Viladecans

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.

Researchers are investigating the relationship between chronic non-cancer pain and chronic insomnia, two conditions that often occur together and negatively impact quality of life. Chronic pain lasts more than three months and affects about 17% of adults in Spain, while chronic insomnia involves persistent trouble with sleep at least three times a week for three months or more. This study aims to estimate how common chronic insomnia is among adults suffering from chronic non-cancer pain, addressing an important gap in current knowledge. The study involves adult patients with chronic non-cancer pain who are receiving usual care from pain specialists or within dedicated pain units in outpatient settings. Participants will be observed to determine the prevalence of chronic insomnia and related factors, without any experimental treatments or interventions. All data collection will occur during a baseline visit. Participants will attend a baseline visit where they will be assessed for the presence of chronic insomnia, pain intensity, sleep quality, anxiety, depression, mood, well-being, functional capacity, and use of sleep-related medications. Researchers will collect these measurements to understand the overlap of insomnia and chronic pain and their impact on patients. The study will provide important information to help develop better integrated treatments for managing pain and sleep problems together.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

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 study compares sclerotherapy to expectant management to determine which approach better helps manage symptoms and quality of life impacts associated with this common form of endometriosis. Participants are randomly assigned to either receive ultrasound-guided alcohol sclerotherapy involving puncture and alcohol treatment of the cysts or to be managed expectantly with standard pain management if needed. The sclerotherapy procedure involves a 15-minute application of absolute ethanol followed by a wash. Both groups will be followed for six months, with assessments at baseline and 6 months post-treatment. During the study, participants will complete quality of life and pain assessments using standardized tools, provide blood and urine samples for biomarker analysis, and undergo ovarian reserve evaluations. Researchers will monitor adverse events, cyst recurrence, fertility outcomes, and healthcare costs. Pregnancy outcomes will be followed for an average of two years. The main outcome is quality of life measured at baseline and 6 months.

Researchers are studying how inflammatory bowel disease IBD activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study aims to understand if frailty and related risks like hospitalization and mortality can be reversed with proactive treatment in frail patients with active IBD. The study also evaluates which frailty index best predicts complications in this population. At the start, four clinical frailty indices will be calculated for each participant, alongside recording clinical variables related to IBD and other health conditions. Patients will be followed through three visits at 3, 6, and 12 months, during which frailty, disease activity, treatment changes, adverse effects, hospitalizations, and mortality will be reassessed to track progress and outcomes. Participants will be involved in these visits where various assessments will be done, including measuring frailty and comorbidities and reviewing their IBD activity and treatments. The main outcomes include assessing the impact of IBD activity on frailty and how frailty affects hospitalization and mortality risk over a 12-month period. The study is led by the Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and runs until May 2027.

This research aims to observe and evaluate clinical differences in patients with migraine who receive preventive treatment targeting calcitonin gene-related peptide CGRP or its receptor. The study focuses on monoclonal antibodies erenumab, galcanezumab, fremanezumab, eptinezumab and gepants rimegepant, atogepant over a 2-year observation period. It includes patients who meet local reimbursement criteria and have a confirmed migraine diagnosis following international standards. Participants will start treatment with one of the anti-CGRP monoclonal antibodies or gepants as prescribed. Baseline assessments will be done before treatment begins. Follow-up visits will occur every 6 months to check treatment effectiveness, side effects, patient-reported outcome measures, and eligibility to continue using the study drug. The observation phase will last for 2 years. During the study, participants will undergo regular evaluations including headache frequency, migraine impact, anxiety, depression, sleep quality, and quality of life measures through various questionnaires. Researchers will monitor changes in monthly headache and migraine days, along with other clinical and patient-reported outcomes. The study will ensure ongoing safety and treatment monitoring throughout the 2-year period.