Getafe

Researchers are evaluating a new medication called VH4524184 for treating adults with HIV-1 who have never received treatment before. This Phase 2b study compares two doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide FTCTAF, against a standard HIV treatment combining dolutegravir and lamivudine DTG3TC. The goal is to collect long-term data on the antiviral activity of VH4524184 and to understand the best dosing for future studies. Participants are assigned to one of several groups one group receives a low dose of VH4524184 plus FTCTAF daily for 12 months, another group receives a high dose of VH4524184 plus FTCTAF daily for 12 months, and a third group takes DTG and 3TC daily for 24 months. After 12 months, those on VH4524184 may continue with a selected dose combined with FTCTAF daily until month 24. All medications are taken orally. During the study, participants attend scheduled visits for assessments including blood tests to measure HIV-1 RNA levels, CD4 T-cell counts, and drug concentrations. Researchers monitor the percentage of participants achieving viral suppression at 12 months and maintain it through 24 months. Safety is closely observed through tracking adverse events until roughly month 36. The total participation time may span up to 36 months to evaluate the long-term effects and safety of the treatments.

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 in people living with chronic kidney disease, some of whom have type 2 diabetes and are overweight or obese. This Phase 2 study also compares NNC0519-0130 to semaglutide, an already prescribed medicine, and a placebo to see how they may improve kidney function. Participants will be randomly assigned to receive once-weekly subcutaneous injections of NNC0519-0130 with a fixed dose escalation until reaching a maintenance dose, semaglutide with a similar dosing schedule, or a placebo matching NNC0519-0130. The treatment period lasts up to 43 weeks with several dosing schemes and groups. During the study, participants will have their kidney function monitored through urine albumin-to-creatinine ratio changes at weeks 12, 24, and 36. Other assessments include estimated glomerular filtration rate, body weight changes, waist circumference, blood pressure, and glycated hemoglobin levels. Safety will be evaluated by tracking adverse events throughout the trial duration. Participants will be regularly assessed to understand the medicines effects and safety.

Researchers are evaluating how well the 20-valent pneumococcal conjugate vaccine 20vPnC works against pneumonia caused by seven new types of the Streptococcus pneumoniae bacteria. This study focuses on adults aged 65 years and older who are hospitalized with pneumonia confirmed by chest imaging. The study aims to compare the presence of pneumonia caused by these specific bacteria types in people vaccinated with 20vPnC versus those with pneumonia caused by other bacteria or strains. This observational study involves adults 65 years and older hospitalized with radiologically-confirmed community-acquired pneumonia RADCAP. Participants will provide a urine sample for testing pneumococcal bacteria using BinaxNOW and specific urinary antigen detection assays UAD-1 and UAD-2. Cases are identified by detection of the seven additional bacteria types in 20vPnC beyond the previous 13-valent vaccine, while controls include other pneumonia cases without these serotypes. No treatment is given as part of the study. Participants will be involved for about 1 to 2 days for urine sample collection and providing medical history. Researchers will collect detailed information on illness and hospital stay up to 30 days through medical record review. The main outcome measured is the effectiveness of 20vPnC against pneumonia caused by the seven additional bacterial types over approximately 55 months. Other clinical features and pneumonia types will also be reviewed during this period.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

The study focuses on patients admitted to the intensive care unit ICU, a key part of modern healthcare that provides specialized care for critically ill individuals. It aims to analyze how patient outcomes and mortality rates have changed over time from 1991 to 2026 at the Hospital Universitario Getafes 18-bed medical-surgical ICU. The research highlights the evolution of intensive care practices, particularly regarding mechanical ventilation and its impact on patient survival. This is an observational study that does not involve specific treatments or interventions. Instead, it reviews data collected over several decades, including changes in ICU management strategies, respiratory support techniques, and other critical care practices. The study covers various outcomes such as use of mechanical ventilation, length of ICU and hospital stay, and complications during ICU admission. Participants will have their medical records and outcomes analyzed retrospectively without additional procedures or interventions. Researchers will measure ICU mortality at 180 days as the primary outcome and also examine hospital mortality, 28-day mortality, mechanical ventilation use, length of stay, and complications over the same period. The study spans from patients admitted since 1991 through to 2026, providing a long-term view of ICU patient care evolution and outcomes.

Researchers are evaluating the effects of regular caffeine consumption versus caffeine abstinence on heart rate control in adults with permanent atrial fibrillation AF. The CAFIB trial is a multicenter, randomized, open-label crossover study designed to understand if moderate habitual caffeine intake affects heart rate management in this population, considering that traditional advice often recommends avoiding caffeine despite growing evidence suggesting moderate coffee consumption may not worsen AF and might offer cardiovascular benefits. Participants will be randomly assigned to one of two groups continuing their usual caffeinated coffee intake at least one cup daily or complete caffeine abstinence while allowing decaffeinated coffee. Energy drinks are prohibited for both groups. The study has no washout period between crossover phases due to caffeines short biological half-life. Adherence to caffeine intake or abstinence will be monitored through diaries and interviews during the study. Participants will attend three scheduled visits over 60 days at baseline, 30 days, and 60 days. Each visit includes clinical assessments, ECG, 24-hour Holter monitoring to measure heart rate, blood sampling, and quality-of-life questionnaires. The primary outcome is the 24-hour mean heart rate. Secondary outcomes include changes in heart rate, symptom severity, quality of life, heart failure biomarkers, adverse events, and medication changes. The study aims to recruit 50 patients and includes careful statistical analysis to assess the impact of caffeine on heart rate control.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are evaluating the effect of continued nutritional support after hospital discharge compared to usual care in medical patients at nutritional risk. This trial focuses on adults who have experienced malnutrition, a condition linked to higher risks of death, rehospitalization, and loss of function, especially among elderly and multi-ill patients. Previous studies showed that in-hospital nutritional support helps reduce complications and mortality, but the long-term benefits after discharge remain unclear. Participants are randomly assigned to one of two groups. The intervention group receives customized nutritional support from an experienced dietician to meet their individual energy and protein needs, including oral nutritional supplements as needed. The control group receives general advice on healthy eating habits at discharge without ongoing nutritional support. Follow-up includes regular phone calls every 2 to 4 weeks to monitor adherence and adjust dietary plans as necessary. During the study, participants are monitored for up to three years. Researchers assess key outcomes such as time to death from any cause, hospital readmissions, major complications, and changes in functional status using the Barthel index. Quality of life is measured with the European Quality of Life 5 Dimensions index and a visual-analogue scale at regular intervals by phone. This comprehensive follow-up helps determine whether sustained nutritional support after discharge improves long-term health and recovery.

Researchers are examining the use of dexamethasone in adults with acute hypoxemic respiratory failure AHRF, including acute respiratory distress syndrome ARDS, caused by infections such as COVID-19. This condition leads to severe lung inflammation requiring mechanical ventilation and has high mortality rates. The effectiveness of corticosteroids like dexamethasone in treating AHRF and ARDS remains uncertain, prompting this study to compare different dosing strategies to better understand their impact on patient outcomes. The trial is a randomized, controlled, open-label study conducted across multiple centers in Spain. Participants who are mechanically ventilated with confirmed infection-related AHRF will be assigned to receive either a low dose of dexamethasone 6 mg daily for 10 days or a higher dose 20 mg daily for 5 days, followed by 10 mg daily for 5 days. The study compares these two dosing regimens to determine which may better reduce mortality and improve ventilator-free days. During the trial, participants will be closely monitored in intensive care units, with primary outcomes measured by mortality at 60 days and secondary outcomes by the number of days free from mechanical ventilation within 28 days. Researchers will gather data on lung function, infection status, and overall health. Participants progress will be followed to assess the safety and effects of the dexamethasone doses over the study period.

Researchers are evaluating the use of a computational ecosystem called MOTIVA to provide motivational support and functional assessment for an autonomous exercise program aimed at promoting healthy aging in community-dwelling older adults who are robust or prefrail. The study focuses on improving independence as well as physical and cognitive health while potentially reducing healthcare use. This intervention targets adults aged 70 and older, addressing motivational traits and behavior change to combat abandonment and low compliance in unsupervised exercise programs. Participants will be randomly assigned to one of two groups a control group using the VIVIFRAIL Application without motivational support, or an intervention group using the VIVIFRAIL Application combined with the MOTIVA ecosystem, which personalizes exercise monitoring and encouragement based on each users motivational profile. The exercise program is autonomous, without professional supervision or caregiver involvement, and will be followed for 12 months. During the study, participants will undergo periodic assessments including the MOTIVA ecosystem evaluation, the Short Physical Performance Battery SPPB, global assessments, and digital assessments to track physical and cognitive health changes. Researchers will monitor adherence and motivational levels throughout the treatment period. The total duration of participation spans from enrollment through the 12-month treatment phase, with the goal of supporting healthy aging and reducing healthcare utilization.