There are about 10394 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Gastroparesis is a chronic and debilitating gastric disease associated with poor quality of life, psychological distress, frequent hospitalisations, and high healthcare utilization and associated costs. It is defined by persistent upper gastrointestinal symptoms and delayed gastric emptying with no mechanical gastric outlet obstruction. Gastric emptying scintigraphy (GES) is the current gold standard for diagnosing gastroparesis but its clinical utility is currently being questioned. Current management strategies have often been found to be ineffective, largely due to an incomplete understanding of the disease's pathophysiology. There is a critical need for more advanced diagnostic testing that can better diagnose patients and guide personalized targeted therapy. Body surface gastric mapping (BSGM) using Gastric Alimetry (Alimetry Ltd., New Zealand) is a new FDA-cleared medical device to assess gastric function by non-invasively assessing gastric motility using simultaneous high-resolution electrogastrography and symptom profiling. BSGM has demonstrated clinical utility in the assessment of gastric function through patient phenotyping in a variety of cohorts, including patients with nausea and vomiting disorders, diabetes, delayed gastric emptying, and post-gastric surgery. Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to GES (43% vs 23%). Clinical application of these phenotypes has also aided in changing management decisions, which reduced healthcare utilization and associated costs. However, how GES and BSGM test results differentially influence clinical management in patients is uncertain. This exploratory pilot study proposes a two-arm, prospective trial to assess whether BSGM-guided care could change clinical outcomes compared to the standard of care (GES) in patients with suspected gastroparesis. The trial consists of two phases. Phase 1 involves participants separately undertaking a GES and BSGM test. Based on these results, the referring clinician will devise management plans for treatment using a standardized form: 1) unblinded to one test (GES or BSGM) but blinded to the other test; and 2) unblinded to both tests (GES + BSGM). They will be asked to recommend any changes to interventions (medications, diet, endoscopic/surgical referral or other) and additional testing. In phase 2, those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period. A separate set of participants will be recruited to undergo standard of care (GES only) in parallel with Phase 1 participants. After 12 months, those on the standard of care arm will be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months. Questionnaires will assess symptoms, quality of life, health psychology, sleep, and work impact. If validated, this may change clinical practice by reducing the need for invasive or radioactive-based procedures to diagnose these patients and facilitating a more targeted treatment approach.
This is a long-term, multicenter, non-interventional study of children ages 2.5 to <17 years with hypochondroplasia (HCH). The objective is to evaluate growth, HCH-related medical complications, health-related quality of life, functional abilities and cognitive functions of study participants. Data collected will contribute to the characterization of the natural history of children with HCH. No study medication will be administered.
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers
Glucagon-like receptor-1 agonists (GLP-1 RAs), such as Semaglutide (Ozempic), are a class of drugs used for glycemic control in diabetes, and for weight loss and management in obesity. It has been shown to delay gastric emptying and lead to gastrointestinal symptoms. However, the exact mechanisms are unknown. Alterations in gastric function, including myoelectrical activity, may be a likely mechanism of gastrointestinal side effects. Body Surface Gastric Mapping (BSGM) using the FDA-approved medical device Gastric Alimetry is a novel non-invasive diagnostic tool to assess gastric myoelectrical activity and patient-reported symptoms to achieve accurate non-invasive biomarkers of gastric dysfunction. A proof-of-principle case study of Ozempic using Gastric Alimetry showed abnormal gastric myoelectrical activity along with the development of severe bloating following the meal after 5 weeks of Ozempic use. This study will extend on this initial finding by conducting an exploratory pilot study to investigate the effects on gastric motility in patients with and without diabetes before and after Ozempic. It is hypothesized that Gastric Alimetry will show changes in gastric myoelectrical activity and symptoms in patients after being on the weekly injectable Ozempic compared to baseline.
The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug
This is a multicenter, multiple expansion cohort, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-0201 in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.
The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (>=) 60 YOA and above