Segovia

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are collecting real-world data on how tislelizumab is used and its clinical outcomes in European adults with resectable or advanced non-small cell lung cancer NSCLC and extensive-stage small cell lung cancer SCLC. The study includes patients receiving tislelizumab as part of their routine medical care in various clinical settings, focusing on treatment patterns and effectiveness across different patient groups. Participants receive tislelizumab according to routine clinical practice determined by their treating physicians, following local standards and the approved product guidelines. The study observes four patient cohorts based on their lung cancer type and disease stage, including those with resectable NSCLC at high risk of recurrence, non-squamous NSCLC with high PD-L1 expression, locally advanced or metastatic squamous NSCLC, and extensive-stage SCLC. During the study, researchers gather information on the timing of first dose, treatment duration, dose changes, and treatment discontinuation over up to 30 months. They also assess response rates, pathological complete response, and overall survival at specific time points. This observational study monitors participants receiving their usual care without altering treatment and continues until the study ends or the participant stops treatment.

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 evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating if a combination of Venetoclax, Azacytidine, and Quizartinib works better than the standard treatment of Venetoclax and Azacytidine to treat adult patients with newly diagnosed acute myeloid leukemia AML who cannot receive standard induction therapy due to age, other health issues, or risk factors. The study aims to determine which treatment offers a better chance of overall survival. Participants will be randomly assigned to one of two treatment groups. One group will receive Azacytidine by subcutaneous injection daily for seven days in each 28-day cycle, Venetoclax orally for seven days alongside Azacytidine, and Quizartinib orally from days 8 to 21, with doses adjusted based on genetic markers. The other group will receive Azacytidine injections for seven days and Venetoclax orally for seven days per cycle without Quizartinib. Treatments continue until disease progression, unacceptable side effects, or other criteria for stopping are met. During the study, participants will have regular visits for treatment and monitoring. Researchers will collect survival information and follow up by phone or clinic visits every three months for two years after the last patient enrolls. The main outcome measured is overall survival over four years. Additional outcomes include event-free survival and complete response rates over four years. Safety and health assessments will be regularly conducted throughout the trial.

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 the safety and effectiveness of subcutaneous immunotherapy in patients aged 12 to 65 who have rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, and who are sensitive to cupressaceae and grass pollen. This phase 3, multicenter, randomized, double-blinded, placebo-controlled trial aims to better understand treatment options for allergy symptoms related to these pollens. Participants will be randomly assigned to one of three groups two groups receiving different doses of a purified and polymerized allergen extract from grasses and cupressaceae mixed with aluminum hydroxide, and one placebo group receiving a similar solution without active ingredients. The treatment will be given by subcutaneous injections and will last for 18 months. The study will monitor symptoms and medication use during the specific pollen seasons for cupressaceae January to March and grasses May to June. Throughout the trial, participants will record their symptoms and medication intake using an electronic diary via a smartphone. Researchers will assess combined symptom and medication scores as the primary outcome, along with various secondary measures such as symptom-free days, medication-free days, asthma and rhinitis symptom scores, quality of life, immunological parameters, and safety. The total participation time for each subject is 18 months, during which their health and response to treatment will be closely monitored.

Researchers are examining the use of dexamethasone in adults with acute hypoxemic respiratory failure AHRF, including acute respiratory distress syndrome ARDS, caused by infections such as COVID-19. This condition leads to severe lung inflammation requiring mechanical ventilation and has high mortality rates. The effectiveness of corticosteroids like dexamethasone in treating AHRF and ARDS remains uncertain, prompting this study to compare different dosing strategies to better understand their impact on patient outcomes. The trial is a randomized, controlled, open-label study conducted across multiple centers in Spain. Participants who are mechanically ventilated with confirmed infection-related AHRF will be assigned to receive either a low dose of dexamethasone 6 mg daily for 10 days or a higher dose 20 mg daily for 5 days, followed by 10 mg daily for 5 days. The study compares these two dosing regimens to determine which may better reduce mortality and improve ventilator-free days. During the trial, participants will be closely monitored in intensive care units, with primary outcomes measured by mortality at 60 days and secondary outcomes by the number of days free from mechanical ventilation within 28 days. Researchers will gather data on lung function, infection status, and overall health. Participants progress will be followed to assess the safety and effects of the dexamethasone doses over the study period.

Researchers are investigating the effectiveness of two types of videolaryngoscope blades, hyperangulated and Macintosh, for tracheal intubation in patients admitted to intensive care units ICUs. The study aims to determine which blade type improves the chances of successful intubation on the first attempt, addressing complications and difficulties commonly seen in ICU intubations. This is a prospective multicenter randomized clinical trial focused on critically ill patients needing airway management.

The trial investigates treatment options for adults with newly diagnosed multiple myeloma who are eligible for stem cell transplantation. It is a Phase III, open-label, randomized study comparing three treatment approaches to evaluate their effectiveness in achieving minimal residual disease negativity using next-generation flow cytometry. The study aims to compare an extended VRD regimen plus early rescue intervention with two Isatuximab-containing regimens. Participants are assigned to one of three groups Arm A receives Isatuximab combined with VRD followed by autologous stem cell transplant ASCT, then consolidation and continuous treatment with Lenalidomide and monthly Isatuximab Arm B receives an extended VRD regimen with ASCT plus early rescue intervention involving Isatuximab-Iberdomide-Dexamethasone, followed by consolidation and continuous treatment with adjusted VRD cycles Arm C is treated with Isatuximab, Iberdomide, VRD, and ASCT, followed by consolidation and continuous treatment with Iberdomide and monthly Isatuximab. Each treatment phase includes induction, ASCT, consolidation, and continuous therapy lasting approximately 24 months or longer. Throughout the study, participants undergo multiple cycles of treatment with frequent dosing schedules, including intravenous infusions and oral medications. Researchers assess the primary outcome by measuring the proportion of participants who are MRD-negative after 18 cycles plus ASCT, approximately 24 months. Safety and progression-free survival are monitored over about 78 months. The study also involves bone marrow analyses, adherence tracking, and reviews of therapeutic programs up to 36 months. Participants are followed closely for treatment response and adverse events during and after therapy.