Clinical Trials Registry and Results Database

$395 / year

The Clinical Trials Registry and Results Database compiles information on publicly and privately supported clinical trial studies on a wide range of diseases and conditions. Its main goal is to provide an easy access to both privately and publicly funded clinical trials information for patients, their family members, healthcare professionals, researchers, and the public.

Complexity

ClinicalTrials.gov is an online clinical trials database created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA required the U.S. Department of Health and Human Services (HHS), through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions.

NIH and the Food and Drug Administration (FDA) worked together to develop the ClinicalTrials.gov website, which was made available to the public in February 2000. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the website (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. The ClinicalTrials.gov Web site and database of clinical studies is commonly referred to as a “registry and results database.”

ClinicalTrials.gov contains information about medical studies in human volunteers. Most of the records on ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access). Studies listed in the database are conducted in all 50 States and in 200 countries.

ClinicalTrials.gov does not contain information about all the clinical studies conducted in the United States because not all studies are required by law to be registered (for example, observational studies and trials that do not study a drug, biologic, or device). However, the rate of study registration has increased over time as more policies and laws requiring registration have been enacted and as more sponsors and investigators have voluntarily registered their studies.

The ClinicalTrials.gov results database contains summary information on study participants and study outcomes, including adverse events.

Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following:
– Disease or condition
– Intervention (for example, the medical product, behavior, or procedure being studied)
– Title, description, and design of the study
– Requirements for participation (eligibility criteria)
– Locations where the study is being conducted
– Contact information for the study locations
– Links to relevant information on other health Web sites, such as NLM’s MedlinePlus® for patient health information and PubMed® for citations and abstracts of -Scholarly articles in the field of medicine.

Some records also include information on the results of the study, such as:
– Description of study participants (the number of participants starting and completing the study and their demographic data)
– Outcomes of the study
– Summary of adverse events experienced by study participants.

Date Created

2011-12-13

Last Modified

2018-10-30

Version

2018-10-30

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

World

Source

John Snow Labs => ClinicalTrials.Gov

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

The U.S. National Institutes of Health, Department of Health and Human Services, National Library of Medicine (NLM), National Guideline Clearinghouse (NGC), Agency for Healthcare Research and Quality (AHRQ), National Institutes of Health (NIV)

Keywords

Clinical trials, Medical trials, Clinical research studies, Interventional studies, Observational studies

Other Titles

The Registry and Results Database, ClinicalTrials.gov Database, Clinical Studies Database, US Clinical Trials of Human Participants Database

Name Description Type Constraints
Clinical_Study_IdNCT ID is a unique identification code given to each clinical study registered on ClinicalTrials.gov. The format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419).stringrequired : 1
Overall_StatusThe 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".stringenum : Array
RankThe rank of the clinical study in the current selection.integerlevel : Ordinal
Clinical_Study_Secondary_IdSecondary Id for the clinical study.string-
Organization_Study_IdAlternative organization specific Id.string-
First_Received_DateThe First Received date is the date on which summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry. There is typically a delay of a few days between the First Received date and when the study information is available on ClinicalTrials.gov.date-
Last_Changed_DateThe Last Updated date is the most recent date on which changes to a study record were submitted to ClinicalTrials.gov. There may be a delay between the Last Updated date and when the updated study information is available on ClinicalTrials.gov. Also, this date may be different from the Last Verified date.date-
First_Received_Results_DateThis value is only available for studies that have results. It is the date when the results were first received.date-
Short_TitleA short title of the clinical study written in language intended for the lay public. stringmaxLength : 3000
Official_TitleThe title of the clinical study, corresponding to the title of the protocol. string-
Brief_SummaryA short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public. stringmaxLength : 5000
Detailed_DescriptionExtended description of the protocol, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures. stringmaxLength : 32000
Primary_Disease_or_ConditionThe name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT), that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus.string-
Primary_Disease_or_Condition_KeywordsWords or phrases that best describe the protocol. Keywords help users find studies in the database. Use NLM's Medical Subject Heading (MeSH)-controlled vocabulary terms where appropriate. Be as specific and precise as possible. Avoid acronyms and abbreviations.string-
Primary_Outcome_InformationA 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). Note: "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."string-
Secondary_Outcome_InformationA 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). Note: "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 exploratory or other measures. A clinical study may have more than one secondary outcome measure.string-
Study_Start_DateThe 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.date-
Primary_Completion_DateThe 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 prespecified 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. Once the clinical study has reached the primary completion date, the responsible party must update the Primary Completion Date to reflect the actual primary completion date.date-
Study_Completion_DateThe 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 prespecified protocol or was terminated. Once the clinical study has reached the study completion date, the Responsible Party must update the Study Completion Date to reflect the actual study completion date.date-
Record_Verification_DateThe date on which the responsible party last verified the clinical study information in the entire ClinicalTrials.gov record for the clinical study, even if no additional or updated information is being submitted. date-
Study_Stopped_ReasonsA brief explanation of the reason(s) why such clinical study was stopped (for a clinical study that is "Suspended," "Terminated," or "Withdrawn" prior to its planned completion as anticipated by the protocol). string-
Sponsor_LeadThe name of the entity or the individual who is the sponsor of the clinical study. The name of the entity or the individual who is the sponsor of the clinical study. The sponsor is the organization or person (see also Sponsor-Investigator) who oversees the clinical study and is responsible for analyzing the study data.string-
Investigator_InformationThe principal investigator is designated by the sponsor as the responsible party for conducting the study. The principal investigator has access to and control over the data from the study; has the right to publish the results of the study, and has the ability to meet all of the requirements for submitting and updating clinical study information.string-
Sponsor_CollaboratorsOther organizations (if any) providing support, including funding, design, implementation, data analysis and reporting. The responsible party is responsible for confirming all collaborators before listing them. string-
Study_TypeThe nature of the investigation or investigational use for which clinical study information is being submitted.stringenum : Array
Oversight_InfoStudies a U.S. FDA-regulated Drug Product - 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.string-
Study_PhaseFor 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. N/A: Trials without phases (for example, studies of devices or behavioral interventions).stringenum : Array
Study_Design_AllocationThe method by which participants are assigned to arms in a clinical trial.stringenum : Array
Study_Design_Primary_PurposeThe main objective of the intervention(s) being evaluated by the clinical trial.stringenum : Array
Study_Design_Intervention_ModelThe strategy for assigning interventions to participants.stringenum : Array
Study_Design_Intervention_Model_DescriptionProvide details about the Interventional Study Model.string-
Study_Design_Observational_ModelProvide details about the Observational Study Model.string-
Study_Design_Time_PerspectiveTemporal relationship of observation period to time of participant enrollment.stringenum : Array
Study_Design_MaskingThe party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants. Select all that apply. Roles, if Masking: Participantstring-
Study_Design_Masking_DescriptionProvide information about other parties who may be masked in the clinical trial, if any. string-
InterventionsSpecify the intervention(s) associated with each arm or group; at least one intervention must be specified for interventional studies. For observational studies, specify the intervention(s)/exposure(s) of interest, if any. If the same intervention is associated with more than one arm or group, provide the information once and use the Arm or Group/Intervention Cross-Reference to associate it with more than one arm or group.string-
Interventions_MESHKeywords that identify the interventions associated with each arm or group.string-
Conditions_MESHThe name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT), that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus.string-
Number_of_ArmsThe number of arms in the clinical trial. For a trial with multiple periods or phases that have different numbers of arms, the maximum number of arms during all periods or phases. Note: "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol.integerlevel : Nominal
Arm_Group_InformationA description of each arm of the clinical trial that indicates its role in the clinical trial; provides an informative title; and, if necessary, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol.string-
Number_of_GroupsNumber of study groups/cohorts. Enter "1" for a single-group study. Many observational studies have one group/cohort; case-control studies typically have two.integerlevel : Nominal
Participants_EnrolledThe estimated total number of participants to be enrolled (target number) or the actual total number of participants that are enrolled in the clinical study. Note: "Enrolled" means a participant’s, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for a study, but do not participate in the study, are not considered enrolled unless otherwise specified by the protocol.integerlevel : Nominal
Eligibility_Study_Population_DescriptionA description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town). string-
Eligibility_Sampling_MethodIndicate the method used for the sampling approach and explain in the Detailed Description.stringenum : Array
Eligibility_CriteriaA limited list of criteria for the 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.stringmaxLength : 15000
Eligibility_GenderThe sex of the participants eligible to participate in the clinical study.stringenum : Array
Is_Eligibility_Gender_BasedThe sex and, if applicable, gender of the participants eligible to participate in the clinical study. boolean-
Eligibility_Gender_DescriptionIf eligibility is based on gender, provide descriptive information about Gender criteria.stringmaxLength : 1000
Eligibility_Minimum_AgeThe numerical value, if any, for the minimum age a potential participant must meet to be eligible for the clinical study.string-
Eligibility_Maximum_AgeThe numerical value, if any, for the maximum age a potential participant can be to be eligible for the clinical study.string-
Is_Healthy_Volunteer_AcceptedIndication 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.boolean-
Is_Expanded_AccessAn investigational drug product (including biological product) available through expanded access for patients who do not qualify for enrollment in a clinical trial. Expanded Access includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including emergency use; (2) for intermediate-size patient populations; and (3) under a treatment IND or treatment protocol.boolean-
Expanded_Access_InfoThis field is used to describe new protocol flags that only appear on records with study type, "Expanded Access"string-
Patient_Data_SharingSpecifies if the study will shade patient data and if so under what conditions.string-
Location_FacilitiesFor each participating facility in a clinical study, the following information: Facility Name: Full name of the organization where the clinical study is being conducted. City State/Province: Required for U.S. locations (including territories of the United States) ZIP/Postal Code: Required for U.S. locations (including territories of the United States) Countrystring-
Location_CountriesThe list of countries where the study is conducted.string-
Removed_CountriesThe list of countries removed from the study.string-
Responsible_PartyThe contents of the study record are provided by this organization or person. This sponsor, sponsor-investigator, or sponsor-designated principal investigator is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. Administrative information to identify and enable communication with the responsible party by telephone, email, and regular mail or delivery service. Responsible Party Contact Information is for the individual who is the responsible party or of a designated employee of the organization that is the responsible party. (Will not be made public - for administrative purposes only.)string-
Overall_OfficialPerson(s) responsible for the overall scientific leadership of the protocol, including study principal investigator. Include the following information: First Name, Middle Initial, Last Name, Degree, Organizational Affiliation: Full name of the official's organization. If none, specify Unaffiliated. Official's Role: Position or function of the official. Select one of: Study Chair, Study Director, Study Principal Investigatorstring-
SourceThe source of the data.string-
Results_Participant_Flow_Recruitment_DetailsKey information relevant to the recruitment process for the overall study, such as dates of the recruitment period and types of location (For example, medical clinic), to provide context. string-
Results_Participant_Flow_Pre_Assignment_Details Description of significant events in the study (for example, wash out, run-in) that occur after participant enrollment, but prior to assignment of participants to an arm or group, if any. For example, an explanation of why enrolled participants were excluded from the study before assignment to arms or groups. string-
Results_Participant_Flow_Group_ListArms or groups for describing the flow of participants through the clinical study. In general, it must include each arm to which participants were assigned.string-
Results_Participant_Flow_Period_ListDiscrete stages of a clinical study during which numbers of participants at specific significant events or points of time are reported. There is no limit to the number of periods that may be used to describe a single study. Each subsequent period represents a study stage following the previous period. That is participants "flow" from earlier to later periods.string-
Results_Baseline_PopulationIf the Overall Number of Baseline Participants (or units) differs from the number of participants (or units) assigned to the arm or comparison group and overall, a brief description of the reason(s) for the difference such as how the analysis population was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.string-
Results_Baseline_Analyzed_ListThe statistical analysis section is a table associated with an Outcome Measure. It summarizes the resultsstring-
Results_Baseline_Group_ListArms or groups for describing the flow of participants through the clinical study. In general, it must include each arm to which participants were assigned.string-
Results_Baseline_Measure_ListA description of each outcome measure.string-
Results_OutcomesDetailed description of the outcomes observed during the clinical study. These are the actual outcomes while Primary and Secondary outcomes are the ones anticipated at the beginning of the study.string-
Results_Reported_Events_Time_FrameThe specific period of time over which adverse event data were collected.string-
Results_Reported_Events_Group_ListArms or groups for describing the flow of participants through the clinical study. In general, it must include each arm to which participants were assigned.string-
Results_Reported_Events_SeriousA table of all anticipated and unanticipated serious adverse events, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.string-
Results_Reported_Events_OthersA table of anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold (for example, 5 %) within any arm of the clinical study, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.string-
Results_AgreementsThe existence of agreements that restricts the results publication or discussion at a scientific meeting or any other public or private forum. Information indicating whether there exists an agreement between the sponsor or its agent and the principal investigators (unless the sponsor is an employer of the principal investigators) that restricts in any manner the ability of the principal investigators (PIs), after the completion of the study, to discuss the results of the study at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the study. This does not include an agreement solely to comply with applicable provisions of law protecting the privacy of participants.string-
Results_Limitations_and_CaveatsDescribe the significant limitations of the study. Such limitations may include not reaching the target number of participants needed to achieve target power and statistically reliable results or technical problems with measurements leading to unreliable or uninterpretable data.stringmaxLength : 500
Results_Point_of_ContactPoint of contact for scientific information about the clinical study results information. string-
First_Received_Results_Disposition_DateDate when a sponsor indicates that they will be delaying the posting of results (and are certifying initial approval or new use), or when they apply for an extension of the deadline.date-
Clinical_Study_IdOverall_StatusRankClinical_Study_Secondary_IdOrganization_Study_IdFirst_Received_DateLast_Changed_DateFirst_Received_Results_DateShort_TitleOfficial_TitleBrief_SummaryDetailed_DescriptionPrimary_Disease_or_ConditionPrimary_Disease_or_Condition_KeywordsPrimary_Outcome_InformationSecondary_Outcome_InformationStudy_Start_DatePrimary_Completion_DateStudy_Completion_DateRecord_Verification_DateStudy_Stopped_ReasonsSponsor_LeadInvestigator_InformationSponsor_CollaboratorsStudy_TypeOversight_InfoStudy_PhaseStudy_Design_AllocationStudy_Design_Primary_PurposeStudy_Design_Intervention_ModelStudy_Design_Intervention_Model_DescriptionStudy_Design_Observational_ModelStudy_Design_Time_PerspectiveStudy_Design_MaskingStudy_Design_Masking_DescriptionInterventionsInterventions_MESHConditions_MESHNumber_of_ArmsArm_Group_InformationNumber_of_GroupsParticipants_EnrolledEligibility_Study_Population_DescriptionEligibility_Sampling_MethodEligibility_CriteriaEligibility_GenderIs_Eligibility_Gender_BasedEligibility_Gender_DescriptionEligibility_Minimum_AgeEligibility_Maximum_AgeIs_Healthy_Volunteer_AcceptedIs_Expanded_AccessExpanded_Access_InfoPatient_Data_SharingLocation_FacilitiesLocation_CountriesRemoved_CountriesResponsible_PartyOverall_OfficialSourceResults_Participant_Flow_Recruitment_DetailsResults_Participant_Flow_Pre_Assignment_DetailsResults_Participant_Flow_Group_ListResults_Participant_Flow_Period_ListResults_Baseline_PopulationResults_Baseline_Analyzed_ListResults_Baseline_Group_ListResults_Baseline_Measure_ListResults_OutcomesResults_Reported_Events_Time_FrameResults_Reported_Events_Group_ListResults_Reported_Events_SeriousResults_Reported_Events_OthersResults_AgreementsResults_Limitations_and_CaveatsResults_Point_of_ContactFirst_Received_Results_Disposition_Date
NCT02383082Withheld3A[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT00576953Withheld07[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT00784641Withheld496[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT01820741Withheld305[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT01558609Withheld401[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT01309867Withheld680[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT01300065Withheld642[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT01873846Withheld817[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT00748917WithheldAU1[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]
NCT01318577Withheld682[Trial of device that is not approved or cleared by the U.S. FDA][Trial of device that is not approved or cleared by the U.S. FDA]agency:[Redacted] name_title:[Redacted]|organization:[Redacted][Redacted]