ANZCTR search results

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

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32082 results sorted by trial registration date.
  • PuMPS Trial – Pulsatile Flow Impact on Postoperative Organ Function and Mortality – A Multicentre Randomised Controlled Trial in High Risk Cardiac Surgery Patients Requiring Prolonged Cardiopulmonary Bypass

    Cardiopulmonary bypass (CPB) is a critical component of most open-heart surgeries, allowing surgeons to operate on a still and bloodless field. However, its use is associated with a range of potential complications. Conventional CPB circuits produce non-pulsatile continuous flow (CF), which is the most widely adopted perfusion mode in cardiac surgery. Although CF maintains systemic circulation during cardiac surgery, it lacks the natural pulsatility of normal cardiac output. Pulsatile flow (PF) has been proposed as an alternative perfusion strategy that more closely mimics the natural arterial pulse generated by the heart. This project will compare the clinical-effectiveness, cost-effectiveness, and safety of pulsatile versus continuous flow cardiopulmonary bypass perfusion strategies. It is hypothesised that PF will improve a hierarchical composite measure of early postoperative organ dysfunction and all-cause mortality, without safety concern, compared to CF cardiopulmonary bypass.

  • The Effect of Red Light on Cognitive Function in Alzheimer's and Parkinson's Disease

    The prevalence of neurodegenerative disease is expected to increase globally over the coming decades. The most common neurodegenerative diseases are Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), with AD being the second leading cause of death in Australia. Early data suggests that photobiomodulation (PBM), or red light therapy, could offer significant benefits for patients with neurodegenerative disorders including AD and PD. PBM involves administering red and near-infrared light to the patient via a helmet, which activates the affected cells in the brain and recruits circulating stem and immune cells, ultimately promoting improved cell functioning and mitigating inflammation. This study research will assess whether red light therapy adminstered twice daily over a 12 month period is effective in improving cognitive function in AD and PD patients. Assessments are to be conducted 3 monthly and include a series of pen-and-paper cognition tests and motor function tests in PD patients.

  • A Study of Tirzepatide’s Role in Affective and Neurobiological Dynamics (STRAND) in Binge Eating Disorder

    This study investigates how tirzepatide affects brain activity in adults with binge eating disorder (BMI > 30 kg/m²). Tirzepatide (Mounjaro) is a GLP-1/GIP receptor agonist that lowers blood sugar and supports weight loss by regulating insulin and appetite. Although approved by the TGA for type 2 diabetes, weight management, and obstructive sleep apnoea, it has not been approved for binge eating disorder. Limited evidence suggests similar drugs may reduce binge-eating episodes. The study aims to examine changes in brain activity after 24 weeks of tirzepatide use and explore how daily and questionnaire data relate to these neurobiological changes.

  • Determining the effects of short-term resistance exercise on muscle growth responses prior to an acute period of step-reduction physical inactivity between females and males aged 18-25 years

    Exercise has been shown to reduce the prevalence of diseases such as cardiovascular disease, cancer, and Type II diabetes by regulating numerous systems that underpin skeletal muscle health. However, the intricacies of how exercise and physical inactivity impacts skeletal muscle are currently not fully understood. Thus, how exercise may play a role in fending off muscle wasting during an acute period of physical inactivity and whether biological sex may influence the effects of this is at the forefront of this project’s investigations.

  • A Sequential Multiple Assignment Randomised Trial (SMART) of personalised treatment for Bulimia Nervosa and Binge Eating Disorder - TailorED

    The TailorED study will test personalised interventions for bulimia nervosa and binge eating disorder. Participants who respond to established first line cognitive behavioural therapy guided self help treatment after four weeks (that is, participants whose objective binge eating episodes reduce by at least 70%) will be randomly allocated to: a) continue with a guide as they complete a further six weeks of cognitive behavioural therapy guided self help treatment, or b) to complete a further six weeks of cognitive behavioural therapy guided self help treatment with 'light contact' from a guide. Light contact means 5-10 minutes of non-clinical weekly contact via email, text message or phone to ensure participant has what they need to complete the program. Participants who are non-rapid responders to established cognitive behavioural therapy treatment (that is, objective binge eating episodes do not reduce by at least 70%) will be randomly allocated to continue with 16 weeks of either: a) an extended dose of guided cognitive-behavioural therapy guided self help treatment, or b) a transcranial magnetic stimulation treatment package, or c) a personalised psychotherapy treatment package.

  • STATEsMAN- A Phase 2 trial of SaciTuzumAb TirumotEcan (sac-TMT) in patients with MetastAtic castration resistant prostate cancer (mCRPC)

    This is a study to investigate whether Sacituzumab tirumotecan (an antibody-drug conjugate) will be an effective treatment for metastatic castration resistant prostate cancer participants. Who is it for? This study is for participants who have histologically confirmed adenocarcinoma of the prostate and who have progressed after being treated with Androgen Deprivation Therapy. Study Details: There is only one treatment available as part of this study, All participants who choose to enrol will be offered the same treatment. Sacituzumab tirumotecan will be given to participants via an infusion into a vein, once every 2 weeks. Participants will need to attend the treating hospital to receive this treatment. They will also undergo additional assessments like blood test, urine test, vital signs and CT/PSMA PET scans. Participants will be asked to undergo a PSMA PET/CT imaging at the time that they enrol in the study, then at 8 weeks, 16 weeks, 26 weeks and then at 12-weekly increments. Participants will also be asked to complete a quality-of-life questionnaire throughout the study. It is hoped the result of this study will be used to inform and design randomised phase III trials of sacituzumab tiromotecan.

  • Amino acid infusion versus placebo to determine if renal outcomes are improved after pulmonary organ transplantation

    Acute kidney injury (AKI) occurs in up to two-thirds of patients after lung transplantation, and renal replacement therapy is required in 10%. Amino acid infusion has been shown to reduce AKI in cardiac surgical patients. No trial of amino acid infusion has taken place in lung transplant. The AIRPORT study will determine feasibility of a larger definitive trial and investigate efficacy using markers of kidney function.

  • Treating first responder’s trauma symptoms following a recent critical incident: A Randomised Controlled Trial of Eye Movement Desensitisation and Reprocessing Protocol for Recent Critical Incidents (EMDR-PRECI) compared with Psychosocial Skills Training

    The aim of this study is to assess and compare the effectiveness of two different early -intervention treatments to reduce posttraumatic stress in paramedics following recent exposure to a traumatic event. The treatments that will be offered in the study are Eye Movement Desensitisation and Reprocessing (i.e., EMDR-PRECI) therapy and Psychosocial Skills Training. It is hypothesised that EMDR-PRECI will be superior to psychosocial skills training in reducing posttraumatic stress symptoms in relation to the recent critical incident, both immediately following treatment and at follow-up. Similarly, it is hypothesised that EMDR-PRECI will be superior to psychosocial skills training in reducing posttraumatic stress symptoms associated with other trauma events, both immediately following treatment and at follow-up.

  • Accuracy of robotically enhanced glenoid prosthesis positioning for total shoulder arthroplasty.

    The primary purpose of this study is to evaluate the effectiveness of a robotic-assisted approach in accurately placing the glenoid component during reverse total shoulder arthroplasty (rTSA) surgery. We aim to determine whether the use of the Mako robotic system can lead to better surgical outcomes compared to traditional patient-specific instrumentation methods. Our hypothesis is that robotic assistance will improve the precision of glenoid component placement, resulting in fewer errors and better functional recovery for patients. This study will assess key outcomes such as the accuracy of glenoid placement, the range of motion in the shoulder, and overall patient satisfaction after surgery. By understanding the benefits of robotic technology in shoulder surgery, we hope to enhance surgical techniques and improve long-term results for individuals requiring shoulder replacements. Participants in this study will contribute to groundbreaking research that could change how shoulder surgeries are performed in the future.

  • Feasibility, safety, and usability assessment of the Wellumio Axana portable magnetic resonance device for diagnosis of stroke

    - Neuroimaging for stroke diagnosis is limited to many Australians. - This study is a first-in-human study of a portable low field magnetic resonance imaging device named 'Axana' to diagnose stroke, ultimately in the pre-hospital and emergency department setting. - This study aims to test the feasibility and safety of this device in a stroke and healthy cohort in the hospital setting.

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