{"id":"W2539044895","doi":"10.2337/db16-0234","title":"National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities","year":2016,"lang":"en","type":"article","venue":"Diabetes","topic":"Pancreatic function and diabetes","field":"Medicine","cited_by":197,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Alberta","funders":"National Center for Advancing Translational Sciences; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Allergy and Infectious Diseases; University of Alberta; Feinberg School of Medicine; Leonard M. Miller School of Medicine, University of Miami; Perelman School of Medicine, University of Pennsylvania; Novo Nordisk Fonden; University of California, San Francisco; University of Illinois at Urbana-Champaign; University of Minnesota; Northwestern University; Emory University; National Center for Research Resources; Leonard M. Miller School of Medicine; University of Pennsylvania; Faculty of Medicine and Dentistry, University of Alberta; University of Miami","keywords":"Transplantation; Medicine; Clinical trial; Product (mathematics); Good manufacturing practice; Manufacturing engineering; Operations management; Engineering; Surgery; Internal medicine; Regulatory affairs","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.008224713,0.0008061554,0.001006609,0.000514177,0.0008234963,0.001090793,0.0008491947,0.001020284,0.002087601],"category_scores_gemma":[0.002561829,0.0003804682,0.000781823,0.0007315006,0.0009827535,0.0005571011,0.0007688312,0.001935016,0.0003713357],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00121101,"about_ca_system_score_gemma":0.004148794,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001400837,"about_ca_topic_score_gemma":0.002435355,"domain_scores_codex":[0.9966117,0.00199647,0.0001951014,0.000358279,0.0005362012,0.0003023467],"domain_scores_gemma":[0.998293,0.0002405836,0.0003973882,0.0004187031,0.0002537723,0.0003966313],"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":[0.525363,0.09368838,0.04625985,0.0007756553,0.001678514,0.0007808064,0.0007071284,0.009124164,0.1388683,0.001195414,0.005514159,0.1760446],"study_design_scores_gemma":[0.2106199,0.6768052,0.04934698,0.00007871393,0.001224737,0.0007890126,0.0002385823,0.003270037,0.04610965,0.0004424944,0.01099092,0.00008382507],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9819978,0.0005083086,0.004348818,0.00021065,0.00006536737,0.01001839,0.0006174789,0.00007944523,0.002153847],"genre_scores_gemma":[0.9719272,0.0003915809,0.01506705,0.0006931329,0.0001029878,0.008357467,0.002147926,0.00004226158,0.001270487],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.008224713,"threshold_uncertainty_score":0.04349697,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.08117609451133721,"score_gpt":0.3535758101315311,"score_spread":0.2723997156201938,"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."}}