AACT Data Dictionary

AACT is composed of 47 tables that provide information related to clinical trials. Every table is related by NCT ID to the Studies table. Click here to view a listing of all 47 tables with description and row counts. Detailed information about all data elements included in these tables can be found in the data dictionary below.

All ClinicalTrials.gov data are available in the ctgov schema of the AACT database. The ctgov schema also includes two tables from another source; mesh_terms & mesh_headings provide a recent copy of the Medical Subject Headings (MeSH terms & headings) published by the National Library of Medicine. These 2 tables are included to help people who use MeSH terms to categorize studies. (ClinicalTrials.gov uses browse_conditions & browse_interventions to link studies to related MeSH terms.)

To facilitate public sharing of information acquired during previous research efforts, the AACT database also includes 'project schemas'. These schemas allow any database user to access select sets of derived data artifacts that were gathered & curated during previous AACT-based research. Currently, data for three projects are available in AACT. Click here to learn more about these projects.

The schema diagrams below show the current set of schemas and tables that comprise this 'AACT Projects' feature.

The National Library of Medicine updates the MeSH Thesaurus each year. Select annual versions of MeSH terms are provided in the mesh_archive schema.

The database also includes a support schema which contains only tables needed to update & maintain the information in the ctgov schema. A companion database also exists, AACT_ADMIN, which supports this website and user registration.

AACT schema diagrams and documentation may be downloaded from the following links:

Please refer to the National Library of Medicine's (NLM) documentation for authoritative definitions of the data elements:

AACT Data Elements

The Data Dictionary (table below) provides detailed information about each data element in the AACT database. Every study-related table/column in the AACT relational database is represented as a row in this table. (AACT includes a few administrative tables that contain data not directly related to studies. Information about these tables is not included in the data dictionary. Information about these tables is available.)

Click on the icon that appears at the beginning of the data element row to view the section of the NLM documentation that defines that particular data element. (The icon appears only for data element defined by NLM.)

  • Sort: Click on a column header to sort the table alphabetically by the values in that column.

  • Search/Filter: An input box appears under each column name. Enter a search term in one or more boxes & press [Enter] to filter the display. You many enter values in multiple columns to further restrict a search. The filter ignores case and will find all data elements that 'include' the term you enter (ie. your term does not need to be the complete value.)

  • Search Support: The first column provides icons that support filtering. The larger magnifying glass in the top row toggles display of the filter row. The smaller magnifying glass below it can be clicked to launch a search (same as pressing [Enter]). Clicking the funnel icon will clear filter values.

  • Authoritative Source: Please refer to the National Library of Medicine's (NLM) documentation for official definitions of all study/protocol and results data data elements. The icon that appears at the beginning of a row will open a tab in your browser to display NLM information about the data element on that row.

  • Horizontal Scroll: All columns do not fit on a page; you may scroll horizontally to view and filter on additional information about the data elements.

  • Source Column This column identifies the XML tag path used to obtain values for the data element from ClinicalTrials.gov API. Click here for the XML format specifications (xsd) and here to see an example of a study as provided by NLM via their API; this represents the source information used to populate the AACT database.

  • Row Count Column Each table's primary key definition includes the table's current row count.

  • Enumerations Column Some AACT table columns are used to store a discrete set of predefined terms (enumerations). For example, Public::Study.enrollment_type can only contain values: 'Anticipated', 'Actual' or null. If the table/column is for a set of enumerations, the data dictionary presents each of the enumeration values along with the corresponding number of rows with that value.

AACT Tables

The list below describes the 47 study-related tables in the AACT database and provides current row counts for each.

Schema Name Row Count Description Domain Rows per Study
ctgov Baseline_Counts 98,596 Sample size at baseline for each study group; usually a count of participants but can represent other units of measure such as 'hands', 'hips', etc. Results many
ctgov Baseline_Measurements 909,195 Summaries of demographic & baseline measures collected by arm or comparison group and for the entire population of participants in the clinical study.  Results many
ctgov Brief_Summaries 297,198 A single text column that provides a brief description of the study. Protocol one
ctgov Browse_Conditions 528,743 NLM uses an internal algorithm to assess the data entered for a study and creates a list of standard MeSH terms that describe the condition(s) being addressed by the clinical trial. This table provides the results of NLM's assessment Protocol many
ctgov Browse_Interventions 307,125 NLM uses an internal algorithm to assess the data entered for a study and creates a list of standard MeSH terms that describe the intervention(s) being addressed by the clinical trial. This table provides the results of NLM's assessment Protocol many
ctgov Calculated_Values 297,993 An AACT-provided table that contains info that's been calculated from the information received from ClinicalTrials.gov. For example, number_of_facilities and actual_duration are provided in this table. Protocol one
ctgov Central_Contacts 115,817 Contact info for people (primary & backup) who can answer questions concerning enrollment at any location of the study. Protocol many
ctgov Conditions 489,520 Name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Can include NLM's Medical Subject Heading (MeSH)-controlled vocabulary terms. Protocol many
ctgov Countries 430,951 Countries in which the study has facilities/sites. Protocol many
ctgov Design_Group_Interventions 640,776 A cross reference for groups/interventions. If a study has multiple groups and multiple interventions, this table shows which interventions are associated with which groups. Protocol many
ctgov Design_Groups 518,258 Defines the protocol-specified group, subgroup, or cohort of participants in a clinical trial assigned to receive specific intervention(s) or observations according to a protocol. Protocol many
ctgov Design_Outcomes 1,501,050 Description of planned outcome measures and observations that will describe patterns of diseases and traits/associations with exposures, risk factors or treatment. Protocol many
ctgov Designs 297,993 Description of how the study will be conducted, including comparison group design and strategies for masking and allocating participants. Protocol one
ctgov Detailed_Descriptions 193,475 A single text column that provides a detailed description of the study protocol. Protocol one
ctgov Documents 9,931 The full study protocol and statistical analysis plan must be uploaded as part of results information submission, for studies with a Primary Completion Date on or after January 18, 2017. The protocol and statistical analysis plan may be optionally uploaded before results information submission and updated with new versions, as needed. Informed consent forms may optionally be uploaded at any time. Results many
ctgov Drop_Withdrawals 263,811 Summarized information about how many participants withdrew from the study, when and why. This information explains disposition of participants relative to the numbers starting and completing the study (enumerated in the Milestones table). Results many
ctgov Eligibilities 297,993 Information about the criteria used to select participants; includes inclusion and exclusion criteria Protocol one
ctgov Facilities 2,113,950 Name, address and recruiting status of the facilities participating in the study. Protocol many
ctgov Facility_Contacts 264,534 Contact information for people responsible for the study at each facility. (primary and backup) Facility contact information is available if the facility status (Facilities.Status) is ‘Recruiting’ or ‘Not yet recruiting’, and if the data provider has provided such information. Contact information is removed from the publicly available content at ClinicalTrials.gov when the facility is no longer recruiting, or when the overall study status (Studies.Overall_status) changes to indicate that the study has completed recruitment. Protocol many
ctgov Facility_Investigators 186,885 Names of the investigators at each study facility. Facility investigator information is available if the facility status (Facilities.Status) is ‘Recruiting’ or ‘Not yet recruiting’, and if the data provider has provided such information. Investigator information is removed from the publicly available content at ClinicalTrials.gov when the facility is no longer recruiting, or when the overall study status (Studies.Overall_status) changes to indicate that the study has completed recruitment. Protocol many
ctgov Id_Information 411,467 Identifiers (other than the NCT ID) that uniquely identify the study such as that assigned by the sponsor, or an NCT ID that had previously been used for the study. Protocol many
ctgov Intervention_Other_Names 259,863 Terns or phrases that are synonymous with an intervention. (Each row is linked to one of the interventions associated with the study.) Protocol many
ctgov Interventions 517,281 The interventions or exposures (including drugs, medical devices, procedures, vaccines, and other products) of interest to the study, or associated with study arms/groups. Protocol many
ctgov Keywords 843,248 Provides words or phrases that best describe the protocol. Keywords help users find studies in the database. Can include NLM's Medical Subject Heading (MeSH)-controlled vocabulary terms. Protocol many
ctgov Links 51,525 Web site directly relevant to the protocol. (ie, links to educational, research, government, and other non-profit Web pages) Protocol many
ctgov Milestones 356,294 Information summarizing the progress of participants through each stage of a study, including the number of participants who started and completed the trial. Enumeration of participants not completing the study is included in the Drop_Withdrawals table. Results many
ctgov Outcome_Analyses 143,972 Results of scientifically appropriate statistical analyses performed on primary and secondary study outcomes. Includes results for treatment effect estimates, confidence intervals and othe rmeasures of dispersion, and p-values. Results many
ctgov Outcome_Analysis_Groups 278,328 Identifies the comparison groups that were involved with each outcome analysis Results many
ctgov Outcome_Counts 619,731 Sample size included in analysis for each outcome for each study group; usually participants but can represent other units of measure such as eyes 'lesions', etc. Results many
ctgov Outcome_Measurements 1,950,476 Summary data for primary and secondary outcome measures for each study group. Includes parameter estimates and measures of dispersion/precision. Results many
ctgov Outcomes 262,830 Descriptions of outcomes, or observation that were measured to determine patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Includes information such as time frame, population and units. (Specific measurement results are stored in the Outcome_Measurements table.) Results many
ctgov Overall_Officials 308,327 People responsible for the overall scientific leadership of the protocol including the principal investigator. Protocol many
ctgov Participant_Flows 35,039 Recruitment information relevant to the recruitment process & pre-assignment details (ie. significant events in the study that occur after participant enrollment, but prior to assignment of participants). Information about participant flow that applies to all milestones. Results one
ctgov Pending_Results 21,582 Provides information about events related to the submission of study results for quality control (QC) review before the results are publicly posted. Events reported: submissions, cancellations and returns for modifications. 'Unknown' is specified for cancellations that occurred before 05/08/2018 (when this data began being collected). When a study passes quality control review: 1) results_first_submitted_date is set to the study's first submission date, 2) results_first_submitted_qc_date is set to the submission date of the version of results that passed QC, 3) the study's pending_results rows are removed, and 4) the results are posted on ClinicalTrials.gov. The latest versions of all studies are posted every business day but, there can be unexpected delays. The results_first_posted_date value will usually be identified as an 'Estimate' when first posted. This will switch to 'Actual' (and the date may be adjusted) on the next posting cycle, when the true posting date is known. Results many
ctgov Reported_Events 4,460,750 Summary information about reported adverse events (any untoward or unfavorable medical occurrence to participants, including abnormal physical exams, laboratory findings, symptoms, or diseases), including serious adverse events, other adverse events, and mortality. Results many
ctgov Responsible_Parties 278,705 People who have access to and control over the data from the study, have the right to publish study results, and have the ability to meet all of the requirements for the submission of study information. Protocol many
ctgov Result_Agreements 35,039 Info about whether an agreement exists between the sponsor & the principal investigators (PIs) that restricts the PIs ability to discuss study results at scientific meetings or other public or private forums, or to publish info concerning the study in scientific or academic journals after the study is completed. Results many
ctgov Result_Contacts 35,039 Point of contact for scientific information about the clinical study results information.  Results many
ctgov Result_Groups 870,702 Consolidated, aggregate list of group titles/descriptions used for reporting summary results information. Results many
ctgov Sponsors 472,627 Name of study sponsors and collaborators. The sponsor is the entity or individual initiating the study. Collaborators are other organizations providing support, including funding, design, implementation, data analysis, and reporting. Protocol many
ctgov Studies 297,993 Basic info about study, including study title, date study registered with ClinicalTrials.gov, date results first posted to ClinicalTrials.gov, dates for study start and completion, phase of study, enrollment status, planned or actual enrollment, number of study arms/groups, etc. Protocol & Results one
ctgov Study_References 384,101 Citations to publications related to the study protocol and/or results. Includes PubMed Unique Identifier (PMID) and/or full bibliographic citation.  Protocol many
proj_tag_nephrology Tagged_Terms Table of terms determined to be nephrology-related by a team of Duke clinicians. The source of the terms is the 2010 MeSH thesaurus as well as free-text terms/phrases used to identify interventional studies registered in ClinicalTrials.gov between 2007 and 2010. Project n/a
proj_tag_nephrology Analyzed_Studies Information identifying the studies used to support the 2014 JK Inrig publication in Am J Kidney Disease. The studies identified were determined to be nephrology-related in the course of conducting the investigation. Project n/a
proj_cdek_standard_orgs CDEK_Organizations Table of standard organization names that serve to Project n/a
proj_cdek_standard_orgs CDEK_Synonyms Table of organization names that have been entered into ClinicalTrials.gov, along with the preferred (standard) name as determined by CDEK. Project n/a
proj_results_reporting Analyzed_Studies Trials that were determined likely subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. Regression models were used to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. Project n/a