ANZCTR search results

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

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32684 results sorted by trial registration date.
  • Hyperbaric Oxygen Therapy and its Effects on Left Ventricular function

    When someone is undergoing hyperbaric oxygen therapy (HBOT), they are exposed to higher amounts of oxygen than they would normally get every day. It is believed that the heart may respond to more oxygen differently depending on: · Age / Sex · Other medical conditions With this study, we perform an ultrasound scan of the heart before, during, and after your HBOT to see its response. The information we get from these scans may help us better understand patients with different medical conditions react to HBOT and improve how care is provided in hospitals and other HBOT units in Australia.

  • Exploring the Feasibility and Clinical Utility of a Fully Immersive Virtual Reality Shopping Tool for Training Instrumental Activities of Daily Living (IADLs): A Pilot Study in Older Adults and Adults with Neurological and Visual Impairments

    This pilot study aims to evaluate the acceptability, usability, and feasibility of a custom-made, fully immersive virtual reality (VR) shopping tool designed to train Instrumental Activities of Daily Living. It also aims to explore preliminary effects in functional ability, health-related quality of life, community participation, and implementation outcomes (adoption and appropriateness). Participants will include community-living adults (older adults with mild cognitive impairment, adults with functional vision impairment, adults with acquired brain injury, and healthy older adult controls) and clinicians working with these populations. Participants will complete a four-week VR intervention consisting of two 30-minute sessions per week, with task difficulty tailored and progressively adjusted. Primary outcomes will be assessed using a purpose-designed questionnaire, focus groups, and semi-structured interviews. Secondary outcomes include in-app VR performance metrics, measures of functional ability and quality of life, and community participation in shopping activities. Expected outcomes include evidence of feasibility and preliminary therapeutic potential.

  • Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitors to Treat Heart Failure with Preserved Ejection Fraction in Patients with Atrial Fibrillation - The SHAPE-AF Trial

    Subclinical heart failure with preserved ejection fraction is common amongst patients with atrial fibrillation and is associated with poorer exercise capacity and worse symptoms. SGLT2-inhibitors are an established treatment for patients with overt heart failure. Their efficacy in patients with AF and subclinical heart failure with preserved ejection fraction has not been established. We hypothesise that the use of SGLT2-inhibitors post-ablation will reduce AF recurrence rates in patients with AF and haemodynamically confirmed HFpEF. This study will randomise patients with AF and subclinical HFpEF to either dapagliflozin 10mg daily or placebo and will assess improvement in peak oxygen consumption on cardiopulmonary exercise testing as the primary outcome.

  • Can a short psychoeducation session on functional nutrition reduce disordered eating and improve body image?

    Topic: Information on “functional nutrition” helps to reduce disordered eating. Functional nutrition is psychoeducation about the biological benefits of nutrition accompanied by a simple message: eat carbs regularly throughout the day. This randomised trial will compare a control condition to two intervention groups – both will receive a single session intervention containing psychoeducation about functional nutrition. One group will receive a goal setting exercise related to nutrition (i.e., indulging) and the second group will additionally be asked to think about current obstacles that impede the realization of the goal (i.e., mental contrasting). Evidence suggests that mental contrasting significantly increases the likelihood of behaviour change. Aims: 1. Can we replicate the effect of psychoeducation on disordered eating and body image? This would involve a comparison of the combined intervention groups with the control. 2. Does the use of mental contrasting produce significantly better outcomes than indulging or control in terms of goal attainment, disordered eating, body image, and mood? 3. Does weight concern status (low, high) moderate outcomes? Design: Conducted in first year Psychology students. Assessment will occur on three occasions: baseline (state and trait variables), immediately post-baseline after psychoeducation (state variables), 1-week post baseline (state and trait variables). We can categorise students as being at high or low risk of having disordered eating – using the 5-iem Weight Concern Scale.

  • Time Mat(t)ers: A study to evaluate shared care for cancer patients in follow up care for specific patient cohorts, currently including Colorectal and prostate cancer.

    This study is assessing the implementation of a model of shared care between cancer doctors and general practitioners to provide follow-up care to colorectal or prostate cancer patients Who is it for? You may be eligible to join this study if you are aged 18 years or above and receiving post active (follow-up) care for colorectal cancer or receiving ongoing surveillance of androgen deprivation therapy (ADT) for prostate cancer Study details Participants who opt into this study will receive a shared care plan provided to them by their treating specialists (Medical or Radiation Oncologist) that outlines follow up schedule, (shared care plan), including details of treatment and overall duration of follow up. Participants who opt out of the study will not receive a shared care plan but will continue with their routine follow up care. All participants will complete patient reported outcomes questionnaires at baseline, 6 and 12 months and the patient reported experience questionnaire at 12 months. The aim of this project is to integrate shared care models into CMN outpatient cancer services consistent with national guidelines and recommendations for care, improving access for new cancer patients and delivery of outpatient follow up care (including patient communication) to all patients.

  • Comparison of a restricted salt diet to a non-restricted salt diet in patients with liver cirrhosis on handgrip strength

    To determine whether an unrestricted sodium diet, compared to a low sodium diet as prescribed by in patient hospital dietician initially and then delivered by participants at home over 30 days improves handgrip strength without increasing the need for large-volume paracentesis in patients with decompensated cirrhosis and ascites.

  • PERTIL-01: A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients with Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma

    This is a single arm, open label phase II study to determine the activity of Perkileucel, a tumour infiltrating lymphocyte (TIL) adoptive cell transfer therapy (ACT), in adult patients with unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting. Who is it for? This study may be suitable for adults aged between 18 to 70 years of age who have unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting. Participants need to have a reasonable general health (ECOG 0–1) and a life expectancy greater than 6 months. Study details: All participants will receive the investigational treatment Perkileucel. To create this therapy, participants need to undergo surgical excision of the melanoma lesion to harvest the TILs prior to treatment. Once the TILs have been manufactured, participants will be admitted to hospital to receive 5 days of chemotherapy to prepare their body (lymphodepletion) for the TIL-ACT. Treatment with TIL-ACT will then be given on Day 0 as a single intravenous infusion followed by up to 6 intravenous infusions of high-dose interleukin 2. Blood tests and other assessments will be performed regularly to monitor safety and response. The total duration of the study is 8 years. Safety will be assessed throughout the full duration of the study. Patients will be monitored for delayed adverse events. This study will show whether Perkileucel can help control melanoma that has not responded to other treatments and demonstrate feasibility of manufacture and delivery of this treatment in an Australian healthcare setting.

  • A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Vanizem (Aframomum melegueta seeds extract) on Stress, Anxiety, Sleep, and Mood in Adults with Mild-to-Moderate Stress.

    In this randomised, double-blind, placebo-controlled study, 100 adults aged 18 to 60 years experiencing high perceived stress will be randomly assigned to receive an Aframomum melegueta seed extract (Vanizem) or a matching placebo for 28 days. Changes in self-reported perceived stress, anxiety, general mood, sleep quality, and fatigue will be assessed over time. Moreover, to examine potential mechanisms of action, changes in heart rate variability as well as blood and salivary markers associated with stress, mood, sleep, and cognitive function will be evaluated.

  • Milk Intolerance Lactose-free Knowledge (MILK) Trial, the effect of A1-protein-free lactose-free milk compared to conventional lactose-free milk in adults who identify as lactose intolerant.

    Lactose intolerance results from reduced activity of the lactase enzyme, leading to incomplete digestion of lactose and fermentation by gut microbiota, which can produce symptoms such as bloating, pain, and discomfort. While lactose malabsorption is common globally, symptoms occur in only a subset of individuals and self-reported lactose intolerance often does not align with objective clinical diagnosis. Lactose-free milk products have been developed to address lactose malabsorption, however, research shows inconsistent effects on gastrointestinal symptoms. Emerging evidence suggests that intolerance symptoms attributed to lactose may also be influenced by other milk components, particularly the A1 beta-casein protein. This study will investigate the effects of A1-protein-free lactose-free milk compared with conventional lactose-free milk in individuals with self-perceived lactose intolerance. Outcomes will include gastrointestinal symptoms and markers of inflammation and immune response. The study hypothesises that A1-protein-free lactose-free milk will improve tolerance and reduce symptoms compared with conventional lactose-free milk, while maintaining the nutritional benefits of dairy consumption.

  • Neural Drivers of Early Strength Gains in Resistance Training

    The human nervous system exhibits neuroplastic adaptations in response to strength training, which enhance muscle force production. Neuroplasticity refers to the ability of the neuromuscular system to modify its function in response to physical activity, often involving reorganisation within the primary motor cortex that controls movement. Strength training has been shown to induce such plastic changes; however, limited evidence exists regarding how training affects the neural pathways connecting the neuromuscular system and skeletal muscle. Although the corticospinal pathway has been extensively studied in motor control and is considered one of the main sites of neural adaptation following resistance training, the role of other descending motor pathways, such as the reticulospinal pathway, remains largely unexplored in humans. It is also unclear whether strength training can modify the function of this pathway. Therefore, this project will investigate the effects of strength training on the modulation of neural systems, particularly the corticospinal and reticulospinal pathways, as well as motor unit behaviour, using non-invasive neurophysiological techniques. This research will provide new insights into neural adaptations and their contribution to training-induced increases in force output.

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