ANZCTR search results

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.

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.

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.

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 3-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 (45-64 years). The three groups are a physical activity and sleep group, a physical activity only intervention and a 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.

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).

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.

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.

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.

This is a pilot study assessing feasibility, acceptability of a larger study, as well as to estimate the incidence of postoperative sore throat.. These results will inform a larger study that has the aim to assess patient experience outcomes following elective intubation comparing between DL and VL

This research will primarily aim to quantify the mobilisation of T-cell subsets (CD8+ and CD4+) in response to a bout of HIIT vs MICT exercise. These cells have been specifically chosen as the PD-1 and CTLA-4 receptors are expressed on these cells respectively. The PD-1 and CTLA-4 pathways are targets of first line immunotherapies for advanced melanoma such as Nivolumab, Pembrolizumab and Ipilimumab. Who is it for? You may be eligible for this study if you are a male or female age 18 or older with stage III-IV melanoma, receiving any immunotherapy. Study details Participants will cycle on a cycle ergometer. Physiological measures (heart rate, oxygen saturation, and blood pressure) will be taken during the pre-exercise resting period, warm-up, exercise task, cool-down, and recovery periods. Rate of perceived exertion (RPE) will also be recorded throughout exercise. It is hoped that findings from this study will establish the optimal exercise intensity parameters for the translation of exercise as an adjunct to immunotherapy.