Viladecans

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are evaluating whether ultrasound-guided alcohol sclerotherapy can reduce pelvic pain and improve quality of life in women aged 18 to 45 diagnosed with ovarian endometriomas. This condition involves abnormal growth of endometrial tissue outside the uterus and can cause chronic pelvic pain and infertility. The study compares sclerotherapy to expectant management to see which approach better improves pain and quality of life using the EHP-5 score. Participants will be randomly assigned to either the sclerotherapy group, which undergoes ultrasound-guided puncture and alcohol injection, or the control group, which receives expectant management without intervention. The study focuses on evaluating pain relief, quality of life, pregnancy rates, recurrence, adverse events, and treatment costs over six months. During the study, participants will complete pain and quality of life assessments at the start and after six months. They will also provide blood and urine samples for biomarker analysis and have ovarian reserve tests. Researchers will monitor safety, recurrence of endometriomas, fertility outcomes, and cost-effectiveness. The goal is to understand the benefits and risks of sclerotherapy compared to no treatment over this time period.

Researchers are evaluating how inflammatory bowel disease (IBD) activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study also aims to understand how frailty influences the risk of hospitalization and death in this population. The study seeks to determine if frailty and its related complications can be reversed with proactive treatment and which frailty index best predicts these risks in patients with active IBD. At the start of the study, four clinical frailty indices will be calculated along with clinical information about IBD, including diagnosis, disease characteristics, treatments, and comorbidities. Patients will be followed for 12 months with three visits at 3, 6, and 12 months. During these visits, frailty, comorbidities, disease activity, changes in medical treatments, adverse effects, hospitalizations, and mortality will be reassessed to monitor progress and outcomes. Participants will have detailed assessments including frailty scales and clinical data collection at the beginning and during follow-up visits. Researchers will track hospitalizations and mortality over the year-long period. This monitoring will help evaluate the impact of both IBD activity and frailty on patient health outcomes in a real-world setting.

Researchers are conducting a 2-year, multicenter observational study to evaluate clinical differences in patients with migraine who are treated with medications targeting calcitonin gene-related peptide (CGRP) or its receptor. These medications include monoclonal antibodies such as erenumab, galcanezumab, fremanezumab, and eptinezumab, as well as gepants like rimegepant and atogepant. The study includes patients diagnosed with migraine according to specific criteria and who meet local reimbursement guidelines for these treatments. Participants will begin treatment with one of the anti-CGRP drugs or gepants, and a baseline assessment will be performed. Follow-up visits will occur every 6 months to monitor treatment effectiveness, side effects, patient-reported outcomes, and eligibility to continue the study medication. The observation period for each participant will last for 2 years. During the study, researchers will track changes in the number of monthly headache days and monthly migraine days as primary outcomes. Participants will undergo regular assessments including clinical evaluations and questionnaires. Safety and treatment adherence will be monitored throughout the two-year observation period to better understand real-world use of these migraine preventive therapies.