (IT) is thought to be the most likely strategy to offer a “cure” for food allergy. Immunotherapy has been shown to be effective in the management of aeroallergen and venom allergy. This technique involves regular and prolonged exposure to the allergen in question, initially starting with very small doses and then increasing the dose over a period of time to a level where the person does not respond with an allergic reaction when re-exposed to it. Food immunotherapy trials have so far only had a few participants and often achieved only temporary desensitization which is lost rapidly when treatment is stopped, and also have a high rate of side effects. Gut microbes are implicated in food allergy. They can increase the levels of small chain fatty acids (SCFA), namely acetate, butyrate and propionate, in the gut by fermenting fibre- leading to significant changes to bacteria present in the gut (i.e. the gut microbiome), with increased beneficial bacteria promoting a non-allergic environment. Experiments in mice fed a high-fiber diet or SCFAs found they were protected from food allergy. In particular, they had increased oral tolerance to peanuts with an increase in the number and function of immune cells important in controlling allergic reactions . This study aims to examine whether using a dietary fibre supplement which is high in a key short chain fatty acid- butyrate -whilst using small and increasing daily doses of peanut in peanut allergic children and teenagers will provide them with sustained unresponsiveness to peanut and render them non allergic (or tolerant ) to peanut.

The present study will assess whether for children on the autism spectrum, teaching them the new skills to practice gentle breath-centered movement practices and mindful attention training based on the principles of yoga, will influence and promote their self-regulation of behavior, emotions, improve their cognitive control of executive functions, their emotion and body awareness, and benefit sleep, in those children with parent-identified sleep difficulties in the initial assessment. The study will explore the benefits of active involvement of parents in sessions, assess whether psychologists, with little or no experience in yoga, can deliver the modified, age-appropriate, user-friendly, and simple yoga-based exercises effectively as a training tool. It will examine whether a modified and manualized yoga skills training program is suitable and effective for this population and their parents and whether it can be used as an adjunct to existing treatment. 60 children on the autism spectrum between the ages of 8-12 years will be randomly assigned to either an intervention group or a wait-list control group. The intervention group will receive the 6-week yoga-based intervention program delivered once per week/6weeks. The intervention program will be delivered face-to-face by the lead researcher and two other facilitators. The wait-list control group will wait for 12 weeks before receiving the intervention.

This trial is being undertaken to evaluate the safety and tolerability of oral doses of a new drug NPI-001 in healthy volunteer subjects. It will determine the effect of NPI-001 on their vital signs, and they will undergo physical examinations and clinical laboratory tests. Blood samples will be taken to determine where the drug goes in the body and how long it stays in the body following single and multiple doses. The study is randomized, and double blinded. In each group of subjects some will receive the new drug in a sugar solution and 2 will receive just the sugar solution - a placebo.

The purpose of this pilot study is to determine the feasibility of a larger scale study and the potential for its subsequent success. Particularly, implementing a strength and conditioning program into various curricula to attempt to prevent future injuries in the manual therapy professions. All participants will undergo a series of baseline measures over seven days. This will include demographic information, history of musculoskeletal injury, and maximal strength of muscle groups, which will be estimated using the multiple repetition test procedure (5-10 submaximal strength test) instead of traditional one repetition maximum test (1RM). 1RM will be calculated for each of: strict shoulder press (SP), bench press, seated row, Latissimus Dorsi pull down, deadlift, and back racked lunge. Participants will be instructed on correct usage of equipment prior to the testing session and given time to familiarize themselves with the equipment. A warm up will be completed prior to testing. Thereafter, 3-5 separate single attempts will be performed. Subjects will lift a weight initially 40%-60% of the perceived 1-RM. The increments of weight are dependent upon the effort required for the lift. The weight added will become smaller as the effort to lift the weight increases. If subjects are able to perform more lifts than designated by the testing protocol, subjects are allowed a minimum of four min rest and then reassessed. Participants will be instructed to perform each exercise to acute muscular exhaustion or form fatigue. Any repetitions that are not performed with a full range of motion will be discarded. When the subject can only lift the weight five to ten times, that weight and the number of repetitions are considered to estimate the 1-RM. Grip strength dynamometry will be performed during the strength testing procedure. After completion of all baseline measures, each participant will be randomly assigned to either the intervention (n=5) or comparison (n=5) group using a random number generator. Intervention group participants will undergo a 12-week strength and conditioning program, whilst the control group will perform 30 minutes of moderate intensity walking 3 days per week. After the 12-week period all participants will undergo the same assessments completed at the baseline.

Neurally Adjusted Ventilatory Assist (NAVA) is a new ventilatory technique in neonates to aid babies with respiratory distress. It uses the baby's diaphragmatic electrical activity as a trigger for each breath. This electrical activity is measured using a special nasogastric tube (Edi catheter) with electrodes at the level of the diaphragm. To date, there is a little data on the Edi signal in neonates with no existing respiratory conditions and on no respiratory support. By gaining a reference Edi data range, clinicians will be better equipped to titrate NAVA levels in ventilated neonates. We hypothesise that Edi peak and Edi min were higher in (1) Higher gestational age group, (2) awake and postprandial states and (3) after caffeine administration (caffeine is only administered to those infants using the medication as part of their hospital treatment).

Smoking prevalence amongst people with alcohol and other drug (AOD) problems is extremely high. In Australia, up to 95% of people entering AOD treatment smoke tobacco, which is five times greater than for the general adult population. Although number of quit attempts are high, sustaining cessation is challenging for people with AOD dependence: many factors related to addiction, lack of cessation support and the high levels of smoking in their social network contribute to high relapse rates in this population. Nicotine Replacement Therapy (NRT) can reduce withdrawal symptoms and cravings and aid cessation, however our research with AOD users indicate they are hesitant to use traditional forms of NRT. Electronic Nicotine Devices (ENDs) hold significant potential as both cessation aids and harm reduction support. Unlike combustible tobacco cigarettes, ENDs deliver nicotine in an inhalable form without the tobacco, hence removing many of the health harms associated with smoking. This proposal is for a trial aimed at exploring the feasibility, acceptability and potential effectiveness of the use of electronic nicotine devices (ENDs) as smoking cessation aids when used in conjunction with one of two commonly used quit smoking strategies: 'abrupt cessation' and 'gradual cessation'. Abrupt cessation involves smoking tobacco as normal until a designated quit day, followed by total abstinence. Gradual reduction strategies also involve the designation of a quit day, however smokers utilizing this method aim to reduce or scale their intake of tobacco cigarettes prior to the quit day, usually according to a predefined schedule (i.e. a 25% reduction in tobacco cigarette consumption by week 1). Specifically, this study will aim to determine how the use of ENDs and liquid nicotine in conjunction with a 'gradual reduction' or 'abrupt cessation' quit strategy impacts smoking cessation or smoking reduction outcomes. It will determine whether the provision of ENDs assists smokers with AOD addiction to quit or reduce their tobacco consumption and whether using these devices reduces cigarette cravings and withdrawal symptoms. Finally, this study will evaluate whether AOD clients find ENDs devices acceptable as a quit smoking aid.