Antiepileptika bei Frauen im gebärfähigen Alter und in der Schwangerschaft: Vergleich der Fachinformationen in Deutschland und der Schweiz mit dem aktuellen Wissensstand

Zusammenfassung: Hintergrund: Viele Heilberufler nutzen Fachinformationen als eine von verschiedenen möglichen Informationsquellen zu Risiken einer Arzneimittelanwendung bei Frauen im gebärfähigen Alter und in der Schwangerschaft. Ziel dieser Arbeit ist es, eine Übersicht über das teratogene Potenzial verschiedener Antiepileptika zu präsentieren und mit den Angaben ausgewählter Fachinformationen zu vergleichen. Methoden: Es wurde eine Literaturrecherche zum teratogenen Risiko von 19 Antiepileptika durchgeführt. Die Ergebnisse wurden mit den Angaben der Fachinformationen von 38 in der Schweiz und in Deutschland erhältlichen Fertigarzneimitteln verglichen. Ergebnisse: In allen Fachinformationen wird das teratogene Risiko anhand epidemiologischer Daten diskutiert. Eine Quantifizierung des Fehlbildungsrisikos und die Anzahl dokumentierter Schwangerschaften fehlen jedoch meistens. Angaben zur Notwendigkeit der Überwachung von Plasmaspiegeln während der Schwangerschaft mit etwaiger Dosisanpassung fehlen in fünf schweizer und zwei deutschen Fachinformationen. Diskussion: Die Angaben in den Fachinformationen der untersuchten Antiepileptika zur Anwendung bei Frauen im gebärfähigen Alter und in der Schwangerschaft sind heterogen und entsprechen überwiegend nicht dem aktuellen Kenntnisstand. Eine durch die zuständigen Behörden angestoßene Überarbeitung der Fachinformationen scheint notwendig zu sein, damit diese Dokumente für Heilberufler tatsächlich von Nutzen sein können

Simulation and Analysis of Dynamic Regimes Involving Ground and Excited State Transitions in Quantum Dot Passively Mode-Locked Lasers

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Artificial intelligence weights the importance of factors predicting complete cytoreduction at secondary cytoreductive surgery for recurrent ovarian cancer

Objective: Accumulating evidence support that complete cytoreduction (CC) at the time of secondary cytoreductive surgery (SCS) improves survival in patients affected by recurrent ovarian cancer (ROC). Here, we aimed to determine whether artificial intelligence (AI) might be useful in weighting the importance of clinical variables predicting CC and survival. Methods: This is a retrospective study evaluating 194 patients having SCS for ROC. Using artificial neuronal network (ANN) analysis was estimated the importance of different variables, used in predicting CC and survival. ANN simulates a biological neuronal system. Like neurons, ANN acquires knowledge through a learning-phase process and allows weighting the importance of covariates, thus establishing how much a variable influences a multifactor phenomenon. Results: Overall, 82.9% of patients had CC at the time of SCS. Using ANN, we observed that the 3 main factors driving the ability of achieve CC included: disease-free interval (DFI) (importance: 0.231), retroperitoneal recurrence (importance: 0.178), residual disease at primary surgical treatment (importance: 0.138), and International Federation of Gynecology and Obstetrics (FIGO) stage at presentation (importance: 0.088). Looking at connections between different covariates and overall survival (OS), we observed that DFI is the most important variable influencing OS (importance: 0.306). Other important variables included: CC (importance: 0.217), and FIGO stage at presentation (importance: 0.100). Conclusion: According to our results, DFI should be considered as the most important factor predicting both CC and OS. Further studies are needed to estimate the clinical utility of AI in providing help in decision making process

A georeferenced dataset of Italian occurrence records of the phylum Rotifera

We report a dataset of known and published occurrence records of Italian taxa from species (and subspecies) to family rank of the phylum Rotifera; we considered only Bdelloidea, Monogononta, and Seisonacea, and did not include Acanthocephala. The dataset in-cludes 15,525 records (12,015 of which with georeferenced coordinates) of 584 valid species and subspecies names and other taxa at family level, gathered from 332 published papers. The published literature spans the period from 1838 to 2022, with the lowest number of papers published during the first half of the twentieth century, followed by an increasing number of papers, from 20 to more than 60 in each decade. The Italian regions with the highest number of records and species are Emilia-Romagna, Lombardy, and Piedmont, whereas no records are known for Molise. The number of species known from each region mostly mirrors sampling efforts, measured as the number of publications per region. The dataset is available through the Open Science Framework (OSF), and all the georeferenced occurrence data have been uploaded to the Global Biodiversity Information Facility (GBIF). ial use only

Three-Dimensional Printing of Fetal Models of Congenital Heart Disease Derived From Microfocus Computed Tomography: A Case Series

This article presents a case series of n = 21 models of fetal cardiovascular anatomies obtained from post mortem microfocus computed tomography (micro-CT) data. The case series includes a broad range of diagnoses (e.g., tetralogy of Fallot, hypoplastic left heart syndrome, dextrocardia, double outlet right ventricle, atrio-ventricular septal defect) and cases also had a range of associated extra-cardiac malformations (e.g., VACTERL syndrome, central nervous system anomalies, renal anomalies). All cases were successfully reconstructed from the microfocus computed tomography data, demonstrating the feasibility of the technique and of the protocols, including in-house printing with a desktop 3D printer (Form2, Formlabs). All models were printed in 1:1 scale as well as with the 5-fold magnification, to provide insight into the intra-cardiac structures. Possible uses of the models include education and training

A georeferenced dataset of Italian occurrence records of the phylum Rotifera

We report a dataset of known and published occurrence records of Italian taxa from species (and subspecies) to family rank of the phylum Rotifera; we considered only Bdelloidea, Monogononta, and Seisonacea, and did not include Acanthocephala. The dataset includes 15,525 records (12,015 of which with georeferenced coordinates) of 584 valid species and subspecies names and other taxa at family level, gathered from 332 published papers. The published literature spans the period from 1838 to 2022, with the lowest number of papers published during the first half of the twentieth century, followed by an increasing number of papers, from 20 to more than 60 in each decade. The Italian regions with the highest number of records and species are Emilia-Romagna, Lombardy, and Piedmont, whereas no records are known for Molise. The number of species known from each region mostly mirrors sampling efforts, measured as the number of publications per region. The dataset is available through the Open Science Framework (OSF), and all the georeferenced occurrence data have been uploaded to the Global Biodiversity Information Facility (GBIF)

Progress and status of APEmille

We report on the progress and status of the APEmille project: a SIMD parallel computer with a peak performance in the TeraFlops range which is now in an advanced development phase. We discuss the hardware and software architecture, and present some performance estimates for Lattice Gauge Theory (LGT) applications.Comment: Talk presented at LATTICE97, 3 pages, Late

Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program

Background: The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Methods: Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. Results: A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7-6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3-4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. Conclusions: The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab

Evidence for alterations in fixational eye movements in glaucoma

BACKGROUND: Fixation changes in glaucoma are generally overlooked, as they are not strikingly evident as in macular diseases. Fundus perimetry might give additional insights into this aspect, along with traditional perimetric measures. In this work we propose a novel method to quantify glaucomatous changes in fixation features as detected by fundus perimetry and relate them to the extent of glaucomatous damage. METHODS: We retrospectively analysed fixation data from 320 people (200 normal subjects and 120 with glaucoma) from the Preferred Retinal Locus (PRL) detection of a Compass perimeter. Fixation stability was measured as Bivariate Contour Ellipse Area (BCEA), and using two novel metrics: (1) Mean Euclidean Distance (MED) from the Preferred Retinal Locus, and (2) Sequential Euclidean Distance (SED) of sequential fixation locations. These measures were designed to capture the spread of fixation points, and the frequency of position changes during fixation, respectively. RESULTS: In the age corrected analysis, SED was significantly greater in glaucomatous subjects than controls (P = 0.002), but there was no difference in BCEA (P = 0.15) or MED (P = 0.054). Similarly, SED showed a significant association with Mean Deviation (P  0.14 for both). CONCLUSION: Changes in the scanning pattern detected by SED are better than traditional measures of fixation spread (BCEA) for describing the changes in fixation stability observed in glaucoma

Posture of the arm when grasping spheres to place them elsewhere

Despite the infinitely many ways to grasp a spherical object, regularities have been observed in the posture of the arm and the grasp orientation. In the present study, we set out to determine the factors that predict the grasp orientation and the final joint angles of reach-tograsp movements. Subjects made reach-to-grasp movements toward a sphere to pick it up and place it at an indicated location. We varied the position of the sphere and the starting and placing positions. Multiple regression analysis showed that the sphere's azimuth from the subject was the best predictor of grasp orientation, although there were also smaller but reliable contributions of distance, starting position, and perhaps even placing position. The sphere's initial distance from the subject was the best predictor of the final elbow angle and shoulder elevation. A combination of the sphere's azimuth and distance from the subject was required to predict shoulder angle, trunkhead rotation, and lateral head position. The starting position best predicted the final wrist angle and sagittal head position. We conclude that the final posture of the arm when grasping a sphere to place it elsewhere is determined to a larger extend by the initial position of the object than by effects of starting and placing position. © 2010 Springer-Verlag