Liu Zhiji's Shitong and its Revival in Ming Dynasty—Pacing Historiography Anew

The aim of the present research project was to prove the thesis of a significant break in the tradition of Chinese historiography in late Ming dynasty (1396-1644). This break found its specification in the revival of works which had been neglected and forbidden for several hundred years, especially the so-called shiping 史評-literature (literature about discussing and criticizing history and history works). In consequence, the emergence of ever more critical history works or works criticizing history can be observed. For the investigation of this thesis of a significant change in the field of historiography firstly the main features and progressions of Ming dynasty were sketched-the first part of the dissertation. To test the thesis of this change in tradition, Liu Zhiji's 劉知幾 (661-721) Shitong 史通 (Generalities on Historiography) from Tang dynasty was chosen as a characteristic example of the shiping-literature which was rediscovered eight hundred years after its emergence. Therefore, the Shitong and the "renaissance" of the Shitong-as a peculiarity of on-going processes in this time-was the subject of the second main part and the so-called case study. The aim was to introduce Liu Zhiji's important work and examine the importance and the cause of this "rediscovery" of Liu Zhiji's work. As part of this, it further was an object of the work to translate untranslated parts of the Ming time commentaries into a Western language, as well as statements and comments of Ming time historians concerning the reception of this work. Hence, this part of this research project consists of the translation of important parts of the commentaries-especially the insightful prefaces-and the occupation with the setting and background of the commentaries. The idea behind this concentration on the commentaries of the Shitong was always to regard them as specifications of the break in historiographical tradition. To understand the correlations and influences which contributed to the happenings in the realm of Ming historiography, it was important to understand ongoing processes in Ming China-particularly in the academic and philosophical realm-before concentrating on historiography. In the next step the research focused on the important point of the ongoing gonglun 公論 debate which tried to find a measure for what is right and wrong. This characteristic of the academic world was then put into the context of historiography. This part on the historiography of Ming China represents the main part of the whole research project. On the basis of many different Ming time history works (like e.g. Zhu Minggao's Shijiu 史纠, Shao Bao's Xueshi 學史or Lu Shen's Chuanyi Lu 傳疑録) the changes concerning the development of historiography in Ming China were put into light and exemplified. It was a matter of especially showing symptoms of the discontinuity in the development of Chinese historiography. Hereby, the revival of the Shitong as one important example of the shiping-category of literature appeared as an expression of this break, new order and public debate in Ming dynasty. The public discourse and the attempt to find a standard measure for what is right and wrong in history writing are the innovative peculiarities of Ming historiography and they were displayed in the main part of the present study. In sum, it was discovered that many critical works about history writing from Ming dynasty give testimony of these characteristics, the significant developments and the break with tradition in Ming dynasty.Ziel des vorliegenden Forschungsprojektes war es, die These von einem bedeutenden Bruch in der Tradition der chinesischen Geschichtsschreibung in der späten Ming-Dynastie (1396-1644) zu beweisen. Dieser Bruch fand seine Spezifikation in der Wiederbelebung von Werken, die seit mehreren hundert Jahren vernachlässigt und verboten worden waren, vor allem die so genannte shiping 史評 -Literatur (Literatur über die Diskussion und Kritik von Geschichte und Geschichtsschreibung). Infolgedessen kann die Entstehung immer kritischerer Geschichtswerke oder Werke, die Geschichte kritisieren, beobachtet werden. Für die Untersuchung dieser These von einer bedeutenden Veränderung auf dem Gebiet der Geschichtsschreibung wurden zunächst die Hauptmerkmale und Entwicklungen der Ming-Dynastie skizziert - der erste Teil der Dissertation. Um die These von diesem Bruch in der Tradition zu testen, wurde Liu Zhijis 劉知幾 (661-721) Shitong 史通 (Leitfaden der Historiographie) aus der Tang-Dynastie als charakteristisches Beispiel für die shiping-literatur gewählt, die achthundert Jahre nach ihrer Entdeckung wiederentdeckt wurde Entstehung. Deshalb war das Shitong und die "Renaissance" des Shitongs - als eine Besonderheit der aktuellen Prozesse in dieser Zeit - Gegenstand des zweiten Teils und die sogenannte Fallstudie. Ziel war es, das wichtige Werk von Liu Zhiji vorzustellen und die Bedeutung und die Ursache seiner "Wiederentdeckung"zu untersuchen. Als Teil davon war es weiterhin Gegenstand der Arbeit, unübersetzte Teile der Ming zeitlichen Kommentare in eine westliche Sprache zu übersetzen, sowie Aussagen und Kommentare von Ming-Historikern über die Rezeption dieses Werkes. Daher besteht dieser Teil dieses Forschungsprojekts aus der Übersetzung wichtiger Teile der Kommentare - vor allem der aufschlussreichen Vorworte - und der Beschäftigung mit dem Hintergrund der Kommentare. Die Idee hinter dieser Konzentration auf die Kommentare des Shitong war immer, die Wiederentdeckung als Spezifikationen des Bruchs in der historiographischen Tradition zu betrachten. Um die Zusammenhänge und Einflüsse zu verstehen, die zu den Ereignissen im Bereich der Ming-Geschichtsschreibung beigetragen haben, war es wichtig, Prozesse in Ming China - vor allem im akademischen und philosophischen Bereich - zu verstehen, bevor man sich der Geschichtsschreibung zu wendet. Im nächsten Schritt konzentrierte sich die Forschung auf den wichtigen Schwerpunkt der gonglun 公論 Debatte, die versucht, ein Maß für richtig und falsch zu finden. Dieses Merkmal der akademischen Welt wurde dann in den Kontext der Geschichtsschreibung gestellt. Dieser Teil über die Geschichtsschreibung von Ming China stellt den Hauptteil des Forschungsprojekts dar. Auf der Basis vieler verschiedener Ming-zeitlicher Geschichtswerke (wie z. B. Zhu Minggaos Shijiu 史糾, Shao Baos Xueshi 學史 oder Lu Shens Chuanyi Lu 傳疑録) wurden die Veränderungen in der Entwicklung der Geschichtsschreibung in Ming China beleuchtet und veranschaulicht. Es ging darum, besonders die Symptome der Diskontinuität in der Entwicklung der chinesischen Geschichtsschreibung zu zeigen. Dabei erschien die Wiederbelebung des Shitong als ein wichtiges Beispiel für die shiping-Kategorie der Literatur als Ausdruck dieses Bruchs, der neuen Ordnung und der öffentlichen Debatte in der Ming-Dynastie. Der öffentliche Diskurs und der Versuch, ein Standardmaß für richtig und falsch in der Geschichtsschreibung zu finden, sind die innovativen Besonderheiten der Ming-Geschichtsschreibung; diese wurden im Hauptteil der vorliegenden Studie gezeigt. Zusammenfassend wurde gezeigt, dass viele kritische Werke über Geschichte und Geschichtsschreibung Zeugnis über diese Eigenschaften, die bedeutenden Entwicklungen und den Bruch mit der Tradition in der Ming-Dynastie geben

Komplikationen nach Nierentransplantation: eine retrospektive Studie über 15 Jahre von 1991 bis Juni 2005

Nach erfolgreicher Nierentransplantation ist es von enormer Bedeutung das Komplikationsspektrum in Hinblick auf eine Vermeidung und therapeutischer Optionen einordnen zu können. Daher wurde ein konsekutives Kollektiv von insgesamt 700 Nierentransplantationen, die im Zeitraum von Januar 1991 bis Juni 2005 im Nierentransplantationszentrum des Universitätsklinikums Jena stattfanden, in die vorliegende retrospektive Analyse einbezogen

The MedXFit-study – CrossFit as a workplace health intervention: a one-year, prospective, controlled, longitudinal, intervention study

IntroductionWorkplace health interventions aim to motivate employees toward healthy behaviors to improve fitness and health in the long-term. We investigated whether CrossFit® is an effective training concept to achieve these goals in inactive employees with sedentary occupations.MethodsThe study followed a prospective, controlled intervention design. Employees were invited to participate in intervention group (IG) or control group (CG) on their own preferences. Inclusion criteria were a predominantly sedentary occupation and execution of less than two muscle and/or mobility enhancing training sessions per week at the time of enrolling. The IG did at least two times a week a CrossFit training of 1 h. Mobility, strength, well-being, and back-issues were measured at the beginning, after 6, and 12 months. Participants in the CG were free to choose any other activities offered at the same time (e.g., circuit training, meditation, full body stability training). Adherence, respectively, behavioral change and maintenance qualities were evaluated based on the COM-B system and presence of behavior maintenance motives.Results89 employees were enrolled into the trial, from where 21 dropped out due to external factors (24%). From the remaining participants, 10 out of 39 (26%) in the IG and 1 out of 29 (4%) in the CG stopped for intrinsic reasons, leading to a non-adherence to the intervention of 22 percentage points. Motivation for behavioral change and maintenance in the IG was primarily driven by enhanced physical and psychological capability. Development of physical capability was evident by significant improvements (p < 0.001) in the IG compared to the CG for mobility (d = 3.3), maximal isometric strength (min. d = 1.7, max. d = 2.5), as well as reduction in pain intensity (p = 0.003, r = 0.4) and frequency (p = 0.009, r = 0.35) after 12 months. Significant improvements between the 6-month and the 12-month measurement in mobility and 6 out of 8 strength measures within the IG indicated the effectiveness of CrossFit beyond the beginner phase.ConclusionCrossFit is a motivating training concept that led to long-term health and fitness improvements in inactive employees doing sedentary work and should be given greater consideration in workplace health promotion

A novel European H5N8 influenza A virus has increased virulence in ducks but low zoonotic potential

We investigated in a unique setup of animal models and a human lung explant culture biological properties, including zoonotic potential, of a representative 2016 highly pathogenic avian influenza virus (HPAIV) H5N8, clade 2.3.4.4 group B (H5N8B), that spread rapidly in a huge and ongoing outbreak series in Europe and caused high mortality in waterfowl and domestic birds. HPAIV H5N8B showed increased virulence with rapid onset of severe disease and mortality in Pekin ducks due to pronounced neuro- and hepatotropism. Cross-species infection was evaluated in mice, ferrets, and in a human lung explant culture model. While the H5N8B isolate was highly virulent for Balb/c mice, virulence and transmissibility were grossly reduced in ferrets, which was mirrored by marginal replication in human lung cultures infected ex vivo. Our data indicate that the 2016 HPAIV H5N8B is avian-adapted with augmented virulence for waterfowl, but has low zoonotic potential. The here tested combination of animal studies with the inoculation of human explants provides a promising future workflow to evaluate zoonotic potential, mammalian replication competence and avian virulence of HPAIV.Peer Reviewe

Neratinib as Extended Adjuvant Treatment of HER2-Positive/HR-Positive Early Breast Cancer Patients in Germany, Austria, and Switzerland: Interim Results of the Prospective, Observational ELEANOR Study.

Prognosis of patients diagnosed with HER2+ early breast cancer (eBC) has substantially improved, but distant recurrences impacting quality of life and survival still occur. One treatment option for extended adjuvant treatment of patients with HER2+/HR+ eBC is neratinib, available in Europe for patients who completed adjuvant trastuzumab-based therapy within 1 year. The ELEANOR study is investigating the real-world use of neratinib in Germany, Austria, and Switzerland. Results from an interim analysis of the first 200 patients observed for ≥3 months are reported. The primary objective of this prospective, multicenter, observational study is to assess patient adherence to neratinib (defined as the percentage of patients taking neratinib on ≥75% prescribed days). Secondary objectives are patient characteristics and treatment outcomes. At cut-off (May 2, 2022), a total of 202 patients had been observed for ≥3 months, with neratinib treatment documented for 187 patients (median age: 53.0 years; 67.9% at increased risk of disease recurrence). In total, 151 (80.7%) patients had received prior neoadjuvant treatment; of these, 82 (54.3%) patients achieved a pathologically complete response. Neratinib was initiated at a median 3.6 months after trastuzumab-based treatment, with 36.4% starting at a dose <240 mg/day. Treatment is ongoing for 46.0% of patients, with median treatment duration of 11.2 (interquartile range 0.9-12.0) months. Diarrhea was the most common adverse event (78.6% any grade, 20.3% grade ≥3); pharmacologic prophylaxis was used in 85.6% of patients. The pattern of anti-HER2 pretreatment observed reflected the current treatment for HER2+/HR+ eBC in Germany, Austria, and Switzerland. These interim results suggest that neratinib as an extended adjuvant is a feasible option after various anti-HER2 pretreatments and that its tolerability can be managed and improved with proactive diarrhea management

PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant

Background Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (HER2 −) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g., palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients’ satisfaction and early detection/management of side effects. New strategies for continuous support of oncological patients are needed. An eHealth-based platform can help to support therapy management and physician–patient interaction. Methods PreCycle is a multicenter, randomized, phase IV trial in HR + HER2 − MBC. All patients (n = 960) receive the CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates and compares the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g., adherence), genetic background, and drug efficacy, the trial includes both patient-reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS). Discussion The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = “Deterioration of quality of life” (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016–004191-2

Evaluating the ability of an artificial-intelligence cloud-based platform designed to provide information prior to locoregional therapy for breast cancer in improving patient's satisfaction with therapy: the CINDERELLA trial

Background: Breast cancer therapy improved significantly, allowing for different surgical approaches for the same disease stage, therefore offering patients different aesthetic outcomes with similar locoregional control. The purpose of the CINDERELLA trial is to evaluate an artificial-intelligence (AI) cloud-based platform (CINDERELLA platform) vs the standard approach for patient education prior to therapy. Methods: A prospective randomized international multicentre trial comparing two methods for patient education prior to therapy. After institutional ethics approval and a written informed consent, patients planned for locoregional treatment will be randomized to the intervention (CINDERELLA platform) or controls. The patients in the intervention arm will use the newly designed web-application (CINDERELLA platform, CINDERELLA APProach) to access the information related to surgery and/or radiotherapy. Using an AI system, the platform will provide the patient with a picture of her own aesthetic outcome resulting from the surgical procedure she chooses, and an objective evaluation of this aesthetic outcome (e.g., good/fair). The control group will have access to the standard approach. The primary objectives of the trial will be i) to examine the differences between the treatment arms with regards to patients' pre-treatment expectations and the final aesthetic outcomes and ii) in the experimental arm only, the agreement of the pre-treatment AI-evaluation (output) and patient's post-therapy self-evaluation. Discussion: The project aims to develop an easy-to-use cost-effective AI-powered tool that improves shared decision-making processes. We assume that the CINDERELLA APProach will lead to higher satisfaction, better psychosocial status, and wellbeing of breast cancer patients, and reduce the need for additional surgeries to improve aesthetic outcome