Guadalajara

This research aims to assess the effectiveness and safety of eloralintide in adults with moderate to severe obstructive sleep apnea who are also obese or overweight. The study is organized under a master protocol called YDAO, which supports two separate studies: YSA1 for participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy, and YSA2 for those who have been using PAP therapy for at least three months and intend to continue it during the study. This is a Phase 3 randomized, double-blind, placebo-controlled trial focused on this specific population. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once weekly. They will be assigned to one of two groups based on their current PAP therapy use: those not using PAP (YSA1) and those continuing PAP (YSA2). The study treatment and observation will last about 76 weeks, allowing detailed evaluation over time. During the study, participants will undergo assessments including polysomnography to measure the apnea-hypopnea index (AHI) and body weight changes from baseline to week 64. Researchers will monitor weight, sleep apnea severity, and safety throughout the trial. The long participation period includes screening, treatment, and follow-up to capture comprehensive data on eloralintide’s effects and tolerability.

Researchers are evaluating patient-reported satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in adults with lung cancer or hepatocellular carcinoma treated in routine clinical practice. This non-interventional, multicenter, multicountry study collects primary data on health-related quality of life and treatment satisfaction for participants receiving Atezolizumab for approved indications. The study focuses on patients with specific lung cancer subtypes and advanced liver cancer who meet defined criteria regarding prior treatments and tumor characteristics. Atezolizumab is given subcutaneously at the discretion of the treating physician independently of study participation. Patients eligible for the study include those with early-stage or metastatic non-small cell lung cancer (NSCLC) with specific PD-L1 expression and genetic profiles, extensive-stage small cell lung cancer (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) not previously treated with systemic therapy. Treatment administration follows routine clinical practice, with no experimental interventions assigned by the study. Participants complete questionnaires assessing their satisfaction with Atezolizumab treatment and health-related quality of life during cycles 2 and 3 of therapy, each lasting three weeks. The primary outcome measure is the Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) score at these cycles. Safety and effectiveness data are monitored as part of routine care. The study collects data on patient experiences to better understand the real-world use of Atezolizumab over the treatment period.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

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.

This research aims to observe and evaluate the safety of immunotherapy for treating allergies to hymenoptera venom, such as bee and wasp stings, in real-life settings. The study is conducted across multiple centers in Spain and focuses on participants who are allergic to hymenoptera venom and are at least 14 years old, regardless of gender. It includes monitoring reactions to both controlled and spontaneous stings. Participants will receive treatment with VENOX, an allergy vaccine targeting venom from Vespula species (wasps) or Apis mellifera (bees), as determined by clinical need. This observational study prospectively collects data on up to 80 participants undergoing this immunotherapy according to standard clinical practice. The treatment is given based on individual clinical indications without a comparator group. During the study, participants will be followed for 12 months to assess the incidence of any treatment-emergent adverse reactions. Researchers will monitor safety, tolerability, and allergic responses throughout the follow-up period. The study involves collecting clinical data on participants' experiences with immunotherapy and any stings encountered during the observation time.

Researchers are conducting a multicenter cohort study to collect long-term information from female patients diagnosed with early-stage invasive breast cancer. These patients were previously included in neoadjuvant or adjuvant clinical trials conducted by the GEICAM group. The study aims to describe the long-term evolution and outcomes of these patients over approximately 30 years of follow-up, providing valuable data on treatment effects and any late-occurring consequences beyond initial analyses. The study involves patients who completed follow-up from their original neoadjuvant or adjuvant GEICAM clinical trials starting from 1998. Participants will be observed for up to 30 years to thoroughly assess event-free survival in neoadjuvant studies and disease-free survival in adjuvant studies. This extended monitoring period allows researchers to evaluate the long-term efficacy and safety of treatments received during those trials. Throughout the study, participants' health status will be regularly assessed to monitor survival outcomes and any disease recurrence. Information such as survival without events and disease-free survival will be collected and tracked across the entire follow-up period. The long-term data gathered will support healthcare professionals, patients, and society in understanding breast cancer progression and the lasting impact of treatments over decades.

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), involves chronic inflammation in different parts of the digestive tract, causing relapsing symptoms. The inflammatory process features increased activated granulocytes and monocyte-macrophages, which contribute to tissue damage. Granulocytapheresis (GMA) is being studied as a treatment alternative, especially for patients dependent on corticosteroids, to reduce inflammation by selectively removing these inflammatory cells from the blood. The study evaluates the use of the Adacolumn4 medical device for GMA therapy in adults diagnosed with UC or CD under real-world conditions. Patients will receive GMA sessions typically once a week for five weeks, with some receiving more frequent or maintenance sessions depending on their condition. The treatment aims to decrease the need for steroids and may be combined with other therapies. The study includes up to four visits: baseline, 1 month, 6 months, and 12 months after the final induction session. Participants will be monitored through routine clinical visits without extra interventions beyond usual care. Data collected include clinical remission rates without steroids six months after GMA therapy, safety information, changes in treatment, and quality of life measures. The total follow-up after treatment completion is approximately 12 months, ensuring careful observation of treatment effects and patient well-being.

Researchers are conducting an observational study called SOGUG-PRINCIS to collect and analyze data on the effectiveness of drugs recently approved for treating genitourinary tumors under routine clinical practice in Spain. This national, multicenter study includes both retrospective patient data and prospective follow-up, aiming to validate real-world outcomes compared to those reported in phase III clinical trials. The study covers cancers originating in the kidney, ureter, bladder, prostate, testicle, urethra, penis, and seminal vesicles. The study observes patients treated with drugs such as darolutamide combined with androgen deprivation therapy and docetaxel, adjuvant nivolumab after surgical removal of urothelial carcinoma, and enfortumab vedotin. All treatments follow their approved dosing and administration guidelines in standard clinical practice. New subprojects may be added as new drugs gain funding approval by the Spanish National Health System, with each subproject focusing on specific primary endpoints. Participants' involvement includes treatment decisions made independently from the study, with data collected afterward to assess outcomes. Researchers will track progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after treatment initiation. The study also serves as a registry for genitourinary cancer treatments funded nationally, supporting long-term evaluation of drug effectiveness in real-world settings.

Researchers are evaluating the safety and clinical performance of the Oscar Peripheral Multifunctional Catheter in treating lesions in the femoral, popliteal, and infrapopliteal arteries. This observational study focuses on patients with peripheral arterial disease and aims to confirm procedural success rates and monitor in-hospital complications related to endovascular interventions. The study includes a wide range of patients undergoing standard care practices for these artery lesions. The treatment involves using the Oscar Peripheral Multifunctional Catheter, which includes three components: the Oscar Support Catheter with integrated Lock Grip, the Oscar Dilator, and the Oscar PTA Balloon. The balloon can also be used separately but only with the pre-supplied support catheter. The procedures target lesions located either above or below the knee, and certain vascular inflow lesions may be treated during the same procedure according to local standard care. Participants will be involved in the study by undergoing endovascular procedures using the catheter, with researchers monitoring procedural success defined by lesion crossing and residual stenosis under 30%, and absence of complications like vessel perforation or embolization. The study collects data on procedural outcomes and complications during hospital stay. The primary outcome measure is the success rate of the procedure using the Oscar device. Participants must be adults aged 18 or older and will be observed during their treatment and hospitalization period.

Researchers are investigating the timing of intubation in patients with acute hypoxemic respiratory failure (AHRF) who are supported with nasal high flow (NHF) therapy. The study evaluates whether using an algorithm that includes the ROX index can lead to earlier intubation compared to traditional criteria. The ROX index is designed to predict the success or failure of NHF treatment, aiming to reduce the risks associated with delayed intubation. The trial is an international, multicenter, randomized controlled study with two groups: one following traditional intubation criteria, and the other using both traditional criteria and the ROX index for intubation decisions. Patients receive NHF therapy with flow rates up to 60L/min and oxygen titrated to target specific oxygen saturation levels. The ROX index is measured frequently during the first 12 hours after randomization, with specific thresholds guiding adjustments in NHF support and decisions about intubation. Participants are monitored closely with assessments every 2 hours initially, then less frequently after 24 hours, including after any clinical deterioration. The study measures early intubation rates within 12 hours of starting NHF. Follow-up continues for up to one month or until ICU discharge or death, whichever comes first. The study involves regular evaluations of respiratory status, oxygen levels, and the ROX index to guide treatment and assess outcomes.