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.
  • A randomised controlled trial comparing the cost effectiveness of jaw-in-a-day (JIAD) surgery versus standard jaw reconstruction with delayed prosthetic rehabilitation.

    This study aims to compare the costs and overall value of jaw-in-a-day (JIAD) surgery with the standard approach, where teeth are replaced some-time after jaw reconstruction surgery. Who is it for? You may be eligible for this study if you are male or female, aged 18 years or older undergoing jaw reconstruction with an osseous free flap, suitable for dental implant placement, with American Society of Anesthesiologists (ASA) score I-III, and able to self-care and maintain good dental hygiene. Study details Participants who choose to enrol in this study will be randomised to either JIAD or standard jaw reconstruction. JIAD involves replacing the missing teeth at the same time as the jaw reconstruction surgery, instead of the standard approach where teeth are replaced some-time after jaw reconstruction surgery. The Head and Neck Reconstructive surgery is planned and will take 6-10 hours (standard of care). After surgery, participants will attend routine outpatient clinic visits, and CT scans will be collected every three months for the first year as part of standard care. Will also complete questionnaires at the above time points. In the second year, this process will continue every six months. It is hoped this research will help others in the future who may benefit from gathering new information about the cost and value of different ways of replacing missing teeth after the jaw reconstruction.

  • Better Bedtimes: A brief behavioural sleep intervention for insomnia in middle childhood

    Better Bedtimes is a brief, two-session psychologist-delivered intervention designed to help children aged 6 to 11 years fall asleep faster and stay asleep throughout the night. The primary aim of this study is to evaluate the efficacy and acceptability of the intervention for children with insomnia symptoms. A secondary exploratory aim is to compare outcomes between children with and without a comorbid anxiety disorder.

  • PANDA: Psilocybin-assisted therapy for treatment of alcohol use disorder and comorbid depression

    We aim to assess feasibility, acceptability and preliminary results of the effectiveness of psilocybin in the treatment of alcohol use disorder (AUD) and depressive symptoms, in addition to routine alcohol and other drug (AOD) treatment. This pilot study will use a single dose of psilocybin in addition to standard counselling care for people experiencing co-morbid AUD and depression. Ten participants will be recruited from advertising and clinician referrals at the study site.

  • CLinician-perfOrmed bedside ulTrasound for Screening for Proximal deep venOus Thrombosis in Intensive Care Unit (the CLOT-SPOT study)

    This prospective observational study aims to evaluate bedside two-zone lower limb compression point-of-care ultrasound (POCUS) for the detection of deep vein thrombosis (DVT) in critically ill adults.

  • Comparing ALternative Models of carE to manage diabetes Distress (CALMED): A type 1 hybrid implementation - effectiveness trial to improve psychological and glycaemic outcomes and avoid hospitalisations in people with type 1 diabetes.

    The current study aims to address a major gap in care for people with diabetes distress (DD). By conducting a pragmatic randomised controlled trial, the goal is to compare three models of care for people with DD: i) SMOC (recommend GP to refer patient to a psychologist via the mental health care plan) ii) IMOC (individual assessment and management of DD by a DM-informed psychologist) and iii) GMOC (6-session behavioural therapy program delivered via Virtual Care group by DM-informed psychologist and diabetes educator; 3-6 participants per group). Specifically, the study aims to determine the comparative efficacy of GMOC, IMOC and SMOC in improving DD, glycaemic control and reducing hospitalisations in patients with T1DM and DD. The cost effectiveness of each Model of Care will also be examined. The research will generate new knowledge and evidence regarding sustainable models of care addressing an urgent clinical need, as diabetes places an increasing burden on our health system.

  • Optimising Green Spaces in Specialist and Mainstream Primary Schools: The Green Schools Project Protocol

    Working closely with industry and education stakeholders, this project will generate vital evidence regarding the potential benefits of green spaces for social and emotional well-being, nature connection, and school enjoyment among students and nature connection and occupational well-being/engagement among staff. It will also explore barriers and facilitators to green space innovation and provide insights on the processes of co-designing, adopting and implementing greening. This project will address current gaps in the field by assessing the impacts of co-designed school greening interventions at both specialist and mainstream primary schools. Specialist schools focus on vulnerable communities and are an over-looked setting. This research is also novel in its inclusion of both indoor and outdoor greening and a focus on the impacts of greening for both students and school staff. Finally, it will foster an understanding of the real-world implications of real-world retrofitted greening interventions at multiple schools, enabling the production of practical and policy-relevant greening recommendations for both specialist and mainstream schools.

  • Exploring a health app to support daily tasks and wellbeing for caregivers and people with cognitive decline

    This study is testing a smartphone app called Perx, designed to help people with cognitive decline and their caregivers manage daily health and wellbeing tasks. Participants will use the app to track tasks like taking medications, attending appointments, and completing optional wellbeing activities. Caregivers will also have access to supportive content developed with dementia specialists. The study aims to understand enrollment feasibility, how engaged participants are, and whether it helps with daily routines and adherence to health tasks. Insights from this pilot will help improve the app and inform future studies to better support people living with cognitive changes and their caregivers.

  • An ALLG international randomised phase III trial of Surovatamig versus radiotherapy with or without Rituximab in limited stage nodal Follicular Lymphoma

    What the study is about: This study will evaluate whether surovatamig, a novel CD19 × CD3 bispecific T-cell engager, can improve outcomes for people with previously untreated, limited-stage nodal follicular lymphoma (FL). The trial will compare surovatamig with the current standard of care: involved-site radiotherapy (ISRT) with or without rituximab. The aim is to determine whether surovatamig can produce deeper and more durable responses, reduce the risk of disease relapse, and improve event-free survival. Who is it for: This study is for adults aged 18 years or older who have: 1. Histologically confirmed classical follicular lymphoma (Grade 1–3a), Ann Arbor stage I or II nodal, non-bulky disease ( less or equal to 7 cm) 2. PET-positive, measurable disease 3. No prior lymphoma-directed therapy Study details: This is an international, Phase III randomised clinical trial. Participants will be randomised 1:1 on either Surovatamig (6 doses over 12 weeks using a triple step-up dosing schedule) or to the standard of care treatment (Involved-Site Radiotherapy (24 Gy) with or without 6 doses of rituximab, according to each site's predefined standard). Participants will be followed up for 10 years after treatment to assess long-term outcomes. A total of 168 participants will be enrolled across Australia, New Zealand, the United Kingdom, Ireland and Nordic countries. Of these, 60 participants are expected from Australian and New Zealand sites. What is hoped from it: If successful, surovatamig could represent a new standard of care for patients with early-stage nodal follicular lymphoma that is highly effective, well-tolerated, non-radiation frontline option for patients with limited-stage FL.

  • The CAMAS Study: A Cross-sectional magnetic resonance imaging study on the myocardial effects of long-term anaerobic exercise using structure-function correlation

    The CAMAS study is a prospective, longitudinal observational cohort study examining the effects of long-term anaerobic exercise on myocardial structure and function. Adults with predominantly anaerobic gym training are compared with individuals undertaking predominantly aerobic exercise using cardiac magnetic resonance imaging (CMR) and electrocardiography. Blood samples are collected for exploratory molecular analyses where funding permits. Participants are followed annually for up to ten years to document cardiac diagnoses and cardiovascular events. The study aims to identify imaging-based phenotypes associated with anaerobic exercise and potential cardiovascular risk.

  • Using technology to ensure all patients presenting for physiotherapy receive an evidence-based physiotherapy exercise program

    This study aims to determine the feasibility of implementing strategies (PTX Implementation Strategy Tollkit) designed to encourage physiotherapists to use recommended sets of exercises (via freely available online software: physiotherapyexercises.com - PTX) and to provide patients with copies of their exercises. This study is a pilot study for a larger, nationwide trial that will test the effectiveness of the PTX Implementation Strategy Toolkit to promote the use of PTX to promote physiotherapists to (i) use recommended sets of exercises available through the PTX software, and (ii) provide patients with copies of their exercises.

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