Achieving orphan designation for placental insufficiency: annual incidence estimations in Europe

Objective To determine whether a novel therapy for placental insufficiency could achieve orphan drug status by estimating the annual incidence of placental insufficiency, defined as an estimated fetal weight below the 10th centile in the presence of abnormal umbilical artery Doppler velocimetry, per 10 000 European Union (EU ) population as part of an application for European Medicines Agency (EMA ) orphan designation. Design Incidence estimation based on literature review and published national and EU statistics. Setting and population European Union. Methods Data were drawn from published literature, including national and international guidelines, international consensus statements, cohort studies and randomised controlled trials, and published national and EU statistics, including birth rates and stillbirth rates. Rare disease databases were also searched. Results The proportion of affected pregnancies was estimated as 3.17% (95% CI 2.93–3.43%), using a weighted average of the results from two cohort studies. Using birth rates from 2012 and adjusting for a pregnancy loss rate of 1/100 gave an estimated annual incidence of 3.33 per 10 000 EU population (95% CI 3.07–3.60 per 10 000 EU population). This fell below the EMA threshold of 5 per 10 000 EU population. Conclusions Maternal vascular endothelial growth factor gene therapy for placental insufficiency was granted EMA orphan status in 2015 after we demonstrated that it is a rare, life‐threatening or chronically debilitating and currently untreatable disease. Developers of other potential obstetric therapies should consider applying for orphan designation, which provides financial and regulatory benefits

Maternal outcomes and risk factors for COVID-19 severity among pregnant women.

Pregnant women may be at higher risk of severe complications associated with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which may lead to obstetrical complications. We performed a case control study comparing pregnant women with severe coronavirus disease 19 (cases) to pregnant women with a milder form (controls) enrolled in the COVI-Preg international registry cohort between March 24 and July 26, 2020. Risk factors for severity, obstetrical and immediate neonatal outcomes were assessed. A total of 926 pregnant women with a positive test for SARS-CoV-2 were included, among which 92 (9.9%) presented with severe COVID-19 disease. Risk factors for severe maternal outcomes were pulmonary comorbidities [aOR 4.3, 95% CI 1.9-9.5], hypertensive disorders [aOR 2.7, 95% CI 1.0-7.0] and diabetes [aOR2.2, 95% CI 1.1-4.5]. Pregnant women with severe maternal outcomes were at higher risk of caesarean section [70.7% (n = 53/75)], preterm delivery [62.7% (n = 32/51)] and newborns requiring admission to the neonatal intensive care unit [41.3% (n = 31/75)]. In this study, several risk factors for developing severe complications of SARS-CoV-2 infection among pregnant women were identified including pulmonary comorbidities, hypertensive disorders and diabetes. Obstetrical and neonatal outcomes appear to be influenced by the severity of maternal disease

D2.4 Software prototype v1 ; DURAARK - Durable Architectural Knowledge ; FP7 - ICT - Digital Preservation

This report describes the first version of the integrated software prototype comprising the software prototypes developed in DURAARK so far. It exposes the functionality of the prototypes as a service-oriented platform (the "Workbench") and provides it to stakeholders via a coherent graphical user interface (the "WorkbenchUI"), yielding an integrated application for performing long-term archival tasks for BIM data from the view of a front-end stakeholder. Additionally, the software acts as a service provider for third party developers to be able to integrate the functionality developed in DURAARK in their own (existing) applications. The report guides a stakeholder through the usage of the graphical user interface, describes the components on a technical level and gives interested readers and developers information on how to use the Workbench as a service provider

Web-based Visualization Platform for Geospatial Data

This paper describes a new platform for geospatial data analysis. The main purpose is to explore new ways to visualize and interact with multidimensional satellite data and computed models from various Earth Observation missions. The new V-MANIP platform facilitates a multidimensional exploring approach that allows to view the same dataset in multiple viewers at the same time to efficiently find and explore interesting features within the shown data. The platform provides visual analytics capabilities including viewers for displaying 2D or 3D data representations, as well as for volumetric input data. Via a simple configuration file the system can be configured for different stakeholder use cases, by defining desired data sources and available viewer modules. The system architecture, which will be discussed in this paper in detail, uses Open Geospatial Consortium web service interfaces to allow an easy integration of new visualization modules. The implemented software is based on open source libraries and uses modern web technologies to provide a platform-independent, plugin-free user experience

A Scalable Repository Infrastructure for CH Digital Object Management

In recent decades, researchers of archaeological 3D digitalization found that the collection and archive of processing intermediate data are extremely tiresome tasks. They need large of man power and material resources, even though, mistakes can be raised and break the whole working chain. The traditional documentation of digitalization process is also a pending challenge, although, the ISO standard CIDOC-CRM (ISO 21127:2006) has been introduced to the archaeologists and museum professionals since years, but there are still some obvious gaps between practice and theory: (1) How to connect the discrete archaeologists, museums, CH research institutions, and the public? (2) How to ensure the integrity of whole digitalization process and simplify the process? (3) How to maximize the usability of the public digital objects in CH community? (4) How to long term preserve the huge amount of datasets? (5) How to present and disseminate the digital object to the public? This paper presents an operational and optimal infrastructure that realizes not only a distributed storage system, but also a content management system. This infrastructure works as a backbone of whole digitalization process, provides a complete solution suite for archaeologists, museum professionals, museum visitors, and IT technicians

Tangible Culture - Designing virtual Exhibitions on Multi-Touch Devices

Cultural heritage institutions such as galleries, museums and libraries increasingly use digital media to present artifacts to their audience and enable them to immerse themselves in a cultural virtual world. With the application eXhibition:editor3D, museum curators and editors have a software tool at hand to interactively plan and visualize exhibitions. The software is running on standard PCs as well as multi-touch devices, which allow a user to utilize intuitive gestures for positioning exhibition objects. Furthermore, multi-touch technology offers the integration of collaborative work into a decision making process

A repository infrastructure for working with 3D assets in cultural heritage

The development of a European market for digital cultural heritage assets is impeded by the lack of a suitable digital marketplace, i.e., a commonly accepted exchange platform for digital assets. We have developed the technology for such a platform over the last two years: The 3D-COFORM Repository Infrastructure (RI) is a secure content management infrastructure for the distributed processing of large-volume datasets. Three of the key features of this system are (1) owners have complete control over their data, (2) binary data must have attached metadata, and (3) processing histories are documented. Our system can support the complete production pipeline for digital assets from data acquisition (photo, 3D scan) over processing (cleaning, whole filling) to interactive presentation and content delivery over the internet. In this paper we present the components of the system and their interplay. One particular focus of the software development was to make it as easy as possible to connect client-side applications to the RI. Therefore we present the RIAPI in some detail and present several RI-enabled client-side applications that use it

An enhanced distributed repository for working with 3D assets in cultural heritage

The development of a European market for digital cultural heritage assets is impeded by the lack of a suitable marketplace, i.e., a commonly accepted distributed exchange platform for digital assets. We have developed such a platform over the last two years, a centralized content management system with distributed storage capability and semantic query functionality. It supports the complete pipeline from data acquisition (photo, 3D scan) over processing (cleaning, hole filling) to interactive presentation, and allows collecting a complete process description (paradata) alongside. In this paper we present the components of the system and explain their interplay. Furthermore, we present and explain which functional components, from transactions to permission management, are needed to operate the system. Finally, we prove the suitability of the API and present a few software applications that use it

An Enhanced Distributed Repository for Working with 3D Assets in Cultural Heritage

The development of a European market for digital cultural heritage assets is impeded by the lack of a suitable marketplace, i.e., a commonly accepted distributed exchange platform for digital assets. We have developed such a platform over the last two years, a centralized content management system with distributed storage capability and semantic query functionality. It supports the complete pipeline from data acquisition (photo, 3D scan) over processing (cleaning, hole filling) to interactive presentation, and allows collecting a complete process description (paradata) alongside. In this paper we present the components of the system and explain their interplay. Furthermore, we present and explain which functional components, from transactions to permission management, are needed to operate the system. Finally, we prove the suitability of the API and present a few software applications that use it