ANZCTR search results

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

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32694 results sorted by trial registration date.
  • Exercise programs for pregnant women who are breast cancer survivors.

    Brief description of the study purpose: This study aim to identify preferences, barriers, and facilitators for engaging in exercise among women who are diagnosed with breast cancer (or undergoing treatment) and are pregnant / within 18 months of giving birth. Who was it for? This study was eligible for a woman aged 18 years and older diagnosed with breast cancer during pregnancy or within 18 months postpartum in the past 5 years. All participants completed the Exercise and Sport Science Australia (ESSA) pre-exercise screening and obtained medical clearance. Study details Participants who enrolled in this study underwent semi-structured interviews to explore their exercise history, preferences, and the barriers and facilitators influencing physical activity during pregnancy, postpartum, and cancer treatment. Participants were then offered an 8-week supervised online exercise program delivered via Microsoft Teams, consisted of both aerobic and resistance training. Baseline assessments included anthropometrics, functional tests (2-minute step test, chair rise, and 30-second push-up), and quality of life using the EORTC QLQ-C30, with follow-up testing completed 3–5 days after the program. The result from this study helped to investigate the feasibility of running an exercise intervention with this population, and how it affects quality of life, strength, and functional physical capacity.

  • A randomised, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of LactoSpore in perimenopausal women.

    In this randomised, double-blind, placebo-controlled study, 90 women aged 40 to 55 years experiencing menopausal symptoms will be randomly assigned to receive LactoSpore (Heyndrickxia coagulans MTCC 5856) or a matching placebo for 12 weeks. Changes in self-reported menopausal symptoms, quality of life, depression, anxiety, sleep, and fatigue will be assessed over time. Moreover, to examine potential mechanisms of action, changes in sex-related hormones, metabolic-related hormones, an inflammatory marker, and blood lipids will be evaluated.

  • A Study to Evaluate the Safety, Tolerability and Efficacy of IMD303 in Participants With Advanced Malignant Solid Tumors

    Study Purpose This study aims to evaluate a new investigational treatment called IMD303 to determine a safe dose and understand how the body responds to it in people with advanced solid cancers. Who Can Participate? You may be eligible for this study if you are aged 18 years or older and have an advanced or recurrent solid tumour such as melanoma, non-small cell lung cancer, renal cell carcinoma, hepatocellular carcinoma, or bladder cancer and whose cancer has progressed despite standard treatment, who cannot tolerate standard treatment, or who have chosen not to pursue further standard therapy. Study details Those who are eligible will receive IMD303 as an intravenous infusion on Day 1 of each treatment cycle. Each dose level will include around 3 to 6 participants, and there is an element of chance because participants are enrolled into sequential dose groups depending on when they join the study. Study Duration The anticipated study duration for each participant in Phase 1a is at least four treatment cycles (each cycle is of 21 days). The Safety Monitoring Committee may assess whether the treatment could continue beyond Cycle 8 based on the emerging evidence of clinical benefit (e.g., partial or complete response). Potential Benefits It is hoped that this research will help determine whether IMD303 is safe and how it affects cancer growth, providing important early information that may support the development of new treatment options in the future.

  • 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.

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