ANZCTR search results

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.

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?

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

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.

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

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.

This study is a follow-up to the original CAESAR study to further establish a stronger relationship between coronary artery calcification (CAC) and osteoporosis with the use several scans. It involves a two-part set-up, including an invitation for patients to return for a questionnaire to be asked in-person, and a comprehensive skeletal and cardiovascular assessment. The aim of this study is to identify pre-existing or new comorbidities for the patient group, medication compliance and patient well-being. Additionally, we aim to re-establish the effectiveness of anti-resorptive treatment and side-effect profile of these medications, whilst also establishing a correlation between changes in CAC score over time and changes in bone mineral density (BMD) over time. It is hypothesised that CAC may alter the efficacy of anti-resorptive therapy in patients with osteoporosis due to shared metabolic pathways, and that due to poor efficacy of these drugs, different therapies such as an anabolic therapy may be more effective.

Research Aims: 1. To determine the effectiveness of individual Triple P Online System (TPOS) variants (Family Transitions Triple P Online, Stepping Stones Triple P Online, Resilience Triple P Online and Teen Triple P Online) on child and parent outcomes. 2. To examine the relationship between pre-intervention characteristics (moderators) and program outcomes (child and parent effects, module completion, and program satisfaction). The Triple P Online System has been disseminated in Australia since 2014 and randomized controlled trials have shown that the system is effective in improving parenting practices, enhancing parenting efficacy and reducing child behavioural and emotional problems. Little is known however about its efficacy in a practice-as-usual context and about parents’ interaction with the program and the mediators and moderators that influence program outcomes. This study will take advantage of a roll-out of TPOS within Australia, funded for dissemination to all eligible Australian parents by the Commonwealth Government, to collect data on effectiveness in a practice-as-usual context. A mix of routinely collected TPOS process data, mapped against parent and child characteristics and parent questionnaire responses pre, during and post program completion will track program effectiveness and allow rapid identification of specific areas for improvement.

SAGE is a pragmatic cluster randomised controlled trial to reduce the use of high-risk medicines in people with chronic back and/or neck pain. The SAGE intervention provides GPs with support to help their patients with chronic back and/or neck pain to safely reduce or cease the use of high-risk medicines (benzodiazepine, gabapentinoid or opioid) for pain. It will be compared to the usual care control group. We hypothesise that: i) more patient-participants treated by study GPs in the SAGE intervention will have their target high-risk medicine ceased than patient-participants in the usual care control group; ii) patient-participants receiving care from study GPs in the SAGE intervention will experience fewer medicines-related harms and have no worse clinical outcomes, including pain, function and quality of life, than patient-participants in the usual care control group; iii) the SAGE intervention will be cost-effective (concerning medicine dispensations and health care use) compared with usual care control group.

This study will investigate whether combining computerised cognitive training (CT) with intermittent theta burst stimulation (iTBS), a non-invasive brain stimulation technique, can improve memory, executive function, and brain function in older adults with mild cognitive impairment (MCI). Participants will be randomly allocated to receive CT with iTBS, CT with sham (inactive) iTBS, or a waitlist control. We hypothesise that CT combined with iTBS will lead to greater improvements in cognitive function and brain activity compared to CT alone or no intervention.