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    Ανάπτυξη και εφαρμογή πρωτοκόλλων διασφάλισης ποιότητας και επιτήρησης μιας κλινικής μελέτης

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    Οι κλινικές μελέτες στην ιατρική διεξάγονται για να επηρεάσουν την κλινική πρακτική και να βελτιώσουν την δημόσια υγεία. Για το λόγο αυτό πρέπει να έχουν όσο το δυνατόν λιγότερα σφάλματα και μεροληψίες, ορθή διαχείριση δεδομένων και ερμηνεία αποτελεσμάτων και μετέπειτα ενσωμάτωση στην κλινική πρακτική. Αυτά είναι εφικτά με ένα σύστημα διασφάλισης ποιότητας των κλινικών μελετών. Σκοπός της παρούσας εργασίας ήταν να διερευνηθεί η ανάπτυξη και η εφαρμογή των πρωτοκόλλων διασφάλισης ποιότητας και επιτήρησης των κλινικών μελετών. Πραγματοποιήθηκε αναζήτηση στις βάσεις δεδομένων Google Scholar και Pubmed, χωρίς χρονολογικό περιορισμό, στην Αγγλική γλώσσα, με λέξεις κλειδιά: “clinical trials”, “protocols”, “quality assurance”, “monitoring”. Οι πρακτικές διασφάλισης ποιότητας των κλινικών μελετών επικεντρώνονται στη συνεχή βελτίωση της διαδικασίας σε όλα τα στάδια της μελέτης για να εγγυηθεί την ποιότητα τους. Έχουν διατυπωθεί ενιαία πρωτόκολλα για την ποιότητα και εποπτεία των κλινικών μελετών, η δήλωση SPIRIT 2013 (Standard Protocol Items: Recommendations for Interventional Trials) και τα διάφορα έγγραφα της Διεθνούς Διάσκεψης για την Εναρμόνιση. Σημαντικά στοιχεία της ποιότητας των κλινικών μελετών είναι η συγγραφή του πρωτοκόλλου, ο σχεδιασμός της μεθοδολογίας, η ακεραιότητα, η μέθοδος συλλογής, διαχείρισης και ερμηνείας των δεδομένων, η ασφάλεια των συμμετεχόντων (απόρρητο και εμπιστευτικότητα), η τυχαιοποίηση των συμμετεχόντων, τα ηθικά ζητήματα και η προστασία από μεροληψία και σύγκρουση συμφερόντων. Ένα σύστημα διασφάλισης ποιότητας ελέγχει όλα τα στάδια της μελέτης να συμμορφώνονται με τα διεθνή και εθνικά πρότυπα και πρωτόκολλα. Επίσης, οι κλινικές μελέτες πρέπει να επιτηρούνται και να υφίστανται εξωτερικό έλεγχο από ειδική επιτροπή επιτήρησης που εφαρμόζει επιτόπια επιτήρηση ή κεντρική και στατιστική επιτήρηση. Η ικανότητα των προγραμμάτων διασφάλισης ποιότητας να μειώνουν τις διακυμάνσεις στη θεραπεία έχει αποδειχθεί και οδηγεί σε βελτίωση της ποιότητας των κλινικών δοκιμών. Για να είναι αποτελεσματικά τέτοια προγράμματα διασφάλισης ποιότητας, οι χορηγοί, τα συμμετέχοντα ιδρύματα και όλοι οι ερευνητές θα πρέπει να τα υιοθετήσουν και να τα ενσωματώσουν βέβαια στη κλινική έρευνα.Clinical trials in medicine are conducted to influence clinical practice and improve public health. For this reason they must have as few errors and biases as possible, proper data management and interpretation of results and subsequent integration into clinical practice. These are achievable with a clinical trial quality assurance system. The purpose of this paper was to investigate the development and implementation of clinical trial quality assurance and surveillance protocols. Google Scholar and Pubmed databases were searched, without chronological limitation, in the English language, with key words: “clinical trials”, “protocols”, “quality assurance”, “monitoring”. Clinical study quality assurance practices focus on continuous process improvement at all stages of the study to guarantee their quality. Uniform protocols have been formulated for the quality and supervision of clinical trials, the SPIRIT 2013 statement (Standard Protocol Items: Recommendations for Interventional Trials) and the various documents of the International Conference on Harmonization. Important elements of the quality of clinical trials are the writing of the protocol, the design of the methodology, the integrity, the method of data collection, management and interpretation, the safety of the participants (privacy and confidentiality), the randomization of the participants, ethical issues and the protection against bias and conflict of interest. A quality assurance system checks that all stages of the study comply with international and national standards and protocols. Also, clinical studies must be monitored and externally audited by a special monitoring committee that implements on-site surveillance or central and statistical surveillance. The ability of quality assurance programs to reduce variation in treatment has been demonstrated to lead to improved clinical trial quality. For such quality assurance programs to be effective, sponsors, participating institutions, and all researchers should adopt them and of course integrate them into clinical research

    Θεραπευτικές προσεγγίσεις βασισμένες στην ανίχνευση γονιδίων στόχων

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    Τις τελευταίες τρεις δεκαετίες η γονιδιακή θεραπεία έχει κατορθώσει αξιοσημείωτα βήματα κλινικών επιτυχιών και εμπορικού ενδιαφέροντος. Η κατανόηση της παθολογίας των ασθενειών και της τεχνολογίας μεταφοράς γονιδίων οδήγησαν σε καινοτόμες θεραπείες. Ειδικά σχετικά με τις θεραπείες που στηρίζονται στην ανίχνευση γονιδίων-στόχων, διερευνώνται διάφορες μέθοδοι για την αποτελεσματικότερη μεταφορά γονιδίων. Οι πιο διαδεδομένοι φορείς γενετικού υλικού είναι τα πλασμίδια, η χρήση γυμνού DNA, οι μη ιικοί φορείς (μικρά μόρια, λιπιδικά νανοσωματίδια, συνδέτης GalNAc) και οι ιικοί φορείς (αδενοϊοί, ρετροϊοί, λεντοϊοί, ανασυνδιασμένοι αδενο-σχετιζόμενοι ιοί, ιός του απλού έρπητα κ.α.), ενώ σημαντικές εξελίξεις έχουν σημειωθεί τα τελευταία χρόνια και στον τομέα της κυτταροδιαμεσολαβούμενης γονιδιακής θεραπείας (αυτόλογη και αλλογενής κυτταροθεραπεία). Καθεμία από τις παραπάνω μεθόδους έχει τα δικά της προτερήματα και περιορισμούς και όλες βρίσκουν εφαρμογή στην ανάπτυξη γονιδιακών θεραπειών που αποτελούν την αιχμή της τεχνολογίας στην θεραπεία σοβαρών και απειλητικών για τη ζωή νοσημάτων. Οι συνεχείς εξελίξεις στη βιολογία των ασθενειών, την τεχνολογία μεταφοράς γονιδίων και τις διαδικασίες παραγωγής θα ανοίξουν πιθανότατα το δρόμο για περισσότερες κανονιστικές εγκρίσεις και την ανάπτυξη νέων θεραπειών. Στην παρούσα ανασκόπηση εξετάζουμε τις εγκεκριμένες θεραπείες που στηρίζονται σε συστήματα γονιδιακής στόχευσης, τους μηχανισμούς δράσης, καθώς και τις ενδείξεις κάθε προσέγγισης.In the last three decades, gene therapy has achieved remarkable strides in clinical success and commercial interest. Understanding of disease pathology and gene delivery technology has led to innovative therapies. In particular with regard to therapies based on target gene detection, various methods for more efficient gene transfer are being explored. The most widespread carriers of genetic material are plasmids, naked DNA, non-viral vectors (small molecules, lipid nanoparticles, GalNAc ligand) and viral vectors (adenoviruses, retroviruses, lentiviruses, recombinant adeno-associated viruses, herpes simplex virus, etc.). a.), while important developments have also been made in recent years in the field of cell-mediated gene therapy (autologous and allogeneic cytotherapy). Each of the above methods has its own strengths and limitations and all are being applied in the development of gene therapies that represent the state-of-the-art in the treatment of serious and life-threatening diseases. Continued advances in disease biology, gene delivery technology and manufacturing processes will likely pave the way for more regulatory approvals and the development of new therapies. In this review, we examine the approved therapies based on gene targeting systems, their mechanisms of action, and the indications for each approach

    Ακαδημαϊκά συναισθήματα και κίνητρα αναφορικά με την αναγνωστική κατανόηση σε μαθητές με και χωρίς μαθησιακές δυσκολίες

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    Η αναγνωστική κατανόηση είναι μία πολύπλοκη διαδικασία, η οποία επηρεάζεται από πολλούς και διαφορετικούς παράγοντες. Σκοπός της συγκεκριμένης εργασίας ήταν η διερεύνηση του πώς ψυχοσυναισθηματικοί παράγοντες και πιο συγκεκριμένα τα ακαδημαϊκά συναισθήματα και τα κίνητρα την επηρεάζουν, αλλά και το πώς αυτά βιώνονται από μαθητές με και χωρίς Μαθησιακές Δυσκολίες που φοιτούν στο Δημοτικό. Επιπλέον, έγινε προσπάθεια να διερευνηθεί το αν υπάρχουν και παρατηρούνται διαφοροποιήσεις μεταξύ αυτών των παραγόντων που να σχετίζονται με την αναγνωστική κατανόηση σε διαφορετικά πλαίσια, όπως είναι η ανάγνωση στη σχολική τάξη, η μελέτη στο σπίτι και η εξέταση της ανάγνωσης. Το δείγμα της έρευνας αποτέλεσαν 148 μαθητές Γ΄, Δ΄, Ε΄ και Στ΄ Δημοτικού και συγκεκριμένα 51 μαθητές με μαθησιακές δυσκολίες και 97 μαθητές χωρίς μαθησιακές δυσκολίες. Για τη συλλογή των δεδομένων της έρευνας χρησιμοποιήθηκαν τα ακόλουθα εργαλεία: Ερωτηματολόγιο Ακαδημαϊκών Συναισθημάτων - Δημοτικό Σχολείο (AEQ), Ερωτηματολόγιο Ακαδημαϊκών Συναισθημάτων για Προεφήβους (AEQ-PA), Κίνητρα για την Ανάγνωση (MRQ), Ερωτηματολόγιο αυτορρύθμισης και κίνητρα ανάγνωσης (SRQ) και Συστοιχία αξιολόγησης της αναγνωστικής κατανόησης κειμένου. Η ανάλυση των δεδομένων ήταν ποσοτική. Τα αποτελέσματα της έρευνας έδειξαν την ύπαρξη σχέσης μεταξύ κινήτρων, αυτορρύθμισης και συναισθημάτων, καθώς και διαφοροποιήσεις μεταξύ των συναισθημάτων και των κινήτρων των μαθητών με και χωρίς Μαθησιακές Δυσκολίες. Τέλος, αναφορικά με τους παράγοντες φύλο και ηλικία εντοπίστηκαν διαφοροποιήσεις, τόσο σε σχέση με τα κίνητρα για την Ανάγνωση, όσο και τα συναισθήματα. Τα αποτελέσματα της παρούσας έρευνας συμβάλουν στη διαμόρφωση ενός σχολικού περιβάλλοντος που θα υποστηρίζει και θα διευκολύνει την ανάπτυξη θετικών ακαδημαϊκών συναισθημάτων και την καλλιέργεια κινήτρων στους μαθητές για τη γενικότερη βελτίωση των ακαδημαϊκών επιδόσεών τους, μέσα από τη διερεύνηση και την κατανόηση των παραπάνω ψυχοκοινωνικών παραγόντων.Reading comprehension is a complex process, which is influenced by many different factors. The main purpose of this study was to investigate how psycho - emotional factors and more specifically academic emotions and motivations affect it, but also how they are experienced by students with and without learning disabilities who attend primary school. In addition, an attempt was made to investigate whether there are significant differences between these factors related to reading comprehension in different context, such as reading in the classroom, studying at home and assessment of reading. The sample of the research consisted of 148 students of elementary school (3rd, 4th, 5th, 6th grade) and specifically 51 students with learning difficulties and 97 students without. The following tools were used to collect the research data: Achievement Emotions Questionnaire – Elementary School (AEQ), Achievement Emotions Questionnaire for Pre-Adolescents (AEQ - PA), Motivations for Reading Questionnaire (MRQ), Self-Regulation Questionnaire (SRQ) and Test Battery of increasing difficulty texts with comprehension questions. Data analysis was quantitative. The results of the research not only showed the existence of a relationship between motivations and self – regulation, but also the relationship between academic emotions and motivation as well as the differences between emotions and motivation of students who may or may not experience learning difficulties. Finally, differences were identified in terms of gender and age, both relating to motivation for reading and emotions. The results of the present study contribute to the formation of such a school environment that will support and facilitate the development of positive academic emotions and cultivate motivation in students for the overall improvement of their academic performance, through the investigation and understanding of the above mentioned psychosocial factors

    The Interplay of Cesarean-Section Delivery and First-Birth Order as Risk Factors in Acute Lymphoblastic Leukemia

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    BACKGROUND: Childhood B-cell precursor acute lymphoblastic leukemia (BCP-ALL) has been associated with early-life exposures, including birth by cesarean section (C-section), and a deficit of social exposure (first child). These exposures as proxies for microbiome acquisition in infancy are essential to prime the immune system and restrain later dysregulated immune responses that can trigger ALL in susceptible individuals. We tested risk factors pertaining to immune stimulation that may impact BCP-ALL development. METHODS: Cases comprised 1,126 children (0-12 years) with ALL (BCP-ALL: 78.5%) from the EMiLI study group in Brazil (2002-2020). Age- and sex-matched controls (n = 2,252) were randomly selected from healthy children whose mothers participated in the National Placental and Umbilical Cord Blood Bank donation. Multiple logistic regression was run fitted and adjusted for selected covariates models. RESULTS: C-section delivery was associated with increased risk for ALL [odds ratio (OR) ALL: 1.10; 95% confidence intervals (CI), 1.04-1.15; ORBCP-ALL: 1.09; 95% CI, 1.03-1.14], as well as being the firstborn child. Interaction analysis showed a significant effect of first birth on the observed C-section associations (P < 0.0001). Indeed, high-risk children, namely, firstborn children delivered via C-section were at increased risk for ALL (OR: 2.33; 95% CI, 2.40-4.84) compared with non-first, vaginally born children. An increased risk was found for firstborn children delivered by C-section and non-breastfed with ALL (ORALL: 2.32; 95% CI, 1.27-4.24; ORBCP-ALL: 2.37; 95% CI, 1.18-4.76). CONCLUSIONS: Our observations are in accord with the prediction that exposures determining microbiome composition and adrenal pathway in infancy contribute to the risk of BCP-ALL. IMPACT: These findings encourage the exploration of potential preventive interventions. See related commentary by Wiemels and Gallant, p. 292. ©2022 American Association for Cancer Research

    Cost and reimbursement analysis of end-of-life cancer inpatients. The case of the Greek public healthcare sector

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    Background: While hospital-based Palliative Care services are usually covered through the main funding healthcare framework, traditional reimbursement methods have been criticized for their appropriateness. The present study investigates for the first time the case of treating end-of-life cancer patients in a Greek public hospital in terms of cost and reimbursement. Methods: This retrospective observational study used health administrative data of 135 deceased cancer patients who were hospitalized in the end of their lives. Following the cost estimation procedure, which indentified both the individual patient and overhead costs, we compared the relevant billing data and reimbursement requests to the estimated costs. Results: The average total cost per patient per day was calculated to be 97 EUR, with equal participation of individual patient's and overhead costs. Length of stay was identified as the main cost driver. Reimbursement was performed either by per-diem fees or by Diagnosis Related Groups’ (DRGs), which were correspondingly associated with under or over reimbursement risks. In the case of the combined use of the two available reimbursement alternatives a cross-subsidization phenomenon was described. Conclusion: Although the cost of end-of-life care proved to be quite low, the national per-diem rate fails to cover it. DRGs designed for acute care needs are rather unsuitable for such sub acute hospitalizations. Policy summary: There is a concrete need for reconsidering the current reimbursement schemes for this group of patients as part of any national plan concerning the integration and reformation of Palliative Care services. Otherwise, there is a serious danger for public institutions’ reluctance to admit them with a serious impact on access and equity of end-of-life cancer care. © 2023 Elsevier Lt

    Leukocyte Telomere Length in Children With Congenital Adrenal Hyperplasia

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    Context: Exposure to chronic stress and hypercortisolism is associated with decreased leukocyte telomere length (LTL), a marker for biological aging and cardiovascular disease. Children with congenital adrenal hyperplasia (CAH) are treated with glucocorticoids. Objective: To investigate LTL in children with CAH. Methods: In this prospective observational cohort study, conducted at 4 academic pediatric endocrinology outpatient clinics, children with genetically confirmed CAH were assessed at 2 follow-up visits (mean 4.1 ± 0.7 months apart). At each visit, LTL was determined by quantitative real-time PCR. All subjects underwent detailed clinical and endocrinologic evaluation and were classified as undertreated, optimally treated, or overtreated, accordingly. The influence of clinical factors on LTL was investigated using linear mixed models adjusted for age, sex, and BMI-z. Results: We studied 76 patients, of whom 31 (41%) were girls, 63 (83%) had classic CAH, 67 (88%) received hydrocortisone, and 8 (11%) prednisolone. Median age at first visit was 12.0 years (IQR, 6.3-15.1), and median BMI-z was 0.51 (IQR, -0.12 to 1.43). LTL was shorter in patients with classic vs nonclassic CAH (-0.29, P = 0.012), in overtreated than in optimally treated patients (-0.07, P = 0.002), and patients receiving prednisolone compared with hydrocortisone (-0.34, P < 0.001). LTL was not associated with undertreatment or daily hydrocortisone-equivalent dose (P > 0.05). Conclusion: LTL is shorter in patients with classic than nonclassic CAH, and in those who are overtreated with hydrocortisone or treated with long-acting glucocorticoids. These findings may be attributed to chronic exposure to supraphysiologic glucocorticoid concentrations and indicate that LTL may be used as a biomarker for monitoring glucocorticoid treatment. © 2022 The Author(s). Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved

    Reverse impression technique: A fully digital protocol for the fabrication of the definitive fixed prosthesis for completely edentulous patients

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    In complete arch implant rehabilitation, one of the greatest difficulties still encountered in the digital workflow is the deviation of the implant position during intraoral scanner (IOS) data acquisition. As a result, the passivity of a definitive prosthesis fabricated using IOS data might be compromised. Thus, an implant position verification method is essential, either digitally or conventionally executed. A fully digital protocol for the fabrication of the definitive fixed prosthesis for completely edentulous patients, without the interference of any conventional step within the digital process, is presented. For the verification of the captured position of the scan-bodies, novel scan analogs were connected to the interim prosthesis extraorally and scanned. The virtual superimposition of the interim prosthesis intraorally with the same prosthesis extraorally served as a verification device for the position of the implants. © 2023 Editorial Council for the Journal of Prosthetic Dentistr

    A mini review for lipid-based nanovaccines: from their design to their applications

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    Nanovaccines have shown to be effective, and this is the reason they are preferred than conventional vaccines. The scope of this review is to describe the role, mechanisms, and advantages of nano vaccines based on lipids, and present the most important types, their physicochemical characteristics, as well as their challenges. The most important categories of lipid nano-vaccines are liposomal nano vaccines and (virus-lipid nanoparticles (NPs)/virosomes. Examples of vaccine formulations from each category are presented and analyzed below, focusing on their structure and physicochemical characteristics. In all cases, a nanoscale platform is used, enriched with adjuvants, antigens, and other helping agents to trigger immune response process and achieve cell targeting, and eventually immunity against the desired disease. The exact mechanism of action of each vaccine is not always completely known or understood. Physicochemical characteristics, such as particle size, morphology/shape, and zeta potential are also mentioned as they seem to affect the properties and mechanism of action of the vaccine formulation. © 2023 Informa UK Limited, trading as Taylor & Francis Group

    CROSSED PRODUCTS OF DUAL OPERATOR SPACES AND A CHARACTERIZATION OF GROUPS WITH THE APPROXIMATION PROPERTY

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    Let G be a locally compact group. We prove that every L∞(G)- comodule is nondegenerate and saturated, whereas every L(G)-comodule is nondegenerate if and only if every L(G)-comodule is saturated if and only if G has the approximation property of Haagerup and Kraus. This allows us to extend known results from the duality theory of crossed products of von Neumann algebras to the recent theory of crossed products of dual operator spaces. Also, we obtain a characterization of groups with the approximation property involving crossed products improving a recent result of Crann and Neufang and we generalize a theorem of Anoussis, Katavolos and Todorov providing a less technical proof of it. © Copyright by THETA, 202

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