ANZCTR search results

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

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31632 results sorted by trial registration date.
  • Arthroscopic administration of local anaesthesia in the posterior joint capsule after posteromedial meniscal repair and ACL reconstruction - a prospective randomised controlled trial

    The objective of this RCT is to evaluate whether arthroscopically administered local anaesthesia in patients undergoing an anterior cruciate ligament reconstruction and posteromedial meniscal repair results in significant effects on acute pain relief and lower consumption of oral analgesia.

  • Assessing the Impact of Virtual Reality on Stress and Anxiety Levels in Patients Admitted to Intensive Care Units

    In intensive care units (ICUs), patients are subject to many treatments, which may limit mobility and result in sensory overload and disorientation. More importantly, they have reduced social interaction, which can result in substantial emotional distress. The extended ICU stay often results in long-term psychological consequences, including anxiety, depression, and post-traumatic stress disorder. Although medications can be used, there is increasing uptake of non-pharmacological interventions (i.e. other than medications) to manage these stressors, with Virtual Reality (VR) emerging as a promising solution. VR offers immersive, interactive environments that temporarily distract patients from their surroundings, promoting calmness and emotional regulation. While VR has been used in healthcare (e.g. medical training, pain distraction), it has not been used in ICU. Early studies suggest that VR may reduce stress and anxiety, but its implementation is not standardised, making it difficult to make a clear stand. As such, a structured evaluation of VR’s therapeutic potential in ICUs is needed. This study will help develop standardised VR protocols for ICUs and support future innovation by involving early-career researchers across health, design, and technology. Findings will be shared at conferences and published in high-impact journals to guide future clinical adoption and large-scale implementation.

  • Investigating the efficacy and tolerability of CPAP administered through a novel interface

    Myofunctional Research Company have recently developed a novel CPAP connection to their MyOSA S1H oral device. Airflow from a CPAP machine can now be ported into the oral device while a patient with OSA is sleeping. Initial trials in 4 CPAP-compliant OSA patients (during wakefulness) have shown that is possible to deliver CPAP at different pressures without leaks. Furthermore 2/4 of these patients reported that they found it so comfortable that they wanted to take it home immediately after the trial (indicating a potential patient preference over their existing interface). However, to date the efficacy and tolerability of this mode to deliver CPAP has not been tested in OSA patients during sleep. The aims of this study are therefore to; 1. Assess patient comfort and tolerability using the MRC device and compare it to the comfort/tolerability when the patients use their existing nasal/oronasal mask 2. Assess the therapeutic pressure requirement using the MRC device and compare it to the pressure required when the patients use their existing nasal/oronasal mask. We hypothesize that CPAP provided via the MyOSA S1H oral device will be more tolerable and require a lesser therapeutic CPAP level compared to a regular CPAP interface.

  • ALLG CLL10/CLLRT2: A prospective, open-label, randomised, multicenter phase-III trial to evaluate the efficacy of pirtobrutinib and epcoritamab compared with R-(mini)-CHOP for treatment of patients with Richter Transformation

    The primary purpose of this study is to evaluate if treatment with epcoritamab plus pirtobrutinib will improve outcomes for patients than standard of care R-(mini)-CHOP in patients with previously untreated Richter transformation. Who is it for? Patients over 18 with confirmed CLL and diagnosis of Diffuse Large B-cell Lymphoma (DLBCL)-type Richter's transformation (RT) who have not received prior treatment for RT. Study details This is a randomized, open-label, phase-III study. Arm A consists of patients that will receive standard of care (SOC) R- CHOP or R-(mini)-CHOP. R-CHOP regimen consists of cyclophosphamide, doxorubicin, vincristine, rituximab, and prednisolone. Given in 6 cycles, with each cycle being 21 days. Arm B consists of patients that will receive epcoritamab plus pirtobrutinib. Given in 12 cycles (each cycle is 21 days). Additional treatments will be stem cell transplant and radiation if deemed necessary by treating physician. There will be a cross-over option. If the standard treatment doesn't work, patients can switch to the other treatment arm. To monitor treatment response and safety, several diagnostic tests will be performed, including Positron Emission Tomography (PET)-Computed Tomography (CT) scans, bone marrow biopsies, electrocardiograms (ECG), and laboratory evaluations. These tests help assess disease progression, organ function, and potential adverse effects. It is hoped this research will determine if epcoritamab and pirtobrutinib can improve outcomes for patients previously untreated for RT.

  • ALLG AMLM30/EVOLVE II: Randomised study to assess revumenib in combination with azacitidine + venetoclax in adult patients with newly diagnosed NPM1-mutated or KMT2A-rearranged Acute Myeloid Leukaemia (AML) ineligible for intensive chemotherapy

    The primary aim of this study is to assess the effectiveness and safety of revumenib combined with azacitidine and venetoclax in treating adult patients with newly diagnosed acute myeloid leukemia (AML) who have NPM1 mutations or KMT2A rearrangements and are ineligible for intensive chemotherapy. This patient population has an unmet clinical need for effective therapy. Who is it for: Adult patients, over 18 years of age, with newly diagnosed acute myeloid leukemia (AML) who have NPM1 mutations or KMT2A rearrangements and are ineligible for intensive chemotherapy. Study details: This is a randomised trial to determine if adding a new drug, revumenib, to the existing treatment with azacitidine and venetoclax will improve patient outcomes. Participants will be randomly divided into two groups. One group will receive the new combination of revumenib, azacitidine, and venetoclax, while the other group will receive azacitidine and venetoclax with a placebo. The study will involve multiple cycles of treatment, with each cycle lasting 28 days. After each cycle, a response will be assessed to evaluate the continuation of treatment. It is hoped that this research will determine if the addition of a new drug, revumenib, can improve survival rates and patient outcomes in this AML patient population.

  • Examining novel digital single-session interventions addressing risk factors for self-harm and suicidal ideation in young people

    The present study is a pilot feasibility trial, aiming to evaluate the acceptability and feasibility of four novel digital single-session interventions aimed at addressing risk for self-injurious thoughts and behaviours in young people. This trial aims examine the acceptability of the novel interventions, and adherence the treatment protocol developed to encourage skill use and engagement after the session. Consistent with the aims of a pilot trial aiming to establish evidence for the study methods and procedures that are needed to inform a larger-scale trial, this study seeks address the following research questions: 1. Are the D-SSIs acceptable to adolescents and do they expect to benefit from them? 2. What role does ‘free choice’ of intervention have in treatment completion versus recommendation by a clinician? 3. How well do young people adhere to the post-intervention protocol (feasibility), and do those who had brief, warm follow-up contact have higher adherence to the post-intervention protocol? 4. What individual- and environmental factors are associated with adherence to the treatment protocol (both treatment completion and post-intervention skill use)? 5. What recruitment pathways most effectively enable us to reach and recruit adolescents who self-harm?

  • Effectiveness of Stroke Thrombectomy Access in Cancer on Home Outcomes and decreased Morbidity: STAY-HOME-Cancer Phase II trial

    The aim of this trial is to deliver high quality evidence of the effectiveness of Stroke Thrombectomy in patients with cancer. Who is it for? You would be eligible if you are 18 years or older, have acute ischemic stroke within 24 hours of onset, and moderate or severe stroke severity, a low pre-stroke disability, and large vessel occlusion on brain imaging and active cancer. Study details You would have clot extraction with a catheter inserted into blood vessel from the groin and navigate up to the brain. This research will help to understand if clot extraction for patients with active cancer and large vessel occlusion will help patients to resume cancer therapy

  • Implementing a collaborative prescribing, pharmacist-nurse-led adult diabetes clinic within the Robina Health Precinct: A pilot study.

    Despite improvements in medications, nutrition, information technology and digital health solutions, the management of patients with diabetes (DM) remains suboptimal. This increases patient risk of death and further sickness, increasing strain on the health care system and economy. Whilst Gold Coast Hospital and Health Service runs a monthly diabetes clinic at the Robina Health Precinct (RHP) with an endocrinologist, current referrals to this service have outstripped the clinic capacity to see patients in a timely manner. International literature suggests pharmacist-led DM management services are a practical solution to addressing suboptimal management of DM. Here, pharmacists work collaboratively with endocrinologists and multidisciplinary teams to optimise doses of evidence-based medications to improve diabetes control. Since 2023, the RHP has been running a collaborative prescribing pharmacist nurse led DM clinic to support the endocrinologist clinic and increase patient access. We plan to study how feasible it is to run this collaborative prescribing pharmacist-nurse led clinic compared to the usual endocrinologist clinic, with the aim to develop, implement and evaluate this model of care in a future larger, multisite study.

  • Clinical audit of the long-term use of oral ketamine for management of chronic pain

    Oral ketamine has been used for many years as a treatment for chronic pain. Evidence supports the efficacy and relative safety of short to medium term use ( one year) for patients with intractable chronic pain. The aim of this study is to carry out an audit of these patients to assess the safety and efficacy of long-term oral ketamine therapy

  • Loneliness, social isolation and chronic illness: A randomised controlled trial of a remote-delivered psychological treatment for older adults with co-occurring loneliness and chronic illness.

    The purpose of this study is to determine whether a Loneliness-enhanced Chronic Conditions Course is effective in improving loneliness in older adults with chronic illness. Who is it for? You may be eligible for this study if you are an adult over the age of 60 who has been diagnosed with a chronic illness (e.g. arthritis, diabetes, cancer, osteoporosis, etc.) and are experiencing loneliness. Study details People in the study are randomly placed into two groups: one starts the Chronic Conditions Course right away, while the other waits three months before beginning. The Course includes five lessons, delivered over 8-weeks. The lessons are all delivered via the internet, and provide information and skills on improving emotional wellbeing, loneliness and quality of life. While working through the Course, people are provided with support from a clinician. Participants will be asked to complete questionnaires across the study. It is hoped that this research will help determine if the Loneliness-enhanced Chronic Conditions Course is helpful in improving loneliness in older adults with chronic conditions.

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