1️⃣ DKDComposite-Adj DM · DKD trial endpoint
디케이디컴포지트엣지 — CKD-EPI 2021 race-free eGFR sustained decline + UACR doubling + ESKD + renal/CV death 5점 composite 자동 도달 + 2-reader paired blinded adjudication + Lan-DeMets DSMB dashboard standalone HTML
DKD phase 3/4 RCT(FLOW · SOUL · EMPA-KIDNEY · CONFIDENCE · ZENITH-CKD · PROTECT · MAESTRO renal sub) sponsor/CRO/DSMB용 endpoint adjudication. eCRF CSV(REDCap/Medidata 호환) ingest → CKD-EPI 2021 race-free formula(여성 1.012 보정 포함) → configurable threshold(30%/40%/57% × 28/30/90d × 2~3 consecutive confirmation) → 5점 composite(eGFR decline / UACR doubling / ESKD dialysis≥90d·transplant·eGFR<15 / renal death / CV death MedDRA SMQ) first-event 자동 정렬 → Kaplan-Meier(Chart.js stepped) → 2-reader paired blinded(좌우 random·patient ID mask·visit timeline 표시) + 3rd adjudicator routing + Cohen's κ → SGLT2i/Finerenone/GLP-1RA ever-use 토글 covariate sensitivity → CDISC ADKID/ADRENAL schema preview + 한국어 site-level summary print stylesheet. 한국 DKD ~170~230만 명, 글로벌 DKD trial 동시 ~50~80건 표준 도구 후보.
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2️⃣ AntiObesityBoneLean-Kor Obesity · 항비만약 BMD+lean
안티오베시티본린코어 — 항비만약(GLP-1RA/tirzepatide/CagriSema/MariTide/retatrutide/orforglipron) trial DXA + bone turnover + functional 추적 + 약물별 expected loss curve + sarcopenic obesity composite + FRAX 10년 + sample size library standalone HTML
STEP-bone · SURMOUNT-bone · MaSquerade · RECLAIM-Korea · RESET 등 BMD/lean 명시 endpoint trial sponsor/CRO/site용. (1) Multi-format DXA(Hologic Apex/GE Lunar enCORE/Norland) ingest + cross-machine 5% systematic 보정 (2) 약물별 expected BMD loss reference(STEP 1: sema 2.4 −1.5%/y · SURMOUNT-1: tirzep 15 −2.1%/y · TRIUMPH: retatrutide 12 −2.5%/y · CagriSema −1.2%/y · MariTide −0.8%/y · orforglipron −0.6%/y · survodutide −1.0%/y) overlay + deviation flag (3) Sarcopenic obesity composite 5축(BMD T≤-2.5 + ALMI + grip + STS-5 + gait) + EWGSOP2/AWGS/KSSO toggle + FRAX 10-yr (4) STEP/SURMOUNT/TRIUMPH ES library + power calculator(formula+simulation) (5) Cohort spaghetti + KSSO/KOSSO/KSBMR 한국어 학회 발표 layout(print stylesheet) + CDISC ADBMD/ADBONE/ADFUNC export. OpenClaw 바이오 피벗 직접 alignment.
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3️⃣ MASHConMedHarmonize MASLD · MASH ConMed
매시콘메드하모나이즈 — MASH RCT 동반약물(한국어/영어/복합제/OTC/한약 free-text) → ATC 자동 매핑 + dose normalization + exposure window + endpoint(PDFF/LSM/ALT/ELF/NAS) sensitivity + 15 DDI signal auto-flag + 프로토콜 deviation standalone HTML
MAESTRO-NASH · HARMONY · LIVERAGE · SYNERGY-NASH · SURPASS-NASH · NATIV3 · ENLIVEN 등 MASH RCT sponsor/CRO용. (1) ConMed free-text ingest + Fuse.js fuzzy matching + 102개 drug dictionary(한국 brand 다파엠정·자누비아 등 + 영문 generic + 복합제 split rule + 한약 milk thistle/berberine/curcumin/resveratrol + OTC paracetamol/ibuprofen) → ATC code 자동 매핑 + 신뢰도 badge + 사용자 review/correct UI (2) PDD→DDD 자동 + visit-level exposure binary/duration/cumulative + run-in/washout timeline (3) 5 endpoint × 8 subgroup forest plot + interaction Δ (metformin/SGLT2i/GLP-1RA/statin/levothyroxine/pioglitazone/ezetimibe/한약 ever-use) (4) 15 DDI signal(levothyroxine+resmetirom THR-β / statin+ALT / SGLT2i+LSM / GLP-1RA+PDFF / MTX hepatotoxic) auto-flag + protocol deviation severity (5) Cohort heat map + DDI signal annotated timeline + KASL/KSGH 학회 print layout + CDISC ADCM/ADEX export. 한국 MASH ~75~150만 명, 글로벌 MASH trial 동시 ~50~70건 표준 도구 후보.
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