Clinical Trial unique identifier

The title of the clinical study, corresponding to the title of the protocol.

A unique identifier assigned to the protocol by the sponsor.

Full name of the official's organization.

A short title of the clinical study.

The recruitment status for the clinical study as a whole, based upon the status of the individual sites. If at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting.". Not yet recruiting: Participants are not yet being recruited. Recruiting: Participants are currently being recruited, whether or not any participants have yet been enrolled. Enrolling by invitation: Participants are being (or will be) selected from a predetermined population. Active, not recruiting: Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled. Completed: The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred). Suspended: Study halted prematurely but potentially will resume. Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Withdrawn: Study halted prematurely, prior to enrollment of first participant.

A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.

The nature of the investigation or investigational use for which clinical study information is being submitted. Select one.

A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest.

The sex of the participants eligible to participate in the clinical study.

The estimated date on which the clinical study will be open for recruitment of participants, or the actual date on which the first participant was enrolled.

The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.

The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.

Indication that a clinical study is studying a drug product (including a biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of the Public Health Service Act.

Indication that a clinical study is studying a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act.

Extended description of the protocol, including more technical information (as compared to the Brief Summary). Does not include the entire protocol. Does not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures.

The name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study.

For a clinical trial of a drug product (including a biological product), the numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21 and in 21 CFR 312.85 for phase 4 studies.

A description of each primary outcome measure (or for observational studies, specific key measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment). "Primary outcome measure" means the outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation. Most clinical studies have one primary outcome measure, but a clinical study may have more than one.

A description of each secondary outcome measure (or for observational studies, specific secondary measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment). "Secondary outcome measure" means an outcome measure that is of lesser importance than a primary outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention or interventions under investigation in a clinical study and is not specified as an exploratory or other measure. A clinical study may have more than one secondary outcome measure.

Indication that participants who do not have a disease or condition, or related conditions or symptoms, under study in the clinical study are permitted to participate in the clinical study.

The numerical value, if any, for the minimum age a patient must meet to be eligible for the clinical study.

The numerical value, if any, for the maximum age a potential participant can be to be eligible for the clinical study.