Cartagena

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Parkinson's disease (PD) is a neurological condition that affects the brain, causing symptoms such as tremors, stiffness, and slow movement. This research aims to evaluate changes in sleep disturbances in adults with advanced Parkinson's disease who are receiving subcutaneous Foslevodopa/Foscarbidopa treatment. The study focuses on participants diagnosed with levodopa-responsive idiopathic Parkinson's disease experiencing severe motor fluctuations and hyperkinesia or dyskinesia. Participants will be treated with Foslevodopa/Foscarbidopa via subcutaneous infusion as prescribed by their doctors under routine clinical practice. Approximately 103 adults will be enrolled from around 20 sites across Spain. The treatment will follow the approved summary of product characteristics, and participants will be observed for up to approximately 12 weeks. During the study, participants will attend regular hospital or clinic visits according to their usual care schedule. Researchers will assess changes in Parkinson's disease-related sleep disturbances using the Parkinson's Disease Sleep Scale - 2 (PDSS-2). Cognitive function, treatment adherence, and any contraindications will also be monitored to ensure participant safety and study compliance throughout the observation period.

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 effects of continuing cetuximab treatment beyond first-line progression in adults with metastatic colorectal cancer whose tumors have specific genetic characteristics, including RAS and BRAF wild-type status. This Phase 3 trial aims to compare chemotherapy combined with cetuximab against chemotherapy combined with bevacizumab to see if cetuximab continuation improves tumor response, progression-free survival, overall survival, and safety. The study builds on earlier trials suggesting potential benefits of cetuximab continuation in this patient group. Participants will receive a standard chemotherapy regimen, either FOLFOX or FOLFIRI, combined with either cetuximab or bevacizumab every two weeks. Cetuximab is administered as an intravenous infusion of 500 mg/m² every 14 days, while bevacizumab is given at 5 mg/kg every 14 days. Treatment continues until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be regularly assessed using imaging scans according to RECIST criteria. Throughout the study, patients will undergo regular CT or MRI scans, laboratory tests, and clinical evaluations to monitor disease status and safety. Biological samples such as tumor tissue, blood, and stool will be collected for research on treatment resistance and the gut microbiome. The primary outcome is the overall response rate measured from randomization until progression, death, or study completion, with assessments continuing up to 48 months. Approximately 360 patients will participate across sites in Italy and Spain.

Researchers are working to develop and validate a model that predicts the risk of acquiring sexually transmitted infections (STIs) among people using HIV pre-exposure prophylaxis (PrEP) within Spain's national program. This study includes individuals who use PrEP, following them across multiple hospitals in Spain to understand factors associated with STI acquisition. The study focuses on various STIs including syphilis, gonorrhea, chlamydia, herpes, hepatitis, HIV infection, and MPOX. Participants will be followed quarterly according to national protocols. At each visit, samples will be collected from different sites such as blood, throat, urine, rectum, genital areas, and ulcers to diagnose STIs. There is no intervention, as this is an observational cohort study. The main goal is to track if participants develop an STI and to count the number of diagnosed STIs over time. Statistical models will be used to analyze the data and validate the best predictive models. During the study, participants will have regular follow-up visits every three months where medical evaluations and STI testing will be performed. Researchers will use the collected data to create and validate a predictive model for STI risk over an average of five years. The study does not exclude any participants based on specific criteria, and all individuals who have started oral PrEP and meet the national guidelines are eligible to take part.

Researchers are collecting real-world data from cancer patients who are treated with radiotherapy. This study aims to support radiotherapy research and provide evidence on how radiation oncology fits into a multidisciplinary cancer treatment approach. It is a prospective, open-ended, non-interventional, and non-therapeutic multi-cohort study. Participants included in this study are those planned to receive radiotherapy as part of their cancer treatment. The study involves observing and collecting data without introducing any new treatments or interventions. It includes patients aged 12 years and older with pathologically confirmed cancer who have consented to participate. During the study, researchers will monitor and record the number of patients treated with radiotherapy over a five-year period. There are no additional interventions or treatments given; the focus is on gathering information to better understand radiotherapy's role in cancer care. Participation duration varies as the study is open-ended and ongoing.

Children and adolescents with chronic pain often do not receive proper diagnosis or treatment, which can lead to ongoing pain into adulthood. This research aims to develop, test, and implement a smartphone app called "Digital Solution for Pain in Adolescents" (Digital SPA) to provide pain management resources for young people with chronic pain and their parents. The app is co-designed with patients to ensure it meets their needs and helps prevent future disability. The study has multiple phases. First, focus groups with patients, parents, and clinicians will identify unmet pain care needs to guide the app design. Next, the content and usability of the app will be developed based on psychological techniques like Cognitive Behavioral Therapy and Acceptance and Commitment Therapy, focusing on skills such as relaxation, goal setting, sleep management, and communication. Finally, an effectiveness and implementation study will enroll adolescents aged 12 to 17 with chronic pain and one parent to use the Digital SPA intervention. Participants will take part in interviews, complete online questionnaires, and use the smartphone app. Researchers will measure changes in pain interference, emergency room visits due to pain, and global impressions of change at multiple points: before treatment, mid-treatment (4 weeks), post-treatment (8 weeks), and at a 3-month follow-up. The study will monitor these outcomes to evaluate the app's impact on managing chronic pain in youth.

Chronic pain is a widespread condition that can greatly reduce quality of life. Researchers are evaluating the effectiveness and safety of implantable neurostimulation systems as a treatment for chronic pain in Spain. This study aims to gather real-world data on how well these implantable devices work and how safe they are for patients with chronic refractory pain. The study invites all Spanish hospitals that perform implantable neurostimulation procedures for pain treatment to participate. Patients will be recruited before they receive the implant and will provide informed consent. Demographic and clinical data about their condition and the procedure will be collected. Follow-up assessments will take place six months and twelve months after the implant procedure. Participants will be monitored through these follow-ups to measure outcomes such as the percentage of patients achieving at least 50% pain relief in their main pain area after one year. The study will track safety and effectiveness over this period, helping to understand the impact of implantable neurostimulation for chronic pain in a real-world setting.

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.