{"id":"W4362664139","doi":"10.1136/bmjopen-2022-068363","title":"Study protocol of a phase 2, randomised, placebo-controlled, double-blind, adaptive, parallel group clinical study to evaluate the efficacy and safety of recombinant alpha-1-microglobulin in subjects at high risk for acute kidney injury following open-chest cardiac surgery (AKITA trial)","year":2023,"lang":"en","type":"article","venue":"BMJ Open","topic":"Acute Kidney Injury Research","field":"Medicine","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"Université du Québec; Institut universitaire de cardiologie et de pneumologie de Québec; McGill University; Saint John Regional Hospital; Hamilton Health Sciences; University of Toronto; Population Health Research Institute; Université de Montréal; St. Michael's Hospital","funders":"","keywords":"Medicine; Interim analysis; Placebo; Renal function; Dosing; Clinical trial; Adverse effect; Internal medicine; Incidence (geometry); Acute kidney injury; 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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01635865,0.0060864,0.01001664,0.001133669,0.003390668,0.002830684,0.00369986,0.007317401,0.0601113],"category_scores_gemma":[0.01400295,0.0029866,0.003194914,0.001672045,0.003513267,0.00280919,0.001377083,0.00677927,0.01391293],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002959461,"about_ca_system_score_gemma":0.01407779,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001254998,"about_ca_topic_score_gemma":0.003023425,"domain_scores_codex":[0.989707,0.005443396,0.0009281281,0.001783126,0.001201371,0.0009369525],"domain_scores_gemma":[0.9923018,0.001365393,0.001409953,0.001030433,0.001551965,0.002340472],"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":[0.9571303,0.01050353,0.0006775706,0.004961886,0.0008002993,0.0001312163,0.000128064,0.0005321075,0.001915324,0.001324299,0.007397956,0.01449735],"study_design_scores_gemma":[0.955709,0.02716525,0.001113615,0.000481384,0.0003852645,0.00004551353,0.00002671617,0.0004637853,0.0003353491,0.0006763547,0.01354746,0.00005027162],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.009706706,0.0008031042,0.002468943,0.0003984785,0.0009265251,0.980238,0.00320782,0.0001635606,0.002086776],"genre_scores_gemma":[0.01253992,0.0004528554,0.00366065,0.0008238431,0.0003292184,0.9796116,0.001052376,0.00001625009,0.001513306],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.0601113,"threshold_uncertainty_score":0.2010923,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2001622331169594,"score_gpt":0.5244612424996495,"score_spread":0.3242990093826901,"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."}}