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A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of subcutaneous NAV-242 in adults with Hidradenitis Suppurativa.
Expand descriptionThis study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of NAV 242 participants with HS. Approximately 6 participants with HS (1 cohort with 6 participants). Each part of the study will include a screening period of up to 6 weeks, a treatment period of 60 days and a follow up period of 24 weeks .The approximate total study duration is 38 weeks for each participant.
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A Phase II study of medicinal cannabis products in the treatment of chronic pain in patients with opioid dependence
Expand descriptionThis Phase 2 clinical trial examines the role of different types of medicinal cannabis (MC) products for managing chronic low back pain in people with opioid dependence. The study will compare three types of oral MC products (THC, CBD and THC/CBD combination) against placebo on a range of outcomes, including pain severity, pain interference, mood, anxiety, substance use, sleep, safety (adverse events, abuse liability) and participant experience. Each participant will experience all four medication conditions.
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BALANCE Trial: Bronchoscopic versus Across-the-pleura Lung nodule biopsy: A randomised feasibility trial comparing Accuracy, Nodule access, Complications, and Efficacy
Expand descriptionThis study is exploring two ways to take a sample(biopsy) from lung nodules that might be lung cancer. Method 1:a needle biopsy through chest wall, guided by a conventional Computed Tomography (CT) scan. This technique is widely used and usually gives good results, but it sometimes causes problems like collapsed lung or bleeding. Method 2: a newer technique using a thin camera (bronchoscope) guided into the lungs. This is done with the help of 'Cone Beam' CT, a special type of CT imaging that helps improve the accuracy of the bronchoscopic biopsy. We want to find out if Method Two (called Cone Beam Computed Tomography [CBCT] bronchoscopy) is as good as the traditional needle biopsy in terms of; getting a clear diagnosis and being safer for the patient. In this study, patients who need a lung biopsy and meet the criteria will be randomly assigned to have their biopsy using one of the two methods. We will compare how successful the two methods are, the duration, how much radiation they use, and any side effects. This is a small-scale version to test whether it’s practical to run a larger, full-scale study in the future. If this trial shows that CBCT bronchoscopy works well and is safer, it could become a more commonly used way to sample lung nodules, improving care for patients.
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Computed Tomography Coronary Angiography Screening of Asymptomatic Patients With Chronic Limb-Threatening Ischaemia at Hospital Discharge: A Randomised Control Trial
Expand descriptionChronic limb-threatening ischaemia (CLTI) represents the most severe form of lower-extremity peripheral artery disease. where patients present with ischaemic rest pain or ulceration/gangrene of the extremities. CLTI is associated with 1-year mortality rates exceeding 20% and 5-year mortality beyond 50–60%. Much of this excess risk is driven by concomitant but often silent coronary artery disease (CAD). Contemporary CT coronary angiography (CTCA) and CT-derived fractional flow reserve (FFR-CT) studies in CLTI cohorts without known CAD or cardiac symptoms have reported haemodynamically significant coronary ischaemia in ~70% of patients. Observational data suggest that FFR-guided revascularisation of silent CAD after lower-extremity revascularisation may markedly reduce death and myocardial infarction (MI), but current vascular and PAD guidelines do not recommend routine coronary screening in asymptomatic PAD patients. The utility of systematic CTCA screening at or shortly after hospital discharge for CLTI therefore remains uncertain. We aim to conduct a multi-centre randomised control trial within Australia of patients presenting with CLTI, with no prior history of CAD. Our primary objective will be to determine the diagnostic yield, management impact, and 12-month cardiovascular outcomes of systematic CTCA screening at discharge in patients hospitalised with CLTI who are asymptomatic for CAD and have no previous CAD diagnosis.
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Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SCY-247 for Intravenous Administration in Healthy Participants
Expand descriptionThe primary objective of Study SCY-247-103 is to evaluate the safety, tolerability, and pharmacokinetic profile of the SCY-247 intravenous formulation following single and multiple intravenous infusion administrations in healthy participants. The results from this study will inform and support dose selection for subsequent clinical studies.
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HIIT the Gym: The effects of High Intensity Interval Training (HIIT) on improving fatigue in Multiple Sclerosis
Expand descriptionThe study examines the effects of an 8-week high-intensity interval training (HIIT) program, involving two 30-minute sessions per week, in two groups of people with multiple sclerosis—those with high and low levels of fatigue. The aim is to measure changes in fatigue, cognitive function, and biological processes related to metabolism and gut microbiome diversity. It is expected that both groups will show benefits from the program, but that the extent and pattern of improvement will differ depending on participants’ baseline fatigue levels.
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Effects of hyaluronic acid-based gel as adjunctive therapy on the clinical, microbiological, and radiological outcome in treatment of peri-implantitis: A randomized controlled clinical trial in adult dental patients
Expand descriptionThis study investigates whether adding a gel containing a naturally occurring molecule that helps with wound healing, hyaluronic acid (HA), can improve treatment outcomes for people with an infection around dental implants that causes gum inflammation and bone loss (peri-implantitis). The hypothesis is that the additional use of the gel will improve clinical outcomes.
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Critical Illness, Infection and Immunology Biobank
Expand descriptionThe Critical Illness, Inflammation, and Immunology (CI3) Biobank has been developed to improve insights into the immune mechanisms that contribute to critical illness. Our aims are to develop a world-class biospecimen repository that will support future translational research in this area. Using careful safeguards to protect patient privacy we will link a range of biological specimens to detailed demographic, diagnostic, management, and patient-reported outcome data. Working in partnership with leading researchers we hope to provide new insights into the immunobiology and inflammation in critical illnesses with a focus on identifying novel treatment strategies, improving patient care and outcomes.
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Testing a new digital platform (ReMedi) to help people report and manage side effects from medicines
Expand descriptionThis randomised controlled trial is the third phase of the ReMedi project and will evaluate a co-designed, consumer-focused digital platform to support reporting and management of medicine side-effects. The ReMedi platform enables consumers to easily report side-effects directly to the Therapeutic Goods Administration (TGA), share reports with their healthcare professionals, and keep a personal record of their experiences. The service aims to empower consumers to recognise and report medicine side-effects early and to support follow-up care by pharmacists and general practitioners. By improving consumer engagement in side-effects reporting, ReMedi may increase both the number and quality of reports submitted to the TGA, helping to strengthen medicine safety monitoring and regulatory decision-making. The trial will compare ReMedi alone with ReMedi plus SMS reminders to assess feasibility, usability, and implementation in real-world community pharmacy and general practice settings. The study will recruit 806 participants from sites in Adelaide, South Australia. The expected outcome is an easy-to-use, stakeholder-acceptable platform for medicine side-effect reporting and management that enhances consumer engagement.
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Prevention in primary schools: Increasing support and training in child anxiety to primary school educators
Expand descriptionWhen children have high levels of anxiety (fear or worry), this can prevent the student from learning or engaging in class. Many primary school teachers report not receiving enough training to help their students with anxiety effectively. We have developed a teacher training program designed to improve educators’ understanding of childhood anxiety and how to support students. Initial testing of the program showed promising results, and we now aim to test this program with more teachers nationwide using quantitative and qualitative research methodologies through surveys for primary school teachers in Australia. We hypothesise that the teacher training program will increase teachers' knowledge, confidence, and behavioural practices when identifying and supporting students with anxiety, and reduce anxiety-related stigma (attitudes towards anxiety disorders).