1. Microbiologic findings in a cohort of patients with erythema migransEva Ružić-Sabljić, Vera Maraspin-Čarman, Petra Bogovič, Tereza Rojko, Martina Jaklič, Franc Strle, 2024, original scientific article Abstract: Erythema migrans (EM) is the initial and the most frequent clinical manifestation of Lyme borreliosis (LB). Herein, we report on the capacity of culture and serology for the demonstration of Borrelia infection in a cohort of 292 patients diagnosed with typical EM at a single medical center. The median duration of EM at diagnosis was 12 days, and the largest diameter was 16 cm; 252 (86.3%) patients presented with solitary EM, whereas 40 (13.7%) had multiple EM. A total of 95/292 (32.5%) patients had positive IgM, and 169 (57.9%) had positive IgG serum antibodies; the Borrelia isolation rate was 182/292 (62.3%). The most frequent species by far was B. afzelii (142/148, 95.9%) while B. garinii (2.7%) and B. burgdorferi s.s. (1.4%) were rare. IgM seropositivity was associated with a younger age, multiple EM and the absence of underlying chronic illness; IgG seropositivity was associated with the duration of EM at diagnosis, the diameter of the EM, having had a previous episode of LB and the absence of symptoms at the site of the EM. Furthermore, the Borrelia isolation rate was statistically significantly lower in patients with positive Borrelia IgM antibodies. Although microbiologic analyses are not needed for the diagnosis of typical EM, they enable insights into the etiology and dynamics of the immune response in the course of early LB. Keywords: erythema migrans, Lyme borreliosis, Borrelia afzelii, culture, serology Published in DiRROS: 12.06.2026; Views: 273; Downloads: 202
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2. Smernice za dobro klinično prakso (ICH E6 (R3))2026, dictionary, encyclopaedia, lexicon, manual, atlas, map Abstract: Dobra klinična praksa (GCP) je temelj etičnega, kakovostnega in sledljivega izvajanja kliničnih raziskav, saj v ospredje postavljajo varovanje pravic, varnosti in dobrobiti udeležencev ter zanesljivost rezultatov. Posodobljene smernice ICH GCP E6(R3), veljavne od 23. julija 2025, poudarjajo, da se kakovost raziskave začne že pri idejni zasnovi in pripravi protokola, zato je treba ključne dejavnike kakovosti, tveganja, dokumentacijo in nadzor opredeliti že na začetku. Novosti vključujejo tudi večji poudarek na upravljanju podatkov, sledljivosti sprememb, varnosti informacijskih sistemov, vlogi etične komisije, nadzoru sponzorja ter preglednosti po zaključku raziskave, vključno s pravočasno objavo rezultatov. Smernice so strukturirane v osrednji dokument s splošnimi načeli in Prilogo 1 za intervencijska klinična preskušanja, medtem ko Priloga 2, ki bo zajela ne tradicionalna preskušanja in podatke iz realnega sveta, v tej izdaji še ni vključena. Slovenski prevod je pripravljen z namenom, da bi bila vsebina smernic bolj razumljiva širšemu krogu strokovnjakov in drugim sodelujočih v kliničnih raziskavah. Keywords: klinična medicina, klinične raziskave, standardi, medicinska etika, medicinske raziskave Published in DiRROS: 10.03.2026; Views: 507; Downloads: 240
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3. No short-term effects of acromioclavicular joint augmentation in acute acromioclavicular joint stabilization surgery : a randomized controlled clinical trial on 70 patientsMiha Ambrožič, Matej Cimerman, Kristjan Omahen, Martina Jaklič, Veronika Kralj-Iglič, Ladislav Kovačič, 2025, original scientific article Abstract: Background: Optimal treatment for high-grade acromioclavicular (AC) joint dislocations is still not unanimous. Improving horizontal AC stability has been emphasized in recent years. Biomechanical studies and computer simulations have demonstrated that adequate horizontal stability could be restored with an additional AC fixation. We aim to prospectively investigate if AC augmentation leads to better clinical and radiological results. Methods: A total of 70 patients with a mean (±SD) age of 42 ± 11 years with acute AC joint dislocation Rockwood type IIIb and V were prospectively randomized into two equal groups. All patients underwent arthroscopically assisted stabilization using a double coracoclavicular (CC) suspensory system. Group N (No-augmentation group) had no additional fixation across the AC joint, while group T (tape-augmentation group) had additional fixation with tape. Patients were evaluated at 3, 6, and 12 months postoperatively. Primary clinical outcome measures included the Constant–Murley score and the Specific AC Score (SACS). Secondary outcome measures included the Subjective Shoulder Value (SSV), the Simple Shoulder Test (SST), the Disabilities of the Arm, Shoulder, and Hand (DASH) outcome measure, and the AC Joint Instability (ACJI) Score. Horizontal stability was radiologically measured with overlapping length (OL) and overlapping area (OA). Vertical alignment was measured with the CC distance. All radiological measurements were compared to the uninjured side and expressed in percentages as relative values. Results: There were no significant differences found between groups regarding the Constant score (p = 0.664), SACS (p = 0.518), or any other outcome measure at the one-year follow-up. Pain level (p = 0.635) and strength (p = 0.217) at the one-year mark also showed no significant differences. Clinical drawer testing for residual horizontal instability was non-significant (p = 0.061), but showed a tendency for a more stable AC joint in group T. The CC distance was smaller in group T at 6 and 12 months (p = 0.047 and p = 0.046, respectively). A two-way mixed factorial ANOVA test showed significantly lower CC differences for group T (p = 0.032); however, the gradual increase in CC distance was similar for both groups over time (p = 0.869). No significant differences were found in OL (p = 0.619) or OA (p = 0.236). Conclusions: The results of our study show that both CC stabilization with the double suspensory system alone and with additional AC fixation are effective surgical treatment options for acute AC joint dislocations, without any important clinical differences. CC distance similarly increased over one year in both groups but was better retained in the AC-augmented group, which showed a tendency toward a more stable fixation. Keywords: acromioclavicular joint dislocation, horizontal acromioclavicular instability, acromioclavicular augmentation, overlapping length, overlapping area, coracoclavicular distance, arthroscopic assisted surgery Published in DiRROS: 10.03.2026; Views: 496; Downloads: 367
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4. SGLT2 inhibitors are associated with left ventricular reverse remodeling in patients with non-compaction cardiomyopathy : a prospective observational cohort trialAndraž Cerar, Gregor Poglajen, Gregor Zemljič, Sabina Frljak, Neža Žorž, Martina Jaklič, Renata Okrajšek, Miran Šebeštjen, Bojan Vrtovec, 2025, original scientific article Abstract: Background/Objectives: Sodium glucose co-transporter 2 inhibitors (SGLT2is) improve outcomes in heart failure; however, data in left ventricular non-compaction cardiomyopathy (LVNC) patients are limited. We sought to analyze the clinical effects of the SGLT2is dapagliflozin and empagliflozin in patients with LVNC. Methods: Thirty consecutive LVNC patients diagnosed by CMR were prospectively enrolled. Clinical, biochemical and echocardiography data were obtained at the initiation of the SGLT2is and at the 12-month follow-up. All patients were on stable guideline-directed medical therapy. A response to SGLT2i therapy was defined as an improvement in LVEF ≥ 5% at 12 months. Results: Of the 30 enrolled patients, 25 were male, with a mean age of 49 ± 16 years and few comorbidities. Dapagliflozin 10 mg was prescribed to 23 patients and empagliflozin 10 mg to 7 patients. Five patients experiened an adverse event during follow-up (one sudden cardiac death; four heart transplantations or LVAD implantations). During follow-up, significant improvements were observed in LVEF (32.1 ± 6.9% vs. 43.5 ± 9.7%; p = 0.003), LVOT VTI (14.8 ± 6.5 cm vs. 17.6 ± 3.3 cm; p = 0.008), E/e′ (14.8 ± 4.7 vs. 10.0 ± 4.1; p < 0.001), and TAPSE (2.0 ± 0.4 cm vs. 2.3 ± 0.4 cm; p = 0.012). NT-proBNP levels decreased significantly (2025 ± 2198 pg/mL vs. 582 ± 803 pg/mL; p = 0.005). Eighteen patients responded favorably to SGLT2i therapy (Group A), whereas seven showed no significant LVEF improvement (Group B). The groups did not differ significantly in age, sex, baseline creatinine, or bilirubin. Compared to Group B, Group A had a smaller baseline LV end-diastolic diameter (6.3 ± 0.8 cm vs. 7.1 ± 0.9 cm; p = 0.025) and lower NT-proBNP levels (1720 ± 1662 pg/mL vs. 4527 ± 4397 pg/mL; p = 0.02). Conclusions: In patients with LVNC, SGLT2i therapy is associated with significant reverse remodeling and functional improvement. Benefits may be greater in those with less advanced disease. Keywords: non-compaction cardiomyopathy, guideline-directed heart failure medical therapy, myocardial recovery Published in DiRROS: 15.12.2025; Views: 614; Downloads: 367
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5. Project management digitalisation of the clinical research at the University Medical Centre : good practice of using REDCap as a digitalisation toolZdenko Garaševič, Franc Strle, Martina Jaklič, 2025, original scientific article Abstract: Objective: The digital tool REDCap (Research Electronic Data Capture) was implemented at the University Medical Centre Ljubljana (UMCL) with the goal of digitalising and streamlining research processes. This study aimed to assess the efficiency and transparency of clinical research following the implementation of REDCap. Methods: The implementation of REDCap for funded research began in 2021. It comprised four key steps: (I) the initial creation of Central Research Registry, followed by additional functionalities including (II) the establishment of the Central Database for ’Pre-Contract Activities’ for clinical trials; (III) the integration of Reporting on Research Progress directly into the Central Research Registry; and (IV) the development of a semi-automated Workflow for internal agreements. Results: Between 2021 and 2023, UMCL established a Central Research Registry using REDCap, transitioning from paper-based to digital data collection for over 2,500 research projects. These projects included clinical trials, national and international studies, as well as academic research. In addition to serving as a registry, the central system provided comprehensive data management, streamlined communication, and enhanced collaboration among stakeholders in clinical trial research at UMCL. The implementation of REDCap significantly reduced administrative burden and shortened the time required to finalise clinical trial agreements from 202 to 147 days. It also improved coordination, transparency, and real-time monitoring of research activities, facilitating more efficient research execution. Additionally, the digitalisation of internal agreements processes between researchers and stakeholders within UMCL improved coordination and expedited research execution timelines. Furthermore, REDCap enabled real-time monitoring of research progress, further contributing to the efficiency and transparency of research activities. Conclusion: The digitalisation of research processes using REDCap improved the organisation and execution of research, leading to greater efficiency and transparency, reduced administrative workload, and enhanced collaboration. This approach contributed to higher-quality research outcomes and ultimately benefited patient care. Keywords: digitalisation, REDCap, clinical research, efficiency, transparency, research registry, data management Published in DiRROS: 24.11.2025; Views: 1142; Downloads: 449
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6. Izvajanje spremljanja stanja populacij izbranih ciljnih vrst hroščev v letu 2013 in 2014 : Carabus variolosus, Lucanus cervus, Rosalia alpina, Morimus funereus, Osmoderma eremita, Cucujus cinnaberinusAl Vrezec, Špela Ambrožič Ergaver, Andrej Kapla, Irena Bertoncelj, Dejan Bordjan, 2014, final research report Abstract: V končnem poročilu so predstavljeni rezultati terenskih raziskav šestih varstveno pomembnih vrst hroščev v Sloveniji v letih 2013 in 2014. Za močvirskega krešiča (Carabus variolosus), rogača (Lucanus cervus), alpskega kozlička (Rosalia alpina) in bukovega kozlička (Morimus funereus) je v Sloveniji že vzpostavljena shema populacijskega in distribucijskega monitoringa s pripadajočimi metodološkimi protokoli in je pričujoča naloga poročilo o stanju v letih 2013 in 2014 glede na podatke zbrane v okviru populacijskega in distribucijskega monitoringa. Za tri vrste (močvirski krešič, rogač in alpski kozliček) smo izračunali populacijske trende in ugotovili zmeren upad populacije močvirskega krešiča ter stabilni populaciji tako rogača kot alpskega kozlička. Za alpskega in bukovega kozlička smo po zaključku petletnega ciklusa snemanja evalvirali shemo monitoringa in podali predloge izboljšave sheme za nadaljnji monitoring vrst. V poročilu so predstavljeni rezultati popisa v letih 2013 in 2014 za dopolnitev razširjenosti vrste puščavnika (Osmoderma eremita) in škrlatnega kukuja (Cucujus cinnaberinus). Glavni namen pričujoče naloge je bilo tudi testiranje metode lova puščavnika v letu 2014. Poznavanje razširjenosti škrlatnega kukuja (Cucujus cinnaberinus) v zahodni Sloveniji je slabše, zato je bila izvedena dodatna raziskava razširjenosti. Glede na dosedanja vedenja o populacijah vseh že potrjenih vrst hroščev evropskega varstvenega pomena pri nas, podajamo nekaj smernic nujnih raziskav, ki bi jih bilo potrebno iz tega naslova izvesti v Sloveniji. Pri tem smo se osredotočili le na dejansko potrjene vrste. Keywords: hrošči, monitoring, ekologija Published in DiRROS: 16.09.2024; Views: 1734; Downloads: 1116
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7. Vzpostavitev in izvajanje monitoringa koščaka (Austropotamobius torrentium) in koščenca (Austropotamobius pallipes) v letih 2014 in 2015 : projekt ʺVzpostavitev in izvajanje monitoringa populacij izbranih ciljnih vrst rakov v letih 2014 in 2015ʺMarijan Govedič, Aleksandra Lešnik, Vesna Grobelnik, Ali Šalamun, Al Vrezec, Martina Jaklič, Špela Ambrožič Ergaver, Andrej Kapla, 2015, final research report Abstract: V okviru naloge “Dodatne raziskave kvalifikacijskih vrst Natura 2000 ter vzpostavitev in izvajanje monitoringa ciljnih vrst rakov v letu 2010 in 2011 (končno poročilo)”, ki jo je po naročilu Ministrstva RS za okolje in prostor izvajal Center za kartografijo favne in flore s sodelovanjem Nacionalnega inštituta za biologijo in zunanjih sodelavcev (Govedič in sod. 2011) je bil predlagan okvirni načrt monitoringa potočnih rakov v Sloveniji. Večji del raziskav je bil takrat opravljen za namene opredelitve novih Natura 2000 območij za koščaka (Austropotamobius torrentium). Večina predlaganih območij iz leta 2011 (Govedič in sod. 2011) je bila v letu 2013 tudi vključena v razširjeno omrežje Natura 2000 (Uradni list RS 33/2013) in kasneje potrjena na Biogeografskem seminarju leta 2014.
V okviru sedanje naloge “Vzpostavitev in izvajanje monitoringa populacij izbranih ciljnih vrst rakov v letih 2014 in 2015” smo izdelali končno metodologijo monitoringa potočnih rakov v Sloveniji, večinoma pa smo sledili predlogu iz leta 2011 (Govedič in sod. 2011). V poročilu so predstavljeni rezultati terenskega dela. Analize populacijskih in distribucijskih trendov še niso mogoče, interpretirali pa smo nekatere izstopajoče rezultate. Glede na prejšnja poročila monitoringa (Govedič in sod. 2007, 2011) smo dopolnili glavne dejavnike ogrožanja potočnih rakov v Sloveniji s predlogi uvedbe nujnega spremljanja v Sloveniji najbolj perečih dejavnikov kot podporo upravljanju območij Natura 2000 za potočne rake.
Keywords: raki, razširjenost, Slovenija Published in DiRROS: 16.09.2024; Views: 1373; Downloads: 1224
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