{"id":"W4401541812","doi":"10.3389/fneur.2024.1437913","title":"Innovation and optimization in autoimmune encephalitis trials: the design and rationale for the Phase 3, randomized study of satralizumab in patients with NMDAR-IgG-antibody-positive or LGI1-IgG-antibody-positive autoimmune encephalitis (CIELO)","year":2024,"lang":"en","type":"article","venue":"Frontiers in Neurology","topic":"Autoimmune Neurological Disorders and Treatments","field":"Medicine","cited_by":17,"is_retracted":false,"has_abstract":true,"ca_institutions":"SickKids Foundation; Hospital for Sick Children; University of Toronto","funders":"Medical Research Council; F. Hoffmann-La Roche","keywords":"Medicine; Autoimmune encephalitis; Autoantibody; Antibody; Neuromyelitis optica; Immunology; Placebo; Encephalitis; Immunotherapy; Internal medicine; Immune system; Pathology; Virus","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.002008497,0.0003519345,0.001421851,0.0005390121,0.0001558606,0.00005655378,0.0001588182,0.0001928523,0.00002513823],"category_scores_gemma":[0.001340704,0.0001911116,0.00008675084,0.001131347,0.0005822261,0.0002289925,0.00007477248,0.0004316341,2.533195e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00005008022,"about_ca_system_score_gemma":0.0001544894,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004379124,"about_ca_topic_score_gemma":0.00003386725,"domain_scores_codex":[0.9952702,0.00212078,0.001306547,0.0006415133,0.0002959424,0.0003650383],"domain_scores_gemma":[0.9954292,0.003704755,0.0003944378,0.000275537,0.0001671042,0.00002892601],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"observational","study_design_scores_codex":[0.7875906,0.008471511,0.1035625,0.0002619798,0.002082214,0.0006629177,0.01753202,0.02233414,0.0005305604,0.003032485,0.0002970487,0.05364201],"study_design_scores_gemma":[0.361478,0.0168586,0.4770152,0.0002709356,0.0008824636,0.0000536313,0.001406607,0.1397825,0.00007429736,0.001735172,0.00008815558,0.0003543553],"study_design_candidate":"randomized_trial","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9015964,0.002763106,0.08226408,0.001901071,0.0004244465,0.01091736,0.00007245006,0.00003253745,0.00002852885],"genre_scores_gemma":[0.9955484,0.0008002298,0.001875941,0.0004737012,0.00001717863,0.0008901982,0.0003020944,0.00003622904,0.00005598709],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4261126,"threshold_uncertainty_score":0.7793304,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02606988606134259,"score_gpt":0.3222239131659335,"score_spread":0.2961540271045909,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}