Barcelona

Researchers are evaluating the safety and effectiveness of personalized, dynamic titanium prostheses designed to reconstruct the chest wall after tumor removal, severe trauma, or other chest defects. Traditional reconstruction methods often use rigid materials that can cause discomfort and breathing difficulties. This study aims to test 3D-printed titanium implants that mimic natural rib movement, potentially improving breathing function and patient comfort. The study is a multicenter registry combining past and new cases from major Spanish hospitals, running prospectively from January 2024 to January 2026 with follow-up through 2027. Participants receive a custom prosthesis created using a preoperative CT scan and manufactured from titanium alloy using electron beam melting. Surgery involves removing the affected chest wall segment and implanting the custom prosthesis anchored to the ribs and sternum. Follow-up evaluations occur at hospital discharge, 1 month, 6 months, and 12 months after surgery. The prosthesis is designed to restore chest wall structure and allow dynamic flexibility similar to natural rib movement. Throughout the study, participants undergo assessments including lung function tests, pain scales, CT imaging, and quality of life questionnaires. Data on surgical details, prosthesis characteristics, complications, and functional outcomes are securely collected and analyzed. The primary outcomes focus on changes in lung function measured by various spirometric parameters from baseline to one year after surgery. The total participation time includes surgery and a 12-month follow-up period, with data handling compliant with privacy regulations.

Researchers are investigating the drug bezuclastinib in an open-label, two-part Phase 2 study for patients with Advanced Systemic Mastocytosis (AdvSM), including Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL). The study aims to evaluate the safety, effectiveness, and how the drug behaves in the body for these serious conditions. Bezuclastinib is given orally as tablets taken continuously in 28-day cycles. The study has two parts: Part I focuses on identifying safe and tolerable doses of bezuclastinib over 18 months, while Part II evaluates its effectiveness by measuring the objective response rate and confirming the relationship between drug exposure and response during another 18-month period. Participants will undergo assessments including clinical evaluations, laboratory tests, and monitoring of their disease status to determine treatment effects and safety. Researchers will track the drug's impact on the disease and patient health throughout the study, which involves continuous treatment and follow-up over the specified time frames.

Researchers are evaluating the safety and effectiveness of elenestinib (BLU-263) combined with symptom-directed therapy (SDT) compared to placebo plus SDT in people with indolent systemic mastocytosis (ISM) whose symptoms are not well controlled by SDT alone. This Phase 2/3 randomized, double-blind, placebo-controlled study includes participants with ISM and smoldering systemic mastocytosis, and also involves groups for pharmacokinetic studies and participants who previously received a selective KIT inhibitor. The study is divided into multiple parts. Parts 1 and 2 enroll participants with ISM who will receive either elenestinib oral tablets or placebo alongside their symptom-directed therapy. Participants from Part 2 may continue into Part 3, which is an open-label extension where all receive elenestinib. Part K enrolls participants with ISM who have prior experience with selective KIT inhibitors. The study tracks treatment effects and safety over time. Participants will be monitored for up to 5 years, with assessments including the number of treatment-emergent adverse events, changes in symptom scores measured by the ISM-Symptom in Assessment Form, and overall safety monitoring. Evaluations occur at baseline, 13 weeks, 49 weeks, and throughout the long-term follow-up. The study also includes detailed tracking of symptom control and adverse events to evaluate the impact of treatment on participants' health and quality of life.

Researchers are evaluating the +AGIL Barcelona program to help older adults improve their physical abilities and delay disability. This study focuses on frail older adults aged 65 and above and aims to assess how well the program can be adapted and expanded to different community health centers in Barcelona. The study uses a stepped-wedge cluster randomized trial design involving three primary care centers, with a total of 396 participants. The program is based on a Comprehensive Geriatric Assessment and guided by the World Health Organization's Integrated Care for Older People framework, focusing on improving intrinsic capacity and preventing disability. Participants will engage in up to 10 weekly group exercise sessions led by a physiotherapist, focusing on resistance, endurance, balance, and flexibility. Exercises are tailored to individual needs and supported with materials designed for low literacy or cognitive challenges. In addition, participants receive nutritional guidance for a Mediterranean diet, screening and counseling for swallowing and cognitive issues, sleep hygiene advice, medication reviews for optimization, and support to connect with community resources to reduce social isolation. After the initial 10-week intervention, the program encourages continued activation through local gyms, civic centers, and other community facilities. Throughout the study, participants' physical performance will be measured using the Short Physical Performance Battery (SPPB) at the start, after 3 months, and again at 6 months. Researchers will also assess participants' experiences and how the program is implemented across sites. The study aims to provide practical information on how to deliver effective, community-based programs that support healthy aging and independence in older adults.

Researchers are evaluating a new treatment approach for meningiomas that continue to grow despite local therapies like surgery and radiotherapy. This trial focuses on the precision medicine concept of combining molecular imaging for patient selection with targeted treatment using a radioligand called 177Lu-DOTATATE. The study builds on evidence showing high expression of somatostatin receptors in meningiomas and prior success of this radioligand therapy in other tumors, aiming to explore its use in refractory meningiomas in a randomized Phase II study. Participants are randomly assigned to receive either the investigational treatment 177Lu-DOTATATE given by intravenous injection or the local standard of care, which may include treatment or observation as decided by their doctor. The trial involves baseline PET imaging to confirm somatostatin receptor positivity and follows patients after treatment. This design allows researchers to compare the effects of the new therapy against current practices in managing recurrent meningioma. During the study, participants undergo assessments including cranial MRI scans to measure tumor status and PET imaging for receptor evaluation. Blood tests are performed to monitor organ function and electrolytes before and during treatment. The main outcome measured is progression-free survival, tracking the time from randomization until disease progression or death, with follow-up for up to two years. Safety and treatment adherence are closely monitored throughout the study period.

Twenty years after the first nationwide record of anesthesia activity in Spain, called ANESCAT 2003, healthcare demands in this specialty have grown beyond earlier expectations. This research aims to update the assessment of anesthesia services to evaluate if the resources allocated match the increased workload and to provide objective data for future planning and resource allocation. The study collects data on anesthesia activities in various clinical settings including surgical procedures, intensive care units, chronic pain units, and delivery rooms. This information is gathered over a 14-day period within one year using several questionnaires designed to capture all anesthesia-related work involvement. Participants include all patients who receive anesthesia services during this 14-day monitoring period, without any restrictions. Researchers will assess anesthesia activity levels to understand workload distribution and resource needs. The study's findings will support healthcare planning and ensure adequate resource provision for anesthesia services in Spain.

Researchers are evaluating remibrutinib (LOU064) in adolescents aged 12 to under 18 years who have chronic spontaneous urticaria (CSU) that is not well controlled by H1-antihistamines. This Phase 3 trial aims to assess the effectiveness, how the drug is processed in the body, and safety of remibrutinib compared to a placebo. The study also intends to gather long-term data on how well remibrutinib works and its safety over several years after treatment ends. The trial includes three periods. First, the core period is a 24-week double-blind phase where about two-thirds of participants receive remibrutinib and one-third receive placebo, with about 10 site visits over approximately 32 weeks. Next is an optional open-label extension lasting from one to three years, where participants who completed the core period may receive remibrutinib or enter an observational treatment-free phase depending on their symptoms. Participants may cycle through treatment and observational periods up to six times. Finally, an optional long-term treatment-free follow-up can last up to three years with one site visit and up to four phone calls. During the study, participants undergo assessments including changes in urticaria activity scores (UAS7), itching severity (ISS7), and hive severity (HSS7) measured from baseline to 12 weeks. Regular visits monitor safety, symptoms, and drug effects. The study tracks these measures to understand remibrutinib's impact on CSU symptoms and overall safety profile during and after treatment, with total participation potentially lasting several years.

Preterm birth before 37 weeks' gestation is common and linked to many health challenges, especially when it occurs before 29 weeks. At this early stage, infants often face breathing difficulties due to immature lungs, sometimes requiring resuscitation. This study aims to compare two oxygen concentrations, 30% and 60%, used during resuscitation of very preterm infants to determine which leads to better survival and neurodevelopmental outcomes by about two years of age. The study uses a cluster randomized crossover design, where hospitals alternate between using 30% and 60% oxygen to resuscitate infants born between 23 and 28 weeks gestation. Infants receive the assigned oxygen concentration for the first 5 minutes after birth, with adjustments made based on oxygen saturation levels to maintain safe ranges. The intervention lasts 10 minutes, including initial resuscitation and oxygen titration to stabilize the infant. Participants will be closely monitored during their hospital stay and followed up at 24 months corrected age to assess survival and major neurodevelopmental outcomes. Data collected will include oxygen saturation, heart rate during resuscitation, and longer-term health measures. The study's results aim to guide safer oxygen use in resuscitating extremely preterm infants worldwide.

Kienbock's disease is a condition involving ischemic necrosis of the lunate bone in the wrist. This research evaluates surgical treatments using 3D printing models and personalized guides to plan different types of radial osteotomies for stages II and III of the disease. The study focuses on modifying anatomical risk factors to reduce pain, maintain wrist function, and avoid disease progression based on the patient's wrist anatomy and disease stage. The main intervention involves performing radial osteotomies guided by 3D printed models and personalized surgical guides to improve accuracy. Different osteotomy techniques, including shortening, wedge, and dorsolateral biplane closing osteotomies, are selected depending on factors like radial inclination angle and the presence of cubitus minus. Osteosynthesis with a plate is used to stabilize the distal radius after the osteotomy. Participants will be monitored over 22 months with preoperative and postoperative clinical evaluations including the Mayo Wrist Score, grip strength, pain, and range of motion. Radiological assessments of wrist anatomy and disease stage will also be performed using various measurements on wrist X-rays. The study aims to measure functional outcomes and anatomical changes to assess the surgical planning approach and osteotomy effectiveness.

Researchers are working to create a comprehensive reference database focused on intracranial aneurysms (IA). This project aims to gather detailed clinical history, imaging data, biological samples, and other related information to better understand risk markers for aneurysm formation and rupture, along with prognostic factors for different management strategies. The study also seeks to develop patient-specific management protocols and assess how the database and its tools can improve care, reduce costs, and support new discoveries and industrial developments. Participants include patients with newly diagnosed or known intracranial aneurysms, healthy volunteers, and family members of patients with a familial history of IA. Data collected includes demographic details, medical history, imaging scans such as MRI angiography and CT angiography, and various biological samples like blood, cerebrospinal fluid, saliva, and stool. Participants are asked to provide consent for data and sample use, including genetic analysis and potential future research applications. There are no limits on the number of participants for this database. During the study, participants will provide access to their health records, complete questionnaires, and undergo imaging and sample collection. Researchers will track clinical outcomes, imaging results, and quality of life measures over time. The primary outcome is disease model validation over 5 years. Consent includes provisions for confidentiality, withdrawal without impact on care, and possible re-contact for additional information or consent. The study ensures safety through ethical oversight and insurance coverage for any direct harm related to participation.