How Research Data Management Plans Can Help in Harmonizing Open Science and Approaches in the Digital Economy

Within this perspective article, we intend to summarise definitions and terms that are often used in the context of open science and data-driven R&D and we discuss upcoming European regulations concerning data, data sharing and handling. With this background in hand, we take a closer look at the potential connections and permeable interfaces of open science and digital economy, in which data and resulting immaterial goods can become vital pieces as tradeable items. We believe that both science and the digital economy can profit from a seamless transition and foresee that the scientific outcomes of publicly funded research can be better exploited. To close the gap between open science and the digital economy, and to serve for a balancing of the interests of data producers, data consumers, and an economy around services and the public, we introduce the concept of generic research data management plans (RDMs), which have in part been developed through a community effort and which have been evaluated by academic and industry members of the NFDI4Cat consortium. We are of the opinion that in data-driven research, RDMs do need to become a vital element in publicly funded projects

NFDI4Cat: Local and overarching data infrastructures

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Berlin Climate Record - Daily Mean Temperature - Inner City - 1766-1934

Berlin has one of the longest climate records in the world (Cubasch and Kadow, 2011). In the 17th century mainly the family of the astronomer Kirch started measuring the temperature and wrote down general weather patterns. In the beginning of the 18th century the measurements became more regular including multiple measures per day. Over time, more inner city stations appeared but also disappeared. Therefore, this Berlin Climate Record is a moving station, but representable for the inner city of Berlin. Many approaches were combining these datasets including bias correction efforts. With this dataset from 01.01.1766 to 31.12.1934 we reactivate the long inner city temperature record. In this study, we digitized, analyzed, and corrected the data set on the daily time frequency. The dataset has been reconstructed from: "Das Klima von Berlin (II) Temperatur - Abh. des Met. Dienstes der DDR Nr. 103, Band XIII, Akademie-Verlag 1971

Berlin Climate Record - Daily Precipitation - Inner City - 1876-1908

Berlin has one of the longest climate records in the world (Cubasch and Kadow, 2011). In the 17th century mainly the family of the astronomer Kirch started measuring the temperature and wrote down general weather patterns. In the beginning of the 18th century the measurements became more regular including multiple measures per day. Over time, more inner city stations appeared but also disappeared. Therefore, this Berlin Climate Record is a moving station, but representable for the inner city of Berlin. Many approaches were combining these datasets including bias correction efforts. With this dataset from 1876-01-01 to 1908-12-31 we reactivate the long inner city precipitation record, related to Kadow et al. 2016. In this study, we digitized, analyzed, and corrected the precipitation data set on the daily time frequency. The dataset has been reconstructed from: "Das Klima von Berlin (III) Niederschlag, Luftfeuchtigkeit, Dampfdruck, Bewölkung, Sonnenscheindauer, Wind, Luftdruck - Abh. des Met. Dienstes der DDR Nr. 118, Band XV, Akademie-Verlag 1976"

Berlin Climate Record - Inner City - 1766-1934

Berlin (Germany) has one of the longest climate records in the world (Cubasch and Kadow, 2011). In the 17th century mainly the family of the astronomer Kirch started measuring the temperature and wrote down general weather patterns. In the beginning of the 18th century the measurements became more regular including multiple measures per day. Over time, more inner city stations appeared but also disappeared. Therefore, this Berlin Climate Record is a moving station, but representable for the inner city of Berlin. With these datasets we reactivate the long inner city climate record in several variables. In this study, we digitized, analyzed, corrected, reconstructed, and provide the datasets on the very rare daily time frequency

NFDI4Cat: Local and overarching data infrastructures

publishedVersio

Testing novel strategies for patients hospitalised with HIV-associated disseminated tuberculosis (NewStrat-TB): protocol for a randomised controlled trial

Background: HIV-associated tuberculosis (TB) contributes disproportionately to global tuberculosis mortality. Patients hospitalised at the time of the diagnosis of HIV-associated disseminated TB are typically severely ill and have a high mortality risk despite initiation of tuberculosis treatment. The objective of the study is to assess the safety and efficacy of both intensified TB treatment (high dose rifampicin plus levofloxacin) and immunomodulation with corticosteroids as interventions to reduce early mortality in hospitalised patients with HIV-associated disseminated TB. Methods: This is a phase III randomised controlled superiority trial, evaluating two interventions in a 2 × 2 factorial design: (1) high dose rifampicin (35 mg/kg/day) plus levofloxacin added to standard TB treatment for the first 14 days versus standard tuberculosis treatment and (2) adjunctive corticosteroids (prednisone 1.5 mg/kg/day) versus identical placebo for the first 14 days of TB treatment. The study population is HIV-positive patients diagnosed with disseminated TB (defined as being positive by at least one of the following assays: urine Alere LAM, urine Xpert MTB/RIF Ultra or blood Xpert MTB/RIF Ultra) during a hospital admission. The primary endpoint is all-cause mortality at 12 weeks comparing, first, patients receiving intensified TB treatment to standard of care and, second, patients receiving corticosteroids to those receiving placebo. Analysis of the primary endpoint will be by intention to treat. Secondary endpoints include all-cause mortality at 2 and 24 weeks. Safety and tolerability endpoints include hepatoxicity evaluations and corticosteroid-related adverse events. Discussion: Disseminated TB is characterised by a high mycobacterial load and patients are often critically ill at presentation, with features of sepsis, which carries a high mortality risk. Interventions that reduce this high mycobacterial load or modulate associated immune activation could potentially reduce mortality. If found to be safe and effective, the interventions being evaluated in this trial could be easily implemented in clinical practice. Trial registration: ClinicalTrials.gov NCT04951986. Registered on 7 July 2021 https://clinicaltrials.gov/study/NCT04951986

Testing novel strategies for patients hospitalised with HIV-associated disseminated tuberculosis (NewStrat-TB): protocol for a randomised controlled trial.

BACKGROUND: HIV-associated tuberculosis (TB) contributes disproportionately to global tuberculosis mortality. Patients hospitalised at the time of the diagnosis of HIV-associated disseminated TB are typically severely ill and have a high mortality risk despite initiation of tuberculosis treatment. The objective of the study is to assess the safety and efficacy of both intensified TB treatment (high dose rifampicin plus levofloxacin) and immunomodulation with corticosteroids as interventions to reduce early mortality in hospitalised patients with HIV-associated disseminated TB. METHODS: This is a phase III randomised controlled superiority trial, evaluating two interventions in a 2 × 2 factorial design: (1) high dose rifampicin (35 mg/kg/day) plus levofloxacin added to standard TB treatment for the first 14 days versus standard tuberculosis treatment and (2) adjunctive corticosteroids (prednisone 1.5 mg/kg/day) versus identical placebo for the first 14 days of TB treatment. The study population is HIV-positive patients diagnosed with disseminated TB (defined as being positive by at least one of the following assays: urine Alere LAM, urine Xpert MTB/RIF Ultra or blood Xpert MTB/RIF Ultra) during a hospital admission. The primary endpoint is all-cause mortality at 12 weeks comparing, first, patients receiving intensified TB treatment to standard of care and, second, patients receiving corticosteroids to those receiving placebo. Analysis of the primary endpoint will be by intention to treat. Secondary endpoints include all-cause mortality at 2 and 24 weeks. Safety and tolerability endpoints include hepatoxicity evaluations and corticosteroid-related adverse events. DISCUSSION: Disseminated TB is characterised by a high mycobacterial load and patients are often critically ill at presentation, with features of sepsis, which carries a high mortality risk. Interventions that reduce this high mycobacterial load or modulate associated immune activation could potentially reduce mortality. If found to be safe and effective, the interventions being evaluated in this trial could be easily implemented in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT04951986. Registered on 7 July 2021 https://clinicaltrials.gov/study/NCT04951986