Leganes

Researchers are evaluating the use of sodium zirconium cyclosilicate (SZC) to optimize treatment with renin-angiotensin aldosterone system inhibitors (RAASi) in elderly patients with heart failure and chronic kidney disease who have elevated or at-risk serum potassium levels. This Phase 3 randomized clinical trial aims to find the best strategy to safely increase RAASi doses to recommended levels without causing significant hyperkalemia, which often limits these treatments despite their benefits for reducing mortality and morbidity. Eligible patients have had recent heart failure decompensation requiring hospital admission and intravenous diuretics, with mild hyperkalemia or risk of developing it. Participants will be randomly assigned to receive either SZC along with RAASi therapy or standard care without potassium binders for three months. The study involves up-titrating ACE inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, or mineralocorticoid receptor antagonists according to clinical guidelines. The goal is to evaluate whether SZC helps patients reach target RAASi doses safely. Treatments are managed according to European Society of Cardiology recommendations, and the study is conducted across multiple centers with an open-label, parallel group design. Throughout the study, patients will be monitored from screening to three months after inclusion to assess how many can increase their RAASi doses by at least 25%. Researchers will evaluate potassium levels, kidney function, heart failure status, and adherence to treatment. Safety and tolerability will be observed, and data on hospitalizations, adverse events, and other clinical outcomes will be collected to understand the impact of SZC on optimizing heart failure and kidney disease management in elderly patients.

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are conducting a phase 1, multicenter, nonrandomized, open-label, first-in-human study to evaluate YL201 in patients with advanced solid tumors. The study is taking place in China and the United States and consists of two parts: a dose escalation phase to determine the maximum tolerated dose and recommended dose, followed by a dose expansion phase to further assess safety and efficacy. This study targets patients whose tumors are unresponsive to current therapies or who have no standard treatment options available. Participants will receive YL201 through intravenous infusion once every three weeks as a treatment cycle. In some groups, YL201 is administered alone, while in others it is combined with atezolizumab on the first day of each 21-day cycle. The dose escalation phase involves careful monitoring to identify dose-limiting toxicities. The dose expansion phase will enroll patients at the established dose to better define safety and evaluate responses, including in prostate cancer and other solid tumors. Throughout the study, participants will undergo regular assessments including laboratory tests, evaluation of tumor response using RECIST criteria, and monitoring of adverse events. Researchers will track the occurrence of dose-limiting toxicities during the first treatment cycle and overall safety up to approximately 36 months. They will also measure prostate-specific antigen response rates in prostate cancer patients and objective response rates in other solid tumors. Participants must comply with scheduled visits and procedures during the study period.

Researchers are evaluating how well the 20-valent pneumococcal conjugate vaccine (20vPnC) protects adults aged 65 and older who are hospitalized with radiologically-confirmed community-acquired pneumonia (RAD+CAP). The study focuses on pneumonia caused by seven new types of the Streptococcus pneumoniae bacteria included in the 20vPnC vaccine. This observational study uses a test-negative design to compare the presence of these specific bacterial types in vaccinated and non-vaccinated participants. Participants provide a urine sample that is tested with BinaxNOW4 S. pneumoniae and serotype-specific urinary antigen detection (UAD) assays to detect the bacteria and its strains. Cases are defined as participants with pneumonia caused by the seven additional serotypes in 20vPnC beyond those in the 13-valent vaccine, plus serotype 15C. Controls include participants without these vaccine serotypes or with pneumonia caused by other agents. The main diagnostic procedure is the non-invasive urine test, and all participants are hospitalized adults aged 65 or older with pneumonia confirmed by chest imaging. Participants share demographic and medical history information and undergo urine testing during their hospital stay, which typically lasts 1 to 2 days for study procedures. Researchers collect data on illness and hospitalization for up to 30 days through medical chart reviews. The primary outcome measures how effective 20vPnC is against pneumonia caused by the additional serotypes over a 55-month period, helping to understand the vaccine's real-world performance in this older population.

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 eye health in patients with breast cancer through a multicenter study. The study aims to assess ophthalmic safety by comparing two groups of patients concurrently to account for age-related changes and worsening of existing eye conditions. The study period for ophthalmic assessments will last approximately 12 months to minimize additional burden on participants. The study includes two parallel cohorts, each with at least 60 participants. Ophthalmic examinations will be conducted at the same time points for both groups. These assessments involve tests such as visual acuity using Snellen units, slit lamp examinations, optical coherence tonometry, and fundus examinations to monitor eye health. Participants will undergo ophthalmic evaluations performed by local ophthalmologists and central readers up to 28 days after the study ends. These evaluations include eye scans and detailed eye health reviews. The study monitors changes in vision and eye structure and safety throughout the 12-month period, ensuring participants' eye health is closely observed.

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 aims to compare this approach with a conventional high-intensity strengthening program. The study addresses the limited research on BFRT's benefits in neurological conditions, particularly MS, and investigates whether BFRT can offer superior improvements in muscle strength and daily functioning. Participants will be randomly assigned to one of two groups. The experimental group will perform low-intensity strengthening exercises at 20% of their one-repetition maximum (1RM) combined with BFRT using an external pneumatic tourniquet at 60% of each participant's total restriction pressure. Exercises include wrist flexion and extension, radial and ulnar deviation, forearm pronation and supination, and elbow flexion and extension, completed in sets of 30/15/15/15 repetitions. The control group will perform conventional strengthening exercises at 70% 1RM using dumbbells, with 4 sets of 8 to 12 repetitions, avoiding muscle failure. Participants will be assessed before the intervention, immediately after, and during follow-up. Evaluations include measurements of isometric hand strength, dexterity, muscle fatigability, coordination, and quality of life. Safety and adherence will be monitored throughout. The total planned sample size is 21 participants, with assessments conducted at the Leganés Multiple Sclerosis Association. The trial incorporates examiner blinding and follows CONSORT guidelines to ensure study quality and reliability.

Researchers are evaluating AMG510 (Sotorasib) in patients with unresectable stage III KRAS p.G12C non-small cell lung cancer (NSCLC) who are not eligible for chemo-radiotherapy. This open-label, phase II, multi-center clinical trial will enroll 43 patients to assess the treatment's efficacy by measuring progression-free survival over 12 months. The study aims to provide insights into the potential benefits of AMG510 for this specific lung cancer population. Participants will receive AMG510 tablets at a dose of 960 mg once daily for two 4-week cycles during the induction phase. Patients showing stable disease, partial response, or complete response after induction will continue AMG510 treatment post-induction at the same dose and schedule until disease progression, unacceptable side effects, decision to stop treatment, or death. The trial includes an extended treatment period and follow-up phases to monitor patient outcomes. During the study, participants will undergo various assessments including PET-CT scans, brain CT or MRI, and evaluations of tumor response following RECIST criteria. Researchers will track progression-free survival from the start of treatment until tumor progression or death. Safety and tolerability will be closely monitored, and patients will be followed for up to two years after treatment. The entire study is expected to last over five years, including patient enrollment, treatment, and follow-up.

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.