{"id":"W4362523215","doi":"10.1136/bmjopen-2022-065613","title":"Study protocol of a randomised, double-blind, placebo-controlled, two-arm parallel-group, multi-centre phase 3 pivotal trial to investigate the efficacy and safety of recombinant human alkaline phosphatase for treatment of patients with sepsis-associated acute kidney injury","year":2023,"lang":"en","type":"article","venue":"BMJ Open","topic":"Alkaline Phosphatase Research Studies","field":"Medicine","cited_by":17,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Calgary","funders":"Grifols; Abiomed; Astute Medical; Gilead Sciences; Shionogi; Sanofi; Fresenius Medical Care North America; AstraZeneca; Pfizer; Amgen","keywords":"Medicine; Placebo; Interim analysis; Tolerability; Clinical trial; Internal medicine; Acute kidney injury; Sepsis; Randomized controlled trial; Data monitoring committee; Kidney disease; Renal function; Adverse effect; Surgery; Pathology; Alternative medicine","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.002653435,0.0004616591,0.002317786,0.0002106156,0.0002749671,0.00003797856,0.0003973707,0.0000729333,0.00003399186],"category_scores_gemma":[0.001266369,0.0002550572,0.0002409137,0.0006687709,0.0002583705,0.0001328951,0.0005342711,0.0001130476,0.000003453467],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001440191,"about_ca_system_score_gemma":0.0004954244,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0007719404,"about_ca_topic_score_gemma":0.0002081517,"domain_scores_codex":[0.9960305,0.0004890903,0.00158936,0.0005739641,0.0007888401,0.0005282249],"domain_scores_gemma":[0.9964434,0.0006749642,0.001085308,0.0007605123,0.0005984302,0.0004373678],"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":[0.954618,0.02855644,0.004646458,0.000258544,0.00571307,0.00003249212,0.002188469,0.00001246684,0.0001255223,0.00003108777,0.002926752,0.000890706],"study_design_scores_gemma":[0.9488004,0.04478844,0.001255903,0.0005501134,0.001756055,7.758235e-7,0.0005678195,0.0002421362,0.001284076,0.0000140796,0.0004924974,0.0002477206],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.4785491,0.0000102366,0.000006566714,0.0004776463,0.0000435001,0.519334,0.001547425,0.0000206975,0.00001080199],"genre_scores_gemma":[0.3215592,0.00002284688,0.0006734838,0.00008560527,0.00006417462,0.6742977,0.002605388,0.00008514212,0.0006064119],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.15699,"threshold_uncertainty_score":0.9999902,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1180421893430407,"score_gpt":0.4735775338146222,"score_spread":0.3555353444715815,"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."}}