「clinical」の検索結果

Performs logistic regression for clinical trial outcomes (binary, ordinal, multinomial) with marginal-vs-conditional estimand reporting per FDA 2023 covariate adjustment guidance, g-computation/standardisation for marginal effects, modified Poisson for RR, Brant test for proportional odds, Firth penalty for separation, and Hauck-Donner detection. Use when modeling binary or ordinal endpoints in confirmatory or exploratory clinical trials.

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Tests associations between categorical variables in clinical data using chi-square, Fisher's exact, Boschloo, Cochran-Mantel-Haenszel, and modern McNemar variants with calibrated confidence intervals (Wilson, Newcombe, Miettinen-Nurminen). Use when analyzing categorical outcomes, paired binary endpoints, or testing treatment-outcome independence in confirmatory or exploratory clinical trials.

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Performs time-to-event analysis for clinical trials including Cox proportional hazards regression with PH diagnostics, restricted mean survival time (RMST) under non-PH, competing risks via Fine-Gray vs cause-specific Cox, weighted log-rank and MaxCombo for non-proportional hazards, recurrent events (Andersen-Gill, PWP, WLW), and interval-censored data. Use when analyzing time-to-event endpoints (OS, PFS, DOR, TTR, TTNT) in oncology or other clinical trials.

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Reads, validates, and prepares CDISC SDTM and ADaM clinical trial data for analysis. Covers SDTM domain joins (DM, AE, EX, VS, LB, DS), ADaM architecture (ADSL, BDS, OCCDS, ADTTE) with traceability, treatment-emergent AE conventions, baseline derivation, SUPPQUAL/NSV handling, Define-XML 2.1, and Pinnacle 21 / CORE validation. Use when working with clinical trial datasets in CDISC SDTM/ADaM format, preparing analysis-ready data, or validating for regulatory submission.

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Computes sample size and power for clinical trials including continuous, binary, and time-to-event endpoints; superiority, non-inferiority, and equivalence designs; FDA 2016 non-inferiority margin selection with M1/M2 framework; Schoenfeld 1981 and Lakatos 1988 for survival; Schuirmann TOST and 80-125% bioequivalence; minimum clinically important difference (MCID) vs δ distinction. Use when justifying trial size in protocol or SAP per CONSORT 2025 item 16a.

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Search ClinicalTrials.gov for clinical study information

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Extract structured data from clinical notes with span-level provenance and null-safety. Use when users say "extract [variables] from this note", "abstract this chart", "pull structured data from these notes", "what does this note say about [field]", or when building a chart-abstraction, registry, or cohort dataset from unstructured clinical text.

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Query ClinicalTrials.gov via API v2. Search trials by condition, drug, location, status, or phase. Retrieve trial details by NCT ID, export data, for clinical research and patient matching.

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Query ClinicalTrials.gov API v2 for trial data. Search by condition, drug/intervention, location, sponsor, or phase; fetch details by NCT ID; filter by status; paginate; export CSV. For clinical research, patient matching, and trial portfolio analysis.

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Guidelines for clinical decision support (CDS) documents: biomarker-stratified cohort analyses and GRADE-graded treatment reports. Covers structure, executive summaries, evidence grading (1A–2C), stats (HR, CI, survival), and biomarker integration. Use for pharma research docs, clinical guidelines, regulatory submissions.

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Conducts Privacy Impact Assessment for health data processing under GDPR Article 9, HIPAA, and sector-specific health privacy regulations. Covers special category data safeguards, clinical research data, patient portals, health wearables, genetic data, and cross-border health data transfers. Keywords: health data PIA, DPIA, Article 9, HIPAA, special category data, clinical research, patient privacy, genetic data.

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Addresses healthcare AI privacy at the intersection of HIPAA and the EU AI Act for clinical decision support systems. Covers training data PHI handling, model transparency and explainability, patient rights in algorithmic decisions, FDA/OCR regulatory coordination, and bias monitoring. Keywords: healthcare AI, HIPAA, AI Act, clinical decision support, PHI training data, model transparency.

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Think and work like an expert Clinical Trial Scientist. Use when a task calls for Clinical Trial Scientist judgment. Reasons from protocol SAPs, ICH-GCP, randomization/blinding, and CDISC SDTM while treating protocol deviations and immortal time as first-class failure modes.

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Think and work like an expert Clinical Data Manager. Use when a task calls for Clinical Data Manager judgment. Reasons from ALCOA+ data integrity, traceability, and analysis-ready datasets through CDASH/SDTM/ADaM pipelines, edit-check specs, Pinnacle 21 validation, MedDRA/WHO Drug coding, and define.xml under 21 CFR Part 11, treating blinding breaches, SAE-safety reconciliation gaps, mid-study IG/dictionary version drift, and unspecified partial-date imputation as first-class failure modes.

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Think and work like an expert Clinical Laboratory Scientist. Use when a task calls for Clinical Laboratory Scientist judgment. Reasons from pre-analytical–analytical–post-analytical total testing process; EP15/EP09/EP28 validation, Westgard/Sigma IQC, HIL indices (C56), EP23/IQCP, critical-value read-back, type-and-screen/crossmatch, CLSI M100 direct AST, LC-MS/MS C62, and AUTO10 autoverification.

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Think and work like an expert Clinical Microbiologist. Use when a task calls for Clinical Microbiologist judgment. Reasons from blood-culture volume and contamination criteria, staged Gram–ID–AST reporting, MALDI-TOF/VITEK/Phoenix and EUCAST RAST, CLSI M100 vs EUCAST breakpoint discipline, WHONET antibiograms, and NHSN MDRO alerts—treating contaminant vs pathogen and VME/ME as first-class failure modes.

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Reads, validates, and prepares CDISC SDTM and ADaM clinical trial data for analysis. Covers SDTM domain joins (DM, AE, EX, VS, LB, DS), ADaM architecture (ADSL, BDS, OCCDS, ADTTE) with traceability, treatment-emergent AE conventions, baseline derivation, SUPPQUAL/NSV handling, Define-XML 2.1, and Pinnacle 21 / CORE validation. Use when working with clinical trial datasets in CDISC SDTM/ADaM format, preparing analysis-ready data, or validating for regulatory submission.

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Performs time-to-event analysis for clinical trials including Cox proportional hazards regression with PH diagnostics, restricted mean survival time (RMST) under non-PH, competing risks via Fine-Gray vs cause-specific Cox, weighted log-rank and MaxCombo for non-proportional hazards, recurrent events (Andersen-Gill, PWP, WLW), and interval-censored data. Use when analyzing time-to-event endpoints (OS, PFS, DOR, TTR, TTNT) in oncology or other clinical trials.

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Clinical variant interpretation using ClinVar, ACMG guidelines, and pathogenicity predictors. Prioritize variants for diagnostic and research applications. Use when interpreting clinical significance of variants.

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End-to-end clinical trial analysis workflow from CDISC SDTM/ADaM loading through ICH E9(R1) estimand-driven primary analysis to CONSORT 2025 regulatory-compliant reporting. Covers data preparation, FDA 2023 marginal vs conditional logistic regression, categorical tests with Boschloo, modern HTE/subgroup methods, missing-data sensitivity (MMRM, reference-based MI, Permutt tipping point), graphical multiplicity (Bretz-Maurer), survival analysis (Cox/RMST/competing risks) when applicable, and Table 1. Use when performing a complete analysis of clinical trial data.

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Tests associations between categorical variables in clinical data using chi-square, Fisher's exact, Boschloo, Cochran-Mantel-Haenszel, and modern McNemar variants with calibrated confidence intervals (Wilson, Newcombe, Miettinen-Nurminen). Use when analyzing categorical outcomes, paired binary endpoints, or testing treatment-outcome independence in confirmatory or exploratory clinical trials.

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Query ClinVar for clinical variant significance. Use when user asks about variant pathogenicity, genetic variants, clinical significance, or disease-causing mutations. Triggers on "clinvar", "pathogenic", "variant significance", "clinical significance", "disease variant", "mutation pathogenicity".

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This skill applies the analytical frameworks of Ronald C. Kessler, psychiatric epidemiologist at Harvard University, to problems in precision psychiatry, clinical trial design, and healthcare machine learning. Use this skill whenever you are designing clinical trials, evaluating mental health interventions, analyzing epidemiological survey data, or building clinical decision support algorithms. It is highly relevant when the user asks about sample sizes, treatment matching, patient attrition, suicide prevention, or predictive modeling in healthcare. Trigger this skill to prioritize massive observational data, tiered predictive models, and human-in-the-loop AI over underpowered randomized trials and expensive, unscalable biomarkers.

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Use this skill whenever you are reasoning about public health policy, cancer prevention, epidemiological study design, clinical risk models, or weight management advice. This skill channels the thinking of Graham A. Colditz, epidemiologist at Washington University in St. Louis. Reach for this when evaluating lifestyle interventions, designing disease prevention programs, critiquing clinical prediction tools (e.g., AUC vs. clinical utility), or analyzing life-course risk accumulation. Apply his frameworks to bridge the "implementation gap" between scientific knowledge and societal action, prioritizing prevention over treatment and attainable weight maintenance over drastic weight loss.

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