{"id":"W3119449695","doi":"10.1136/bmjopen-2020-041479","title":"Study protocol of RESCUE-ALS: A Phase 2, randomised, double-blind, placebo-controlled study in early symptomatic amyotrophic lateral sclerosis patients to assess bioenergetic catalysis with CNM-Au8 as a mechanism to slow disease progression","year":2021,"lang":"en","type":"article","venue":"BMJ Open","topic":"Amyotrophic Lateral Sclerosis Research","field":"Medicine","cited_by":51,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"FightMND; National Health and Medical Research Council; ALS Association; Johns Hopkins University; Emory University; Montreal Neurological Institute and Hospital; Massachusetts General Hospital; Western Sydney Local Health District; Thomas Jefferson University","keywords":"Medicine; Amyotrophic lateral sclerosis; Riluzole; Placebo; Teriflunomide; Clinical endpoint; Pharmacokinetics; Clinical trial; Pharmacology; Internal medicine; Multiple sclerosis; Disease; Fingolimod; Pathology; Immunology","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01064636,0.00648874,0.009649866,0.001265395,0.002142638,0.00230077,0.003067296,0.006817246,0.02681044],"category_scores_gemma":[0.006417802,0.002249872,0.003087497,0.001134957,0.003427427,0.002200349,0.001183205,0.005791391,0.00730226],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002010976,"about_ca_system_score_gemma":0.007623987,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001031828,"about_ca_topic_score_gemma":0.002366107,"domain_scores_codex":[0.9951991,0.002043237,0.0004088289,0.0009855252,0.0005930729,0.0007701876],"domain_scores_gemma":[0.9956949,0.0006255843,0.0007465666,0.0005880953,0.0009414551,0.001403391],"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":[0.9656315,0.01639164,0.0003054329,0.002090372,0.0005203765,0.00008156206,0.00008745711,0.0004484412,0.004413385,0.0003804546,0.00236335,0.007285962],"study_design_scores_gemma":[0.9193638,0.07299663,0.0007213965,0.0001347169,0.000280798,0.00002467475,0.0000218534,0.0002870874,0.0005761123,0.0002794697,0.005276653,0.00003674406],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.07434802,0.001867911,0.004182162,0.000858728,0.00182893,0.9091571,0.004033613,0.0003813047,0.003342119],"genre_scores_gemma":[0.06298152,0.0009674504,0.006058554,0.001817293,0.0006393823,0.9219851,0.001333713,0.00004128526,0.004175671],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.02681044,"threshold_uncertainty_score":0.08968985,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1321636561468989,"score_gpt":0.4573727062569956,"score_spread":0.3252090501100967,"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."}}