scholarly journals Medical Devices Made of Substances: Possible Innovation and Opportunities for Complex Natural Products

Planta Medica ◽  
2021 ◽  
Author(s):  
Anna Rita Bilia ◽  
Enrico Stefano Corazziari ◽  
Stefano Govoni ◽  
Alessandro Mugelli ◽  
Marco Racchi

AbstractThe novel Regulation 2017/745/EC on medical devices introduces and strengthens the role of “medical devices made of substances”, which mostly include substances of natural origin. Natural products may follow different regulations, from food to therapeutics. Concerning their isolated constituents, extracts are characterized by a complexity that is not easily tackled from both a scientific and a regulatory point of view, but more importantly, from a therapeutic point of view. The evidence-based approach applied to isolated molecules requires appropriate evidence of quality, efficacy, and safety. The same needs must be reached for complex substances by finding appropriate methods to generate this evidence, and in addition, defining an appropriate regulatory field for them. From a scientific point of view, new methods, such as those proposed by systems biology, are available and applicable to complex substances. From a regulatory point of view, Directive 2001/83/EC on medicinal products seems to be modeled on single (or combinations of single) molecule products. On the other hand, Regulation 2017/745/EC on medical devices seems to apply to complex substances without derogating on quality, efficacy, and safety. The regulation specifically names and strengthens medical devices that include substances, mostly of natural origin, introducing the official term “medical devices made of substances”. This paper discusses and proposes an interpretation of important terms connected to this legislation, regarding both scientific and regulatory issues, and the opportunities the regulation may give for innovation and therapeutic improvement with natural complex substances.

Author(s):  
Anatoly S. Kuprin ◽  
Galina I. Danilina

The purpose of this study is the analysis of limit situation in the narrative of war. The material of the study is the novel of Daniil Granin “My Lieutenant” and related texts. In the first part of the paper, the authors explore existing approaches to the term “limit situation” and similar concepts into scientific and philosophical traditions; limits of its applicability in literary studies and its relation to the categories of “narrative instances” and “event”. Proposed a literary-theoretical definition of the limit situation, which can be used in the analysis of fiction texts. Existing approaches to the examination of the situation of war are analyzed: philosophical-existential, psychoanalytic, sociological, literary. In the second part of the paper, the authors propose their method for analyzing limit situations in texts about war, which basis on existing approaches and preserves the text-centric principle of studying the structure of the story. Two interrelated areas of research have been identified: the study of war as a continuous limit situation in the intertextual aspect (the discourse of war); the study of limit situations (death, suffering, guilt, accident) in the narrative of war as part of a specific text. In the third part of the scientific work,the analysis of war as a continuous limit situation results in the study of the concept of “limit” (border) in a fiction text. The role of “limit” (border) concept in the texts about the war is studied, the possible types of limits in the discourse of war are examined. Limit situations in the narrative of war are analyzed on the basis of the novel “My Lieutenant” by Daniil Granin. A review of journalistic and scientific works about the novel revealed both the continuity and the differences between the novel and the “lieutenant” prose of the 20th century. An analysis of the limit situations in the novel revealed their key position in the narrative. These situations are independent of the fiction time, of the fluctuation of the point of view’; the function of the abstract author is to build the narrative as a “directive” immersion of the hero and narrator in these situations.


2020 ◽  
Vol 2020 ◽  
pp. 1-20 ◽  
Author(s):  
Klara Komici ◽  
Valeria Conti ◽  
Sergio Davinelli ◽  
Leonardo Bencivenga ◽  
Giuseppe Rengo ◽  
...  

Dietary phytochemicals are considered an innovative strategy that helps to reduce cardiovascular risk factors. Some phytochemicals have been shown to play a beneficial role in lipid metabolism, to improve endothelial function and to modify oxidative stress pathways in experimental and clinical models of cardiovascular impairment. Importantly, investigation on phytochemical effect on cardiac remodeling appears to be promising. Nowadays, drug therapy and implantation of devices have demonstrated to ameliorate survival. Of interest, sex-gender seems to influence the response to HF canonical therapies. In fact, starting by the evidence of the feminization of world population and the scarce efficacy and safety of the traditional drugs in women, the search of alternative therapeutic tools has become mandatory. The aim of this review is to summarize the possible role of dietary phytochemicals in HF therapy and the evidence of a different sex-gender-oriented response.


Litera ◽  
2021 ◽  
pp. 1-9
Author(s):  
Vurgun Georgievich Mekhtiev

The subject of this research is the negative-axiological, satirical layers of the novel “The Islanders”, associated with the image of the demonic character, which M. Y. Lermontov turned into the archetype and poetic myth in the Russian literature. The object of this research is the stylistic techniques and ideological motifs of N. S. Leskov underlying “desacralization” of the romantic myth. The author meticulously examines the following aspects: 1) role of Lermontov's poem “The Demon” and romantic poetry of the 1840s in creation of the myth of the demonic character; 2) semantic deformations that led Leskov to wander from the conventional meanings of the myth ; 3) satirical modus used as the key technique in creation of the the image of Istomin. Particular attention is given to Leskov’s satire in its function of “recoding” of the myth. The conclusion is made that the image of the painter Istomin is appointed with the task to dispel the romantic myth. Therefore, the axiological-emotional lexis, as well as elements of satire that reflect the point of view of the “subjective” narrative are arrayed around him. All of that imparts semantic transparency to the character, which contradicts the “mysterious code” of the myth of romanticism. The author’s special contribution consists in the establishment of correlation between the myth of about the demon and the myth of Prometheus, which is important for assessing the complexity and multifacetedness of the semantic core of the phenomenon under review. The novelty of this research lies in revelation of underlying motif of the satirical style of N. S. Leskov. Its point is not to create a “myth about the myth” or an “anti-myth”; the novel forms the “non-myth” to achieve complete elimination of the literary myth of the demonic character. The writer uses satire for typification, rather than individualization of the character.


2020 ◽  
Vol 40 (7) ◽  
Author(s):  
Yuan Liu ◽  
Yusheng Dou ◽  
Liang Yan ◽  
Xiaobin Yang ◽  
Baorong He ◽  
...  

Abstract Recently, Rho GTPases substrates include Rac (Rac1 and Rac2) and Cdc42 that have been reported to exert multiple cellular functions in osteoclasts, the most prominent of which includes regulating the dynamic actin cytoskeleton rearrangements. In addition, natural products and their molecular frameworks have a long tradition as valuable starting points for medicinal chemistry and drug discovery. Although currently, there are reports about the natural product, which could play a therapeutic role in bone loss diseases (osteoporosis and osteolysis) through the regulation of Rac1/2 and Cdc42 during osteoclasts cytoskeletal structuring. There have been several excellent studies for exploring the therapeutic potentials of various natural products for their role in inhibiting cancer cells migration and function via regulating the Rac1/2 and Cdc42. Herein in this review, we try to focus on recent advancement studies for extensively understanding the role of Rho GTPases substrates Rac1, Rac2 and Cdc42 in osteoclastogenesis, as well as therapeutic potentials of natural medicinal products for their properties on the regulation of Rac1, and/or Rac2 and Cdc42, which is in order to inspire drug discovery in regulating osteoclastogenesis.


2004 ◽  
Vol 10 ◽  
Author(s):  
Zsolt Sógor

This paper wishes to analyse two early novels by Samuel Beckett; Murphy and Watt. It takes a chronological point of view from which it argues that the later of the two, Watt, is closer to Beckett's mature voice, mainly due to its relation with language. This means, in other words, that though in Murphy quite a lot of emphasis is to fall on the role of language, in Watt, with a bit of exaggeration, there is hardly anything else to concentrate on but the language of the novel and language as such in general. The emphasis on language leads to considering Beckett's relation to languages. Since Watt was for a long time the last longer prose work that Beckett wrote in English, the paper regards this novel as a harbinger of the approaching change for French. Or rather, the approaching bilingual state, because, as it is argued, Beckett may be said to have been approaching an in-between state in, or beyond, the two languages of composition. Taking the author's bilingualism into consideration means, however, an author-oriented approach - this is what the paper undertakes to present; to find Beckett's fingerprints between the lines.


2020 ◽  
pp. 109-125
Author(s):  
Florij Batsevych

In recent decades, the researchers of artistic stories have paid their attention to the narrative analysis of a set of weird texts of mystical and absurd content, works of “black humour”, fantastic (khymerna) prose created by a non-anthropic narrator or by an author in a changed state of consciousness. These texts serve the field of actualizing atypical and non-usual narrative structures, the sphere of meaningful changes within the bounds of narrative categories and, which is important, of forming special communicative senses of aesthetic nature. The basic problems of the linguistic analysis of “unnatural” stories are identifying the types of changes in the narration constituents, reasons of these changes and narrative categories (first of all, events, participants, objects, chronotope characteristics, points of view, moduses, modalities, etc.). The article analyses one of the texts of mystical content aiming at the revealing of some specificities of the structure and functioning of the so-called “unnatural artistic narrations”. The object of the research is V. Shevchuk’s novel “The Beginning of Horror”. The subject of the analysis is lingual means of the narrative structure formation, the author’s objectification of the mystical artistic sense and lingual “signals” of a reader’s perception of these senses. The most important semantic means of creating mystical atmosphere of the story are predicates that ascribe the names of their referents atypical dynamic and static features connected with the Christian view of the infernal world. It helps to form narrative events that root in weird situations, which cannot take place in reality. Non-dispositional nature of these situations correlates with the reference to the mystery that goes far beyond the bounds of a usual perceptive and psycho-mental background. Among the pragmatic means of creating mystical atmosphere of the main hero’s story as well as of the novel in general, we specify the individual inimitative perception of the flow of time and modality of “real unreality” formed by the role of an unreliable narrator and a vague point of view of the described event with its perceptive, ideological and time planes of objectification. Due to the increasing interest to various expressions of the esoteric, the increase of the number of artistic works of such content and growth of their popularity, we consider it topical to proceed in further investigations of lingual-narrative aspects of “unnatural” stories, in particular, the ones with the modus of mystical in them.


2019 ◽  
Vol 3 ◽  
pp. 00022
Author(s):  
Fauzan Hanif

<p class="Abstract">Such cultural experiences have a possibility to be embedded in a memory of one generation. But there are mostly in form of traumatic experiences. And then, we learn that these memories could be transferred onto their children, or we could say it as “post generation”. In the novel <i>Dora Bruder</i>, such things happen when the author, Patrick Modiano, plays his attribute in composing genres to arrange and transfer his message. The story mainly concerns as the narrator try to find a missing girl named Dora Bruder. She was gone in 1941, or in the moment when Nazi was occupying France. This research aims to discover the relationship between the role of genre on emerging the message, particularly the traumatic ones by using the concept of genre and postmemory. From the analysis we conclude that Modiano use genres to transfer his message traumatic. It exists in form of the impression of absence. From the sensation of absence, he continues to transmit consecutively another impression of hollow, doubt, and also hope. For transferring his message and memory, Modiano mixes real documents and his fiction. He manifest them by constructing a story of another person and narrating it from the first-person point of view. He uses this technique to identify himself, because the “shared idea” of one’s could be related with another’s.</p>


2017 ◽  
Vol 25 (1) ◽  
pp. 9-26
Author(s):  
Monica Licker ◽  
Roxana Moldovan ◽  
Elena Hogea ◽  
Delia Muntean ◽  
Florin Horhat ◽  
...  

Abstract The term biofilm designates an aggregate of microorganisms belonging to one or more species which adhere to various surfaces but also to each another. These microbial communities are included and interconnected within an organic structure known as slime, composed of protein substances, polysaccharides, and DNA. The Center for Disease prevention and control considers infections with bacteria in biofilms among the 7 most important challenges which must be overcome in order to improve the safety of health services. The risk of microbial biofilm development exists for a long list of medical devices and equipment, as well as in certain diseases such as cystic fibrosis. An aggravating aspect is represented by the almost 1,000 times higher antimicrobial resistance of bacteria growing and multiplying within biofilms. Thus, in case of biofilm-infected medical devices, the resistance to antimicrobial treatments requires the removal of the device which essentially means the failure of the exploratory or therapeutic intervention in question. The role of microbial biofilms in medical pathology is a subject that raises interest for both researchers and clinicians in order to establish new methods for prevention and treatment of biofilms. This paper is intended as an overview in the management of microbial biofilms, presenting future insights, with technological progress in microscopy, molecular genetics, and genome analysis. Therefore the present paper will focus on describing the mechanisms involved in biofilm development, biofilm related infections, methods of detection and quantification of microbial communities and therapeutical approaches.


Author(s):  
Gurvir Rai ◽  
Anokhee Thakker ◽  
Hasti Patel

Obstructive Sleep Apnea (OSA) is a common sleep disorder in mammals which is characterized by the repeated collapse of the upper airway. It is a known cause of hypertension, cardiovascular disease, and, in some cases, death. OSA is commonly treated by medical devices and surgeries. Although effective, these treatments are associated with unwanted side-effects and further complications. In recent years, the role of medicinal marijuana has grown as a potential treatment for sleep disorders. Further research must be conducted to determine the efficacy and safety of cannabis as a treatment for OSA.


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