ANZCTR search results

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

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32850 results sorted by trial registration date.
  • Effect of electronic fetal monitoring method used during labour on emergency caesarean section rates: START (STan Australian Randomised Trial).

    Women in high risk labour have their babies monitored by electronic fetal monitoring. This detects unborn babies not coping during labour, but may lead to unnecessary caesarean sections by incorrectly indicating that the baby is at risk. We will compare CTG to STan monitoring, which may give fewer false readings. We will show if STan reduces emergency caesarean section, and will investigate the impact on the baby, assess psychological aspects such as mental health and wellbeing, and costs.

  • Improving care for adolescents during an inpatient admission following self-harm and suicidal acts

    This pilot study will randomise young people admitted to Banksia ward following a suicide attempt or self-harm to either standard care or structured care. Comparisons will be made in terms of attendance and engagement with community mental health services, parental protective factors in supporting the young person in crisis, self-rated suicide resilience, satisfaction with inpatient services, and readmission rates within 1 and 3 months. Measures will be taken at baseline, discharge from Banksia ward, and 1 and 3 months follow-up. Between-group differences will be analysed using chi square, analysis of variance (ANOVA) and t tests.

  • Comparison of Average volume assured pressure support (AVAPS) and standard bilevel modes of non invasive ventilation in children

    We believe that AVAPS mode of ventilation is tolerated better by patients than standard therapy. We aim to demonstrate that AVAPS is not inferior to standard pressure support ventilation when looking at clinical outcomes.

  • Physical activity in hospitalised older adults after hip fracture

    This project looks to provide additional physiotherapy sessions to older adults aged 65 and over who are recovering from a broken hip. Extra physiotherapy sessions will be offered during their hospital stay. Participants will be encouraged to undertaken a series of seated or standing exercises plus walking, depending on their ability. The safety and practicality of providing physiotherapy three times per day will be measured. Acceptability of the program will be examined by interviewing participants and their families, as well as therapists.

  • The effect of a social robot on pain and behavioural and psychological symptoms in people with dementia: A pilot randomised controlled study

    As pain is a disturbing problem for people living with dementia, pharmacological approaches are necessary for pain management, but medications may bring undesirable side effects; however, non-pharmacological interventions have been recommended to manage pain without obvious side effects. Among them, social robot intervention such as PARO is promising to reduce pain and it is convenient for both health care providers and patients, especially for people with dementia. Findings from this study may provide an evidence-based intervention to improve pain management thus improving the quality of life for people with dementia and decreasing the care burden for nursing staff as well as family carers.

  • Westmead Feelings Program pilot study for adolescents with autism and mild intellectual disability

    One in 100 children is diagnosed with Autism Spectrum Disorder (ASD). Up to 70% of children and adolescents with Autism also experience mental illnesses including anxiety and depression. In addition to the impact of Autism on individuals, the mental illnesses they suffer from are of at least the same severity as that of their disability. However, unlike Autism, mental health problems are reversible and preventable. While approximately 40-50% of adolescents with Autism also have an Intellectual Disability (ID), there is very little research or evidence based programs aimed at this vulnerable population that aim to promote mental health, emotional development and social skills. For adolescents with Autism and an intellectual disability there is no intervention promoting mental well-being. The Westmead Feelings Program (WFP) is an innovative autism specific program developed and researched by psychologists at the Children’s Hospital at Westmead. It is a group based program consisting of 3 modules and a booster session (16 sessions in total). Previous implementation research on the WFP has established the effectiveness of emotion-based learning for primary school-aged children on the autism spectrum, with and without an intellectual disability, and adolescents without an intellectual disability, both in school and clinical settings, in improving emotions competence and reducing symptoms of mental disorder. The aim of this study is to address a current gap in intervention, by developing an adaptation of the Westmead Feelings Program for adolescents with autism and mild intellectual disability, to be piloted in a clinic and school based setting. This study is divided into three parts: Part A: Literature review and development of WFP adapted for adolescents with autism and mild intellectual disability. Part B: Explore and co-design the content in the adapted WFP in focus groups with target population participants (adolescents, parents, educations and other professionals) and explore the adapted WFP feasibility. Part C: Adapted intervention pilot across two settings (clinic setting and a school based setting) – to assess the participant experience, feasibility, barriers to successful implementation and explore whether there are improvements in adolescent well-being, social skills and emotions competence over time, concurrent with using adapted WFP. It is expected that the study will confirm adequate positive experience, feasibility and improvements over time concurrent with using the WFP adapted for adolescents, which may warrant further feasibility and acceptability testing of the adapted WFP in a larger study.

  • A randomised trial of Curcuma longa for treating symptoms and effusion-synovitis of knee osteoarthritis.

    Osteoarthritis is a common joint disorder for which there is no cure. Curcuma longa (commonly known as Turmeric) has anti-inflammatory, cartilage and bone protective properties, and can potentially be used to treat osteoarthritis patients with an inflammatory form of osteoarthritis. Previous studies of Curcuma longa have been of dubious quality and did not select patients with knee swelling, which is a clinical indication of inflammation. The aim of this clinical trial is to determine the efficacy of Curcuma longa extract for treating knee osteoarthritis symptoms and effusion-synovitis (assessment of excess joint fluid using MRI). If successful, treatment with Curcuma longa can be easily implemented as it is inexpensive, safe and available over-the-counter.

  • The Influence of Serum and Aqueous Cytokine Concentrations on the Efficacy of Intravitreal Ranibizumab for the Treatment of Diabetic Macular Oedema

    Diabetic retinopathy is one of the most debilitating complications of diabetes. Diabetic Macular Oedema (a retinopathy) may be related to a combination of inflammatory and angiogenic cytokines that exist in the blood and aqueous fluid in the eye. The main objective of the study is to assess if aqueous and plasma cytokine concentrations of angiogenic/ inflammatory cytokines correlate with the change in mean best-corrected visual acuity from baseline to 12 months

  • A trial to evaluate an oral medicinal cannabis extract compared with placebo for the treatment of insomnia.

    Insomnia is the most common sleep disorder. Australian surveys have shown that 13-33% of the adult population have regular difficulty getting to sleep or staying asleep. Previous studies have shown the benefit of synthetic delta-t-tetrahydrocannabinol (THC) and medical cannabis for a range of sleep disorders, however these trials were mainly targeted to investigate outcomes in other conditions such as pain and multiple sclerosis. The aim of this study is to provide preliminary evidence for orally delivered medical cannabis for the treatment of sleep disorders due to insomnia. This trial will enrol 24 participants aged (25-70) inclusive who have insomnia defined as self-reported difficulty initiating and/or maintaining sleep for 3 or more nights per week for at least 3 months. Participants will also be screened with a clinically validated questionnaire for insomnia by an Investigator team member before being recruited into the trial. Participants involvement in the trial will be for approximately 8-11 weeks (depending on their availability to take the assessments). After completing a series of health asessments and questionnaires relating to their sleep, participants will commence the trial with a 2 week period of baseline measures (without investigational product or placebo) where they will need to wear a wrist-worn device to measure their quantity and quality of their sleep, as well as complete a sleep diary. On the final night of the 2 week period (night 14) they will have an overnight sleep study at the sleep centre site using a non-invasive measuring device to measure sleep patterns and assessments with questionnaires about their sleep by the Investigator team. Following a 1 week break, participants will be randomly allocated (by chance) to receive investigational product or placebo. Each of the treatment phases of both investigational product and placebo will be for 2 week periods including a 1 week break in between the treatments. The same requirements including measurements and assessments as per the baseline will be requried for each of the 2 week periods of investigational product and placebo. This trial will provide information on the efficacy of medical cannabis for the treatment of sleep disorders due to insomnia.

  • Phase I non-randomised safety study of prophylactic topical dexamethasone/hyaluronic acid formulation on facial nerves during parotidectomy and neck dissection surgery

    This study seeks to determine the safety of applying the potent corticosteroid dexamethasone in a slow release hyaluronic acid gel formulation directly to exposed nerve branches of the facial nerve during standard parotidectomy and neck dissection surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are undergoing parotidectomy (malignant or benign) or neck dissection surgery. Study details Consenting patients will receive the dexamethasone in a slow release gel formulation directly to the exposed nerve during surgery, in which the surgeon will coat exposed branches of the facial nerve with the formulation once. Consenting participants will undergo their standard clinical treatment involving parotidectomy or neck dissection surgery which includes an initial consult involving facial nerve function assessments, parotidectomy or neck dissection surgery and follow-up visits assessing wound healing/infection and facial nerve function over 2 months.

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