{"id":"W1985938632","doi":"10.1016/j.ahj.2011.05.026","title":"Berlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: Study design and rationale","year":2011,"lang":"en","type":"article","venue":"American Heart Journal","topic":"Mechanical Circulatory Support Devices","field":"Engineering","cited_by":112,"is_retracted":false,"has_abstract":false,"ca_institutions":"Stollery Children's Hospital; University of Alberta","funders":"U.S. Food and Drug Administration","keywords":"Medicine; Ventricular assist device; Investigational device exemption; Intensive care medicine; Cardiology; Internal medicine; Heart failure; Clinical trial","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":[0.02311377,0.00289605,0.004771296,0.001582234,0.00148122,0.002348426,0.001938072,0.002528391,0.008830137],"category_scores_gemma":[0.01503129,0.001990554,0.001678286,0.001798552,0.002363412,0.001380108,0.001521821,0.002093868,0.002329013],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001242535,"about_ca_system_score_gemma":0.003320128,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0006113673,"about_ca_topic_score_gemma":0.001515193,"domain_scores_codex":[0.9810988,0.01254396,0.001767645,0.001954726,0.001614806,0.001019924],"domain_scores_gemma":[0.9933497,0.003213665,0.001204411,0.0007834587,0.000792007,0.0006567095],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"not_applicable","study_design_scores_codex":[0.6689144,0.0165042,0.1813781,0.009227303,0.007356802,0.001852899,0.002115326,0.002600355,0.01076975,0.02414002,0.01290491,0.06223588],"study_design_scores_gemma":[0.539395,0.1083139,0.2153618,0.002219958,0.009907087,0.001675309,0.001448566,0.005229441,0.005478682,0.01346175,0.09704176,0.0004666736],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"protocol","genre_scores_codex":[0.5583633,0.02003022,0.03060479,0.002643666,0.001516371,0.3450883,0.016376,0.0001414156,0.02523595],"genre_scores_gemma":[0.5836849,0.003842338,0.0216111,0.003456886,0.001537207,0.3730028,0.005632076,0.00007769481,0.007155026],"genre_candidate":"protocol","genre_consensus":null,"teacher_disagreement_score":0.02311377,"threshold_uncertainty_score":0.1222388,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06706748682791755,"score_gpt":0.2744212309333072,"score_spread":0.2073537441053896,"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."}}