ANZCTR search results

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

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31196 results sorted by trial registration date.
  • Neural mechanisms of lisdexamfetamine in binge eating disorder.

    While Lisdexamfetamine dimesylate (LDX) is indicated for moderate to severe binge-eating disorder (BED) in Australia, the exact mode of its therapeutic action in BED remains unknown. This study aims to provide a comprehensive understanding of the neural mechanisms by which LDX improves symptoms of BED. We hypothesise that: 1. LDX will act by altering connectivity within and between brain circuits responsible for reward and inhibition. 2. A reduction in binge-eating behaviours will correlate with increased activity and connectivity of brain regions within reward and inhibition circuits.

  • For replacing a single missing tooth with implant, is there a difference between the traditional and the new techniques for placing implants in relation to accuracy and restoration longevity

    The purpose of this study is to compare the ease of use and accuracy of 3 different protocols currently used at the Royal Dental Hospital of Melbourne to place dental implants. Specifically, the study will measure exactness of the placed implant in comparison to the planned implant position. In addition, it will evaluate if the type of implant restoration has an effect on the clinical outcome.

  • Resuscitating newborn infants with the umbilical cord intact- The Baby-Directed Umbilical Cord Cutting (Baby-DUCC) Trial

    Participants: In infants greater than or equal to 32 weeks gestational age at birth who require resuscitation at delivery, Intervention: Does establishing effective ventilation, either via PPV or effective spontaneous breathing, prior to umbilical cord clamping* versus Comparator: Standard care- immediate cord clamping followed by resuscitation Outcome: Result in a higher average heart rate between 60-120 after birth. *In the intervention arm (Baby-DUCC), infants that receive PPV will have umbilical cord clamping at least 1 minute after pedicap/neostat colour change, or at least 2 minutes after delivery, which ever time occurs last. Pedicap/neostat colour change indicates exhaled carbon dioxide levels are greater than or equal to 15mmHg, therefore, the lungs are aerated and pulmonary gas exchange has begun. If the infant is still receiving PPV at 5 minutes, the umbilical cord will be cut and the infant will be moved to the warming bed. If the infant requires respiratory support after birth, the infant will be randomised to Baby-DUCC (resuscitation prior to umbilical cord clamping) or the control arm (immediate cord clamping and the infant will be moved to the warming bed for resuscitation measures). If the infant is vigorous and does not need resuscitation, the infant will not be randomised and umbilical cord clamping will occur at least 2 minutes after birth, oxytocin administration will occur after umbilical cord clamping. In these vigorous infants, we aim to collect heart rate and SpO2 data in the first 10 minutes after birth.

  • Development of Recommendations for Speech-Language Pathologists in Paediatric Palliative Care Teams (ReSP3CT)

    Given the scarcity of literature and no clinical practice guidelines written for speech pathologists (SPs) currently working in paediatric palliative care, a need was identified to explore the scope of clinical practice and strategies used by SPs. This study therefore aims to undertake an international investigation of clinical practice by gathering data from comprehensive literature searches, demographic surveys, in­-depth interviews and an online Delphi study, to identify current speech pathology (SP) practices, experiences and opinions with the purpose of developing current consensus-­driven 'Recommendations for Speech­Language Pathologists in Paediatric Palliative Care Teams' (ReSP3CT).

  • 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.

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