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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.
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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.
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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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Video Laryngoscope versus Direct Laryngoscope and postoperative sore throat
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
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Exercise-induced immune cell mobilisation in advanced melanoma: a comparison of high intensity interval training (HIIT) vs moderate intensity continuous training (MICT)
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.
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Supervised exercise for people with myositis
This is a randomised wait-list control study. Participants will be randomised to participate in either a structured, individualised, supervised exercise program (intervention group) or to usual care (wait-list control group). Participants allocated to the intervention group will complete a 12 week, 3 times per week, structured, individualised, 1 on 1 supervised exercise program (mixed between face to face and "live" telehealth on Microsoft teams). Participants allocated to the control group will continue with their usual care over the 12 week period and then be invited to receive the full 12 weeks intervention on completion of the 36 weeks follow up assessment period. Blinded assessments will be undertaken at baseline (week 0), following the intervention (Week 12), and at follow-up (36 weeks).
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Implementation and referral of the ecofit physical activity intervention within Diabetes Alliance Program Plus among regional and remote type 2 diabetes patients in a primary care setting.
This study aims to evaluate the ecofit program (which comprises an app and web-based resources) across remote and rural primary health care settings in the Hunter New England Health District for patients with T2D within the Diabetes Alliance Project Plus study. The current study will assess the reach, adoption, appropriateness, feasibility, fidelity and reach of the ecofit program among general practitioners and general practice staff. The study will also assess the reach, acceptability dosage and effectiveness of the ecofit program among DAP+ patients, It is hypothesized that the effective implementation of the ecofit program within DAP+ as a physical activity resource for adults with T2D will result in DAP+ patients participating in increased physical activity and experiencing the associated health benefits.
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Acute effect of the renally excreted low-calorie sweetener, acesulfame potassium (Ace-K), on urinary glucose excretion in healthy humans.
Low-calorie sweeteners (LCS) have been widely used in food and beverages in recent decades. However, a recent World Health Organisation (WHO) report highlighted that people who consume LCS regularly have an increased risk of developing type 2 diabetes (T2D). Acesulfame potassium (Ace-K) is a widely used low-calorie sweetener that is absorbed from the gut and excreted in the urine. We want to find out whether Ace-K consumption reduces the amount of glucose excreted in the urine in healthy humans.
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RECENTRE: Determining the Acceptability and Efficacy of The Enhancing Women's Recovery after Cancer Treatment Program
The purpose of this study is to implement and evaluate The Enhancing Women’s Recovery after Cancer Treatment Program (known as RECENTRE) as standard practice after treatment, Queensland-wide, across Mater Misercordiae facilities. RECENTRE is a digitally enabled lifestyle program for prevention of additional chronic disease in women treated for breast and gynaecological cancer. Who is it for? You may be eligible for this study if you are a female who has been diagnosed with breast or gynaecological cancer, that has completed intensive cancer treatment more than 4 weeks ago. Study details In this study, all participants receive the 12-week RECENTRE intervention targeting physical activity, diet, alcohol management, body weight, smoking cessation, sleep, stress, menopausal symptoms, and sexual health. These strategies are personalised based on individual goals and functional capacities. The RECENTRE program involves online modules and virtual consultations, if required. Participants will be followed up for 6 months, and asked to complete questionnaires throughout the study to follow-up on overall health. It is hoped that this study will help determine if the RECENTRE program is an effective and safe way to provide support to women after cancer treatment.
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Residual heparinisation after cardiac surgery: A prospective observational study
This observational study aims to assess whether a residual heparin effect is contributing to post-operative bleeding in cardiac surgical patients at a single institution. It will also assess whether testing for a residual heparin effect will help in reduce the transfusion of blood components perioperatively. The hypothesis being tested is that a proportion of patients undergoing cardiac surgery are returning to ICU with heparin activity affecting their normal coagulation and that this might result in inappropriate administration of platelets and other blood components.