ANZCTR search results

The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are: * Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant? * Is consolidation epcoritamab after ASCT deliverable and safe? * Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease? * Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population. Participants will undergo three phases in this trial: 1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab 2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures. 3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT.

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks.

Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.

ADOPT-lung is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 µg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 µg in a population with COPD and elevated cardiopulmonary risk.

This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.

This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine.

In Australia, nearly 70 men are diagnosed with Prostate cancer every day. Prostate removal (Radical Prostatectomy) is the proven treatment option to control cancer spread. Most of the prostate removal surgeries are done using robots. Robotic assisted prostate removal surgeries have been invented to minimise the risk of side effects post-surgery. Doctors prefer the robots over open surgery as there are benefits to patients (shorter hospital stays, lesser blood loss and better quality of life) and surgeons (better dexterity, improved field of vision and less pain). However, the cost of the robot outweighs the benefits at present and there is very less information concerning the long-term outcomes for patients. Studies conducted so far are small scale studies and the results from these studies cannot be generalized to the population at large in Australia. So, there is need for a largescale study that will look at the long-term outcomes and the factors that impact robotic surgeries across the metropolitan and rural hospital sectors. Hence, this comprehensive database has been setup to collaborate with major hospitals, across metropolitan and rural areas in Australia. Through this database, researchers will be able to explore the diagnostic pathway for Prostate cancer and understand the long-term benefits of robotic surgery through patient reported questionnaires. Outcomes from this database will also help compare the quality of care against other powerhouses of robotic surgery. Eventually, the database aims to standardize diagnostic pathways and clinical notes that are the same across different hospitals conducting robotic-assisted surgeries for Prostatectomy and improve care for prostate cancer patients across the country.

The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions. Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks. This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.

The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * How the two formulations compare in terms of their effectiveness in treating TRD. * How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness. Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.