Ayr

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are studying breast cancer patients who have Triple Negative Breast Cancer TNBC andor a germline BRCA mutation gBRCA to see if adding olaparib, a PARP enzyme inhibitor, to platinum-based neoadjuvant chemotherapy is safe and improves the complete response rate at surgery. This is a randomized, open-label phase IIIII trial conducted in three stages, involving at least 780 patients, including 220 with gBRCA mutations. Participants receive at least 21 weeks of chemotherapy before surgery. Study groups include a control arm receiving paclitaxel and carboplatin, and two experimental arms where patients receive the same chemotherapy plus oral olaparib tablets taken twice daily during specified days of each 3-week cycle. Additional treatments such as prophylactic granulocyte-colony stimulating factor and anthracyclines are given as per local practice. Patients with residual disease after chemotherapy may join a sub-study with further treatments. During the trial, patients undergo screening tests including BRCA mutation testing, tumor marker assessments, and standard cancer staging. Researchers monitor treatment safety and effectiveness through pathological complete response rates, adverse events, survival outcomes, quality of life questionnaires, and imaging. Follow-up occurs for up to 10 years after surgery, with safety data regularly reviewed by independent committees to ensure participant well-being.

Aortic stenosis AS affects many older adults, with a rising number of people over 65 and 75 years old experiencing moderate to severe disease. This study aims to compare the benefits of early aortic valve replacement AVR versus expectant management in patients with severe asymptomatic AS. It addresses a significant gap, as no randomized controlled trials have yet compared these approaches to determine which leads to better outcomes and cost-effectiveness. Participants will be randomly assigned to either early AVR, where surgery or transcatheter AVR TAVI is planned within six months, or to expectant management, involving regular monitoring according to standard hospital practice. The study will be conducted across multiple centers in the UK, Australia, and New Zealand, with an internal pilot phase to confirm recruitment feasibility. Those in the AVR group may undergo additional tests such as coronary angiography, with further treatment decisions made by their care team. During the study, participants will be followed for a median of 5.5 years, with assessments including cardiovascular events, hospitalizations, quality of life questionnaires, and health economics evaluations. Researchers will measure a combined outcome of cardiovascular death, heart failure hospitalization, and stroke, along with other health and disability measures. The study will use intention-to-treat analysis, ensuring participants are evaluated in their assigned groups regardless of treatment received.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant ASCT. It is a phase III, randomized, controlled, multi-center, open-label study aiming to assess whether adding a proteasome inhibitor to salvage ASCT conditioning improves depth of response and how consolidation and maintenance therapy influence the durability of response. The study also evaluates overall survival, progression-free survival, response rates, minimal residual disease, toxicity, and quality of life. Participants first receive re-induction therapy with 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone ITD, each cycle lasting 28 days. Those achieving at least stable disease are randomly assigned to receive either conventional ASCT using melphalan alone or augmented ASCT combining melphalan with ixazomib. After ASCT, participants with minimal response or better are further randomized to either receive consolidation with 2 cycles of ITD followed by ixazomib maintenance until disease progression or no further treatment. During the study, participants undergo regular assessments including response evaluation 100 days post-ASCT, monitoring of progression-free survival for up to 120 months, and measurement of minimal residual disease at several time points. Safety and toxicity are closely monitored throughout re-induction, post-ASCT, consolidation, and maintenance phases. Quality of life questionnaires are completed at baseline, post-re-induction, post-ASCT, and during follow-up visits up to 24 months. The study plans to register 406 participants, with 284 randomized at the first stage and 248 at the second stage.

This research aims to support the safety and performance evaluation of an investigational monofocal toric intraocular lens IOL, focusing on optimizing lens constants based on vision correction outcomes. It involves adults aged 18 years or older who have cataracts and regular corneal astigmatism, scheduled for cataract surgery. The study is a Phase 4 interventional trial sponsored by Carl Zeiss Meditec AG. Participants will receive the investigational device, which is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens designed to replace the natural cataractous lens and correct corneal astigmatism. The IOL power ranges between 18.0 D to 28.0 D, with cylinder power from 1.0 D to 2.5 D. The study includes unilateral or bilateral implantation during cataract surgery. During the study, participants will undergo preoperative and postoperative assessments up to twelve months, including measurements of refractive predictability, visual acuity, IOL rotation and stability, intraocular pressure, and patient satisfaction. Follow-up evaluations will monitor outcomes such as axis misalignment and spectacle independence. The total participation duration extends to at least twelve months after surgery to capture comprehensive visual outcomes and device performance.