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.
  • The Language Acquisition through Motor Planning (LAMP) therapy approach for autistic children with complex communication needs

    A total of 16 autistic children (3-8 years of age) who are nonverbal or minimally speaking will be recruited to participate in this project to evaluate Language Acquisition through Motor Planning (LAMP). LAMP is an AAC based therapeutic approach based on neurological and motor learning principles. A non-concurrent multiple baseline design with randomised baselines will be used to examine the effectiveness of LAMP delivered (1hr/week for 20 weeks) in a clinical setting. This research project has three key aims: 1. To evaluate the acceptability, feasibility, and effectiveness of LAMP for autistic children with minimal verbal language, delivered in a clinical setting. 2. To explore child, family, and service characteristics associated with individual outcomes. 3. To examine the clinician maintenance of fidelity to the LAMP therapy approach after completing the LAMP training workshop and certification program.

  • Step-down Therapy Evaluation of Pantoprazole in Eosinophilic Esophagitis (STEP-EoE): A randomised trial of Pantoprazole at 40mg orally once daily compared to 20mg orally once daily in patients with Eosinophilic esophagitis (EoE) who initially respond to Pantoprazole 40mg orally twice daily.

    Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition causing narrowing of the oesophagus, manifesting clinically as dysphagia and food bolus impaction (FBO).Proton pump inhibitors (PPI’s) are a mainstay in treatment of EoE, and have proven efficacy in inducing and maintaining remission according to systematic reviews and meta-analysis. Optimal total daily dose and dose frequency schedule of PPI is an under-researched area of immediate relevance to patient care and implications include convenience, cost and safety. In the context of a current knowledge gap for optimal dosing of pantoprazole for patients with EoE who have responded to routine dosing at 40mg orally twice daily, we propose a RCT of dose adjustment to 40mg tablet orally once daily compared to 20mg tablet orally once daily, with a formalised treatment protocol and the ascertainment of symptom scores (questionnaire), endoscopic appearance, and histological findings (biopsy). The results will have the potential to improve management in future.

  • Randomised trial of Budesonide Orodispersible tablet (BOT) at 2mg orally once daily compared to 1mg orally once daily in patients with Eosinophilic oesophagitis (EoE) who initially respond to Budesonide 1mg orally twice daily.

    Eosinophilic oesophagitis (EoE) is a common cause of dysphagia and is now the leading cause of food bolus impaction (FBO) in Western countries. The most effective treatment for EoE is budesonide orodispersible tablet (BOT - Jorveza™). A new topical corticosteroid called Jorveza became available in May of 2022 and demonstrated efficacy with complete resolution of EoE at 1mg orally twice daily in 80% of recipients. Many patients and clinicians attempt dose reduction to 1mg orally once daily with the hope of improving convenience, compliance and reducing side effects, yet there is no evidence that reducing total dose or reducing dose frequency will maintain remission. A randomised trial of Budesonide Orodispersible tablet (BOT) at 2mg orally once daily compared to 1mg orally once daily in patients with EoE who initially respond to 1mg orally twice daily is thus proposed.

  • How Low-Level Laser Therapy Affects Tooth Movement, Root Health, and Pain During Braces Treatment

    This study aims to investigate the effects of low-level laser therapy (LLLT) during orthodontic tooth intrusion. Specifically, it will assess whether LLLT can reduce tooth root resorption, preserve pulp chamber volume, and decrease patient-reported pain compared to a sham (inactive) laser. Maxillary first premolar teeth will be intruded over an 8-week period, and changes in root and pulp volumes will be quantitatively measured using micro-CT imaging.

  • Do High Efficiency Particulate Air (HEPA) filters reduce asthma symptoms? : a randomised controlled trial in adults with asthma (OVERNIGHT study)

    This study is testing whether using HEPA filter air purifiers at home overnight can improve the quality of life for adults with asthma, particularly during high pollution days. Adults with asthma will be randomly assigned to receive either a real HEPA air purifier or a look-alike placebo purifier that does not filter the air. The study will measure changes in asthma symptoms, sleep quality, nasal health, and lung function before and after intervention.

  • Impact of night-to-night variability of Sleep Apnoea on Atrial Fibrillation

    Atrial fibrillation (AF) is the most common chronic heart rhythm problem and controlling risk factors are pivotal in management. Obstructive Sleep Apnoea (OSA) has emerged as an independent risk factor for AF and is defined by repetitive airway obstruction during sleep which overtime gives rise to AF. Nightly autonomic dysfunction as a result of sleep apnoea is important in understanding AF. The study hopes to better understand about nightly autonomic dysfunction on daily AF burden overtime and assess whether treatment including CPAP or MAS has a direct, positive impact.

  • Bridging the Urban and regIonaL Divide in Stroke care (BUILDS): A national Tele-Stroke Unit Inpatient Service for rural and remote Australia

    BUILDS is a multicentre non-randomised cluster crossover trial with Type 1 hybrid effectiveness-implementation design to be conducted across seven Australian rural and regional health networks. It will systematically evaluate the effectiveness and adoption of a national stroke physician-led Tele-Stroke Unit inpatient service using a purpose-built digital platform to improve the quality of care and outcome of stroke patients in rural and remote communities.

  • Combination pharmacotherapy for co-morbid insomnia and obstructive sleep apnea (COMISA)

    Co-morbid insomnia and obstructive sleep apnea (COMISA) is common. When these disorders co-occur, they result in additive impairments to patients’ sleep, daytime functioning, and quality of life. Compared to OSA-only patients, patients with COMISA are likely to have mild upper airway collapsibility and a low respiratory arousal threshold. Targeting these two physiological traits serves as the scientific rationale for this investigation. Interestingly, trazodone is the only hypnotic that has been shown to significantly increase the arousal threshold in patients with obstructive sleep apnea (OSA). Trazodone is also effective in treating insomnia. Sulthiame has been shown to target airway collapsibility and high loop gain. As such, the combination of these two agents is postulated as a synergistic approach to the treatment of OSA and insomnia in patients with COMISA. Study Aims: The primary goal of the current study is to determine the effect of the combination of sulthiame and trazodone on OSA and insomnia severity in patients with COMISA. Specifically, we will assess the effect of combination pharmacological therapy on OSA severity as measured by the apnea-hypopnea index [AHI 3a% criteria, primary outcome] and insomnia as measured by the insomnia severity index [ISI, secondary outcome]. Hypothesis: We will test the primary hypothesis that combining therapies to lower loop gain (sulthiame) and increase the arousal threshold (trazodone) will improve OSA severity (AHI3a) and insomnia severity (ISI) compared to placebo in patients with COMISA.

  • Pain Education to Optimise Care for Total Knee Replacement Surgery (OPTIMISE)

    Post total knee replacement surgery, approximately 34% of people have a poor clinical outcome with approximately 15% developing chronic post-surgical pain (long-lasting severe-extreme pain) after surgery. Post total knee replacement pain outcomes can be improved via early graded resumption of activity and early targeted medical attention if not improving. However, current total knee replacement care does not always facilitate this. Physiotherapist led pain science education to update inaccurate beliefs about pain, paired with activity goals has demonstrated reductions in pain and improved self-rated activity for people with knee osteoarthritis. Thus, we have now co-designed a total knee replacement-specific pain science-education intervention with osteoarthritis consumers and clinicians that is ready to pilot test. This parallel-group randomised controlled trial aims to determine whether pain science education informed optimised care for total knee replacement surgery is feasible, acceptable and demonstrates the potential for efficacy when embedded into Australian hospitals relative to usual care.

  • Feasibility and acceptability of EDBridge: A brief contact intervention for adolescents at risk of suicide and their parents

    Suicide remains a leading cause of death for Australian adolescents, and suicide and self-harm related Emergency Department presentations are rising. Brief contact interventions are an important component of comprehensive treatment approaches for adolescent suicide risk. Research has found that families feel excluded from their adolescent’s care in the ED and don’t receive sufficient information about how to support them, despite evidence suggesting involving families in adolescent suicide prevention interventions leads to better outcomes. Additionally, there is a need to provide continuity of care after discharge from the ED. The EDBridge Pilot Feasibility & Acceptability trial involves a multi-component brief-contact intervention for adolescents aged 12-18 who are discharged from an Emergency Department with suicidal thoughts or behaviours, and their parents/carers. It involves a suicide safety planning intervention for adolescents, a parent factsheet resource to support parents to manage adolescent suicide risk outside the ED, and an automated follow-up text message support program for both adolescents and their parents/carers. The aims of this trial are to determine whether EDBridge is feasible (that is, how easy or practical EDBridge is to provide), and acceptable to adolescents, parents, and clinicians. We also aim to collect early information about whether EDBridge can help improve the mental health and suicide-related symptoms of parents and adolescents, and increase their engagement with community mental health support. We hypothesise that EDBridge will be feasible and acceptable to clinicians, adolescents, and parents. We also hypothesise that the pilot trial will give early indication that EDBridge can support adolescents and parents to improve suicide-related and mental health outcomes and increase engagement with community mental health support.

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