ANZCTR search results

We are running a small, early-phase research study across several hospitals in Melbourne, Australia. The study will involve up to 100 young adults between the ages of 18 and 55 who have had a stroke. Our goal is to test how practical it is to carry out a detailed health assessment process-called "deep phenotyping"-with this group. This process involves collecting a wide range of information and samples from stroke survivors to better understand each participant's condition. We'll look at how well this approach works in practice, including how easy it is to use, whether it's done consistently, and how acceptable it is to participants. At the same time, we'll also explore how different factors-such as biological markers (biomarkers), age, sex, type of stroke, lifestyle, and environment-might be related to stroke recovery. This pilot study will help us prepare for larger studies in the future.

This open label clinical trial aims to assess the safety of abdominal vagus nerve stimulation (aVNS) for moderate to severe, adult-onset rheumatoid arthritis (RA) that has not responded to medication. The aVNS is an active medical device placed into the body to allow electrical stimulation of the abdominal vagus nerve. Participants will undergo stimulation treatment with the aVNS device from two to 24 weeks after the device is implanted by keyhole surgery. Safety, device performance and potential benefits will be assessed. Participants will be monitored for specific events for 5 years post surgery.

This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and anti-tumor activity of SSGJ-709 as a single agent in patients with advanced malignancies.

This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)

The goal of this single-arm interventional study is to assess the feasibility and acceptability of co-designed telehealth family psychoeducation (FPE) among individuals with major depressive disorder (MDD) and families. The study will also assess the intervention's preliminary impact on personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns. The main questions it aims to answer are: * What are patients', families', and mental health professionals' views about telehealth FPE for MDD? * What are the feasibility and acceptability of telehealth FPE for MDD among individuals with MDD and their families? * What is the preliminary impact of telehealth FPE for MDD on personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns? Study participants will include individuals with MDD who have prescriptions for antidepressant medications and their family members. Participants will receive three biweekly FPE sessions and a six-week follow-up session via telehealth using a single-family format. The study intervention, telehealth family psychoeducation for MDD, will cover structured modules to enhance participants' understanding of MDD and its treatment, coping strategies, and self-efficacy skills. It will also focus on recognising early signs of relapse and empowering participants to engage in treatment decision-making actively. Hence, the study intervention is termed the Supportive Program for Advancing Recovery, Knowledge, and Empowerment in Depression (SPARKED). At baseline, post-intervention, and follow-up, participants with MDD will complete self-reported measures for personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns. In contrast, their family members or caregivers will complete only an outcome measure for medication necessity beliefs and concerns.

The intervention in this study consists of 75-minute intraduodenal infusions of isosmotic solutions containing either saline (control), L-tryptophan, or calcium combined with L-tryptophan. Participants enrolled into the study will receive, in a randomised, double-blind fashion either (i) saline (control), (ii) L-tryptophan at a rate of 0.1 kcal/minute, (iii) combination of L-tryptophan (0.1 kcal/minute) + 500 mg calcium, or (iv) combination of L-tryptophan (0.1 kcal/minute) + 1000 mg calcium in four separate sessions, each of which will be separated by at least 4 (and up to 10) days. Each study session will be 4-6 hours. Studies will be carried out in the Clinical Research Facility of the Adelaide Medical School, the University of Adelaide, by staff and students trained in the required techniques.

This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and unsuppression of Plasma Renin Activity (PRA) in approximately 180 participants = 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks to based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and approximately 12 countries.

The aim of this project is to learn about how a change in diet will affect sleepiness, quality of life and metabolic health in people living with narcolepsy and idiopathic hypersomnia. The dietary changes we will be testing are well researched and safe in a wide range of patient groups (such as in obesity, type one and two diabetes, cancer and dysfunction related to the nervous system) but has not been researched in conditions of hypersomnolence such as narcolepsy and idiopathic hypersomnia. It is important to test adjunct therapies and lifestyle changes such as dietary interventions to ensure that people living with hypersomnolence have a range of options in addition to medications, to improve their health. If effective, this project will be tested in more people and may become a part of routine patient care. These dietary approaches have been shown to improve health and quality of life in people living with chronic pain, neurological conditions such as epilepsy and have been shown to be safe in these populations as well as people living with type one diabetes. This is a new area of research for people living with hypersomnolence.

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).