ANZCTR search results

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

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31611 results sorted by trial registration date.
  • A prospective evaluation of the use of intestinal ultrasound as an assessment tool in predicting the course of intestinal inflammation and response to therapy in patients with inflammatory bowel disease

    Patients with inflammatory bowel disease when commencing on new medical therapy for treatment of their disease will be recruited for participation in this gastrointestinal ultrasound study. The purpose of the study is to determine if gastrointestinal ultrasound can predict who will respond to a particular medical therapy. Gastrointestinal ultrasound findings will also be compared to other routine markers of disease activity such as clinical scores and biochemical markers.

  • BEMPU Temperature Device Study for Low Birth Weight Babies

    The aim of the study is to determine whether neonatal monitoring of low birth weight babies with the BEMPU TempWatch along with standard neonatal care, as compared with standard neonatal care alone, decreases the need for escalation of care to invasive warming measures such as placement in an incubator or radiant warmer.

  • BlueCheck: a blue dye for detection of early-stage caries

    This is a prospective trial designed to evaluate the diagnostic performance of the BlueCheck caries detection system in a cohort of adolescent and adult participants pursuing orthodontic treatment with fixed appliances. The study will recruit participants with at least one active carious lesion, identified by visual inspection. After recruitment, participants will undergo caries diagnosis using both visual inspection and BlueCheck detection (primary objective). Each inspection will be performed by separate assessors. Standardized photographs for orthodontic diagnostic purposes (intraoral frontal and buccal views) will document the dentition before and after BlueCheck detection, and again after BlueCheck removal. Photographic records will subsequently be scored by blinded investigators. Data will be recorded as binary (yes/no) for visual inspection of: 1. initial caries, 2. activity status, and 3. BlueCheck detection. All investigators will have training on caries inspection/assessment evaluations. Lay description: This study will show if caries can be detected by BlueCheck. If so, BlueCheck may be a valuable tool allowing correction of early tooth decay using remineralisation products and obviate the need for more invasive procedures.

  • Brain Bootcamp: the effect of a behaviour change intervention on brain health in older adults

    Brain Boot Camp is funded by the NSW Government Community Project Grant and was voted by members of the public. It is a research initiative which aims to improve awareness of older adults brain health, dementia and its risk factors. We aim to demonstrate how everyday activities can make a difference in supporting older adults’ brain health. Individuals will participate in an online survey to determine their brain health score, receive a box which contains five physical items to promote better brain health and complete a follow-up online survey 3 months later.

  • Does preoperative muscle mass predict outcomes after heart and/or lung transplantation

    Heart and/or lung transplantation is performed in patients with significant co-morbidities and burden of disease. Their peri-operative period is high risk and recovery may be prolonged due to the risk of complications. There is considerable effort applied to appropriate risk stratification and selection of these patients prior to listing for transplantation. Recently sarcopenia has been used as a surrogate for frailty. Patients undergoing heart and/or lung transplant surgery may be particularly susceptible to the risks associated with frailty. In heart/lung transplant surgical patients objective measurements of sarcopenia has been difficult and not fully investigated. The hypothesis of this study is that reduced cross sectional area of the rectus femoris muscles as assessed by ultrasound and/or reduced heart rate variability will be associated with poorer outcomes amongst cardio-thoracic patients undergoing major surgery.

  • Physical activity levels in secondary school students with type 1 diabetes

    The study will take place over 7 days in a free-living environment. It will involve secondary school students between the ages of 12 and 17.9 years who have had type 1 diabetes for greater than 6 months and their siblings (when available) aged 12 and 17.9 years who do not have diabetes. During this 7-day period, physical activity levels will be monitored continuously using GT3X+ accelerometers and interstitial blood glucose levels will be monitored through the use of a continuous glucose monitor. At study visit 1, the participants with type 1 diabetes and one parent or guardian will be asked to complete a fear of hypoglycaemia survey each. Participants with type 1 diabetes will also complete a barriers to physical activity survey. At the end of the study period physical activity outcomes will be compared to published data from an age-matched population. This will help us gather information on physical activity levels in secondary school children with type 1 diabetes.

  • A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GRX-917 in Healthy Subjects

    This project is testing the safety and pharmacokinetics and pharmacodynamics of single and multiple oral doses of a new drug called GRX-917. GRX-917 has the potential to treat depression and anxiety. Who is it for? You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. Study details Participants will be randomised (assigned randomly, like flipping a coin) to receive a single oral dose of either the active study drug or placebo. Total participation will last between 11 days and 25 days which will include a screening period and between 3 days (2 nights) and 9 days (8 nights) in the clinic during which we will need to collect blood and urine samples. It is hoped that this research will help determine the safety of GRX-917 when given to healthy men or women so that it can be tested in patients with depression.

  • eHealth for mental health in DCD: Can a family-based eHealth program improve mental health in Developmental Coordination Disorder?

    Developmental Coordination Disorder (DCD) is a lifelong disorder that makes learning and moving very difficult. DCD affects 1 in 20 children globally. It increases rates of anxiety and depression even in very young children, impacts negatively on the family unit, and leads to poorer physical and mental health in adulthood. Physical activity (PA) is known to improve mood, reduce depressive symptoms, increase self-esteem and act as a preventative for poor mental health. While PA is a cost-effective and accessible intervention, movement difficulties mean that for children with DCD, PA is challenging. This project will utilise an invitation-only Facebook group for parents of children with DCD, alongside an educational website, to educate, support and motivate parents to engage their children in appropriate PA. We expect this program to increase PA levels and lead to improvements in mental health and quality of life for children with DCD. As many children with DCD have co-occurring Attention Deficit Hyperactivity Disorder (ADHD) and PA is thought to improve symptoms of ADHD, we will also explore whether ratings of ADHD symptoms improve post-intervention.

  • Trial of combination drug therapy to treat sleep apnoea

    Aim: To determine in a proof-of-concept study if re-purposing existing approved medications that target the sleep/wake system and upper airway muscle control reduce sleep apnoea severity. Research design: randomised, double -blind, placebo-controlled, cross-over. Methods: Participants will be required to attend 2 overnight visits, each separated by 1 week in the sleep laboratory. Standard sleep monitoring equipment will be applied including: electrodes on the surface of the head, face and chest to monitor wakefulness and sleep, a sensor placed on the finger to monitor oxygen levels, bands placed around the chest and abdomen along with airflow sensors or a mask over the nose to monitor breathing. Participants will be randomised to receive either a placebo (sugar pill) or a combination of two medications (betahistine 96 mg + oxybutynin 5 mg) just prior to sleep.

  • Use of Expiratory Muscle Strength Training (EMST) in the treatment of dysarthria associated with Parkinsons Disease.

    Individuals with Parkinsons Disease typically experience changes to speech and voice associated with poor breath support. While it may be hypothesised that breathing exercises could improve communication function, available evidence does not support this. Expiratory Muscle Strength Training (EMST) devices encourage a specific style of breathing training, where individuals must use maximal strength of expiration to overcome a high level of resistance. It is hypothesised that this high challenge is more likely to lead to gains than training without a device. Training with EMST in isolation has seen improvements in voice and speech in some other populations. There is no known evidence to support its use for people with Parkinsons Disease. This case series (2 participants) study aims to determine if there perceptual change to voice volume/quality, or speech articulation following intensive training with an EMST device, with nil co-occurring therapy, in people with Parkinsons Disease.

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