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2. AI techniques for automated penetration testing in MQTT networks: a literature investigation

Author

Alencar, Reno C., Fernandes, Bruno J. T., Lima, Paulo H. E. S., and da Silva, Carlo M. R.

Abstract

The proliferation of IoT has made MQTT systems frequent targets of cyberattacks. While existing literature predominantly focuses on intrusion detection systems, this research aims to explore how machine learning algorithms can be leveraged to automate penetration testing in MQTT environments. A review of the literature reveals a significant gap in the field of automated testing, with few studies utilizing specific brokers and realistic datasets. This study contributes to the security of MQTT networks through: (a) a survey of widely used MQTT brokers, detailing their features, vulnerabilities, and mitigation measures; (b) an analysis of common attacks against brokers, including the identification of attack vectors, intrusion techniques, and defense mechanisms; (c) a mapping of machine learning models, such as Decision Trees (DT), Generative Adversarial Networks (GANs), and Boosting Algorithms, for detecting malicious activities and automating penetration testing in MQTT environments; and (d) the proposal of metrics to evaluate the effectiveness of the proposed models, considering both their ability to detect attacks and to successfully exploit vulnerabilities.

Published
2025
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3. Inositol hexakisphosphate kinases differentially regulate trafficking of vesicular glutamate transporters 1 and 2

Author

Haiyan Li, Maia Datunashvili, Reno C. Reyes, and Susan M. Voglmaier

Subjects
synaptic vesicle, vesicular glutamate transporter, endocytosis, inositol hexakisphosphate kinase (IP6K), exocytosis, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Inositol pyrophosphates have been implicated in cellular signaling and membrane trafficking, including synaptic vesicle (SV) recycling. Inositol hexakisphosphate kinases (IP6Ks) and their product, diphosphoinositol pentakisphosphate (PP-IP5 or IP7), directly and indirectly regulate proteins important in vesicle recycling by the activity-dependent bulk endocytosis pathway (ADBE). In the present study, we show that two isoforms, IP6K1 and IP6K3, are expressed in axons. The role of the kinases in SV recycling are investigated using pharmacologic inhibition, shRNA knockdown, and IP6K1 and IP6K3 knockout mice. Live-cell imaging experiments use optical reporters of SV recycling based on vesicular glutamate transporter isoforms, VGLUT1- and VGLUT2-pHluorins (pH), which recycle differently. VGLUT1-pH recycles by classical AP-2 dependent endocytosis under moderate stimulation conditions, while VGLUT2-pH recycles using AP-1 and AP-3 adaptor proteins as well. Using a short stimulus to release the readily releasable pool (RRP), we show that IP6K1 KO increases exocytosis of both VGLUT1-and VGLUT2-pH, while IP6K3 KO decreases the amount of both transporters in the RRP. In electrophysiological experiments we measure glutamate signaling with short stimuli and under the intense stimulation conditions that trigger bulk endocytosis. IP6K1 KO increases synaptic facilitation and IP6K3 KO decreases facilitation compared to wild type in CA1 hippocampal Schaffer collateral synapses. After intense stimulation, the rate of endocytosis of VGLUT2-pH, but not VGLUT1-pH, is increased by knockout, knockdown, and pharmacologic inhibition of IP6Ks. Thus IP6Ks differentially affect the endocytosis of two SV protein cargos that use different endocytic pathways. However, while IP6K1 KO and IP6K3 KO exert similar effects on endocytosis after stimulation, the isoforms exert different effects on exocytosis earlier in the stimulus and on the early phase of glutamate release. Taken together, the data indicate a role for IP6Ks both in exocytosis early in the stimulation period and in endocytosis, particularly under conditions that may utilize AP-1/3 adaptors.

Published
2022
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4. Neuronal Glutathione Content and Antioxidant Capacity can be Normalized In Situ by N-acetyl Cysteine Concentrations Attained in Human Cerebrospinal Fluid.

Author

Reyes, Reno C, Cittolin-Santos, Giordano Fabricio, Kim, Ji-Eun, Won, Seok Joon, Brennan-Minnella, Angela M, Katz, Maya, Glass, Graham A, and Swanson, Raymond A

Subjects
Animals, Mice, Inbred C57BL, Humans, Mice, Rats, Rats, Sprague-Dawley, Acetylcysteine, Glutathione, Antioxidants, Brain Chemistry, Dose-Response Relationship, Drug, Cysteine, Parkinson’s disease, cerebrospinal fluid, human, oxidative stress, target engagement, Parkinson's disease, Neurology & Neurosurgery, Neurosciences, Pharmacology and Pharmaceutical Sciences, Public Health and Health Services
Abstract

N-acetyl cysteine (NAC) supports the synthesis of glutathione (GSH), an essential substrate for fast, enzymatically catalyzed oxidant scavenging and protein repair processes. NAC is entering clinical trials for adrenoleukodystrophy, Parkinson's disease, schizophrenia, and other disorders in which oxidative stress may contribute to disease progression. However, these trials are hampered by uncertainty about the dose of NAC required to achieve biological effects in human brain. Here we describe an approach to this issue in which mice are used to establish the levels of NAC in cerebrospinal fluid (CSF) required to affect brain neurons. NAC dosing in humans can then be calibrated to achieve these NAC levels in human CSF. The mice were treated with NAC over a range of doses, followed by assessments of neuronal GSH levels and neuronal antioxidant capacity in ex vivo brain slices. Neuronal GSH levels and antioxidant capacity were augmented at NAC doses that produced peak CSF NAC concentrations of ≥50 nM. Oral NAC administration to humans produced CSF concentrations of up to 10 μM, thus demonstrating that oral NAC administration can surpass the levels required for biological activity in brain. Variations of this approach may similarly facilitate and rationalize drug dosing for other agents targeting central nervous system disorders.

Published
2016

5. Activation of Neuronal NMDA Receptors Induces Superoxide-Mediated Oxidative Stress in Neighboring Neurons and Astrocytes

Author

Reyes, Reno C, Brennan, Angela M, Shen, Yiguo, Baldwin, Ylva, and Swanson, Raymond A

Subjects
Biomedical and Clinical Sciences, Neurosciences, Neurological, Animals, Astrocytes, Cells, Cultured, Membrane Glycoproteins, Mice, Mice, Knockout, NADPH Oxidase 2, NADPH Oxidases, Neurons, Oxidative Stress, Receptors, N-Methyl-D-Aspartate, Superoxides, Medical and Health Sciences, Psychology and Cognitive Sciences, Neurology & Neurosurgery
Abstract

Excitotoxic neuronal death is mediated in part by NMDA receptor-induced activation of NOX2, an enzyme that produces superoxide and resultant oxidative stress. It is not known, however, whether the superoxide is generated in the intracellular space, producing oxidative stress in the neurons responding to NMDA receptor activation, or in the extracellular space, producing oxidative stress in neighboring cells. We evaluated these alternatives by preparing cortical neuron cultures from p47(phox-/-) mice, which are unable to form a functional NOX2 complex, and transfecting the cultures at low density with GFP-tagged p47(phox) to reconstitute NOX2 activity in widely scattered neurons. NMDA exposure did not induce oxidative stress or cell death in the nontransfected, p47-phox(-/-) cultures, but did produce oxidative stress and neuronal death in neurons surrounding the transfected, NOX2-competent neurons. This cell-to-cell spread of NMDA-induced oxidative injury was blocked by coincubation with either superoxide dismutase or the anion channel blocker 4'-diisothiocyanostilbene-2,2'-disulphonate, confirming superoxide anion as the mediating oxidant. In neurons plated on a preexisting astrocyte layer, NMDA induced oxidative stress in both the neurons and the astrocytes, and this was also prevented by superoxide dismutase. These findings show that activation of NMDA receptors on one neuron can lead to oxidative stress and cell death in neighboring neurons and astrocytes by a process involving the extracellular release of superoxide by NOX2.

Published
2012

6. Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Author

Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P. W., Bucsa C., Osman A., Liddiard M., Maques F. B., Petrelli G., Sonderlichova S., Thurin N. H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L. A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P. M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M. P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Mastropasqua D., Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P.W., Bucsa C., Osman A., Liddiard M., Maques F.B., Petrelli G., Sonderlichova S., Thurin N.H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L.A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P.M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M.P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., and Mastropasqua D.

Subjects
COVID-19 Vaccines, safety, Surveillance Systems, Pivotal Clinical Trials
Abstract

Background and Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. Results: The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years; n = 250 and adolescents aged 12–17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. Conclusions: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Published
2023

7. Phased target trial design and meta-analysis in a head-to-head treatment comparison

Author

Singh, Jagmeet P., Wieloch, Mattias, Reynolds, Shannon L., Blomström-Lundqvist, Carina, Sandhu, Alex T., Camm, A. John, Kabadi, Shaum M., Pundi, Krishna, Turakhia, Mintu, Boiron, Rania, Coudert, Mathieu, Din, Natasha, Fan, Jun, Heller, Caroline G., Leeming, Reno C., McKindley, David, Sajedian, Renee M., Kowey, Peter R., Singh, Jagmeet P., Wieloch, Mattias, Reynolds, Shannon L., Blomström-Lundqvist, Carina, Sandhu, Alex T., Camm, A. John, Kabadi, Shaum M., Pundi, Krishna, Turakhia, Mintu, Boiron, Rania, Coudert, Mathieu, Din, Natasha, Fan, Jun, Heller, Caroline G., Leeming, Reno C., McKindley, David, Sajedian, Renee M., and Kowey, Peter R.

Abstract

Background: For conditions with rare clinical outcomes, real-world treatment comparisons are challenging to design and prone to confounding. Objectives: To present a robust methodologic approach for rigorous and transparent assessment of rare outcomes using real-world data. Methods: We emulated a target trial using an active comparator, new-user design to compare dronedarone to sotalol for rhythm control in atrial fibrillation (AF) as both are recommended for similar patient phenotypes. Using one protocol, a pre-specified stepwise approach was implemented across 4 datasets (Optum CDM; IBM MarketScan; Veterans Affairs Electronic Health Records; Swedish National Patient Register). Meta-analysis was used to ensure sufficient capture of specific, rare primary outcomes (cardiovascular (CV) hospitalization and ventricular proarrhythmia) and to evaluate consistency of findings across patient populations. Steps 1–3 focused on cohort selection, propensity score matching (PSM), baseline equipoise and residual confounding assessment via negative control outcome analyses. In steps 4–6, outcomes in the individual cohorts were analyzed using an as-treated approach and Cox proportional hazards models. Step 7 included a heterogeneity assessment, meta-analysis using fixed effects models, and hypothesis testing using a hierarchical approach. In step 8, sensitivity analyses, including E-values and Inverse Probability of Censoring Weighting, were conducted to verify the robustness of findings. Results: In step 1, 35,467 sotalol and 27,955 dronedarone patients with AF who were antiarrhythmic drug-naive were identified across databases. In steps 2–3, 23,275 dronedarone patients were PS-matched to 23,275 sotalol patients. Baseline covariates were well-balanced and little-to-no residual confounding was observed via the negative control analyses. Individual HRs were estimated in steps 4–6, and, when no significant heterogeneity between databases was observed, hazard ratios (HRs) were pooled

Published
2023

10. Diet Quality and Survival in a Population-Based Bladder Cancer Study

Author

Reno C. Leeming, Margaret R. Karagas, Diane Gilbert-Diamond, Jennifer A. Emond, Michael S. Zens, Alan R. Schned, John D. Seigne, and Michael N. Passarelli

Subjects
Cancer Research, Nutrition and Dietetics, Urinary Bladder Neoplasms, Oncology, Sodium, Humans, Medicine (miscellaneous), Diet, Healthy, Article, Diet, Proportional Hazards Models
Abstract

Nutrition may impact bladder cancer survival. We examined the association between diet quality and overall and bladder cancer-specific survival. Bladder cancer cases from a population-based study reported pre-diagnosis diet. Diet quality was assessed using the 2010 Alternate Healthy Eating Index (AHEI-2010). Vital status was ascertained from the National Death Index. Adjusted hazard ratios (HR) and 95% confidence intervals (CI) were estimated using proportional hazards and competing risks regression models. Overall AHEI-2010 adherence was not associated with overall or bladder cancer-specific survival among non-muscle invasive bladder cancer (NMIBC) cases (HR, 1.00; 95% CI, 0.98–1.01; HR, 1.00; 95% CI, 0.97–1.02) or muscle invasive bladder cancer (MIBC) cases (HR, 0.99; 95% CI, 0.96–1.03; HR, 1.01, 95% CI 0.97–1.06). AHEI-2010 sugar-sweetened beverages adherence was associated with poorer overall survival (HR, 1.04; 95% CI, 1.01–1.08) and AHEI-2010 sodium adherence was associated with better overall and bladder cancer-specific survival after NMIBC diagnosis (HR, 0.92, 95% CI, 0.85–1.00; HR, 0.82; 95% CI, 0.68–0.98). AHEI-2010 fruit adherence was associated with poorer overall and bladder cancer-specific survival after MIBC diagnosis (HR, 1.17; 95% CI, 1.02–1.33; HR, 1.26; 95% CI, 1.03–1.55). Consumption of sugar-sweetened beverages, sodium, and fruit, not overall AHEI-2010 adherence, may be associated with bladder cancer survival.

Published
2021
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13. Bladder cancer risk variants and overall and disease‐specific survival in two independent cohorts

Author

Michael S. Zens, Alan R. Schned, Michael N. Passarelli, Margaret R. Karagas, John D. Seigne, and Reno C. Leeming

Subjects
Male, Oncology, Carcinoma, Transitional Cell, medicine.medical_specialty, Bladder cancer, business.industry, Urology, Disease specific survival, Urinary Bladder, Prognosis, medicine.disease, Article, Urinary Bladder Neoplasms, Internal medicine, Humans, Medicine, Female, business
Published
2021
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14. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety

Author

Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P. M., Fantini M. P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P.M., Fantini M.P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Luxi, N., Giovanazzi, A., Capuano, A., Crisafulli, S., Cutroneo, P. M., Fantini, M. P., Ferrajolo, C., Moretti, U., Poluzzi, E., Raschi, E., Ravaldi, C., Reno, C., Tuccori, M., Vannacci, A., Zanoni, G., Trifiro, G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., and Montresor V.

Subjects
Allergy, IMPACT, COVID-19 Vaccine, Breastfeeding, Review Article, Toxicology, Settore MED/42 - Igiene Generale E Applicata, CLINICAL CHARACTERISTICS, Pregnancy, Pharmacology (medical), Pregnancy Complications, Infectious, Child, OUTCOMES, education.field_of_study, CANCER, Vaccination, Europe, CORONAVIRUS DISEASE 2019, CLINICAL CHARACTERISTICS, CANCER, RECIPIENTS, SEVERITY, OUTCOMES, IMPACT, RATES, Breast Feeding, Child, Preschool, Practice Guidelines as Topic, Female, 2019-nCoV Vaccine mRNA-1273, Human, Adult, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, BNT162 Vaccine, COVID-19, ChAdOx1 nCoV-19, Humans, Infant, SARS-CoV-2, Hypersensitivity, Immunocompromised Host, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Population, MEDLINE, CORONAVIRUS DISEASE 2019, medicine, RATES, education, Pharmacology, business.industry, medicine.disease, Vaccine efficacy, RECIPIENTS, SEVERITY, Family medicine, Pregnancy Complications, Infectiou, business
Abstract

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit–risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01131-6.

Published
2021

15. Mis-tweeting communication: a Vaccine Hesitancy analysis among twitter users in Italy

Author

Gori D., Durazzi F., Montalti M., Di Valerio Z., Reno C., Fantini M. P., Remondini D., Gori D., Durazzi F., Montalti M., Di Valerio Z., Reno C., Fantini M.P., and Remondini D.

Subjects
Vaccines, Pandemic, Italy, SARS-CoV-2, Communication, COVID-19, Humans, Pandemics, Social Media, Human
Abstract

BACKGROUND AND AIM: A previously unseen body of scientific knowledge of varying quality has been produced during the ongoing COVID-19 pandemic. It has proven extremely difficult to navigate for experts and laymen alike, originating a phenomenon described as "Infodemic", a breeding ground for misinformation. This has a potential impact on vaccine hesitancy that must be considered in a situation where efficient vaccination campaigns are of the greatest importance. We aimed at describing the polarization and volumes of Italian language tweets in the months before and after the start of the vaccination campaign in Italy. METHODS: Tweets were sampled in the October 2020-January 2021 period. The characteristics of the dataset were analyzed after manual annotation as Anti-Vax, Pro-Vax and Neutral, which allowed for the definition of a polarity score for each tweet. RESULTS: Based on the annotated tweets, we could identify 29.6% of the 2,538 unique users as anti-Vax and 12.1% as pro-Vax, with a strong disagreement in annotation in 7.1% of the tweets. We observed a change in the proportion of retweets to anti-Vax and pro-Vax messages after the start of the vaccination campaign in Italy. Although the most shared tweets are those of opposite orientation, the most retweeted users are moderately polarized. Conclusions: The disagreement on the manual classification of tweets highlights a potential risk for misinterpretation of tweets among the general population. Our study reinforces the need to focus Public Health's attention on the new social media with the aim of increasing vaccine confidence, especially in the context of the current pandemic.

Published
2021

19. Effectiveness and healthcare cost of adding trastuzumab to standard chemotherapy for first-line treatment of metastatic gastric cancer: A population-based cohort study

Author

Franchi, M, Tritto, R, Torroni, L, Reno, C, La Vecchia, C, Corrao, G, Franchi M., Tritto R., Torroni L., Reno C., La Vecchia C., Corrao G., Franchi, M, Tritto, R, Torroni, L, Reno, C, La Vecchia, C, Corrao, G, Franchi M., Tritto R., Torroni L., Reno C., La Vecchia C., and Corrao G.

Abstract

A randomized clinical trial showed that trastuzumab, added to traditional chemotherapy, significantly improved overall survival in human epidermal growth factor receptor 2 (HER2)-overexpressing metastatic gastric cancer patients. This population-based study aimed at evaluating both the clinical and economic impact of trastuzumab in a real-world setting. By using the healthcare utilization databases of Lombardy, Italy, a cohort of patients newly diagnosed with metastatic gastric cancer during the period 2011–2016 was selected. Among these, patients initially treated with either trastuzumab-based chemotherapy or standard chemotherapy alone were followed up until death, migration in other regions or June 2018. Overall survival and average cumulative costs were estimated and compared between the two treatment arms. Among the 1198 metastatic gastric cancer patients who started therapy within six months after metastasis detection, 87 were initially treated with trastuzumab-based chemotherapy and 1111 with standard chemotherapy. Median overall survival and restricted mean survival were 10.2 and 7.4 months, and 14.9 and 11.4 months, respectively, in the two treatment arms. The adjusted hazard ratio of death was 0.73 (95% CI 0.57–0.93). The average per capita cumulative healthcare costs were, respectively, EUR 39,337 and 26,504, corresponding to an incremental cost-effectiveness ratio of EUR 43,998 for each year of survival gained. Our study shows that adding trastuzumab to conventional chemotherapy is effective and cost-effective.

Published
2020

20. Renal function performance in CKD stage 5: a sealed fate?

Author

Cannarile, D. C., Liberali, M., Gaggi, R., Reno, C., Gibertoni, D., ELENA MANCINI, Cannarile D.C., De Liberali M., Gaggi R., Reno C., Gibertoni D., and Mancini E.

Subjects
malattia renale cronica, CKD, progressione, filtrato glomerulare, insufficienza renale cronica
Abstract

Introduzione e scopo: Gli stadi 4 e 5 della Malattia Renale Cronica sono sempre stati considerati difficili da modificare nella loro progressione ed evoluzione. Noi abbiamo valutato retrospettivamente i nostri pazienti in CKD5 (dall’1/1/2016 al 31/12/2018), per analizzarne l’evoluzione funzionale nel tempo. Materiale e Metodi: Sono stati inclusi pazienti con follow-up >6 mesi e almeno 4 controlli che includessero la clearance della creatinina misurata (ClCr) e stimata mediante la formula CKD-EPI (eGFR). Abbiamo analizzato: la concordanza fra ClCr ed eGFR mediante analisi di Bland-Altman, la modalità di progressione classificata come rapida (perdita di eGFR >5 ml/min/anno), lenta (perdita di eGFR 1-5 ml/min/anno) e non evolutiva (perdita di eGFR 5 ml/min/anno, mentre nella grande maggioranza dei pazienti si è assistitito ad una progressione lenta ma anche alla possibilità di una stabilizzazione o di un recupero funzionale. Nonostante i limiti legati alla numerosità del campione, questi dati ci incoraggiano a non considerare il CKD5 un inesorabile e breve viaggio verso il trattamento sostitutivo. Introduction and aims: Stages 4 and 5 of chronic kidney disease (CKD) have always been considered hard to modify in their speed and evolution. We retrospectively evaluated our CKD stage 5 patients (from 01/1/2016 to 12/31/2018), with a view to analyzing their kidney function evolution. Material and Methods: We included only patients with longer than 6 months follow-up and at least 4 clinical-laboratory controls that included measured Creatinine Clearance (ClCr) and estimated GFR with CKD-EPI (eGFR). We evaluated: the agreement between ClCr and eGFR through Bland-Altman analysis; progression rate, classified as fast (eGFR loss >5ml/min/year), slow (eGFR loss 1-5 ml/min/year) and non-progressive (eGFR loss 5 ml/min/year). The vast majority showed a slow progression, stabilisation or even an improvement. Despite the limits due to the small sample size, the data has encouraged us not to consider CKD stage 5 as an inexorable and short journey towards artificial replacement therapy.

Published
2021

21. Parents' perception of overweight-obese children Quality of Life in different settings

Author

Esposito, F., Sanmarchi, F., Sofia Marini, Masini, A., Gori, D., Scrimaglia, S., Reno, C., Serra, L., Vandini, S., Dallolio, L., Esposito, F, Sanmarchi, F, Marini, S, Masini, A, Gori, D, Scrimaglia, S, Reno, C, Serra, L, Vandini, S, and Dallolio, L

Subjects
Parents’ perception, obese, children, Public Health, Environmental and Occupational Health, Quality of Life, overweight
Abstract

Background Children's Health-Related Quality of Life (HRQoL) has been frequently investigated, in particular among individuals affected by chronic diseases. It is reported that agreement between child and parent ratings regarding the child's HRQoL is strongly influenced by the latter's health status. To our knowledge, there is no evidence of how this agreement is related to different healthcare settings. Thus, our study aims to examine the relationship between child's and parent-proxy reported HRQoL of similar overweight/obese children according to the recruitment setting. Methods A cross-sectional study was conducted among 68 overweight/obese children, aged 6-10, recruited in a primary school (Group1, G1) and in a hospital outpatient clinic (Group2, G2) of Imola (Italy) in 2019. HRQoL was assessed using Italian version 4.0 of the Pediatric Quality of Life (PedsQL) questionnaire. For each child, we obtained self-reported children's and parents' perceived children's HRQoL total score (5 questions investigating Physical Health domain and 10 questions investigating Psychosocial Health domain divided in Emotional, Social and School Functioning). Results In G1 there were n = 42 overweight/obese children and in G2 n = 26. The correlation between children's reported and parents' perceived HRQoL scores is lower in G1 (Physical Health: r=-0,17; Psychosocial Health: r = 0.38) compared to G2 (Physical Health: r = 0.80; Psychosocial Health: r = 0.66). Notably, in G1, parents tend to overestimate their children's HRQoL, specifically in the Physical Health domain. Conclusions Correlation between children's and parents' HRQoL scores is higher in the clinical setting compared to the school setting. Implementing this questionnaire on a large scale would allow us to identify settings which need awareness-raising initiatives to improve parents' knowledge about their children's health. Key messages Parents’ overestimate children’s HRQoL in the school setting, particularly in the Physical Health domain. Children’s HRQoL misinterpretation might determine less targeted actions to improve their wellbeing and highlights the need for raising parents’ awareness about obesity and its effects on children.

Published
2021

26. Diet quality, common genetic polymorphisms, and bladder cancer risk in a New England population-based study

Author

Reno C, Leeming, Stella, Koutros, Margaret R, Karagas, Dalsu, Baris, Molly, Schwenn, Alison, Johnson, Michael S, Zens, Alan R, Schned, Nathaniel, Rothman, Debra T, Silverman, and Michael N, Passarelli

Subjects
Urinary Bladder Neoplasms, Case-Control Studies, Cyclins, Humans, DNA, Polymorphism, Single Nucleotide, Genome-Wide Association Study, Diet
Abstract

We examined the interaction between common genetic bladder cancer variants, diet quality, and bladder cancer risk in a population-based case-control study conducted in New England.At the time of enrollment, 806 bladder cancer cases and 974 controls provided a DNA sample and completed a diet history questionnaire. Diet quality was assessed using the 2010 Alternate Healthy Eating Index (AHEI-2010) score. Single nucleotide polymorphisms (SNPs) reported in genome-wide association studies to be associated with bladder cancer risk were combined into a polygenic risk score and also examined individually for interaction with the AHEI-2010. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were calculated using logistic regression.A 1-standard deviation increase in polygenic risk score was associated with higher bladder cancer risk (OR, 1.34; 95% CI 1.21-1.49). Adherence to the AHEI-2010 was not associated with bladder cancer risk (OR, 0.99; 95% CI 0.98-1.00) and the polygenic risk score did not appear to modify the association between the AHEI-2010 and bladder cancer risk. In single-SNP analyses, rs8102137 (bladder cancer risk allele, C) modified the association between the AHEI-2010 total score and bladder cancer risk, with the strongest evidence for the AHEI-2010 long chain fat guideline (OR for TT, 0.92; 95% CI 0.87-0.98; OR for CT, 1.02; 95% CI 0.96-1.08; OR for CC, 1.03; 95% CI 0.93-1.14; p for interaction, 0.02).In conclusion, rs8102137 near the cyclin E1 gene ( CCNE1 ) may be involved in gene-diet interactions for bladder cancer risk.

Published
2021

29. Diet Quality and Survival in a Population-Based Bladder Cancer Study.

Author

Leeming, Reno C., Karagas, Margaret R., Gilbert-Diamond, Diane, Emond, Jennifer A., Zens, Michael S., Schned, Alan R., Seigne, John D., and Passarelli, Michael N.

Subjects
BLADDER tumors, CONFIDENCE intervals, NUTRITIONAL value, DIET, REGRESSION analysis, CANCER patients, RISK assessment, DIETARY sucrose, MEDICAL protocols, SURVIVAL analysis (Biometry), POPULATION-based case control, FRUIT, FOOD quality, PROPORTIONAL hazards models
Abstract

Nutrition may impact bladder cancer survival. We examined the association between diet quality and overall and bladder cancer-specific survival. Bladder cancer cases from a population-based study reported pre-diagnosis diet. Diet quality was assessed using the 2010 Alternate Healthy Eating Index (AHEI-2010). Vital status was ascertained from the National Death Index. Adjusted hazard ratios (HR) and 95% confidence intervals (CI) were estimated using proportional hazards and competing risks regression models. Overall AHEI-2010 adherence was not associated with overall or bladder cancer-specific survival among non-muscle invasive bladder cancer (NMIBC) cases (HR, 1.00; 95% CI, 0.98-1.01; HR, 1.00; 95% CI, 0.97-1.02) or muscle invasive bladder cancer (MIBC) cases (HR, 0.99; 95% CI, 0.96-1.03; HR, 1.01, 95% CI 0.97-1.06). AHEI-2010 sugar-sweetened beverages adherence was associated with poorer overall survival (HR, 1.04; 95% CI, 1.01-1.08) and AHEI-2010 sodium adherence was associated with better overall and bladder cancer-specific survival after NMIBC diagnosis (HR, 0.92, 95% CI, 0.85-1.00; HR, 0.82; 95% CI, 0.68-0.98). AHEI-2010 fruit adherence was associated with poorer overall and bladder cancer-specific survival after MIBC diagnosis (HR, 1.17; 95% CI, 1.02-1.33; HR, 1.26; 95% CI, 1.03-1.55). Consumption of sugar-sweetened beverages, sodium, and fruit, not overall AHEI-2010 adherence, may be associated with bladder cancer survival. [ABSTRACT FROM AUTHOR]

Published
2022
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30. PO-05-184 COMPARATIVE SAFETY OF DRONEDARONE VERSUS SOTALOL FOR THE TREATMENT OF ATRIAL FIBRILLATION AMONG ANTIARRHYTHMIC DRUG-NAÏVE PATIENTS: A META-ANALYSIS

Author

Singh, Jagmeet P., Wieloch, Mattias, Reynolds, Shannon L., Blomström-Lundqvist, Carina, Sandhu, Alexander, Camm, A. John, Kabadi, Shaum, Pundi, Krishna, Turakhia, Mintu P., Boiron, Rania, Coudert, Mathieu, Din, Natasha, Fan, Jun, Heller, Caroline G., Leeming, Reno C., McKindley, David S., Sajedian, Renee M., and Kowey, Peter R.

Published
2023
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31. Plasmalemmal Na/Ca Exchanger Modulates Ca-Dependent Exocytotic Release of Glutamate from Rat Cortical Astrocytes

Author

Reno C Reyes, Alexei Verkhratsky, and Vladimir Parpura

Subjects
Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Astroglial excitability operates through increases in Ca 2+ cyt (cytosolic Ca 2+ ), which can lead to glutamatergic gliotransmission. In parallel fluctuations in astrocytic Na + cyt (cytosolic Na + ) control metabolic neuronal-glial signalling, most notably through stimulation of lactate production, which on release from astrocytes can be taken up and utilized by nearby neurons, a process referred to as lactate shuttle. Both gliotransmission and lactate shuttle play a role in modulation of synaptic transmission and plasticity. Consequently, we studied the role of the PMCA (plasma membrane Ca 2+ -ATPase), NCX (plasma membrane Na + /Ca 2+ exchanger) and NKA (Na + /K + -ATPase) in complex and coordinated regulation of Ca 2+ cyt and Na + cyt in astrocytes at rest and upon mechanical stimulation. Our data support the notion that NKA and PMCA are the major Na + and Ca 2+ extruders in resting astrocytes. Surprisingly, the blockade of NKA or PMCA appeared less important during times of Ca 2+ and Na + cytosolic loads caused by mechanical stimulation. Unexpectedly, NCX in reverse mode appeared as a major contributor to overall Ca 2+ and Na + homoeostasis in astrocytes both at rest and when these glial cells were mechanically stimulated. In addition, NCX facilitated mechanically induced Ca 2+ -dependent exocytotic release of glutamate from astrocytes. These findings help better understanding of astrocyte-neuron bidirectional signalling at the tripartite synapse and/or microvasculature. We propose that NCX operating in reverse mode could be involved in fast and spatially localized Ca 2+ -dependent gliotransmission, that would operate in parallel to a slower and more widely distributed gliotransmission pathway that requires metabotropically controlled Ca 2+ release from the ER (endoplasmic reticulum).

Published
2012
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46. Abstract B15: Bladder cancer susceptibility polymorphisms and mortality from non-muscle and muscle-invasive bladder cancer

Author

Reno C. Leeming, Diane Gilbert-Diamond, Michael S. Zens, Michael N. Passarelli, John D. Seigne, Brock C. Christensen, and Margaret R. Karagas

Subjects
Oncology, Cancer Research, medicine.medical_specialty, education.field_of_study, Bladder cancer, business.industry, Proportional hazards model, medicine.medical_treatment, Population, Hazard ratio, Cancer, medicine.disease, Cancer registry, Cystectomy, Internal medicine, Genetic model, medicine, business, education
Abstract

Introduction: Genome-wide association studies (GWAS) have identified several common germline single-nucleotide polymorphisms (SNPs) associated with increased risk of bladder cancer. Little is known about whether these variants are also associated with overall and bladder cancer-specific mortality. We examined the association between 13 GWAS-identified bladder cancer risk SNPs and overall and bladder cancer-specific survival in 316 bladder cancer cases recruited as part of a population-based case-control study. Methods: Residents of New Hampshire with primary bladder cancer diagnosed between 2002-2004 were identified from the New Hampshire State Cancer Registry. Medical history and lifestyle factors were collected via in-person interviews at time of enrollment. DNA was isolated from peripheral blood or buccal specimens and genotyping was performed using the Illumina Human610-Quad BeadChip. Date and cause of death were ascertained from the National Death Index with follow-up through December 31, 2013. Non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) were examined separately. We used Cox proportional hazards models to estimate adjusted hazard ratios (HR) and 95% confidence intervals (CI) for overall and bladder cancer-specific survival, assuming a log-additive genetic model. HR estimates for MIBC individuals were adjusted for age at diagnosis, sex, smoking status, American Joint Committee on Cancer stage, initial treatment (including extent of resection, cystectomy, and use of chemotherapy or radiation), and three principal components for genetic ancestry. HR estimates for NMIBC were additionally adjusted for 2004 World Health Organization/International Society of Urologic Pathologists classification. An alpha of 0.05 was used to determine statistical significance. Results: Among 43 participants with MIBC, 30 deaths occurred over a median follow-up of 6.4 years, including 19 from bladder cancer. Among 273 participants with NMIBC, 94 deaths occurred over a median follow-up of 10.3 years, including 23 from bladder cancer. The risk allele [A] of enhancer-associated intergenic SNP rs710521 near TP63 was associated with poorer overall survival after MIBC diagnosis (HR=3.21, 95% CI=1.26-8.16). The risk allele [C] of synonymous SNP rs10936599 of MYNN/TERC was associated with better overall survival after NMIBC diagnosis (HR=0.66, 95% CI=0.46-0.94). No associations with bladder cancer-specific survival were identified. Conclusions: Common bladder cancer susceptibility variants rs710521 and rs10936599 may be associated with overall survival after diagnosis of MIBC and NMIBC, respectively. Citation Format: Reno C. Leeming, Michael S. Zens, John D. Seigne, Brock C. Christensen, Diane Gilbert-Diamond, Margaret R. Karagas, Michael N. Passarelli. Bladder cancer susceptibility polymorphisms and mortality from non-muscle and muscle-invasive bladder cancer [abstract]. In: Proceedings of the AACR Special Conference on Bladder Cancer: Transforming the Field; 2019 May 18-21; Denver, CO. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(15_Suppl):Abstract nr B15.

Published
2020
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48. Bladder cancer risk variants and overall and disease‐specific survival in two independent cohorts.

Author

Leeming, Reno C., Karagas, Margaret R., Zens, Michael S., Schned, Alan R., Seigne, John D., and Passarelli, Michael N.

Subjects
BLADDER cancer, DISEASE risk factors, OVERALL survival
Abstract

Allele frequencies for these common, low-penetrance bladder cancer susceptibility SNPs are not substantially different among the bladder patients in these studies and the broader European population. 1 TableAssociations of bladder cancer risk single nucleotide polymorphisms and polygenic risk score with overall and disease-specific survival in the New Hampshire cohort (n = 273 non-muscle invasive and n = 43 muscle-invasive bladder cancer) and the UK Biobank cohort (n = 364 incident bladder cancer cases). Abbreviations GWAS genome-wide association study HR hazard ratio ICD International Statistical Classification of Diseases MIBC muscle-invasive bladder cancer NMIBC non-muscle-invasive bladder cancer PRS polygenic risk score SNP single nucleotide polymorphism TURBT transurethral resection of bladder tumour Each year 573 000 bladder cancer diagnoses and 212 000 bladder cancer-related deaths occur worldwide [1]. We found no association between bladder cancer susceptibility variants, individually or as a PRS, and overall survival or disease-specific survival after bladder cancer diagnosis (Table 1). [Extracted from the article]

Published
2022
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