University Leipzig (Sponsor)

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Related items

BASALIT

Coordinating investigators Prof. Dr. Jan C. Simon Prof. Dr. Regina Treudler Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Leipzig

Sponsor Universität Leipzig Ritterstr. 26, 04109 Leipzig

EudraCT: 2009-011737-27

Programme: University Leipzig (Sponsor)

Public web page: Not specified

ADIPO-VENT

TitelOptimierung der perioperativen maschinellen Ventilation bei adipösen und normalgewichtigen Patienten durch PEEP-Titration anhand der Elektrischen Impedanz-Tomografie – eine randomisierte kontrollierte klinische StudieStudienleitungProf. Dr. Hermann WriggeKlinik und Poliklinik für Anästhesiologie und IntensivtherapieUniversitätsklinikum LeipzigDRKS0000419

Programme: University Leipzig (Sponsor)

Public web page: Not specified

TIBICO

TitelEffektivität der transnasalen Insufflation (TNI) im Vergleich zur nicht-invasiven BiPAP-Beatmung bei Patienten mit chronisch respiratorischer Globalinsuffizienz bei COPD**Studienleitung:**Prof. Dr. med. Hubert WirtzDr. med. Jens BräunlichUniversität LeipzigDepartment Innere Medizin, Neurologie und DermatologieAbteilung für Pneumologieclinicaltrials.gov: NCT02007772

Programme: University Leipzig (Sponsor)

Public web page: Not specified

GRAFT

TitleGranulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure: A multicentre randomized trialCoordinating investigator:Prof. Dr. Thomas BergSektion Hepatologie, Klinik und Poliklinik für Gastroenterologie und Rheumatologie, Universitätsklinikum LeipzigSponsorUniversität Leipzig Ritterstr. 26, 04109 LeipzigEudraCT: 2015-002212-32ClinicalTrials.gov: NCT02669680

Programme: University Leipzig (Sponsor)

Public web page: Not specified

AbCD

TitleProspective multicentre trial of Antibody diagnostics in paediatric Coeliac Disease**Coordinating investigator:**Prof. Dr. Thomas MothesInstitut für Laboratoriumsmedizin, Klinische Chemie und Molekulare DiagnostikUniversität LeipzigDRKS-No.: DRKS00003854

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Public web page: Not specified

STOP-NUC

Coordinating investigator: Prof. Dr. Florian van Bömmel Sektion Hepatologie, Klinik und Poliklinik für Gastroenterologie und Rheumatologie, Universitätsklinikum Leipzig

Sponsor Universität Leipzig Ritterstr. 26, 04109 Leipzig

EudraCT: 2013-004882-15 DRKS: DRKS00006240

Programme: University Leipzig (Sponsor)

Public web page: Not specified

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BASALIT trial: double-blind placebo-controlled allergen immunotherapy with rBet v 1-FV in birch-related soya allergy.
BASALIT

Abstract (Expand)

BACKGROUND: Conflicting results exist on the effect of allergen immunotherapy (AIT) on pollen-related food allergy. We aimed to investigate the efficacy of one-year AIT with the folding variant (FV) … of recombinant (r) Bet v 1 on birch-related soya allergy. METHODS: Of 138 subjects with Bet v 1 sensitization, 82 were positive at double-blind placebo-controlled food challenge (DBPCFC) with soya. A total of 56 of 82 were randomized in the ratio of 2:1 (active: placebo). Per-protocol population (PPP) had received >/=150 mug of allergen or placebo preparation. OUTCOME MEASURES: lowest observed adverse effect levels (LOAEL), postinterventional occurrence of objective signs (objS) at any dose level, sIgE/IgG4 against Bet v 1 and Gly m 4. Between-group changes were investigated (ancova, Mann-Whitney U-test, Fisher exact test). RESULTS: Baseline characteristics including LOAELs were comparable in both groups with objS and subjS occurring in 82% and 95% of active (n = 38) vs 78% and 83% of placebo group (n = 18). After AIT, objS occurred in 24% and 47%, respectively. LOAEL group differences showed a beneficial tendency (P = 0.081) for LOAEL(objective) in PPP (30 active, 15 placebo). sIgG4 raised only in active group (Bet v 1: P = 0.054, Gly m 4: P = 0.037), and no relevant changes occurred for sIgE. Only 56% of the intended sample size was recruited. CONCLUSION: For the first time, we present data on the effect of rBet v 1-FV on birch-related soya allergy. rBet v 1-FV AIT induced significant immunogenic effects. Clinical assessment showed a tendency in favour of the active group but did not reach statistical significance.

Authors: R. Treudler, A. Franke, A. Schmiedeknecht, B. Ballmer-Weber, M. Worm, T. Werfel, U. Jappe, T. Biedermann, J. Schmitt, R. Brehler, A. Kleinheinz, J. Kleine-Tebbe, H. Bruning, F. Rueff, J. Ring, J. Saloga, K. Schakel, T. Holzhauser, S. Vieths, J. C. Simon

Date Published: 21st Dec 2016

Publication Type: Journal article

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STOP-NUC Trial protocol
STOP-NUC
No description specified

Creator: Oana Brosteanu

Submitter: Oana Brosteanu

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Oana Brosteanu project_administratorprogramme_administrator

Projects: Clinical Trials Leipzig, NFDI4Health, STOP-NUC, AbCD, GRAFT, BASALIT, TIBICO, ADIPO-VENT

Institutions: Zentrum für Klinische Studien Leipzig (ZKS Leipzig), Universität Leipzig

https://orcid.org/0000-0002-8706-217X
Peggy Houben

Projects: Clinical Trials Leipzig, NFDI4Health, STOP-NUC, BASALIT

Institutions: Zentrum für Klinische Studien Leipzig (ZKS Leipzig), Universität Leipzig

René Hänsel adminproject_administratorasset_housekeeperasset_gatekeeperprogramme_administrator

Projects: LHA - Leipzig Health Atlas, LIFE Adult, LIFE - Leipzig Research Center for Civilization Diseases, LIFE HNC - Head and Neck Cancer Group, LIFE Heart, MMML - Molecular mechanisms in malignant lymphoma, GLA - German Lymphoma Alliance, MMML Demonstrators - Molecular Mechanisms in Malignant Lymphomas - Demonstrators of Personalized Medicine, HaematoOpt - Individualized model-based managing of the next-cycle thrombopenia of CHOEP/CHOP treated patients based on platelets dynamics during the previous cycles, e:Med, GC-HBOC - German Consortium for Hereditary Breast and Ovarian Cancer, GC-HNPCC - German Consortium for Hereditary Non-Polyposis Colorectal Cancer, MMML-MYC-SYS, NLP4CR - Natural Language Processing for Clinical Research, Genetical Statistics and Systems Biology, SepNet - German Competence Network Sepsis, LIFE Child, HNPCC-Sys - Genomic and transcriptomic heterogeneity of colorectal tumours arising in Lynch syndrome, GGN - German Glioma Network, CAPSys - Footprints of Sepsis Framed Within Community Acquired Pneumonia in the Blood Transcriptome, CapSys - Systems Medicine of Community Acquired Pneumonia, ProstataCA, HaematoSys - Systems biology of haematopoiesis and haematopoietic neoplasia, SMITH - Smart Medical Information Technology for Healthcare, Task Force COVID-19 Leipzig, NFDI4Health, POLAR - Polypharmacy, Drug Interactions, Risks, Management of health information systems, LivSys Transfer - Transfer of the LivSys in vitro system for hepatotoxicity into application, Project Test Demonstrator, Fundus photography as tool for analysis of eyes of subjects with diabetes, Clinical Trials Leipzig, NFDI4Health - TA3 Services, STOP-NUC, SCALE-TORT, EarlyAMDRate

Institutions: Institute for Medical Informatics, Statistics and Epidemiology (IMISE)

https://orcid.org/0000-0001-8344-0658
Frank A. Meineke adminproject_administratorprogramme_administrator

Projects: LHA - Leipzig Health Atlas, SMITH - Smart Medical Information Technology for Healthcare, POLAR - Polypharmacy, Drug Interactions, Risks, Management of health information systems, Project Test Demonstrator, NFDI4Health - TA3 Services, NFDI4Health, Methodical Use Case PheP, STOP-NUC, BASALIT

Institutions: Institute for Medical Informatics, Statistics and Epidemiology (IMISE)

https://orcid.org/0000-0002-9256-7543
food allergy
BASALIT

Taxonomy URI: http://purl.obolibrary.org/obo/DOID_3044

Synonyms: food hypersensitivity

Definitions: A hypersensitivity reaction type I disease that is an abnormal response to a food, triggered by the body's immune system.

hepatitis B
STOP-NUC

Taxonomy URI: http://purl.obolibrary.org/obo/DOID_2043

Synonyms: chronic hepatitis B

Definitions: A viral infectious disease that results_in inflammation located_in liver, has_material_basis_in Hepatitis B virus, which is transmitted_by sexual contact, blood transfusions, or fomites like needles or syringes. The infection has_symptom fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, clay-colored bowel movements, joint pain, and jaundice.

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