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To subscribe to the NIDDK Central Repository news feed via email, register an account using the link in the header above and login for the first time to activate your account. NIH employees may login with their NIH credentials, no registration is needed. Upon login, users may update subscription preferences via their account profile.
The S-index challenge, led by the National Eye Institute (NEI), aims to incentivize and reward data sharing by promoting a new metric, the S-index, that will assess how effectively researchers share data. This metric will incorporate factors such as adherence to Findable, Accessible, Interoperable, and Reusable (FAIR) standards, data timeliness, completeness of annotation, frequency of utilization in other studies, and related publications and patents. Phase 1 for this challenge is to generate a proof of concept proposal and will open on April 21, 2025 at 8:00 a.m. EDT. Check out Challenge.gov to learn more about the challenge, how to enter, eligibility, and cash prizes.
Data have been updated for Antithymocyte Globulin (ATG) and Pegylated Granulocyte Colony Stimulating Factor (GCSF) in New Onset Type 1 Diabetes (TN19). This update includes additional flow analysis datasets.
If you have already been approved to receive the TN19 data package, please contact us through your request to download the updated data package.
The TN19 study was a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which participants either received active Anti-Thymocyte Globulin (ATG) and Granulocyte Colony Stimulating Factor (GCSF), received ATG alone, or received a placebo alone within 100 days from diagnosis of T1D. TrialNet researchers assessed whether ATG used alone or in combination with GCSF helped participants continue to make some of their own insulin.
A new study, Longitudinal Assessment of Transient Elastography in Cystic Fibrosis (ELASTIC-CF), has been posted to the NIDDK Central Repository. Data from this study are now available for request.
The ELASTIC-CF study assessed if combining FibroScan® measurement of liver stiffness transient elastography with ultrasound would improve the prediction of the development of a nodular liver on ultrasound and development of portal hypertension over time in children and young adults with CF. Study visits occurred at baseline and for at least two annual follow-up visits.
The AI in Precision Medicine for Diabetes and Other Chronic Diseases pre-workshop webinar series hosted by NIDDK is designed to set the stage to start the discussion in precision medicine offered by recent advances in AI and data science. The first webinar in this series titled “The bio-behavioral dimensions of diabetes heterogeneity” on Thursday, October 17, 2024, will feature presentations from Dr. Yao Qin, Assistant Professor at the University of California, Santa Barbara, and Senior Research Scientist at Google DeepMind, on “Data-Driven Machine Learning: Unlocking the Future of Closed-Loop Diabetes Care” and from Dr. Ashu Sabharwal, Ernest Dell Butcher Professor at Rice University, on “Bio-behavioral Pathways in Diabetes”. Join the webinar on Thursday, October 17, 2024, from 11-1 PM EST using the participant Zoom link: https://nih.zoomgov.com/j/1617468705?pwd=JlqDARcaIBItOmw9bORkRLaCX70And.1
The AI in Precision Medicine for Diabetes and Other Chronic Diseases pre-workshop webinar series hosted by NIDDK is designed to set the stage to start the discussion in precision medicine offered by recent advances in AI and data science. The second webinar in this series titled “Advances in AI and applications in biomedicine” on Thursday, October 24, 2024, will feature presentations from Dr. James Zou, Associate Professor at Stanford University, on “AI agents for biomedicine” and from Dr. Eran Halperin, Professor at University of California, Los Angeles, on “AI challenges and opportunities across data modalities in medicine”. Join the webinar on Thursday, October 24, 2024, from 1-3 PM EST using the participant Zoom link: https://nih.zoomgov.com/j/1605069617?pwd=Ibhhv0HU2ZBIzEaldMPoqXyC32TuG8.1
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is hosting a two-day hybrid workshop on October 30-31, 2024, at the Neuroscience Center Building, 6001 Executive Blvd., Bethesda, MD. This workshop aims to bring together biomedical researchers and artificial intelligence and machine learning (AI/ML) experts, to discuss the critical challenges, crosscutting gaps, and opportunities for and actionable items in leveraging AI/ML and other recent data science advances in precision medicine, with a focus on diabetes and other chronic disease areas relevant to the NIDDK mission. For more information and to register for the workshop, visit the NIDDK website: https://www.niddk.nih.gov/news/meetings-workshops/2024/artificial-intelligence-in-precision-medicine-of-diabetes-2024
A new study, Validation of Bladder Health Instrument for Evaluation in Women (VIEW), has been posted to the NIDDK Central Repository. Data from this study are now available for request.
The VIEW study prospectively collected data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that assessed the full range of bladder health of women. The study collected data from the general population using mailed surveys, from the clinical population using surveys and in-person evaluations, and from postpartum women.
A new study, Biliary Atresia Study in Infants and Children (BASIC), has been posted to the NIDDK Central Repository. Analysis data from this study are now available for request as well as three analysis datasets using combined data from the PROBE and BASIC studies.
The Biliary Atresia Study in Infants and Children (BASIC) is a prospective, observational study that was established by ChiLDReN to collect pertinent clinical information and biospecimens to aid in the understanding of the disorder. Specific aims of the study include identifying the gene(s) implicated in the etiology of biliary atresia, identifying the polymorphisms that may influence disease progression, and characterizing the natural history of the older, non-transplanted patients with biliary atresia.
The Federation of American Societies for Experimental Biology (FASEB) and the National Institutes of Health (NIH) partnered together to host the 2024 DataWorks! Prize. This challenge is a collaboration with the seven generalist repositories participating in the NIH-funded Generalist Repositories Ecosystem Initiative (GREI) and will focus on best practices in data reuse and secondary analysis that advance human health. NIDDK-CR data may be used for this challenge in combination with data from a participating GREI repository. Phase 1 for this challenge closes on 11:59 p.m. EDT on October 23, 2024. Check out Challenge.gov to learn more about the challenge, how to enter, eligibility, and prizes.
A new study, Rare and Atypical DIAbetes NeTwork (RADIANT), has been posted to the NIDDK Central Repository. Data from this study are now available for request.
The Rare and Atypical DIAbetes NeTwork (RADIANT) is a multicenter prospective cohort study that is dedicated to characterizing (discovering and defining) rare and atypical forms of diabetes. Individuals will be screened for evaluation of suspected atypical diabetes of unknown origin. Among the pool of evaluated individuals, those found to have a known form of diabetes will be excluded from further study. The remaining participants will be prioritized for genetic/genomic analysis and further testing.
Data have been updated for the Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC) study. This study is part of the Childhood Liver Disease Research Network (ChiLDReN). An additional analysis dataset is now available for request.
If you have already been approved to receive the LOGIC data package, please contact us through your request to download the updated data package.
The primary objectives of the LOGIC study include determining the frequency of poor growth and decreased bone mineral density and its predictors; identifying modifier genes that influence the incidence, severity, and progression of liver disease among affected individuals; and developing a repository of biospecimens to be used in ancillary studies of predictor biomarkers.
Data have been updated for A Prospective Database of Infants With Cholestasis (PROBE). This update includes an analysis dataset from PROBE. Additionally, this update includes three analysis datasets using combined data from the PROBE, BASIC, and START studies.
If you have already been approved to receive the PROBE data package, please contact us through your request to download the updated data package.
PROBE is a multi-center project to establish a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and neonatal hepatitis in order to perform research in these liver problems.
Data have been updated for Careful Urinary Tract Infection Evaluation (CUTIE). This update includes an additional renal scan dataset.
If you have already been approved to receive the CUTIE data package, please contact us through your request to download the updated data package.
The CUTIE study was an observational study designed to determine why some children develop kidney scars after urinary tract infections (UTIs). The study was aimed at understanding which children were at the greatest risk of developing renal scarring following a UTI, so physicians can provide targeted therapies and appropriate interventions.
Data have been updated for The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C). This update includes Biopsy Adverse Event data.
If you have already been approved to receive the HALT-C data package, please contact us through your request to download the updated data package.
The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C) was a randomized clinical trial of long-term use of peginterferon alfa-2a in participants with chronic hepatitis C. The study investigated whether long-term antiviral therapy could prevent progressive liver disease—including cirrhosis, liver failure, hepatocellular carcinoma, and death—in chronic hepatitis C participants.
Winners of the Intermediate/Advanced-level Data Centric Challenge, Dr. Ali Loveys and Fiona Meng from FI Consulting, presented Laying the Foundation for AI-Ready Data at the ODSS Data Sharing and Reuse Seminar on May 10, 2024. The FI Consulting team successfully consolidated and unified multiple TrialNet data sets and identified data outliers, then enhanced raw data to ensure consistent variable representation and identified numeric and categorical “missingness” to prevent modeling bias, thus enhancing TrialNet data for AI-readiness. View the recording from the past webinar .
Data have been updated for Diabetes Prevention Program (DPP). This update includes PFAS (per- and polyfluoroalkyl substances) Secondary data.
If you have already been approved to receive the DPP data package, please contact us through your request to download the updated data package.
The Diabetes Prevention Program (DPP) is a clinical trial that investigated whether modest weight loss through dietary changes and increased physical activity or treatment with the oral diabetes drug metformin (Glucophage) could prevent or delay the onset of type 2 diabetes in high risk individuals with prediabetes.
Data have been updated for Diabetes Prevention Program Outcomes Study (DPPOS). This update includes Phase 3 data and PFAS (per- and polyfluoroalkyl substances) Secondary data.
If you have already been approved to receive the DPPOS data package, please contact us through your request to download the updated data package.
The Diabetes Prevention Program Outcomes Study (DPPOS) is the long-term follow-up of the original DPP (Diabetes Prevention Program) study. The DPPOS sought to evaluate the effects of the interventions on the further development of diabetes and diabetes complications, including retinopathy, microangiopathy, and cardiovascular disease.
Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M199, M208, M233, and M239.
If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package.
The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.
Data have been updated for Anti-CD3 Mab (Teplizumab) for Prevention of Diabetes in Relatives At-Risk for Type 1 Diabetes Mellitus (TN10) study. This update includes additional secondary outcomes analysis datasets.
If you have already been approved to receive the TN10 data package, please contact us through your request to download the updated data package.
TN10 was a phase 2 prevention trial of TrialNet, studying the effect of teplizumab on insulin production in the relatives of type 1 diabetics who were at high risk of developing the disease. Participants were randomly assigned to either the active or placebo group of the study and monitored and tested over time until diagnosed with diabetes.
Data have been updated for A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants with Biliary Atresia (START) study. This update includes an additional vitamin deficiency analysis dataset, and two analysis datasets using combined data from the Prospective Database of Infants with Cholestasis (PROBE) and START studies.
If you have already been approved to receive the START data package, please contact us through your request to download the updated data package.
The START study participants were recruited from the PROBE study and randomized into either the corticosteroid or placebo group within 72 hours after the portoenterostomy procedure. Participants were given their assigned treatments daily over the course of 13 weeks. After the treatment period, participants underwent follow-up testing and assessments until age 24 months.
Data have been updated for FibroScan in Pediatric Cholestatic Liver Disease (FORCE) study. This update includes an additional biomarkers analysis dataset.
If you have already been approved to receive the FORCE data package, please contact us through your request to download the updated data package.
The FibroScan in Pediatric Cholestatic Liver Disease (FORCE) study, a natural history study within ChiLDReN, was a cross-sectional and longitudinal assessment of the utility of liver stiffness measurement (LSM) in children with chronic cholestatic liver disease.
This Notice of Special Interest (NOSI) solicits competitive revision applications that focus on data reuse and secondary data analysis in NIH-funded data repositories and knowledgebases to advance scientific inquiry and address health research questions. For additional details on the opportunity see the the NIH grant page
A new study, Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects with Alagille Syndrome (IMAGINE-II), has been posted to the NIDDK Central Repository. Data from this study are now available for request.
The IMAGINE-II study was a multicenter, extension study of LUM001 in children diagnosed with Alagille syndrome (ALGS) who had completed participation in a core LUM001 treatment protocol (ITCH study). Efficacy was assessed by evaluating the effect of LUM001 on the biochemical markers and pruritus associated with ALGS.
A new study, A Phase I/IIa Trial of Intravenous Immunoglobulin (IVIG) Therapy Following Portoenterostomy in Infants with Biliary Atresia (PRIME), has been posted to the NIDDK Central Repository. Data from this study are now available for request.
The PRIME study was a multicenter prospective phase I/IIa open label trial, aimed at assessing the feasibility, tolerability, and safety of intravenous immunoglobulin (IVIG) therapy following hepatic portoenterostomy (HPE) in infants with biliary atresia (BA).
A new study, Nonalcoholic Fatty Liver Disease Pediatric Database 2 (NAFLD Pediatric Database 2), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request.
The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) was initiated in 2002 to conduct multicenter, collaborative studies on the etiology, contributing factors, natural history, complications, and treatment of NASH. The Nonalcoholic Fatty Liver Disease Pediatric Database 2 (NAFLD Pediatric Database 2) continued the longitudinal follow-up of participants enrolled in earlier NASH CRN studies and recruited new participants with recent liver biopsies.
NIDDK Central Repository (NIDDK-CR) has released a revised policy that aligns with the NIH Data Management and Sharing (DMS) policy and NIDDK DMS Guidance: https://grants.nih.gov/grants/guide/notice-files/NOT-DK-24-003.html. More details and complete NIDDK-CR Resource Archival and Sharing policy are available under “Helpful Information”- “General Information”: https://repository.niddk.nih.gov/pages/general_information
Data have been updated for the Adolescent Bariatrics: Assessing Health Benefits & Risks (Teen-LABS) study. This update includes data through the end of the study and additional analysis datasets.
If you have already been approved to receive the Teen-LABS, please contact us through your request to download the updated data package.
Teen-LABS conducted coordinated clinical, epidemiological, and behavioral research focused on adolescent bariatric surgery. The study developed common clinical protocols and a bariatric surgery database for the purpose of collecting information from participating clinical centers that performed bariatric surgery on teenagers.
In September 2023, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository announced the Data Centric Challenge aimed at enhancing NIDDK datasets for future artificial intelligence (AI) applications. Challenge participants were tasked to generate an AI-ready dataset that can be used for future data challenges and produce methods to enhance the AI-readiness of NIDDK data. Participation in the Challenge was tiered (i.e., beginner-level and intermediate/advanced-level) and utilized data from two longitudinal studies focused on type 1 diabetes (TEDDY and TrialNet). NIDDK is excited to announce ICF Inc. and FI Consulting as the Data Centric Challenge winners. Visit Challenge.gov to read more about the winning solutions: https://www.challenge.gov/?challenge=niddk-central-repository-data-centric-challenge&tab=winners
A new study, Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B (HBRN Immunology Cohort), has been posted to the NIDDK Central Repository. Data from this study are now available for request.
The Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B (HBRN Immunology Cohort) study aimed to assess whether the balance between immune regulatory and effector responses in HBV-infected individuals defines the level of viremia, liver inflammation, and treatment outcomes.
A new study, Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B (HBRN Immunology Treatment), has been posted to the NIDDK Central Repository. Data from this study are now available for request.
Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B (HBRN Immunology Treatment) study sought to examine the effects of antiviral therapy in host immune phenotype and to investigate if antiviral immune responses before, during, and after therapy can predict long term therapeutic response.
A new study, Nonalcoholic Fatty Liver Disease Adult Database 2 (NAFLD Adult Database 2), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request.
The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) was initiated in 2002 to conduct multicenter, collaborative studies on the etiology, contributing factors, natural history, complications, and treatment of NASH. The Nonalcoholic Fatty Liver Disease Adult Database 2 (NAFLD Adult Database 2) continued the longitudinal follow-up of participants enrolled in earlier NASH CRN studies and recruited new participants with recent liver biopsies.
A new study, Combination Therapy of Peginterferon Alfa-2a and Tenofovir versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B (HBRN Immune Active), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request.
The Combination Therapy of Peginterferon Alfa-2a and Tenofovir versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B (HBRN Immune Active) study sought to compare the long-term efficacy of combination therapy with peginterferon plus tenofovir versus tenofovir monotherapy in the treatment of chronic hepatitis B.
A new study, Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic HBV Infection (HBRN Immune Tolerant P), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request.
The HBRN Pediatric Immune Tolerant Trial (HBRN Immune Tolerant P) sought to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.
A new study, Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults with Chronic Hepatitis B (HBRN Immune Tolerant A), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request.
The HBRN Adult Immune Tolerant Trial (HBRN Immune Tolerant A) was designed to determine the efficacy of treatment with 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon in the treatment of chronic hepatitis B in hepatitis B “e” antigen (HBeAg) positive adults who were in the immune tolerant phase.
The goal of this Notice of Special Interest (NOSI) is to provide support through administrative supplements collaborations to improve interoperability/re-use for NIDDK supported T2D data sets and related resources such as repositories and knowledgebases. NIDDK mandates its funded projects to comply with the FAIR principles, i.e., making all data sets and related resources Findable, Accessible, Interoperable and Reusable. While Findability and Accessibility are usually achieved, many projects face unexpected challenges in making their data sets and related resources Interoperable with that from other programs and projects, which consequently also affect the Reusability. This also poses obstacles in the reuse of data and tools that capitalize on the latest data science advancements such as those in AI/ML, where the greatest potential lies in automated integration of large multi-modal data types for discovery and novel hypothesis generation. For additional details on the opportunity, see the NIH grant page. Submissions are due July 11, 2023.
Join us for a two-day virtual workshop on September 19th and 20th, from 10 a.m. to 3:00 p.m. (Eastern Time), focused on promoting secondary research to accelerate medical breakthroughs and foster innovation. Renowned guest speakers, engaging panel discussions, and informative lightning talks will shed light on the history and valuable resources of NIDDK-CR as we commemorate its 20th anniversary. Plus, don’t miss the introduction of our new analytics workspace and the launch of our data-centric challenge to enhance research capabilities. Mark your calendars now and be part of this extraordinary event! Register here: https://www.niddk.nih.gov/news/meetings-workshops/2023/central-repository-20th-anniversary-workshop
DOIs are now available for every NIDDK-CR R4R study! DOIs increase resource visibility and accessibility and enable appropriate credit citation and interoperability. Researchers are encouraged to use them when making public releases using NIDDK-CR R4R resources. A study’s DOI can be found at the top of the study’s overview page along with citation guidance. Additionally, a data availability statement, with data package version and DOI, is available to requestors who are submitting publications.
As of January 25, 2023, the NIH Policy for Data Management and Sharing (DMS) is in effect. All research that is funded in whole or in part by NIH is required to submit a DMS plan outlining how scientific data and accompanying metadata will be managed and shared. NIH DMS plans should address the elements described in the Supplemental Information to the NIH DMS Policy. NIH has provided a DMS plan format on the Writing a Data Management and Sharing Plan page on the NIH Scientific Data Sharing website. NIDDK is offering Institute-specific guidance for Writing a DMS Plan and provides NIDDK DMS Tools and Examples.
This revamped, streamlined process for requesting biospecimens incorporates user feedback to better facilitate access to biospecimens. Certain requests will still require an X01 Resource Access Award; however, many will need only an administrative review or will leverage existing grant applications peer review if one was submitted. The new request process is designed to share NIDDK-CR resources with more researchers faster and easier to continue fostering innovative research. Researchers can visit the Material Counts page to explore the available resources and start a request.
Vivli and the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), part of the National Institutes of Health (NIH), will be working together to broaden exposure and strengthen NIDDK data ecosystem. As part of Vivli’s award to serve as one of six generalist repositories that will work with the NIH Office of Data Science Strategy under its Generalist Repository Ecosystem Initiative (GREI), NIDDK will include NIDDK Central Repository (NIDDK-CR) resources in the Vivli global clinical research data sharing platform. NIDDK-CR’s resources inclusion within Vivli as part of GREI improves discoverability and reuse of NIDDK-CR hosted resources making data more Findable, Accessible, Interoperable, and Reusable (FAIR), increases the scientific value by providing additional opportunities to the NIDDK scientific community, and maximizes the contributions of research participants.
To learn more: contact Dr. Rebecca Rodriguez or visit the Vivli member page.
This funding opportunity announcement invites applications from multidisciplinary teams to perform secondary data analysis, using existing datasets from two or more multi-site clinical research projects, including clinical trials, natural history studies, and/or comparative effectiveness research. Secondary analyses should address scientific and / or clinical hypotheses that can advance the understanding or care of neurological disorders and conditions within the NINDS mission. In this phased award funding mechanism, applications are required to systematically and comprehensively perform cross-project data harmonization and curation, assessed using go/no-go data-quality metrics, prior to performing secondary analyses of existing clinical data. Consistent with the FAIR (findable, accessible, interoperable and reusable) data principles, this funding opportunity expects open-source cataloging of the processes and tools used for harmonization, curation, and analysis, as well as controlled access to the curated datasets. For additional details on the opportunity, see the NIH grant page.
The NIDDK Central Repository (CR) plays a crucial role in making data Findable, Accessible, Interoperable, and Reusable (FAIR). To enhance FAIRness of studies in the Repository, NIDDK and Booz Allen Hamilton, the current Data Repository contractor, have piloted a natural language processing (NLP) pipeline project for harmonizing study variables with NIH CDEs and for identifying potential new CDEs from dataset variables mapped to ontology concepts. Initial results show highly specific mapping of variables to CDEs as well as successful identification of relevant concepts for new CDEs. The pipeline can be refined and applied to other studies to potentially improve FAIRness of the NIDDK CR.
Contact Dr. Rebecca Rodriguez with any questions.
NIDDK has posted an opportunity for those using secondary data in new analyses. The eligible data includes that which can be requested via the repository website. For additional details on the opportunity, see the NIH grant page.
