Sant Joan Despi

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

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 examining the relationship between chronic non-cancer pain and chronic insomnia, conditions that often occur together and significantly reduce quality of life. Chronic pain, defined as pain lasting more than three months, affects about 17% of adults in Spain. Insomnia, which involves difficulty falling or staying asleep and daytime impairment, is common but varies in definition and prevalence. This study aims to estimate how many adults with chronic non-cancer pain also have chronic insomnia, addressing a gap in current knowledge to support better combined treatment approaches. The study observes adults with chronic non-cancer pain who are receiving usual care from pain specialists or dedicated pain units in outpatient settings. There is no experimental intervention; instead, patients continue their standard treatments while researchers collect data on their sleep and pain conditions. The main focus is to identify the proportion of these patients who meet criteria for chronic insomnia during a baseline visit. Participants will be involved in assessments during a baseline visit to determine the presence of chronic insomnia symptoms and their impact. Researchers will evaluate sleep difficulties and daytime impairments related to insomnia alongside chronic pain symptoms. The primary measurement is the proportion of patients with chronic non-cancer pain who also have chronic insomnia at that single time point. This information will help guide future integrated care strategies for this population.

Researchers are evaluating the role of Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) with Mitomycin-C in patients with colon cancer that has spread to the peritoneum. The study focuses on patients undergoing complete surgical removal of these metastases combined with systemic chemotherapy. This Phase IV multicenter trial aims to determine if adding HIPEC with Mitomycin-C improves the time patients remain free from cancer recurrence in the peritoneal cavity, addressing limitations seen in previous studies using a different drug and treatment approach. Participants will be divided into two groups: one receiving complete cytoreductive surgery plus HIPEC with Mitomycin-C for 90 minutes, and the other undergoing surgery alone without HIPEC. The HIPEC procedure uses a dose of 35 mg/m2 Mitomycin-C delivered in a heated solution for 90 minutes with specific dose fractionation at set intervals. Only patients with limited volume peritoneal metastases, complete tumor removal, and colon (not rectal) cancer are included. Systemic chemotherapy is given before and/or after surgery as part of the treatment. During the study, patients will be closely monitored to confirm complete tumor removal and disease extent. Researchers will track peritoneal recurrence-free survival over three years as the primary outcome. Patients undergo assessments to ensure they meet health and surgical risk criteria before enrollment. Safety and disease progression are also regularly evaluated, with informed consent and ongoing follow-up care provided throughout the trial.

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.

Treatment of fluid buildup is a key goal for patients hospitalized with acute heart failure. This research evaluates leftover congestion at hospital discharge using multiple methods and compares how well each predicts patient outcomes. The study also uses artificial intelligence to create a combined prediction model that may improve on standard approaches. Participants will have their residual congestion assessed by clinical signs like swelling and breathing difficulty, imaging tests including ultrasound scores, and lab tests measuring blood markers such as NT-proBNP and troponin T. This multiparametric evaluation aims to capture a complete picture of congestion at discharge. During the study, researchers will monitor participants for worsening heart failure or cardiovascular death up to six months after discharge. Various clinical, imaging, and laboratory data will be collected to track health status and outcomes over time.

This research aims to compare two imaging methods used during difficult laparoscopic gallbladder removal surgery (cholecystectomy) to help identify important bile duct anatomy. The study focuses on patients who need this surgery but are expected to have technical challenges due to conditions like acute inflammation, previous abdominal surgeries, or obesity. It is a multicenter, prospective clinical trial conducted to see which imaging technique better identifies the bile duct junction during surgery. Participants will have both laparoscopic ultrasound (LUS) and fluorescence cholangiography using indocyanine green (ICG) during their surgery. The imaging will follow a set order: first LUS, then fluorescence cholangiography before the critical dissection area called Calot's triangle is explored. This allows a direct comparison of the two methods in the same patient. The study also records other details like the time needed to see the bile ducts, total surgery time, and any complications during or after surgery. During the surgery, researchers will assess how clearly the key bile duct junction can be identified using both imaging methods. They will also note visualization of specific bile duct structures and timing factors. Safety will be monitored by tracking any complications related to the surgery. Participants must be adults and provide consent, and the study involves careful tracking during the operation but no additional long-term follow-up is described.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.