ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33055 results sorted by trial registration date.
  • Associations of usual free sugar intake on the body mass index z-score of Australian children and adolescents

    Previous studies suggested dietary sugar consumption as one of the main factors of obesity, yet the findings on children were inconsistent. Notably, although the consumption of sugar-sweetened beverages (SSB) was found to be positively associated with body weight gain in children, the association between the consumption of free sugar, as defined by the World Health Organization (WHO), and weight gain on children remained inconclusive. Hence, the current analysis aimed to assess the effects of consuming free sugar on the BMI z-score of a group of Australian children and adolescents.

  • An audit of clinical service delivery and outcomes using Tumour Necrosis Factor Inhibition therapy (- a Biological agent that targets inflammation) for the treatment of Diffuse Idiopathic Skeletal Hyperostosis (a condition where calcification of ligaments, tendons and joint capsule insertions in the spine causes pain, stiffness and restricted movements).

    Diffuse idiopathic skeletal hyperostosis (DISH), is a skeletal disorder for which, apart from non-steroidal anti-inflammatory drugs and analgesics, there is no effective pharmacological treatment. The aim of this retrospective/prospective data audit is to determine the effect of tumour necrosis factor inhibitors in clinically active DISH patients. This will be achieved by the comparison of changes in pain and function in people with DISH that are treated with tumour necrosis factor inhibitor (TNFi) to similar people with DISH that are not treated with TNFi, with people with ankylosing spondylitis, over time.

  • Feasibility, acceptability and potential efficacy of group tummy time exercise classes to promote tummy time among infants

    This study is looking to see if group tummy time exercise classes can be an effective way to promote tummy time. It will also see if there are any positive health effects by infants who engage in tummy time. Approximately 40 mothers and their healthy infants who agree to attend a mother's group will be recruited from the Illawarra region of New South Wales. Participants will be recruited from their home visit with their child and family health nurse. Those who would like to be involved in the study will be randomly assigned to either an intervention (group tummy time exercise class) or a control group (usual care). The measurements to assess the effectiveness of the classes will be the amount of time spent in tummy time by the infants, the infant’s ability to move, their head shape, the amount of sleep and screen time they have and the accuracy of the parents to recall the amount of tummy time the baby has been given. A measurement device that the infant wears around their waist will be used to determine the amount of tummy time the infant receives. They will wear this device for at least 3, 24-hour periods over 1 week. The parents will also be asked to complete a questionnaire which will have questions about their education, where they live, how much knowledge they have about tummy time etc. The group tummy time exercise class will run for about 20 minutes, once per week, for 4 weeks. They will be run by a Physiotherapist. To provide encouragement to attend, build relationships and enhance the learning in the group exercise class, a closed Facebook or WhatsApp group will also be created so mothers can contact each other and share tips and strategies they have found helpful about tummy time during the week.

  • Perceptually-regulated exercise testing and training for cardiac rehabilitation

    The aim of this study is to evaluate the validity, reliability and sensitivity of predicting VO2max from a perceptually-regulated exercise test (PRET) and to evaluate the efficacy of regulated exercise intensity during cardiac rehabilitation using perceived exertion. Specifically, the study will assess how perceptions of effort change over a 6-week exercise program and will quantify these changes in relation to physiological (i.e. heart rate and VO2) and performance (i.e. work rate) indicators of exercise intensity. Participants referred for cardiac rehabilitation, following myocardial infarction or cardiac surgery, will complete a symptom-limited exercise test to establish VO2max and 3 PRETs. Participants will then be randomised to a supervised exercise or wait-list control. Supervised exercise will consist of 6-weeks of exercise training for 1 hour 2x per week. Exercise intensity will be regulated at RPE 13 on Borg’s 6-20 RPE scale. Heart rate will be measures in each session and oxygen uptake objectively measured during the first and last week. Participants will then repeat the symptom-limited exercise test and 3 PRETs.

  • The relationship between hospital outcomes and increased sugar levels due to illness (stress hyperglycaemia) using a new marker called the Stress Hyperglycaemia Ratio

    Hyperglycaemia in hospitalised patients is independently associated with increased morbidity and mortality in a wide range of patient groups, including post-operative outcomes. The association between hyperglycaemia and poor outcomes is strong in patients without diabetes, but a weaker predictor in patients with diabetes. This discrepancy is in part driven by the difficulty in distinguishing genuine stress hyperglycaemia from chronic high levels seen in diabetic patients. A high plasma glucose concentration in a hospitalised patient can occur because of chronic poor diabetes control and be “normal” for that patient, represent a transient physiologic response to an inter¬current illness (stress hyperglycaemia), or be a combination of the above. A metric for stress hyperglycaemia has been developed at Flinders Medical Centre - the Stress Hyperglycaemia Ratio is defined as glucose concentration divided by the Estimated Average Glucose concentration, which is calculated from HbA1c. This enables quantification of the relative change in hyperglycaemia eg a patient with a SHR of 1.4 has an glucose concentration 40% higher than their average glucose over the prior 3 months. Our previous work indicated that the relative change in glucose was a better indicator of stress hyperglycaemia and more strongly associated with adverse patient outcomes than glucose. This initial work needs to be confirmed in a further population of hospitalised patients. We also aim to study some specific subgroups of interest, namely infections (both at admission and those that develop during the admission), and events related to blood clots (heart attacks, stroke, deep vein thromboses, and pulmonary emboli). This will enable us to determine those patients who might benefit most from early management of elevated glucose levels due to stress hyperglycaemia.

  • The function and usability of two hybrid closed loop systems in patients aged 13 - 25 years with type 1 diabetes during a 7 day hotel study.

    Hybrid closed loop (HCL) systems for the treatment of type 1 diabetes are rapidly advancing, particularly with respect to the algorithms that are used to calculate the automated insulin delivery. Hybrid closed loop systems consists of an insulin pump, a continuous glucose monitor, and an algorithm that determines the rate of insulin delivery between meals. Meals are still required to be announced by the user, and an insulin bolus proportional to the carbohydrate ingested is delivered according to an individualised carbohydrate ratio. The first commercially available HCL system has been FDA approved and is available in the United States. However, ongoing enhancements are required to improve glycaemic outcomes and patient user experience. We will conduct a single-center pilot study, that is randomized, two arm parallel group in design in a hotel setting for 7 days, in subjects with type 1 diabetes on insulin pump therapy. Patients aged 13-25 years will be randomized in 2 groups to either use the 670G 3.0 system or the 670G 3.1+UmaxCB system. The objective is to assess function and usability of the two alternate algorithms in a highly supervised environment and provide an estimate of effect size and standard deviation in order to power future larger studies. During the study, we will challenge the performance of the two systems with different meal compositions and exercise.

  • Impact of a Chronic Disease Management Model in patients with decompensated liver disease: The Australian Liver Failure Trial (ALFIE)

    Randomised Controlled Multi Centre Trial to research the effectiveness of a chronic disease management model to care for patients with decompensated liver disease.

  • Efficacy of a multi-faceted web based resource on spinal health literacy in patients with low back pain - a randomised controlled trial

    We have developed a comprehensive LBP website in collaboration with Arthritis Australia, the peak national consumer organisation for individuals with musculoskeletal pain. The website integrates evidence-based LBP information, tailored guidance and explicitly considers the needs and preferences of people with LBP. We currently seek to evaluate the website in a randomised controlled trial to measure its effect on health literacy, treatment choices and clinical outcomes. This step is vital before dissemination of the website can occur.

  • The efficacy of low-frequency ultrasonic debridement (LFUD) and Polyhexamethylene Biguanide (PHMB) combination therapy for adults with chronic wounds; a randomised controlled trial

    The aim of this research is to determine the effectiveness of one dressing product over another on bacterial levels/counts and wound healing outcomes in a controlled clinical trial that includes the use of ultrasonic debridement therapy for adults with chronic wounds. Chronic wounds place an enormous burden on the individual and the health care system. it is well known that individuals with non-healing wounds suffer from a reduced quality of life, experience pain, anxiety, report a financial strain, and attend frequent medical appointments. They often require antibiotics and have an increased risk of infection and further complications. There are a wide variety of dressing products available these days, all of which aim to assist the healing process. One way to assess the effectiveness of one product over another is within a clinical trial. This type of investigation can provide information to help the researcher determine how wound products perform at a cellular level. This clinical trial will involve participants being randomly assigned to receive one of two different regimes to find out which one works best. Each participant will receive ultrasonic therapy weekly for six weeks, after that a particular dressing product will continue for a further six weeks, totaling 12 weeks or upon healing. It is hypothesised that the application of ultrasound therapy will assist with reducing the bacterial burden that is common in chronic wounds and furthermore the application of dressing products with antiseptics in combination with the ultrasound are thought to further assist with preventing bacterial burden reformation and promote wound healing. This study aims to assess this hypothesis.

  • Targeting the proprioceptive system to improve behaviours for children with Autism Spectrum Disorder (ASD)

    Sensory-based intervention (SBI) aims to improve undesirable behaviours of children with autism spectrum disorder (ASD). Proprioceptive input is one type of SBI that is hypothesised to organise the central nervous system and aid sensory regulation. Proprioceptive input arises as a result of an individual’s own movement, specifically, active muscle contraction against resistance. However the research on SBI is inconclusive as it remains unclear how to effectively use proprioceptive input to improve behaviour of children with ASD. This study aims to understand how undesirable behaviours of children with ASD and co-occurring sensory over-responsiveness change following parent-facilitated proprioceptive input. The research uses an ABA single-case design (SCD) research over a 9 week period. Five children, aged 4-14 years, with ASD and co-occurring sensory over-responsiveness will participate in the study. Following training from the researcher (occupational therapist), their parents will facilitate responsive, proprioceptive input during play and tasks in the home environment. The parents will score their target behaviour prior to intervention (A1), during the proprioceptive intervention (B), and following the intervention period (A2) on a visual analogue scale. Visual analysis of the VAS data for each participant will be used to establish preliminary evidence of a causal relationship between parent-facilitated, responsive proprioceptive input and undesirable behaviours for children with ASD and co-occurring sensory over-responsiveness.

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