[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07217730":3,"trial-entities:NCT07217730":115,"trial-summary:NCT07217730":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":16,"conditions":17,"keywords":26,"study_type":52,"primary_purpose":53,"phases":54,"enrollment_info":55,"interventions":58,"primary_outcomes":81,"secondary_outcomes":86,"sex":90,"minimum_age":53,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":95,"locations":99,"central_contacts":108,"overall_officials":109,"references":113,"see_also_links":114},"NCT07217730","PRS-HI-AFK-SC-US-101325-GS","Healthcare Integrity & Anti-Fraud Enforcement","§ PHX-AFK-US: Public Health Exchange Protocol for Anti-Fraud, Kickback Prevention & Secure Chain Integrity in U.S. Healthcare Facilities","ENROLLING_BY_INVITATION","2034-10-13","2025-10","2025-10-20","2025-10-13","Truway Health, Inc.","INDUSTRY",false,"The PHX-AFK-US Protocol is a coalition-backed regulatory scaffold designed to restore healthcare integrity across U.S. facilities. It targets fraud, kickback schemes, and supply chain opacity through validator governance, smart contract enforcement, and public transparency. Anchored by notarized affidavits, NFT fiscal instruments, and dashboard oversight, this protocol empowers whistleblowers, mobilizes validators, and escalates complaints to federal and state regulators. It integrates secure audit trails, DAO voting logic, and asset freeze triggers to ensure accountability, reform, and systemic trust.",[18,19,20,21,22,23,24,25],"Healthcare Fraud Schemes","Kickback Networks","Supply Chain Vulnerabilities","Governance Failures","Whistleblower Activation","Regulatory Escalation Pathways","Validator Oversight & DAO Governance","Public Transparency & Auditability",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"Healthcare Integrity","Anti-Fraud","Kickback Prevention","Secure Supply Chain","Validator Governance","Coalition Oversight","NFT Fiscal Instruments","Smart Contract Enforcement","DAO Voting","SHA-256 Notarization","Whistleblower Affidavits","Regulatory Escalation","Public Transparency","Audit Trail","Asset Freeze Logic","CMS \u002F DOJ \u002F OIG Complaints","Procurement Reform","Phantom Billing","Referral Schemes","Medical Device Provenance","Coalition Dashboard","Public Health Exchange","SOP Violations","Facility Sanctions","DeFi Escrow Logic","OBSERVATIONAL",null,[],{"count":56,"type":57},100,"ESTIMATED",[59,67,74],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":65},"OTHER","Validator-Governed Reform & Regulatory Escalation Protocol","This intervention deploys a validator-governed framework to monitor, escalate, and reform healthcare facilities exhibiting fraud, kickback schemes, and supply chain vulnerabilities. It integrates notarized affidavits, smart contract enforcement, NFT fiscal declarations, and DAO voting logic to trigger sanctions, regulatory complaints, and operational restructuring. Facilities are observed prospectively, with all actions logged to a public dashboard and anchored via SHA-256 hash notarization. No biospecimens are retained; all data is legal, technical, and governance-based.",[64],"Flagged Healthcare Facilities - Validator Oversight Cohort",[66],"PHX-AFK-US Protocol",{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"DEVICE","Coalition-Grade Validator Dashboard Module (CVDM-1)","The Coalition-Grade Validator Dashboard Module (CVDM-1) is a secure, web-based device deployed across enrolled healthcare facilities to enable real-time validator oversight, whistleblower affidavit intake, and smart contract enforcement. It integrates QR-linked audit trails, NFT fiscal declarations, and DAO voting logic. The device anchors all inputs via SHA-256 hash notarization and transmits reform metrics to coalition dashboards. CVDM-1 supports public transparency, regulatory escalation, and validator governance across the PHX-AFK-US Protocol. It does not collect biospecimens and operates solely within legal, technical, and governance domains.",[64],[73],"PHX-AFK-US Governance Terminal",{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"DRUG","Coalition-Flagged Pharmaceutical Audit Trigger (CFPAT-1)","The Coalition-Flagged Pharmaceutical Audit Trigger (CFPAT-1) is a governance-based drug intervention targeting facilities with suspected fraud, kickback schemes, or supply chain irregularities involving pharmaceuticals. While not a therapeutic agent, CFPAT-1 functions as a regulatory scaffold that flags drug procurement, formulary manipulation, and referral-linked prescribing patterns. It integrates validator ballots, smart contract logic, and SHA-256 hash anchors to escalate complaints to CMS, DOJ, and state boards. All flagged drugs are traced via QR-linked audit trails and NFT fiscal declarations. No biospecimens are retained; the intervention operates within legal, technical, and governance domains.",[64],[80],"CFPAT-1",[82],{"measure":83,"description":84,"timeFrame":85},"Change in Fraudulent Billing and Kickback Incidents Across Enrolled Facilities","Description:\n\nThis outcome measures the change in frequency and severity of fraudulent billing practices-including upcoding, phantom billing, and referral-based kickback schemes-across facilities enrolled in the SHA-256 Trial Protocols.\n\nFacilities are assessed using the Unified Impact Index derived from:\n\nHistorical billing anomalies\n\nValidator audit results\n\nWhistleblower declarations\n\nSHA-256 hash-anchored incident reports\n\nFacilities are ranked and monitored for reform compliance, ethical standards, and onboarding validation. All scoring logic is notarized and displayed via coalition dashboards.\n\nTime Frame: Baseline to 12 Months Post-Validator Onboarding.","Baseline to 12 Months Post-Validator Onboarding",[87],{"measure":88,"description":89,"timeFrame":85},"Change in Supply-Chain Traceability and Compliance Across Enrolled Facilities","This outcome measures change in traceability and regulatory compliance for pharmaceuticals, medical devices, and non-pharmaceutical supplies. Facilities are evaluated using:\n\nValidator Traceability Score (VTS) composite metrics\n\nNFT tagging for supply-chain nodes\n\nBlockchain-based audit trails\n\nComparative analysis dashboards identifying gaps and escalation pathways for non-compliant entities","ALL",{"inclusion":92,"exclusion":93,"raw_text":94},[],[],"Inclusion Criteria:\n\nFacility has documented billing, compliance, or procurement irregularities.\n\nFacility participates in coalition validator onboarding and SHA-256 protocol enrollment.\n\nFacility provides access to billing, procurement, and whistleblower-anchored datasets for auditing.\n\nExclusion Criteria:\n\nFacility refuses validator onboarding or coalition integration.\n\nFacility lacks traceable procurement or compliance records.\n\nFacility has no whistleblower declaration or validation artifact.\n\nFacility operates outside U.S. jurisdiction or coalition-recognized governance zones.",[96,97,98],"CHILD","ADULT","OLDER_ADULT",[100],{"facility":101,"city":102,"state":102,"zip":103,"country":104,"geoPoint":105},"Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016","New York","10016","United States",{"lat":106,"lon":107},40.71427,-74.00597,[],[110],{"name":111,"affiliation":13,"role":112},"Gavin C Solomon, President & CEO","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":117},[21,18,19,20],[],{"nct_id":4,"found":15,"summary":53,"prompt_version":53}]