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Massive Real-World database aims to map how chronic diseases interact

NCT ID NCT03813862

Knowledge-focused Sponsor: Epividian Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

OPERA is a large observational database that collects health records from people treated for chronic conditions such as HIV, liver disease, inflammatory bowel disease, heart disease, rheumatic disease, and neurodegenerative disease. Researchers use the records to study how these conditions and their treatments affect patients over time, including groups often underrepresented in medical research. The database tracks things like viral load in HIV patients and other routine lab results, but it does not test new treatments or assign anyone to a specific therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the database works as intended, it could give researchers a clearer picture of how chronic diseases interact and how well treatments perform in everyday practice, including for groups often left out of studies.
What could go wrong
This is an observational database, not a treatment trial, so it cannot prove that any treatment causes a particular outcome. The quality of the findings depends on how completely and consistently clinics enter data, and results may not apply to patients outside the participating practices.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2013

Expected to finish

Nov 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The patient population includes a diverse group of individuals treated in ambulatory practice with a focus on those living with chronic disease.

Ages

0 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who are treated in the practices who enroll and participate in the study * Patients whose treatment is documented in the practice's electronic health record system Exclusion Criteria: * Patients who opt out of OPERA

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Conditions

The condition(s) this trial relates to.

AIDS cardiovascular disorder Chronic Disease hepatitis B virus infection hepatitis C virus infection HIV infectious disease inflammatory bowel disease liver disorder neurodegenerative disease rheumatic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Chronic disease HIV/AIDS Inflammatory bowel diseases Liver diseases Neurodegenerative diseases Rheumatic diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Epividian

    RECRUITING

    Durham, North Carolina, 27703, United States

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