{"id":"W4391168380","doi":"10.1186/s13063-023-07828-6","title":"Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)","year":2024,"lang":"en","type":"article","venue":"Trials","topic":"Neonatal and fetal brain pathology","field":"Medicine","cited_by":11,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Universitätsklinikum Tübingen; Horizon 2020 Framework Programme; Sykehuset i Vestfold; Akershus Universitetssykehus; Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu; Medizinische Universität Graz; Karl-Franzens-Universität Graz; Universität Ulm; Ruhr-Universität Bochum; Warszawski Uniwersytet Medyczny; Hospital for Sick Children; Goethe-Universität Frankfurt am Main; Universitair Medisch Centrum Utrecht; St. Antonius Ziekenhuis; Uniwersytet Medyczny im. Piastów Slaskich we Wroclawiu; Wayne State University; Centre hospitalier universitaire Sainte-Justine; Università Cattolica del Sacro Cuore; University of Washington; Eberhard Karls Universität Tübingen; Universitätsklinikum Erlangen; European Commission; Technische Universität Dresden; Uniwersytet Warszawski; University College London","keywords":"Medicine; Hypoxic Ischemic Encephalopathy; Randomized controlled trial; Hypothermia; Population; Encephalopathy; Placebo; Allopurinol; Clinical endpoint; Neurocognitive; Pediatrics; Anesthesia; Internal medicine; Psychiatry; Pathology; Cognition","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.05538672,0.002849313,0.004880785,0.003161924,0.001299328,0.00306658,0.002058471,0.003223892,0.2015158],"category_scores_gemma":[0.109031,0.001945094,0.006221811,0.003257699,0.002670086,0.002129519,0.002228016,0.008214758,0.02100301],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002207713,"about_ca_system_score_gemma":0.009758076,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001581823,"about_ca_topic_score_gemma":0.001893473,"domain_scores_codex":[0.9494107,0.03668575,0.003123654,0.003819216,0.004610465,0.002350375],"domain_scores_gemma":[0.960466,0.02166675,0.004251947,0.008017909,0.0041002,0.001497179],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.4344073,0.003993344,0.004330968,0.01890841,0.01101136,0.0004960956,0.001150843,0.006874196,0.006413294,0.03151578,0.3270292,0.1538692],"study_design_scores_gemma":[0.3617716,0.03284608,0.02317339,0.008536751,0.007846766,0.0003698575,0.0005764354,0.06427564,0.01107829,0.04024631,0.448772,0.0005069658],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.01648564,0.001104821,0.09139331,0.004165447,0.008089275,0.7680459,0.08136886,0.01013373,0.01921297],"genre_scores_gemma":[0.01377232,0.000276593,0.09389313,0.001073872,0.0003790098,0.8764133,0.003595331,0.0006539578,0.009942575],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.2015158,"threshold_uncertainty_score":0.6741374,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.07174552482714365,"score_gpt":0.416704030685498,"score_spread":0.3449585058583544,"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."}}