Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol

Background Sedation prior to performance of diagnostic esophagogastroduodenoscopy (EGDE) is widespread and increases patient comfort. But 98% of all serious adverse events during EGDEs are ascribed to sedation. The S3 guideline for sedation procedures in gastrointestinal endoscopy published in 2008 in Germany increases patient safety by standardization. These new regulations increase costs because of the need for more personnel and a prolonged discharge procedure after examinations with sedation. Many patients have difficulties to meet the discharge criteria regulated by the S3 guideline, e.g. the call for a second person to escort them home, to resign from driving and working for the rest of the day, resulting in a refusal of sedation. Therefore, we would like to examine if an acupuncture during elective, diagnostic EGDEs could increase the comfort of patients refusing systemic sedation. Methods/Design A single-center, double blinded, placebo controlled superiority trial to compare the success rates of elective, diagnostic EGDEs with real and placebo acupuncture. All patients aged 18 years or older scheduled for elective, diagnostic EGDE who refuse a systemic sedation are eligible. 354 patients will be randomized. The primary endpoint is the rate of successful EGDEs with the randomized technique. Intervention: Real or placebo acupuncture before and during EGDE. Duration of study: Approximately 24 months. Discussion Organisation/Responsibility The ACUPEND - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Interdisciplinary Endoscopy Center (IEZ) of the University Hospital Heidelberg is responsible for design and conduct of the trial, including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI) and the Center of Clinical Trials (KSC) at the Department of General, Visceral and Transplantation Surgery, University of Heidelberg.

Intersection of Tradition and Need of Change in Romanian Child Protection System

The reconstruction of the child protection system in the post-communist period so as to meet professional standards while responding to the needs of children is an enormous task. In order to understand the features of the current stage of the development of the Romanian child protection system and to evaluate its trends towards change, Roth-Szamoskozi analysed data from scientific literature and collected statistics to document the evolution of the child-protection structure. Empirical data collection using qualitative methods (content analysis of documents and interviews with staff) were designed to reflect the degree to which child welfare laws correspond to internationally accepted regulations and to analyse the attitudes of those working in the field at different decision-making levels. An experiment with a group of 12 students showed that there have been basic changes in the legal framework of Romanian child welfare. Students could see that the required principles exist in the new Romanian child protection law, but also identified areas which are still inadequately represented. 61 staff members working in child welfare agencies (both state and non-governmental) were also interviewed, using a systematic, circular interview. Using the criteria of competence and the existence of specific social goals, professionalism in solving social problems and respect for social-work values, the 30 non-governmental organisations were divided into three categories. The first (7 organisations) are active in the area, know the law and are fairly professional, the second (5) are motivated in their work with specific problems, but with no great competence. The 18 organisations in the third group have no competence in the social field and in issues concerning children and do only charitable work. The state agencies are still dominated by routine, but there were many staff members who were developing reform and strategic roles and were actively directing the system towards change. Many staff members in both governmental and non-governmental organisations were directing the system towards a stress on intervention in the interests of the child in the context of its family. Roth-Szamoskozi found that staff members felt the need of a more accurate evaluation system which would enable them to show their results more clearly.

Astroblastoma with rhabdoid features and favorable long-term outcome: report of a case with a 12-year follow-up

Astroblastoma is a historically traded microscopic diagnosis to denote a rare neuroepithelial tumor of uncertain nosology, involving a distinctive pattern of pseudorosette arrangement of neoplastic cells. While displaying some glial properties, the latter shall not - by definition - be either reducible to or part of any conventional glioma type. We report on clinicopathologic correlations in a case of astroblastoma involving an extensive rhabdoid phenotype of tumor cells. The male patient was operated on at the age of 53 and 59 years for a left parietal tumor measuring 5.8 cm in diameter at the first presentation. On magnetic resonance imaging and angiography, both the primary and its recurrence were discrete, highly vascularized, and contrast-enhancing. The second surgery was complemented with radiotherapy of 66 Gy, followed by chemotherapy with Temozolomide. Twelve years into clinical history, the patient has stable minimal residual disease at the age of 65. A review of pathology samples from both surgeries showed well-differentiated astroblastoma according to current standards, with an MIB-1 labeling index of 1% and 4%, respectively. Neither of the specimens involved cellular anaplasia, overt mitotic activity, microvascular proliferation, or palisading necrosis. Most tumor cells harbored paranuclear filamentous rhabdoid inclusions that were immunostained for vimentin and, in part, also for GFAP. No polyantigenic reactivity was observed. This example contributes another facet to the spectrum of the so-called composite rhabdoid tumors. Involving a low-grade parent neoplasm, it also further substantiates the incipient perception that the rhabdoid phenotype neither is a peculiar but nonspecific convergence point of anaplastic evolution, nor are such lesions indiscriminately bound for a relentless course.

Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome

OBJECTIVES: We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California). BACKGROUND: Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis. METHODS: Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age > or =80 years with a logistic EuroSCORE > or =20% (21-F group) or age > or =75 years with a logistic EuroSCORE > or =15% (18-F group); or 3) age > or =65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support. RESULTS: A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 +/- 0.19 cm2 (21-F) and 0.54 +/- 0.15 cm2 (18-F), a mean age of 81.3 +/- 5.2 years (21-F) and 83.4 +/- 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 +/- 13.5% (21-F) and 19.1 +/- 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%. CONCLUSIONS: Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.

Immediate transmucosal implant placement in molar extraction sites: a 12-month prospective multicenter cohort study

AIM: To assess the clinical and radiographic outcomes of immediate transmucosal placement of implants into molar extraction sockets. STUDY DESIGN: Twelve-month multicenter prospective cohort study. MATERIAL AND METHODS: Following molar extraction, tapered implants with an endosseous diameter of 4.8 mm and a shoulder diameter of 6.5 mm were immediately placed into the sockets. Molars with evidence of acute periapical pathology were excluded. After implant placement and achievement of primary stability, flaps were repositioned and sutured allowing a non-submerged, transmucosal healing. Peri-implant marginal defects were treated according to the principles of guided bone regeneration (GBR) by means of deproteinized bovine bone mineral particles in conjunction with a bioresrobable collagen membrane. Standardized radiographs were obtained at baseline and 12 months thereafter. Changes in depth and width of the distance from the implant shoulder (IS) and from the alveolar crest (AC) to the bottom of the defect (BD) were assessed. RESULTS: Eighty-two patients (42 males and 40 females) were enrolled and followed for 12 months. They contributed with 82 tapered implants. Extraction sites displayed sufficient residual bone volume to allow primary stability of all implants. Sixty-four percent of the implants were placed in the areas of 36 and 46. GBR was used in conjunction with the placement of all implants. No post-surgical complications were observed. All implants healed uneventfully yielding a survival rate of 100% and healthy soft tissue conditions after 12 months. Radiographically, statistically significant changes (P<0.0001) in mesial and distal crestal bone levels were observed from baseline to the 12-month follow-up. CONCLUSIONS: The findings of this 12-month prospective cohort study showed that immediate transmucosal implant placement represented a predictable treatment option for the replacement of mandibular and maxillary molars lost due to reasons other than periodontitis including vertical root fractures, endodontic failures and caries.

INVESTIGATION OF STRATEGIES TO PROMOTE EFFECTIVE TEACHER PROFESSIONAL DEVELOPMENT EXPERIENCES IN EARTH SCIENCE

This dissertation serves as a call to geoscientists to share responsibility with K-12 educators for increasing Earth science literacy. When partnerships are created among K-12 educators and geoscientists, the synergy created can promote Earth science literacy in students, teachers, and the broader community. The research described here resulted in development of tools that can support effective professional development for teachers. One tool is used during the planning stages to structure a professional development program, another set of tools supports measurement of the effectiveness of a development program, and the third tool supports sustainability of professional development programs. The Michigan Teacher Excellence Program (MiTEP), a Math/Science Partnership project funded by the National Science Foundation, served as the test bed for developing and testing these tools. The first tool, the planning tool, is the Earth Science Literacy Principles (ESLP). The ESLP served as a planning tool for the two-week summer field courses as part of the MiTEP program. The ESLP, published in 2009, clearly describe what an Earth science literate person should know. The ESLP consists of nine big ideas and their supporting fundamental concepts. Using the ESLP for planning a professional development program assisted both instructors and teacher-participants focus on important concepts throughout the professional development activity. The measurement tools were developed to measure change in teachers’ Earth science content-area knowledge and perceptions related to teaching and learning that result from participating in a professional development program. The first measurement tool, the Earth System Concept Inventory (ESCI), directly measures content-area knowledge through a succession of multiple-choice questions that are aligned with the content of the professional development experience. The second measurement, an exit survey, collects qualitative data from teachers regarding their impression of the professional development. Both the ESCI and the exit survey were tested for validity and reliability. Lesson study is discussed here as a strategy for sustaining professional development in a school or a district after the end of a professional development activity. Lesson study, as described here, was offered as a formal course. Teachers engaged in lesson study worked collaboratively to design and test lessons that improve the teachers’ classroom practices. Data regarding the impact of the lesson study activity were acquired through surveys, written documents, and group interviews. The data are interpreted to indicate that the lesson study process improved teacher quality and classroom practices. In the case described here, the lesson study process was adopted by the teachers’ district and currently serves as part of the district’s work in Professional Learning Communities, resulting in ongoing professional development throughout the district.

Soft tissues healing at immediate transmucosal implants placed into molar extraction sites with buccal self-contained dehiscences. A 12-month controlled clinical trial

AIM: To assess soft tissues healing at immediate transmucosal implants placed into molar extraction sites with buccal self-contained dehiscences. MATERIAL AND METHODS: For this 12-month controlled clinical trial, 15 subjects received immediate transmucosal tapered-effect (TE) implants placed in molar extraction sockets displaying a buccal bone dehiscence (test sites) with a height and a width of > or =3 mm, respectively. Peri-implant marginal defects were treated according to the principles of Guided Bone Regeneration (GBR) by means of deproteinized bovine bone mineral particles in conjunction with a bioresorbable collagen membrane. Fifteen subjects received implants in healed molar sites (control sites) with intact buccal alveolar walls following tooth extraction. In total, 30 TE implants with an endosseous diameter of 4.8 mm and a shoulder diameter of 6.5 mm were used. Flaps were repositioned and sutured, allowing non-submerged, transmucosal soft tissues healing. At the 12-month follow-up, pocket probing depths (PPD) and clinical attachment levels (CAL) were compared between implants placed in the test and the control sites, respectively. RESULTS: All subjects completed the 12-month follow-up period. All implants healed uneventfully, yielding a survival rate of 100%. After 12 months, statistically significantly higher (P<0.05) PPD and CAL values were recorded around implants placed in the test sites compared with those placed in the control sites. CONCLUSIONS: The findings of this controlled clinical trial showed that healing following immediate transmucosal implant installation in molar extraction sites with wide and shallow buccal dehiscences yielded less favorable outcomes compared with those of implants placed in healed sites, and resulted in lack of 'complete' osseointegration.

Social Work in Republic of Buryatia/Russia

The Republic of Buryatia is situated in Eastern Sibiria, the eastern coast of Baikal Lake. The total area of the republic is 351 thousand square kilometers. The capital of Republic is Ulan-Ude. The modern social-economic situation in Russia is extremely paradoxical and multiaspectual - negative processes take place almost in all spheres of the society. The introduction of market economy principles, the process of privatisation, and the last economic crises in the Federation of Russia have brought many social phenomena - among them increasing poverty, homelessness and still high rate of unemployment are the worst one. It makes the changes in the state social welfare programmes and functioning patterns be implemented. Social problems are especially very important in the so-called "depressive" regions of Russia (Buryatia Republic is among those regions). The most important is the staff supplement of social services and the level of professionalism of people who work there. This problem consists of two aspects: first, the number of specialists with professional education of social workers is not enough; second, the level of professionalism of the workers is very low.

Analysts' Forecast Accuracy in Germany: The Effect of Different Accounting Principles and Changes of Accounting Principles

This paper assesses the influence of an adoption of IAS/IFRS or US GAAP on the financial analysts’ forecast accuracy in a homogenous institutional framework. Our findings suggest that the forecast accuracy is higher for estimates based on IFRS or US GAAP data than for forecasts based on German GAAP data.Moreover, in the year of switching from German GAAP to US GAAP the forecast accuracy is lower than in other years. The paper contributes to prior research by providing evidence about the usefulness of international accounting data and about the adoption effects of a change to such accounting principles.

The EU Policy on Institutional Multilingualism: Between Principles and Practicality

This article brings to light several inconsistencies within the narrative of the EU policy on institutional multilingualism. The EU has invoked fundamental EU principles of democracy, equality and transparent government, to publically bolster the need for its institutions to communicate and operate in the languages of its citizens. However, these principles do not allow for the pragmatic and budgetary arguments that the EU uses to justify the in reality limited number of official and de facto working languages of its institutions. The article argues that this disagreement could be resolved if the narrative of the EU's language policy would include the objective that all European citizens master any of the languages that the EU institutions use. In that light, the article recommends that further research is done into the question whether the EU should accept or even encourage the spontaneous development of English as a de facto pan-European lingua franca.