ANZCTR search results

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

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31193 results sorted by trial registration date.
  • Exploring pain in children and developing new technologies to address challenges

    QUENDA is part of a broader research program aimed at using mobile devices and digital technology to better assess children’s pain. Digital mobile technology (e.g. mobile phones, tablets) can enable pain assessment tools that are interactive and respond to children’s inputs. The broader program seeks to embrace the potential of digital-enabled interactive tools and create new approaches to the assessment of pain that are better for kids, allow more engagement, and therefore give clinicians better insight into children’s pain, and enable better care. QUENDA is the first step in the program and is designed to better understand how children perceive and communicate their pain.

  • Comparing two different interventions for treatment of volar plate injuries.

    This study plans to determine if splinting in a neutral (straight) position of more effective than buddy loops in preventing reduced extension (straightening) at the proximal interphalangeal joint (middle joint of the finger). Specific hypotheses will address; splinting the PIPJ in a neutral position produces a) a lower average extension contracture of FFD than splinting in buddy loops; b) lower mean pain scores than buddy loops; c) lower mean oedema measure than buddy loops; and d) splinting the PIPJ in a neutral position results in changed Participants will be randomly assigned to one group and both will commence active exercises within the splint or buddy loop. Both interventions will be worn full-time for 3 weeks and then discharged at 5 weeks. Each participant will be treated and assessed by experienced hand therapists (occupational therapists or physiotherapists) and the assessing therapist will be blinded to the treatment group of there participants. Assessment will be undertaken at their initial presentation, weeks' 3, 5 and 8.

  • Digital Support For People With Chronic Pain Who Are Reducing Prescription Opioids

    This double-blind randomised controlled trial will investigate the the feasibility, acceptability, and efficacy of digital support to improve pain and well-being of people with chronic pain who are reducing prescription opioids. Participants will be patients with chronic non-cancer pain who are commencing prescription opioid tapering (dose reduction). 74 participants who meet the selection criteria will be randomized to receive either an educational video followed by text messages for 12 weeks (group 1) or an educational video (group 2) in addition to their usual care. The digital support intends to increase the self-efficacy to taper prescription opioids. This includes pain management and opioid tapering information, as well as supportive content. The study will evaluate the efficacy of the intervention in improving pain and well-being as the primary objective.

  • Investigating the safety and efficacy of sternal closure with the Waston Sternal Claw Fixation System for Cardiothoracic Surgical Patients

    This is an Investigator led trial to assess the safety and efficacy of the Waston Sternal Claw Fixation System against Standard of Care Wire Cerclage as an advantageous of Median Sternotomy Closure. Wire cerclage has long been the gold standard and lone method of median sternotomy closure, yet this method has substantial and obvious limitations that can cause patients considerable complications post-procedure. The use of the Waston Sternal Claw Plate has been proposed as an advantageous method of sternal closure compared to all previous closure methods due to the structure of the device, however there has only been one study evaluating the effectiveness of the Waston Sternal Claw as a method of sternotomy closure against wire cerclage. As such, the purpose of this research is to justify the use of the sternal claw system as an improved method for median sternotomy closure and provide additional evidence of its benefit to patient outcomes post-sternotomy. Participants planned for Cardiac Surgery involving a Median Sternotomy method of heart access will be recruited into the study. Participants will be evaluated for their appropriateness to partake in the study and will be randomised into 1 of 3 arms of sternal closure post cardiac surgery. Participants will have their sternum closed according to the method they were randomised to and will be assessed for 6 weeks post-intervention to assess the safety and efficacy of their sternal closure method. Assessments will be conducted to assess the effectiveness of sternal closure and sternal union, participant safety and quality of life post-intervention.

  • An investigation of the effectiveness of a therapeutic assessment intervention on engagement in aftercare services for young people who present to the emergency department for deliberate self-harm

    The study aims to evaluate the effectiveness of the TA intervention in young people who present to the ED for DSH or suicidal ideation with past DSH behaviour. The results of this project will be used to determine whether TA is effective in adherence to aftercare services and repeat presentations to the ED for DSH. The objectives are to: 1) To examine the effectiveness of the TA intervention on adherence to aftercare services at 6-months and 12-months post-presentation to the ED for DSH, including young people who present with suicidal ideation with a history of DSH. 2) To examine the effectiveness of the TA intervention on reducing rates of re-presentations to the ED for DSH or suicidal ideation at 6-months and 12-months post-presentation. 3) To identify key modifiable factors associated with access and availability of aftercare services for young people post presentation to ED for DSH or suicidal ideation with a history of DSH, in metropolitan and regional settings.

  • Investigating the effects of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on paediatric acute-onset neuropsychiatric syndrome (PANS): An open-label study.

    This is an 18 to 54-week open-label study to evaluate the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of paediatric acute-onset neuropsychiatric syndrome (PANS) in children. The purpose of this study is to determine how effective NTI164 is in patients with PANS when treated for 18 to 54 weeks. Participants will commence treatment with a daily dose of 5mg/kg of NTI164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase). Participants who wish to continue receiving their maximum tolerated dose beyond the 8-week Treatment phase may do so for up to fifty-four (54) weeks (Extension phase). At the end of the Treatment or Extension phase, participants will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of their participation (Down-titration phase). Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the emotions and behaviour of patients with PANS. Whole blood RNA sequencing will validate the immune dysfunction signature.

  • Investigating the effect of manager training on help-seeking in police officers

    There is considerable evidence that harsh managerial styles influence workplace efficiency and worker wellbeing. In contrast, supportive managerial styles that are characterized by empathy and non-judgmental attitudes to workers are associated with more positive workplaces and productivity. This issue is particularly influential in organisations that are characterized by demanding work duties, where mental health issues are more prevalent and contribute to absenteeism. The goal of this research is to evaluate the extent to which training managers in NSW Police can result in more supportive behavior of managers, and promote better help seeking in officers with mental health problems. This project is being conducted in collaboration with NSW Police. Sergeants in 6 regional commands in NSW will be trained in how to (a) provide supportive managerial assistance to officers under their command, (b) identify officers who may experience mental health issues or be dissatisfied with their work environment, (c) engage in supportive discussions in a way that promotes a better sense of employee control and work satisfaction, and (d) offer them confidential referrals for assistance they may need with personal issues. These trainings will be conducted in face-to-face group sessions in the 6 commands (each one comprising 10-20 sergeants) in 1 x 2.5-hour session. The outcomes of the project will be compared with 6 matched commands in NSW (identified by NSW Police). The primary outcomes of the project will be sergeants' reports of frequency of referring an officer for mental health assistance. Secondary outcomes will be knowledge of appropriate strategies to provide to officers; this data will be obtained from sergeants when they complete a brief questionnaire that is emailed to them by NSW Police. The primary outcome timepoint will be 26 weeks after the program.

  • Taking the first step: Investigating the effect of novel strategies on the number of people with knee osteoarthritis accessing exercise management.

    Every clinical guideline recommends that individuals with knee osteoarthritis (OA) undertake planned, structured, and repetitive physical exercise. Such programs are ideally provided by physiotherapists or exercise physiologists. However, referral for planned exercise programs for people with OA by their GP is low. This prevents many people with knee OA from having the opportunity to participate in a treatment that will improve their knee pain. This study will investigate the effectiveness of two strategies designed to improve access to exercise programs provided by physiotherapists or exercise physiologists. Strategy 1 is including an educational message that exercise is important in the report sent to the GP after the person with knee OA has undergone x-ray. Strategy 2 supplements the GP educational message with an infographic to the person with knee OA informing them about the benefits of exercise for pain and function. We will work with radiology clinics in NSW to compare the strategies with current practice (no information to people with OA or GPs). We expect both strategies will be more effective than current practice in increasing the number of people being referred and attending appointments with physiotherapists or exercise physiologists.

  • The associations of pneumonia with cardiac injury and new-onset heart failure

    This is a longitudinal observation study which is evaluating the association of hospitalised community-acquired pneumonia with (i) myocardial fibrosis and with (ii) new-onset left ventricular dysfunction. An abundance of epidemiological data strongly associates pneumonia and subsequent new-onset heart failure, however the mechanism is unclear. Experimental animal data suggest that bacterial invasion of the myocardium with resulting cardiac fibrosis could be implicated. In a recent exploratory study of 20 adults with bacterial community-acquired pneumonia, highly-selected to ensure no prior history of any heart disease, we reported the highly novel finding of myocardial fibrosis and new-onset left ventricular dysfunction in 30% and 5% respectively (Rajwani et al, Bacterial pneumonia is associated with myocardial fibrosis and new-onset left ventricular dysfunction, JACC Advances 2022, in press). If this novel finding of a pathophysiological process in the myocardium is replicated in larger studies of pneumonia, this could herald a major paradigm shift in the post-discharge care of pneumonia. In this current larger study, adults free of prior heart disease who are hospitalised with community-acquired pneumonia (except those with positive viral nucleic acid amplification assay at admission) will be recruited. Myocardial function and composition will be assessed during convalescence post-discharge, as well as longer-term clinical outcomes for heart failure. Predictors of myocardial fibrosis will also be evaluated, in order to allow enrichment of future translational studies exploring preventative strategies.

  • High-flow Oxygen and Nitric Oxide inhalation versus high-flow oxygen alone on the incidence of intubation in hypoxaemic Respiratory failure (HONOR): a pilot randomised controlled trial.

    Induced coma and breathing machines have become synonymous with intensive care units (ICU). Breathing machines are undoubtedly life-saving in many situations where a person can’t breathe for themselves. Despite it being one of the most potent life-sustaining technology available, it causes significant increases in hospital length of stay, an increased hospital cost burden and a leading cause of distress for patients and families in ICU. Non-invasive alternatives such as nasal high-flow oxygen delivery systems or pressurised face masks are usually used as first line treatment to prevent a breathing machine. Low oxygen levels can also be improved with the addition of nitric oxide gas. One study has demonstrated a trend toward decreased need for breathing machines for a portion of patients receiving nasal high-flow oxygen and nitric oxide gas, however this research remains sparse. Our study will examine the feasibility and clinical outcomes of comparing nasal high-flow oxygen alone over nasal high-flow oxygen with nitric oxide gas in preventing patients to require a breathing machine. Based on previous research and physiological rationale, we hypothesise the latter to be superior.

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