[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelin-oligodendrocyte-glycoprotein-antibody-associated-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelin-oligodendrocyte-glycoprotein-antibody-associated-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,80,105,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100618559","tongji-nads-cohort-100618559",false,"NCT07333196","Tongji NADs Cohort","Tongji NADs Cohort: A Real-world Observation of Neurological Autoimmune Disorders","Inclusion Criteria:\n\n* Participants must meet the following eligibility criteria at the time of screening to participate in this study.\n\n1.1. The subject is able to understand the purpose and risks of the study, provide informed consent and authorize the use of confidential health information in accordance with national and local privacy regulations.\n\n1.2. Open to both men and women, aged 18-80 years (inclusive) at the time of informed consent.\n\n1.3. Must be diagnosed with one of the following conditions:\n\n1.3.1. This study adhered to the 2017 McDonald criteria for diagnosing multiple sclerosis:\n\n1. ≥2 clinical episodes with ≥2 objective clinical evidences of lesions.\n2. ≥2 clinical episodes with one clear historical evidence of the lesion involving specific anatomical site.\n3. ≥2 clinical episodes with objective clinical evidence of one lesion, and spatial multiplicity confirmed by clinical episodes in different CNS sites or MRI findings.\n4. A single episode with ≥2 objective clinical evidences, confirmed by additional clinical episodes or MRI showing temporal multiple lesions or OCB positivity.\n5. A single episode with one objective clinical manifestation, confirmed by clinical seizures or MRI scans across multiple CNS regions to demonstrate spatial multiplicity, and further supported by additional clinical episodes or MRI findings to confirm temporal multiplicity or OCB positivity.\n6. Indication for the progressive multifocal sclerosis (PPMS) phase: Disease progression at 1 year (confirmed retrospectively or prospectively), with two of the following three criteria: \\[1\\] Spatially multifocal evidence of brain lesions: ≥1 T2-weighted lesion in characteristic MS regions (periventricular, corticoprotuberant, or subarachnoid) \\[2\\] Spatially multifocal evidence of spinal lesions: ≥2 T2-weighted lesions in the spinal cord \\[3\\] OCB positivity.\n\n1.3.2. This study adhered to the 2015 IPND diagnostic criteria for adult neuromyelitis optica spectrum disorders:\n\n1. NMOSD diagnosis with AQP4-IgG positivity: meeting ≥1 core clinical feature, confirmed by reliable AQP4-IgG detection (CBA method recommended), and excluding other diagnoses.\n2. Diagnostic criteria for NMOSD with AQP4-lgG negative or undetermined status: In at least one clinical episode, the presence of ≥2 core clinical features meeting all of the following criteria: ①≥1 core clinical feature is ON, acute LETM, or bulbar syndrome; ②≥2 distinct core clinical features; ③MRI supplementary criteria are satisfied. AQP4-lgG should be reliably detected as negative or undetected, and other diagnoses must be excluded.\n\nNote: Core clinical features include six cardinal signs: optic neuritis (ON), acute myelitis (LETM), and the final area syndrome (unexplained paroxysmal hiccups, nausea, and vomiting); other brainstem syndromes; symptomatic narcolepsy\u002Fhypothalamic syndrome with characteristic hypothalamic MRI lesions; and brain syndrome with characteristic cerebral MRI lesions.\n\nMRI diagnostic criteria: Acute optic neuritis (ON) requires MRI demonstrating one of the following: ① Normal brain MRI or non-specific white matter lesions; ② Long T-weighted signal or T-weighted enhancement exceeding 1\u002F2 of optic nerve length, or optic chiasm involvement; ③ Acute myelitis (LETM) requires three or more consecutive vertebral segments with spinal cord lesions, or spinal cord atrophy exceeding three consecutive vertebral segments in patients with myelitis history; ④ Final region syndrome: lesions in the dorsal medulla or final region. Acute brainstem syndrome: periventricular lesions in the brainstem.\n\n1.3.3. This study adhered to the MOGAD diagnostic criteria established by the International Parkinson's Disease and Movement Disorders (IPMD) in 2023:\n\n1. A diagnosis of MOGAD can be confirmed when: (a) fixed or live-cell CBA detects strong positivity of MOG-IgG in serum with ≥1 core clinical manifestation, and (b) other diagnoses (e.g., MS, NMOSD) are excluded;\n2. If the CBA shows weak positivity of MOG-IgG in serum, or MOG-IgG positivity without titer, or negative serum MOG-IgG with strong positivity in cerebrospinal fluid (CSF), the diagnosis requires: 1) ≥1 core clinical manifestation, 2) ≥1 supporting clinical or imaging feature, 3) negative serum AQP4-IgG, and 4) exclusion of other diagnoses (e.g., MS, NMOSD).\n\nNote: The core clinical features include six main signs: optic neuritis, myelitis, acute disseminated encephalomyelitis, monofocal or multifocal cerebral dysfunction, brainstem or cerebellar functional deficits, and cerebral cortex inflammation with epilepsy.\n\nTypical MRI imaging features: ① Optic Neuropathy (ON): Bilateral optic nerve involvement with long-segment optic nerve damage (\\>50% optic nerve length), optic nerve sheath enhancement, and papilledema. ② Myelitis: Long-segment transverse myelitis with central spinal cord damage or \"H\" sign, and conus medullaris damage. ③ Cerebral, brainstem, or cerebral cortex symptoms: Multifocal ill-defined T2 hyperintense lesions in supratentorial and infratentorial white matter, deep gray matter involvement, ill-defined T2 hyperintense lesions in pons, cerebellar midfoot, or medulla oblongata, and cortical lesions with or without focal enhancement and local dural enhancement.\n\nThe strong positive result of serum and cerebrospinal fluid MOG-IgG was defined as the value of the live CBA was more than 2 times the detection limit or the fixed CBA titer was ≥1:100. The weak positive result was defined as the value of the live CBA was in the lower range or the fixed CBA titer was ≥1:10 but less than 1:100.\n\n1.3.4. This study followed the expert consensus on the diagnosis and treatment of autoimmune encephalitis in China (2022 edition)\n\n1. Possible AE: meeting the following three diagnostic criteria A, B, and D; confirmed AE: meeting the four diagnostic criteria A, B, C, and D.\n2. Diagnostic criteria:\n\nA. Clinical presentation: Acute or subacute onset (\\\u003C3 months) with ≥1 of the following neurological or psychiatric symptoms or clinical syndromes: limbic system symptoms, encephalitis syndrome, lymphocytic inflammation in cerebrospinal fluid cytology, and positive specific oligoclonal bands.\n\nB. Neuroimaging or electrophysiological abnormalities: T2 or FLAIR abnormal signals in the limbic system (unilateral or bilateral), or T2\u002FFLAIR abnormalities in other regions (excluding nonspecific white matter changes and stroke); or PET findings of high metabolism in the limbic system, or multiple high metabolic areas in the cortex and\u002For basal ganglia; or EEG abnormalities such as focal epilepsy or epileptiform discharges (in the temporal lobe or outside it), or diffuse or multifocal slow-wave rhythms.\n\nC. Diagnostic test: Positive for anti-neuronal antibodies. D. Reasonably rule out other possible causes.\n\n1.3.5. This study adhered to the diagnostic criteria for AIDP, CIDP, and autoimmune Ranvier node disease:\n\n1. AIDP: Essential features include: ① Progressive weakness in the upper and\u002For lower limbs, ranging from mild bilateral lower limb weakness to complete paralysis of all limbs (including trunk, medullary muscles, and facial muscles) and oculomotor muscle paralysis; ② Weakened or absent deep tendon reflexes in the affected limbs; ③ Symptom progression ≤4 weeks. Supporting features include: ① Symptom progression from days to 4 weeks; ② Relatively symmetrical bilateral symptoms; ③ Trunk or limb pain; ④ Cranial nerve symptoms or signs; ⑤ Autonomic dysfunction; ⑥ Respiratory insufficiency; ⑦ Mild or absent sensory dysfunction; ⑧ History of prodromal systemic infection in approximately 70% of cases; ⑨ No fever at symptom onset; ⑩ Elevated cerebrospinal fluid protein with normal or mildly elevated white blood cell count (\\\u003C5 mm³); ⑪ Electrophysiological examination showing abnormalities consistent with Guillain-Barré syndrome (GBS); ⑫ Recovery begins 2-4 weeks after symptom stabilization.\n2. CIDP: CIDP develops in 2%-5% of patients initially diagnosed with AIDP, with the following clinical features: ① Progressive or recurrent disease progression lasting over 8 weeks; ② Only approximately 30% of patients experience prodromal events; ③ Additional supporting features include: ≥3 acute relapses or exacerbations occurring ≥8 weeks after symptom onset, milder symptoms, preserved independent walking ability throughout the disease course, and absence of cranial nerve involvement or frequent respiratory system involvement.\n3. Autoimmune Ranvier node disease:\n\n   * Clinical manifestations: a. Acute, subacute or chronic course, with persistent progression after 8 weeks of onset; b. Clinical features consistent with polyneuropathy; c. May be accompanied by significant ataxia, tremor or neuropathic pain; d. May be associated with nephrotic syndrome.\n   * Electrophysiological findings: a. Motor nerve conduction tests reveal prolonged distal motor latency, slowed conduction velocity, abnormal waveform dispersion, and conduction block, with decreased F-wave conduction velocity, consistent with myelination abnormalities; b. Both motor and sensory nerve conduction show markedly reduced amplitude. Electromyography (EMG) at needle electrodes demonstrates abnormal spontaneous potentials and decreased recruitment, indicating early axonal damage.\n   * Antibody detection: serum anti-Langfei junction antibody was positive, especially serum anti-NF155, anti-CNTN1, anti-Casp1 and anti-NF140\u002F186 antibody.\n   * Cerebrospinal fluid (CSF) analysis: Protein-cell dissociation is observed, with CSF protein levels typically showing significant elevation.\n\n1.3.6. This study adheres to the diagnostic criteria of the 2024 China Expert Consensus on the Diagnosis and Treatment of Refractory Systemic Myasthenia Gravis\n\n1. Basic conditions\n\n   ① Meet the diagnostic criteria in the China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 edition).\n\n   ② The patient's Myasthenia Gravis Activities of Daily Living (MG-ADL) score was ≥6, and the ocular muscle score was less than 50% of the total score.\n2. Diagnostic criteria:\n\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents (including both corticosteroids and non-corticosteroid immunosuppressants), the post-intervention status (PIS) remains unchanged or worsens.\n   * After adequate doses and duration of at least two conventional immunotherapeutic drugs, the PIS showed improvement, but the MG-ADL score remained ≥6 points for at least six months.\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents, the PIS was remitted or improved, but during the regular tapering of immunotherapy, disease symptoms worsened ≥2 times per year (MG-ADL score ≥6).\n   * Patients who, after a crisis, received multiple immunotherapies including intravenous immunoglobulin (IVIG), plasma exchange, and high-dose intravenous methylprednisolone (IVMP), along with active infection control, still remained unable to wean off mechanical ventilation for more than 14 days due to MG-induced respiratory muscle weakness.\n\nDiagnostic criteria: meeting all the above basic conditions plus 1 of the 4 diagnostic conditions.\n\n1.3.7. This study adheres to the 2017 diagnostic criteria for idiopathic inflammatory myopathy (IIM) established by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), following the EULAR\u002FACR classification system. Patients with a probability score ≥55% in the table below are considered suspected IIM cases. Suspected IIM patients can be diagnosed with dermatomyositis in adults if they meet the following criteria: ① Age ≥18 years at first onset of IIM-related symptoms; ② Presence of Heliotrope sign, Gottron papules, or Gottron sign; ③ Objective proximal symmetrical arm weakness (confirmed by manual muscle strength testing or other strength assessment methods), typically progressive, or objective proximal symmetrical leg weakness, typically progressive, or more pronounced neck flexor weakness than neck extensor weakness, or more pronounced proximal leg weakness than distal leg weakness. If patients meet criteria ① and ② but not ③, they may be diagnosed with non-myopathic dermatomyositis. Compared to previous standards, this criterion demonstrates higher sensitivity and specificity. In this standard, patients with typical clinical manifestations (such as characteristic rashes) do not require further tests (e.g., muscle biopsy), while some patients without typical rashes may be missed.\n\nExclusion Criteria:\n\n* This is an observational study with no specific exclusion criteria.\n* The investigators identified other unexplained factors that may have disqualified participants from enrollment.","ALL","18 Years","80 Years",{"count":20,"type":21},1550,"ESTIMATED","10 Years","OBSERVATIONAL","Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular junctions. This study examines clinically significant NADs such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein G antibody-related diseases (MOGAD), autoimmune encephalitis (AE), immune-mediated peripheral neuropathy (PN), myasthenia gravis (MG), and idiopathic inflammatory myopathy (IIM). While sharing the core pathogenesis of autoimmune response, these diseases exhibit significant heterogeneity in epidemiological patterns, clinical manifestations, therapeutic approaches, and disease progression. This heterogeneity stems from multiple factors: (1) Differences in immune targets: MS primarily involves T-cell-mediated myelin attack, NMOSD is mainly driven by astrocyte damage caused by anti-AQP4 antibodies, MOGAD results from myelin surface loss mediated by antibodies against myelin oligodendrocyte glycoprotein immunoglobulin G, while AE involves synaptic dysfunction due to antibodies against neuronal surface proteins (e.g., anti-NMDA-R antibodies); (2) Genetic-environmental interactions: MS is more prevalent in European and American populations, whereas NMOSD is more aggressive in Asian populations; (3) Variability in treatment response: Some diseases respond well to immunomodulatory therapy, but most still face challenges such as high relapse rates, progressive disability accumulation, and irreversible neurological damage.\n\nWhile randomized controlled trials (RCTs) provide high-quality core evidence for drug registration, their strict inclusion\u002Fexclusion criteria, relatively homogeneous patient populations, and short-term observation designs often fail to fully capture the complex disease progression and treatment response patterns in real-world clinical settings. Additionally, long-term RCTs are frequently constrained by economic factors and sustainability challenges. Therefore, conducting comprehensive real-world observational studies (RWS) on NADs-integrating multi-disease cohorts, long-term follow-up data, and diverse clinical practices-holds significant scientific and clinical value for optimizing treatment strategies and improving long-term patient outcomes.",[26,27,28,29,30,31,32,33,34],"Multiple Sclerosis","NMO Spectrum Disorder","Autoimmune Encephalitis","Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease","Autoimmune Nodopathy","Acute Inflammatory Demyelinating Polyradiculoneuropathy","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Myasthenia Gravis","Idiopathic Inflammatory Myopathies","NOT_YET_RECRUITING","2026-01-17",{"date":38,"type":39},"2026-01-21","ACTUAL",{"date":41,"type":21},"2026-03-01",{"date":43,"type":21},"2037-03-01",{"name":45,"class":46},"Tongji Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100537663","clinical-impact-through-ai-assisted-ms-care---a-retrospective-multi-center-observational-study-100537663","NCT06280755","Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.","Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study","RECLAIM","Inclusion criteria:\n\n* Patients must have a confirmed diagnosis of MS, NMOSD, MOGAD, CIS or RIS.\n* Patient (or patient's legal representative) has previously signed and dated an informed consent form (ICF) for the secondary use of their data, or assent form. Alternatively, the secondary use of the patient's data is allowed following Institutional Review Board (IRB)\u002FEthical Committee (EC) approval in accordance with national and local subject privacy regulations.\n\nExclusion criteria:\n\n* Patients under 18 years of age will be excluded.\n* Other unspecified reasons that, in the opinion of the Investigator or Joint Steering Committee, make the patient unsuitable for participation in the study.",true,{"count":58,"type":21},7000,"The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression.",[26,27,29,61,62],"Radiologically Isolated Syndrome","Clinically Isolated Syndrome",[26,64,65,66,67],"Prognosis","Progression","AI models","disease worsening","RECRUITING","2025-12-05",{"date":71,"type":39},"2025-12-12",{"date":73,"type":39},"2024-03-01",{"date":75,"type":21},"2027-04",{"name":77,"class":78},"icometrix","INDUSTRY",3,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":47},"100552548","efficacy-and-safety-of-calculus-bovis-sativus-cbs-for-idiopathic-inflammatory-demyelinating-disease-cbsiniidd-100552548","NCT06474520","Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)","An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease","Inclusion Criteria:\n\n* IIDD cohort:\n\n  * Subjects are capable of understanding the purpose and risks of the study, providing informed consent and authorizing the use of confidential health information in accordance with national and local privacy regulations.\n  * Both men and women are welcome, and the age at the time of providing informed consent is 18-65 years (inclusive).\n  * All women of childbearing age and all men must use contraceptive measures during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.\n  * Must be diagnosed with\n\n    ① Multiple sclerosis, meet the 2017 revised McDonald criteria, and enter the MS cohort;\n\n    ② Aquaporin Protein-4-positive (AQP4) neuromyelitis optica spectrum disease, meet the 2015 international consensus diagnostic criteria for neuromyelitis optica spectrum disease (NMOSD), and AQP4 antibody positive, enter the AQP4-NMOSD cohort;\n\n    ③ Myelin oligodendrocyte glycoprotein antibody-related disease, clinically diagnosed as MOGAD according to the 2023 international MOGAD diagnostic criteria, and positive MOG autoantibody test by cell-based-assay method;\n\n    ④ Acute disseminated encephalomyelitis, clinically diagnosed as ADEM according to the 2013 International Pediatric Multiple Sclerosis Study Group (IPMSSG) diagnostic criteria, characterized by multifocal neurological deficits, must have encephalopathy manifestations (behavioral changes and\u002For changes in consciousness that cannot be explained by fever, including irritability), and exclude other specific antibody-positive IIDD.\n  * EDSS score ≤ 4 points at baseline (visit 1).\n  * Stable neurological examination within 30 days prior to Baseline (Visit 1).\n* Healthy cohort:\n\n  * Age ≥ 18 years old when signing the informed consent form\n  * Healthy adult subjects without underlying diseases\n\nExclusion Criteria:\n\n* Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.\n* Any untreated teratoma or thymoma at the baseline visit (randomization)\n* Other causes of symptoms, including central nervous system infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatic disease, Reyes syndrome, or inborn errors of metabolism.\n* History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except laparoscopic surgery or minor surgery (defined as surgery requiring only local anesthesia or conscious sedation, i.e., surgery that does not require general, neuraxial, or regional anesthesia and can be performed on an outpatient basis; e.g., toenail surgery, mole surgery, wisdom tooth extraction), excluding thymoma or teratoma removal.\n* Planned surgery during the study (except minor surgery).\n* History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of study treatment.\n* Current or history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma and squamous cell carcinoma that have been completely resected and considered cured for at least 12 months prior to Day -1). Subjects with cancer remission for more than 5 years prior to baseline (Visit 1) may be included after discussion with the sponsor\u002Fsponsor approval.\n* A history of gastrointestinal surgery (except appendectomy or cholecystectomy performed more than 6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant active gastrointestinal diseases in the opinion of the investigator.\n* A history of clinically significant recurrent or active gastrointestinal symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days before screening, including the need to start symptomatic treatment (e.g., start medication for gastroesophageal reflux disease) or a change in symptomatic treatment within 90 days before screening (e.g., dose increase).\n* A history of diverticulitis or concurrent severe gastrointestinal (GI) abnormalities (e.g., symptomatic diverticular disease) because the investigator believes that this may lead to an increased risk of complications such as GI perforation.\n* A history of blood donation (1 unit or more), plasma donation, or platelet donation within 90 days before screening.\n* Active suicidal ideation within 6 months before screening, or a history of suicide attempt within 3 years before screening.\n* Based on the investigator's judgment, there are serious diseases or abnormalities in the clinical laboratory test results that prevent the patient from completing the study or participating in the study safely.\n* Pregnant or lactating, or planning to become pregnant during the study or within 3 months after the last dose of the study drug; women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the start of the study.\n* The subject's mental or physical condition will hinder the evaluation of efficacy and safety.\n* Systolic blood pressure \\>150 mmHg or \\\u003C90 mmHg after sitting still for 5 minutes or before dosing at screening. If out of range, it can be measured again at screening and before dosing. If the repeated measurement value is still out of range, the subject shall not receive the drug.\n* Subjects with second or third degree atrioventricular block or sick sinus syndrome, poorly controlled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction, or significant ECG abnormalities, including corrected QT interval \\>450 msec (male) or 470 msec (female), where corrected QT interval is determined based on the Fridericia correction method, within 3 months prior to the screening visit.\n* Planned elective procedures or surgeries at any time after signing the Informed Consent Form by follow-up visit.\n* Any condition that affects the absorption of study treatment (e.g., gastrectomy).\n* History of hypersensitivity to heparin or history of heparin-induced thrombocytopenia.\n* Subjects with abnormalities in medical history, physical examination, ECG, or diagnostic laboratory tests that the investigator considers to be clinically relevant.\n* History of human immunodeficiency virus (HIV) or positive test results at screening.\n* Current infection with hepatitis C (defined as positive hepatitis C virus (HCV) antibodies and detectable HCV RNA). Subjects with positive HCV antibodies and HCV RNA below the limit of detection are eligible to participate in the study.\n* Current infection with hepatitis B (defined as positive HBsAg and\u002For positive total anti-HBc).\n* Chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) within 90 days prior to baseline (visit 1).\n* History of tuberculosis (TB) diagnosis or positive latent TB test result.\n* Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 28 days prior to baseline (visit 1). Subjects with localized fungal infection (e.g., candidiasis, tinea) are eligible for rescreening after successful treatment of the infection.\n* Infection requiring hospitalization or IV anti-infective medication within 4 weeks prior to baseline visit.\n* Any live or live attenuated vaccine within 28 days prior to baseline (visit 1) or planned during the study.\n* Contraindications to all of the following salvage therapies: rituximab, intravenous immunoglobulin, high-dose corticosteroids, or IV cyclophosphamide.\n* History of or receipt of the following treatments: Total lymphoid irradiation, cladribine, T-cell or T Cell recipient vaccination, total body irradiation, or total lymphoid irradiation at any time. Stem cell transplantation at any time.\n* Abnormal laboratory values determined by the investigator to be clinically significant at Screening or Baseline (Visit 1).\n* Any of the following blood test abnormalities at Screening: a. White blood cell count \\\u003C 3.0 × 10\\^3\u002FµL. b. Absolute neutrophil count \\\u003C 2.0 × 10\\^3\u002FµL. c. Absolute lymphocyte count \\\u003C 0.5 × 10\\^3\u002FµL. d. Platelet count \\\u003C × 10 × 10\\^4\u002FµL. e. glutamic-pyruvic transaminase, glutamic oxaloacetic transaminase, or γ-glutamyl transpeptidase ≥ 3 x upper limit of normal (ULN) or bilirubin \\> 2 x ULN. f. glomerular filtration rate ≤ 60 mL\u002Fmin\u002F1.73 m2. g. Lymphocyte count \\\u003C lower limit of normal\n* Any of the following urine test abnormalities at Screening: a. β-2-microglobulin\\>0.3 μg\u002FmL. b. Albumin\u002Fcreatinine ratio\\>22.6 mg\u002Fmmol.\n* Previous participation in this study.\n* Blood donation (1 unit or more) within 90 days before screening, plasma donation within 1 week before screening, and platelet donation within 6 weeks before screening.\n* History of alcohol or drug abuse in the past year (determined by the investigator).\n* Pregnant or lactating subjects, as well as subjects planning to become pregnant or start breastfeeding at any time during the study and within 30 days after completion of study treatment.\n* Participating in a clinical trial or having participated in a clinical trial within 90 days before screening.\n* History of clinically significant suicidal thoughts or behaviors in the past 12 months as assessed by Columbia-Suicide Severity Rating Scale at screening.\n* Unwilling or unable to comply with protocol requirements.\n* The patient has obvious hearing or vision impairment, language barriers, claustrophobia, etc., which makes the patient unable to cooperate with the neuropsychological scale assessment and MRI examination.\n* The researcher or sponsor believes that there are other unknown reasons that make the subject unsuitable for inclusion.",{"count":88,"type":21},250,"INTERVENTIONAL",[91],"NA","According to the records of traditional Chinese medicine, CBS has the following functions: clearing the heart, resolving phlegm, promoting bile secretion, and calming the nerves. It can treat fever, coma, delirium, epilepsy, convulsions in children, dental caries, throat swelling, oral sores, carbuncle, and furuncle.\n\nThe significant pathophysiological process of primary inflammatory demyelinating disease of the central nervous system (hereinafter referred to as IIDD) is the activation of the immune system of the central nervous system and the enhancement of inflammation. It includes several common diseases: multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-related disease (MOGAD), acute disseminated encephalomyelitis (ADEM), concentric sclerosis, tumor-like inflammatory demyelinating disease, etc.\n\nCombined with the inspiration brought to us by the above background research, especially bilirubin and bile acid are closely related to intestinal digestive function, and CBS is clinically effective through oral administration by subjects, the investigators speculate that CBS is likely to exert its immune, anti-inflammatory and neuroprotective effects on the brain by changing the intestinal flora and regulating the brain-gut axis. In terms of symptoms, CBS is likely to have the effect of improving the clinical symptoms of IIDD subjects and reducing disability.",[94,26,95,29,96],"Idiopathic Inflammatory Demyelinating Disease","Neuromyelitis Optica Spectrum Disorder","Acute Disseminated Encephalomyelitis","2024-09-19",{"date":99,"type":39},"2024-09-20",{"date":101,"type":39},"2024-08-08",{"date":103,"type":21},"2029-12",{"name":45,"class":46},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":115,"conditions":116,"keywords":120,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":47},"100557708","sun-yat-sen-cohort-of-cns-idiopathic-inflammatory-demyelinating-diseases-100557708","NCT06541626","Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases","Sun Yat-Sen Prospective Cohort Study of Central Nervous System Idiopathic Inflammatory Demyelinating Diseases","Inclusion Criteria:\n\n1. Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD);\n2. The clinical syndrome of the attack meets one of the following: MS, NMOSD, MOGAD, ADEM, clinically isolated syndrome, demyelinating encephalopathy, demyelinating myelitis, or brainstem encephalitis (see below A-E);\n3. Agree to participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of tumors or diagnosis of central nervous system tumors;\n2. Infectious lesions of the central nervous system;\n3. Hereditary, metabolic, toxic, vascular, or traumatic demyelinating diseases of the brain\u002Fspinal cord;\n4. Non-compliance with treatment and follow-up.","65 Years",{"count":114,"type":21},450,"The goal of this observational study is to learn about pathogenesis and clinical prognosis of CNS IIDD in the Chinese population and to provide evidence-based clues for clinical treatment decisions.\n\nThe main questions it aims to answer are:\n\nQuestion 1: Clarify the clinical characteristics and prognostic factors of various diseases (MS, NMOSD, MOGAD, etc.) within IIDD in the Chinese population.\n\nQuestion 2: Analyze the relationship between biomarkers and the occurrence, progression, and prognosis of CNS IIDD cases in our hospital.\n\nParticipants will\n\n1. Receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus, without additional special interventions.\n2. Receive clinical evaluation, follow-up, and management from dedicated neuroimmunology specialists.",[117,118,29,96,62,119],"Multiple Sclerosis, MS","Neuromyelitis Optica Spectrum Disorders","Demyelinating Disorder",[121,122],"CNS IIDD","follow-up","2024-08-02",{"date":125,"type":39},"2024-08-07",{"date":127,"type":39},"2024-01-01",{"date":129,"type":21},"2035-12-31",{"name":131,"class":46},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":142,"conditions":143,"keywords":150,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":47},"100454970","ms-researchbiomarkers-100454970","NCT05204459","MS-ResearchBiomarkerS","Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders","MS-ReBS","Inclusion Criteria:\n\n* Subjects who meet any one of the following diagnostic criteria:\n\n  * Diagnosis of MS, CIS,or RIS based on the 2017 revised McDonald criteria.\n  * Diagnosis of NMOSD based on the 2015 revised NMOSD consensus diagnostic criteria.\n  * Diagnosis of myelin oligodendrocyte glycoprotein (MOG)-related encephalomyelitis, optic neuritis, or other associated disease.\n  * Diagnosis of neurological disorders other than MSRD.\n  * Healthy volunteer.\n* Age ≥18.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Patients will be excluded from the MRI portions of the study if they have a contraindication to MRI(metallic implantsor foreign bodies, claustrophobia, MRI-incompatible pacemakers, MRI- incompatible prosthetic heart valves).\n* Patients will be excluded from the MRI portions of the study if they are pregnant, but their demographic, clinical information,and disability measures may still be captured under the study.\n* Patients will be excluded from the visual assessment portions of the study if they have had any recent ocular surgery (within the past two months), refractive errors of greater than or equal to ±6 diopters or other eye diseases that may affect or confound OCT\u002FOCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).",{"count":141,"type":21},1000,"This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part of the skull where eyes are located), and\u002For spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.",[26,144,145,146,62,61,118,29,147,148,149],"Multiple Sclerosis, Relapsing-Remitting","Multiple Sclerosis, Primary Progressive","Multiple Sclerosis, Secondary Progressive","Neurologic Autoimmune Disease","Neurologic Disorder","Healthy Aging",[26,144,145,146,62,61,118,151,147,148,149],"Myelin oligodendrocyte glycoprotein antibody-associated disease","2024-02-05",{"date":154,"type":39},"2024-02-06",{"date":156,"type":39},"2021-11-11",{"date":158,"type":21},"2041-11-11",{"name":160,"class":46},"Cedars-Sinai Medical Center"]