ANZCTR search results

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

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32707 results sorted by trial registration date.
  • An evaluation of the Sleeping Sound program on children's sleep difficulties in children with Autism Spectrum Disorder and Intellectual Disability.

    ASD is a prevalent neurodevelopmental disorder associated with serious adverse outcomes, which compromises the individual’s life chances and productivity. Up to 80% of children with ASD experience sleep problems, with these sleep problems exacerbating existing impairments. Treating sleep problems in children with ASD is associated with markedly improved functioning, including improvements in the core symptoms of ASD. To date, sleep interventions for ASD are largely based on research conducted in samples of children with ASD who are intellectually able. There is a gap in services available for children with ASD with an intellectual disability. We now plan to extend the Sleeping Sound program for children with ASD who also have an intellectual disability, with the ultimate goal of using this intervention to improve outcomes for the entire autism spectrum. The development of such program will represent a major treatment breakthrough for children with ASD with an intellectual disability. The proposed study will also result in a significant advance in the treatment of sleep problems in children with developmental disabilities. It is hypothesised that the Sleeping Sound program will be acceptable and feasible to parents of children with ASD+ID and that the following benefits will be observed in comparison to a treatment as usual comparison group: 1. Reduced sleep problems 2. Fewer social-communication symptoms, emotional/behavioural disturbance 3. Improved quality of life 4. Improved parent mental health.

  • Amyloid deposition and cognitive function in Obstructive Sleep Apnoea

    Obstructive Sleep Apnoea (OSA) is a highly prevalent chronic illness, characterised by repetitive collapse of the airway during sleep, causing falls in blood oxygen levels and sleep disruption. OSA is associated with cognitive deficits, especially memory impairments. Another common condition, dementia, is in the top 4 causes of burden of disease of high-income nations. It affects over 340,000 Australians. OSA is common in patients with dementia, with estimates of 38-45% of dementia patients having OSA. The risk of Alzheimer’s disease and vascular dementia has been shown to increase in patients with OSA. However, a direct causal link between these two conditions has not been established. Beta-amyloid deposits are commonly found in the brains of patients with dementia, and are implicated in the development of dementia. Positron emission tomography (PET) can be used to assess levels of amyloid in the brains of patients, and these levels can be associated with cognitive function. Previous studies performed at Austin Health have found significant associations between amyloid levels and memory impairment in patients with mild cognitive impairment. To date, no studies have examined whether OSA is associated with higher levels of beta amyloid deposits or Alzheimer’s disease -type neural changes, or how these changes relate to cognitive performance. This study will use PET scanning techniques to examine the levels of amyloid in the brains of patients with OSA, and compare these to brain scans of healthy participants. This study will also conduct cognitive assessments in the OSA patients and healthy controls, examining associations between cognitive performance and amyloid levels. Identifying potential biomarkers of amyloid burden in OSA could have important implications for early detection and risk assessment. Early identification of the risk of developing dementia in patients with OSA is important as it allows the possibility of a simple intervention that targets the sleep disorder that may be contributing towards the development of neural and cognitive impairment, before it progresses to dementia.

  • Bowel Preparation Assessment Using Ultrasound Examination II

    Poor bowel preparation is common in inflammatory bowel disease (IBD) and can lead to incomplete colonoscopic assessments and missed pathology. As such the patients are required to undergo either a second colonoscopy or earlier surveillance colonoscopies. This creates cumulative risks of colonoscopies (double the anesthetic and procedural risks), increased burden to the health care system (extra resources and colonoscopy spots used that could be used by other patients) and the patient (more inconvenience of further bowel prep and missed work for the procedure) as well as financial costs both to the health care system as well as the patient in multiple ways. Being able to assess the patient's bowel preparation before giving them anaesthetic and more importantly, being able to know their prep is poor and given them extra bowel prep and have their procedure delayed by a few hours (put at the end of the endoscopy list) would be of huge benefit for both the patient and the health care system. Our aim is to show that randomisation to the rapid ultrasound assessment (no radiation and no risks to the patient) that focuses on a few specific areas of the bowel to assess bowel preparation quality and allow for intervention (extra bowel prep) if required will be superior to the current standards (no ultrasound assessment) and can avoid the detrimental effects of poor bowel prep.

  • Kindred: A pilot study of moderated online social therapy for carers of youth with borderline personality disorder

    This study is a single group, pre- and post-follow-up pilot trial that aims to evaluate the acceptability and safety of an innovative moderated online social therapy (MOST) intervention called Kindred, designed to support carers of young people who are receiving treatment for borderline personality disorder (BPD) pathology within a specialist early intervention service for youth. Kindred comprises three highly integrated functions within one web-based application. These include: (1) online psychoeducation and interactive therapy (divided into specific thematic pathways which are further separated into individual "steps"); (2) expert moderated social networking (via a "cafe"); and, (3) peer moderation. Acceptability and safety will be assessed by patterns of use of the Kindred intervention along with an interview with carers and a questionnaire, the Post-Study Usability Questionnaire (PSSUQ).

  • Testing a Peer Support Program for Intensive Care Unit Survivors to improve Psychological Recovery - Pilot Randomized Controlled Trial

    International and local research indicates that ICU survivors (patients and families) experience adverse outcomes. In Australia, ICU survivors return home with little or no follow-up. Peer support holds potential to improve post-ICU outcomes although this warrants explorations. Typically new models of care are designed only from the perspective of the health professionals without any patient or family input. We have recently conducted Phase 1 of the icuRESOLVE Project, where we engaged both ICU survivors and staff using a new and innovative method called experience-based co-design (EBCD). Through EBCD a Peer Support model for ICU survivors was developed. This study (phase 2 of the icuRESOLVE Project) aims to test the developed Peer Support Model to see if it is feasible to deliver (attendance rates, participant satisfaction, participant recruitment) as well as the impact of attending peer support on psychological and social outcomes. This is a small pilot study and the results of this study will inform a larger, multi-site randomized study. The time commitment required by participants in the intervention group (peer support) is estimated at 13 hours over approximately 14 weeks. For participants in the control group (no peer support), time commitment is estimated at 1 hour (to complete health related questionnaires). Anticipated ethical issues for the intervention group relate to a small risk of psychological distress by participating in the group sessions as they will be discussing their ICU experiences and recovery. For participants in both groups their may be a small degree that some of the questionnaires may be stressful or upsetting. Survivors are able to access any help needed. We do not anticipate any risk to staff.

  • Comparing the long-term clinical outcome of two designs of high strength ceramic (zirconia) crowns on dental implants

    The purpose of the study is to compare the clinical outcome of two different design concepts of full contour monolithic zirconia (FCZ) implant supported restorations. Metal-ceramic restorations are traditional restorations and have been used for many years with success. However, metal-ceramic restorations have multiple steps in the fabrication process, which makes the fabrication process time intensive and technically demanding. With increasing demands for aesthetic and metal-free dentistry, the use of ceramic restorations is increasing. Zirconia is a relatively new material with high strength, good aesthetics and contains no metal. Although zirconia may be a reasonable replacement for traditional metal-ceramic restorations, long-term clinical data is still lacking.

  • The Diet and Breast Milk Composition Study

    Breast milk is made up of nutrients including fat and sugar. It also contains hormones that help control how hungry or full we feel and how our body uses energy. When a mother breastfeeds, these hormones are transferred from the breast milk to the baby and may play a role in how baby grows and develops. We now know that what a mother eats while breastfeeding can affect how much breast milk she produces, but we still know very little about how this affects breast milk composition, including the levels of these hormones. The purpose of this study is to look at how consuming a breakfast meal containing different levels of fat and sugar affects the amounts of nutrients and other factors, including hormones in breast milk over the following 12 hours. This research will help us to understand the effect of different dietary choices during breastfeeding on the composition of the breast milk and, in the future, may help inform dietary guidelines for breastfeeding women.

  • Cannabinoids and Acute Post-operative Pain in Participants having Stoma Reversal.

    This is a research study examining whether medicinal cannabis can safely be given to people who are having a surgical procedure involving the bowel. When a person undergoes major surgery on the abdomen, care after the surgery involves the administration of medications that help relieve pain associated with the surgical procedure. Some of these drugs are called “opioids”. Most patients in this study will probably have had these drugs for the previous surgery in the form of morphine or “morphine-like” drugs given via the intravenous drip or a tablet taken by mouth. The side effects of these drugs include: • Slowing of bowel function • Sleepiness • Slowed breathing • Nausea and vomiting • Decreased appetite This study is not designed to test if medical cannabis is an effective pain management option, but rather seeks to assess if the drug can be safely administered and can be tolerated by patients having surgery such as your procedure and measure blood levels of cannabis chemicals.

  • A study of the effectiveness of Experiential Awareness Therapy for the treatment of Eating Disorders

    This study is evaluating a group therapy, Experiential Awareness Therapy, for people experiencing disordered eating. Experiential Awareness Therapy is an evidenced based therapy aimed at enhancing psychological functioning for eating disorder recovery. Benefits of participating This therapy will aim to: • Increase participants ability to regulate their emotions • Increase participants sense of self-worth and support a realistic and functional understanding of others • Enhance participants ability to identify and understand their emotions and feelings and also identify others intentions, emotions and feelings. • To facilitate an understanding of how these areas of psychological functioning impact eating disordered symptomology. Enhancing these abilities has been shown to be supportive of recovery from disorder eating and also enhance quality of life.

  • Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth lifestyle behaviours intervention for pregnant women integrated into clinical practice – a randomised controlled trial

    Inactivity and poor nutrition during pregnancy are associated with adverse health and pregnancy related outcomes for the mother and her unborn child. This innovative randomised controlled trial aims to increase physical activity and improve nutritional behavours in pregnant women by integrating an already examined eHealth intervention (Fit4Two) into clinical practice. This intervention will provide participants with highly personalised and automated physical activity and nutritional feedback, endorsed by their practitioner. As such, participants will receive high quality care in a convenient, credible and time efficient manner, whilst placing very little additional burden on practitioners.

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