Alcazar De San Juan

Researchers are evaluating patient-reported satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in adults with lung cancer or hepatocellular carcinoma treated in routine clinical practice. This non-interventional, multicenter, multicountry study collects primary data on health-related quality of life and treatment satisfaction for participants receiving Atezolizumab for approved indications. The study focuses on patients with specific lung cancer subtypes and advanced liver cancer who meet defined criteria regarding prior treatments and tumor characteristics. Atezolizumab is given subcutaneously at the discretion of the treating physician independently of study participation. Patients eligible for the study include those with early-stage or metastatic non-small cell lung cancer (NSCLC) with specific PD-L1 expression and genetic profiles, extensive-stage small cell lung cancer (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) not previously treated with systemic therapy. Treatment administration follows routine clinical practice, with no experimental interventions assigned by the study. Participants complete questionnaires assessing their satisfaction with Atezolizumab treatment and health-related quality of life during cycles 2 and 3 of therapy, each lasting three weeks. The primary outcome measure is the Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) score at these cycles. Safety and effectiveness data are monitored as part of routine care. The study collects data on patient experiences to better understand the real-world use of Atezolizumab over the treatment period.

Alport syndrome (AS) is a rare genetic disorder caused by changes in specific genes that produce collagen, leading to kidney disease, hearing loss, and eye abnormalities. People with AS are at high risk of developing chronic kidney disease, where the kidneys gradually lose their function, often marked by excess protein in the urine called proteinuria. This study focuses on evaluating BAY 3401016, a monoclonal antibody designed to block the protein Semaphorin 3A, which may contribute to kidney damage in AS, aiming to slow kidney function loss in adults with rapidly progressing AS. Participants will receive either BAY 3401016 or a placebo in a randomized, double-blind, parallel group Phase 2a study. The study includes an extension phase to further assess the treatment's effects. The treatment duration covers at least 24 weeks with follow-up visits extending up to 90 days after the end of treatment. The study measures the urinary albumin creatinine ratio (UACR) over weeks 16, 20, and 24 to evaluate kidney function. During the study, participants will undergo regular assessments including kidney function tests and urine measurements to monitor protein levels. Safety and efficacy will be tracked throughout treatment and follow-up. The study includes adults aged 18 to 45 with specific criteria related to kidney function and proteinuria levels. Overall participation spans the treatment period plus a 90-day post-treatment follow-up, with researchers closely observing changes in kidney health and safety outcomes.

Researchers are investigating the effects of different doses of dexamethasone, a corticosteroid, in adults with acute hypoxemic respiratory failure (AHRF) caused by infections, including COVID-19. This condition ranges from mild respiratory illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The trial aims to clarify whether moderate doses of dexamethasone reduce mortality more than low doses in patients requiring mechanical ventilation in intensive care units. Participants will be randomly assigned to receive intravenous dexamethasone either at a low dose of 6 mg per day for 10 days or a higher dose regimen of 20 mg per day for 5 days followed by 10 mg per day for another 5 days. This is a randomized, controlled, open-label study conducted across multiple centers in Spain. The study focuses on patients who are mechanically ventilated with confirmed pulmonary or systemic infections causing AHRF or ARDS. During the study, researchers will monitor patients for 60-day mortality as the main outcome and assess the number of days they are free from mechanical ventilation within 28 days. The study follows the intention-to-treat principle, ensuring all randomized patients are analyzed according to their assigned treatment. The trial includes detailed clinical assessments, chest imaging, and oxygenation measurements as part of patient evaluation throughout the treatment period.

Researchers are conducting an observational study called SOGUG-PRINCIS to collect and analyze data on the effectiveness of drugs recently approved for treating genitourinary tumors under routine clinical practice in Spain. This national, multicenter study includes both retrospective patient data and prospective follow-up, aiming to validate real-world outcomes compared to those reported in phase III clinical trials. The study covers cancers originating in the kidney, ureter, bladder, prostate, testicle, urethra, penis, and seminal vesicles. The study observes patients treated with drugs such as darolutamide combined with androgen deprivation therapy and docetaxel, adjuvant nivolumab after surgical removal of urothelial carcinoma, and enfortumab vedotin. All treatments follow their approved dosing and administration guidelines in standard clinical practice. New subprojects may be added as new drugs gain funding approval by the Spanish National Health System, with each subproject focusing on specific primary endpoints. Participants' involvement includes treatment decisions made independently from the study, with data collected afterward to assess outcomes. Researchers will track progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after treatment initiation. The study also serves as a registry for genitourinary cancer treatments funded nationally, supporting long-term evaluation of drug effectiveness in real-world settings.

This observational, multicenter study focuses on patients diagnosed with lung cancer and other thoracic tumors. It aims to improve treatment and prognosis by exploring patient data related to the expression of markers that predict responses to chemotherapy and molecular inhibitors. The study reflects a commitment to individualized treatment and understanding the epidemiology of thoracic tumors in Spain, addressing the high mortality and variability in diagnosis and treatment. The study collects information both retrospectively and prospectively from clinical histories of patients treated by thoracic surgeons and medical oncologists. It investigates epidemiological and therapeutic factors associated with thoracic tumors, including lung cancer, to support strategies like multidisciplinary care and early diagnosis. There are no interventions or treatments assigned, as this is an observational registry gathering comprehensive real-world data. Participants will have their clinical data reviewed to describe characteristics of lung cancer and other thoracic tumors over up to 10 years. The study aims to explore the epidemiology and treatment approaches, supporting future improvements in care. There is no age or gender restriction, and data collection includes both patients receiving active treatment and those under palliative care. The study duration, follow-up, and specific assessments are based on patient records and available medical information.