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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.
Data have been updated for the Hepatitis B Research Network Pediatric Cohort Study (HBRN Cohort P). This update includes final study datasets, analysis datasets, and additional ancillary datasets.
If you have already been approved to receive the HBRN data package, please contact us through your request to download the updated data package.
The HBRN Pediatric Cohort Study (HBRN Cohort P) was designed to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.
Data have been updated for the Hepatitis B Research Network Adult Cohort Study (HBRN Cohort A). This update includes final study datasets, analysis datasets, and additional ancillary datasets.
If you have already been approved to receive the HBRN data package, please contact us through your request to download the updated data package.
The HBRN Adult Cohort Study (HBRN Cohort A) was designed to describe participants with hepatitis B virus (HBV) infection and identify predictors of disease activation and progression. The relationship of HBV genotype to clinical, biochemical, and histological characteristics and to pregnancy was also explored.
Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes TEDDY data through 2021.
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 the Chronic Renal Insufficiency Cohort Study (CRIC). This update includes updated datasets.
If you have already been approved to receive the CRIC data package, please contact us through your request to download the updated data package.
The Chronic Renal Insufficiency Cohort (CRIC) Study is an observational study that examined risk factors for progression of chronic renal insufficiency (CRI) and cardiovascular disease (CVD) among CRI patients. The study enrolled adults aged 21 to 74 years with a broad spectrum of renal disease severity, half of whom were diagnosed with diabetes mellitus. Subjects underwent extensive clinical evaluation at baseline and at annual clinic visits and via telephone at 6 month intervals.
A new study, Losartan for the Treatment of Pediatric Nonalcoholic Fatty Liver Disease (STOP-NAFLD), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request.
The STOP-NAFLD trial was a multicenter, double-masked, placebo-controlled, randomized phase 2 trial designed by the Nonalcoholic Steatohepatitis Clinical Research Network (NASH) to determine whether treatment with losartan improves measures of NAFLD in children.
Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M78, M144, M210, and updated TEDDY data through 2020.
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 the Acute Liver Failure Study Group: Adult Acute Liver Failure Study (AALF). Additional study datasets are now available for request.
If you have already been approved to receive the AALF data package, please contact us through your request to download the updated data package.
ALFSG conducted a Multi-Center Trial to Study Adult Acute Liver Failure (AALF) with acute liver failure and acute liver injury participants and those less severe that had coagulopathy but not the threshold of encephalopathy, a pilot study with a subset of AALF participants using rotational thromboelastography as a dynamic measure of coagulation, and a clinical trial with a subset of AALF participants using 13C labeled methacetin breath testing to determine outcomes in acute liver failure patients being considered for transplantation.
A new study, The MAPP II Study of Urologic Chronic Pelvic Pain Syndrome: The Trans-MAPP Symptom Patterns Study (MAPP II), has been posted to the NIDDK Central Repository. Data from this study are now available for request.
The second phase (MAPP II) of the NIDDK Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network was designed to conduct a prospective, observational study of men and women with urologic chronic pelvic pain syndrome (UCPPS). A central goal of MAPP II, like MAPP I, was to create a new knowledge base for informing future, targeted UCPPS clinical trials and ultimately to provide insights that will improve the clinical management of patients.
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
Data have been updated for the Multidisciplinary Approach to the Study of Pelvic Pain (MAPP I). This update includes updated datasets and new derived variables for the MAPP I study.
If you have already been approved to receive the MAPP I data package, please contact us through your request to download the updated data package.
The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network was established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men. Participants with some form or symptoms of IC or CP were asked to join the Trans-MAPP Epidemiology and Phenotyping (EP) Study. Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome (CFS)) were recruited for the Trans-MAPP Control Study. These participants were a reference/control group for the Trans-MAPP EP Study.
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.