「clinical-trial」の検索結果

通过 ClinicalTrials.gov API v2 实时检索官方临床试验注册数据。触发词包括 ClinicalTrials.gov、临床试验、NCT、试验注册、招募状态、phase 1/2/3、RCT lookup、interventional trial、observational study。专注实时单次查询(≤1000 条/请求),适合"某试验最新状态/招募信息/主次要终点"场景。批量历史分析请用 aact-bulk-trials,文献检索用 pubmed-search/europepmc。

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Query ClinicalTrials.gov via APIv2. Use when you want to search for trials by condition, drug, location, status, or phase; retrieve trial details by NCT ID; check eligibility/inclusion criteria; count trials across conditions or time periods; identify a sponsor's trial portfolio; find recruiting trials for patient matching.

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Extracts clinical trial baseline data (study, region, participants, etc.) from article text or PMID. Checks PubMed for metadata; always falls back to LLM extraction for full details.

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Draft a clinical trial protocol synopsis with the elements regulators and IRBs expect. Use when asked to write a clinical trial protocol, a study protocol synopsis, a trial design, or to structure endpoints/eligibility/statistics for an interventional study. Produces a structured protocol synopsis — objectives, design, population with eligibility, interventions, endpoints, statistics, and safety/ethics — for expert review. (For non-clinical/UX research, use research-protocol.)

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Structures biological experiments so inference is valid by construction, covering Fisher's principles (randomization, replication, local control), the experimental-vs-observational unit distinction and pseudoreplication (Hurlbert 1984; Lazic 2018), randomization mechanics (complete, restricted, stratified, rerandomization, run-order), blocking layouts (randomized complete block, Latin square, incomplete block), factorial designs and interactions, and the split-plot/nested error strata hidden inside multi-batch genomics. Use when deciding the experimental unit and what counts as a replicate, planning randomization and run order, choosing a blocked/factorial/split-plot/nested layout, avoiding pseudoreplication in cell-culture or animal studies, or specifying the random-effects structure of the analysis model. For assigning samples to sequencing batches/lanes/plates and batch-effect correction see experimental-design/batch-design; for regulated clinical-trial randomization see clinical-biostatistics.

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Estimates the minimum biological replicates (or cells/events) for a target power at a target FDR in genomics experiments using ssizeRNA, PROPER, powsimR for scRNA-seq, and pilot-data dispersion estimation from DESeq2/edgeR. Covers the biological-versus-technical replication distinction (technical replicates do not add degrees of freedom for biological inference), replicate-number-versus-sequencing-depth budgeting, scRNA-seq sample-versus-cell allocation under a pseudobulk model, and the critique that "n=3" is a publication convention rather than a power calculation. Use when budgeting a sequencing experiment, writing the sample-size justification in a grant, estimating replicates from pilot data, allocating a fixed budget between samples and depth, or planning scRNA-seq cohort size. For clinical-trial sample size see clinical-biostatistics/power-and-sample-size; for the power-given-n direction see experimental-design/power-analysis.

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Calculates statistical power for high-dimensional genomics experiments (bulk RNA-seq, scRNA-seq, ATAC-seq, ChIP-seq, methylation, proteomics) under negative-binomial count models using RNASeqPower, PROPER, and simulation via powsimR, distinguishing per-gene from marginal (transcriptome-wide) power, the role of mean expression and dispersion, and the sequencing-depth-versus-replicate tradeoff. Covers simulation as the honest default for overdispersed counts, FDR-aware average power versus single-test power, observed/post-hoc power as an anti-pattern, and the winner's-curse / Type-S / Type-M consequences of underpowering. Use when planning replicate number for a sequencing experiment, deciding whether to add depth or samples, choosing closed-form versus simulation power, estimating power from pilot dispersions, or justifying replication in a grant. For clinical-trial power see clinical-biostatistics/power-and-sample-size; for the inverse sample-size question see experimental-design/sample-size.

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Generate clinical trial protocols for medical devices or drugs. This skill should be used when users say "Create a clinical trial protocol", "Generate protocol for [device/drug]", "Help me design a clinical study", "Research similar trials for [intervention]", or when developing FDA submission documentation for investigational products.

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Generate clinical trial protocols for medical devices or drugs. This skill should be used when users say "Create a clinical trial protocol", "Generate protocol for [device/drug]", "Help me design a clinical study", "Research similar trials for [intervention]", or when developing FDA submission documentation for investigational products.

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Guides DPIA for health and medical data processing covering Art. 9(2)(h)-(j) exemptions, HIPAA crosswalk for transatlantic operations, clinical trial data protection under EU CTR 536/2014, and genetic data specifics under Art. 9(1). Activate for healthcare systems, clinical research, health apps, or medical device data. Keywords: health data, DPIA, Art. 9, clinical trial, genetic data, HIPAA, medical records, special category.

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Weekly clinical-trial status diff — the 11-category change report over the stored weekly snapshots (spec 055 FR-B03). Surfaces exactly what changed on the trial registry for your coverage: New / Suspended / Withdrawn / Terminated / Recruiting / Recruitment-Complete / Completed / Ahead / Delayed / Upsized / Downsized, every row carrying previous and new values, with risk flags on Terminated and Downsized and re-timing flags on Ahead and Delayed. The stored-previous-value discipline makes each week's diff reproducible.

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Clinical-trial readout analysis: pull the trial, evaluate the readout with AdCom-style scrutiny (endpoints, statistics, subgroups, missing data, safety, tolerability/persistence), place it in a cross-trial comparison lattice vs SoC and class peers, and size the stock reaction with historical grounding. The judgment core for binary biotech events.

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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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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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Patterns for designing and analyzing clinical trials, including survival analysis, endpoint selection, sample size calculation, interim analyses, and regulatory considerations. Covers FDA/EMA guidelines and modern adaptive designs. Use when ", " mentioned.

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Designing clinical trials — phases, randomization, endpoints, sample size, and CONSORT-compliant reporting.

日本語の概要は準備中です。原文の説明を表示しています。

Structures biological experiments so inference is valid by construction, covering Fisher's principles (randomization, replication, local control), the experimental-vs-observational unit distinction and pseudoreplication (Hurlbert 1984; Lazic 2018), randomization mechanics (complete, restricted, stratified, rerandomization, run-order), blocking layouts (randomized complete block, Latin square, incomplete block), factorial designs and interactions, and the split-plot/nested error strata hidden inside multi-batch genomics. Use when deciding the experimental unit and what counts as a replicate, planning randomization and run order, choosing a blocked/factorial/split-plot/nested layout, avoiding pseudoreplication in cell-culture or animal studies, or specifying the random-effects structure of the analysis model. For assigning samples to sequencing batches/lanes/plates and batch-effect correction see experimental-design/batch-design; for regulated clinical-trial randomization see clinical-biostatistics.

日本語の概要は準備中です。原文の説明を表示しています。

Estimates the minimum biological replicates (or cells/events) for a target power at a target FDR in genomics experiments using ssizeRNA, PROPER, powsimR for scRNA-seq, and pilot-data dispersion estimation from DESeq2/edgeR. Covers the biological-versus-technical replication distinction (technical replicates do not add degrees of freedom for biological inference), replicate-number-versus-sequencing-depth budgeting, scRNA-seq sample-versus-cell allocation under a pseudobulk model, and the critique that "n=3" is a publication convention rather than a power calculation. Use when budgeting a sequencing experiment, writing the sample-size justification in a grant, estimating replicates from pilot data, allocating a fixed budget between samples and depth, or planning scRNA-seq cohort size. For clinical-trial sample size see clinical-biostatistics/power-and-sample-size; for the power-given-n direction see experimental-design/power-analysis.

日本語の概要は準備中です。原文の説明を表示しています。

Calculates statistical power for high-dimensional genomics experiments (bulk RNA-seq, scRNA-seq, ATAC-seq, ChIP-seq, methylation, proteomics) under negative-binomial count models using RNASeqPower, PROPER, and simulation via powsimR, distinguishing per-gene from marginal (transcriptome-wide) power, the role of mean expression and dispersion, and the sequencing-depth-versus-replicate tradeoff. Covers simulation as the honest default for overdispersed counts, FDR-aware average power versus single-test power, observed/post-hoc power as an anti-pattern, and the winner's-curse / Type-S / Type-M consequences of underpowering. Use when planning replicate number for a sequencing experiment, deciding whether to add depth or samples, choosing closed-form versus simulation power, estimating power from pilot dispersions, or justifying replication in a grant. For clinical-trial power see clinical-biostatistics/power-and-sample-size; for the inverse sample-size question see experimental-design/sample-size.

日本語の概要は準備中です。原文の説明を表示しています。

医学证据等级排序与编排层 skill。当用户请求"证据等级 / GRADE / 证据排序 / 医学证据评估 / evidence grading / quality of evidence / 系统评价排序 / 临床证据排序 / 证据金字塔"时触发。本 skill 不直接调用 NCBI/Europe PMC/ClinicalTrials API,而是编排 6 个底层原子 skill(pubmed-eutils / europepmc-search / clinical-trials-v2 / aact-bulk-trials / bioc-fulltext-fetch / pubtator-entity-search)的召回结果,按 ChatGPT 推荐的证据金字塔(指南 > Meta > RCT > Cohort > Case-Control > Case Report)做 GRADE 自动评级,自动剔除 editorial / letter / comment。优先使用 BioMCP MCP server 做 fan-out(genomoncology/biomcp),无 BioMCP 时走自建 slow-path 兜底。

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医学证据等级排序与编排层 skill - evidence grading orchestrator. 当用户请求"证据等级 / GRADE / 证据排序 / 医学证据评估 / 系统评价排序 / 临床证据排序 / 证据金字塔 / 给 PMID 打分 / Practice Guideline 优先 / Cochrane 优先 / 反向证据交叉验证 / evidence grading / quality of evidence / evidence pyramid / GRADE assessment / Cochrane review ranking / clinical evidence ranking"时,**调用本 skill 进行医学证据自动分级,自动选择最佳信息源**。本 skill 是编排层(L2)·不直接打 NCBI/Europe PMC/ClinicalTrials API,而是编排 6 个底层原子 skill(pubmed-eutils / europepmc-search / clinical-trials-v2 / aact-bulk-trials / bioc-fulltext-fetch / pubtator-entity-search)的召回结果,按证据金字塔(指南 > Meta > RCT > Cohort > Case-Control > Case Report)做 GRADE A/B/C/D 自动评级,自动剔除 editorial/letter/comment。优先使用 BioMCP MCP server 做 fan-out(genomoncology/biomcp);无 BioMCP 时走自建 slow-path 兜底。跨平台无锁(Claude Code / Codex / Gemini CLI)。

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Europe PMC RESTful Web Service 多源文献聚合检索原子 skill。**使用本 skill 进行医学文献广召回 / RAG 知识库构建 / 跨库聚合 / 预印本扫描 / 全文链接发现**。一次调用同时召回 PubMed (MED) + PMC + AGRICOLA + CABI + 预印本(bioRxiv / medRxiv / ChemRxiv / Research Square)+ NCBI Bookshelf + 专利,自动按 PMID/PMCID/DOI 三级去重,返回完整元数据(全文 OA 链接、citations、grants 资助信息)。**定位:广召回 · 多源 · RAG 友好**(与 pubmed-eutils 互补 — 后者做单源精准官方检索 + Clinical Queries;本 skill 做"撒网"式多源聚合)。触发词:Europe PMC / EuropePMC / 多源文献聚合 / 广召回 / RAG 召回 / RAG 知识库 / 预印本搜索 / preprint search / bioRxiv / medRxiv / ChemRxiv / DOI 检索 / DOI lookup / 全文链接 / full-text links / OA 全文 / PMCID / 灰色文献 / grey literature / 跨库去重 / 资助检索 / grant search / NIH funded / Wellcome funded / citations metadata。**不做**:NCBI E-utilities 直检(→ pubmed-eutils)、临床试验注册(→ clinical-trials-v2)、全文 XML 抽取(→ bioc-fulltext-fetch)、实体识别(→ pubtator-entity-search)、证据分级(→ medical-evidence-grading)、参考文献终态写入(→ evidence-appendix-sync)。

日本語の概要は準備中です。原文の説明を表示しています。

Europe PMC RESTful Web Service 多源文献聚合检索原子 skill。一次调用同时召回 PubMed + PMC + AGRICOLA + CABI + 预印本(bioRxiv / medRxiv / ChemRxiv 等)+ 灰色文献,自动按 PMID/PMCID/DOI 三级去重,返回完整元数据(含全文 OA 链接、citations metadata、grants 资助信息)。当任务出现 Europe PMC、多源文献聚合、广召回、RAG 检索、预印本搜索、bioRxiv、medRxiv、全文链接、DOI 检索、跨库去重、灰色文献、资助检索 等触发词时使用。**定位**:广召回 · 多源聚合 · RAG 友好(与 pubmed-eutils 互补——后者做精准官方源、Clinical Queries;本 skill 做"撒网"式广召回)。**不做**:NCBI E-utilities 直检(交给 pubmed-eutils)、临床试验(clinical-trials-v2)、全文 XML 抽取(bioc-fulltext-fetch)、实体识别(pubtator-entity-search)、证据分级(medical-evidence-grading)。

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当用户询问 ClinicalTrials.gov / 临床试验 / NCT / 试验注册 / 招募状态 / phase 1/2/3 / RCT lookup / sponsor 检索 / interventional trial / observational study / 主次要终点 / trial outcomes / 试验招募中 / recruiting status 时,通过 ClinicalTrials.gov API v2 实时检索官方注册数据。专注实时单次查询(≤1000 条/请求),典型场景: "某 NCT 试验最新状态"、"BTK 抑制剂 Phase 3 在招募试验"、"某试验已发布的主次要终点结果"。明确边界: 批量 >10k 试验 / 全库 SQL 历史分析 → aact-bulk-trials; 关联 PubMed 文献 → pubmed-eutils; RCT 自动 GRADE 评级 → medical-evidence-grading; 引用入报告附录 → evidence-appendix-sync。跨平台无锁(Claude Code / Codex / Cursor 通用)。

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