Barcelona

Researchers are evaluating the use of personalized, dynamic titanium prostheses made with 3D printing to reconstruct the chest wall after tumor removal or severe trauma. This study addresses the challenges of traditional rigid reconstruction methods that can cause pain or breathing difficulties by testing implants designed to mimic natural rib movement, potentially improving function and comfort. The study is a multicenter, ambispective registry collecting both retrospective and prospective data across major Spanish hospitals. The treatment involves creating a custom 3D-printed titanium prosthesis based on preoperative CT scans, manufactured using titanium alloy powder. During surgery, the prosthesis is implanted and anchored to the ribs or sternum to restore chest wall integrity while preserving natural dynamics. The study includes retrospective cases and prospective enrollment over 24 months, with follow-up evaluations at discharge, 1 month, 6 months, and 12 months post-surgery. Participants will undergo assessments including pulmonary function tests, pain scales, imaging like X-rays and CT scans, and quality of life questionnaires. Data is securely stored and anonymized in a centralized database compliant with European data protection laws. The primary outcomes measure changes in lung function parameters over one year. Participants can withdraw at any time, and the study aims to improve prosthesis design and surgical practices through comprehensive monitoring and analysis.

Researchers are investigating CGT9486, also known as bezuclastinib, in an open-label Phase 2 study for patients with Advanced Systemic Mastocytosis AdvSM. This includes those diagnosed with 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, pharmacokinetics, and pharmacodynamics of bezuclastinib in this patient population. Participants will receive bezuclastinib tablets orally, taken continuously in 28-day cycles. The study is divided into two parts Part I focuses on identifying effective and tolerable dosing exposures over 18 months, while Part II evaluates the drugs efficacy by measuring objective response rates and confirming the exposure-response relationship, also over 18 months. Additional assessments include effects on mutation allele burden, serum tryptase levels, histopathologic changes, spleen and liver volume, and safety monitoring. During the study, participants will undergo various clinical evaluations, including laboratory tests, imaging to monitor organ size changes, and assessments of disease response and progression. Researchers will track adverse events and pharmacokinetic profiles throughout the 18 months. The study involves continuous monitoring of participants to understand the treatments impact on survival and disease progression over this period.

Researchers are evaluating the safety and effectiveness of elenestinib BLU-263 combined with symptom directed therapy SDT compared to placebo plus SDT in adults with indolent systemic mastocytosis ISM whose symptoms are not well controlled by SDT alone. This randomized, double-blind, placebo-controlled Phase 23 study includes multiple parts to assess different doses and durations of elenestinib treatment, including an open-label extension for participants finishing earlier phases. The study also enrolls participants who have previously received an approved selective KIT inhibitor and includes pharmacokinetic groups. Participants receive oral elenestinib or placebo once daily alongside SDT, which is personalized based on individual symptom management needs. Part 1 focuses on short-term treatment lasting up to 12 weeks, while Part 2 extends treatment to approximately 48 weeks. Part 3 and other parts allow treatment for up to about 5 years. The study monitors participants through these phases to evaluate how elenestinib affects symptoms, disease markers, and safety over time. During the study, participants undergo regular assessments of symptoms using the ISM-Symptom Assessment Form ISM-SAF, laboratory tests including serum tryptase and KIT D816V allele levels, bone marrow evaluations, and quality of life measures. Researchers track adverse events and changes in disease-related factors at various points up to 5 years. This thorough monitoring helps measure treatment effects and safety over both short and long-term periods, with total participation lasting several years depending on the study part.

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating the AGIL Barcelona program to help frail older adults improve their physical abilities and delay disability. This study focuses on adapting and expanding the program across different community health centers in Barcelona. It aims to measure improvements in physical performance using a simple test SPPB and assess how well the program can be implemented in various neighborhoods. The program includes up to 10 weekly group exercise sessions led by a physiotherapist, emphasizing strength, balance, flexibility, and endurance. Participants receive personalized exercises supported by easy-to-understand materials. The program also offers advice on healthy habits like the Mediterranean diet, sleep improvement, and managing swallowing or memory issues. Medication reviews are conducted to ensure safe and appropriate treatments, and support is provided to connect participants with local activities to reduce social isolation. Participants will be involved in assessments of their physical performance, quality of life, cognitive function, social engagement, diet adherence, medication use, and any adverse events at the start, three months, and six months. The study uses a stepped approach to introduce the program at different sites gradually. Researchers will also gather qualitative feedback on participants experiences and program implementation. The total participation duration includes baseline and follow-up visits over six months.

Researchers are investigating new treatment options for meningiomas that continue to grow despite local therapies like surgery or radiotherapy. This trial focuses on evaluating a precision medicine approach that combines PET-based imaging to select patients with tumors expressing somatostatin receptors and a targeted radioligand therapy called 177Lu-DOTATATE. This is the first randomized clinical trial studying this therapy in patients with meningiomas that have not responded to other treatments. Participants will be randomly assigned to one of two groups. One group receives 177Lu-DOTATATE through intravenous infusions every four weeks for a total of four cycles. The other group receives local standard care, which may include treatments like hydroxyurea, bevacizumab, sunitinib, octreotide, everolimus, or observation with supportive care, based on the investigators choice. This study is designed to compare the effects of 177Lu-DOTATATE against various standard treatments in this patient population. During the study, participants will undergo regular MRI scans to measure tumor size and progression. Researchers will also assess overall survival, neurological function, quality of life, and treatment side effects over a period extending up to two years after enrollment. Monitoring includes imaging, laboratory tests, and health questionnaires to evaluate how the disease and treatments affect participants over time.

This research aims to assess the current work situation of anaesthesiology services in Spain, 20 years after the first comprehensive record called ANESCAT 2003. It evaluates whether the increase in healthcare activity matches the growth in resources allocated to the specialty and provides objective data for future planning and demands. The study focuses on collecting data on anaesthesia activities across several areas, including surgical procedures, intensive care units, chronic pain units, and delivery rooms. This data is gathered through various questionnaires covering a 14-day activity period over the course of one year. Participants will be involved by having their anaesthesia work activity recorded during this 14-day period. Researchers will measure the extent of anaesthesia services in different clinical settings and evaluate staff activity levels, as well as the role of anaesthesiology in managing polytrauma patients and cardiorespiratory arrest. The study spans one year to capture comprehensive activity data.

Preterm birth, defined as birth before 37 weeks of gestation, occurs in about 8 percent of pregnancies in Canada and is linked to many health challenges, especially when it happens before 29 weeks. At this early stage, infants often face breathing difficulties and may require resuscitation. This trial compares resuscitation using either low 30% or high 60% oxygen levels to determine which approach results in better survival and neurodevelopmental outcomes at around 24 months of age. The study uses a cluster randomized crossover design where hospitals alternate between starting resuscitation with 30% or 60% oxygen for groups of 30 infants. Resuscitation includes standard care steps like lung expansion and ventilation support as needed. Oxygen is initially given at the assigned concentration for the first 5 minutes, then adjusted based on the infants oxygen saturation levels and heart rate over the next 5 minutes to maintain target saturation ranges. This approach aims to balance risks of too much or too little oxygen. Participants are infants born between 23 and 28 weeks gestation who receive full resuscitation at participating centers. During the study, infants have oxygen saturation monitored continuously, and adjustments to oxygen concentration are made carefully. Researchers will evaluate survival and major neurodevelopmental outcomes at 24 months corrected age, along with several safety and health measures during the neonatal intensive care stay. The trial is expected to provide important evidence to guide oxygen use during resuscitation of extremely preterm infants.

Kienbocks disease, a condition involving ischemic necrosis of the lunate bone, has several surgical treatments depending on the disease stage and anatomical risk factors. This research focuses on stages II and III of the disease. Various surgeries aim to unload the lunate bone, restore its blood supply, or replace damaged parts, with most options working to maintain wrist structure, prevent disease progression, and reduce pain. This study evaluates the use of 3D printing models and personalized guides to plan different types of radial osteotomies tailored to patients anatomical features. These osteotomies include radial shortening, closed wedge, and dorsolateral biplane closing osteotomies, chosen based on factors like cubitus minus and radial inclination angle. The procedures involve osteosynthesis with a plate on the distal radius to decompress and protect the lunate bone. Participants will undergo clinical and radiological evaluations before and after surgery, including assessments of wrist function, pain, grip strength, and range of motion. Radiographic measurements such as Lichtman classification, carpal height ratio, and various wrist angles will be monitored over 22 months. These evaluations aim to track changes related to the surgical planning aided by 3D models, with ongoing follow-up to assess outcomes and recovery.

Researchers are working to create and use a comprehensive database focused on intracranial aneurysms IA. This project collects and studies clinical history, imaging data, biological samples, and other information to understand factors linked to the formation and rupture of aneurysms. They aim to identify genetic, environmental, and anatomical markers, as well as evaluate outcomes from different treatment strategies and improve patient care protocols. Participants include patients with diagnosed aneurysms, both ruptured and unruptured, family members of affected individuals, and healthy volunteers. Data collected involves detailed clinical records, imaging scans like MRI angiography and CT angiography, and various biological samples such as blood, cerebrospinal fluid, saliva, and stool. Consent covers access to medical records, use of biological samples, and potential future research uses including genetic analyses. During the study, participants provide health and lifestyle information, imaging data, and biological samples. Researchers will monitor multiple long-term outcomes including disease progression, life expectancy, quality of life, neurological and cognitive status, and treatment effects over periods up to 20 years. Data confidentiality is maintained, and participants can withdraw at any time without affecting their medical care. The study aims to validate disease models and support advances in aneurysm management and research.