ANZCTR search results

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

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33311 results sorted by trial registration date.
  • Buprenorphine vs tapentadol for pain management post haemorrhoidectomy: an open-label randomised clinical trial (BOLT)

    Studies have shown that 20-40% of patients experience severe pain following haemorrhoidectomy surgery, often requiring opioid analgesics. Although various pain management strategies have been explored, no universally accepted approach has emerged. Emerging opioids have shown great promise for postoperative pain after haemorrhoidectomy surgery. Tapentadol and buprenorphine are both atypical opioids with multimodal action and reduce gastrointestinal side effects due to their opioid sparing effects, that may be beneficial for patients after haemorrhoidectomy surgery. However, these two opioids have not been directly compared, emphasising the need for research to inform safe prescribing. This RCT directly aims to directly compare the efficacy of buprenorphine and tapentadol (primary: AUC bowel motion pain) and safety (AEs, constipation), informing safer prescribing to accelerate recovery, reduce opioid loads, and mitigate population-level harms in opioid-vulnerable surgical cohorts.

  • Can a computer program help identify stroke patients faster in the Emergency Department? A study of automated triage note analysis.

    SCANSTROKE study will assess the utility of a software tool to identify ED patients suitable for acute stroke treatment. The tool will assess language present in the documented notes by ED triage clinicians. This will be compared against whether patients were actually activated as a stroke code at the time and whether they ended up having a stroke as their final diagnosis.

  • GIM-407 Phase 2a Pilot Study in Adults with Coeliac Disease

    The purpose of this research study is to investigate how safe GIM-407 is when it is administered to adult participants with Coeliac Disease and how this investigational treatment is absorbed and processed by the human body. This study will also look to see if any indicators of the disease are affected by GIM-407. Participants will receive either GIM-407 or a placebo, and be asked to drink a slurry containing a measured amount of gluten each day for several weeks (this is called a 'gluten challenge'), under close medical supervision. The gluten challenge is done to monitor how their body responds to gluten while they are receiving the study treatment.

  • A clinical safety trial evaluating an amended shortened version of the apomorphine pen initiation recommendations in people with Parkinson's disease.

    This pilot safety clinical trial proposes an amended shortened version of the apomorphine pen initiation for patients with no prior history of PD medication induced nausea. This streamlined approach has the potential to significantly improve the initiation process for PD patients, making it quicker without compromising safety. The initial dose will be in line with current recommendations of 2mg (0.2mL) without the presence of an antinausea medication. The dose will be slowly titrated as required until the optimum dosage has been reached. This study will provide valuable insights and pave the way for protocol adjustments that benefit both patients and healthcare providers.

  • A Safety and Feasibility Evaluation of a Novel Bronchoscopic Ultrasound Scope: The NOVUS Study - Phase 2

    This study is a prospective, single-arm, single-centre, first-in-human clinical investigation evaluating the safety and feasibility of a new bronchoscopic ultrasound system for the survey and sampling of mediastinal and hilar lymph node stations in patients with confirmed or suspected lung cancer. Who is it for? You may be eligible for this study if you are aged 21 years or older and have a confirmed diagnosis of lung cancer or have been assessed by the Investigator as having a high clinical suspicion and indicated for staging lung cancer. Study details In this Phase 2 study, all participants will be sedated and undergo a standard bronchoscopic procedure. Survey and Sampling of lymph node stations will be conducted using the investigational device. Follow-up visits will be at 1-week, 30 days and 3 months post-procedure (chart review only). All participants are monitored for adverse events and outcomes related to the procedure and device through 30 days post procedure. It is hoped that findings from this study will help researchers and clinicians determine whether use of this new system is safe and feasible.

  • A memory-based digital intervention (MemFlex) for young people struggling with low mood

    Here, we aim to evaluate the app-version of a simple, memory-based program MemFlex. A paper version of the program has been previously evaluated in young people and was demonstrated to improve symptoms of depression and ameliorate cognitive difficulties that predict prognosis and impede the efficacy of psychological therapy (Mirabolfathi et al., 2024). Our key aim is to determine the acceptability of the app-based delivery of MemFlex to young people, as well as assess whether the program may improve symptoms of depression and autobiographical memory bias, known to be a cognitive predictor of mental ill-health.

  • Assessing the effectiveness after a less restrictive, faster rehabilitation program following a minimally invasive (“key-hole”) lumbar discectomy for a herniated disc.

    This study is testing whether people recover just as safely, or better after a less restrictive, faster rehabilitation program following a minimally invasive (“key-hole”) lumbar discectomy for a herniated disc. Endoscopic surgery uses smaller cuts than traditional microdiscectomy and may let patients return to normal activities sooner, but rehabilitation advice is often still based on cautious programs designed for more invasive procedures. Participants will follow one of three pathways: microdiscectomy with a standard rehabilitation program, or endoscopic discectomy with participants being randomly assigned to either a standard rehabilitation program or a faster, self-guided approach. To prevent expectations affecting their self-reported questionnaires, participants having endoscopic surgery won’t be told which rehabilitation plan they’re on. Recovery will be checked every two weeks for 12 weeks, and then again at 1 and 2 years after surgery, using questionnaires, patient-reported measures, and simple physical tests at the clinic and/or at home. The main goal of this study is to see if faster rehabilitation helps a same number or more patients to achieve minimal clinically important differences in the Oswestry Disability Index by 12 weeks post-surgery for patients undergoing endoscopic discectomy.

  • Assessing the effectiveness of a less restrictive, faster rehabilitation program for patients undergoing anterior-to-psoas (ATP) lumbar fusion surgery.

    This study looks at whether people recover better after anterior-to-psoas (ATP) lumbar fusion surgery when they follow a less restrictive rehabilitation plan. Although ATP is a minimally invasive technique that may allow earlier movement and return to activity, rehabilitation advice is often still based on older, more cautious programs designed for more invasive surgery. Before surgery, participants will be randomly assigned before surgery to either a standard or an accelerated rehabilitation program. A multidisciplinary clinical team will support recovery in both groups, with wound healing and patient safety prioritised throughout. Recovery will be checked every two weeks for 12 weeks, and at 1 and 2 years after surgery using questionnaires, patient-reported outcome measures, and functional tests. The primary objective of this study is to determine whether the accelerated rehabilitation group results in equal or more patients achieving minimal clinically important differences in Oswestry Disability Index by 12 weeks post-surgery for patients undergoing ATP lumbar fusion surgery.

  • Springfield Healthy Hearts Pop-Up Screening: Feasibility and Risk Identification

    This study will evaluate whether a pop-up “Heart Health Check” can be used to feasibly and acceptably screen adults in the Springfield community for previously unrecognised cardiometabolic risk. Adults aged 18 years and over who attend a pop-up screening session will complete a brief questionnaire and screening measures including glycated haemoglobin, blood pressure, body measurements, and liver health assessment using FibroScan, and will receive a printed summary of their results. Participants will also be invited to complete a brief online follow-up questionnaire 2 weeks later about any health-related actions they took after screening, how useful they found the screening, and any barriers to follow-up. The study is expected to provide early evidence about the feasibility and acceptability of this community screening model, the burden of cardiometabolic risk identified, and whether receiving personalised screening results prompts short-term follow-up action. It is hypothesised that the pop-up screening model will be feasible and acceptable and will identify a meaningful burden of previously unrecognised cardiometabolic risk in this community

  • Using PET-CT imaging to explore new ways of identifying and monitoring endometriosis

    Currently, endometriosis is diagnosed by invasive surgery (laparoscopically followed by histopathology), or severe disease may be detected by imaging modalities (ultrasound or MRI). No early, non-invasive diagnostic test exists for endometriosis. This prospective study aims to explore the use of fluoro-17beta-estradiol PET/CT imaging as a potential non-invasive, early diagnostic test for endometriosis relative to surgical/histological outcomes. We hypothesize that PET/CT imaging with fluoro-17beta-estradiol has potential application in the diagnosis of endometriosis.

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