{"id":"W4415620268","doi":"10.1186/s13063-025-09124-x","title":"POINTER: study protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following open-chest cardiac surgery","year":2025,"lang":"en","type":"article","venue":"Trials","topic":"Acute Kidney Injury Research","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"Royal Victoria Hospital; University of Toronto; St. Michael's Hospital; Institut universitaire de cardiologie et de pneumologie de Québec","funders":"","keywords":"Clinical study; Protocol (science); Clinical trial; Renal function; Research design; Phases of clinical research; Multicenter study","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":[0.01969525,0.005468167,0.008492745,0.001295176,0.004190082,0.003216493,0.004077908,0.008363585,0.1650046],"category_scores_gemma":[0.02201981,0.002742034,0.003763579,0.002170395,0.002893746,0.003362085,0.001770467,0.009510898,0.03834894],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002971665,"about_ca_system_score_gemma":0.011556,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001108774,"about_ca_topic_score_gemma":0.003037106,"domain_scores_codex":[0.9890369,0.006301376,0.001374935,0.001367318,0.0009122514,0.001007315],"domain_scores_gemma":[0.9869857,0.0025432,0.002434572,0.002264317,0.00315765,0.002614451],"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":[0.8834374,0.01104871,0.0005765175,0.01888639,0.001065528,0.0002019385,0.0002634701,0.0007303474,0.003371027,0.004468626,0.04466322,0.03128687],"study_design_scores_gemma":[0.8711742,0.02617672,0.001593336,0.003117844,0.000614335,0.00008325931,0.00007820534,0.0007323711,0.0007478766,0.002369553,0.09321727,0.00009519835],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.002768215,0.0007444638,0.00315044,0.000379256,0.00100445,0.9834827,0.004701998,0.0002769585,0.00349154],"genre_scores_gemma":[0.003745834,0.0003311789,0.004112823,0.0005183943,0.0001748699,0.988231,0.001049659,0.0000283556,0.001807856],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.1650046,"threshold_uncertainty_score":0.5519955,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3390786867043201,"score_gpt":0.5582883839487258,"score_spread":0.2192096972444057,"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."}}