ANZCTR search results

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

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32814 results sorted by trial registration date.
  • Effects of systematically developed health warning labels for alcohol containers on drinking intentions and behaviours among Australian adult regular drinkers.

    Alcohol use ranks among the top five contributors to global disease burden, yet the public has relatively poor awareness of the wide range and seriousness of alcohol-related harms. Following successful use in tobacco control, health warnings on alcohol containers have been proposed as a potential alcohol harm reduction measure. This study aims to investigate the efficacy of alcohol health warning labels on drinking intentions and behaviours among Australian adults who drink alcohol regularly. Additionally, the study aims to investigate the degree to which the format of the warning labels influence health warning efficacy. The five alternative warning label scenarios to be tested via the online experiment include: two control groups that represent the usual situation (A) no warning label; and (B) DrinkWise voluntary warning labels; and systematically developed (C) text-only warning labels; (D) text & pictogram warning labels; and (E) text & photograph warning labels. The findings from this study will contribute to the evidence base available for advocacy and forthcoming policy deliberations on alcohol warning labels.

  • The IDEAL-EX Project: Ideal Exercise for Cardiometabolic Risk in Older Adults

    The IDEAL-EX Project will compare the effect of combined high-intensity interval training (HIIT) and progressive resistance training (PRT) against HIIT alone for improving cardiometabolic risk factors in older adults. Both groups will attend UNSW and receive supervised exercise sessions, 3 non-consecutive days a week over 12 weeks. The HIIT+PRT group will perform 20 minutes of HIIT followed by 4 high-intensity PRT exercises. The HIIT group will perform 20 minutes of HIIT only and be instructed to avoid PRT during the intervention. Study Importance: Investigating whether a novel, combined high-intensity aerobic and resistance training exercise program is safe, feasible and more efficacious at improving muscle strength than HIIT alone in an older adult population with moderate risk of cardiometabolic disease. We aim to build on the emerging literature that high-intensity aerobic and resistance exercise can be safe as well as effective in these individuals. The IDEAL-EX Project may also help to determine whether HIIT+PRT can deliver superior improvements to cardiorespiratory fitness and cardiovascular risk factors (such as blood pressure, cholesterol levels and blood glucose levels) compared to HIIT alone for older adults. The results will aim to guide clinicians and professional organisations on the use of alternate exercise prescription for older adults with cardiometabolic disease risk. With adults reporting less time to exercise, this research aims to determine if a low-moderate volume HIIT exercise program is as effective as HIIT+PRT.

  • Evaluating outcomes of above-knee versus below-knee nailing of tibial shaft fractures.

    Tibial shaft fractures are commonly treated with intramedullary nailing. Anterior knee pain is an often reported complication after this surgery. The aetiology of anterior knee pain remains unclear, but the surgical approach may play an important role. The central aim of this study is to conduct a pilot randomised controlled trial (RCT) investigating the influence of surgical approach (suprapatellar nailing (SPN) versus infrapatellar nailing (IPN)) on tibial shaft fractures treated with intramedullary nailing, via development of a biomechanically validated methodology for assessing post-operative anterior knee pain and functional patient outcomes. This pilot study will follow a prospective randomised controlled design at the Royal Adelaide Hospital (South Australia). We aim to recruit a total of 60 patients between the ages of 18 – 60 years old, who will be randomly assigned to one of the approaches after a decision has been made for surgical fixation. All nails used in this study will be Stryker T2 Alpha nails. Patients will be followed up to 18 months after surgery, and will complete a number of patient-reported outcome measures and functional movement and gait assessments in the Gait Lab at Clinical Research Facility located in the Adelaide Health and Medical Sciences Building. This study will help to provide clarity on the effect of SPN versus IPN for intramedullary nailing of tibial shaft fractures. We hypothesize that there is a difference in clinical and functional outcomes between patients managed suprapatellar or infrapatellar intramedullary nailing approaches.

  • A First-in-Human Study of a new Controlled Release Formulation of Octreotide acetate in healthy male volunteers

    This study will determine the pharmacokinetics and safety of the controlled released formulation of Octreotide acetate in healthy male volunteers Who is it for? You may be eligible to join this study if you are male, aged 18-45, and in good general health. Study details After a screening period beginning up to 28 days before admission to the Clinical Research Unit (CRU), all participants in this study will receive one injection of Octreotide acetate. As part of the study, participants will undergo safety assessments, pharmacokinetic, pharmacodynamic and global local tolerance assessment. Participants will be admitted to the CRU until day 2. This new formulation of Octreotide will provide a significant reduction of the volume of administration and deliver an immediate onset of action. Additionally the long-acting release is intended to potentially result in less frequent dosing which could improve treatment compliance and quality of life in patients.

  • The Healthy Optimal Australian Microbiome (HOAM) Study

    Researchers at the Microbiome Research Centre, UNSW Sydney are inviting healthy and active adults to join in a study to help them discover what is the optimal human microbiome-state. The microbiome is the population of microbes occupying various sites on our bodies, and is already known to have a major impact on human health. If we can determine what the normal microbiome of a the supremely healthy person is made up of, then we have the potential to positively change health outcomes for many future generations by using the microbiome as a target for clinical therapies.

  • Support After Stroke with group-based classeS: The SASS study

    Stroke is the leading cause of disability from physical, social and mental health impacts (e.g. 1 in 3 survivors have depression after stroke) and affects over 420,000 Australians, with 50,000 new events each year. Community-based options for preventing comorbidity and supporting recovery after stroke are limited. We are proposing to test whether a mindfulness-based intervention (MBI), specifically designed for survivors of stroke that uses movement and meditation to focus on body awareness and breathing is acceptable and feasible. Prior studies of MBIs in older adults, cardiac and cancer populations provide evidence of reduced stress, fatigue, mood disorders such as anxiety and depression, lower blood pressure and improved quality of life. Our aim is to perform a feasibility trial among people within 3-12 months of a stroke who are living at home. Participants will either receive the SASS intervention (12 week MBI program includes weekly group class and home practice) or attention control intervention (12 week social group). This research project will provide important pilot data for work that will have the potential to impact on a large number of survivors of stroke living in the community who need support with managing the consequences of their stroke. If successful this pilot data will provide the rationale for future related work which has the potential to save lives and improve the quality of life of thousands of survivors of stroke.

  • A study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MET642 in healthy subjects.

    MET642 is a tablet that is taken once daily. This study will look at the safety of single and multiple doses of MET642 when compared to placebo. This study will also determine the PK and PD of MET642 in healthy subjects.

  • Examining whether receiving optimal messages influences attitudes, intentions and take-up of pre-commitment among monthly sports/race bettors.

    Rationale. Most Australian licensed online wagering operators already offer voluntary pre-commitment through setting deposit limits. However, uptake of this tool is reportedly quite low and it is often associated with problem gambling, rather than being considered a useful tool for all online bettors to monitor their betting expenditure over time. Therefore, substantial trialling and testing is required to determine how to increase the uptake of voluntary opt-out precommitment for online wagering. Aim. This project will examine whether receiving optimal messages influences attitudes, intentions and take-up of pre-commitment. Methodology. The proposed evaluation methodology is a Randomised Control Trial to be conducted with 600 Australian monthly sports/race bettors.

  • Getting Back on Track after a cardiac event: Trial of an online patient self-management program comparing self-directed and health-professional supported delivery options

    The Australian Centre for Heart Health (ACHH) developed the Back on Track online program to help patients manage their health behaviours and emotional wellbeing after a cardiac event. This project will trial the Back on Track program, and test two methods of program delivery – one self-directed by the patient, and one including two telephone sessions with a health psychologist. The project aims to assess whether patients obtain enhanced benefit through psychologist support, over and above benefit obtained through completing the online program alone. We anticipate that Back on Track will assist patients' recovery, and represents a flexible, easily accessible, user-friendly and effective alternative or adjunct to centre-based programs.

  • Biomarker Use in Evidence of Neuronal Damage in Response to Anaesthesia and Surgery (The BOUNDARY Study)

    This study aims to investigate if markers of neuronal damage (neurofilament light and tau) are associated with general anesthesia and surgery. Specifically, we wish to confirm and expand our recent preliminary findings that this damage is associated with anesthetic type and with clinical outcomes of delirium and postoperative cognitive dysfunction. To establish this, patients undergoing major elective non-cardiac surgery will be randomly allocated to receive sevoflurane maintenance anaesthesia or propofol maintenance anaesthesia. Cognitive and memory testing will take place prior to surgery, at 7 days after surgery and at 3 months after surgery. Tests for delirium and collection of blood samples will also be conducted during the participants' time in hospital.

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