ANZCTR search results

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

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31196 results sorted by trial registration date.
  • OsteoVelocity - Effects of different Velocities in Resistance Training on Bone Mineral Density in Women: A Randomized Controlled Trial

    Bone loss is a common health problem in older people, particularly women, and can significantly affect their quality of life. Progressive resistance training has been shown to be effective in preventing bone loss. However, several questions remain regarding the optimal design of such interventions. One such aspect is movement velocity. The aim of this project is to investigate whether faster movement velocities are more effective in improving bone mineral density.

  • A Phase 1 Open-label Skin Safety, Tolerability and Pharmacokinetic Study of MRX-7MLL (Memantine Transdermal Delivery System) in Healthy Adults

    This Phase 1, first-in-human, open-label, fixed-sequence, 3-period, 3-treatment study is designed to assess the skin safety, tolerability and PK of MRX-7MLL compared to the oral reference product, Namenda® (Memantine HCl oral tablet) or generic equivalent. This pilot study will also assess TDS adhesion, validate analytical methodology, assess inter- and intra-participant variability, and/or optimize PK sample collection timepoints for MRX-7MLL and oral memantine HCl tablets. The results of this study will support dose selection in future bioequivalence studies with MRX-7MLL and oral reference product or may be used to identify candidate formulation(s) for the pivotal study.

  • Clinical Evaluation of Amyloid Positron Emission Tomography (PET) for Alzheimer’s Disease Assessment

    This study aims to evaluate whether a new type of brain imaging called an Amyloid PET/CT scan can improve the diagnosis of Alzheimer’s disease in patients where previous tests have been inconclusive. The hypothesis is that this scan will provide additional diagnostic information, helping doctors make a clearer diagnosis or exclude Alzheimer’s disease. Fifty patients with unclear results from an earlier scan (FDG PET/CT) will undergo the Amyloid PET/CT scan. The results will be reviewed by a team of specialists to determine if the new imaging adds value to the diagnosis.

  • Cellular Pathophysiology of Trigeminal Neuropathic Pain

    Chronic trigeminal neuropathic pain resulting from a nerve lesion/disease and affecting the mouth/face, is a highly prevalent condition having severe effects on an individual's quality of life. Although functional brain imaging studies have established brain regions involved in chronic pain processing, the altered engagement of neuroglia astrocytes and microglia remain under-investigated. To develop personalised pain treatments, a better understanding of these non-neuronal cells which encompass and support ascending and descending pain pathways needs to be established. The aim of this proposal is to use a multimodal approach to investigate underlying neurobiology of trigeminal neuropathic pain.

  • Effect of Lifestyle Modification Program and Supplementation with Dietary Fibre on Metabolic Health in overweight adults.

    It was hypothesised that combining lifestyle modification with dietary fibre supplementation will be more effective for weight loss than either strategy alone. The aim was to examine the effect of a specific lifestyle modification program (LSMA, AstonRx Program) combining time-restricted eating (TRE) and dietary fibre supplementation on body weight, body composition and biomarkers of metabolic health in healthy overweight adults. Using a randomized, double-blind, placebo-controlled trial, the study aimed to examine the effect of a specific lifestyle modification program (LSMA, AstonRx Program) combining time-restricted eating (TRE) and dietary fibre supplementation on body weight, body composition and biomarkers of metabolic health, and safety and tolerability of a new dietary fibre BioPB-01 in healthy overweight adults. The primary outcomes included – changes in body weight and composition and safety and tolerability of BioPB-01 dietary fibre. The secondary outcomes included - changes in lipid profiles, fasting blood glucose and insulin levels, gut microbiota structure and function and inflammatory markers.

  • Evaluating change in the colonic luminal environment with protein supplementation (EAT PROTEIN)

    The purpose of this study is to determine the effect of protein-supplementation on faecal hydrogen sulphide production in healthy adult males. We hypothesise that protein supplementation will altern the colonic microbial environment but be safe, tolerable and adhered to by healthy adult males.

  • The relationship between sleep architecture and body temperature, and the influence of exercise

    There has been previous reports that changes in sleep following exercise (either positive or negative) have been attributed to changes in core temperature, however, no studies to date have examine the effect of active (exercise) or passive heating on sleep quantity or quality. 12 participants will be recruited to complete three trials in a randomised order followed by sleep assessments (total sleep time, wake after sleep onset, sleep efficiency, sleep latency and sleep staging) using Actigraphy and Polysomnography and core temperature using an ingestible capsule. It is hypothesised that there will be a significant relationship with core temperature and sleep quality and changes in sleep staging.

  • Implementing integrated psychological and physical care in routine physiotherapy practice for patients with musculoskeletal road traffic injury (PICOT): a hybrid implementation-effectiveness type III cluster randomised controlled trial.

    Primary purpose: To compare the effectiveness of the two implementation strategies (PICOT versus in-person training) on the implementation of StressModex in routine physiotherapy practice. Secondary purpose: To evaluate the effectiveness of the two implementation strategies on patient health outcomes. Third purpose: To assess the cost-effectiveness of the two implementation strategies We hypothesise that (1) physiotherapists who receive the PICOT implementation strategy will be more likely to deliver StressModex to their patients with musculoskeletal spinal (neck and/or back) pain following non-catastrophic road traffic crash (measured by reach, adoption, dose, fidelity and sustainability of StressModex) compared to physiotherapists who receive usual in-person training; (2) patients of physiotherapy clinics participating in PICOT will have better health outcomes; and (3) the PICOT implementation strategy will be cost-effective compared to usual in-person training.

  • Comparing cold and room temperature saline for tonsil removal

    Using chilled saline as a medium for Coblation has been shown to reduce post-operative pain in both paediatric and adult extracapsular tonsillectomy. Its effect on the more minimally invasive intracapsular tonsillectomy (ICT) is unknown. A double-blind randomised controlled trial was performed to identify the effect of chilled saline on operation length, intra/post-operative bleeding, post-operative pain and return to normal activity in paediatric Coblation ICT.

  • Evaluating implementation and clinical outcomes for the Murdoch Childrens Research Institute Concussion Centre

    Clinical trial examining implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, implementation costs) and clinical outcomes of an intervention, delivered within a concussion clinic model. The trial will offer an innovative, integrated stepped-care model that provides individualised, evidence-based intervention and continuity of care for children and adolescents following the initial assessment and diagnosis of concussion in Emergency or Primary Care settings. Concussion Essentials is a proven effective intervention for treating concussion symptoms and can be implemented in routine clinical practice.

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