In this study, the direct effect of the MiSight contact lens (Cooper Vision), a daily disposable contact lens recently approved in Germany for the treatment of myopia, will be investigated. The aim of this study is to demonstrate an increase in choroidal thickness due to the myopic defocus induced by the contact lens. The increase in choroidal thickness after 30 minutes of exposure to the myopic defocus induced by the contact lens will be demonstrated by measuring the subfoveal and macular choroidal thickness.

开始日期2024-08-13

申办/合作机构

Universitatsklinikum Augsburg

DRKS00034026 / RecruitingN/A

Do different cardiopulmonary blood flow settings influence perioperative outcome in cardiac surgery patients? - CardioFlow

开始日期2024-07-01

申办/合作机构

Universitatsklinikum Augsburg

100 项与 Universitatsklinikum Augsburg 相关的临床结果

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0 项与 Universitatsklinikum Augsburg 相关的专利（医药）

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项与 Universitatsklinikum Augsburg 相关的文献（医药）

2024-10-01·JAMA Neurology

A Randomized Clinical Trial

Article

作者: Gruber, Andreas ; Wessels, Lars ; Bendszus, Martin ; Rohde, Veit ; Gempt, Jens ; Kerschbaumer, Johannes ; Hecht, Nils ; Wolf, Stefan ; Hirschmann, Dorian ; Mielke, Dorothee ; Breitenbach, Jörg ; Thomé, Claudius ; Adage, Tiziana ; Meyer, Bernard ; Gmeiner, Matthias ; Bavinzski, Gerhard ; Wostrack, Maria ; Vajkoczy, Peter

ImportanceCerebral vasospasm largely contributes to a devastating outcome after aneurysmal subarachnoid hemorrhage (aSAH), with limited therapeutic options.ObjectiveTo investigate the safety and efficacy of localized nicardipine release implants positioned around the basal cerebral vasculature at risk for developing proximal vasospasm after aSAH.Design, Setting, and ParticipantsThis single-masked randomized clinical trial with a 52-week follow-up was performed between April 5, 2020, and January 23, 2023, at 6 academic neurovascular centers in Germany and Austria. Consecutive patients with World Federation of Neurological Surgeons grade 3 or 4 aSAH due to a ruptured anterior circulation aneurysm requiring microsurgical aneurysm repair participated.InterventionDuring aneurysm repair, patients were randomized 1:1 to intraoperatively receive 10 implants at 4 mg of nicardipine each plus standard of care (implant group) or aneurysm repair alone plus standard of care (control group).Main Outcome and MeasuresThe primary end point was the incidence of moderate to severe cerebral angiographic vasospasm (aVS) between days 7 and 9 after aneurysm rupture as determined by digital subtraction angiography.ResultsOf 41 patients, 20 were randomized to the control group (mean [SD] age, 54.9 [9.1] years; 17 female [85%]) and 21 to the implant group (mean [SD] age, 53.6 [11.9] years; 14 female [67%]). A total of 39 patients were included in the primary efficacy analysis. In the control group, 11 of 19 patients (58%) developed moderate or severe aVS compared with 4 of 20 patients (20%) in the implant group (P = .02). This outcome was paralleled by a lower clinical need for vasospasm rescue therapy in the implant group (2 of 20 patients [10%]) compared with the control group (11 of 19 patients [58%]; P = .002). Between days 13 and 15 after aneurysm rupture, new cerebral infarcts were noted in 6 of 19 patients (32%) in the control group and in 2 of 20 patients (10%) in the implant group (P = .13). At 52 weeks, favorable outcomes were noted in 12 of 18 patients (67%) in the control group and 16 of 19 patients (84%) in the implant group (P = .27). The adverse event rate did not differ between groups.Conclusions and RelevanceThese findings show that placing nicardipine release implants during microsurgical aneurysm repair can provide safe and effective prevention of moderate to severe aVS after aSAH. A phase 3 clinical trial to investigate the effect of nicardipine implants on clinical outcome may be warranted.Trial RegistrationClinicalTrials.gov Identifier: NCT04269408

2024-10-01·Die Anaesthesiologie

Erratum zu: 55/m mit beginnender Urosepsis

作者: Spring, O ; Eilenberger, S

2024-09-16·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Single or Double Induction With 7 + 3 Containing Standard or High-Dose Daunorubicin for Newly Diagnosed AML: The Randomized DaunoDouble Trial by the Study Alliance Leukemia.

Article

作者: Müller-Tidow, Carsten ; Szotkowski, Tomas ; Röllig, Christoph ; Weinbergerova, Barbora ; Kaufmann, Martin ; Platzbecker, Uwe ; Stölzel, Friedrich ; Baldus, Claudia D ; Burchert, Andreas ; Middeke, Jan Moritz ; Alakel, Nael ; Held, Gerhard ; Mertová, Jolana ; Fransecky, Lars ; Herbst, Regina ; Haake, Annett ; Fiebig, Frank ; Niemann, Dirk ; Kramer, Michael ; Kayser, Sabine ; Mayer, Jiri ; Bornhäuser, Martin ; Steffen, Björn ; Thiede, Christian ; Jost, Edgar ; Scholl, Sebastian ; Schaich, Markus ; Serve, Hubert ; Berdel, Wolfgang E ; Ehninger, Gerhard ; Sauer, Tim ; Hochhaus, Andreas ; Mikesch, Jan-Henrik ; Neubauer, Andreas ; Schliemann, Christoph ; Schetelig, Johannes ; Noppeney, Richard ; Schäfer-Eckart, Kerstin ; Hanoun, Maher ; Hänel, Mathias ; Rank, Andreas ; Novák, Jan ; Krause, Stefan W ; Schmid, Christoph

PURPOSETo determine the optimal daunorubicin dose and number of 7 + 3 induction cycles in newly diagnosed AML, this randomized controlled trial compared a once daily dose of 60 mg/m² with 90 mg/m² daunorubicin in the first 7 + 3 induction and one versus two cycles of 7 + 3 induction.PATIENTS AND METHODSPatients age 18-65 years with newly diagnosed AML were randomly assigned to 60 versus 90 mg/m² daunorubicin once daily plus cytarabine. Patients with marrow blasts below 5% on day 15 after first induction were randomly assigned to receive a second induction cycle or no second induction cycle.RESULTSEight hundred and sixty-four patients with a median age of 52 years were randomly assigned. After a preplanned interim analysis showing no significant difference in response between 60 and 90 mg/m², all consecutive patients received 60 mg/m² daunorubicin once daily. The proportion of good early responders was 44% versus 48% (P = .983) with a composite complete remission (CRc) rate of 90% versus 89% after induction (P = .691); the 3-year relapse-free survival (RFS) after 60 versus 90 mg/m² once daily was 54% versus 50% (P = .561), and the 3-year overall survival (OS) was 65% versus 58% (P = .242). Among 389 good responders, CRc rates at the end of induction were 87% after single induction and 85% after double induction. The 3-year RFS was 51% versus 60% (hazard ratio [HR], 1.3; P = .091), and the 3-year OS was 76% versus 75% after single versus double induction (HR, 1.0; P = .937).CONCLUSIONThe use of 90 mg/m² daunorubicin once daily in the context of classical 7 + 3 induction does not significantly improve early response and does not lead to higher remission rates or longer survival than 60 mg/m² once daily. In patients with a good early response after first induction, a second induction has only a limited impact on RFS and does not result in an OS benefit.

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100 项与 Universitatsklinikum Augsburg 相关的转化医学

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