Search Results - "Maria Teresa Garcia Morales"
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TransFAIR study: a European multicentre experimental comparison of EHR2EDC technology to the usual manual method for eCRF data collection
Published in BMJ health & care informatics (01-06-2023)“…PurposeRegulatory authorities including the Food and Drug Administration and the European Medicines Agency are encouraging to conduct clinical trials using…”
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Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study
Published in Drug safety (01-12-2023)“…Introduction Individual case reports are the main asset in pharmacovigilance signal management. Signal validation is the first stage after signal detection and…”
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No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study
Published in Research and practice in thrombosis and haemostasis (01-01-2023)“…Several cases of unusual thrombotic events and thrombocytopenia were described after vaccination with recombinant adenoviral vectors encoding the spike protein…”
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Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial
Published in Journal of clinical medicine (21-02-2022)“…We evaluated in this randomised, double-blind clinical trial the efficacy of melatonin as a prophylactic treatment for prevention of SARS-CoV-2 infection among…”
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Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial
Published in The Lancet (British edition) (10-07-2021)“…To date, no immunological data on COVID-19 heterologous vaccination schedules in humans have been reported. We assessed the immunogenicity and reactogenicity…”
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Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort study
Published in EClinicalMedicine (01-04-2023)“…Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines,…”
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Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort studyResearch in context
Published in EClinicalMedicine (01-04-2023)“…Background: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with…”
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Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study
Published in EClinicalMedicine (01-08-2022)“…The CombiVacS study was designed to assess immunogenicity and reactogenicity of the heterologous ChAdOx1-S/BNT162b2 combination, and 14-day results showed a…”
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Predictive Power of the "Trigger Tool" for the detection of adverse events in general surgery: a multicenter observational validation study
Published in Patient safety in surgery (08-02-2022)“…In spite of the global implementation of standardized surgical safety checklists and evidence-based practices, general surgery remains associated with a high…”
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KRAS/NRAS/BRAF genotyping in patients with mestastatic colorectal cancer
Published in Journal of clinical oncology (01-02-2018)“…Abstract only 718 Background: mCRC is the 2º cause of death in the world. Development of targeted therapies has increased the survival. The efficacy of these…”
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