[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-mediated-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-mediated-diseases":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100428886","metabolic-profiling-of-immune-responses-in-immune-mediated-diseases-100428886",false,"NCT04864886","Metabolic Profiling of Immune Responses in Immune-mediated Diseases","Metabolic Profiling of Immune Responses in Immune-Mediated Diseases","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Meets one of the following:\n\n   1. Has documentation of PID confirmed by genetic evaluation demonstrating a deleterious variant in the gene (or genes) known to be associated with immune deficiency (confirmed PID); or\n   2. Has documented variant of undetermined significance in a gene (or genes) that is predicted to be deleterious in immune function by the investigators OR a clinical history of infections which are more frequent, more chronic, or more severe than normal (suspected PID); or\n   3. Has physician-diagnosed psoriasis; or\n   4. Has physician-diagnosed AD; or\n   5. Does not have clinically apparent evidence of any monogenic or digenic immune defect, AD, or psoriasis (healthy volunteers).\n2. Aged 18 to 75 years.\n3. Willing to allow storage of blood, biopsy tissue, bacterial and fungal cultures, and any other samples collected for future research.\n4. Able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs).\n2. Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator.\n3. History of keloid formation.\n4. Pregnancy, lactating, or breastfeeding.\n5. Any condition that, in the opinion of the investigator, contraindicates participation in the study.\n\nCo-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.",true,"ALL","18 Years","75 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","Background:\n\nThe immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficult for their skin to heal. Researchers want to learn more to better treat conditions that affect immune response.\n\nObjective:\n\nTo learn about how the immune system and skin healing are related to each other.\n\nEligibility:\n\nPeople ages 18-75 with primary immune deficiency, eczema, or psoriasis. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will be screened with a medical and medicine history and a physical exam. They may take a pregnancy test.\n\nParticipants will discuss the medicines or supplements they take as well as skin products they use, such as soaps and lotions.\n\nParticipants will have up to 4 skin biopsies taken from the forearm. A needle will inject an anesthetic into the skin where the biopsy will be done. A sharp tool that looks like a tiny cookie cutter will be used to remove a round plug of skin a bit smaller than the tip of a pencil.\n\nParticipants will give at least 1 blood sample.\n\nParticipants may have optional skin swab collection. A cotton swab will be used to swab the skin on the arm.\n\nParticipants may have optional skin tape collection. A sticky strip of tape will be placed on the arm and then removed.\n\nParticipants may give leftover samples taken as part of their regular medical care.\n\nParticipation will last for about 4 days. Participants will have 2 visits that each last about 1 hour. They may be asked to repeat the study in the future.",[26,27,28,29],"Primary Immunodeficiency","Psoriasis","Atopic Dermatitis","Immune-mediated Diseases",[26,27,28,31,32],"pathways","Natural History","RECRUITING","2026-05-28",{"date":36,"type":37},"2026-05-29","ACTUAL",{"date":39,"type":37},"2021-08-10",{"date":41,"type":22},"2027-06-30",{"name":43,"class":44},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":23,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100595531","impact-of-in-utero-exposure-to-immunomodulatory-drugs-on-neonatal-immune-system-development-100595531","NCT07033663","Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development","Study of the Impact of Intrauterine Exposure to Immunomodulatory Drugs on the Development of the Immune System of Children Born to Mothers With Chronic Inflammatory or Oncologic Diseases: The NEWborn-IMM-PACT Study","NEWbornIMMPACT","Inclusion Criteria:\n\nPregnant women with immune-mediated inflammatory or oncologic diseases, categorized into:\n\n1. High-exposed group: monoclonal treatment throughout pregnancy.\n2. Low-exposed group: monoclonal treatment limited to the first\u002Fsecond trimester.\n3. Non-exposed group: No monoclonal exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease.\n\n   \\-",{"count":55,"type":22},90,"12 Months","What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy. These treatments are necessary for women with autoimmune, inflammatory, allergic, or cancer-related diseases who cannot stop their medication while pregnant.\n\nWhy is it important? Although these treatments help keep the mother and baby healthy, some medications can cross the placenta and affect the baby's immune system. Since pregnant women are usually not included in clinical trials, the investigators still don't know exactly how these drugs might influence the baby's immune development.\n\nHow will the investigators do it? The investigators will follow a group of pregnant women receiving these treatments and monitor their babies at birth, and at 3, 6, and 12 months. The study will take place in three leading hospitals in Spain: Hospital Sant Joan de Déu, Hospital Clínic, and Vall d'Hebron. The investigators will also use organoid models in the lab to better understand how these drugs affect fetal development.\n\nWho will benefit? This study will help parents concerned about the impact of treatments during pregnancy on their child's health. It will also give doctors the evidence they need to make safer treatment decisions, and support the creation of new clinical guidelines to protect both mothers and babies.",[59,29],"Pregnancy Related",[61,62,63],"monoclonal antibodies","pregnancy","immunomodulators","2025-08-11",{"date":66,"type":37},"2025-08-15",{"date":68,"type":37},"2018-06-01",{"date":70,"type":22},"2028-05-01",{"name":72,"class":73},"Fundació Sant Joan de Déu","OTHER",3]