[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CorEvitas\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":228},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,39,61,80,96,118,136,151,169,199],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100534433","corevitas-international-adolescent-atopic-dermatitis-ad-drug-safety-and-effectiveness-registry-100534433",false,"NCT06238765","CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry","Inclusion Criteria:\n\n* To be eligible to participate in this registry, an individual must meet all the following criteria:\n\n  1. Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified healthcare provider\n  2. Is 10 - 15 years of age at the time of enrollment.\n  3. Subject has initiated or is initiating an enrollment-eligible medication at the time of enrollment\n\n     Exclusion Criteria:\n* An individual who meets any of the following criteria will be excluded from participation in the registry:\n\n  1. Is participating or planning to participate in a blinded clinical trial for an AD drug.\n  2. Is unwilling or unable to provide standing height measurements.",true,"ALL","10 Years","15 Years",{"count":20,"type":21},1500,"ESTIMATED","OBSERVATIONAL","Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.",[25],"Atopic Dermatitis","RECRUITING","2026-06-25",{"date":29,"type":30},"2026-06-29","ACTUAL",{"date":32,"type":30},"2023-12-02",{"date":34,"type":21},"2099-12-31",{"name":36,"class":37},"CorEvitas","NETWORK",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":15,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":46,"targetDuration":48,"studyType":22,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100641842","ppd-corevitas-psoriasis-pso-early-treatment-response-non-interventional-study-100641842","NCT07648602","PPD™ CorEvitas™ Psoriasis (PSO) Early Treatment Response Non-Interventional Study","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n1. Patient is at least 18 years of age at the time of study enrollment.\n2. Patient has a diagnosis of moderate to severe plaque psoriasis based on an investigator Global Assessment (IGA, score of 3 or 4 at the time of Enrollment).\n3. Patient is initiating new Eligible Medication for the first time for the treatment of PSO.\n4. Patient is willing and able to provide informed consent to participate in this study.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in the study:\n\n1. Patient is participating in a blinded clinical trial.\n2. Patients that do not receive at least 1 dose of the advanced therapy within 14 days following the Enrollment\u002FBaseline visit for the study.\n3. Patients cannot be concurrently enrolled in both the CorEvitas PSO Registry and the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study. A. Patients currently enrolled in the CorEvitas PSO Registry are ineligible for participation in the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study.\n\nB. Patients otherwise meeting eligibility criteria can be enrolled in the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study C. Following completion or at time of Exit from the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study, patients will be eligible to enroll into the CorEvitas PSO Registry for long term follow-up at the standard of care cadence supported by the registry. A separate Informed consent will be obtained.","18 Years",{"count":47,"type":21},2500,"26 Weeks","This is a 24-week prospective, single-arm cohort, study of patients initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 16 (+\u002F- 5 days) and 24 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures. Data will be collected from both subjects and their treating dermatology provider at predetermined scheduled intervals (Baseline, Week 16 and Week 24) using a structured and standardized data collection tool.",[51],"Psoriasis","2026-06-11",{"date":54,"type":30},"2026-06-15",{"date":56,"type":21},"2026-06-01",{"date":58,"type":21},"2036-12-31",{"name":36,"class":37},2,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":79,"locationsCount":4},"100643807","ppdtm-corevitastm-chronic-hand-eczema-che-drug-safety-and-effectiveness-registry-100643807","NCT07598058","PPDTM CorEvitasTM Chronic Hand Eczema (CHE) Drug Safety and Effectiveness Registry","Inclusion Criteria:\n\n* To be eligible to participate in this registry, an individual must meet all of the following criteria:\n\n  1. Diagnosed with moderate-to-severe CHE by a dermatologist or other qualified healthcare provider at the time of enrollment and initiating an eligible medication.\n  2. Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment\n  3. Is willing and able to consent to participation in the registry\n  4. Is willing and able to complete registry-related forms electronically via personal devices.\n  5. Is willing and able to provide the information (first name, last name, email address, language and primary time zone) required to create an account to allow you to complete registry forms via a personal device;\n  6. Is willing and able to provide Personal Information (full legal name, sex, date of birth, home address zip or postal code and email address or phone number at a minimum) if required based on registry location and applicable laws and regulations.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in the registry:\n\n1\\) Is participating or planning to participate in a blinded clinical trial for a CHE drug",{"count":68,"type":21},2000,"The design is a prospective, observational registry for subjects with CHE under the care of dermatology or other qualified healthcare provider. Longitudinal data are collected from both subjects and their treating provider during routine clinical encounters using a structured and standardized data collection method",[71],"Chronic Hand Eczema","NOT_YET_RECRUITING","2026-06-05",{"date":75,"type":30},"2026-06-09",{"date":77,"type":21},"2026-05-29",{"date":34,"type":21},{"name":36,"class":37},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":15,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":38},"100637533","ppd-corevitas-psoriasis-pso-rapid-response-non-interventional-study-100637533","NCT07615712","PPD™ CorEvitas™ Psoriasis (PSO) Rapid Response Non-Interventional Study","Inclusion Criteria:\n\nThe inclusion criteria for this study will be as follows:\n\n1. Patient is at least 18 years of age at the time of study enrollment\n2. Patient has a diagnosis of moderate to severe plaque psoriasis based on an Investigator Global Assessment (IGA, part of routine care) score of 3 or 4 at the time of Enrollment.\n3. Patient is initiating new Eligible Medication for the first time for the treatment of PSO.\n4. Patient is willing and able to provide informed consent to participate in this study.\n5. Patient is willing to be seen in-person by their treating dermatology provider at two (2), four (4), and sixteen (16) weeks following initiation of the advanced therapy.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in the study:\n\n1. Patient is participating in a blinded clinical trial.\n2. Patients that do not receive at least 1 dose of the advanced therapy within 14 days following the Enrollment\u002FBaseline visit for the study.\n3. Patients cannot be concurrently enrolled in both the CorEvitas PSO Registry and the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.\n\nA. Patients currently enrolled in the CorEvitas PSO Registry are ineligible for participation in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.\n\nB. Patients otherwise meeting eligibility criteria can be enrolled in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study C. Following completion or at time of Exit from the CorEvitas Psoriasis (PSO) Rapid Response Non Interventional Study, patients will be eligible to enroll into the CorEvitas PSO Registry for long term follow up at the standard of care cadence supported by the registry. A separate Informed consent will be obtained.",{"count":47,"type":21},"This is a 16-week prospective, single-arm cohort, study of patients initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 2 (+\u002F- 5 days), 4 (+\u002F- 5 days), and 16 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures. Data will be collected from both subjects and their treating dermatology provider at predetermined scheduled intervals (Baseline, Week 2, Week 4, and Week 16) using a structured and standardized data collection tool.",[51],"2026-05-28",{"date":77,"type":30},{"date":92,"type":30},"2025-04-30",{"date":94,"type":21},"2035-12",{"name":36,"class":37},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":102,"targetDuration":104,"studyType":22,"phases":4,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":117,"locationsCount":38},"100577881","corevitas-systemic-lupus-erythematosus-sle-drug-safety-and-effectiveness-registry-100577881","NCT06804057","CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry","Inclusion Criteria:\n\nTo be eligible to participate in this registry, an individual must meet all the following criteria:\n\n1. Has been diagnosed with SLE by a rheumatologist or a qualified rheumatology practitioner.\n2. Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.\n3. Willing and able to provide informed consent.\n4. Willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, and home address zip\u002Fpostal code at a minimum) if required based on registry location and applicable laws and regulations.\n5. In addition, subjects must meet at least one of the following criteria:\n\n   * New diagnosis of SLE (=\\\u003C12 months) from registry enrollment, OR\n   * Initiation of a biologic or immunosuppressant for the treatment of SLE at registry enrollment, OR\n   * Lupus Nephritis (LN; class III-V) diagnosed within 2 years of registry enrollment\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in the registry:\n\n1. Is participating in a double-blind clinical trial for a SLE drug\n2. Subjects participating in any non-blinded trial for any indication, with the exception of non-blinded CAR-T or other cell\u002Fgene therapies for the treatment of SLE",{"count":103,"type":21},1000,"6 Months","Prospective, observational registry for subjects with SLE under the care of a rheumatology provider. Longitudinal data are collected from both subjects and their treating rheumatology provider during routine clinical encounters using a structured and standardized data collection method.",[107],"Systemic Lupus Erythematosus",[107,109,110],"SLE","Lupus","2026-02-05",{"date":113,"type":30},"2026-02-06",{"date":115,"type":30},"2024-09-26",{"date":34,"type":21},{"name":36,"class":37},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":135,"locationsCount":38},"100559295","corevitas-international-adolescent-alopecia-areata-aa-drug-safety-and-effectiveness-registry-100559295","NCT06562270","CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry","Inclusion Criteria:\n\nTo be eligible to participate in this registry, an individual must meet all the following criteria:\n\n1. Has ever been diagnosed with severe AA by a dermatologist or a qualified dermatology provider.\n2. Is 12-17 years of age at the time of enrollment.\n3. Is willing to provide consent\u002Fassent for participation in the registry.\n4. Has been prescribed a new commercially available advanced therapy and\u002For conventional systemic therapy for the treatment of severe AA in adolescents in the context of routine clinical care that is consistent with local prescribing guidelines and\u002For regulations for the country where the site is located.\n\nA new therapy is a medication that the subject has never taken before.\n\n1. At the time of registry enrollment OR\n2. Within 6 months prior to registry enrollment In the opinion of the treating provider, is deemed a candidate for treatment with a commercially available advanced therapy and\u002For conventional systemic therapy for the treatment of severe AA in adolescents but has not received nor is planning to initiate treatment at the time of registry enrollment.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in the registry:\n\n1. Is participating or planning to participate in a blinded clinical trial for any investigational medication.\n2. Is unwilling or unable to provide standing height measurements.","12 Years","17 Years",{"count":20,"type":21},"Prospective observational registry focusing on an adolescent cohort diagnosed with severe alopecia areata,receiving routine care from dermatology providers. Visit schedules for patients will be determined by the provider in accordance with routine clinical care, and any prescriptions provided to patients will adhere to product availability and local prescribing guidelines\u002Fregulations in the country where the participating registry site is located.",[129],"Alopecia Areata",{"date":131,"type":30},"2026-02-09",{"date":133,"type":30},"2024-03-07",{"date":34,"type":21},{"name":36,"class":37},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":150,"locationsCount":38},"100496527","corevitas-alopecia-areata-aa-safety-and-effectiveness-registry-100496527","NCT05745389","CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry","Inclusion Criteria:\n\n* A subject must meet all the following criteria to participate in the registry:\n\n  1. Has been diagnosed with alopecia areata by a dermatologist or a qualified dermatology practitioner.\n  2. Is at least 18 years of age or older.\n  3. Is willing to provide Personal Information.\n  4. Is prescribed or starting an Enrollment Eligible Medication at the time of enrollment.\n\nExclusion Criteria:\n\n* Any of the following would exclude the subject from participating in the registry:\n\n  1. Is participating or planning to participate in a double-blind randomized trial for an AA drug. Note:\n\nConcurrent participation in another observational registry or open-label Phase 3b\u002F4 trial is allowed.",{"count":143,"type":21},5000,"Prospective, observational cohort study for subjects with AA under the care of a dermatology provider. Approximately 5,000 subjects and 100 clinical sites in North America will be recruited to participate with no defined upper limit for either target.",[129],{"date":131,"type":30},{"date":148,"type":30},"2022-10-25",{"date":34,"type":21},{"name":36,"class":37},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":15,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":38},"100523844","corevitas-generalized-pustular-psoriasis-gpp-drug-safety-and-effectiveness-registry-100523844","NCT06100991","CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry","Inclusion Criteria:\n\n* A subject must meet all the following criteria to participate in the registry:\n\n  1. Has been diagnosed with GPP by a dermatologist or a qualified dermatology practitioner.\n  2. Is at least 18 years of age and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted.\n  3. Is willing to provide consent for participation in the registry.\n  4. Is willing to provide Personal Information\n\nExclusion Criteria:\n\n* Any of the following would exclude the subject from participating in the registry:\n\n  1. Is participating or planning to participate in a blinded clinical trial evaluating a systemic agent for the treatment or prevention of flares related to GPP.\n  2. Is enrolled in another CorEvitas registry for a dermatological condition. Subjects enrolled in another CorEvitas registry must be exited to be eligible for enrollment into the GPP Registry",{"count":158,"type":21},200,"Prospective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 clinical sites in North America will be recruited to participate with no defined upper limit for either target",[161],"Generalized Pustular Psoriasis","2026-02-04",{"date":131,"type":30},{"date":165,"type":30},"2023-09-19",{"date":167,"type":21},"2099-12",{"name":36,"class":37},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":177,"minAge":45,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":38},"100586067","ibd-pregnancy-registry-100586067","NCT06910553","IBD Pregnancy Registry","CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)","IBD-PR","Inclusion Criteria:\n\nExposed and unexposed cohort:\n\n* A resident of the US or Canada at enrollment\n* Currently pregnant\n* 18 to 50 years of age at enrollment\n* Physician-confirmed diagnosis of IBD (UC, CD, other and unspecified noninfective gastroenteritis and colitis \\[ICD-10 K52\\] and indeterminate colitis \\[ICD-10 K52.3\\])\n* Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant institutional review board (IRB)\u002Findependent ethics committee, verbal consent, indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study\n* Authorize their HCP to provide data to the registry\n* Provide contact information (for participant and HCPs)\n\nExposed cohort only:\n\n\\- Exposed to an IBD pharmacotherapy during pregnancy\n\nExclusion Criteria:\n\nExposed and unexposed cohort:\n\n* Exposure to methotrexate during pregnancy","FEMALE","50 Years",{"count":180,"type":21},832,"Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following:\n\nResearch question: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to Inflammatory Bowel Disease (IBD) treatments during pregnancy?\n\nThe primary objective of the registry is to estimate the prevalence of major congenital malformations among pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy.\n\nThe secondary objectives of the registry are:\n\nTo estimate the prevalence of other maternal, fetal, and infant outcomes among pregnant individuals with IBD who are exposed to IBD pharmacotherapies during pregnancy.\n\nTo contextualize the prevalence of outcomes among pregnant individuals who are exposed to IBD pharmacotherapies during pregnancy and estimate the prevalence of all outcomes of interest among pregnant individuals with IBD who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.\n\nIf sample size permits, to estimate the risk ratio for each outcome, comparing the outcomes of pregnant individuals with IBD who are exposed to IBD pharmacotherapy with those who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.\n\nData collection may be used to determine pharmacotherapy-specific use with or without unexposed cohorts on an as-needed basis, as sample size allows.",[183],"Inflammatory Bowel Disease (IBD)",[185,186,187,188,189,190],"Pregnant","IBD","Registry","UC","Inflammatory Bowel Disease","Ulcerative Colitis","2025-04-02",{"date":193,"type":30},"2025-04-04",{"date":195,"type":21},"2025-04",{"date":197,"type":21},"2032-09",{"name":36,"class":37},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":15,"sex":177,"minAge":45,"maxAge":178,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":38},"100556196","rsv-vaccine-pregnancy-registry-100556196","NCT06521944","RSV Vaccine Pregnancy Registry","CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)","RSV-PR","Inclusion Criteria:\n\n* Individuals must meet the following inclusion criteria to be eligible for inclusion in the study:\n\n  1. A resident of the US at enrollment\n  2. 18 to 50 years of age at enrollment\n  3. Gestational age of ≥32 weeks, 0 days at enrollment\n  4. If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation\n  5. Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB\u002Findependent ethics committee, verbal consent indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study\n  6. Authorization obtained for the relevant HCP(s) to provide data to the registry\n  7. Contact information available (for participant and HCPs)\n\nExclusion Criteria:\n\n* Individuals meeting any of the following criteria will not be included in the study:\n\n  1. Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation\n  2. Multi-fetal pregnancy\n  3. Enrolled in the RSV-PR with a previous pregnancy",{"count":208,"type":21},2062,"The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal\u002Finfant outcomes, following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation in the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry (RSV-PR)? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.\n\nThe secondary study objective is to estimate the risk of other safety outcomes of interest following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including:\n\n* Pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes, preterm premature rupture of membranes, cesarean delivery, prolonged maternal duration of hospital stay\n* Maternal outcomes: thrombocytopenia, Guillain-Barré syndrome, other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death\n* Neonatal\u002Finfant outcomes: small for gestational age, large for gestational age, low birth weight, admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth at 1 year of age The exploratory study objective is to describe the most frequently reported maternal adverse events following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.",[211],"Respiratory Syncytial Virus (RSV)",[185,187,213,214,215,216,217,218,219],"RSV","RSV Vaccine","Respiratory Syncytial Virus","Infections","Virus Diseases","Lung Diseases","Respiratory Tract Diseases","2024-07-23",{"date":222,"type":30},"2024-07-26",{"date":224,"type":30},"2024-06-28",{"date":226,"type":21},"2030-09-30",{"name":36,"class":37},""]