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The feasibility of Can Walk Can Run
Expand descriptionThis study is evaluating the feasibility of Can Walk Can Run, a program that was co-developed to support physical activity and healthy lifestyles in people affected by cancer. Who is it for? You may be eligible for this study if you are a community dwelling adult living with or beyond any type of cancer and are able to walk independently. Study details The intervention will include a ‘couch to 5k’ style walking and running program delivered in outdoor locations, in-person for up to 12-weeks, supported by education and social support. Audit of study records, surveys/questionnaires, and participant interviews will determine feasibility. It is hoped that findings from this study will provide insight into how to support physical activity and healthy lifestyles in people affected by cancer.
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Regenerating lost jaw bone using patient specific 3D-printed resorbable polycaprolactone mesh versus a titanium mesh
Expand descriptionThe purpose of this clinical trial is to compare a custom made (3D-printed) biodegradable (polymer called polycaprolactone or PCL) mesh with a custom made (3D-printed) metal (titanium or Ti) mesh in the reconstruction of jaw bone deficiency. Currently there is no ideal technology for the treatment of large or complex jaw bone deficiencies. We have developed a biodegradable, customizable, 3D printed mesh to regenerate alveolar (jaw) bone (the part of the skull bone that houses the teeth) to allow for dental implant placement. The use of a biodegradable, customized and accurate device may lead to advantages such as reduced surgical time, improved patient recovery and improved ridge contour when compared to the control device. This specific material called Polycaprolactone (PCL) is already approved in Australia for use in sutures, screws and dermal fillers. However, it is not approved to treat jaw bone deficiency. Therefore, it is an experimental treatment for jaw bone regeneration.
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A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of subcutaneous NAV-242 in Healthy Adults.
Expand descriptionThis study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of NAV 242 in healthy participants. Approximately 40 healthy adult volunteer participants, in Part A and Part B (up to 5 cohorts with 8 participants per cohort). Each part of the study will include a screening period of up to 6 weeks, a treatment period of 4 days (Part A), or 60 days (Part B) and a follow up period of 32 weeks. The approximate total study duration is 38 weeks for each participant in Part A, 46 weeks for each participant in Part B, 40 weeks.
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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 32 weeks .The approximate total study duration is 46 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.