Roll-Out of the NFDI4health Local Data Hubs for Medical Research Data Management.
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BiBTeXThe NFDI4Health (National Research Data Infrastructure for Personal Health Data) develops Local Data Hubs (LDHs), which allow data-holding organizations to use both a research data management platform and a connection to the central study registers of NFDI4Health. We describe our approach to rolling out a broad test of the LDH for different DHO types - from university clinics to clinical trial centers. The aim is to exchange the NFDI4Health standardized study metadata and to promote the idea of data sharing in general. We report on the application process and the first results with this approach.
SEEK ID: https://ldh.zks.uni-leipzig.de/publications/11
PubMed ID: 40380570
Trial Projects: BASALIT: Birch Associated Soy Allergy and Immuno-Therapy
Publication type: Journal
Journal: Stud Health Technol Inform
Citation: Stud Health Technol Inform. 2025 May 15;327:771-772. doi: 10.3233/SHTI250461.
Date Published: 15th May 2025
Registered Mode: by PubMed ID
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Created: 16th Jan 2026 at 13:37
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Trial Projects:
- BASALIT: Birch Associated Soy Allergy and Immuno-Therapy
- ADIPO-Vent: Optimierung der perioperativen maschinellen Ventilation bei adipösen und normalgewichtigen Patienten durch PEEP-Titration anhand der Elektrischen Impedanz-Tomografie
- GRAFT: Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure
- AbCD: Antibody diagnostics in paediatric Coeliac Disease
- TIBICO: Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients
- STOP-NUC: A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response
Institutions: Zentrum für Klinische Studien Leipzig (ZKS Leipzig), Universität Leipzig
https://orcid.org/0000-0002-9256-7543
For each clinical trial conducted according to the German Medicines Act (AMG) or the Medical Devices Act (MPG), a sponsor must be named who assumes overall responsibility for the clinical trial. In the case of human clinical trials initiated and managed by staff of the Medical Faculty of the University of Leipzig or Leipzig University Hospital (UKL) (Investigator Initiated Trials; IITs), the University of Leipzig assumes the function of sponsor if no third party is the sponsor.
Trial Projects:
- STOP-NUC: A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response
- BASALIT: Birch Associated Soy Allergy and Immuno-Therapy
- ADIPO-Vent: Optimierung der perioperativen maschinellen Ventilation bei adipösen und normalgewichtigen Patienten durch PEEP-Titration anhand der Elektrischen Impedanz-Tomografie
- GRAFT: Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure
- AbCD: Antibody diagnostics in paediatric Coeliac Disease
- TIBICO: Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients
A multi centre randomised placebo-controlled double-blind clinical trial for the evaluation of efficacy of specific immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen r Bet v1-FV on Bet v 1 associated soy allergy (Birch Associated Soy Allergy and Immuno-Therapy)
Coordinating investigators: Prof. Dr. Jan C. Simon Prof. Dr. Regina Treudler Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Leipzig ...
Sponsor: Leipzig University (Sponsor)
Public web page: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011737-27/DE
End date: 18th Jul 2014
