Leganes

Researchers are evaluating the use of sodium zirconium cyclosilicate SZC to help optimize renin-angiotensin aldosterone system inhibitor RAASi therapies in elderly patients aged 70 and older who have heart failure and chronic kidney disease. Many patients with these conditions do not receive recommended RAASi doses because of elevated potassium levels, which can be dangerous. This study aims to see if adding SZC allows safer and more effective use of RAASi medications by managing potassium levels. This is a randomized, open-label clinical trial where eligible participants who have been hospitalized for heart failure worsening and have mild or at-risk hyperkalemia will be assigned to one of two groups. One group receives SZC along with standard RAASi treatment, while the other receives RAASi treatment alone without potassium binders. The treatment period lasts three months, during which RAASi doses are adjusted following European Society of Cardiology guidelines. Participants will be monitored from screening through three months of treatment to measure how many can increase their RAASi doses by at least 25%. Evaluations include clinical assessments, potassium level monitoring, and adherence to therapy. The study will also track secondary outcomes related to higher dose increases. Safety and treatment effects will be observed throughout the trial, which is expected to provide important insights for managing these conditions in elderly patients.

Researchers are conducting a prospective, multicenter observational study to create a registry for patients with unresectable locally advanced or metastatic breast cancer. This study includes patients diagnosed from January 2016 onwards, either at first diagnosis or after recurrence. Treatment choices are made independently by physicians, and the study does not specify any treatment regimen. The study groups are defined by breast cancer subtypes based on receptor expression, including Luminal A-like, Luminal B-like HER2 negative and positive, HER2-enriched, and Triple Negative subtypes. Since this is an observational study, patients receive standard care as determined by their doctors, and no intervention is assigned by the study. Participants medical records and disease management data will be collected and reviewed over an 8-year period. Researchers will evaluate the distribution of breast cancer subtypes, patient and tumor characteristics, hereditary risk factors, gender differences in disease progression, timing of primary tumor surgery, and biomarker presence in tumor and blood samples. Patients may withdraw consent at any time, and the study aims to follow patients until death or study completion.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are conducting a phase 1, multicenter, nonrandomized, open-label study to evaluate YL201 in patients with advanced solid tumors that have not responded to current treatments or lack standard therapy options. The study includes two parts Part 1 focuses on finding the maximum tolerated dose and recommended dose levels through dose escalation, while Part 2 enrolls patients with selected tumor types to further assess safety and efficacy of YL201. Participants will receive YL201 as an intravenous infusion once every three weeks in cycles. Some patients may receive YL201 alone at different dosages or in combination with atezolizumab during each 21-day cycle. Part 1 involves dose escalation cohorts to determine appropriate dosing, followed by Part 2 dose expansion cohorts to better define safety and evaluate treatment responses. Throughout the study, participants undergo tumor evaluations using RECIST criteria, laboratory tests, and safety monitoring to track adverse events, dose-limiting toxicities, and pharmacokinetics. For prostate cancer patients, prostate-specific antigen response and progression-free survival will be measured. The study lasts approximately 36 months, with ongoing assessments of tumor response, survival, and laboratory abnormalities conducted at regular intervals.

Researchers are evaluating how well the 20-valent pneumococcal conjugate vaccine 20vPnC works against pneumonia caused by seven new types of the Streptococcus pneumoniae bacteria. This study focuses on adults aged 65 years and older who are hospitalized with pneumonia confirmed by chest imaging. The study aims to compare the presence of pneumonia caused by these specific bacteria types in people vaccinated with 20vPnC versus those with pneumonia caused by other bacteria or strains. This observational study involves adults 65 years and older hospitalized with radiologically-confirmed community-acquired pneumonia RADCAP. Participants will provide a urine sample for testing pneumococcal bacteria using BinaxNOW and specific urinary antigen detection assays UAD-1 and UAD-2. Cases are identified by detection of the seven additional bacteria types in 20vPnC beyond the previous 13-valent vaccine, while controls include other pneumonia cases without these serotypes. No treatment is given as part of the study. Participants will be involved for about 1 to 2 days for urine sample collection and providing medical history. Researchers will collect detailed information on illness and hospital stay up to 30 days through medical record review. The main outcome measured is the effectiveness of 20vPnC against pneumonia caused by the seven additional bacterial types over approximately 55 months. Other clinical features and pneumonia types will also be reviewed during this period.

This observational, prospective study focuses on patients with post-percutaneous coronary intervention PCI angina who are referred for invasive coronary angiography ICA. It aims to identify the causes and origins of post-PCI angina using an advanced invasive diagnosis AID strategy combined with angiography derived physiology ADP. The study includes patients with a history of PCI who present angina or documented myocardial ischemia, investigating both obstructive and non-obstructive causes of ischemia. Participants undergo ICA with the structured AID strategy, starting with coronary angiography to evaluate severe-grade stenosis. Intermediate-grade stenosis is further assessed using fractional flow reserve FFR and non-hyperaemic pressure ratios NHPR. Patients with non-obstructive coronary artery disease or normal arteries undergo tests for microcirculatory and vasomotor disorders. ADP is applied using specialized software to analyze coronary angiograms from both the current and previous procedures. Treatment decisions are made by clinicians based on these assessments. Patients complete the Seattle Angina Questionnaire SAQ at baseline and at 1, 6, and 12 months after the procedure to evaluate angina symptoms. The main outcome is the proportion of patients in whom the origins of obstructive disease and causes of post-PCI angina are identified. The study also measures angina symptom improvement at 6 months. Follow-up includes clinical evaluations and symptom questionnaires to monitor outcomes over one year.

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 effects of a low-intensity muscle strengthening program combined with Blood Flow Restriction Training BFRT on upper limb strength, muscle fatigue, coordination, dexterity, functionality, and quality of life in people with multiple sclerosis MS. This randomized controlled trial compares this approach to a conventional high-intensity strengthening program. The study aims to fill the gap in research about BFRTs impact on forearm and hand muscles in individuals with MS and to assess adherence and satisfaction with the intervention. Participants will be randomly assigned to one of two groups a control group performing a conventional high-intensity strengthening program using dumbbells at 70% of one repetition maximum 1RM with 4 sets of 8-12 repetitions, and an experimental group performing a low-intensity strengthening program at 20% 1RM combined with the BFRT system. The BFRT will be applied via an external pneumatic tourniquet at 60% of the total restriction pressure TRP during exercises involving palmar flexion, dorsal flexion, ulnar deviation, radial deviation, pronation, supination, and elbow flexion and extension. Each session includes rest periods based on fatigue. Participants will undergo assessments before, immediately after, and during follow-up up to 8 weeks. Evaluations include isometric hand strength, coordination tests, functional status of the upper limb, quality of life questionnaires, and satisfaction surveys. Researchers will monitor safety, feasibility, and adherence throughout the study, which is scheduled to start in March 2025 and run until December 2026. The total number of participants planned is 21, accounting for possible dropouts.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are evaluating AMG510 Sotorasib in adults with unresectable stage III non-small cell lung cancer NSCLC that has the KRAS p.G12C mutation and who cannot have chemo-radiotherapy. This open-label, non-randomized, phase II study aims to assess the treatments effect on progression-free survival at 12 months in 43 patients across multiple centers. The trial includes patients with specific lung cancer stages and medical conditions preventing standard chemo-radiotherapy. Participants will receive AMG510 tablets at a dose of 960 mg once daily for two 4-week cycles during an induction phase. Those with stable disease, partial response, or complete response after induction will continue AMG510 once daily during a post-induction treatment phase. Treatment continues until disease progression, unacceptable side effects, a decision to stop by patient or doctor, or death. The study plans patient enrollment over five and a half years, with treatment lasting up to 1.5 years. During the trial, participants will undergo regular assessments including PET-CT scans, brain imaging, and tumor evaluations based on standard criteria. Researchers will monitor progression-free survival, overall response rate, overall survival, sites of disease failure, and treatment side effects. Safety will be observed from consent through 30 days after treatment ends. Follow-up will continue for two years after treatment to track long-term outcomes and survival.