ANZCTR search results

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

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33572 results sorted by trial registration date.
  • Implementation and effectiveness of the Connect for Relative/Kinship Carers program

    The goals of this research project are to evaluate the implementation and effectiveness of an attachment-based and trauma-informed intervention for relative/kinship caregivers. The program is delivered in group format across 9 weekly 1.5 hr sessions and introduces caregivers to a set of attachment-informed principles relating to sensitive caregiving, child and youth development and family wellbeing. Overall, the program aims to reduce caregiver strain and promote caregivers' understanding of and sensitive responding to their child's attachment needs, and, in turn, strengthen the quality of the caregiver-child relationship and promote children's behavioural and socio-emotional wellbeing.

  • Can a pharmacist-led education and support intervention assist patients to reduce their glucocorticoid (steroid) dose and improve outcomes for patients with rheumatic diseases?

    Glucocorticoids (GCs, also known as steroids or prednisolone) are often used to treat rheumatic diseases such as Rheumatoid Arthritis (RA), Polymyalgia Rheumatica (PMR) and Giant Cell Arteritis (GCA), While they can relieve symptoms, they are also associated with many side effects including reduced life expectancy, infection, weight gain, hypertension, diabetes, osteoporosis, cataracts, mood disturbance, thin skin, and easy bruising. In recognition of this, Australian Living Guidelines for RA recommend against the long-term use of GCs. However, studies have shown that once GCs are started, they are often difficult to stop even when the joint disease of RA appears to be well-controlled. Reducing and stopping GCs is often difficult to achieve in the clinic setting, where there are insufficient resources to provide comprehensive education and support. There are no proven methods to improve implementation of these recommendations. The aim of this study is to develop a pharmacist-led GC intervention to assist with GC reduction and cessation and minimise the side effects associated with GC use in patients with rheumatic diseases compared to “usual care”. Rheumatologists will refer people with RA, PMR and GCA who require gradual reduction of GC dose and/or cessation. Patients will either receive the new pharmacist-led intervention or receive “usual care” in an existing routine clinic plus a written schedule for reducing the GC dose from the pharmacist. Patients in the new intervention arm will receive 4-weekly telehealth appointments or phone calls when the pharmacist will collect patient reported data on dose, side effects, and barriers to dose reduction. All participants will have face-to-face visits at baseline, 6 months, and 12 months, when additional information including height, weight, BMI, blood pressure, disease activity and relapse will be collected. The aim will be to see if the pharmacist-led intervention increases the likelihood of achieving the target GC dose at 6 months and reduces the overall GC dose, relapses/flares, side effects, ED presentations and hospitalisations.

  • SAFETY AND TECHNICAL EVALUATION OF THE CLARIA SYSTEM FOR TISSUE EXTRACTION DURING HYSTERECTOMY

    We are doing this research to evaluate a new device intended to improve outcomes in patients undergoing laparoscopic hysterectomy and overall patient care. Historically, without contained tissue reduction, malignancy (cancer) can spread within the pelvic space. The Claria System is designed to capture, reduce, and remove uterine tissue without the spreading of potentially malignant (cancer) cells. This research study is intended to demonstrate the function of the new Claria System and its ability to successfully contain, morcellate, and remove uterine tissue during hysterectomy. Safety of the system will also be evaluated.

  • TLB-001 safety and tolerability study

    This study will assess safety and pharmacokinetics of inhaled (nebulised) TLB001 which is being developed as a potential treatment for idiopathic pulmonary fibrosis. It will be run as a single ascending dose (Part A) and multiple ascending dose (Part B) study. Participants will be residential in the unit for 3 (Part A) or 16 (Part B) nights, and also attend final study outpatient visits.

  • Assessing the effects of a broccoli sprout extract on flow-mediated dilation

    Sulforaphane is a naturally occurring compound found in cruciferous vegetables such as broccoli, and has potent anti-inflammatory and antioxidant effects. Sulforaphane is administered in the form of broccoli sprout supplements as they're cheap, room temperature stable and have a proven safety profile in clinical trials outside of pregnancy including cancer and autism spectrum disorder. This trial will use non-invasive clinical methodologies to assess the vasculature in women both before and after a dose of a broccoli sprout extract. We would like to recruit up to 30 women for this trial (non-pregnant, pregnant, pregnant with hypertension) to assess blood pressure, collect one blood sample, and assess flow mediated dilation. This will assess whether a single dose of a broccoli sprout extract has immediate effects on the vasculature. We hypothesise that a single dose of a broccoli sprout extract will not affect blood pressure but will increase flow-mediated dilation in all non-pregnant and pregnant women.

  • Improving activity-sleep patterns to enhance glucose control in higher risk mid aged adults.

    A large proportion (i.e., approximately 30%) of individuals with prediabetes develop type-2 diabetes. Improving glucose control by increasing regular physical activity can help to prevent diabetes, and for adults with poor sleep, improving sleep can also improve glucose control and strengthen the effect of physical activity. A 2-group randomised control trial to compare the effect of different digital interventions to improve lifestyle behaviours and the effect this has on glucose control in mid-aged adults (45 years and above). The two groups are a physical activity and sleep group and an education-only control group. Outcomes will be assessed at 6 weeks, 12 weeks (primary endpoint), and 24 weeks after intervention commencement. The intervention program will provide participants continuous access to a mobile app and website for the 24-week study period, where participants can manually set and review goals, enter (i.e., self-monitor) their behavioural data on group-respective target behaviours, and view feedback, historical log data (i.e., representing progress over time) and educational materials.

  • A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection

    This is a Phase 1b study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod ± BJT-778 is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. Part B will evaluate open-label, cavrotolimod plus BJT-778, HBsAg monoclonal antibody, in combination. Thi sStudy duration of Part B: Up to 52 weeks (up to 4 weeks for Screening, 24 weeks for treatment, and 12 to 24 weeks for follow up).

  • A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection

    This is a Phase 1b study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod ± BJT-778 is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. The study consists of two parts (Part A and Part B). Part A is multiple ascending dose study with 5 cohorts. Each cohort will enroll a total of 4 participants with 3 randomized to treatment arm and 1 randomized to the placebo treatment arm. Safety Review Committee will review the participant safety data as needed and determine dose escalation to the next cohort.

  • Movement Treatment Following Rhizolysis

    The aim of this study is determine the effectiveness and feasibility of implementing the Movement is Medicine (MiM) small-group program after patients undergo facet joint rhizolysis for their chronic back pain. Participants randomly allocated to the intervention condition attend one of four 6-week (18 hours total) Movement is Medicine small-group interventions following their rhizolysis procedure, with around 8 participants per group, and led by two trained facilitators. Sessions include pain science, relaxation/breathing, and guided demonstrations of various low-intensity exercise options, with all of these techniques suggested as homework between sessions. Control participants simply attend their usual healthcare appointments following their rhizolysis procedure. Outcome measures include functional assessments, as well as self-reported symptoms of pain intensity/interference, lower back pain disability, fear of movement, depression, anxiety and stress, pain self-efficacy, and pain catastrophising, completed immediately before and after the intervention, and three months later (and similar timepoints for controls). If the intervention improves self-management, functional outcomes and quality of life, these patients may "live well despite the pain" and be less reliant on repeated and costly hospital-based care, and findings may provide grounds for offering the intervention to our procedural patients more broadly.

  • Strengths-based, tiered, accessible, resources and supports (STARS for Kids) program

    Every nine minutes, an Australian child is born at risk of developmental challenges (e.g., speech delay, autism) and at the start of school, one in five Australian children do not have the developmental skills to thrive. Access to timely support is hindered by the complex, poorly co-ordinated, and inefficient nature of the Australian child and family service system which is characterised by fragmentation, duplication, and service delivery gaps. We propose to implement and evaluate a co-designed, technologically innovative, and translational program called Strengths-based Tiered Access to Resources and Supports (STARS) for Kids program to systematically improve the quality and consistency of universal screening methods using opportunistic contacts; and the engagement/empowerment of parents for its uptake and use across three sites: a culturally and linguistically diverse (CALD) community in South Western Sydney (SWS) and a rural/regional community in Taree in NSW and a low socioeconomic area of the Wanneroo catchment in WA. By providing a tiered transdisciplinary care system, we will address the current limitations in traditional services that are disorder/discipline specific, narrow, and restricted with siloed approaches.

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