bluuebunny/crossref_metadata_2025_split huggingface dataset:
Rechtliche Rahmenbedingungen für Psychopharmaka-Forschung in Deutschland
Authors: Fritze J. 
Published: September 2018

ZusammenfassungDie im Arzneimittelgesetz (AMG) formulierten Rechtsgrundlagen entsprechen im Wesentlichen europäischen Richtlinien. Interventionelle Studien, seien sie Sponsor- oder Investigator- initiiert, sind genehmigungspflichtig, strikt durch Standards guter klinischer Praxis (GCP) reguliert und werden überwacht. Nicht-interventionelle Studien sind anzeigepflichtig. Für Psychopharmaka-Studien gibt es keine besonderen Bedingungen, besonders häufig aber stellt sich die Frage der Einwilligungsfähigkeit. Krankenhausbedürftigkeit kann nicht zu Lasten der Krankenversicherung gehen, wenn sie allein aus Studiengründen resultiert. Studien mit zugelassenen Arzneimitteln in nicht zugelassener Indikation („off-label“) können zu Lasten der GKV durchgeführt werden.
Einfluss der molekularen Bildgebung auf innovative Therapie-Verfahren am Beispiel der M. Alzheimer-Therapie
Authors: Vernaleken I. 
Published: September 2018

ZusammenfassungDie Positronen-Emissionstomografie bietet in Abhängigkeit von den verwendeten Liganden ein hohes Maß an Strukturspezifität bei gleichzeitiger räumlicher Information unter in-vivo Bedingungen. Dennoch fand sich neben den durchaus etablierten [18F]FDG-PET Messungen kaum eine fundierte Anwendung mit direkter therapeutischer Konsequenz. Fortschritte in der Pharmakotherapie psychischer Erkrankungen können die PET allerdings auch klinisch rasch in eine relevante Schlüsselposition bringen. Am Beispiel der in Erprobung befindlichen Immun- Therapeutika für die Alzheimer-Demenz-Erkrankung wird gezeigt, dass die Liganden- Entwicklung zur Frühdiagnose (Amyloid-Imaging) integraler Bestandteil des gesamten Therapie- Prozesses werden kann. Die Entwicklung von geeigneten Amyloid-bindenden Liganden nimmt daher aktuell einen breiten Raum der Neuro-PET-Forschung ein.
Pharmakotherapie der juvenilen Schizophrenie mit atypischen Neuroleptika
Authors: Härtling F. 
Published: September 2018

ZusammenfassungAuch wenn nur etwa 0,1–1% der Schizophrenien vor dem 10. Lebensjahr beginnen, sind es doch 7 –10%, die sich in der Adoleszenz manifestieren. Sie treffen die Patienten in einer besonders sensiblen Phase ihrer Entwicklung und prägen in der Regel ihr weiteres Leben maßgeblich. Obschon auch für diese jungen Schizophrenie-Patienten eine Pharmakotherapie mit Antipsychotika eine entscheidende Säule der Behandlung darstellt, ist die Verfügbarkeit von Studiendaten – und damit auch von zugelassenen Atypika – für den Kinder- und Jugendbereich deutlich schlechter als im Erwachsenenbereich. Der vorliegende Artikel gibt einen Überblick über den Zulassungsstatus sowie die Wirkungen und Nebenwirkungen atypischen Antipsychotika in der Akut- und Langzeitbehandlung der juvenilen Schizophrenie.
Networking, Leadership, Empowerment
Authors: Calliess I. T. , Treichel K. , Nikitopoulos J. , Malik A. , Rojnic Kuzman M. 
Published: September 2018

SummaryAs society’s expectations of mental health professional change radically, educational programs and policies need to keep pace with this change. Trainees and young psychiatrists have established their distinct identity and assured that educational policies are reformed to create competent mental health professionals who are fit for purpose in tomorrow’s world. In order for this to happen, it has taken over a decade of dedication, hard work and motivation from past and present psychiatric trainees and young psychiatrists to travel the journey from having a vision of an international network to develop the existing highly structured network. Networking and empowerment facilitated by national and international young psychiatrists’ organizations has allowed young psychiatrists to participate in decision-making processes and create frameworks for their own professional development. This paper outlines the principles and objectives that underpin the existing networks of national and international young psychiatrists’ organizations. It also describes the various educational and networking activities undertaken by these organizations and uses the case study from Croatia to describe the role of these networks in the formation of national associations of young psychiatrists and trainees.
Psychisch kranke Frauen
Authors: Riecher-Rössler A. 
Published: September 2018

ZusammenfassungObwohl die Lebenszeitprävalenz psychischer Erkrankungen insgesamt bei beiden Geschlechtern gleich hoch ist, kommen bestimmte psychische Erkrankungen häufiger bei Frauen vor, andere wiederum häufiger bei Männern. Die Ursachen dieser Unterschiede sind vielfältig. Zum einen handelt es sich nur um vermeintliche Unterschiede; doch es gibt auch zahlreiche echte Geschlechtsunterschiede. Diese sind meist multifaktoriell bedingt - durch das biologische Geschlecht, das sogenannte „sex“, einerseits, durch das psychosoziale Geschlecht, das sogenannte „gender“, mit all den zugeschriebenen und übernommenen Rollen in Partnerschaft, Familie, Beruf, Politik, etc. andererseits. Eine ”geschlechtersensible” Psychiatrie berücksichtigt all diese Einflüsse sowohl in der Diagnostik als auch in der Therapie.
Escitalopram – Daten zur Langzeitwirksamkeit
Authors: Volz H.-P. 
Published: September 2018

ZusammenfassungEscitalopram, das pharmakodynamisch aktive S-Enantiomer des Razemats Citalopram, hat sich in Akutstudien als eines der wenigen Antidepressiva überhaupt, nicht nur effektiver als Placebo, sondern auch effektiver als Vergleichssubstanzen erwiesen. Darüber hinaus zeigen auch eine Reihe von Daten aus Langzeitstudien die gute Wirksamkeit in der Erhaltungstherapie sowie Wirkvorteile vs. Duloxetin und Paroxetin bei tendenziell besserer Verträglichkeit. Für die Langzeittherapie der Depression steht damit eine neue interessante Option zur Verfügung, die auch geeignet ist, Compliance-Probleme der Patienten zu vermindern, da eine sehr gute Wirksamkeit mit guter Verträglichkeit kombiniert ist.
Tracheoinnominate Artery Fistula Formation in a Child with Long-Term Tracheostomy Dependence
Authors: Chauhan Jigar , Hertzog James , Viteri Shirley , Slamon Nicholas 
Published: September 2018

AbstractWe report a fatal tracheoinnominate artery fistula (TIF) in a 13-year-old female patient with long-term tracheostomy tube dependence due to chronic respiratory failure. Thirteen years after placement of her tracheostomy tube, the patient experienced two separate episodes of sentinel bleeding prior to a fatal hemorrhagic event. Diagnostic evaluation after the sentinel events was mostly nonconclusive. This case highlights the risk of TIF in pediatric age group, even years after initial tracheostomy tube placement, and the need for a high index of suspicion for TIF when children present with unexplained tracheal bleeding.
A Case of Chromosome 22q11.2 Deletion Syndrome with White Matter Abnormalities and Hypernasal Speech: Importance of Extracardiac Symptoms for Earlier Diagnosis
Authors: Fujioka Kaoru , Kanemura Hideaki , Tando Tomoko , Aihara Masao 
Published: September 2018

AbstractChromosome 22q11.2 deletion syndrome (22q11.2DS) is one of the most common genetic syndromes. The varying presentation and severity of this syndrome result in diagnostic delays, especially in patients without cardiac malformation or characteristic features. We report a noncardiac case of 22q11.2DS with white matter abnormalities and velopharyngeal insufficiency. The recognition of white matter abnormalities as a feature of 22q11.2DS contributed to early diagnosis. Diagnostic delay could lead to inappropriate management and unfavorable outcomes. Increased awareness of the various minor features of 22q11.2DS may enable clinicians to diagnose this syndrome earlier and provide appropriate medical management.
Eine Stellungnahme zur Debatte über die „atypischen“ Antipsychotika
Authors: Schmied A. , Kissling W. , Davis J. M. , Leucht S. 
Published: September 2018

ZusammenfassungSeit etwa zehn Jahren gibt es eine kontrovers geführte Debatte über die Antipsychotika der zweiten Generation („second generation antipsychotics“, SGA) in der Schizophreniebehandlung, die in der Publikation der sogenannten Effektivitätsstudien CATIE (Clinical Antipsychotic Trial of Intervention Effectiveness), CUtLASS (Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study) und EUFEST (European First-Episode Schizophrenia Trial) gipfelte. In der vorliegenden Übersicht fassen wir die Ergebnisse dreier aktueller systematischer Reviews zusammen, in denen die Antipsychotika der zweiten Generation (SGAs) mit Placebo, mit konventionellen Antipsychotika oder direkt miteinander verglichen wurden. Wir stellen die Metaanalysen in den Kontext anderer systematischer Reviews und beleuchten sie vor dem Hintergrund von CATIE, CUtLASS und EUFEST. Unserer Meinung nach sind viele Ergebnisse konsistent, sie werden aber von verschiedenen Experten und Interessensvertretern unterschiedlich interpretiert. Die Daten zeigen, dass SGAs keine homogene Gruppe darstellen und dass diese eher verwirrende Einteilung aufgegeben werden sollte. Unserer Meinung nach stellen die SGAs nicht den Durchbruch dar, den die Industrie gerne sehen würde. Ihre unterschiedlichen Eigenschaften erlauben aber eine bessere Ausrichtung des Behandlungsplans an den Problemen des individuellen Patienten. Diese Medikamente haben die Behandlungspalette deutlich erweitert und die meisten Psychiater, ganz zu schweigen von den Patienten, würden wohl nur sehr ungerne auf diese Präparate verzichten wollen.
Impacts of Dengue Epidemics on Household Labor Market Outcomes
Authors: Walsh Amanda C. 
Published: September 2018

AbstractExisting research on household‐level dengue impacts only assesses families of individuals with disease. However, behavioral and economic factors affect all households within an epidemic region. I assess changes in work hours among males and females in Iquitos, Peru, during intermittent dengue epidemics from 2005–2010. Epidemics are associated with large decreases in work hours for men and women who work. Females reduce hours more than males, and reduce hours when no household members report illness. The findings suggest that current government interventions aimed at reducing transmission during epidemics may inadvertently deter labor market activity. This research contributes to the infectious disease literature by separately assessing the impacts of epidemics on males and females in all households in an affected region.
Reconfiguration of Dynamic Functional Connectivity in Sensory and Perceptual System in Schizophrenia
Authors: Dong Debo , Duan Mingjun , Wang Yulin , Zhang Xingxing , Jia Xiaoyan , Li Yingjia , Xin Fei , Yao Dezhong , Luo Cheng 
Published: September 2018

AbstractSchizophrenia is thought as a self-disorder with dysfunctional brain connectivity. This self-disorder is often attributed to high-order cognitive impairment. Yet due to the frequent report of sensorial and perceptual deficits, it has been hypothesized that self-disorder in schizophrenia is dysfunctional communication between sensory and cognitive processes. To further verify this assumption, the present study comprehensively examined dynamic reconfigurations of resting-state functional connectivity (rsFC) in schizophrenia at voxel level, region level, and network levels (102 patients vs. 124 controls). We found patients who show consistently increased rsFC variability in sensory and perceptual system, including visual network, sensorimotor network, attention network, and thalamus at all the three levels. However, decreased variability in high-order networks, such as default mode network and frontal–parietal network were only consistently observed at region and network levels. Taken together, these findings highlighted the rudimentary role of elevated instability of information communication in sensory and perceptual system and attenuated whole-brain integration of high-order network in schizophrenia, which provided novel neural evidence to support the hypothesis of disrupted perceptual and cognitive function in schizophrenia. The foci of effects also highlighted that targeting perceptual deficits can be regarded as the key to enhance our understanding of pathophysiology in schizophrenia and promote new treatment intervention.
FA01.04: HIGH HOSPITAL VOLUME IS ASSOCIATED WITH SHORTER LEARNING CURVES AND LESS LEARNING ASSOCIATED MORBIDITY AFTER MINIMALLY INVASIVE ESOPHAGECTOMY
Authors: Workum Frans , Claassens Linda , Rovers Maroeska , Rosman Camiel 
Published: September 2018

Abstract

Background
Ivor Lewis totally minimally invasive esophagectomy (TMIE) is associated with a long learning curve and high learning associated morbidity. Factors that are associated with a shorter learning curve and less associated morbidity have not been investigated from clinical data. The aim of this study was to investigate whether there is a relationship between hospital volume and the length of the learning curve and learning associated morbidity.

Methods
Prospectively collected data were retrospectively analyzed of all consecutive patients undergoing Ivor Lewis TMIE in expert centers in Sweden, Denmark and the Netherlands. The primary outcome parameter was anastomotic leakage requiring reoperation or reintervention. Learning curves were plotted using weighted moving average and CUSUM analysis was used to determine after how many cases the plateau was reached. Learning associated morbidity was calculated with area under the curve analysis. The length of the learning curve and learning associated morbidity were compared between hospitals < 50 procedures per year (normal volume) and hospitals performing > 50 procedures (high volume) per year.

Results
Nine centers participated and 906 patients were included. The mean number of Ivor Lewis TMIE performed per center per year was 41 (range 22–60). The overall length of the learning curve was 136 cases and this was 148 cases in the normal volume group versus 122 cases in the high volume group. Learning associated anastomotic leakage occurred in 10 patients (7.4% of all patients operated during the learning curve) and this was 13 patients (8.5%) in the normal volume group versus 6 patients (5.2%) in the high volume group.

Conclusion
Learning curves were shorter and learning associated morbidity was lower in centers with higher case volume. This is the first study demonstrating this effect from clinical data. Patient safety can be significantly compromised during surgical learning curves and probably, patient safety can be increased if surgeons learn technically challenging procedures in higher volume centers. Our data can guide the design of implementation programs for technically challenging procedures. This abstract was submitted on behalf of the esophagectomy learning curve collaborative group.

Disclosure
All authors have declared no conflicts of interest.
FA01.05: EARLY RESULTS OF ROBOT ASSISTED ESOPHAGECTOMY COMPARED WITH CONVENTIONAL THORACOSCOPIC APPROACH FOR ESOPHAGEAL CANCER: A RANDOMIZED CLINICAL TRIAL
Authors: Li Bin , Li Zhigang 
Published: September 2018

Abstract

Background
Minimally invasive esophagectomy (MIE) has become increasingly adopted as a standard surgical approach for esophageal cancer because of less tissue damage and a more rapid recovery. Recent developments in robotic technology have made robot-assisted minimally esophagectomy as another surgical option for MIE. The aim of the study was to compare early results between robot-assisted thoraco-laparoscopic esophagectomy (RATLE) and conventional thoraco-laparoscopic esophagectomy(CTLE) for the treatment of esophageal squamous cell carcinoma (ESCC).

Methods
We designed a randomized controlled parallel-group trial study. Patients aged 18–75 years with histologically proven surgically resectable (cT1b-3, N0–2, M0) ESCC of the intrathoracic esophagus were randomly assigned to receive either RATLE or CTLE. All patients received McKeown esophagectomy. Clinical characteristics and perioperative outcomes between the two groups were compared.

Results
Seventy patients were randomly assigned to RATLE group(n = 36) and CTLE group(n = 34). The two groups were comparable in preoperative clinical characteristics. Patients who underwent RATLE had shorter total operation time than the CTLE group (217.3 ± ± 44.5 vs. 261.5 ± 62.1 minutes, P = 0.001), particularly in thoracoscopic time (74.0 ± 23.6 vs. 104.1 ± 34.2 minutes, P < 0.001). The incidence of recurrent laryngeal palsy is higher in RATLE group(25%) than CTLE group(11.8%), but it was not statistically significant (P = 0.155). Intraoperative blood loss, length of hospital stay and the incidence of postoperative complications were not statistically different between the two groups. Four (11.1%) patients have anastomotic leakage in the RATLE group, compared to 4 (11.8%) patients in the CTLE group (P = 0.772). The RATLE and CTLE groups did not differ significantly with regard to the total number of harvested lymph nodes (18.8 ± 7.0 vs. 20.1 ± 8.3, P = 0.468), the numbers of lymph nodes dissected from recurrent laryngeal nerve chains(4.7 ± 3.1 vs. 4.9 ± 3.4, P = 0.779) and the abdomen(5.9 ± 3.5 vs. 5.1 ± 3.1, P = 0.354).

Conclusion
There is technical superiority with shorter operation time and similar short-term surgical results for RATLE compared with CTLE. Though the incidence of postoperative recurrent laryngeal palsy is slightly higher for RATLE, it doesn’t affect postoperative recovery. Long-term survival data should be followed in the future to compare the oncological outcome between the two groups.

Disclosure
All authors have declared no conflicts of interest.
FA02.01: PREVALENCE AND RISK FACTORS FOR ESOPHAGEAL CANCER FOLLOWING ACHALASIA TREATMENT: NATIONAL POPULATION-BASED CASE-CONTROL STUDY
Authors: Markar Sheraz , Wiggins Tom , Mackenzie Hugh , Faiz Omar , Zaninotto Giovanni , Hanna George 
Published: September 2018

Abstract

Background
Achalasia is associated with an increased risk of esophageal cancer, however the specific population at greatest risk remains unknown. The objectives of the present study were from a large national population based cohort study to: (i) Identify the prevalence of esophageal cancer in treated achalasia patients. (ii) Consider patient and treatment related risk factors, associated with an increased prevalence of esophageal cancer.

Methods
Patients with esophageal achalasia diagnosed and receiving a treatment between 2002 and 2012 were identified from the Hospital Episode Statistics database. The primary outcome measure was esophageal cancer. All patients with a diagnosis of esophageal cancer within one year of achalasia primary treatment were excluded to avoid inclusion of pseudoachalasia patients. Patient and treatment factors were compared between patients who developed esophageal cancer and those that did not using univariate and multivariate analyses.

Results
Over the 11-year study period 7487 patients receiving an interventional treatment for esophageal achalasia were included and 101 patients (1.3%) developed esophageal cancer. The median time to cancer development was 3 years (range 1 to 11 years) from primary achalasia treatment. Patients who developed esophageal cancer were older with a greater proportion of patients aged > 60 (71.3% vs. 45.4%; P < 0.001), and more commonly were primarily treated with pneumatic dilation (82.2% vs. 60.3%; P < 0.001). In the esophageal cancer group there was also an increase in the number of patients requiring re-interventions (47.5% vs. 38.0%; P = 0.041) and the average total number of re-interventions per patient over the study period (1.2 vs. 0.8; P = 0.026). Subset analyses for surgical myotomy and pneumatic dilation primary treatment groups showed similar associations between re-intervention and increased risk of cancer. Multivariate analysis confirmed associations between increased patient age (> 80 years, HR = 18.71; 95%CI 4.30–81.44) and pneumatic dilation (HR = 2.27; 95%CI 1.03–5.03), and risk of esophageal cancer.

Conclusion
This national achalasia population based case-control study identified increasing patient age, pneumatic dilation and re-intervention as potential risk factors associated with the development of esophageal cancer. Patients with these risk factors should receive more intensive endoscopic surveillance to ensure esophageal cancer is appropriately diagnosed at an early stage.

Disclosure
All authors have declared no conflicts of interest.
FA03.01: LONG-TERM OUTCOMES OF PATIENTS WITH RECURRENT SQUAMOUS CELL CARCINOMA OF THE ESOPHAGUS UNDERGOING SALVAGE ENDOSCOPIC RESECTION
Authors: Ego Mai , Abe Seiichiro , Nakatani Yukihiro , Nonaka Satoru , Suzuki Haruhisa , Yoshinaga Shigetaka , Oda Ichiro , Kato Ken , Honma Yoshitaka , Ito Yoshinori , Itami Jyun , Daiko Hiroyuki , Boku Narikazu 
Published: September 2018

Abstract

Background
introduction:
Definitive chemoradiotherapy (dCRT) is a treatment option for esophageal squamous cell carcinoma (ESCC). Salvage endoscopic resection (ER) has a potential of cure for patients with local recurrence or residual tumor after dCRT, which is less invasive compared with salvage esophagectomy. Aim:
To evaluate the long-term outcomes of patients with recurrence ESCC undergoing salvage ER and to identify risk factors associated with disease recurrence after salvage ER.

Methods
Retrospective analysis of 42 patients with ESCC treated with salvage ER for either local failure or recurrent disease after dCRT between January 2000 and December 2017. Salvage ER was indicated for clinically diagnosed T1N0M0 post dCRT in our hospital. Cox hazard model analysis was used to identify risk factors for recurrence after post-salvage ER.

Results
A total of 42 patients (35 males, 5 females), mean age 65 years (39–85), TNM stage before dCRT (I, II, III) 22/13/6, complete response (35 [85%]) were evaluated. The median time to salvage ER from the initiation of dCRT was 18.3months (2–130). ESD, EMR-C, and SB were performed for 4, 26, 11 patients. En-bloc resection rates were 100% (4/4), 61% (16/26) and 18% (2/11) for ESD, EMR-C, SB, respectively. There were no severe adverse event. Histological findings in the ER specimen was as follows; depth of invasion: T1a/T1b = 27/14(65/35%), lymphovascular invasion +/− = 7/34 (17/83%), vertical margin: 0/1/X = 34/4/3, and horizontal margin: 0/1/X = 25/5/11. A total of 19 patients (46%) developed recurrence after salvage ER. Recurrence sites were local/lymph node/local + lymph node/lymph nodes + distant metastasis in 9/8/2. For recurrent disease after ER, esophagectomy, lymphadenectomy and chemotherapy and best supportive care were performed for 8, 2, 4, 4 and 2, respectively, resulting in 6 death from ESCC. Three-year recurrence free survival rate, overall survival rate, and disease specific survival rate were 53.9%, 84.2%, and 88.4%, respectively. Multivariate analysis revealed that lymphovascular invasion was independent predictor of disease recurrence after salvage ER (HR = 2.96, 95%C. I 1.05–8.38, P = 0.04).

Conclusion
Salvage ER is clinically safe and effective in patients with local recurrence of ESCC after dCRT.
Careful follow-up might be recommended for the patients with lymphovascular invasion.

Disclosure
All authors have declared no conflicts of interest.