Segovia

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

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 evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

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 safety and effectiveness of subcutaneous immunotherapy in people aged 12 to 65 who have allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, sensitized to cupressaceae and grass pollens. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to compare active treatments with a placebo over an 18-month period. The study focuses on reducing symptoms and medication use during the pollen seasons of cupressaceae (January to March) and grasses (May to June). Participants will receive one of three treatments: two different doses of purified and polymerized allergen extracts from a mix of grasses and cupressaceae, or a placebo that looks the same but contains no active ingredients. These treatments are given as subcutaneous injections. Each participant will be treated and monitored for 18 months, covering multiple pollen seasons with continuous dosing. During the study, participants will track their symptoms and medication use daily using an electronic diary on their smartphone. Researchers will assess combined symptom and medication scores to measure treatment effects during pollen seasons. Safety and adherence will be monitored throughout the 18 months. The study involves 180 participants and includes various clinical assessments to ensure accurate evaluation of treatment impact and participant wellbeing.

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 comparing two types of blades used with videolaryngoscopes to see which is better for first-attempt tracheal intubation in patients admitted to intensive care units (ICU). This study focuses on critically ill patients who need intubation and aims to find out if the hyperangulated blade improves the success rate compared to the Macintosh blade, which is more similar to traditional laryngoscopy blades. The study is a prospective, multicenter, randomized trial designed to provide clarity on the best blade choice during ICU intubations. Participants will be randomly assigned to have their tracheal intubation performed using either a hyperangulated videolaryngoscope blade or a Macintosh videolaryngoscope blade during their first attempt. Both groups use videolaryngoscopy as the device for intubation, but differ in the blade type. The study evaluates the success of intubation on the first try using these different blades. During the study, researchers will monitor the intubation process to measure the percentage of successful first attempts. They will also track any complications or difficulties related to intubation. The study includes adult ICU patients from 18 to 90 years old who require intubation. Data on intubation success and related outcomes will help determine which blade offers better airway management in critically ill patients.

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.

This trial focuses on adult patients aged 18 to 60 years with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph-negative ALL). The study evaluates treatment approaches based on measurable residual disease (MRD) and genetic analysis done at the start. The goal is to determine the best continuation therapy after initial consolidation treatment to improve overall survival over three years. Participants first receive a uniform four-drug induction chemotherapy including vincristine, prednisone, pegylated asparaginase, and daunorubicin. Patients who do not respond adequately receive a second induction with fludarabine, Ara-C, G-CSF, and idarubicin (FLAG-IDA). Those with good MRD clearance proceed through early consolidation, delayed intensification, reinduction, and maintenance phases with pediatric-type chemotherapy drugs. Patients with less favorable MRD or genetic profiles may receive early or delayed allogeneic hematopoietic stem cell transplantation (alloHSCT). Throughout the study, participants undergo regular monitoring of disease status and response to therapy. Researchers assess overall survival at three years as the primary outcome. Patients' health status, treatment adherence, and side effects are closely followed. The study aims to personalize treatment plans based on MRD and genetics to optimize outcomes for adults with Ph-negative ALL.