Lebendige Vielfalt kulturellen Schaffens : ein facettenreiches Bild von Afrikas Literatur, Theater und Gesellschaft

Rezension zu: Kreatives Afrika. SchriftstellerInnen über Literatur, Theater und Gesellschaft. Susan Arndt und Katrin Berndt, Festschrift für Eckhard Breitinger, Peter Hammer Verlag, Wuppertal 2005, ISBN 3-7795-0028-0, 522 Seiten, 24,90 Euro

Novel treatments for rare rheumatologic disorders: analysis of the impact of 30 years of the US orphan drug act

Background: Rare rheumatologic diseases are a heterogeneous group of conditions associated with high morbidity. As a whole group, rare rheumatologic diseases afflict millions of people demanding for effective therapies. Therefore, we analyzed the impact of the US Orphan Drug Act on the development of anti-rheumatic orphan drugs. Methods: Analysis of the FDA database for orphan drug designations. Results: In the last three decades, out of 77 orphan drug designations, 14 orphan drug approvals were granted by the FDA for the treatment of rare rheumatologic disorders, i.e. juvenile idiopathic arthritis (N = 5), cryopyrin-associated periodic syndromes (N = 3), uveitis (N = 3), familial Mediterranean fever (N = 1), anti-neutrophil cytoplasmic antibody-associated vasculitis (N = 1), and xerostomia and keratoconjunctivitis sicca in Sjögren’s syndrome (N = 1). Mean time (standard deviation) from designation to approval was 3.9 (2.81) [range 1 … 12] years. Number of FDA-approved small molecules (N = 6, 43 %) and biologics (N = 8, 57 %) was comparable. Almost every fifth (19 %) orphan drug designation was withdrawn. Despite the rarity of conditions, 13/14 pivotal studies were randomized controlled trials. Conclusions: Orphan drug development is challenging: thirty years of US orphan drug act supported the development and FDA approval of 14 orphan drug programs with anti-rheumatic compounds for six rheumatologic diseases

Recruitment and Baseline Characteristics of Participants in the “Sanadak” Trial: A Self-Help App for Syrian Refugees with Post-traumatic Stress

Many Syrian refugees residing in Germany have been exposed to traumatizing events, while treatment options are scarce. Therefore, the self-help app “Sanadak” was developed to target post-traumatic stress in Syrian refugees. We aimed to inspect the recruitment and baseline characteristics of the participants in the trial, which is conducted to evaluate the app. Analyses were based on the recruitment sample (n = 170) and the trial sample (n = 133). Data were collected during structured face-to-face interviews in the Arabic language. Targeted outcomes included post-traumatic stress (primary; Post-traumatic Diagnostic Scale for DSM-5/PDS-5) and depressive symptoms, anxiety, resilience, among others (secondary). Recruited individuals were M = 32.8 (SD = 11.2, range = 18–65) years old; 38.8% were women. The average PDS-5 score was 23.6 (SD = 13.2) regarding trauma exposure, which was most frequently related to experiencing military- or combat-related events (32.9%). Moreover, 46.5% had major depression and 51.8% showed low resilience. Anxiety was present in 40.6% of the trial participants. Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress. This underlines the need for intervention. Our results provide important figures on the mental health of a not well-studied population group in Germany

Avaliação dos Cursos de Extensão Universitária realizados pela Faculdade de Medicina de Ribeirão Preto da USP entre 2002 e 2008

Introdução: A RESOLUÇÃO da Comissão de Cultura e Extensão da Universidade de Sào Paulo- CoCEx-5072 da Universidade de São Paulo(USP) regulamentou os cursos de extensão universitária. A Faculdade de Medicina de Ribeirão Preto da USP(FMRP-USP) passou a incentivar que diversos cursos nãoregulamentados fossem oficializados. Diversos empecilhos foram detectados, sendo necessário reavaliar o processo.Metodologia: Foram avaliados 106 cursos de extensão universitária realizados entre 2002 e 2008.Obteve-se dados referentes ao tipo de curso, Departamento responsável, regularidade e número de vagas oferecidas, comparando-se com a situação dos cursos no Sistema Apolo-USP. O trâmite dos processos foi avaliado através da diferença em dias entre o início e o final do processo. Todos os cursos que tiveram os certificados emitidos e anexados ao processo foram classificados como concluídos. Resultados: 1) O número de cursos regulamentados realizados pela FMRP-USP é baixo, sendo muito inferior à sua potencialidade; 2) A maioria dos cursos compreende cursos de curta duração (Difusão) e são reproduzidos em caráter anual; 3) A Comissão de Cultura e Extensão da FMRP-USP não dispõe de pessoal suficiente para gerenciamento dos cursos, dificultando ações de orientação e tramitação de processos.Conclusões: A infra-estrutura para o gerenciamento dos cursos de extensão da FMRP-USP precisa ser melhorada. Nitidamente, a demanda atual, que é pequena, não está sendo atendida na totalidade exigida com prejuízos sobre a qualidade. Esta situação pode comprometer de modo importante a pretensão de se ampliar o cadastro de novos cursos de extensão. Medidas urgentes de estruturação para o gerenciamento adequado destes cursos devem ser adotadas e os cursos anteriores já cadastrados e não concluídos devem ser reavaliados e finalizados.Background: University of São Paulo(USP) CoCEx-5072 resolution regulates university extension courses. The Medical School of Ribeirão Preto USP(MSRP-USP) has adhered and incentivates documentation of all courses conducted. Several problems were identified, being mandatory process reevaluation. Metodology: 106 courses conducted between 2002 and 2008 were evaluated. Data regarding course type, duration, regularity and number of attendees were recovered and compared with the official USPApolo web system. Duration of process was calculated through the difference between date of beggining and end of process. All courses were considered concluded when certification was emited. Results: 1)The number of courses conducted by MSRP-USP is low, much inferior to its potential; 2) The majority of courses comprehends short duration courses (Difusion) conducted on a yearly basis; 3)There were problems with personal for guiding and documenting the courses in the MSRP-USP. Conclusion: The extension courses management in the MSRP-USP should be improved. Even with the low number of courses, guidance and documentation is not properly undergone. This could jeopardize the policy of increasing the number of courses documented. Urgent measures should be implementeds for adequate management of the actual demand and increasing documentation

Bistable Helmholtz dark spatial optical solitons in materials with self-defocusing saturable nonlinearity

We present, to the best of our knowledge, the first exact dark spatial solitons of a nonlinear Helmholtz equation with a self-defocusing saturable refractive-index model. These solutions capture oblique (arbitrary-angle) propagation in both the forward and backward directions, and they can also exhibit a bistability characteristic. A detailed derivation is presented, obtained by combining coordinate transformations and direct-integration methods, and the corresponding solutions of paraxial theory are recovered asymptotically as a subset. Simulations examine the robustness of the new Helmholtz solitons, with stationary states emerging from a range of perturbed input beams

Regression analysis with categorized regression calibrated exposure: some interesting findings

BACKGROUND: Regression calibration as a method for handling measurement error is becoming increasingly well-known and used in epidemiologic research. However, the standard version of the method is not appropriate for exposure analyzed on a categorical (e.g. quintile) scale, an approach commonly used in epidemiologic studies. A tempting solution could then be to use the predicted continuous exposure obtained through the regression calibration method and treat it as an approximation to the true exposure, that is, include the categorized calibrated exposure in the main regression analysis. METHODS: We use semi-analytical calculations and simulations to evaluate the performance of the proposed approach compared to the naive approach of not correcting for measurement error, in situations where analyses are performed on quintile scale and when incorporating the original scale into the categorical variables, respectively. We also present analyses of real data, containing measures of folate intake and depression, from the Norwegian Women and Cancer study (NOWAC). RESULTS: In cases where extra information is available through replicated measurements and not validation data, regression calibration does not maintain important qualities of the true exposure distribution, thus estimates of variance and percentiles can be severely biased. We show that the outlined approach maintains much, in some cases all, of the misclassification found in the observed exposure. For that reason, regression analysis with the corrected variable included on a categorical scale is still biased. In some cases the corrected estimates are analytically equal to those obtained by the naive approach. Regression calibration is however vastly superior to the naive method when applying the medians of each category in the analysis. CONCLUSION: Regression calibration in its most well-known form is not appropriate for measurement error correction when the exposure is analyzed on a percentile scale. Relating back to the original scale of the exposure solves the problem. The conclusion regards all regression models