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81.
Genska terapija v onkologiji, prvi razvojni koraki v Sloveniji
Maja Čemažar, Tanja Dolinšek, Maša Bošnjak, Boštjan Markelc, Urška Kamenšek, Simona Kranjc, Špela Kos, Urša Lampreht Tratar, Katarina Žnidar, Andrej Renčelj, Urška Matkovič, Teja Valant, Kristina Levpušček, Živa Modic, Tilen Komel, Tim Božič, Urša Kešar, Barbara Starešinič, Katja Uršič Valentinuzzi, Monika Štimac, Primož Strojan, Gorana Gašljević, Maja Ota, Aleš Grošelj, Črt Jamšek, Rosana Hudej, Matjaž Peterka, Franc Smrekar, Barbara Hubad, Marjan Hosta, Jaka Kužnik, Alojz Hosta, Damijan Miklavčič, Matej Reberšek, Aleksandra Cvetkoska, Anja Zajc, Janja Dermol-Černe, Nataša Tozon, Nina Milevoj, Alenka Nemec Svete, Gregor Serša, 2022, strokovni članek

Povzetek: Genska terapija postaja čedalje bolj zanimiva tudi v onkologiji. Med aplikacijami je morda najzanimivejša imunostimulacija. Pripravimo lahko plazmidno DNA, ki nosi zapis za različne imunostimulatorne molekule, ki jih vnesemo v celice tumorjev ali normalnih tkiv. Ta tkiva postanejo proizvajalci teh molekul, ki lahko delujejo lokalno ali pa se izločajo tudi sistemsko v krvni obtok. Ker plazmidna DNA ne prehaja celične membrane, so potrebni dostavni sistemi, virusni ali nevirusni. V naših študijah uporabljamo predvsem nevirusni dostavni sistem – elektroporacijo. Interlevkin 12 (IL-12) je eden od zanimivih citokinov, za katerega je znano protitumorsko delovanje s spodbujanjem imunskega odziva in antiangiogenim delovanjem. Namen projekta SmartGene.si je bil pripraviti plazmid z zapisom za interlevkin 12 (plazmid phIL12) in pripraviti vse potrebno za njegovo klinično testiranje za zdravljenje kožnih tumorjev. V konzorciju smo združili moči s partnerji z akademskega in industrijskega področja. Treba je bilo pripraviti plazmid za uporabo v humani onkologiji po zahtevah Evropske agencije za zdravila (EMA). Za prijavo klinične študije na Javno agencijo za zdravila in medicinske pripomočke (JAZMP) smo morali izvesti tudi vse neklinične raziskave o varnosti in učinkovitosti zdravila. Nato je bilo treba razviti postopek priprave zdravila, zagotoviti primerne prostore za pripravo in izvedbo postopka priprave zdravila. V treh letih smo dosegli vse te zastavljene cilje in dobili dovoljenje za izvajanje klinične študije na kožnih tumorjih, ki ga je izdala JAZMP na osnovi pozitivnega mnenja Komisije Republike Slovenije za medicinsko etiko. Zdaj poteka klinična študija faze I preizkušanja plazmida phIL12 na kožnih tumorjih glave in vratu z namenom preveriti varnost in sprejemljivost genskega elektroprenosa plazmida v tumorje. Cilj študije je prav tako določiti primeren odmerek zdravila, ki bi ga v nadaljnji klinični študiji uporabili kot adjuvantno zdravljenje k ablativnim terapijam, kot sta radioterapija ali elektrokemoterapija.
Ključne besede: genska terapija, interlevkin-12, plazmidna DNA, elektroprenos genov, rak kože
Objavljeno v DiRROS: 01.07.2022; Ogledov: 109; Prenosov: 37
.pdf Celotno besedilo (420,40 KB)

82.
83.
Neoperativni pristop (watch & wait) po zaključenem totalnem neoadjuvantnem zdravljenju raka danke : prikaz primera
Anja Meden, Franc Anderluh, Vaneja Velenik, 2022, strokovni članek

Povzetek: Sodobno standardizirano zdravljenje lokalno napredovalega raka danke (LNRD) je sestavljeno iz predoperativne kemoradioterapije (KTRT), resekcije s totalno mezorektalno ekscizijo (TME) in pri izbranih bolnikih iz pooperativne kemoterapije (KT). S stopnjevanjem intenzivnosti predoperativnega zdravljenja je prišlo do občutnega porasta patoloških (pCR) in kliničnih popolnih odgovorov (cCR). Pri skrbno izbranih bolnikih s cCR je namesto operativnega zdravljenja možno tudi skrbno spremljanje (angl. Watch & Wait – pristop W&W). Preživetje bolnikov, ki so samo sledeni, ni nič slabše od preživetja operiranih, ob tem pa se izognemo s kirurškim zdravljenjem povezano smrtnostjo in pooperativnim zapletom. V Sloveniji je pristop W&W vključen v zadnja nacionalna priporočila za zdravljenje raka debelega črevesa in danke. Kljub številnim prednostim pristopa W&W še vedno ostaja tveganje za ponovitev in napredovanje bolezni s sistemskim razsojem. Za ugoden izid zdravljenja je ključna skrbna selekcija bolnikov. Težava je predvsem subjektivnost ocene cCR. V prispevku je opisan primer bolnika z LNRD, ki je bil zdravljen s predoperativno KTRT, po čemer je prišlo do cCR. Nato je bil obravnavan s pristopom W&W. Po dveh letih od začetka zdravljenja je prišlo do razsoja bolezni, zaradi česar je bolnik pozneje umrl.
Ključne besede: rak danke, neoperativni pristop, neoadjuvantna terapija
Objavljeno v DiRROS: 01.07.2022; Ogledov: 90; Prenosov: 45
.pdf Celotno besedilo (1,58 MB)

84.
A methodological proposal for the climate change risk assessment of coastal habitats based on the evaluation of ecosystem services : lessons learnt from the INTERREG project ECO-SMART
Alberto Barausse, Cécil J. W. Meulenberg, Irene Occhipinti, Marco Abordi, Lara Endrizzi, Giovanna Guadagnin, Mirco Piron, Francesca Visintin, Liliana Vižintin, Alessandro Manzardo, 2022, izvirni znanstveni članek

Povzetek: Climate change is seriously impacting coastal biodiversity and the benefits it provides to humans. This issue is particularly relevant in the case of the European Union’s Natura 2000 network of areas for nature protection, where the sensitivity of local ecosystems calls for intervention to increase resistance and resilience to climate-related risks. Given the complex ways in which climate can influence conservation hotspot areas, there is a need to develop effective strategic approaches and general operational models to identify priorities for management and inform adaptation and mitigation measures. Here, a novel methodological proposal to perform climate risk assessment in Natura 2000 sites is presented that implements the systematic approach of ISO 14090 in combination with the theoretical framework of ecosystem services assessment and local stakeholder participation to identify climate-related issues for local protected habitats and improve the knowledge base needed to plan sustainable conservation and restoration measures. The methodology was applied to five Natura 2000 sites located along the Adriatic coast of Italy and Slovenia. Results show that each of the assessed sites, despite being along the coast of the same sea, is affected by different climate-related issues, impacting different habitats and corresponding ecosystem services. This novel methodology enables a simple and rapid screening for the prioritization of conservation actions and of the possible further investigations needed to support decision making, and was found to be robust and of general applicability. These findings highlight the importance of designing site-specific adaptation measures, tailored to address the peculiar response to climate change of each site in terms of biodiversity and ecosystem services.
Ključne besede: ecosystem, ecosystem services, climate change adaptation, nature conservation, sustainability, coastal management
Objavljeno v DiRROS: 01.07.2022; Ogledov: 89; Prenosov: 66
.pdf Celotno besedilo (4,50 MB)
Gradivo ima več datotek! Več...

85.
86.
87.
Solid cancer patients achieve adequate immunogenicity and low rate of severe adverse events after SARS-CoV-2 vaccination
Urška Janžič, Urška Bidovec, Katja Mohorčič, Loredana Mrak, Nina Fokter Dovnik, Marija Ivanović, Maja Ravnik, Marina Čakš, Erik Škof, Jerneja Debeljak, Peter Korošec, Matija Rijavec, 2022, izvirni znanstveni članek

Povzetek: Background: SARS-CoV-2 vaccination in cancer patients is crucial to prevent severe COVID-19 disease course. Methods: This study assessed immunogenicity of cancer patients on active treatment receiving mRNA-based SARS-CoV-2 vaccine by detection of anti-SARS-CoV-2 S1 IgG antibodies in serum, before, after the first and second doses and 3 months after a complete primary course of vaccination. Results were compared with healthy controls. Results: Of 112 patients, the seroconversion rate was 96%. A significant reduction in antibody levels was observed 3 months after vaccination in patients receiving immune checkpoint inhibitors versus control participants (p < 0.001). Adverse events were mostly mild. Conclusion: Immunogenicity after mRNA-based vaccine in cancer patients is adequate but influenced by the type of anticancer therapy. Antibody levels decline after 3 months, and thus a third vaccination is warranted.
Ključne besede: onkološko zdravljenje, imunogenost, osnovno cepljenje mRNA, čvrsti tumorji, anticancer treatment, immunogenicity, mRNA-based vaccination, solid cancer
Objavljeno v DiRROS: 24.06.2022; Ogledov: 127; Prenosov: 39
.pdf Celotno besedilo (2,03 MB)

88.
Results of screening in early and advanced thoracic malignancies in the EORTC pan-European SPECTAlung platform
Marie Morfouace, Silvia Novello, A. Stevovic, C. Dooms, Urška Janžič, Thierry Berghmans, Rafal Dziadziuszko, T. Gorlia, Enriqueta Felip, Benjamin Besse, 2022, izvirni znanstveni članek

Povzetek: Access to a comprehensive molecular alteration screening is patchy in Europe and quality of the molecular analysis varies. SPECTAlung was created in 2015 as a pan-European screening platform for patients with thoracic malignancies. Here we report the results of almost 4 years of prospective molecular screening of patients with thoracic malignancies, in terms of quality of the program and molecular alterations identified. Patients with thoracic malignancies at any stage of disease were recruited in SPECTAlung, from June 2015 to May 2019, in 7 different countries. Molecular tumour boards were organised monthly to discuss patients' molecular and clinical profile and possible biomarker-driven treatments, including clinical trial options. FFPE material was collected and analysed for 576 patients with diagnosis of pleural, lung, or thymic malignancies. Ultimately, 539 patients were eligible (93.6%) and 528 patients were assessable (91.7%). The turn-around time for report generation and molecular tumour board was 214 days (median). Targetable molecular alterations were observed in almost 20% of cases, but treatment adaptation was low (3% of patients). SPECTAlung showed the feasibility of a pan-European screening platform. One fifth of the patients had a targetable molecular alteration. Some operational issues were discovered and adapted to improve efficiency.
Ključne besede: thoracic neoplasms -- Europe, lung neoplasms -- Europe, diagnostic screening programs -- Europe, malignancies, lung cancer
Objavljeno v DiRROS: 24.06.2022; Ogledov: 82; Prenosov: 59
.pdf Celotno besedilo (4,21 MB)
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89.
Real-world experience with capmatinib in MET exon 14-mutated non-small cell lung cancer (RECAP) : a retrospective analysis from an early access program
Oliver Illini, Hannah Fabikan, Aurélie Swalduz, Anders Vikström, Dagmar Krenbek, Michael Schumacher, Elizabeth Dudnik, Michael Studnicka, Ronny Öhman, Robert Wurm, Tanja Čufer, Katja Mohorčič, Maximilian J Hochmair, 2022, izvirni znanstveni članek

Povzetek: Background: Patients with non-small cell lung cancer (NSCLC) presenting with mesenchymal–epithelial transition (MET) exon 14 skipping mutation have an unfavorable prognosis with standard treatments. Capmatinib is a selective MET inhibitor, which showed promising efficacy in this patient population in early trials. Methods: We performed a retrospective, international, multicenter efficacy and safety analysis in patients with NSCLC treated with capmatinib in an early access program between March 2019 and December 2021. Results: Data from 81 patients with advanced MET exon 14 mutated NSCLC treated with capmatinib in first- or later-line therapy were analyzed. Median age was 77years (range, 48–91), 56% were women, 86% had stage IV disease, and 27% had brain metastases. For all patients, the objective response rate (ORR) to capmatinib was 58% (95% CI, 47–69), whereas it was 68% (95% CI, 50–82) in treatment-naïve and 50% (95% CI, 35–65) in pretreated patients. The median progression-free survival was 9.5months (95% CI, 4.7–14.3), whereas it was 10.6months (95% CI, 5.5–15.7) in first-line and 9.1months (95% CI, 3.1–15.1) in pretreated patients. After a median follow-up of 11.0months, the median overall survival was 18.2 months (95% CI, 13.2–23.1). In patients with measurable brain metastases (n=11), the intracranial ORR was 46% (95% CI, 17–77). Capmatinib showed a manageable safety profile. Grade⩾3 treatment-related adverse events included peripheral edema (13%), elevated creatinine (4%), and elevated liver enzymes (3%). Conclusion: In patients with MET exon 14 skipping mutation, capmatinib showed durable systemic and intracranial efficacy and a manageable safety profile. This analysis confirms previously reported phase II data in a real-world setting.
Ključne besede: non-small cell lung carcinoma -- drug therapy -- genetics, molecular targeted therapy, real-world data, capmatinib, targeted therapy
Objavljeno v DiRROS: 24.06.2022; Ogledov: 73; Prenosov: 64
.pdf Celotno besedilo (943,38 KB)
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90.
Attic dust: an archive of historical air contamination of the urban environment and potential hazard to health?
Martin Gaberšek, Michael J. Watts, Mateja Gosar, 2022, izvirni znanstveni članek

Povzetek: A comprehensive study of attic dust in an urban area is presented. Its entire life cycle, from determining historical emission sources to recognising the processes that take place in attic dust and its potential to impact human health is discussed. Its chemical composition and morphological characteristics of individual solid particles reflect past anthropogenic activities. High levels of Be-Cd-Cu-Sb-Sn-Pb-Te-Zn and occurrence of Cu-Zn shavings are typical for an industrial zone characterised by a foundry and a battery factory. High levels of Co-Fe-Mo-Ni-W-Ba-Cr-Mg-Mn-Nb-Ti and occurrence of various solid Fe-oxides, particularly spherical particles, were identified in another industrial zone, which was dominated by the automotive and metal-processing industries. Emissions from coal combustion affected the distribution of S-Se-Hg-Tl-As-Ag-U. The predominant mineral in attic dust is gypsum, which was presumably formed in situ by the reaction of carbonate dust particles and atmospheric SO2 gas. The high oral bioaccessibility of As-Cd-Cu-Pb-Zn in the gastric phase and high bioaccessibility of As-Cu-Cd-Ni in the gastrointestinal phase were identified. Determined characteristics of attic dust and identified possibilities of prolonged human exposure to it indicate that attic dust should be treated as an excellent proxy for historical air contamination as well as a potentially hazardous material for human health.
Ključne besede: multi-element composition, scanning electron microscopy, oral bioaccessibility, unified BARGE method, urban geochemistry
Objavljeno v DiRROS: 23.06.2022; Ogledov: 94; Prenosov: 50
.pdf Celotno besedilo (1,39 MB)

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