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2021 ◽  
Vol 25 (2) ◽  
pp. 11
Author(s):  
B. K. Kadyraliev ◽  
V. B. Arutyunyan ◽  
I. I. Chernov ◽  
A. H. Umarov ◽  
K. Yu. Zhigalov ◽  
...  

<p>Aortic valve reconstruction remains the ideal approach to treat aortic valve disease, with an aim to increase durability and prevent anticoagulation. Owing to its availability, handling ease, and low cost, autopericardium has been regularly used since the early days of cardiac surgery. Many of these methods have not been standardized yet and are underutilized. One method with promising long-term results is neocuspidization of the aortic valve, as described by Ozaki using glutaraldehyde-fixed autopericardium. Neocuspidization of the aortic valve includes valve prosthetics with its own pericardium. We performed a literature review on aortic valve neocuspidization.</p><p>Received 13 October 2020. Revised 6 November 2020. Accepted 11 November 2020.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> Authors declare no conflict of interest.</p><p><strong>Author contributions</strong><br />Conception and study design: B.K. Kadyraliev, V.B. Arutyunyan, I.I. Chernov, A.H. Umarov, K.Yu. Zhigalov, A. Weymann, S.T. Enginoev<br />Drafting the article: B.K. Kadyraliev, V.B. Arutyunyan, S.T. Enginoev<br />Critical revision of the article: V.B. Arutyunyan, A.H. Umarov, S.T. Enginoev<br />Final approval of the version to be published: B.K. Kadyraliev, V.B. Arutyunyan, I.I. Chernov, A.H. Umarov, K.Yu. Zhigalov, <br />A. Weymann, S.T. Enginoev</p>


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
G. Benfatto ◽  
◽  
F. Drago ◽  

Abstract Background This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial. Methods We retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives. Results Almost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval. Conclusions Preventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits.


2020 ◽  
Vol 24 (4) ◽  
pp. 22
Author(s):  
A. N. Kazantsev ◽  
G. G. Khubulava ◽  
V. N. Kravchuk ◽  
A. A. Erofeev ◽  
K. P. Chernykh

<p>This review investigates the various methods used for carotid endarterectomy (CEE). These methods are presented, and allow us to analyse effective revascularisation with extended damage to the internal carotid artery. The data of studies comparing the results of eversion and classical carotid endarterectomy with plasty of the reconstruction zone with a patch made of diepoxy-treated pericardium are presented. Special attention is paid to emergency carotid endarterectomy and carotid endarterectomy in the acute period of ischemic stroke. The important and main aspects of the glomus-saving species of CEE are also demonstrated. The main complications behind operations, and causes of restenosis in long-term follow-up periods are also duly noted. Similarly, suggestions to eliminate these issues are also proposed. This review comprehensively covers the state of the art of carotid endarterectomy and dissects current techniques and methods in the area.</p><p>Received 16 July 2020. Revised 24 August 2020. Accepted 25 August 2020.</p><p><strong>Conflict of interest:</strong> Authors declare no conflicts of interest.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Author contributions</strong><br />Conception and study design: G.G. Khubulava<br />Drafting the article: A.N. Kazantsev<br />Critical revision of the article: A.A. Erofeev, V.N. Kravchuk, K.P. Chernykh<br />Final approval of the version to be published: G.G. Khubulava, A.N. Kazantsev, A.A. Erofeev, V.N. Kravchuk, K.P. Chernykh</p>


Author(s):  
Michał Hutny ◽  
Jagoda Hofman ◽  
Agnieszka Zachurzok ◽  
Paweł Matusik

Rising child obesity rate creates a need for tools quantifying metabolic changes in obese children and adolescents for purposes of comorbidities early detection or prevention. A candidate for such role seem to be miRNAs &ndash; in vivo serving as the suppressing factors of the gene expression. The aim of this study was to review the recent discoveries in this field and to conclude directions of research or application of studied molecules. Repeated browsing of databases, followed by screening for eligibility of results, led to final approval of 9 articles. Filtered studies examined the differences in miRNA (miR) expression levels of obese subjects and children suffering from obesity comorbidities. Studies concerning the endothelial dysfunction (ED) identified miR-630 as a possible treatment option. Search for the alternative markers in diagnosis of non-alcoholic fatty liver disease (NAFLD) suggested value of miR-199a-5p and miR-122. MiR-486, miR-146b and miR-15b may serve as a panel of markers grading the development of type 2 diabetes mellitus (T2DM) in children, although further research raised doubts in that matter. Another panel of miRNA molecules was indicated as useful in early detection of alterations leading to metabolic syndrome (MetS). No valid link between studied miRNAs and atherosclerosis (AS) was found. MiRNAs seem to be promising prognostic markers for the diagnosis of NAFLD, T2DM and MetS in children. Further studies are required to support these findings.


2020 ◽  
Vol 24 (2) ◽  
pp. 119
Author(s):  
I. S. Murashov ◽  
V. E. Kliver ◽  
T. A. Ageeva ◽  
A. M. Volkov ◽  
E. E. Kliver

<p>Undifferentiated pleomorphic sarcoma is a high-grade malignant tumour, accounting for one-third of all primary cardiac sarcomas. This paper describes a case of undifferentiated pleomorphic sarcoma in an infant using detailed morphological characterisation, immunohistochemical examination and a brief literature review. Taken together, these data will be useful not only for practicing pathologists but also for researchers of other biomedical fields for the development of procedures for differential diagnoses, investigation of the pathogenesis and development of therapeutic approaches for undifferentiated pleomorphic sarcoma.</p><p>Received 4 February 2019. Revised 31 March 2020. Accepted 9 April 2020.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> Authors declare no conflict of interest.</p><p><strong>Author contributions</strong><br />Drafting the article: I.S. Murashov, E.E. Kliver<br />Literature review: V.E. Kliver, T.A. Ageeva<br />Illustrations: V.E. Kliver, A.M. Volkov<br />Critical revision of the article: I.S. Murashov, E.E. Kliver<br />Final approval of the version to be published: I.S. Murashov, V.E. Kliver, T.A. Ageeva, A.M. Volkov, E.E. Kliver</p>


2020 ◽  
Vol 24 (2) ◽  
pp. 9
Author(s):  
O. V. Krestyaninov ◽  
D. A. Khelimskii ◽  
A. G. Badoian ◽  
R. U. Ibragimov ◽  
R. A. Naydenov

<p>Chronic coronary total occlusions (CTOs) represent the most complex group of lesions in interventional cardiology, and technical success in their treatment depends on not only the characteristics of the lesions themselves but also the experience of the operator.<br />Over the past few years, many CTO recanalisation techniques have been proposed, leading to the need for standardisation to achieve a higher success rate. As a result, a number of algorithms that allow the surgeon to choose one or another recanalisation technique depending on the angiographic features of the vessel have been proposed.<br />This article provides an overview of the main algorithms for choosing a CTO recanalisation strategy and considers the clinical and angiographic characteristics that form the basis of the algorithms. The possibility of their use in clinical practice has also been evaluated.</p><p>Received 7 April 2020. Revised 27 April 2020. Accepted 27 April 2020.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> Authors declare no conflict of interest.</p><p><strong>Author contributions</strong><br />Conception and design: O.V. Krestyaninov, D.A. Khelimskii<br />Drafting the article: O.V. Krestyaninov, D.A. Khelimskii, A.G. Badoian, R.A. Naydenov, R.U. Ibragimov<br />Critical revision of the article: R.A. Naydenov, R.U. Ibragimov<br />Final approval of the version to be published: O.V. Krestyaninov, D.A. Khelimskii, A.G. Badoian, R.A. Naydenov, R.U. Ibragimov</p>


2020 ◽  
Vol 9 ◽  
pp. 244-253
Author(s):  
Mohammad Taha Hussein AL-Huseini

The authority that have the right to amend the constitution have to be restricted to two points: the first is to abide by the restrictions which the constitutional legislator imposed for the amendment, and the second is that the amendment should goes through the stages stipulated by it in the constitutional document. Both are found in the Iraqi constitution amendment, so the constitutional legislator imposed a set of restrictions on  the amendment, which must be started with the proposal, the initiative approval  and finally the final approval, whether the amendment  is normal or extraordinary; each has  its terms of success which may cause the  difference  between them.


2020 ◽  
Author(s):  
Arkadiusz Wudarski

This paper describes the development of the principles of fiduciary access to digital assets in the United States. It focuses on US legislation before the drafting of the Revised Uniform Fiduciary Access to Digital Assets Act (RUFADAA) in 2015, examining the legal and social issues faced by American lawyers in their search for a balance between facilitating fiduciary access and respecting privacy. Special attention is paid to the first legislative initiatives at the state level as well as to two model regulations that represent opposite approaches to access to digital assets: the Privacy Expectation Afterlife and Choices Act (PEAC) and the Uniform Fiduciary Access to Digital Assets Act (UFADAA). The analysis considers the requirements for gaining access to the account of a deceased user, conflicts between legally protected interests and conflicting federal and state laws, and the meaning of such legal terms as digital assets, fiduciary, custodian, content of an electronic communication, et. al. The reasons for the failure of these acts to receive final approval are also analysed. Research is based on American doctrine, state and federal legal acts, documentation of the legislative process, and the work of expert groups, including, primarily, the Uniform Law Commission (ULC).  


2019 ◽  
Vol 77 (2) ◽  
pp. 113-121 ◽  

Abstract Purpose The process of updating the recommendations of the ASHP Practice Advancement Initiative (PAI) is described, and the new recommendations targeted toward the year 2030 are presented. Summary The process for updating ASHP recommendations for pharmacy-practice change included online surveys of pharmacists, pharmacy technicians, and other stakeholders; extensive discussions by an advisory panel, a strategic planning group, and participants in a town hall session at a national conference; an online public comment period; and final approval by the ASHP Board of Directors. Conclusion The guidance offered by the 59 updated PAI recommendations, which take into account environment trends that are likely to affect the pharmacy enterprise, will help health-system pharmacists in their ongoing pursuit of optimal, safe, and effective use of medicines.


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