diff --git a/README.md b/README.md index ac2fce1..75de8f6 100644 --- a/README.md +++ b/README.md @@ -1,139 +1,51 @@ # Pulse -Pulse is an AI-powered patient safety and engagement platform designed to modernize clinical trial monitoring. It bridges the gap between scheduled clinic visits by providing continuous, intelligent oversight of participant well-being through conversational AI, wearable data integration, and real-time researcher dashboards. - -## System Overview - -Pulse consists of three primary integrated components: - -1. **AI Symptom Journal (Mobile App):** A React Native application where participants report symptoms through natural language conversations (text or real-time voice) driven by a protocol-aware AI agent. -2. **Wearable Health Integration:** A passive data ingestion pipeline that collects metrics from consumer wearables and employs statistical anomaly detection to identify clinically significant deviations from a patient's personal baseline. -3. **Researcher Safety Dashboard (Web App):** A centralized command center for clinical research coordinators (CRCs) and principal investigators (PIs) to monitor patient risk scores, triage automated alerts, and analyze cohort-level safety signals. - -## High-Level Architecture - -The platform is built as a modular monolith with a Python/FastAPI backend, a React web dashboard, and a React Native mobile app. It uses an event-driven internal architecture for real-time processing. - -```mermaid -graph TD - subgraph "Presentation Layer" - MobileApp[Patient Mobile App
React Native + Expo] - WebDashboard[Researcher Dashboard
React + TypeScript] - end - - subgraph "Backend (FastAPI Monolith)" - API[FastAPI REST & WebSocket API] - - subgraph "AI Orchestration (LangGraph)" - CheckinAgent[Check-in Agent] - Classifier[Symptom Classifier] - end - - subgraph "Engines" - AnomalyEngine[Anomaly Detection] - AlertEngine[Rule & Risk Engine] - end - - subgraph "Real-Time Services" - LiveKitAgent[LiveKit Voice Agent] - WSManager[WebSocket Manager] - end - end - - subgraph "Data & Infrastructure" - Postgres[(PostgreSQL 16)] - Redis[(Redis 7 - Event Bus)] - MinIO[(MinIO - Object Storage)] - LiveKitServer[LiveKit Server] - end - - MobileApp <--> API - MobileApp <--> LiveKitServer - WebDashboard <--> API - WebDashboard <--> WSManager - - API <--> Postgres - API <--> Redis - - CheckinAgent <--> Postgres - Classifier <--> Postgres - - AnomalyEngine --> Redis - Redis --> AlertEngine - AlertEngine --> WSManager - WSManager --> WebDashboard -``` - -## Key Components - -### 1. AI Symptom Journal -The mobile app replaces traditional paper diaries with a conversational interface. -- **Modality:** Supports both text-based chat and low-latency voice interaction. -- **Intelligence:** Uses LangGraph to drive a stateful conversation that adapts based on the trial protocol and patient history. -- **Classification:** Automatically maps free-text descriptions to MedDRA-coded terms and CTCAE severity grades. - -### 2. Wearable Integration & Anomaly Detection -The system ingests objective data (Heart Rate, SpO2, Steps, Sleep) to provide a 360-degree view of patient health. -- **Baselines:** Establishes personalized "normal" ranges for each patient during an initial enrollment period. -- **Detection:** Uses Z-score analysis for point anomalies and sliding-window linear regression for subtle trend detection. -- **Risk Scoring:** Calculates a composite risk score (0-100) factoring in symptom reports, wearable anomalies, and engagement metrics. - -### 3. Researcher Dashboard -A real-time interface for clinical teams to manage safety workflows. -- **Triage:** A prioritized alert queue based on AI-generated risk scores. -- **Human-in-the-loop:** CRCs review and confirm AI symptom classifications before they enter the official trial record. -- **Analytics:** Cohort-level visualizations to detect safety signals across treatment arms. - -## Technical Stack - -| Category | Technologies | -| :--- | :--- | -| **Backend** | Python 3.12, FastAPI, SQLAlchemy (Async), Pydantic | -| **AI/ML** | LangChain, LangGraph, Gemini Live (via LiveKit) | -| **Frontend (Web)** | React 18, TypeScript, Tailwind CSS, Recharts, TanStack Table | -| **Frontend (Mobile)** | React Native, Expo, NativeWind, LiveKit SDK | -| **Real-Time** | LiveKit (Voice), Native WebSockets (Dashboard) | -| **Data Stores** | PostgreSQL 16, Redis 7 (Pub/Sub & Cache), MinIO (S3-compatible) | -| **Infrastructure** | Docker, Docker Compose, Nginx | - -## Data Flow: Symptom Reporting to Dashboard - -```mermaid -sequenceDiagram - participant P as Patient (Mobile) - participant A as AI Agent (LangGraph) - participant DB as PostgreSQL - participant EB as Redis (Event Bus) - participant RE as Alert Engine - participant WS as WebSocket Manager - participant D as Dashboard (Web) - - P->>A: Reports symptom (Text/Voice) - A->>A: Classify symptom (MedDRA/CTCAE) - A->>DB: Save symptom entry - A->>EB: Publish 'symptom.reported' - EB->>RE: Trigger Rule Evaluation - RE->>RE: Recalculate Risk Score - RE->>DB: Save Alert & Risk Score - RE->>WS: Broadcast Update - WS->>D: Push real-time Alert/Risk update -``` - -## Setup and Development - -Pulse is designed to run entirely in a local Docker environment for development and demonstration. - -### Prerequisites -- Docker and Docker Compose -- Node.js (v20+) -- Python 3.12+ -- API Keys: Google Gemini API (for LLM and Voice) - -### Getting Started -1. **Clone the repository.** -2. **Configure Environment:** Copy `.env.example` to `.env` and provide the required API keys. -3. **Start Services:** Run `docker compose up -d` to start the backend, database, and infrastructure. -4. **Backend Setup:** Navigate to `backend/` and install dependencies using `uv`. -5. **Frontend Setup:** Navigate to `apps/dashboard/` and `apps/mobile/` to install Node dependencies. - -For detailed implementation notes, refer to `TECHNICAL_DOC.md` and `DESIGN_DOC.md`. +AI-powered clinical trial patient safety and engagement platform. + +## Inspiration + +Trial safety often depends on sparse site visits and delayed paper trails, while patients experience symptoms and behavior changes every day. We wanted a **continuous signal**—not to replace regulated workflows, but to help sites and sponsors **see risk earlier**, keep patients engaged, and reduce the gap between what happens in real life and what makes it into a safety narrative. + +## What it does + +**Pulse (TrialPulse)** connects **patients**, **wearables**, and **study teams** in one loop: + +- **Mobile app** — Daily check-ins, structured capture of how patients feel, and pathways for voice/chat-style support (e.g. LiveKit-backed flows in the stack). +- **Backend** — FastAPI services for auth, patients, check-ins, wearables, alerts, voice, and analytics; **AI-assisted** classification and check-in reasoning (LangGraph-style flows); **risk scoring** and **alert** generation when patterns worsen. +- **CRC dashboard** — Trial overview, **patient list**, **alert queue**, **visit calendar**, and **cohort analytics** (risk distribution, AE-style views, wearable trends) so coordinators can prioritize who needs attention. + +The goal: **one place** to monitor engagement, symptoms, and device-derived trends so escalations are **timely and explainable**. + +## How we built it + +- **Monorepo** with a **Python/FastAPI** backend (async SQLAlchemy, Pydantic), **PostgreSQL** for trial/patient/alert data, **Redis** for events and coordination, **MinIO** for object storage, and **Docker Compose** for a reproducible dev stack. +- **AI layer** — LLM access via **OpenRouter** (and Gemini-related paths for voice/agent experiments), with **graphs/agents** for check-in and classification workflows. +- **Real-time / voice** — **LiveKit** in the compose stack for future or demo-grade realtime/voice paths. +- **Dashboard** — **React + Vite**, TanStack Query, Recharts, and a proxy to the API for local development. +- **Mobile** — **Expo / React Native** app for the patient experience, wired to the same API concepts. + +## Challenges we ran into + +- **Glueing clinical nuance to engineering** — Balancing realistic CRC workflows (triaging alerts, audit-friendly language) with hackathon scope. +- **End-to-end environments** — Coordinating Postgres, Redis, LiveKit, and backend ports across laptops and Docker (e.g. host port conflicts, env parity between dashboard proxy and API). +- **Native + web + AI** — Keeping mobile, dashboard, and LLM pipelines aligned on the same domain models (patients, trials, symptoms, wearables) without over-building schema migrations mid-hack. + +## Accomplishments that we're proud of + +- A **credible vertical slice**: patient-facing app, API with multiple modules, and a **researcher dashboard** that tells a coherent safety story. +- **Risk and alerts** tied to **symptoms + wearable logic**, not just static mock UI. +- **Dockerized stack** others can actually run: DB seed paths, health checks, and a Makefile for common tasks. +- **Unified patient narrative** on the dashboard (e.g. combining check-in severity, HR trends, and fatigue context) to show how Pulse **summarizes** signal for busy CRCs. + +## What we learned + +- **Safety UX is product work** — Clear copy, alert wording, and “unified clinical picture” views matter as much as the model. +- **Async FastAPI + event bus patterns** scale better for **notifications and future realtime** than a purely CRUD API. +- **DevEx details** (Vite proxy to correct API port, `.env` parity) save hours when judges or teammates try to run the demo. + +## What's next for Pulse + +- Deeper **EDC / CTMS** integration hooks (exports, reference IDs) without storing PHI beyond policy. +- **Prospective validation** of risk scores with study statisticians; calibration per indication and arm. +- **Patient** — richer adherence nudges and localized content; **Site** — workload views and SLA-style alert routing. +- Hardening **voice** flows for regulated use (consent, retention, redaction) and expanding **wearable** normative baselines per protocol. diff --git a/apps/dashboard/.env.example b/apps/dashboard/.env.example new file 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"sha512-/IXtbwEk5HTPyEwyKX6hGkYXxM9nbj64B+ilVJnC/R6B0pH5G4V3b0pVbL7DBj4tkhBAppbQUlf6F6Xl9LHu1g==", + "license": "MIT", + "engines": { + "node": ">= 0.4" + } + }, + "node_modules/mime-db": { + "version": "1.52.0", + "resolved": "https://registry.npmjs.org/mime-db/-/mime-db-1.52.0.tgz", + "integrity": "sha512-sPU4uV7dYlvtWJxwwxHD0PuihVNiE7TyAbQ5SWxDCB9mUYvOgroQOwYQQOKPJ8CIbE+1ETVlOoK1UC2nU3gYvg==", + "license": "MIT", + "engines": { + "node": ">= 0.6" + } + }, + "node_modules/mime-types": { + "version": "2.1.35", + "resolved": "https://registry.npmjs.org/mime-types/-/mime-types-2.1.35.tgz", + "integrity": "sha512-ZDY+bPm5zTTF+YpCrAU9nK0UgICYPT0QtT1NZWFv4s++TNkcgVaT0g6+4R2uI4MjQjzysHB1zxuWL50hzaeXiw==", + "license": "MIT", + "dependencies": { + "mime-db": "1.52.0" + }, + "engines": { + "node": ">= 0.6" + } + }, "node_modules/minimatch": { "version": "3.1.5", "resolved": "https://registry.npmjs.org/minimatch/-/minimatch-3.1.5.tgz", @@ -2814,6 +3115,15 @@ "node": ">= 0.8.0" } }, + "node_modules/proxy-from-env": { + "version": "2.1.0", + "resolved": "https://registry.npmjs.org/proxy-from-env/-/proxy-from-env-2.1.0.tgz", + "integrity": "sha512-cJ+oHTW1VAEa8cJslgmUZrc+sjRKgAKl3Zyse6+PV38hZe/V6Z14TbCuXcan9F9ghlz4QrFr2c92TNF82UkYHA==", + "license": "MIT", + "engines": { + "node": ">=10" + } + }, "node_modules/punycode": { "version": "2.3.1", "resolved": "https://registry.npmjs.org/punycode/-/punycode-2.3.1.tgz", diff --git a/apps/dashboard/src/App.css b/apps/dashboard/src/App.css index 3913e02..9cdc841 100644 --- a/apps/dashboard/src/App.css +++ b/apps/dashboard/src/App.css @@ -40,6 +40,17 @@ --light-font: rgba(255, 255, 255, 0.7); } +/* Visit Calendar tab: calendar first, then patient list, then alert queue */ +.calendar-tab-stack { + display: flex; + flex-direction: column; + width: 100%; +} + +.calendar-tab-stack > *:not(:first-child) { + border-top: 1px solid var(--message-box-border); +} + .app-container { width: 100%; min-height: 100vh; @@ -639,15 +650,7 @@ a { border-top-color: var(--link-color-hover); } -.message-box img { - border-radius: 50%; - object-fit: cover; - width: 40px; - height: 40px; -} - .message-content { - padding-left: 16px; width: 100%; } diff --git a/apps/dashboard/src/App.tsx b/apps/dashboard/src/App.tsx index 953fd14..e4b13fd 100644 --- a/apps/dashboard/src/App.tsx +++ b/apps/dashboard/src/App.tsx @@ -4,10 +4,6 @@ import './App.css' import { CohortAnalytics } from './components/CohortAnalytics' import { VisitCalendar } from './components/VisitCalendar' import { SettingsView } from './components/SettingsView' -import { PatientListPage } from './pages/PatientListPage' -import { PatientDetailPage } from './pages/PatientDetailPage' -import { AlertQueuePage } from './pages/AlertQueuePage' - export type ClinicalTrialCard = { id: string dateLabel: string @@ -23,7 +19,6 @@ export type ClinicalTrialCard = { type PatientConversation = { id: string - avatar: string patientName: string text: string time: string @@ -124,50 +119,38 @@ const clinicalTrialCards: ClinicalTrialCard[] = [ const patientSafetyThreads: PatientConversation[] = [ { id: 't1', - avatar: - 'https://images.unsplash.com/photo-1544723795-3fb6469f5b39?auto=format&fit=crop&w=200&q=80', patientName: 'David T.', - text: 'Anyone else on Arm A feel nauseous the first few hours after dosing? I don’t want to overreact but it’s been rough since Tuesday.', + text: 'Daily check-in: Nausea within a few hours of Arm A dosing, ongoing since Tuesday. Discussed symptom intensity vs. expected AE profile and whether to hold dose or add supportive care.', time: '2 min ago', }, { id: 't2', - avatar: - 'https://images.unsplash.com/photo-1580489944761-15a19d654956?auto=format&fit=crop&w=200&h=200&q=80', patientName: 'Maria G.', - text: 'David — I had that week one too. Sipping ginger tea and smaller meals helped. Happy to compare notes if your team says it’s okay.', + text: 'Daily check-in: Mild GI upset week one of current cycle. Reviewed meal timing and hydration with site; aligned on watch-and-wait unless vomiting or weight loss.', time: '8 min ago', }, { id: 't3', - avatar: - 'https://images.unsplash.com/photo-1500648767791-00dcc994a43e?auto=format&fit=crop&w=200&q=80', patientName: 'Thomas O.', - text: 'Thanks both. I’m on a higher dose and fatigue stacks with the nausea. @Robert did you get any relief after they adjusted your schedule?', + text: 'Daily check-in: Higher dose cohort — fatigue layered on nausea. Trial discussion: prior schedule change for another participant; explored moving PRO window to afternoons for earlier symptom capture.', time: '22 min ago', }, { id: 't4', - avatar: - 'https://images.unsplash.com/photo-1507003211169-0a1dd7228f2d?auto=format&fit=crop&w=200&q=80', patientName: 'Robert K.', - text: 'Yeah — moving check-ins to afternoons made it easier to catch symptoms early. Still tired but more manageable.', + text: 'Daily check-in: Fatigue stable, nausea improved vs. last visit. Discussed shifting remote check-ins to afternoons; patient reports better diary completion and same-day CRC follow-up.', time: '35 min ago', }, { id: 't5', - avatar: - 'https://images.unsplash.com/photo-1544005313-94ddf0286df2?auto=format&fit=crop&w=200&q=80', patientName: 'Jennifer W.', - text: 'Sorry I’ve been quiet — long work days. If someone’s missed a diary entry, did the study app let you backfill or do you call the site?', + text: 'Daily check-in: Missed two e-diary entries due to work travel. Discussed protocol-acceptable backfill in Pulse vs. site call-in; documented reason in source.', time: '1 hr ago', }, { id: 't6', - avatar: - 'https://images.unsplash.com/photo-1524504388940-b1c1722653e1?auto=format&fit=crop&w=200&q=80', patientName: 'David T.', - text: 'Jennifer — I used “add note for yesterday” in Pulse and the CRC messaged me same day. Hope that helps.', + text: 'Follow-up summary: Used “add note for yesterday” after missed diary; CRC acknowledged same day and updated visit worksheet. Reinforced escalation path if nausea worsens.', time: '1 hr ago', }, ] @@ -191,25 +174,25 @@ function App() { const [darkMode, setDarkMode] = useState(false) const [isGridView, setIsGridView] = useState(true) const [messagesOpen, setMessagesOpen] = useState(false) - const [activeTab, setActiveTab] = useState<'overview' | 'analytics' | 'calendar' | 'settings' | 'patients' | 'alerts'>('overview') + const [activeTab, setActiveTab] = useState<'overview' | 'analytics' | 'calendar' | 'settings'>('overview') const [selectedTrialId, setSelectedTrialId] = useState(null) - const [selectedPatientId, setSelectedPatientId] = useState(null) const [trialSearchQuery, setTrialSearchQuery] = useState('') + const [trialsList, setTrialsList] = useState(clinicalTrialCards) const filteredHomeTrials = useMemo( - () => clinicalTrialCards.filter((card) => matchesTrialSearch(card, trialSearchQuery)), - [trialSearchQuery], + () => trialsList.filter((card) => matchesTrialSearch(card, trialSearchQuery)), + [trialSearchQuery, trialsList], ) const status = useMemo(() => { - const recruiting = clinicalTrialCards.filter((c) => c.trialStatusBadge === 'Recruiting').length - const enrolledApprox = 48 * clinicalTrialCards.length + const recruiting = trialsList.filter((c) => c.trialStatusBadge === 'Recruiting').length + const enrolledApprox = 48 * trialsList.length return { - activeTrials: clinicalTrialCards.length, + activeTrials: trialsList.length, recruitingTrials: recruiting, enrolledPatients: enrolledApprox, } - }, []) + }, [trialsList]) return (
@@ -274,7 +257,7 @@ function App() {
{activeTab === 'overview' && ( -
-

Patient conversations

+

Check-in summaries

{patientSafetyThreads.map((msg) => (
-
{msg.patientName}
diff --git a/apps/dashboard/src/components/CohortAnalytics.css b/apps/dashboard/src/components/CohortAnalytics.css index f54e3d1..f6ee059 100644 --- a/apps/dashboard/src/components/CohortAnalytics.css +++ b/apps/dashboard/src/components/CohortAnalytics.css @@ -220,3 +220,111 @@ grid-column: span 1; } } + +/* Add Trial Form */ +.add-trial-form { + background-color: var(--surface-bg); + padding: 32px; + border-radius: 16px; + box-shadow: 0 4px 12px rgba(0,0,0,0.05); + max-width: 600px; + margin-top: 24px; +} + +.form-group { + margin-bottom: 24px; + display: flex; + flex-direction: column; +} + +.form-group label { + font-size: 14px; + font-weight: 600; + color: var(--main-color); + margin-bottom: 8px; +} + +.form-group textarea, +.form-group input[type="file"] { + width: 100%; + padding: 12px; + border-radius: 8px; + border: 1px solid var(--muted-border); + background-color: var(--bg-color); + color: var(--main-color); + font-family: inherit; + font-size: 14px; + transition: border-color 0.2s; +} + +.form-group textarea:focus { + border-color: var(--link-color-hover); + outline: none; +} + +.form-actions { + display: flex; + justify-content: flex-end; + gap: 16px; + margin-top: 32px; +} + +.cancel-btn { + background: none; + border: 1px solid var(--muted-border); + color: var(--secondary-color); + padding: 10px 20px; + border-radius: 8px; + font-size: 14px; + font-weight: 600; + cursor: pointer; + transition: all 0.2s; +} + +.cancel-btn:hover { + background-color: var(--bg-color); + color: var(--main-color); +} + +.submit-btn, +.add-btn-primary { + background-color: var(--link-color); + border: none; + color: white; + padding: 10px 20px; + border-radius: 8px; + font-size: 14px; + font-weight: 600; + cursor: pointer; + transition: all 0.2s; +} + +.submit-btn:hover, +.add-btn-primary:hover { + background-color: var(--link-color-hover); + transform: translateY(-1px); +} + +.analytics-new-trial-empty { + margin-top: 24px; + padding: 32px 28px; + max-width: 640px; + background-color: var(--surface-bg); + border: 1px dashed var(--muted-border); + border-radius: 16px; + color: var(--secondary-color); +} + +.analytics-new-trial-empty-title { + margin: 0 0 12px; + font-size: 18px; + font-weight: 700; + color: var(--main-color); +} + +.analytics-new-trial-empty-copy { + margin: 0; + font-size: 15px; + line-height: 1.55; +} + diff --git a/apps/dashboard/src/components/CohortAnalytics.tsx b/apps/dashboard/src/components/CohortAnalytics.tsx index 0cfa870..59606cf 100644 --- a/apps/dashboard/src/components/CohortAnalytics.tsx +++ b/apps/dashboard/src/components/CohortAnalytics.tsx @@ -16,12 +16,16 @@ import { } from 'recharts' import { useTrialOverview, useCohortAEIncidence } from '../hooks/useAlerts' import type { ClinicalTrialCard } from '../App' +import { PatientListPage } from '../pages/PatientListPage' +import { PatientDetailPage } from '../pages/PatientDetailPage' +import { AlertQueuePage } from '../pages/AlertQueuePage' import './CohortAnalytics.css' interface CohortAnalyticsProps { trialId: string | null onSelectTrial: (id: string) => void trials: ClinicalTrialCard[] + onAddTrial?: (trial: ClinicalTrialCard) => void } const mockHRTrend = [ @@ -34,11 +38,16 @@ const mockHRTrend = [ { day: 'Today', hr: 88 }, ] -export function CohortAnalytics({ trialId, onSelectTrial, trials }: CohortAnalyticsProps) { +export function CohortAnalytics({ trialId, onSelectTrial, trials, onAddTrial }: CohortAnalyticsProps) { const [searchQuery, setSearchQuery] = useState('') + const [isAddingTrial, setIsAddingTrial] = useState(false) + const [newTrialInfo, setNewTrialInfo] = useState('') + const [activeSubView, setActiveSubView] = useState<'stats' | 'patients'>('stats') + const [selectedPatientId, setSelectedPatientId] = useState(null) - const { data: overview, isLoading: overviewLoading } = useTrialOverview(trialId); - const { data: aeData, isLoading: aeLoading } = useCohortAEIncidence(trialId); + const fetchCohortStats = !!trialId && !trialId.startsWith('new-') + const { data: overview, isLoading: overviewLoading } = useTrialOverview(trialId, fetchCohortStats) + const { data: aeData, isLoading: aeLoading } = useCohortAEIncidence(trialId, 30, fetchCohortStats) if (!trialId) { const filteredTrials = trials.filter(t => @@ -46,10 +55,59 @@ export function CohortAnalytics({ trialId, onSelectTrial, trials }: CohortAnalyt t.trialSubtitle.toLowerCase().includes(searchQuery.toLowerCase()) ) + if (isAddingTrial) { + return ( +
+
+

Add New Clinical Trial

+
+
+
+ +