134 results on '"La Gamba, A"'
Search Results
2. Early initiation of combined therapy in severely immunocompromised patients with COVID-19: a retrospective cohort study
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Salvatore Rotundo, Lavinia Berardelli, Sara Gullì, Valentina La Gamba, Rosaria Lionello, Alessandro Russo, Enrico Maria Trecarichi, and Carlo Torti
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SARS-CoV-2 ,COVID-19 ,Immunocompromised ,Combined therapy ,Antivirals ,Monoclonal antibodies ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract This single-centre retrospective cohort study reports on the results of a descriptive (non-comparative) retrospective cohort study of early initiation of antivirals and combined monoclonal antibody therapy (mAbs) in 48 severely immunocompromised patients with COVID-19. The study assessed the outcomes and the duration of viral shedding. The patients started early combined therapy (ECT) a median of 2 days (interquartile range [IQR]: 1–3 days) after the diagnosis of SARS-CoV-2 infection. Except for 1 patient who died due COVID-19-related respiratory failure, patients had their first negative nasopharyngeal swab result after a median of 11 days (IQR: 6–17 days) after starting combined therapy. There were no reports of severe side effects. During a follow-up period of 512 days (interquartile range [IQR]: 413–575 days), 6 patients (12.5%) died and 16 (33.3%) were admitted to hospital. Moreover, 12 patients (25%) were diagnosed with SARS-CoV-2 reinfection a median of 245 days (IQR: 138–401 days) after starting combined treatment. No relapses were reported. Although there was no comparison group, these results compare favourably with the outcomes of severely immunocompromised patients with COVID-19 reported in the literature.
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- 2024
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3. Toward a Search-Based Approach to Support the Design of Security Tests for Malicious Network Traffic.
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Davide La Gamba, Gerardo Iuliano, Gilberto Recupito, Giammaria Giordano, Filomena Ferrucci, Dario Di Nucci, and Fabio Palomba
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- 2024
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4. A discrete choice experiment to evaluate the interest of Piedmont region citizens on MaaS
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Davide La Gamba, Cristiana Botta, Michal Rataj, and Maurizio Arnone
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Mobility as a service (MaaS) ,Discrete choice model (DCM) ,Stated preferences, Revealed preferences, Willingness to pay ,Public transport ,Transportation engineering ,TA1001-1280 - Abstract
Recently an increasing number of goods and services tends to be offered as a service, of which one of the most promising is mobility. The Mobility as a Service (MaaS) paradigm provides the integration of most of the mobility services available within an urban/rural area in a single subscription. The interest of Piedmont Region citizens towards MaaS is investigated through a certain number of choice situations (DCE – Discrete Choice Experiment) in which the respondent must select an alternative from the given set, based on the characteristics of each alternative. To complete the survey, a number of classic questions (multiple choice and open-ended questions) is also submitted.The goal of the surveys is to understand the perception towards MaaS and identify the relevance of each modal alternative, to better design the composition of mobility bundles.The research showed that Piedmont citizens are strongly interested in MaaS solutions and that bundles with highest interest include Local Public Transport (LPT) as a base, with sharing services (car, bike, scooter) in urban areas and car rental or car-sharing in suburban areas.
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- 2024
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5. A discrete choice experiment to evaluate the interest of Piedmont region citizens on MaaS
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La Gamba, Davide, Botta, Cristiana, Rataj, Michal, and Arnone, Maurizio
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- 2024
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6. Evolution of in-hospital patient characteristics and predictors of death in the COVID-19 pandemic across four waves: are they moving targets with implications for patient care?
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Enrico Maria Trecarichi, Vincenzo Olivadese, Chiara Davoli, Salvatore Rotundo, Francesca Serapide, Rosaria Lionello, Bruno Tassone, Valentina La Gamba, Paolo Fusco, Alessandro Russo, Massimo Borelli, Carlo Torti, and the IDTM UMG COVID-19 Group
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SARS-CoV-2 ,COVID-19 ,pandemic waves ,real-world data ,public health ,kidney disease ,Public aspects of medicine ,RA1-1270 - Abstract
ObjectivesThe aim of this work was to study characteristics, outcomes and predictors of all-cause death in inpatients with SARS-CoV-2 infection across the pandemic waves in one large teaching hospital in Italy to optimize disease management.MethodsAll patients with SARS-CoV-2 infection admitted to our center from March 2020 to June 2022 were included in this retrospective observational cohort study. Both descriptive and regression tree analyses were applied to identify factors influencing all-cause mortality.Results527 patients were included in the study (65.3% with moderate and 34.7% with severe COVID-19). Significant evolutions of patient characteristics were found, and mortality increased in the last wave with respect to the third wave notwithstanding vaccination. Regression tree analysis showed that in-patients with severe COVID-19 had the greatest mortality across all waves, especially the older adults, while prognosis depended on the pandemic waves in patients with moderate COVID-19: during the first wave, dyspnea was the main predictor, while chronic kidney disease emerged as determinant factor afterwards.ConclusionPatients with severe COVID-19, especially the older adults during all waves, as well as those with moderate COVID-19 and concomitant chronic kidney disease during the most recent waves require more attention for monitoring and care. Therefore, our study drives attention towards the importance of co-morbidities and their clinical impact in patients with COVID-19 admitted to hospital, indicating that the healthcare system should adapt to the evolving features of the epidemic.
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- 2024
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7. Discrete Choice Experiments to identify user preference for electric mobility.
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Davide La Gamba, Miriam Pirra, Francesco Deflorio, Luis Montesano, Angela Carboni, and Maurizio Arnone
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- 2022
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8. Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study
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Vincenzo Scaglione, Salvatore Rotundo, Nadia Marascio, Carmela De Marco, Rosaria Lionello, Claudia Veneziano, Lavinia Berardelli, Angela Quirino, Vincenzo Olivadese, Francesca Serapide, Bruno Tassone, Helen Linda Morrone, Chiara Davoli, Valentina La Gamba, Andrea Bruni, Bruno Mario Cesana, Giovanni Matera, Alessandro Russo, Francesco Saverio Costanzo, Giuseppe Viglietto, Enrico Maria Trecarichi, Carlo Torti, and IDTM U. M. G. COVID-19 Group
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COVID-19 ,Monoclonal antibodies ,Early therapies ,Antivirals ,Territorial health services ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Background Monoclonal antibodies (mAbs) and antivirals have been approved for early therapy of coronavirus disease (COVID-19), however, in the real-life setting, there are difficulties to prescribe these therapies within few days from symptom onset as recommended, and effectiveness of combined use of these drugs have been hypothesised in most-at-risk patients (such as those immunocompromised) but data supporting this strategy are limited. Methods We describe the real-life experience of SARS-CoV-2 antivirals and/or monoclonal antibodies (mAbs) and focus on the hospitalisation rate due to the progression of COVID-19. Clinical results obtained through our risk-stratification algorithm and benefits achieved through a strategic proximity territorial centre are provided. We also report a case series with an in-depth evaluation of SARS-CoV-2 genome in relationship with treatment strategy and clinical evolution of patients. Results Two hundred eighty-eight patients were analysed; 94/288 (32.6%) patients were treated with mAb monotherapy, 171/288 (59.4%) patients were treated with antivirals, and 23/288 (8%) patients received both mAbs and one antiviral drug. Haematological malignancies were more frequent in patients treated with combination therapy than in the other groups (p = 0.0003). There was a substantial increase in the number of treated patients since the opening of the centre dedicated to early therapies for COVID-19. The provided disease-management and treatment appeared to be effective since 98.6% patients recovered without hospital admission. Moreover, combination therapy with mAbs and antivirals seemed successful because all patients admitted to the hospital for COVID-19 did not receive such therapies, while none of the most-at-risk patients treated with combination therapy were hospitalized or reported adverse events. Conclusions A low rate of COVID-19 progression requiring hospital admission was observed in patients included in this study. The dedicated COVID-19 proximity territorial service appeared to strengthen the regional sanitary system, avoiding the overwhelming of other services. Importantly, our results also support early combination therapy: it is possible that this strategy reduces the emergence of escape mutants of SARS-CoV-2, thereby increasing efficacy of early treatment, especially in immunocompromised individuals.
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- 2022
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9. Persistence of SARS‐CoV‐2 infection and viral intra‐ and inter‐host evolution in COVID‐19 hospitalized patients
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Pavia, Grazia, primary, Quirino, Angela, additional, Marascio, Nadia, additional, Veneziano, Claudia, additional, Longhini, Federico, additional, Bruni, Andrea, additional, Garofalo, Eugenio, additional, Pantanella, Marta, additional, Manno, Michele, additional, Gigliotti, Simona, additional, Giancotti, Aida, additional, Barreca, Giorgio Settimo, additional, Branda, Francesco, additional, Torti, Carlo, additional, Rotundo, Salvatore, additional, Lionello, Rosaria, additional, La Gamba, Valentina, additional, Berardelli, Lavinia, additional, Gullì, Sara Palma, additional, Trecarichi, Enrico Maria, additional, Russo, Alessandro, additional, Palmieri, Camillo, additional, De Marco, Carmela, additional, Viglietto, Giuseppe, additional, Casu, Marco, additional, Sanna, Daria, additional, Ciccozzi, Massimo, additional, Scarpa, Fabio, additional, and Matera, Giovanni, additional
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- 2024
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10. Publisher Correction: Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study
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Vincenzo Scaglione, Salvatore Rotundo, Nadia Marascio, Carmela De Marco, Rosaria Lionello, Claudia Veneziano, Lavinia Berardelli, Angela Quirino, Vincenzo Olivadese, Francesca Serapide, Bruno Tassone, Helen Linda Morrone, Chiara Davoli, Valentina La Gamba, Andrea Bruni, Bruno Mario Cesana, Giovanni Matera, Alessandro Russo, Francesco Saverio Costanzo, Giuseppe Viglietto, Enrico Maria Trecarichi, Carlo Torti, and IDTM U. M. G. COVID-19 Group
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Infectious and parasitic diseases ,RC109-216 - Published
- 2022
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11. Publisher Correction: Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study
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Scaglione, Vincenzo, Rotundo, Salvatore, Marascio, Nadia, De Marco, Carmela, Lionello, Rosaria, Veneziano, Claudia, Berardelli, Lavinia, Quirino, Angela, Olivadese, Vincenzo, Serapide, Francesca, Tassone, Bruno, Morrone, Helen Linda, Davoli, Chiara, La Gamba, Valentina, Bruni, Andrea, Cesana, Bruno Mario, Matera, Giovanni, Russo, Alessandro, Costanzo, Francesco Saverio, Viglietto, Giuseppe, Trecarichi, Enrico Maria, and Torti, Carlo
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- 2022
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12. Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study
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Scaglione, Vincenzo, Rotundo, Salvatore, Marascio, Nadia, De Marco, Carmela, Lionello, Rosaria, Veneziano, Claudia, Berardelli, Lavinia, Quirino, Angela, Olivadese, Vincenzo, Serapide, Francesca, Tassone, Bruno, Morrone, Helen Linda, Davoli, Chiara, La Gamba, Valentina, Bruni, Andrea, Cesana, Bruno Mario, Matera, Giovanni, Russo, Alessandro, Costanzo, Francesco Saverio, Viglietto, Giuseppe, Trecarichi, Enrico Maria, and Torti, Carlo
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- 2022
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13. Arrhythmogenic right ventricular cardiomyopathy in a cat
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Michela Pugliese, Rocky La Maestra, Giulia La Gamba, Giovanni Lanteri, and Annamaria Passantino
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arrhythmogenic right ventricular cardiomyopathy, cardiac arrhythmia, cardiac disease, feline heart disease ,Medicine ,Biology (General) ,QH301-705.5 - Abstract
Cardiomyopathies are a heterogeneous group of disorders of the myocardium, characterized by multiple clinical manifestations with different prognoses (1). In cats, heart disease is frequent and is considered one of the most common causes of death (2,3). ARVC is rare in pets and has a lot of similarities to human ARVC (4,5). Signs of the disease include moderate/severe dilation of the right ventricle, regional or diffuse thinning of the wall, and sometimes aneurysm. The histological examination shows the presence of adipose or fibrous tissue that replaces myocardium, focal myocarditis, and cell apoptosis, more frequent in the right ventricular wall (6). Clinical signs are related to right-sided heart failure; dyspnea caused by pleural effusion, ascites, turgor of the jugular veins, episodes of syncope (5,6). The outcome of the disease is not favorable, especially when the symptoms of heart failure become evident (6).
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- 2021
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14. Late-onset myocardial infarction and autoimmune haemolytic anaemia in a COVID-19 patient without respiratory symptoms, concomitant with a paradoxical increase in inflammatory markers: a case report
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Maria Chiara Pelle, Bruno Tassone, Marco Ricchio, Maria Mazzitelli, Chiara Davoli, Giada Procopio, Anna Cancelliere, Valentina La Gamba, Elena Lio, Giovanni Matera, Angela Quirino, Giorgio Settimo Barreca, Enrico Maria Trecarichi, Carlo Torti, and IDTM UMG COVID-19 Group
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COVID-19 ,Inflammation ,Cardiovascular disease ,AIHA ,Anaemia ,IL-6 ,Medicine - Abstract
Abstract Background In December 2019, a new coronavirus (named severe acute respiratory syndrome coronavirus 2, SARS-CoV-2) spread from China, causing a pandemic in a very short time. The main clinical presentation of SARS-CoV-2 infection (COVID-19, coronavirus disease-2019) is pneumonia, but several cardiovascular complications may also occur (e.g., acute coronary syndromes, pulmonary embolism, stroke, arrhythmias, heart failure and cardiogenic shock). Direct or indirect mechanisms induced by SARS-CoV-2 could be implicated in the pathogenesis of these events. Case presentation We report herein the third case of COVID-19 autoimmune haemolytic anaemia (AIHA) reported so far, which occurredwithout any other possible explanations in a Caucasian patient. The patient also suffered from ST-elevation myocardial injury. Conclusions Both complications occurred quite late after COVID-19 diagnosis and were probably precipitated by systemic inflammation, as indicated by a significant delayed increase in inflammatory markers, including interleukin-6 (IL-6).
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- 2020
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15. Orthopedic Device-Related Infections Due to Emerging Pathogens Diagnosed by a Combination of Microbiological Approaches: Case Series and Literature Review
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Angela Quirino, Nadia Marascio, Giuseppe Guido Maria Scarlata, Claudia Cicino, Grazia Pavia, Marta Pantanella, Giovanni Carlisi, Michele Mercurio, Filippo Familiari, Salvatore Rotundo, Vincenzo Olivadese, Valentina La Gamba, Francesca Serapide, Giorgio Gasparini, and Giovanni Matera
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emerging pathogens ,MALDI-TOF ,16SrRNA sequencing ,Abiotrophia defectiva ,Finegoldia magna ,Medicine (General) ,R5-920 - Abstract
Orthopedic and trauma device-related infections (ODRI) due to high virulence microorganisms are a devastating complication after orthopedic surgery. Coagulase-negative Staphylococci (CoNS) are mainly involved but commensal bacteria, located in human mucous membranes, are emerging pathogens in ODRI. Currently, bacterial culture is the gold standard for ODRI but the diagnostic process remains time consuming and laborious. We evaluated a combination of microbiological approaches in the diagnosis of emerging pathogens involved in ODRI. We analyzed two synovial fluids, five tissue samples and five surgical wound swabs from two different patients with ODRI, attending the Department of Orthopedic and Trauma Surgery of Mater Domini Teaching Hospital, Catanzaro, Italy. Identification was carried out with a combination of microbiological approaches (culture, mass spectrometry and 16s rRNA gene sequencing). We demonstrated the importance of a combination of microbiological approaches for the diagnosis of emerging pathogens in ODRI, because the low number of cases in the literature makes it very difficult to formulate guidelines for the management of patients.
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- 2022
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16. Oxygen therapy via high flow nasal cannula in severe respiratory failure caused by Sars-Cov-2 infection: a real-life observational study
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Giada Procopio, Anna Cancelliere, Enrico Maria Trecarichi, Maria Mazzitelli, Eugenio Arrighi, Graziella Perri, Francesca Serapide, Corrado Pelaia, Elena Lio, Maria Teresa Busceti, Maria Chiara Pelle, Marco Ricchio, Vincenzo Scaglione, Chiara Davoli, Paolo Fusco, Valentina La Gamba, Carlo Torti, and Girolamo Pelaia
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Diseases of the respiratory system ,RC705-779 - Abstract
The worldwide spread of coronavirus disease 2019 (COVID-19), caused by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was declared a pandemic by the World Health Organization (WHO) in March 2020. According to clinical studies carried out in China and Italy, most patients experience mild or moderate symptoms; about a fifth of subjects develop a severe and critical disease, and may suffer from interstitial pneumonia, possibly associated with acute respiratory distress syndrome (ARDS) and death. In patients who develop respiratory failure, timely conventional oxygen therapy through nasal catheter plays a crucial role, but it can be used only in mild forms. Continuous positive airway pressure (CPAP) support or non-invasive mechanical ventilation (NIV) are uncomfortable, and require significant man–machine cooperation. Herein we describe our experience of five patients with COVID-19, who were treated with high-flow nasal cannula (HFNC) after failure of CPAP or NIV, and discuss the role of HFNC in COVID-19 patients. Our findings suggest that HFNC can be used successfully in selected patients with COVID-19-related ARDS. The reviews of this paper are available via the supplemental material section .
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- 2020
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17. Evolution of in-hospital patient characteristics and predictors of death in the COVID-19 pandemic across four waves: are they moving targets with implications for patient care?
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Trecarichi, Enrico Maria, Olivadese, Vincenzo, Davoli, Chiara, Rotundo, Salvatore, Serapide, Francesca, Lionello, Rosaria, Tassone, Bruno, La Gamba, Valentina, Fusco, Paolo, Russo, Alessandro, Borelli, Massimo, and Torti, Carlo
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- 2024
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18. Interleukin-62/lymphocyte as a proposed predictive index for COVID-19 patients treated with monoclonal antibodies.
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Rotundo, Salvatore, Borelli, Massimo, Scaglione, Vincenzo, Lionello, Rosaria, Biamonte, Flavia, Olivadese, Vincenzo, Quirino, Angela, Morrone, Helen Linda, Matera, Giovanni, Costanzo, Francesco Saverio, Russo, Alessandro, Trecarichi, Enrico Maria, Torti, Carlo, IDTM UMG COVID-19 Group, Serapide, Francesca, Tassone, Bruno, Fusco, Paolo, Davoli, Chiara, La Gamba, Valentina, and Berardelli, Lavinia
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COVID-19 ,MONOCLONAL antibodies ,CONVENIENCE sampling (Statistics) ,ASYMPTOMATIC patients ,DISEASE progression - Abstract
In a convenience sample of 93 patients treated with monoclonal antibodies (moAbs) against SARS-CoV-2, the interleukin-6
2 /lymphocyte count ratio (IL-62 /LC) was able to predict clinical worsening both in early stages of COVID-19 and in oxygen-requiring patients. Moreover, we analysed 18 most at-risk patients with asymptomatic or mild disease treated with both moAbs and antiviral treatment and found that only 2 had clinical progression, while patients with a similar risk were reported to have an unfavourable outcome in most cases from recent data. In only one of our 18 patients, clinical progression was attributable to COVID-19, and in the other cases, clinical progression was observed despite IL-62 /LC being above the risk cut-off. In conclusion, IL-62 /LC may be a valuable method to identify patients requiring more aggressive treatments both in earlier and later stages of the disease; however, most at-risk patients can be protected from clinical worsening by combining moAbs and antivirals, even if levels of the IL-62 /LC biomarker are lower than the risk cut-off. [ABSTRACT FROM AUTHOR]- Published
- 2023
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19. Prevalence of Antibiotic Resistance Over Time in a Third-Level University Hospital
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Vincenzo Scaglione, Mariaconcetta Reale, Chiara Davoli, Maria Mazzitelli, Francesca Serapide, Rosaria Lionello, Valentina La Gamba, Paolo Fusco, Andrea Bruni, Daniela Procopio, Eugenio Garofalo, Federico Longhini, Nadia Marascio, Cinzia Peronace, Aida Giancotti, Luigia Gallo, Giovanni Matera, Maria Carla Liberto, Bruno Mario Cesana, Chiara Costa, Enrico Maria Trecarichi, Angela Quirino, and Carlo Torti
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Acinetobacter baumannii ,Hospitals, University ,Microbiology (medical) ,Pharmacology ,Klebsiella pneumoniae ,Drug Resistance, Multiple, Bacterial ,Pseudomonas aeruginosa ,Immunology ,Prevalence ,Humans ,Microbial Sensitivity Tests ,Microbiology ,Anti-Bacterial Agents - Abstract
This study evaluated the spread and possible changes in resistance patterns of ESKAPE bacteria to first-choice antibiotics from 2015 to 2019 at a third-level university hospital after persuasive stewardship measures were implemented. Isolates were divided into three groups (group 1, low drug-resistant; group 2, multidrug/extremely drug-resistant; and group 3, pan-resistant bacteria) and a
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- 2022
20. Orthopedic Device-Related Infections Due to Emerging Pathogens Diagnosed by a Combination of Microbiological Approaches: Case Series and Literature Review
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Quirino, Angela, primary, Marascio, Nadia, additional, Scarlata, Giuseppe Guido Maria, additional, Cicino, Claudia, additional, Pavia, Grazia, additional, Pantanella, Marta, additional, Carlisi, Giovanni, additional, Mercurio, Michele, additional, Familiari, Filippo, additional, Rotundo, Salvatore, additional, Olivadese, Vincenzo, additional, La Gamba, Valentina, additional, Serapide, Francesca, additional, Gasparini, Giorgio, additional, and Matera, Giovanni, additional
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- 2022
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21. Virological and Clinical Outcome of DAA Containing Regimens in a Cohort of Patients in Calabria Region (Southern Italy)
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Vincenzo Scaglione, Maria Mazzitelli, Chiara Costa, Vincenzo Pisani, Giuseppe Greco, Francesca Serapide, Rosaria Lionello, Valentina La Gamba, Nadia Marascio, Enrico Maria Trecarichi, and Carlo Torti
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hcv ,daa ,real-life ,hcc ,outcome ,Medicine (General) ,R5-920 - Abstract
Background and objectives: In Italy, Hepatitis C Virus (HCV) infections are most prevalent in people older than 50 years of age, who often experience multi-morbidities, take co-medications, and have a long history of liver disease. These characteristics could potentially affect tolerability of HCV treatments and adherence in this subgroup. After achievement of sustained virological response (SVR), retention into care is very important both to detect the onset of possible complications and prevent further infections. In this study, SVR rates and retention into care of patients treated with directly acting antivirals (DAAs) of a single-center cohort in Southern Italy were evaluated. Materials and Methods: Patients treated with directly acting antivirals from 2014 to 2018 were included. Patients were stratified by age (i.e., 14.6 KPa or clinical/ultrasound cirrhosis vs. absence of these criteria). Primary outcome was availability of SVR at Weeks 12−24 after the end of treatment. Inter- and intra-group comparisons were performed along the follow-up for significant laboratory parameters. Results: In total, 212 patients were treated; 184 (87%) obtained SVR after the first treatment course and 4 patients after retreatment. Twenty-two (10.4%) patients were lost to follow-up before assessment of SVR, and two patients died before the end of treatment for liver decompensation. Considering only the first treatment episode, per protocol analysis (i.e., excluding patients lost to follow-up) showed the following rates of SVR: 97% (overall), 97% (older age group), 96% (age group Conclusions: High rates of SVR were obtained. However, younger patients and those without cirrhosis displayed an apparent high risk of being lost to follow-up. This may have important implications: since those who are lost may transmit HCV in case SVR is not achieved, these subpopulations should receive appropriate counselling during treatment.
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- 2020
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22. Combining evidence from multiple electronic health care databases: performances of one‐stage and two‐stage meta‐analysis in matched case‐control studies
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La Gamba, Fabiola, Corrao, Giovanni, Romio, Silvana, Sturkenboom, Miriam, Trifirò, Gianluca, Schink, Tania, and de Ridder, Maria
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- 2017
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23. Prevalence of Antibiotic Resistance Over Time in a Third-Level University Hospital
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Scaglione, Vincenzo, primary, Reale, Mariaconcetta, additional, Davoli, Chiara, additional, Mazzitelli, Maria, additional, Serapide, Francesca, additional, Lionello, Rosaria, additional, La Gamba, Valentina, additional, Fusco, Paolo, additional, Bruni, Andrea, additional, Procopio, Daniela, additional, Garofalo, Eugenio, additional, Longhini, Federico, additional, Marascio, Nadia, additional, Peronace, Cinzia, additional, Giancotti, Aida, additional, Gallo, Luigia, additional, Matera, Giovanni, additional, Liberto, Maria Carla, additional, Cesana, Bruno Mario, additional, Costa, Chiara, additional, Trecarichi, Enrico Maria, additional, Quirino, Angela, additional, and Torti, Carlo, additional
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- 2022
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24. Vaginal Birth after Two Previous Cesarean Sections versus Elective Repeated Cesarean: A Retrospective Study
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Massimo Franchi, Stefano Uccella, Domenico Antonio La Gamba, Paolo Manzoni, Raffaella De Lorenzi, Rossella De Leo, and Sonia Torresan
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Adult ,medicine.medical_specialty ,Vaginal birth ,MEDLINE ,Gestational Age ,elective repeated cesarean delivery ,trial of labor ,uterine rupture ,vaginal birth after cesarean ,Cesarean Section, Repeat ,Female ,Humans ,Infant, Newborn ,Italy ,Pregnancy ,Pregnancy Outcome ,Retrospective Studies ,Risk Factors ,Vaginal Birth after Cesarean ,Trial of Labor ,Repeat ,03 medical and health sciences ,0302 clinical medicine ,medicine ,030212 general & internal medicine ,Stage (cooking) ,030219 obstetrics & reproductive medicine ,Previous cesarean ,Cesarean Section ,Obstetrics ,business.industry ,Singleton ,Infant ,Obstetrics and Gynecology ,Gestational age ,Retrospective cohort study ,Newborn ,medicine.disease ,Pediatrics, Perinatology and Child Health ,business - Abstract
Trial of labor after cesarean delivery (TOLAC) is a common practice worldwide but the evidence is still scant regarding this practice in women who underwent 2 previous cesareans. The purpose of this study is to retrospectively review our experience with vaginal birth after two previous cesarean sections (VBA2C), with specific attention to the indications for previous cesarean and to the women's motivation for attempting trial of labor.This was a retrospective cohort study conducted in a primary care hospital between January 2011 and December 2019. Inclusion criteria were: singleton pregnancies, absence of morphological abnormalities at ultrasonographic screening of the second trimester (or at any other stage of pregnancy), and two previous cesarean sections.The final analysis included 114 cases for maternal and neonatal outcomes. In total, 40.4% of women chose trial of labor after two cesarean delivery (TOLA2C group). TOLA2C was associated with a success rate of 76.1%, a higher gestational age at birth, and a shorter hospital stay, compared with elective repeated cesarean delivery group. There were no significant differences in the rate of Apgar scores at 5 minutes7 between both groups. The percentage of successful TOLA2C in women with prior vaginal delivery was 92.8%. Factors related to failed TOLA2C included failure to progress (3/11, 27.3%), nonreassuring fetal heart rate (3/11, 27.3%), and no onset of spontaneous labor after premature rupture of membranes (5/11, 45.4%). In the group of TOLA2C, more than 70% accepted to travel more than 45 minutes to reach our hospital, with the aim to attempt VBA2C.TOLA2C is a possible option for both mothers and neonates in selected cases. Adequate counseling about pros and cons of TOLA2C is mandatory. The woman's motivation represents a key element to determine the success of VBA2C.· Selection of candidates and motivation of the patients represent key elements for successful TOLA2C.. · A careful record of obstetrical history and previous deliveries can provide clinicians useful information.. · Mode of delivery in women with two previous cesareans is strongly associated with doctor's counseling..
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- 2020
25. Bayesian pooling versus sequential integration of small preclinical trials: a comparison within linear and nonlinear modeling frameworks
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Helena Geys, Tom Jacobs, Fabiola La Gamba, Christel Faes, and Jan Serroyen
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Pharmacology ,Statistics and Probability ,Process (engineering) ,business.industry ,Computer science ,Computation ,Bayesian probability ,Pooling ,Linear model ,Bayes Theorem ,Small sample ,Machine learning ,computer.software_genre ,Nonlinear system ,Nonlinear Dynamics ,Sample Size ,Linear Models ,Humans ,Computer Simulation ,Pharmacology (medical) ,Artificial intelligence ,business ,computer - Abstract
Bayesian sequential integration is an appealing approach in drug development, as it allows to recursively update posterior distributions as soon as new data become available, thus considerably reducing the computation time. However, preclinical trials are often characterized by small sample sizes, which may affect the estimation process during the first integration steps, particularly when complex PK-PD models are used. In this case, sequential integration would not be practicable, and trials should be pooled together. This work is aimed at comparing simple Bayesian pooling with sequential integration through a simulation study. The two techniques are compared under several scenarios using linear as well as nonlinear models. The results of our simulation study encourage the use of Bayesian sequential integration with linear models. However, in the case of nonlinear models several caveats arise. This paper outlines some important recommendations and precautions in that respect.
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- 2020
26. Additional file 2 of Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study
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Scaglione, Vincenzo, Rotundo, Salvatore, Marascio, Nadia, De Marco, Carmela, Lionello, Rosaria, Veneziano, Claudia, Berardelli, Lavinia, Quirino, Angela, Olivadese, Vincenzo, Serapide, Francesca, Tassone, Bruno, Morrone, Helen Linda, Davoli, Chiara, La Gamba, Valentina, Bruni, Andrea, Cesana, Bruno Mario, Matera, Giovanni, Russo, Alessandro, Costanzo, Francesco Saverio, Viglietto, Giuseppe, Trecarichi, Enrico Maria, and Torti, Carlo
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Additional file 2: Table S2. Complete list of mutations identified in the SARS-CoV-2 genomes from patients described.
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- 2022
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27. Additional file 1 of Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study
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Scaglione, Vincenzo, Rotundo, Salvatore, Marascio, Nadia, De Marco, Carmela, Lionello, Rosaria, Veneziano, Claudia, Berardelli, Lavinia, Quirino, Angela, Olivadese, Vincenzo, Serapide, Francesca, Tassone, Bruno, Morrone, Helen Linda, Davoli, Chiara, La Gamba, Valentina, Bruni, Andrea, Cesana, Bruno Mario, Matera, Giovanni, Russo, Alessandro, Costanzo, Francesco Saverio, Viglietto, Giuseppe, Trecarichi, Enrico Maria, and Torti, Carlo
- Abstract
Additional file 1: Table S1. Metrics of Next Generation Sequencing reported for each viral isolate.
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- 2022
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28. A Discrete Choice Experiment to Evaluate the Interest of Piedmont Region Citizens on Maas
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La Gamba, Davide, primary, Botta, Cristiana, additional, Arnone, Maurizio, additional, and Rataj, Michal, additional
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- 2022
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29. In vitro Activity of Cefiderocol Against Carbapenem-Resistant Acinetobacter baumannii Clinical Isolates: a Single Center Experience.
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Quirino, Angela, Cicino, Claudia, Scaglione, Vincenzo, Marascio, Nadia, Serapide, Francesca, Scarlata, Giuseppe Guido Maria, Lionello, Rosaria, Divenuto, Francesca, La Gamba, Valentina, Pavia, Grazia, Russo, Alessandro, Torti, Carlo, Matera, Giovanni, and Trecarichi, Enrico Maria
- Subjects
CARBAPENEM-resistant bacteria ,ACINETOBACTER baumannii ,KLEBSIELLA pneumoniae ,MULTIDRUG resistance in bacteria ,MICROBIAL sensitivity tests ,MEDICAL microbiology ,STENOTROPHOMONAS maltophilia - Published
- 2023
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30. Varicella zoster immunity loss in multiple sclerosis patient treated with ocrelizumab
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Rapisarda, L., Valentino, P., Barone, S., Torti, C., La Gamba, V., Fortunato, F., Sammarra, I., and Gambardella, A.
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- 2021
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31. Severe myocarditis due to influenza A(H1N1)pdm09 viral infection in a young woman successfully treated with intravenous zanamivir: A case report
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Mazzitelli, M., Garofalo, E., Bruni, A., Barreca, G. S., Quirino, A., Giancotti, A., Serapide, F., Indolfi, C., Matera, G., Navalesi, P., Trecarichi, E. M., Torti, C., Longhini, F., Peronace, C., Pisani, V., Costa, C., Greco, G., La Gamba, V., Scaglione, V., Biamonte, E., Brescia, V., De Leonardis, B., Karim, A., Cimino, G., La Torre, P., Gemelli, A., Tropea, F. A., Picicco, F., and Gallo, L.
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Drug ,intravenous zanamivir ,medicine.medical_specialty ,Oseltamivir ,Myocarditis ,viruses ,media_common.quotation_subject ,lcsh:Medicine ,Case Report ,Case Reports ,030204 cardiovascular system & hematology ,Viral infection ,Gastroenterology ,influenza A(H1N1)pdm09 virus ,Intestinal malabsorption ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Zanamivir ,Internal medicine ,myocarditis ,medicine ,In patient ,media_common ,lcsh:R5-920 ,business.industry ,lcsh:R ,food and beverages ,virus diseases ,Influenza a ,General Medicine ,biochemical phenomena, metabolism, and nutrition ,medicine.disease ,respiratory tract diseases ,chemistry ,030220 oncology & carcinogenesis ,lcsh:Medicine (General) ,business ,medicine.drug - Abstract
In patients with influenza‐related myocarditis, prompt diagnosis and treatment are important. Intravenous zanamivir can be an alternative to oral oseltamivir, especially in severe cases and when drug intestinal malabsorption is suspected or proven.
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- 2019
32. POS0277 ANABOLIC EFFECT OF LNA043, A NOVEL DISEASE-MODIFYING OSTEOARTHRITIS DRUG CANDIDATE: RESULTS FROM AN IMAGING-BASED PROOF-OF-CONCEPT TRIAL IN PATIENTS WITH FOCAL ARTICULAR CARTILAGE LESIONS
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Trattnig, S., primary, Scotti, C., additional, Laurent, D., additional, Juras, V., additional, Hacker, S., additional, Cole, B., additional, Pasa, L., additional, Lehovec, R., additional, Szomolanyi, P., additional, Raithel, E., additional, Saxer, F., additional, Praestgaard, J., additional, La Gamba, F., additional, Jiménez, J. L., additional, Ramos, D. S., additional, Roubenoff, R., additional, and Schieker, M., additional
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- 2021
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33. Arrhythmogenic right ventricular cardiomyopathy in a cat
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Pugliese, Michela, La Maestra, Rocky, La Gamba, Giulia, Lanteri, Giovanni, and Passantino, Annamaria
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cardiac disease ,cardiac arrhythmia ,QH301-705.5 ,cardiovascular system ,Medicine ,Biology (General) ,Arrhythmogenic right ventricular cardiomyopathy ,feline heart disease ,Arrhythmogenic right ventricular cardiomyopathy, cardiac arrhythmia, cardiac disease, feline heart disease - Abstract
Cardiomyopathies are a heterogeneous group of disorders of the myocardium, characterized by multiple clinical manifestations with different prognoses (1). In cats, heart disease is frequent and is considered one of the most common causes of death (2,3). ARVC is rare in pets and has a lot of similarities to human ARVC (4,5). Signs of the disease include moderate/severe dilation of the right ventricle, regional or diffuse thinning of the wall, and sometimes aneurysm. The histological examination shows the presence of adipose or fibrous tissue that replaces myocardium, focal myocarditis, and cell apoptosis, more frequent in the right ventricular wall (6). Clinical signs are related to right-sided heart failure; dyspnea caused by pleural effusion, ascites, turgor of the jugular veins, episodes of syncope (5,6). The outcome of the disease is not favorable, especially when the symptoms of heart failure become evident (6)., Atti della Accademia Peloritana dei Pericolanti - Classe di Scienze Medico-Biologiche, Vol 109, No 1 (2021): Partial Issue
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- 2021
34. Clinical characteristics and predictors of mortality associated with COVID-19 in elderly patients from a long-term care facility
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Trecarichi, Enrico Maria, Mazzitelli, Maria, Serapide, Francesca, Pelle, Maria Chiara, Tassone, Bruno, Arrighi, Eugenio, Perri, Graziella, Fusco, Paolo, Scaglione, Vincenzo, Davoli, Chiara, Lionello, Rosaria, La Gamba, Valentina, Marrazzo, Giuseppina, Busceti, Maria Teresa, Giudice, Amerigo, Ricchio, Marco, Cancelliere, Anna, Lio, Elena, Procopio, Giada, Costanzo, Francesco Saverio, Foti, Daniela Patrizia, Matera, Giovanni, Torti, Carlo, Laganà, Domenico, Petullà, Maria, Bertucci, Bernardo, Quirino, Angela, Barreca, Giorgio Settimo, Giancotti, Aida, Gallo, Luigia, Lamberti, Angelo, Liberto, Maria Carla, Marascio, Nadia, De Francesco, Adele Emanuela, and IDTM UMG COVID-19 Group
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0301 basic medicine ,Male ,medicine.medical_specialty ,China ,Epidemiology ,Article ,COVID-19 ,Infectious diseases ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Lymphopenia ,Pandemic ,medicine ,Humans ,030212 general & internal medicine ,Hospital Mortality ,Aged ,Aged, 80 and over ,Multidisciplinary ,Hypernatremia ,Proportional hazards model ,business.industry ,Interleukin-6 ,SARS-CoV-2 ,Mortality rate ,Outbreak ,medicine.disease ,Long-Term Care ,Nursing Homes ,Hospitalization ,Long-term care ,030104 developmental biology ,Cardiovascular Diseases ,Cohort ,Female ,business ,Cytokine Release Syndrome ,Cohort study - Abstract
Since December 2019, coronavirus disease 2019 (COVID-19) pandemic has spread from China all over the world and many COVID-19 outbreaks have been reported in long-term care facilities (LCTF). However, data on clinical characteristics and prognostic factors in such settings are scarce. We conducted a retrospective, observational cohort study to assess clinical characteristics and baseline predictors of mortality of COVID-19 patients hospitalized after an outbreak of SARS-CoV-2 infection in a LTCF. A total of 50 patients were included. Mean age was 80 years (SD, 12 years), and 24/50 (57.1%) patients were males. The overall in-hospital mortality rate was 32%. At Cox regression analysis, significant predictors of in-hospital mortality were: hypernatremia (HR 9.12), lymphocyte count
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- 2020
35. Characteristics, outcome and predictors of in-hospital mortality in an elderly population from a SARS-CoV-2 outbreak in a long-term care facility
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Chiara Davoli, Giada Procopio, Marco Ricchio, Daniela Foti, Maria Teresa Busceti, Maria Mazzitelli, Amerigo Giudice, Giuseppina Marrazzo, Valentina La Gamba, Graziella Perri, Giovanni Matera, Anna Cancelliere, Bruno Tassone, Maria Chiara Pelle, Francesco Costanzo, Francesca Serapide, Enrico Maria Trecarichi, Vincenzo Scaglione, Elena Lio, Paolo Fusco, Rosaria Lionello, Carlo Torti, and Eugenio Arrighi
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medicine.medical_specialty ,business.industry ,Proportional hazards model ,Mortality rate ,Outbreak ,medicine.disease ,Long-term care ,Internal medicine ,Pandemic ,Cohort ,medicine ,Hypernatremia ,business ,Cohort study - Abstract
Since December 2019, coronavirus disease 2019 (COVID-19) pandemic has spread from China all over the world, many COVID-19 outbreaks have been reported in long-term care facilities (LCTF). However, data on clinical characteristics and prognostic factors in such settings are scarce. We conducted a retrospective, observational cohort study to assess clinical characteristics and baseline predictors of mortality of COVID-19 patients hospitalized after an outbreak of SARS-CoV-2 infection in a LTCF.A total of 50 patients were included. Mean age was 80 years (SD, 12 years), and 24/50 (57.1%) patients were males. A total of 42/50 (84%) patients experienced symptoms of SARS-CoV-2 infection. The overall in-hospital mortality rate was 32%. In Cox regression, significant predictors of in-hospital mortality were: hypernatremia (HR 9.12), lymphocyte count Our study shows a high in-hospital mortality rate in a cohort of elderly patients with COVID-19 and hypernatremia, lymphopenia, CVD other than hypertension, and higher IL-6 serum levels were identified as independent predictors of in-hospital mortality. Further studies are necessary to better understand and confirm our findings in the setting of a LTCF outbreak of COVID-19.
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- 2020
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36. Virological and Clinical Outcome of DAA Containing Regimens in a Cohort of Patients in Calabria Region (Southern Italy)
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Carlo Torti, Nadia Marascio, Maria Mazzitelli, Valentina La Gamba, Rosaria Lionello, Francesca Serapide, Vincenzo Scaglione, Enrico Maria Trecarichi, Chiara Costa, Giuseppe Greco, and Vincenzo Pisani
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Adult ,Liver Cirrhosis ,Male ,medicine.medical_specialty ,Medicine (General) ,Cirrhosis ,Sustained Virologic Response ,Hepatitis C virus ,Hepacivirus ,medicine.disease_cause ,Antiviral Agents ,Article ,Medication Adherence ,Virological response ,03 medical and health sciences ,Liver disease ,0302 clinical medicine ,R5-920 ,Internal medicine ,medicine ,hcv ,Humans ,030212 general & internal medicine ,real-life ,HCV ,DAA ,HCC ,outcome ,Aged ,Intention-to-treat analysis ,business.industry ,Age Factors ,virus diseases ,General Medicine ,Hepatitis C, Chronic ,Middle Aged ,medicine.disease ,digestive system diseases ,Intention to Treat Analysis ,Italy ,Tolerability ,Cohort ,Treatment episode ,Drug Therapy, Combination ,Female ,Lost to Follow-Up ,030211 gastroenterology & hepatology ,hcc ,business ,daa - Abstract
Background and objectives: In Italy, Hepatitis C Virus (HCV) infections are most prevalent in people older than 50 years of age, who often experience multi-morbidities, take co-medications, and have a long history of liver disease. These characteristics could potentially affect tolerability of HCV treatments and adherence in this subgroup. After achievement of sustained virological response (SVR), retention into care is very important both to detect the onset of possible complications and prevent further infections. In this study, SVR rates and retention into care of patients treated with directly acting antivirals (DAAs) of a single-center cohort in Southern Italy were evaluated. Materials and Methods: Patients treated with directly acting antivirals from 2014 to 2018 were included. Patients were stratified by age (i.e., <, 65 vs. &ge, 65 years) and by cirrhosis presence (i.e., liver stiffness >, 14.6 KPa or clinical/ultrasound cirrhosis vs. absence of these criteria). Primary outcome was availability of SVR at Weeks 12&ndash, 24 after the end of treatment. Inter- and intra-group comparisons were performed along the follow-up for significant laboratory parameters. Results: In total, 212 patients were treated, 184 (87%) obtained SVR after the first treatment course and 4 patients after retreatment. Twenty-two (10.4%) patients were lost to follow-up before assessment of SVR, and two patients died before the end of treatment for liver decompensation. Considering only the first treatment episode, per protocol analysis (i.e., excluding patients lost to follow-up) showed the following rates of SVR: 97% (overall), 97% (older age group), 96% (age group <, 65 years), 94% (cirrhotics), and 100% (non-cirrhotics). By contrast, at the intention to treat analysis (i.e., patients lost were computed as failures), SVR percentages were significantly lower for patients <, 65 years of age (80%) and for non-cirrhotics (85%). Conclusions: High rates of SVR were obtained. However, younger patients and those without cirrhosis displayed an apparent high risk of being lost to follow-up. This may have important implications: since those who are lost may transmit HCV in case SVR is not achieved, these subpopulations should receive appropriate counselling during treatment.
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- 2020
37. Soluble Urokinase Plasminogen Activator Receptor (suPAR) and All-Cause and Cardiovascular Mortality in Diverse Hemodialysis Patients
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Claudia Torino, Patrizia Pizzini, Sebastiano Cutrupi, Maurizio Postorino, Giovanni Tripepi, Francesca Mallamaci, Jochen Reiser, Carmine Zoccali, Giovanni Alati, Eleonora Barreca, Rosalia Boito, Margherita Bovino, Vincenzo Bruzzese, Maria Capria, Simonetta Cassani, Salvatore Chiarella, Antonio Chippari, Teresa Cicchetti, Edoardo Crifò-Gasparro, Carlo Curti, Francesco D’Agostino, Emanuela D’Anello, Maria De Gaudio, Aldo Foscaldi, Cesare Fornaciari, Corrado Franco, Alfredo Gaglioti, Domenico Galati, Francesco Grandinetti, Maurizio Gullo, Maria Rosa La Gamba, Domenico Logozzo, Iginia Maimone, Maria Letizia Mannino, Elena Mazzuca, Agazio Mellace, Giuseppe Natale, Vincenzo Panuccio, Domenico Plutino, Antonio Pugliese, Anna Reina, Rita Roberti, Mariagrazia Santangelo, Arcangelo Sellaro, Rosalba Scicchitano, Carmela Vardè, and Francesco Zingone
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medicine.medical_specialty ,medicine.medical_treatment ,Population ,030232 urology & nephrology ,Inflammation ,030204 cardiovascular system & hematology ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,soluble urokinase plasminogen activator receptor (suPAR) ,Clinical Research ,cardiovascular mortality ,Internal medicine ,Diabetes mellitus ,medicine ,education ,Receptor ,noncardiovascular mortality ,Dialysis ,education.field_of_study ,hemodialysis ,business.industry ,medicine.disease ,mortality ,SuPAR ,Nephrology ,Biomarker (medicine) ,Hemodialysis ,medicine.symptom ,business - Abstract
Introduction The soluble receptor of urokinase plasminogen activator (suPAR) is an innate immunity/inflammation biomarker predicting cardiovascular (CV) and non-CV events in various conditions, including type 2 diabetic patients on dialysis. However, the relationship between suPAR and clinical outcomes in the hemodialysis population at large has not been tested. Methods We measured plasma suPAR levels (R&D enzyme-linked immunosorbent assay [ELISA]) in 1038 hemodialysis patients with a follow-up of 2.9 years (interquartile range = 1.7−4.2) who were enrolled in the PROGREDIRE study, a cohort study involving 35 dialysis units in 2 regions in Southern Italy. Results suPAR was strongly (P < 0.001) and independently related to female gender (β = −0.160), age (β = 0.216), dialysis vintage (β = 0.264), CV comorbidities (β = 0.105), alkaline phosphatase (β = 0.136), albumin (β = −0.147), and body mass index (BMI; β = 0.174) (all P < 0.006). In fully adjusted analyses, suPAR tertiles predicted the risk of all-cause mortality (third tertile vs. first tertile hazard ratio (HR) = 1.91, 95% confidence interval (CI) = 1.47 – 2.48, P < 0.001), CV mortality (HR = 1.47, 95% CI = 1.03–2.09, P = 0.03), and non-CV mortality (HR = 1.94, 95% CI = 1.28–2.93, P = 0.002); these relationships were not modified by diabetes or other risk factors. suPAR added only modest prognostic risk discrimination and reclassification power for these outcomes to parsimonious models based on simple clinical variables. Conclusion In conclusion, suPAR robustly predicted all-cause and both CV and non-CV mortality in a large unselected hemodialysis population. Intervention studies are needed to definitively test the hypothesis that suPAR is causally implicated in clinical outcomes in this population.
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- 2018
38. A Bayesian K-PD model for synergy: A case study
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Christel Faes, Fabiola La Gamba, Helena Geys, Tom Jacobs, and Luc Ver Donck
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Pharmacology ,Statistics and Probability ,Change over time ,Dose-Response Relationship, Drug ,Computer science ,Bayesian probability ,Bayes Theorem ,Drug Synergism ,Model parameters ,Dose level ,Bayesian inference ,Models, Biological ,030226 pharmacology & pharmacy ,01 natural sciences ,010104 statistics & probability ,03 medical and health sciences ,0302 clinical medicine ,Frequentist inference ,Pharmacodynamics ,Humans ,Drug Therapy, Combination ,Pharmacology (medical) ,0101 mathematics ,Biological system ,Indirect response - Abstract
Coadministration of 2 or more compounds can alter both the pharmacokinetics and pharmacodynamics of individual compounds. While experiments on pharmacodynamic drug-drug interactions are usually performed in an in vitro setting, this experiment focuses on an in vivo setting. The change over time of a safety biomarker is modeled using an indirect response model, in which the virtual pharmacokinetic profile of one compound drives the effect of the other. Several experiments at different dose level combinations were performed sequentially. While a traditional frequentist analysis consists of estimating the model parameters based on all the data simultaneously, in this work, we consider a Bayesian inference framework allowing to incorporate the results from a historical dose-response experiment.
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- 2018
39. Vaginal Birth after Two Previous Cesarean Sections versus Elective Repeated Cesarean: A Retrospective Study
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De Leo, Rossella, additional, La Gamba, Domenico Antonio, additional, Manzoni, Paolo, additional, De Lorenzi, Raffaella, additional, Torresan, Sonia, additional, Franchi, Massimo, additional, and Uccella, Stefano, additional
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- 2020
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40. Apparent inefficacy of hydroxychloroquine combined with azithromycin on SARS-CoV-2 clearance in an incident cohort of geriatric patients with COVID-19
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Mazzitelli, Maria, primary, Davoli, Chiara, additional, Scaglione, Vincenzo, additional, Fusco, Paolo, additional, La Gamba, Valentina, additional, Matera, Giovanni, additional, Trecarichi, Enrico Maria, additional, and Torti, Carlo, additional
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- 2020
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41. Bayesian pooling versus sequential integration of small preclinical trials: a comparison within linear and nonlinear modeling frameworks
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La Gamba, Fabiola, primary, Jacobs, Tom, additional, Serroyen, Jan, additional, Geys, Helena, additional, and Faes, Christel, additional
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- 2020
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42. Virological and Clinical Outcome of DAA Containing Regimens in a Cohort of Patients in Calabria Region (Southern Italy)
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Scaglione, Vincenzo, primary, Mazzitelli, Maria, additional, Costa, Chiara, additional, Pisani, Vincenzo, additional, Greco, Giuseppe, additional, Serapide, Francesca, additional, Lionello, Rosaria, additional, La Gamba, Valentina, additional, Marascio, Nadia, additional, Trecarichi, Enrico Maria, additional, and Torti, Carlo, additional
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- 2020
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43. Oxygen therapy via high flow nasal cannula in severe respiratory failure caused by Sars-Cov-2 infection: a real-life observational study
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Procopio, Giada, primary, Cancelliere, Anna, additional, Trecarichi, Enrico Maria, additional, Mazzitelli, Maria, additional, Arrighi, Eugenio, additional, Perri, Graziella, additional, Serapide, Francesca, additional, Pelaia, Corrado, additional, Lio, Elena, additional, Busceti, Maria Teresa, additional, Pelle, Maria Chiara, additional, Ricchio, Marco, additional, Scaglione, Vincenzo, additional, Davoli, Chiara, additional, Fusco, Paolo, additional, La Gamba, Valentina, additional, Torti, Carlo, additional, and Pelaia, Girolamo, additional
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- 2020
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44. Bayesian sequential integration within a preclinical pharmacokinetic and pharmacodynamic modeling framework: Lessons learned
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Fabiola La Gamba, Christel Faes, Moreno Ursino, Helena Geys, Alberto Russu, Tom Jacobs, Jan Serroyen, Thomas Jaki, LA GAMBA, Fabiola, JACOBS, Tom, GEYS, Helena, Jaki, Thomas, SERROYEN, Jan, Ursino, Moreno, Russu, Alberto, FAES, Christel, Lancaster University, University of Cambridge [UK] (CAM), Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École Pratique des Hautes Études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Hasselt University (UHasselt), INCA 9539, and European Project: 633567,H2020,H2020-MSCA-ITN-2014,IDEAS(2015)
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Statistics and Probability ,Computer science ,Bayesian inference ,nonlinear hierarchical models ,pharmacodynamics ,pharmacokinetics ,recursive ,sequential ,[SDV]Life Sciences [q-bio] ,Bayesian probability ,Machine learning ,computer.software_genre ,01 natural sciences ,Models, Biological ,010104 statistics & probability ,03 medical and health sciences ,0302 clinical medicine ,Knowledge integration ,Humans ,Pharmacology (medical) ,Pharmacokinetics ,030212 general & internal medicine ,0101 mathematics ,Pharmacology ,Clinical Trials as Topic ,Scope (project management) ,business.industry ,Bayes Theorem ,Random effects model ,[STAT]Statistics [stat] ,Research Design ,Artificial intelligence ,business ,computer - Abstract
The present manuscript aims to discuss the implications of sequential knowledge integration of small preclinical trials in a Bayesian pharmacokinetic and pharmacodynamic (PK-PD) framework. While, at first sight, a Bayesian PK-PD framework seems to be a natural framework to allow for sequential knowledge integration, the scope of this paper is to highlight some often-overlooked challenges while at the same time providing some guidances in the many and overwhelming choices that need to be made. Challenges as well as opportunities will be discussed that are related to the impact of (1) the prior specification, (2) the choice of random effects, (3) the type of sequential integration method. In addition, it will be shown how the success of a sequential integration strategy is highly dependent on a carefully chosen experimental design when small trials are analyzed. European Union's Horizon 2020 research and innovation programme, Grant/Award Number: 633567; IAP Research Network P7/06 of the Belgian State (Belgian Science Policy); French National Cancer Institute (INCa), Grant/Award Number: INCA 9539
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- 2018
45. POS0277 ANABOLIC EFFECT OF LNA043, A NOVEL DISEASE-MODIFYING OSTEOARTHRITIS DRUG CANDIDATE: RESULTS FROM AN IMAGING-BASED PROOF-OF-CONCEPT TRIAL IN PATIENTS WITH FOCAL ARTICULAR CARTILAGE LESIONS
- Author
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L. Pasa, Jens Praestgaard, Vladimir Juras, J. L. Jiménez, Didier Laurent, Esther Raithel, Matthias Schieker, S. Hacker, R. Lehovec, Brian J. Cole, F. La Gamba, F. Saxer, Ronenn Roubenoff, S. Trattnig, Pavol Szomolanyi, D. S. Ramos, and C. Scotti
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medicine.diagnostic_test ,Cartilage homeostasis ,business.industry ,Cartilage ,Immunology ,Magnetic resonance imaging ,Osteoarthritis ,Placebo ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Condyle ,medicine.anatomical_structure ,Rheumatology ,medicine ,Clinical endpoint ,Immunology and Allergy ,Femur ,Nuclear medicine ,business - Abstract
Background:LNA043 is a modified, recombinant version of the human angiopoietin-like 3 (ANGPTL3) protein acting directly on cartilage-resident cells to transmit its cartilage anabolic effect. A first-in-human study previously demonstrated the favourable safety profile and the modulation of several pathways involved in cartilage homeostasis and osteoarthritis (OA)1. A previous proof-of-mechanism imaging study used high field (7 Tesla) magnetic resonance imaging (MRI) to show formation of hyaline-like tissue after a single injection of 20 mg LNA043 (unpublished data).Objectives:To evaluate non-invasively the chondro-regenerative capacity of multiple intra-articular (i.a.) injections of LNA043 in patients with articular cartilage lesions in the knee (NCT03275064).Methods:This was a randomised, double-blind, placebo (PBO)-controlled, proof-of-concept study in patients with a partial thickness cartilage lesion. In total, 58 patients (43 [20 mg LNA043]; 15 [PBO]), stratified by lesion type (condylar or patellar) were treated with 4 weekly i.a. injections. The primary endpoint was T2 relaxation time measurement as a marker of collagen fiber network, and cartilage lesion-volume was a secondary endpoint, both using 3-Tesla MRI. Assessments were performed at baseline, weeks (wks) 8, 16, 28 and 52 (the latter in 23/58 patients). While lesion-volume for the secondary endpoint was determined from manually segmented images, the cartilage volume of 21 sub-regions spanning the entire knee was also measured from 3D isotropic MR images employing an automated segmentation prototype software (MR Chondral Health 2.1 [MRCH], Siemens Healthcare)2. An exploratory analysis evaluated the treatment effect for the additive volume of the 3 subregions in the weight-bearing area of the medial femur.Results:No change in T2 relaxation time was detected between treatment and PBO groups. Manual segmentation showed continuous filling of the cartilage lesions up to wk 28 in LNA043-treated patients with femoral lesions (p=0.08, vs PBO) while no effect was detected for patients with patellar lesions. Given the limitations of measuring small, irregularly shaped lesions with manual image-analysis, the MRCH approach was used (Figure 1). In the medial femoral weight-bearing region, refilling was detected over time (Δ=123 mm3 at wk 28, N= 37, p= 0.05). No overgrowth was detected in the lateral femoral condyles without cartilage damage. The overall safety profile was favourable; only mild/moderate local reactions were reported, including a higher incidence of joint swelling (9.3% vs 0%) and arthralgia (11.6% vs 6.7%) for LNA043 vs PBO resolving spontaneously or with paracetamol/NSAIDs. No anti-drug antibodies were detected.Conclusion:Treatment with 4 weekly i.a. injections of 20 mg LNA043 resulted in regeneration of damaged cartilage in patients with femoral articular cartilage lesions. Automated measurement of cartilage volume in the femoral index region was able to detect a relevant treatment effect and was found to be more sensitive than the manual segmentation method. No sign of cartilage overgrowth was observed in healthy femoral regions. A Phase 2b study in patients with mild to moderate knee OA is in preparation.References:[1]Scotti et al. ACR Convergence 2020; Abstract #1483[2]Juras et al. Cartilage 2020; Sep 29:1-12Disclosure of Interests:Siegfried Trattnig: None declared, Celeste Scotti Shareholder of: Novartis, Employee of: Novartis, Didier Laurent Shareholder of: Novartis, Employee of: Novartis, Vladimir Juras: None declared, Scott Hacker Grant/research support from: Novartis, Brian Cole: None declared, Libor Pasa: None declared, Roman Lehovec: None declared, Pavol Szomolanyi: None declared, Esther Raithel Employee of: Siemens Healthcare GmbH, Franziska Saxer Shareholder of: Novartis, Employee of: Novartis, Jens Praestgaard Shareholder of: Novartis, Employee of: Novartis, Fabiola La Gamba Shareholder of: Novartis, Employee of: Novartis, José L. Jiménez Employee of: Novartis, David Sanchez Ramos Shareholder of: Novartis, Employee of: Novartis, Ronenn Roubenoff Shareholder of: Novartis, Employee of: Novartis, Matthias Schieker Shareholder of: Novartis, Employee of: Novartis
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- 2021
46. Combining evidence from multiple electronic health care databases: performances of one-stage and two-stage meta-analysis in matched case-control studies
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La Gamba, F, Corrao, G, Romio, S, Sturkenboom, M, Trifiro, G, Schink, T, de Ridder, M, La Gamba F., Corrao G., Romio S., Sturkenboom M., Trifiro G., Schink T., de Ridder M., La Gamba, F, Corrao, G, Romio, S, Sturkenboom, M, Trifiro, G, Schink, T, de Ridder, M, La Gamba F., Corrao G., Romio S., Sturkenboom M., Trifiro G., Schink T., and de Ridder M.
- Abstract
Purpose: Clustering of patients in databases is usually ignored in one-stage meta-analysis of multi-database studies using matched case-control data. The aim of this study was to compare bias and efficiency of such a one-stage meta-analysis with a two-stage meta-analysis. Methods: First, we compared the approaches by generating matched case-control data under 5 simulated scenarios, built by varying: (1) the exposure-outcome association; (2) its variability among databases; (3) the confounding strength of one covariate on this association; (4) its variability; and (5) the (heterogeneous) confounding strength of two covariates. Second, we made the same comparison using empirical data from the ARITMO project, a multiple database study investigating the risk of ventricular arrhythmia following the use of medications with arrhythmogenic potential. In our study, we specifically investigated the effect of current use of promethazine. Results: Bias increased for one-stage meta-analysis with increasing (1) between-database variance of exposure effect and (2) heterogeneous confounding generated by two covariates. The efficiency of one-stage meta-analysis was slightly lower than that of two-stage meta-analysis for the majority of investigated scenarios. Based on ARITMO data, there were no evident differences between one-stage (OR = 1.50, CI = [1.08; 2.08]) and two-stage (OR = 1.55, CI = [1.12; 2.16]) approaches. Conclusions: When the effect of interest is heterogeneous, a one-stage meta-analysis ignoring clustering gives biased estimates. Two-stage meta-analysis generates estimates at least as accurate and precise as one-stage meta-analysis. However, in a study using small databases and rare exposures and/or outcomes, a correct one-stage meta-analysis becomes essential.
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- 2017
47. Bayesian sequential integration within a preclinical PK-PD modeling framework: Lessons learned
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Fabiola La Gamba, Tom Jacobs, Helena Geys, Thomas Jaki, Jan Serroyen, Moreno Ursino, Alberto Russu, and Christel Faes
- Abstract
The present manuscript aims to discuss the implications of sequential knowledge integration of small preclinical trials in a Bayesian PK-PD framework. While, at first sight, a Bayesian PK-PD framework seems to be a natural framework to allow for sequential knowledge integration, the scope of this paper is to highlight some often-overlooked challenges while at the same time providing some guidances in the many and overwhelming choices that need to be made. Challenges as well as opportunities will be discussed that are related to the impact of (i) the prior specification, (ii) the choice of random effects, (iii) the type of sequential integration method. In addition, it will be shown how the success of a sequential integration strategy is highly dependent on a carefully chosen experimental design when small trials are analyzed.
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- 2019
- Full Text
- View/download PDF
48. Bayesian Nonlinear Hierarchical Models: Applications in Preclinical Pharmacometrics
- Author
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LA GAMBA, Fabiola, FAES, Christel, GEYS, Helena, and Jacobs, Tom
- Subjects
Bayesian Inference, Nonlinear Hierarchical Models, Pharmacokinetics, Pharmacodynamics, Preclinical, Recursive, Sequential Analysis - Abstract
Although Bayesian methods are expanding considerably in various scientific areas, their applications in the field of pharmacokinetic/pharmacodynamic (PK/PD) modelling and simulation is still relatively limited. In this work, Bayesian techniques are used to facilitate the estimation of a novel PK/PD model which is developed to quantify the extent of PD synergy between two compounds using historical in vivo data. The model is fitted using package rstan, the R interface to Stan. Stan is a recently developed software package which allows an efficient estimation using the No-U-Turn Sampler (NUTS). Since the data consist of a series of 11 trials performed sequentially, a Bayesian sequential integration is considered: the posteriors resulting from the analysis of one trial are used to specify the hyperparameters of the priors of the next trial. The recursive update of posterior distributions whenever new information is available is less computationally intensive compared to the analysis of all data up to the current trial. However, this method implies the analysis of a limited amount of information during the first integration steps, which may hinder the estimation process. The aim of the present work is to discuss challenges as well as opportunities which are related to the impact of (i) prior specification, (ii) random effect choice and (iii) experimental design. In addition, the results from an extensive simulation study assessing the performance of the Bayesian sequential integration for an increasing model complexity are evaluated. The results suggest that the use of informative prior distributions reduces the correlation among parameters and improves the accuracy of estimates. Moreover, choosing the random effect on a parameter that is not highly correlated with others avoids overcompensations, thus ensuring better predictions. On top of that, trials should be designed so that each of them explores an exhaustive number of doses and sampling times. European Union's Horizon 2020 research and innovation programme, Grant/Award Number: 633567; IAP Research Network P7/06 of the Belgian State (Belgian Science Policy); French National Cancer Institute (INCa), Grant/Award Number: INCA 9539
- Published
- 2019
49. Clinical outcomes of patients treated with intravenous zanamivir for severe influenza A(H1N1)pdm09 infection: A case report series
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Torti, C., Mazzitelli, M., Longhini, F., Garofalo, E., Bruni, A., Giancotti, A., Barreca, G. S., Quirino, A., Liberto, M. C., Serapide, F., Matera, G., Trecarichi, E. M., Navalesi, P., Pisani, V., Costa, C., Greco, G., Scaglione, V., Lionello, R., La Gamba, V., Biamonte, E., La Valle, O., Cimino, G., La Torre, P., Karim, A., and Gemelli, A.
- Subjects
0301 basic medicine ,medicine.medical_specialty ,medicine.medical_treatment ,030106 microbiology ,Case Report ,Severe influenza ,Antiviral Agents ,law.invention ,lcsh:Infectious and parasitic diseases ,03 medical and health sciences ,Influenza A Virus, H1N1 Subtype ,0302 clinical medicine ,Zanamivir ,Medical microbiology ,Randomized controlled trial ,law ,Internal medicine ,Influenza, Human ,ECMO ,ICU ,Influenza A(H1N1)pdm09 ,Humans ,medicine ,Extracorporeal membrane oxygenation ,Influenza A Virus ,lcsh:RC109-216 ,H1N1 Subtype ,030212 general & internal medicine ,Mechanical ventilation ,business.industry ,virus diseases ,Intensive care unit ,Influenza ,respiratory tract diseases ,Infectious Diseases ,Concomitant ,business ,medicine.drug ,Human - Abstract
Background Intravenous (IV) zanamivir could be a suitable alternative for the treatment of severe influenza A(H1N1)pdm09 infection in patients who are unable to take oral or inhaled medication, for example, those on mechanical ventilation and extracorporeal membrane oxygenation (ECMO). However, data on the clinical outcomes of such patients is limited. Case presentation We report the clinical outcomes of four patients who were admitted at the intensive care unit during the 2017–2018 influenza season with severe sepsis (SOFA score > 11) and acute respiratory distress syndrome requiring ECMO and mechanical ventilation. Two patients were immune-compromised. The A(H1N1)pdm09 genome was confirmed by polymerase chain reaction (PCR) on nasopharyngeal specimen swabs prior to administration of IV zanamivir at a dose of 600 mg twice daily. Weekly qualitative PCR analysis was done to monitor viral clearance, with zanamivir treatment being discontinued upon receipt of negative results. In addition, the patients were managed for concomitant multidrug-resistant bacterial infections, with infection resolution confirmed with blood cultures. The median time for zanamivir treatment was 10 days (IQR 10–17). The clinical outcome was favourable with all four patients surviving and improving clinically. All four patients achieved viral clearance of A(H1N1)pdm09 genome, and resolution of multidrug-resistant bacterial infections. Conclusions IV zanamivir could be a good therapeutic option in patients with severe influenza A(H1N1)pdm09 infection who are unable to take oral or aerosolised antiviral medication. We recommend prospective randomized control trials to support this hypothesis.
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- 2019
50. Combining evidence from multiple electronic health care databases: Performances of one-stage and two-stage meta-analysis in matched casecontrol studies (vol 26, pg 1213, 2017)
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La Gamba, F., Corrao, G., Romio, S., Sturkenboom, M., Trifiro, G., Schink, T., and de Ridder, M.
- Published
- 2018
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