ANZCTR search results

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

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31407 results sorted by trial registration date.
  • Love Your Brain: A Digital Platform for Preventing Stroke [Stage 3: Randomised Controlled Trial]

    Stroke affects approximately 1 in 4 people in their lifetime, but is highly preventable through effective management of risk factors such as smoking, inadequate diet, high blood pressure and physical inactivity. Love Your Brain is a digital platform that aims to help people identify and manage their risk factors for stroke. There are three sequential stages of the Love Your Brain digital platform development and evaluation: Co-design (Stage 1), Implement (Stage 2), and Evaluate (Stage 3). This Stage 3 trial will evaluate whether Love Your Brain helps people identify and manage their risk factors, for example: by seeing a medical practitioner (GP or specialist) for assessment or management of their risk factors; having increased knowledge of risk factors and signs of stroke; and adopting healthy behaviours for controlling risk factors of stroke. We hypothesise that participating in Love Your Brain will improve stroke knowledge, leading to more discussions with healthcare professionals and prevention of stroke in Australia.

  • Evaluate the clinical performance of RESpiratory pathogen Point-Of-Care Testing in Emergency Departments (RESPOCT-ED study).

    The prospective observational study aims to evaluate the clinical performance of the ZiP-CoVx-P2 point-of-care test for detecting the SARS-CoV-2 virus in oro-naso-pharyngeal swab samples from patients presenting to the emergency department with respiratory infection symptoms. Participants will provide combined nose and throat swabs at a single time point, in addition to samples collected as part of routine clinical care (e.g., RT-PCR test and/or RAT test). These samples will be tested using the ZiP-CoVx-P2 point-of-care test within the emergency department. The performance of the ZiP-CoVx-P2 test will be compared to a lab-based RT-PCR test, focusing on clinical sensitivity and specificity. Furthermore, the clinical performance of the ZiP-CoVx-P2 test will be compared to the RAT test, and the study will also assess the potential impact of this test on emergency department care outcomes.

  • Regenerating lost jaw bone using patient specific 3D-printed resorbable polycaprolactone mesh versus a resorbable collagen membrane

    The objective of this randomized controlled clinical trial is to compare the efficacy of a patient specific 3D-printed manufactured medical grade polycaprolactone mesh with a collagen membrane that are loaded with particulate anorganic porcine bone mineral and autogenous bone in the reconstruction of alveolar ridge defects. Lay public hypothesis: We anticipate no significant differences when using customized 3D-printed polymer (polycaprolactone) mesh or the current technique of using animal derived collagen membranes trimmed chair-side to reconstruct lost jaw bone. The trial will report results for a extensive range of outcomes including; graft volume, post-operative recovery/morbidity, implant feasibility, histology, peri-implant parameters and patient reported outcomes

  • Understanding Voice Problems in Adults Who Survived ICU Stays with a Breathing Machine: A Study from One Hospital

    In hospitals, mechanical ventilation is crucial for critical conditions, commonly initiated in intensive care units through intubation. Unfortunately, about half of patients undergoing this process may suffer acute laryngeal injury, with limited information on its impact on post-ventilator speech. Our study focuses on how ventilator use for over 48 hours affects the voice in adult ICU patients. Utilising the vocal handicap index (VHI-10) and voice-related quality of life (V-RQOL), we measure the impact on voice and overall well-being at 8 weeks following ventilation. The VHI-10, a 10-question questionnaire, assesses the impact of voice problems, with scores above 11 indicating a significant impact. The V-RQOL questionnaire gauges the burden of these issues. Our findings are crucial for identifying predictive factors, enabling early intervention strategies like check-ups, speech therapies, and psychological support for those with voice issues, significantly improving their well-being.

  • Pilot Study of a Mental Health Intervention for children and adults with Developmental & Epileptic Encephalopathies (DEEs)

    Developmental and Epileptic Encephalopathies (DEEs) are the most severe group of epilepsies. Patients have intellectual disability and a range of mental health disorders in more than 70% of individuals, including mood disorders, behavioural problems, psychosis, and autism spectrum disorder; which often go undiagnosed and untreated. Current therapies for epilepsy aim to control seizures but do not address the comorbidities in patients with DEEs. As children with DEEs grow, their mental health comorbidities often eclipse seizures as the problem of greatest concern. This study will pilot the first mental health clinical intervention for children and adults with DEEs. A psychological intervention (MICE) successfully pioneered in the UK has been adapted for adults and children with DEEs (MICE-DEE) to test the feasibility in a pilot study of 40 patients with DEEs compared with 40 patients receiving assessment enhanced standard care.

  • Evaluating a telehealth exercise model of care for adults with Cystic Fibrosis: A feasibility randomised controlled trial

    Physical activity and exercise are important in the treatment of Cystic Fibrosis (CF) and delivering exercise programs via telehealth for people with CF may minimise the risk of cross infection and increase access to exercise. We asked adults with CF what they wanted to include in a telehealth exercise program and together we designed a new telehealth exercise model of care which will be tested in this project. Adults with CF from the Alfred Hospital will be invited to be part of this study which will run for 12 weeks. Participants will be put into an intervention or a control group by chance (at random). Participants in the control group will continue with their usual care such as appointments with their health care team. Participants who are allocated to the intervention group will receive their usual care and take part in the new telehealth model of care. In this intervention group, participants will be given the choice of attending a live supervised exercise group online, or completing an exercise program which they follow themselves with one-to-one check in sessions via telehealth with a Physiotherapist. The main outcome of this study will be to understand whether it is feasible to deliver a telehealth exercise model of care for people with CF.

  • Sub-Protocol #1 of Umbrella Protocol Study: Limit of Blank Characterization of Vancomycin Biosensor Nutromics Device.

    This is a prospective study with an Umbrella Protocol, where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enrol up to 50 healthy participants in the community. The Sub-Protocol described in this registration form is Sub-Protocol #1: Limit of Blank (LoB) Characterisation of Vancomycin Biosensors on the Nutromics Sensor Device across a 24-hour period.

  • The costs of complications after lung resection surgery

    There has been recent interest in understanding the costs associated with post-operative complications of adult non small cell lung cancer (NSCLC) patients undergoing lung resection. Accurately defining the costs of complications allows institutions to make more informed decisions as to what these costs are, and then implement strategies to reduce the incidence of complications, thereby mitigating hospital costs. The aim of this study is to provide a detailed costs analysis for patients who undergo any type of lung resection. Who is it for? You may be eligible for this study if you are an adult with NSCLC who underwent any type of lung resection. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a radical cystectomy at the Austin Hospital between 1 January 2011 and 31st December 2023. It is hoped that this research will help to provide a better understanding of the costs associated with any type of lung resection surgery.

  • Combined High-Intensity Interval Training for Adults with Disorders of Gut-Brain Interaction

    This will be a pilot trial assessing the feasibility, safety and efficacy of combined high-intensity interval training (C-HIIT) for people with disorders of gut-brain interaction (DGBI). Participants will be recruited from the local Newcastle and Hunter region district (NSW). After consent is provided, participants will undergo testing (including cardiopulmonary exercise testing, body composition, bloods, stool sample, functional strength and a series of questionnaires to capture mental health, gastrointestinal symptoms, overall wellbeing and dietary habits) and then be asked to maintain current dietary and physical activity habits for 8-weeks and then come in to repeat the testing in week 9. Following this, participants will undergo 8- weeks of 3 x weekly, 30-minute C-HIIT sessions, supervised by an accredited exercise physiologist or exercise science student. Participants will then repeat the same testing and will be invited to participate in an interview to better understand their experience with the program.

  • Acceptability of balance-enhancing indoor shoes compared to minimalist indoor shoes in older women: a randomised crossover trial

    The primary objective of this project is to determine if balance-enhancing shoes are more acceptable than minimalist shoes in older women. The secondary objective is to determine if balance-enhancing shoes are more effective at improving balance performance and perceived risk of falls than minimalist shoes in older women. This study will utilise a randomised crossover study design. Participants will be women aged 65 years or older who are free from any conditions which may negatively impact their balance or ability to walk independently. Participants will be randomly allocated to two shoe conditions and will be required to wear the shoes from each condition for six weeks before crossing over to the alternate condition. Participants will attend the university for assessments over four sessions. We hypothesize that participants will find the balance-enhancing indoor shoes more acceptable than the minimalist indoor shoes

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