Puerto Real

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.

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 the use of inclisiran (Leqvio4) in patients with Atherosclerotic Vascular Disease (ASCVD) and/or Heterozygous Familial Hypercholesterolemia (HeFH) treated in clinical practice across Spain. The study aims to find out how many patients reach their low-density lipoprotein-cholesterol (LDL-C) targets based on their cardiovascular risk, 12 months after starting inclisiran treatment. It also assesses changes in LDL-C levels, safety, treatment adherence and persistence, use of other lipid-lowering therapies, and patient satisfaction with inclisiran. This is a non-interventional, prospective, nationwide study conducted at multiple centers in routine clinical practice. Participants receive inclisiran as prescribed by their doctors, with no treatment allocation by the study. The study involves three visits aligned with standard follow-up care. Blood tests to measure LDL-C levels are done at 3, 6, 9, and 12 months after starting inclisiran, following usual clinical procedures. During the study, participants will be monitored through routine clinical assessments without interference in care. Researchers will track LDL-C levels over 12 months to evaluate treatment outcomes. The study also gathers information about safety, medication adherence, use of other lipid-lowering drugs, and patient satisfaction. Total participation spans 12 months after the first dose of inclisiran, with data collected during routine visits.

Researchers are conducting a multicenter, prospective, non-randomized post-market clinical follow-up study to evaluate the safety and performance of the Sequent Please Neo device. The study focuses on a real-world, non-selected patient population with coronary artery disease and ischemic heart disease treated in daily clinical practice. The goal is to confirm that the device meets the European Union Medical Device Regulation requirements for post-market surveillance. Participants treated with the Sequent Please Neo device under routine hospital practice and following manufacturer instructions will be monitored. This study includes patients who have already undergone treatment with the device, with no randomization or comparison groups. The device's clinical safety and performance will be assessed during usual care settings. Participants will be followed for 12 months to monitor the primary outcome of freedom from major adverse cardiac events (MACE). Informed consent will be obtained before enrollment. Researchers will gather data on device safety and effectiveness through routine clinical follow-up visits and assessments. The study aims to support ongoing evaluation of the device's performance in everyday medical use.

Gastric cancer treatment often involves major surgery that can greatly affect patients' quality of life, causing symptoms ranging from digestive problems to emotional distress. Existing quality of life questionnaires do not fully cover symptoms specific to gastric surgery. This research aims to translate, culturally adapt, and validate the Korean KOQUSS-40 quality of life questionnaire into Spanish (called SPQUSS-41) to better assess the quality of life in patients who have undergone curative gastric cancer surgery. This tool will improve personalized care, communication between patients and doctors, and symptom management. The study is a prospective multicenter cohort study conducted under Spain's EURECCA Esophagogastric Cancer Project. It includes two main phases: development and validation. First, the questionnaire will be translated into Spanish and reviewed by experts, followed by a pre-test with 20 patients to check comprehension and a pilot test with 85 patients to refine the questionnaire. In the validation phase, the final Spanish version will be given to at least 410 patients alongside other established quality of life questionnaires, with a retest after 30 days to check reliability. Participants are adults over 18 years old who had curative surgery for gastric cancer from 1 month up to 5 years ago. Researchers will collect demographic and clinical data, including surgery details and treatment history, recorded securely in an online registry. They will analyze questionnaire validity, consistency, and reliability using statistical methods. The study expects to involve at least 10 centers over 1 to 2 years. The main outcome measure is the Spanish validation of the KOQUSS-40 questionnaire evaluated at baseline and again after 30 days.

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.