{"id":"W4393390558","doi":"10.1186/s13063-024-08070-4","title":"A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial","year":2024,"lang":"en","type":"article","venue":"Trials","topic":"Wound Healing and Treatments","field":"Medicine","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Royan Institute; Royan Institute for Stem Cell Biology and Technology","keywords":"Medicine; Transplantation; Second-Degree Burn; Surgery; Randomized controlled trial; Total body surface area; Burn injury; Burn center; Clinical trial; Single Center; Debridement (dental); Keratinocyte; Wound healing; Burn wound; Poison control; Emergency medicine; Internal medicine","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.009566816,0.0002141062,0.001736591,0.00007852886,0.0001735119,0.0001042174,0.0001124072,0.0001040467,0.00004103851],"category_scores_gemma":[0.001606851,0.0001235517,0.0002151306,0.0001128507,0.000097816,0.00009506415,0.00003266972,0.000111535,0.000001026084],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00003663067,"about_ca_system_score_gemma":0.0001474564,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00002439361,"about_ca_topic_score_gemma":0.0001195479,"domain_scores_codex":[0.995407,0.001899337,0.001863723,0.000413486,0.0002512751,0.0001651813],"domain_scores_gemma":[0.9905752,0.008602526,0.0003606596,0.0002159421,0.0001277456,0.0001179545],"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":[0.9713998,0.008866346,0.00006345935,0.0001897176,0.00194238,0.00001595528,0.00438503,0.00003791619,0.001831158,0.0002910353,0.0001984377,0.0107788],"study_design_scores_gemma":[0.978184,0.0163035,0.0001362557,0.0002320035,0.002949343,0.00002396652,0.0003039397,0.0006720076,0.0003679304,0.0001867684,0.0005173488,0.0001229361],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9335771,0.001872302,0.03020989,0.0004656471,0.0004368443,0.03315243,0.0001903357,0.00002802837,0.00006742123],"genre_scores_gemma":[0.98709,0.0005665052,0.01007,0.0001261999,0.0003768237,0.001123162,0.0002841628,0.00002792332,0.0003352507],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.05351287,"threshold_uncertainty_score":0.503829,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3472368239828378,"score_gpt":0.4769932773209338,"score_spread":0.129756453338096,"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."}}