ANZCTR search results

The purpose of this study is to gain first information on the safety and performance of the LivIQ leadless pacemaker system and to inform the preparation of procedures, workflows, and optimized device training for a subsequent international pivotal study investigating the LivIQ system. Its objective is to determine preliminary safety and product performance of LivIQ and understand the implantation experience with LivIQ from implanters’ perspective.

This research project, titled "Evaluation of a ‘culturally tailored iSupport model’ for carers of people with dementia", is a pragmatic, multi-centre, type 1 hybrid effectiveness-implementation randomised controlled trial (RCT). The study aims to evaluate the effectiveness, implementation strategies and cost-effectiveness of a culturally tailored iSupport model intervention for CALD carers of people living with dementia, compared to a usual care group. The intervention comprises bilingual and bicultural facilitator support, carer support groups in their preferred language, dementia care education using the iSupport program in their language, and feedback mechanisms on care services. We hypothesise that carers who receive the culturally tailored iSupport model will experience better health and quality of life, and their relatives with dementia will also have an improved quality of life, compared to those receiving usual care. The primary outcomes for carers include changes in their mental and physical health-related quality of life as measured by the SF-12, while the primary outcome for care recipients is their quality of life as rated by carers using the QOL-AD-Proxy

The study was motivated by the need for improving time-efficiency of the assessments within the local health district and across Australia, Hypothesis 1: clinician time spent conducting clinical interviews and clinical documentation for patients presenting with mental health problems is shorter in the intervention group compared to the control group. Hypothesis 2: the intervention (mental health assessment using self-reported clinical information by patients using touchscreen devices) is acceptable to clinicians and patients.

• To assess changes in axial length of myopic eyes to short-term (60 mins) wear of multifocal and myopia control spectacle lenses. • To assess the wearability to short-term wear of multifocal and myopia control spectacle lenses. Study Hypothesis: The changes in length of an eye when wearing prototype multifocal lenses are no different than when wearing commercially available lenses for controlling shortsightedness. Prototype multifocal lenses provides the same visual comfort and wearability as commercially available lenses for controlling shortsightedness.

This study aims to test the effectiveness of a new mobile app, called the Bud App, developed specifically to support international students in Australia. International students often face unique challenges such as academic pressure, cultural adjustment, loneliness, and limited access to mental health support, which can increase their risk of distress and suicidal thoughts. The Bud App was co-designed with international students to provide culturally relevant, practical support through interactive tools and stories from other students who have navigated similar experiences. The app includes evidence-based activities that help students manage difficult emotions, shift unhelpful thoughts, reflect on their values, and build coping skills. It also features a mood tracker that recommends tools based on how the student is feeling, as well as a brief course to help students learn how to support peers who may be struggling. The main goal of the study is to evaluate whether using the Bud App leads to greater decreases in psychological distress compared to receiving general mental health information. We will also examine whether the app improves help-seeking intentions, reduces feelings of burdensomeness and thwarted belongingness, enhances emotion regulation, improves mental health literacy or decreases suicidal thoughts.

This study aims to assess the efficacy of Total Neoadjuvant Therapy in Early-Stage Low Rectal Cancer. Who is it for? You may be eligible for this study if you are a male or female, aged 18 to 85 years of age, with histologically confirmed rectal adenocarcinoma, lowest part of tumour within 10 cm of anal verge on MRI or sigmoidoscopy, cT2-T3, N0, M0 rectal cancer based on clinical staging, and no extramural vascular invasion (EMVI) or threatened Mesorectal fascia (MRF) on MRI. Study details Participants will undergo Total Neoadjuvant Therapy (TNT) for early-stage low rectal cancer, beginning with six weeks of long-course chemoradiotherapy, including modulated radiation therapy and 5-FU infusion or capecitabine chemotherapy. Patients then take a 2-4 week break before undergoing up to 16-18 weeks of consolidation chemotherapy. Patients begin receiving 4 cycles of mFOLFOX6/FOLFOX over 8 weeks or 3 cycles of CAPOX over 9 weeks. A first response assessment (comprising rectal exam, flexible sigmoidoscopy and MRI pelvis) determines further treatment adjustments (which may include early termination of chemotherapy or completion of the full course), followed by a second response assessment if necessary. To ensure real-world applicability, chemotherapy regimen variations are permitted within set constraints, requiring at least 4 cycles of FOLFOX (up to 8) or at least 3 cycles of CAPOX (up to 6). Additionally, dose modifications or early discontinuation due to toxicity or poor tolerance remain at the treating team’s discretion. This flexible approach aims to optimise treatment while accommodating individual patient needs. During and after the intervention, participants will be assessed utilising modalities such as rectal exam, flexible sigmoidoscopy and MRI pelvis. Subsequent surveillance will also include blood tests, CT scans and colonoscopies. It is hoped that this research will demonstrate a structured yet adaptable TNT approach to improve outcomes for patients with early-stage low rectal cancer, laying the foundation for a new standard care option in these patients.

• Purpose: To test a new method of jaw reconstruction that uses a custom implant in combination with a thin layer of bone with its own blood supply (a flap). This small flap, in combination with the implant is designed to allow for new bone to grow. The implant is designed to dissolve over time as it is replaced by new bone. As this is a new method, the main purpose of this trial is to assess for safety and tolerability of the implant. • Who is Running It? The Plastic and Reconstructive Surgery Department at Princess Alexandra Hospital, under the sponsorship of Metro South Health • Where & How Long? The surgery as well as follow up appointments will take place at the Princess Alexandra Hospital over a total duration of three years. • Ethics Approval: Approved by the Metro South Human Research Ethics Committee.

Study Title: The NIKI-C Study - A study of pharmacokinetics of nebulized ketamine in post-operative cardiac surgery patients in intensive care unit: A phase 2, single site, prospective, interventional, open-label pharmacokinetic study. A minimum of 20 patients will be consented and enrolled to receive a single dose of nebulized ketamine 0.75mg/kg (ideal body weight). Over a 2 hour sampling period 8 blood and 2 urine samples will be collected. Assessments will be conducted to report feasibility, pain, tolerance, concomitant sedatives and analgesia as well as monitoring for study specific adverse events. The hypothesis of the study are that 1. Plasma blood levels of nebulized ketamine in ICU post-operative cardiac surgery patients is adequate to provide analgesia. 2. Nebulized ketamine is not associated with any serious adverse events in the ICU post-operative cardiac surgery patients.

Obesity is a known risk factor for developing MS and a known risk factor for increased disability in established MS. We know that a high proportion of the MS population is living with extra body weight which is a modifiable lifestyle factor. The evidence tells us that if we lose weight this will affect changes beyond body size alone. However, losing weight and maintaining it is difficult and needs the support of a healthcare team to aid behaviour change. We will use a tested randomised controlled trial design to help people living with relapsing-remitting MS to make positive changes to their eating patterns, exercise routine and overall self-management of their MS. Our lifestyle approach includes nutrition, exercise and psychology elements and compares them with usual care delivered by an MS nurse. All strategies will be provided via a telehealth platform. The main hypothesis is that a novel, interdisciplinary approach to an individualised lifestyle intervention will result in greater weight loss compared to usual care. We also hypothesise that the lifestyle approach will be both feasible, acceptable and result in greater improvements to symptoms of MS (tertiary outcome).

This is a prospetive, exploratory, randomised, controlled feeding study looking at whether an anti-inflammatory diet can augment treatment response to 5aminosalicylates (firs tline treatment) in ulcerative colitis. Diet may play a role in developing ulcerative colitis (UC) but we don’t know whether diet can be used to treat ulcerative colitis (UC). The aim of this study is to investigate whether the MAID diet can improve response to medications and quality of life for patients with UC. We will also look at whether diet can also help good gut bacteria, produce anti-inflammatory chemicals and reduce gut leakiness.