Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT06041451
Status:
UNKNOWN
Last Update Posted:
2023-09-18
First Post:
2022-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early and Late Prognosis in Patients With Guillain-Barre Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the severity of Guillain-barre syndrome', 'timeFrame': 'baseline, at 1 week, at 26 weeks', 'description': 'The Guillain-barre syndrome disability score is a wide scale for the severity of Guillain-barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead).The higher the score, the worse the prognosis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Guillain-barre syndrome', 'prognosis'], 'conditions': ['Guillain-Barre Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.', 'detailedDescription': "This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.\n\nExclusion Criteria:\n\n* nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome'}, 'identificationModule': {'nctId': 'NCT06041451', 'briefTitle': 'Early and Late Prognosis in Patients With Guillain-Barre Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Early and Late Prognosis in Patients With Guillain-Barre Syndrome', 'orgStudyIdInfo': {'id': 'Dengbinbin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immunoglobulin group', 'description': 'This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days', 'interventionNames': ['Drug: Intravenous Immunoglobulins, Human']}, {'type': 'EXPERIMENTAL', 'label': 'methylprednisolone group', 'description': 'This group of patients was treated with methylprednisolone 500 MG Injection', 'interventionNames': ['Drug: Methylprednisolone 500 MG Injection']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'This group of patients was treated without immunoglobulin or hormone'}, {'type': 'EXPERIMENTAL', 'label': 'mixed group', 'description': 'This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.', 'interventionNames': ['Drug: Intravenous Immunoglobulins, Human', 'Drug: Methylprednisolone 500 MG Injection']}], 'interventions': [{'name': 'Intravenous Immunoglobulins, Human', 'type': 'DRUG', 'description': 'patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days', 'armGroupLabels': ['immunoglobulin group', 'mixed group']}, {'name': 'Methylprednisolone 500 MG Injection', 'type': 'DRUG', 'description': 'patients were treated with methylprednisolone', 'armGroupLabels': ['methylprednisolone group', 'mixed group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Binbin Deng, Doctor', 'role': 'CONTACT', 'email': 'dbinbin@aliyun.com', 'phone': '+8613695720610'}], 'facility': 'First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Binbin Deng', 'role': 'CONTACT', 'phone': 'dbinbin@aliyun.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}