Torrevieja

This trial investigates the effectiveness and safety of combining lower limb compression therapy with parenteral diuretics versus using parenteral diuretics alone in adults with decompensated heart failure. The study focuses on patients who show mainly systemic tissue congestion without intravascular systemic congestion. The goal is to evaluate whether adding compression therapy can improve outcomes in this patient group. Participants are randomly assigned to receive either standard treatment with parenteral furosemide alone or furosemide combined with compression therapy using the UrgoK2 or UrgoK2 Lite multicomponent compressive bandage system. The bandages provide sustained ankle pressure and are applied for up to 72 hours while furosemide dosing is determined by the treating healthcare professional based on clinical judgment. During the study, researchers monitor participants' urine sodium excretion and weight over 24 hours to assess treatment effects. Patients will undergo evaluations including ultrasonography of the inferior vena cava and assessments of edema severity. Safety and efficacy are closely observed throughout the treatment period to understand the benefits and risks of adding compression therapy to diuretic use in this condition.

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.

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy for patients aged 12 to 65 years who have allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitization to house dust mites Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. This is a double-blinded, placebo-controlled, multicenter Phase 3 trial involving 150 participants to determine the treatment's impact over one year. Participants are randomly assigned to one of three groups: two active treatment groups receiving purified allergenic extracts with concentrations of either 10,000 UT/mL or 30,000 UT/mL, and one placebo group receiving a similar solution without active ingredients. All treatments are given via subcutaneous injections as part of a one-year medication regimen. Throughout the study, participants will use a smartphone to record symptoms and medication use. Researchers will monitor combined symptoms and medication scores over 12 months. Participants will be regularly assessed for safety, treatment adherence, and allergic reactions. The study aims to measure improvements in allergic symptoms and medication needs while ensuring safety during the treatment period.

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 how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

Researchers are conducting the Selution Iberia registry, a post-market, international, multicenter, observational study to evaluate the safety and effectiveness of the SELUTION SLRTM sirolimus-eluting balloon in treating coronary artery disease. This study includes unselected "real-world" patients with native coronary artery lesions or in-stent restenosis across various clinical settings. The main goal is to assess major adverse cardiovascular events over 12 months, such as death, heart attacks, or the need for repeat procedures. Participants receive treatment with the SELUTION SLRTM sirolimus-coated balloon, which is used to manage native vessel lesions, coronary graft lesions, or restenosis as decided by their doctor. There is no control group in this study; instead, all enrolled patients receive this device-based treatment. The study focuses on real-world application rather than experimental comparisons. During the study, patients will be closely monitored for up to 12 months to track major cardiovascular events, including death, heart attacks, and repeat procedures on the treated lesion. Researchers will also evaluate device-related outcomes and patient-centered events such as strokes or any revascularization. This follow-up will help determine the device's performance and safety in everyday clinical practice.

Researchers are evaluating treatment strategies for patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease who have non-functionally significant non-culprit lesions with signs of vulnerable plaque detected by optical coherence tomography (OCT). The study compares preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) against OMT alone. The goal is to determine which approach better manages these vulnerable plaques and improves patient outcomes over time. Patients first undergo fractional flow reserve (FFR) assessment during invasive evaluation of intermediate lesions (40-69% narrowing). If FFR is 0.80 or less, patients receive PCI as standard care and are excluded from randomization. Those with FFR above 0.80 then have OCT imaging; patients without vulnerable plaque findings receive OMT and are followed in a registry. Patients with OCT features of vulnerable plaque enter a randomized phase comparing PCI with stenting plus OMT to OMT alone. Non-culprit lesions suitable for treatment with a single everolimus-eluting stent (EES) are included. Participants will be monitored for up to 4 years, with researchers measuring outcomes such as target vessel failure. The study involves informed consent, careful evaluation of lesions, and exclusion of patients with certain conditions or prior interventions. Safety and efficacy data will be collected through clinical follow-ups and assessments during this period to identify the best management strategy for vulnerable plaques in STEMI patients with multivessel disease.