{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","metaepi_narrow"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.097482,0.0005115545,0.004760011,0.0006458786,0.0004420008,0.0001700858,0.000456826,0.0001888328,0.00006689153],"category_scores_gemma":[0.04834384,0.0003182843,0.00110474,0.0006828477,0.00009333937,0.0001668171,0.0005169255,0.0004941024,0.000009045154],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.000250723,"about_ca_system_score_gemma":0.0009930717,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0003944483,"about_ca_topic_score_gemma":0.0001316842,"domain_scores_codex":[0.9852834,0.007297646,0.004454947,0.001158349,0.0009376366,0.0008680763],"domain_scores_gemma":[0.9654641,0.03177524,0.0009174457,0.0009988104,0.000281737,0.0005626286],"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":[0.9218616,0.009384429,0.040453,0.0001397261,0.004716801,0.00001004597,0.0006887038,0.0000105062,0.0004415087,0.00001805657,0.01828323,0.003992429],"study_design_scores_gemma":[0.9612676,0.02107992,0.008688449,0.0005823116,0.004925051,5.424442e-7,0.0007998947,0.0002546567,0.0004500372,0.0001163601,0.001556534,0.0002786604],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.5198689,0.000007050012,0.0002169918,0.0009353788,0.0004914192,0.4782186,0.0001794848,0.0000302207,0.00005198404],"genre_scores_gemma":[0.5140591,0.000004935678,0.0001040684,0.0001993808,0.000319511,0.4849311,0.00005410036,0.00004462844,0.0002832802],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.04913816,"threshold_uncertainty_score":0.9999269,"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."}}