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GALAXY: Gut-and-liver axis in alcoholic liver fibrosis


Data management plan

Data management described: GALAXY will create an extensive research data warehouse containing clinical and experimental data. The partners University of Southern Denmark, Odense University Hospital, EMBL, University of Copenhagen, University of Oslo and Steno Diabetes Centre will be responsible and be involved in data management. The data management plan will be in five sections: a) Data generation and collection b) Standards used c) Data preservation d) Data security e) Data exploitation

Approvals obtained for SYN-ALD

1. Written study protocol to be used for study execution and applications to the GCP unit, ethics committee and Danish data protection agency. 2. Approvals in writing from the GCP unit, ethics committee and Danish data protection agency.

Project infrastructure established

1. Consortium agreement written and signed by all partners: Administration of contracts including the Grant Agreement and any future amendments, establishment and maintenance of a Consortium Agreement, handling of legal issues, coordination of activities to ensure and monitor respect of ethical rules and gender equity. Also includes IP contracts. 2. Project management plan described, including detailed description of project management structure, coordination, communication, organisational structure, decision-making mechanisms and detailed project management activities. This includes: a) Developing project management and quality assurance plans which describe the plan for project management and collaboration and coordination tools of the project. It will be created as a support to the consortium with the main goal to facilitate the collaboration between partners and ensure that EC requirements are respected. b) Standars for handling of the project correspondence and the day-to-day requests from partners and external bodies. c) Implementing and maintaining the project infrastructure and the internal collaborative website as a platform for secured internal information exchange and project documents archive (not to be confused with the public website). d) Plans for running and hosting of project meetings at months 1, 18, 36, 54 and 72: Planning, organising, executing and post-processing of major project meetings such as Annual meetings, Executive board and Work Group meetings and meetings with the Supervisory board. 3. Provided templates and standard procedures for internal progress reporting and monitoring systems and procedures. Includes progress reports, the results and the necessary changes to the work plan as a result of those findings, according to project milestones and indicators. 4. Coordinated and planned the periodic technical and financial reporting: Designing and maintaining partner-specific templates for collecting input to the required EU documents, coordination of financial and administrative issues: establish and maintain financial records, co-ordinate financial statements submission by all project partners and audit certificates as needed, follow-up of EC payments, calculate partner shares according to rules agreed in the Consortium Agreement. 6. Developed detailed communication and dissemination plan: a) Outlined the target audiences including development of tailored key messages and dissemination material (logo, templates, press releases, website, leaflets, social media, public engagement exercises etc.). b) Development of a corporate style including logos and standard templates will be developed to create and maintain a consistent and recognisable ‘corporate image’ of the network. c) Plan for dissemination activities to enable external stakeholders to become aware of, learn from and implement project results. Includes creating and maintaining links and communications on behalf of the consortium with partners and potential future collaborators within Europe and globally by e.g. newsletters, brochures, digital media platforms. d) Plan for online presence e) Plan for communication of the research results with international relevant societies and with research and public health entities (WHO) in order to secure translation into clinical practise in every or specific regions of the world. f) Organisation of conference to present the results to international press and other relevant European and international stakeholders.

Included first 300 (75%) patients in GALA-ALD

Identified eligible patients with current or prior alcohol overuse and alcoholic liver fibrosis along the entire spectrum of disease. Eligible patients are recruited from alcohol abuse centres, outpatient liver clinics, emergency rooms and family physicians in Region of Southern Denmark and via national web adverts. Collected informed consent, tissue samples and clinical data for first 300 GALA-ALD patients. After consent a one-day inclusion visit are scheduled. We will perform: (i) liver biopsy, (ii) collection of venous fasting blood, faeces, urine and saliva, (iii) physical examinations including anthropometric data, abdominal ultrasonography, heart rate and blood pressure, (iv) non-invasive assessment of liver fibrosis using transient elastography, real-time shear-wave elastography and serum markers, (v) questionnaires evaluating alcohol use, alcohol dependency, demographic data, medicine use, comorbidity and health-related quality of life.

Identified and included 100 healthy controls in GALA-HP

1. Written study protocol to be used for study execution and applications to the ethics committee and data protection agency. 2. Age- and gender-matched healthy controls identified: 100 matched controls without prior or current alcohol overuse and no malignancy, diabetes or liver-, cardiovascular-, renal- and autoimmune-related comorbidities. Controls will be recruited from libraries, train stations, emergency rooms, outpatient clinics and family physicians in Region of Southern Denmark and via national web adverts. 3. Onehundred healthy controls included: Collect informed consent, tissue samples and clinical data. Other than liver biopsy, all investigations will be performed as described in GALA-ALD.

Collaborative website ready to use

Developed, hosted and ensured continued maintenance of a public website. Includes gathering content based on partner contributions, designing the site and ensure the technical implementation

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MicroRNA-155 is upregulated in ascites in patients with spontaneous bacterial peritonitis

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Compartmentalization of Immune Response and Microbial Translocation in Decompensated Cirrhosis

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Collagen type IV remodeling gender-specifically predicts mortality in decompensated liver cirrhosis

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Rho-kinase inhibitor coupled to peptide-modified albumin carrier reduces portal pressure and increases renal perfusion in cirrhotic rats

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Perforin inhibition protects from lethal endothelial damage during fulminant viral hepatitis

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Fast Genome-Wide Functional Annotation through Orthology Assignment by eggNOG-Mapper

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proGenomes: a resource for consistent functional and taxonomic annotations of prokaryotic genomes

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Describing the fecal metabolome in cryogenically collected samples from healthy participants

Author(s): Kajetan Trošt, Linda Ahonen, Tommi Suvitaival, Nina Christiansen, Trine Nielsen, Maja Thiele, Suganya Jacobsen, Aleksander Krag, Peter Rossing, Torben Hansen, Lars Ove Dragsted, Cristina Legido-Quigley
Published in: Scientific Reports, Issue 10/1, 2020, ISSN 2045-2322
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