von Jens P. Dreier ; Coline L. Lemale ; Viktor Horst ; Sebastian Major ; Vasilis Kola ; Karl Schoknecht ; Michael Lothar Scheeler ; Jed A. Hartings ; Peter Vajkoczy ; Stefan Wolf ; Johannes Woitzik ; Nils Nicholas Hecht
von Jürgen Beck ; Christian Fung ; Daniel Strbian ; Lukas Bütikofer ; Werner J. Z'Graggen ; Matthias F. Lang ; Seraina Beyeler ; Jan Gralla ; Florian Ringel ; Karl Schaller ; Nikolaus Plesnila ; Marcel Arnold ; Werner Hacke ; Peter Jüni ; Alexander David Mendelow ; Christian Stapf ; Rustam Al-Shahi Salman ; Jenny Bressan ; Stefanie Lerch ; Arsany Hakim ; Nicolas Martinez-Majander ; Anna Piippo-Karjalainen ; Peter Vajkoczy ; Stefan Wolf ; Gerrit A. Schubert ; Anke Höllig ; Michael Veldeman ; Roland Rölz ; Andreas Gruber ; Philip Rauch ; Dorothee Wachter ; Veit Rohde ; Thomas Kerz ; Eberhard Uhl ; Enea Thanasi ; Hagen B. Huttner ; Bernd Kallmünzer ; L. Jaap Kappelle ; Wolfgang Deinsberger ; Christian Roth ; Robin Lemmens ; Jan Leppert ; Jose L. Sanmillan ; Jonathan M. Coutinho ; Katharina Hackenberg ; Gernot Reimann ; Mikael Mazighi ; Claudio L. A. Bassetti ; Heinrich P. Mattle ; Andreas Raabe ; Urs Fischer ; Renán Sánchez-Porras
BACKGROUND: It is unknown whether decompressive craniectomy improves clinical outcome for people with spontaneous severe deep intracerebral haemorrhage. The SWITCH trial aimed to assess whether decompressive craniectomy plus best medical treatment in these patients improves outcome at 6 months compared to best medical treatment alone. METHODS: In this multicentre, randomised, open-label, assessor-blinded trial conducted in 42 stroke centres in Austria, Belgium, Finland, France, Germany, the Netherlands, Spain, Sweden, and Switzerland, adults (18-75 years) with a severe intracerebral haemorrhage involving the basal ganglia or thalamus were randomly assigned to receive either decompressive craniectomy plus best medical treatment or best medical treatment alone. The primary outcome was a score of 5-6 on the modified Rankin Scale (mRS) at 180 days, analysed in the intention-to-treat population. This trial is registered with ClincalTrials.gov, NCT02258919, and is completed. FINDINGS: SWITCH had to be stopped early due to lack of funding. Between Oct 6, 2014, and April 4, 2023, 201 individuals were randomly assigned and 197 gave delayed informed consent (96 decompressive craniectomy plus best medical treatment, 101 best medical treatment). 63 (32%) were women and 134 (68%) men, the median age was 61 years (IQR 51-68), and the median haematoma volume 57 mL (IQR 44-74). 42 (44%) of 95 participants assigned to decompressive craniectomy plus best medical treatment and 55 (58%) assigned to best medical treatment alone had an mRS of 5-6 at 180 days (adjusted risk ratio [aRR] 0·77, 95% CI 0·59 to 1·01, adjusted risk difference [aRD] -13%, 95% CI -26 to 0, p=0·057). In the per-protocol analysis, 36 (47%) of 77 participants in the decompressive craniectomy plus best medical treatment group and 44 (60%) of 73 in the best medical treatment alone group had an mRS of 5-6 (aRR 0·76, 95% CI 0·58 to 1·00, aRD -15%, 95% CI -28 to 0). Severe adverse events occurred in 42 (41%) of 103 participants receiving decompressive craniectomy plus best medical treatment and 41 (44%) of 94 receiving best medical treatment. INTERPRETATION: SWITCH provides weak evidence that decompressive craniectomy plus best medical treatment might be superior to best medical treatment alone in people with severe deep intracerebral haemorrhage. The results do not apply to intracerebral haemorrhage in other locations, and survival is associated with severe disability in both groups. FUNDING: Swiss National Science Foundation, Swiss Heart Foundation, Inselspital Stiftung, and Boehringer Ingelheim.
The lancet London [u.a.] : Elsevier, 1823 403(2024), 10442 vom: Juni, Seite 2395-2404 Online-Ressource
von Fiona Niedermayer ; Kathrin Wolf ; Siqi Zhang ; Marco Dallavalle ; Nikolaos Nikolaou ; Lars Schwettmann ; Peter Selsam ; Barbara Heidi Hoffmann ; Alexandra Schneider ; Annette Peters
von Wilfried Kunde ; Julia Dal Molin ; Julia Engel ; Stefan Koch ; Tanja Kollei ; Beate Ditzen ; Thomas Ehring ; Nina Heinrichs ; Andrea Kiesel ; Peter Kirsch ; Barbara Krahé ; Thorsten Meiser ; Andreas Mojzisch ; Franz Josef Neyer ; Sabina Pauen ; Katharina Scheiter ; Christiane M. Thiel ; Oliver T. Wolf
Online veröffentlicht: 10. April 2024 ; Gesehen am 10.10.2024 ; Titel in Web of Science: Report of the Psychology Review Board in the German Research Foundation (DFG)
von Julie George ; Lukas Maas ; Nima Abedpour ; Maria Cartolano ; Laura Kaiser ; Rieke Nila Fischer ; Andreas H. Scheel ; Jan-Philipp Weber ; Martin Hellmich ; Graziella Bosco ; Caroline Volz ; Christian Müller ; Ilona Dahmen ; Felix John ; Cleidson Padua Alves ; Lisa Werr ; Jens Peter Panse ; Martin Kirschner ; Walburga Engel-Riedel ; Jessica Jürgens ; Erich Stoelben ; Michael Brockmann ; Stefan Grau ; Martin Sebastian ; Jan Alexander Stratmann ; Jens Kern ; Horst-Dieter Hummel ; Balazs Hegedus ; Martin Schuler ; Till Plönes ; Clemens Aigner ; Thomas Elter ; Karin Toepelt ; Yon-Dschun Ko ; Sylke Kurz ; Christian Grohé ; Monika Serke ; Katja Anne Höpker ; Lars Gerd Hagmeyer ; Fabian Doerr ; Khosro Hekmath ; Judith Strapatsas ; Karl-Otto Kambartel ; Geothy Chakupurakal ; Annette Hülsmeyer ; Franz-Georg Bauernfeind ; Frank Griesinger ; Anne Lüers ; Wiebke Dirks ; Rainer Gerhard Wiewrodt ; Andrea Luecke ; Ernst Michael Rodermann ; Andreas Diel ; Volker Hagen ; Kai Severin ; Roland Ullrich ; Christian Reinhardt ; Alexander Quaas ; Magdalena Bogus ; Cornelius Courts ; Peter Nürnberg ; Kerstin Becker ; Viktor Achter ; Reinhard Büttner ; Jürgen Wolf ; Martin Peifer ; Roman Thomas
von Navid Farassat ; Daniel Böhringer ; Sebastian Küchlin ; Fanni E. Molnár ; Anne Schwietering ; Dorina Seger ; Martin J. Hug ; Anja-Birte Knöbel ; Sabine Schneider-Fuchs ; Gabriele Ihorst ; Bettina Kathrin Wabbels ; Christina Beisse ; Focke Ziemssen ; Frank Schüttauf ; Andrea Martina Hedergott ; Theresia Ring-Mangold ; Claudia Schuart ; Armin Wolf ; Stefanie Schmickler ; Julia Biermann ; Philipp Eberwein ; Karsten Hufendiek ; Anja Eckstein ; Gabriele Gusek-Schneider ; Michael Peter Schittkowski ; Thomas Lischka ; Wolf A. Lagrèze
Clinical trials; Medical ophthalmology; OPHTHALMOLOGY; Paediatric ophthalmology
Introduction Myopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and safety of 0.02% atropine vs placebo in a German population. - Methods and analysis AIM is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with two parallel arms. The primary objective is to assess the efficacy of atropine 0.02% eyedrops for myopia control in children of Caucasian origin. The primary outcome is the change in cycloplegic refraction after 1 year of treatment (D/year). Secondary and tertiary outcome measures comprise the change in axial length (mm/year) in children treated with 0.02% atropine compared with placebo, the myopic progression of participants treated with 0.01% compared with 0.02% atropine (D/year and mm/year), and the safety profile of both 0.02% and 0.01% atropine. Furthermore, the myopic progression 1 year after cessation of therapy with 0.02% atropine will be evaluated. Inclusion criteria are an age of 8-12 years and myopia of −1 D to −6 D with an estimated annual myopia progression of ≥0.5 D. After randomisation, patients will receive either atropine 0.02% (arm A) or placebo eye drops (arm B) in the first year of treatment. In the second year, they will continue to receive atropine 0.02% (arm A) or switch to atropine 0.01% (arm B). In the third year, they will switch to placebo (arm A) or continue with atropine 0.01% (arm B). To achieve a statistical power of 80%, the calculated sample size is 300. The trial has started in October 2021 with a planned recruitment period of 18 months. - Ethics and dissemination AIM has been approved by the Central Ethics Committee of the University Medical Center Freiburg (21-1106), local ethics committees of each participating centre and the German Federal Institute for Drugs and Medical Devices (61-3910-4044659). It complies with the Declaration of Helsinki, local laws and ICH-GCP. Results and underlying data from this trial will be disseminated through peer-reviewed publications and conference presentations. - Trial registration number NCT03865160.
BMJ open London : BMJ Publishing Group, 2011 13(2023), 4, Artikel-ID e068822, Seite 1-11 Online-Ressource
von Sonja K. Eilts ; Johanna M. Pfeil ; Broder Poschkamp ; Tim Ulrich Krohne ; Nicole Eter ; Teresa Barth ; Rainer Guthoff ; Wolf A. Lagrèze ; Milena Grundel ; Marie-Christine Bründer ; Martin Busch ; Jayashree Kalpathy-Cramer ; Michael F. Chiang ; R. V. Paul Chan ; Aaron S. Coyner ; Susan Ostmo ; Peter Campbell ; Andreas Stahl ; Stefan Schrader
von Paul Van de Heyning ; Peter Roland ; Luis Lassaletta ; Sumit Agrawal ; Marcus Atlas ; Wolf-Dieter Baumgartner ; Kevin Brown ; Marco Caversaccio ; Stefan Dazert ; Wolfgang Gstöttner ; Rudolf Hagen ; Abdulrahman Hagr ; Greg Eigner Jablonski ; Mohan Kameswaran ; Vladislav Kuzovkov ; Martin Leinung ; Yongxin Li ; Andreas German Loth ; Astrid Magele ; Robert Arndt Mlynski ; Joachim Mueller ; Lorne Parnes ; Andreas Daniel Radeloff ; Javier Gavilán
