• Covid-19 transmission in fitness centers in Norway - a randomized trial 

      Helsingen, Lise Mørkved; Løberg, Magnus; Refsum, Erle; Gjøstein, Dagrun Kyte; Wieszczy, Paulina; Olsvik, Ørjan; Juul, Frederik Emil; Barua, Ishita; Jodal, Henriette C.; Herfindal, Magnhild; Mori, Yuichi; Jore, Solveig; Lund-Johansen, Fridtjof; Fretheim, Atle; Bretthauer, Michael; Kalager, Mette (Journal article; Tidsskriftartikkel; Peer reviewed, 2021-11-16)
      Background: Closed fitness centers during the Covid-19 pandemic may negatively impact health and wellbeing. We assessed whether training at fitness centers increases the risk of SARS-CoV-2 virus infection.<p> <p>Methods: In a two-group parallel randomized controlled trial, fitness center members aged 18 to 64 without Covid-19-relevant comorbidities, were randomized to access to training at a ...
    • Covid-19 transmission in fitness centers in Norway - a randomized trial 

      Helsingen, Lise Mørkved; Løberg, Magnus; Gjøstein, Dagrun Kyte; Wieszczy, Paulina; Olsvik, Ørjan; Juul, Frederik Emil; Barua, Ishita; Jodal, Henriette C.; Herfindal, Magnhild; Mori, Yuichi; Jore, Solveig; Lund-Johansen, Fridtjof; Fretheim, Atle; Bretthauer, Michael; Kalager, Mette (Journal article; Tidsskriftartikkel; Peer reviewed, 2021-11-16)
      Background: Closed fitness centers during the Covid-19 pandemic may negatively impact health and wellbeing. We assessed whether training at fitness centers increases the risk of SARS-CoV-2 virus infection.<p> <p>Methods: In a two-group parallel randomized controlled trial, fitness center members aged 18 to 64 without Covid-19-relevant comorbidities, were randomized to access to training at a ...
    • The New European Medical Device Regulation: Balancing Innovation and Patient Safety 

      Bretthauer, Michael; Gerke, Sara; Hassan, Cesare; Ahmad, Omer F.; Mori, Yuichi (Journal article; Tidsskriftartikkel; Peer reviewed, 2023-04-18)
      The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveillance of benefits and harms to the entire life cycle of devices. New “expert panels” have been established ...