ANZCTR search results

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

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30792 results sorted by trial registration date.
  • ALLG NHL41: A phase I clinical trial investigating the combination of chimeric antigen receptor-T cell (CAR-T) cell therapy with Zanubrutinib bridging and subsequent Zanubrutinib and Tislelizumab consolidation in patients with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL).

    PCNSL is a subtype of diffuse large B-cell lymphoma (DLBCL) that affects the brain. While regular DLBCL (found outside the brain) responds well to treatments such as chemotherapy and immunotherapy, these approaches don’t work as well for PCNSL as the brain is protected by the blood-brain barrier. Past treatments such as stem cell transplants or whole brain radiation cause serious side effects and don't lead to good outcomes. There are many clinical trials testing new treatments for relapsed systemic DLBCL but these trials do not include patients with PCNSL. Patients with relapsed PCNSL have very few treatment options available. The NHL41 clinical trial is testing a new approach that combines three treatments across three phases; Zanubrutinib, CAR-T cell therapy and Tislelizumab. The main goal of this study is to assess if this combination is a safe and feasible treatment option. Who is it for? You may be eligible for this study if you are aged between 18 and 80, and have been diagnosed with PCNSL. Study details Participants who choose to participate in this trial will undergo treatment in three phases: Part I: Zanubrutinib induction therapy Patients will receive Zanubrutinib as induction bridging therapy until lymphodepletion prior to CAR-T cell therapy. Part II: Lymphodepletion chemotherapy and single CAR-T cell infusion Standard Lymphodepleting chemotherapy will be administered. On the day of CAR T cell infusion, CAR-T cells will be delivered fresh and infused intravenously. Part III: Tislelizumab followed by combination Tislelizumab and Zanubrutinib consolidation The first cycle of Tislelizumab will commence as a single agent. Zanubrutinib will be added in on day 1 post the 2nd infusion of Tislelizumab. This study aims to address this major unmet need by determining a safe and feasible treatment option for rPCNSL patients.

  • Acceptability of balance-enhancing outdoor shoes compared to minimalist outdoor shoes in older women: a randomised crossover trial

    The primary objective of this project is to determine if balance-enhancing shoes are more acceptable than minimalist shoes in older women. The secondary objective is to determine if balance-enhancing shoes are more effective at improving balance performance and perceived risk of falls than minimalist shoes in older women. This study will utilise a randomised crossover study design. Participants will be women aged 65 years or older who are free from any conditions which may negatively impact their balance or ability to walk independently. Participants will be randomly allocated to two shoe conditions and will be required to wear the shoes from each condition for six weeks before crossing over to the alternate condition. Participants will attend the university for assessments over four sessions. We hypothesize that participants will find the balance-enhancing outdoor shoes more acceptable than the minimalist outdoor shoes.

  • A randomized trial of ten-session cognitive behaviour therapy (CBT-T) for eating disorders: Does personalisation of treatment lead to better outcomes?

    The overall aim of this randomised controlled trial is to evaluate the comparative effectiveness and acceptability of CBT-T for non-underweight clients with EDs aged 15 years and above to CBT-TA. To achieve this, participants will be randomised to either receive CBT-T or CBT-TA. We hypothesise that gradual responders in CBT-TA will have significantly lower disordered eating compared to gradual responders in CBT-T at end of treatment and that these gains will be maintained at the 3- and 6-month follow-up. We also hypothesise that remission will be higher in the former than latter group. We also hypothesise the same advantages for the rapid responder group in CBT-TA over rapid responders in CBT-T. We will also explore (1) change in health service utilisation, (2) engagement and completion data between the two conditions to establish the relative acceptability of the interventions, and (3) client’s experiences of therapy in the form of qualitative feedback.

  • BOLDER: Breast cancer decision making and outcomes in OLDER Australians

    This study aims to assess the clinical utility of a previously validated collection of geriatric assessment tools and its impact on clinicians’ treatment recommendations for first-line therapy. Who is it for? You may be eligible for this study if you are aged 70 years or over, of any gender and performance status diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2-breast cancer. Decisions about first-line therapy not yet made at this time of consent. Study details Your study doctor will assess whether this research project is appropriate for you. If you are suitable and agree to take part in this research project, you will be asked to sign a consent form. You will undergo a geriatric assessment (questionnaires, quick bedside tests assessing falls risk and cognition) to help your study doctor make decisions about your treatment. You will also complete a survey within 6 weeks of your initial appointment with the doctor about what factors influenced your treatment decisions and how helpful the geriatric assessments were. You will have a follow-up appointment in 4-6 weeks to determine if you stay on the same treatment or if any changes are needed. It is hoped the finding from this study will determine the usefulness of geriatric assessment tools and its impact on clinical decision and patient outcomes.

  • Testing the effect of optical designs on short-term changes in eye length and vision

    The research questions this project seeks to answer are whether the optical power designs developed by Johnson and Johnson Vision Care (JJVC) for use in contact lenses have the ability to shorten the eye and how much those same designs affect vision levels. This will be a prospective, interventional data collection study comparing the relative effectiveness of the various designs that are tested. It is hypothesized that by varying the optical design and the amount of blur imposed on the eye, small temporary changes in the length of the eye can be measured. Short-term changes in eye length (30 minutes) are thought to be a biomarker for the longer-term growth of the eye and can therefore be used as a predictive tool for whether the specific design will slow or increase myopia progression in longer term clinical trials (over years).

  • Health4Life Parents & Teens Optimisation Trial

    The Health4Life Parents & Teens study aims to test a new digital intervention designed to support parents experiencing socioeconomic disadvantage to encourage healthy habits among their adolescent children. The intervention targets six key lifestyle risk factors for chronic disease: physical inactivity, poor nutrition, alcohol use, smoking/vaping, screen time, and poor sleep. Using the Multiphase Optimisation Strategy, this study will test the individual and combined effects of five parent-based intervention components in improving parental encouragement of adolescent health habits. The five components are: online modules, tailored feedback, stress management, text messages, and health coaching. Findings will be used to build a maximally effective and efficient intervention for parents, to improve youth health outcomes.

  • Restricting and then resuming certain behaviors and the effects on symptoms of anxiety and depression

    The proposed project further extends our systematic efforts to understand the relationship between symptoms of anxiety and depression, and daily actions (i.e., thoughts and behaviours - "Things You Do"). The primary objective of this trial is to compare the effects of restricting and then resuming the Things You DO (TYD). The research design is a parallel group randomised controlled trial. Participants (n = 60) will be Australian adults assigned to either the intervention group (behaviour restricted and then resumed) or a control group. Based on our earlier studies, the primary hypothesis is that restricting and then increasing the frequency of TYD actions will result in significantly greater increases and then reductions in symptoms of anxiety and depression, relative to a control condition.

  • The impact of immersive virtual reality-based nature exposure on the psychological distress of rehabilitation patients

    The overall objective is to test the efficacy of co-designed immersive virtual reality-based nature exposure to reduce psychological distress for inpatients in hospital rehabilitation, and understand how this might be implemented and adopted in a clinical setting. We propose a fully powered randomised controlled trial and process evaluation. We hypothesise that exposure to the virtual nature will significantly reduce symptoms of psychological distress compared with the control group which will complete standard care (with no or extremely limited access to nature).

  • Evaluating a sham diet for food-based interventional trials in ulcerative colitis

    This study aims to investigate the therapeutic appearance, nutritional content and participant acceptability of a sham dietary prescription in healthy individuals. The intent of the sham diet is to have the appearance of a therapeutic diet by excluding or substituting inert food items without altering overall nutrient intake compared to habitual diet. The sham diet has been designed for future use in placebo-controlled dietary advice trials for ulcerative colitis.

  • Addressing public health professionals' social media competency for effective health promotion, communication and advocacy

    To address the dearth of social media training opportunities for health promotion and public health professionals, we intend to evaluate the impact of a MOOC that aims to improve their knowledge and understanding of how to effectively frame health promotion messages and increase their perceived confidence in using social media for health promotion communication and advocacy. A mixed-methods approach, incorporating quantitative pre-and post-surveys and qualitative structured individual interviews, will be used to gain a deeper understanding of both the immediate and long-term effects of the MOOC on various outcomes.

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