Clinical trials

1Description

Structured clinical trial records: titles and descriptions, phases and designs, inclusion and exclusion criteria split into individual items, primary and secondary endpoints, sponsors, investigators and sites, plus posted outcome results where they exist. Pharma competitive-intelligence teams, healthcare investors, CROs planning recruitment and groups training biomedical language models use it to track pipelines, benchmark trial designs and match patients to studies.

Subsets

• Trial descriptions
• Inclusion and exclusion criteria
• Endpoints
• Sponsor and investigator data
• Trial outcome summaries

2Schema

3Sample records

Sample record 1

{
  "nct_id": "NCT03467919",
  "brief_title": "The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis",
  "official_title": "The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis",
  "status": "COMPLETED",
  "phase": "PHASE3",
  "study_type": "INTERVENTIONAL",
  "allocation": "RANDOMIZED",
  "masking": "SINGLE",
  "conditions": [
    "Osteoarthritis, Knee",
    "Knee Pain"
  ],
  "interventions": [
    "Biological: Micro Fragmented Adipose Tissue",
    "Biological: Corticosteroid injection"
  ],
  "arms": [
    {
      "label": "MFAT(Micro Fragmented Adipose Tissue)",
      "type": "EXPERIMENTAL"
    },
    {
      "label": "Conventional therapy",
      "type": "ACTIVE_COMPARATOR"
    }
  ],
  "lead_sponsor": "Stanford University",
  "investigators": [
    "Eugene Y Roh, MD (principal investigator)",
    "Jason Dragoo, MD (principal investigator)",
    "Seth Sherman, MD (principal investigator)"
  ],
  "enrollment": 40,
  "start_date": "2018-04-01",
  "completion_date": "2024-10-29",
  "brief_summary": "This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.",
  "sex": "ALL",
  "age_range": "35 Years to 75 Years",
  "inclusion_criteria": [
    "Age between 35 and 75 years-old",
    "Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3.",
    "Working understanding of the English language and able to fully understand the procedure",
    "Capable of providing informed consent",
    "Able to complete online, in-person or phone surveys for the purposes of follow-up",
    "Capable of understanding pre- and post-procedure care instructions"
  ],
  "exclusion_criteria": [
    "Age < 35 or > 75 years old",
    "Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )",
    "Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)",
    "Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months",
    "Co-morbidity with rheumatologic condition, inflammatory arthritis",
    "Currently undergoing immunomodulatory therapy"
  ],
  "primary_endpoints": [
    {
      "measure": "Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain",
      "time_frame": "Baseline, 3, 6, 12, and 24 months"
    },
    {
      "measure": "Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms",
      "time_frame": "Baseline, 3, 6, 12, and 24 months"
    }
  ],
  "site_count": 1,
  "outcome_summary": {
    "measure": "Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain",
    "unit": "score on a scale",
    "statistic": "mean, Standard Deviation",
    "results": [
      {
        "time_point": "Baseline",
        "values": {
          "MFAT(Micro Fragmented Adipose Tissue)": "64.4 (SD 17.0)",
          "Conventional Therapy": "62.5 (SD 21.3)",
          "All Participants": "63.9 (SD 17.9)"
        }
      },
      {
        "time_point": "Change at 3 Months",
        "values": {
          "MFAT(Micro Fragmented Adipose Tissue)": "13.2 (SD 16.4)",
          "Conventional Therapy": "8.6 (SD 22.8)",
          "All Participants": "12.0 (SD 18.0)"
        }
      },
      {
        "time_point": "Change at 6 Months",
        "values": {
          "MFAT(Micro Fragmented Adipose Tissue)": "11.1 (SD 13.8)",
          "Conventional Therapy": "6.1 (SD 21.2)",
          "All Participants": "9.8 (SD 15.9)"
        }
      },
      {
        "time_point": "Change at 12 Months",
        "values": {
          "MFAT(Micro Fragmented Adipose Tissue)": "10.8 (SD 23.0)",
          "Conventional Therapy": "14.2 (SD 21.6)",
          "All Participants": "11.6 (SD 22.4)"
        }
      }
    ],
    "analysis": {
      "method": "two-sample t-test",
      "p_value": "0.594",
      "comparison": "Between-group analysis of change at 3 months"
    }
  },
  "source_url": "https://clinicaltrials.gov/study/NCT03467919"
}

Sample record 2

{
  "nct_id": "NCT00830063",
  "brief_title": "Tanezumab In Osteoarthritis Of The Knee (2)",
  "official_title": "A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE",
  "status": "COMPLETED",
  "phase": "PHASE3",
  "study_type": "INTERVENTIONAL",
  "allocation": "RANDOMIZED",
  "masking": "QUADRUPLE",
  "conditions": [
    "Arthritis",
    "Osteoarthritis"
  ],
  "interventions": [
    "Biological: tanezumab 10 mg",
    "Biological: tanezumab 5 mg",
    "Drug: naproxen",
    "Other: placebo"
  ],
  "arms": [
    {
      "label": "1",
      "type": "EXPERIMENTAL"
    },
    {
      "label": "2",
      "type": "EXPERIMENTAL"
    },
    {
      "label": "3",
      "type": "ACTIVE_COMPARATOR"
    },
    {
      "label": "4",
      "type": "PLACEBO_COMPARATOR"
    }
  ],
  "lead_sponsor": "Pfizer",
  "investigators": [
    "Pfizer CT.gov Call Center (study director)"
  ],
  "enrollment": 832,
  "start_date": "2009-05-05",
  "completion_date": "2010-08-31",
  "brief_summary": "The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.",
  "sex": "ALL",
  "age_range": "18 Years and older",
  "inclusion_criteria": [
    "Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2"
  ],
  "exclusion_criteria": [
    "Pregnancy or intent to become pregnant",
    "BMI greater than 39",
    "other severe pain, significant cardiac, neurologic or cardiac disease"
  ],
  "primary_endpoints": [
    {
      "measure": "Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)",
      "time_frame": "Baseline (Day 1), Week 16"
    },
    {
      "measure": "Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)",
      "time_frame": "Baseline, Week 16"
    }
  ],
  "site_count": 94,
  "outcome_summary": {
    "measure": "Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)",
    "unit": "units on a scale",
    "statistic": "mean, Standard Deviation",
    "results": [
      {
        "time_point": "Baseline",
        "values": {
          "Placebo": "7.21 (SD 1.43)",
          "Tanezumab 5 mg + Placebo": "7.30 (SD 1.47)",
          "Tanezumab 10 mg + Placebo": "7.25 (SD 1.41)",
          "Naproxen + Placebo": "7.18 (SD 1.37)"
        }
      },
      {
        "time_point": "Change at Week 16",
        "values": {
          "Placebo": "-2.23 (SD 2.56)",
          "Tanezumab 5 mg + Placebo": "-3.55 (SD 2.84)",
          "Tanezumab 10 mg + Placebo": "-3.27 (SD 2.81)",
          "Naproxen + Placebo": "-2.82 (SD 2.54)"
        }
      }
    ],
    "analysis": {
      "method": "ANCOVA",
      "p_value": "<0.001",
      "comparison": "Least square (LS) mean was estimated from the corresponding analysis of covariance (ANCOVA) model. [...]"
    }
  },
  "source_url": "https://clinicaltrials.gov/study/NCT00830063"
}

4Uses

• Pipeline and competitive intelligence for drug and device developers
• Patient-to-trial matching on structured eligibility criteria
• Benchmarking trial designs, endpoints and enrollment
• Training biomedical NLP models on criteria and outcome text
• Investment research on readouts and sponsor activity

6Access

The full Clinical trials dataset (MLC-0401), records on request. Delivered as JSONL, CSV or Parquet under a commercial licence.

Request the full dataset