• Sacral neuromodulation versus personalized conservative treatment in patients with idiopathic slow-transit constipation: study protocol of the No.2-trial, a multicenter open-label randomized controlled trial and cost-effectiveness analysis.

      Heemskerk, S C M; Rotteveel, A H; Benninga, M A; Baeten, C I M; Masclee, A A M; Melenhorst, J; van Kuijk, S M J; Dirksen, C D; Breukink, S O (2018-02-22)
      The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment.
    • Safe innovation approach: Towards an agile system for dealing with innovations

      Soeteman-Hernandez, LG; Apostolova, MD; Bekker, C; Dekkers, A; Grafstrom, RC; Handzhyski, Y; Herbeck-Engel, P; Hoehener, K; Oomen, A; Sips, AJAM; et al. (2019-07-22)
    • Safe(r) by design in the nanotechnology sector.

      Sánchez Jiménez, Araceli; Rodríguez Llopis, Isabel; Noorlander, Cornelle; Suarez, Blanca; Hischier, Roland (2022-03-09)
    • Safe-and-Sustainable-by-Design Framework Based on a Prospective Life Cycle Assessment: Lessons Learned from a Nano-Titanium Dioxide Case Study.

      Tsalidis, Georgios Archimidis; Soeteman-Hernández, Lya G; Noorlander, Cornelle W; Saedy, Saeed; van Ommen, J Ruud; Vijver, Martina G; Korevaar, Gijsbert (2022-04-02)
      Safe-and-sustainable-by-design (SSbD) is a concept that takes a systems approach by integrating safety, sustainability, and functionality throughout a product's the life cycle. This paper proposes a framework based on a prospective life cycle assessment for early safety and sustainability assessment. The framework's purpose is to identify environmental sustainability and toxicity hotspots early in the innovation process for future SSbD applicability. If this is impossible, key performance indicators are assessed. Environmental sustainability aspects, such as global warming potential (GWP) and cumulative energy demand (CED), and toxicity aspects, such as human toxicity potential and freshwater ecotoxicity potential, were assessed upon applying the framework on a case study. The case study regarded using nano-titanium dioxide (P25-TiO2) or a modified nano-coated version (Cu2O-coated/P25-TiO2) as photocatalysts to produce hydrogen from water using sunlight. Although there was a decrease in environmental impact (GWP and CED), the modified nano-coated version had a relatively higher level of human toxicity and freshwater eco-toxicity. For the presented case study, SSbD alternatives need to be considered that improve the photocatalytic activity but are not toxic to the environment. This case study illustrates the importance of performing an early safety and environmental sustainability assessment to avoid the development of toxic alternatives.
    • Safe-by-Design in Engineering: An Overview and Comparative Analysis of Engineering Disciplines.

      van Gelder, Pieter; Klaassen, Pim; Taebi, Behnam; Walhout, Bart; van Ommen, Ruud; van de Poel, Ibo; Robaey, Zoe; Asveld, Lotte; Balkenende, Ruud; Hollmann, Frank; et al. (2021-06-11)
    • Safe-by-Design part I: Proposal for nanospecific human health safety aspects needed along the innovation process.

      Dekkers, S; Wijnhoven, SWP; Braakhuis, HM; Soeteman-Hernandez, LG; Sips, AJAM; Tavernaro, I; Kraegeloj, A; Noorlander, CW (2020-06-23)
    • Safer chemicals using less animals: kick-off of the European ONTOX project.

      Vinken, Mathieu; Benfenati, Emilio; Busquet, François; Castell, José; Clevert, Djork-Arné; de Kok, Theo M; Dirven, Hubert; Fritsche, Ellen; Geris, Liesbet; Gozalbes, Rafael; et al. (2021-06-30)
      The 3Rs concept, calling for replacement, reduction and refinement of animal experimentation, is receiving increasing attention around the world, and has found its way to legislation, in particular in the European Union. This is aligned by continuing high-level efforts of the European Commission to support development and implementation of 3Rs methods. In this respect, the European project called "ONTOX: ontology-driven and artificial intelligence-based repeated dose toxicity testing of chemicals for next generation risk assessment" was recently initiated with the goal to provide a functional and sustainable solution for advancing human risk assessment of chemicals without the use of animals in line with the principles of 21st century toxicity testing and next generation risk assessment. ONTOX will deliver a generic strategy to create new approach methodologies (NAMs) in order to predict systemic repeated dose toxicity effects that, upon combination with tailored exposure assessment, will enable human risk assessment. For proof-of-concept purposes, focus is put on NAMs addressing adversities in the liver, kidneys and developing brain induced by a variety of chemicals. The NAMs each consist of a computational system based on artificial intelligence and are fed by biological, toxicological, chemical and kinetic data. Data are consecutively integrated in physiological maps, quantitative adverse outcome pathway networks and ontology frameworks. Supported by artificial intelligence, data gaps are identified and are filled by targeted in vitro and in silico testing. ONTOX is anticipated to have a deep and long-lasting impact at many levels, in particular by consolidating Europe's world-leading position regarding the development, exploitation, regulation and application of animal-free methods for human risk assessment of chemicals.
    • Safety and immunogenicity of fractional dose intradermal injection of two quadrivalent conjugated meningococcal vaccines.

      Jonker, Emile F F; van Ravenhorst, Mariëtte B; Berbers, Guy A M; Visser, Leo G (2018-05-16)
      Vaccination with conjugated meningococcal vaccines is the best way to prevent invasive meningococcal disease. Changes in serogroup epidemiology have led to the inclusion of quadrivalent vaccines in the national immunization programs of several countries, but vaccines are frequently in short supply. Intradermal administration has the potential to increase vaccine availability through dose reduction, without sacrificing efficacy. It has never before been investigated for glycoconjugate meningococcal vaccines.
    • Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with childhood systemic lupus erythematosus: a real-world interventional multi-centre study.

      Rotstein Grein, Ingrid Herta; Pinto, Natalia Ferreira; Lobo, Aline; Groot, Noortje; Sztajnbok, Flavio; da Silva, Clóvis Artur Almeida; Paim Marques, Luciana B; Appenzeller, Simone; Islabão, Aline Garcia; Magalhães, Claudia Saad; et al. (2020-07-01)
    • Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study.

      Grein, Ingrid Herta Rotstein; Pinto, Natalia Balera Ferreira; Groot, Noortje; Martins, Camila Bertini; Lobo, Aline; Aikawa, Nadia Emi; Barbosa, Cassia; Terreri, Maria Teresa; da Fraga, Aline Coelho Moreira; de Oliveira, Sheila Knupp Feitosa; et al. (2020-11-11)
    • Safety distances due to domino effects

      Laheij, GMH; Spoelstra, MB; Mahesh, S (2019-01-28)
    • Safety distances for hydrogen filling stations

      Matthijsen, A J C M; Kooi, E S (Elsevier, 2006-06-30)
      In the context of spatial planning the Dutch Ministry of Housing, Spatial Planning and the Environment asked the Centre for External Safety of the National Institute for Public Health and the Environment (RIVM) to advice on safe distances pertaining to hydrogen filling stations. The RIVM made use of failure modeling and parameters for calculating the distance in detail. An imaginary hydrogen filling station for cars is used in the determination of ‘external safety’ or third party distances for the installations and the pipe work for three different sizes of hydrogen filling stations. For several failure scenarios ‘effect’ distances are calculated for car filling at 350 and 700 bar. Safe distances of filling stations from locations where people live and work appear to be similar for compressed hydrogen, gasoline/petrol and compressed natural gas. Safe distances for LPG are greater. A filling unit for hydrogen can be placed at gasoline/petrol-filling stations without increasing safety distances
    • Safety evaluation of the food enzyme alpha-amylase from a genetically modified Bacillus subtilis (strain NBA).

      Silano, V; Barat Baviera, JM; Bolognesi, C; Bruschweiler, BJ; Cocconcelli, PS; Crebelli, R; Gott, DM; van Loveren, H (2019-12-12)
    • The safety of dental amalgam and alternative dental restoration materials for patients and users.

      Rodríguez-Farre, Eduardo; Testai, Emanuela; Bruzell, Ellen; De Jong, Wim; Schmalz, Gottfried; Thomsen, Mogens; Hensten, Arne (2016-08)
    • The safety of medical devices containing DEHP plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update).

      Testai, Emanuela; Hartemann, Philippe; Rastogi, Suresh Chandra; Bernauer, Ulrike; Piersma, Aldert; De Jong, Wim; Gulliksson, Hans; Sharpe, Richard; Schubert, Dirk; Rodríguez-Farre, Eduardo (2016-04)
    • The safety of the use of bisphenol A in medical devices.

      Testai, Emanuela; Hartemann, Philippe; Rodríguez-Farre, Eduardo; Rastogi, Suresh Chandra; Bustos, Juana; Gundert-Remy, Ursula; Hensten, Arne; Kopperud, Hilde Molvig; Olea, Nicolás; Piersma, Aldert; et al. (2016-08)
    • Safety risks among frail older people living at home in the Netherlands - A cross-sectional study in a routine primary care sample.

      Lette, Manon; Stoop, Annerieke; Nijpels, Giel; Baan, Caroline; de Bruin, Simone; van Hout, Hein (2020-11-17)
    • Saliva cortisol in relation to aircraft noise exposure: pooled-analysis results from seven European countries.

      Baudin, Clémence; Lefèvre, Marie; Selander, Jenny; Babisch, Wolfgang; Cadum, Ennio; Carlier, Marie-Christine; Champelovier, Patricia; Dimakopoulou, Konstantina; Huithuijs, Danny; Lambert, Jacques; et al. (2019-11-27)
      Statistically significant increases of evening cortisol levels were shown in women with a 10-dB(A) increase in aircraft noise exposure in terms of LAeq, 16h (exp(β) = 1.08; CI95% = 1.00-1.16), Lden (exp(β) = 1.09; CI95% = 1.01-1.18), Lnight (exp(β) = 1.11; CI95% = 1.02-1.20). A statistically significant association was also found in women between a 10-dB(A) increase in terms of Lnight and the absolute variation per hour (exp(β) = 0.90; CI95% = 0.80-1.00). Statistically significant decreases in relative variation per hour were also evidenced in women, with stronger effects with the Lnight (exp(β) = 0.89; CI95% = 0.83-0.96) than with other noise indicators. The morning cortisol levels were unchanged whatever noise exposure indicator considered. There was no statistically significant association between aircraft noise exposure and cortisol outcomes in men.