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Article ; Online: Innovative Multilumen Stent System for Pulmonary Flow Adjustment in Congenital Heart Disease and Dilated Cardiomyopathy.

Tocchi, Monica / Amin, Elena K / Vogt, Paul / Tkach, Emanuel / Antonini, Paola / Ruggieri, Silvia / Bogner, Seth / Jenni, Rolf

JACC. Basic to translational science

2023 Volume 8, Issue 11, Page(s) 1421–1423

Language	English
Publishing date	2023-10-23
Publishing country	United States
Document type	Journal Article
ISSN	2452-302X
ISSN (online)	2452-302X
DOI	10.1016/j.jacbts.2023.10.003
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Article: Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies.

Franconi, Flavia / Campesi, Ilaria / Colombo, Delia / Antonini, Paola

Cells

2019 Volume 8, Issue 5

Abstract: There is a clear sex-gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed ...

Abstract	There is a clear sex-gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed over recent years. Despite this change, a gap still exists. This gap is linked to biological factors (sex) and psycho-social, cultural, and environmental factors (gender). These multidimensional, entangled, and interactive factors may influence the pharmacological response. Despite the fact that regulatory authorities recognize the importance of sex and gender, there is a paucity of research focusing on the racial/ethnic, socio-economic, psycho-social, and environmental factors that perpetuate disparities. Research and clinical practice must incorporate all of these factors to arrive at an intersectional and system-scenario perspective. We advocate for scientifically rigorous evaluations of the interplay between sex and gender as key factors in performing clinical trials, which are more adherent to real-life. This review proposes a set of 12 rules to improve clinical research for integrating sex-gender into clinical trials.
MeSH term(s)	Adult ; Age Factors ; Female ; Gender Identity ; Humans ; Male ; Pharmacological Phenomena/physiology ; Practice Guidelines as Topic ; Precision Medicine ; Pregnancy ; Randomized Controlled Trials as Topic ; Sex Characteristics ; Sex Factors ; Sexism/prevention & control ; Social Class ; Terminology as Topic
Language	English
Publishing date	2019-05-17
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2661518-6
ISSN	2073-4409
ISSN	2073-4409
DOI	10.3390/cells8050476
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Article ; Online: Metabolome-Defined Obesity and the Risk of Future Type 2 Diabetes and Mortality.

Ottosson, Filip / Smith, Einar / Ericson, Ulrika / Brunkwall, Louise / Orho-Melander, Marju / Di Somma, Salvatore / Antonini, Paola / Nilsson, Peter M / Fernandez, Céline / Melander, Olle

Diabetes care

2022 Volume 45, Issue 5, Page(s) 1260–1267

Abstract: Objective: Obesity is a key risk factor for type 2 diabetes; however, up to 20% of patients are normal weight. Our aim was to identify metabolite patterns reproducibly predictive of BMI and subsequently to test whether lean individuals who carry an ... ...

Abstract	Objective: Obesity is a key risk factor for type 2 diabetes; however, up to 20% of patients are normal weight. Our aim was to identify metabolite patterns reproducibly predictive of BMI and subsequently to test whether lean individuals who carry an obese metabolome are at hidden high risk of obesity-related diseases, such as type 2 diabetes. Research design and methods: Levels of 108 metabolites were measured in plasma samples of 7,663 individuals from two Swedish and one Italian population-based cohort. Ridge regression was used to predict BMI using the metabolites. Individuals with a predicted BMI either >5 kg/m2 higher (overestimated) or lower (underestimated) than their actual BMI were characterized as outliers and further investigated for obesity-related risk factors and future risk of type 2 diabetes and mortality. Results: The metabolome could predict BMI in all cohorts (r2 = 0.48, 0.26, and 0.19). The overestimated group had a BMI similar to individuals correctly predicted as normal weight, had a similar waist circumference, were not more likely to change weight over time, but had a two times higher risk of future type 2 diabetes and an 80% increased risk of all-cause mortality. These associations remained after adjustments for obesity-related risk factors and lifestyle parameters. Conclusions: We found that lean individuals with an obesity-related metabolome have an increased risk for type 2 diabetes and all-cause mortality compared with lean individuals with a healthy metabolome. Metabolomics may be used to identify hidden high-risk individuals to initiate lifestyle and pharmacological interventions.
MeSH term(s)	Body Mass Index ; Diabetes Mellitus, Type 2 ; Humans ; Metabolome ; Obesity/complications ; Risk Factors ; Waist Circumference
Language	English
Publishing date	2022-03-14
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc21-2402
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Article: COVID-19: hypofractionation in the Radiation Oncology Department during the 'state of alarm': first 100 patients in a private hospital in Spain.

Larrea, Luis / López, Enrique / Antonini, Paola / González, Verónica / Berenguer, Miguel Ángel / Baños, Maria Carmen / Bea, Jose / Domingo, Jose

Ecancermedicalscience

2020 Volume 14, Page(s) 1052

Abstract: During the COVID-19 pandemic, Spain declared a 'state of alarm' on 14 March 2020. In our Radiation Oncology Department, experienced in administering hypofractionated treatments (partial irradiation in breast cancer, moderate hypofractionation in ... ...

Abstract	During the COVID-19 pandemic, Spain declared a 'state of alarm' on 14 March 2020. In our Radiation Oncology Department, experienced in administering hypofractionated treatments (partial irradiation in breast cancer, moderate hypofractionation in localized prostate cancer, etc), we have increased the hypofractionated treatment indications. We are only deferring the start of non-urgent treatments such as prostate tumours under androgen deprivation or benign brain tumours which are candidates for radiosurgery such as meningiomas or acoustic neuroma. In this hypofractionation era we find that we have decreased the number of sessions per patient and that we can evaluate the last years with the fractionation index (FI) (calculated by dividing the total number of fractions administered in the department by the total number of patients treated). We have gone from 14.4 in 2018 to 13.78 in 2019, excluding brachytherapy. We report the results of the first 100 patients who have experienced radiotherapy treatment since the state of alarm (66 women and 34 men). In these patients, the FI is 12.12-lower than previous years.
Keywords	covid19
Language	English
Publishing date	2020-05-28
Publishing country	England
Document type	Journal Article
ISSN	1754-6605
ISSN	1754-6605
DOI	10.3332/ecancer.2020.1052
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Article: Postapproval Development Options in COPD: A Case Study in Value-Based Healthcare Systems.

Murphy, Michael F / Antonini, Paola / Lai, Zhihong Vicki

American health & drug benefits

2014 Volume 4, Issue 1, Page(s) 19–23

Abstract: Background: Research and development activities in an era of globalization encounter a mosaic of providers, products, services, and intermediaries; regulatory and other government institutions; and consumers. The introduction of novel therapeutics into ... ...

Abstract	Background: Research and development activities in an era of globalization encounter a mosaic of providers, products, services, and intermediaries; regulatory and other government institutions; and consumers. The introduction of novel therapeutics into this environment mandates research programs that are relevant to the registration process, payers and purchasers, transparent pricing, and rule-driven business practices, while providing data relevant to marketing initiatives internationally. Objective: To outline an example for clinical development programs that incorporate the perspective of multiple stakeholders into a portfolio of study designs to provide optimal data platforms that can resonate with diverse recipients. Discussion: A contract research organization directly involved in the design, execution, and analysis of clinical trials for new drugs and devices across pharmaceutical and biotechnology companies provides a unique perspective regarding opportunities and challenges within the international clinical research environment. Drs Murphy, Antonini, and Lai, representing Worldwide Clinical Trials, utilize chronic obstructive pulmonary disease as a demonstration project exploiting its prevalence, direct and indirect costs, and the rapid infusion/diffusion of innovative therapy into practice as a rationale for focus, and illustrate methods of informing registration and technology assessments during a prototypical development process. Conclusion: By virtue of its chronicity, prevalence, and pattern of healthcare utilization, chronic obstructive pulmonary disease provides an ideal case for illustrating the application of clinical trial methodology that can facilitate data evaluation through the prism of multiple stakeholders. Adding an international dimension exacerbates system complexity and serves to illustrate the breadth of issues that can be addressed within this therapeutic area.
Language	English
Publishing date	2014-07-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	2853721-X
ISSN	1942-2970 ; 1942-2962
ISSN (online)	1942-2970
ISSN	1942-2962
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Article: Atypical antipsychotics and metabolic syndrome in patients with schizophrenia: risk factors, monitoring, and healthcare implications.

Riordan, Henry J / Antonini, Paola / Murphy, Michael F

American health & drug benefits

2014 Volume 4, Issue 5, Page(s) 292–302

Abstract: Background: Metabolic syndrome is a leading cause of morbidity and mortality in patients with schizophrenia, with a prevalence rate double that of nonpsychiatric populations. Given the amount of evidence suggesting a link between atypical antipsychotic ... ...

Abstract	Background: Metabolic syndrome is a leading cause of morbidity and mortality in patients with schizophrenia, with a prevalence rate double that of nonpsychiatric populations. Given the amount of evidence suggesting a link between atypical antipsychotic medications and metabolic syndrome, several agencies have recommended regular clinical monitoring of weight, symptoms of hyperglycemia, and glucose in chronically medicated patients with schizophrenia. Objectives: To summarize the current literature on atypical antipsychotic-induced metabolic syndrome in patients with schizophrenia, outline some of the molecular mechanisms behind this syndrome, identify demographic and disease-related risk factors, and describe cost-effective methods for surveillance. Discussion: The differential prevalence of metabolic syndrome associated with various atypical antipsychotic medications has been evidenced across numerous studies, with higher effects seen for certain antipsychotic medications on weight gain, waist circumference, fasting triglyceride level, and glucose levels. Given the association of these symptoms, all atypical antipsychotic medications currently include a warning about the risk of hyperglycemia and diabetes, as well as suggestions for regular monitoring. Despite this, very little data are available to support adherence to these monitoring recommendations. Lack of awareness and resources, diffusion of responsibility, policy implementation, and organizational structure have all been implicated. Conclusion: The treatment of schizophrenia involves a balance in terms of risks and benefits. Failing to treat because of risk for complications from metabolic syndrome may place the patient at a higher risk for more serious health outcomes. Supporting programs aimed at increasing monitoring of simple laboratory and clinical measures associated with metabolic syndrome may decrease important risk factors, improve patients' quality of life, and reduce healthcare costs.
Language	English
Publishing date	2014-07-14
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2853721-X
ISSN	1942-2970 ; 1942-2962
ISSN (online)	1942-2970
ISSN	1942-2962
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Article ; Online: Investigación multidisciplinar en el ámbito de urgencias.

Antonini, Paola / Magrini, Laura / Murphy, Michael / Di Somma, Salvatore

Emergencias : revista de la Sociedad Espanola de Medicina de Emergencias

2015 Volume 27, Issue 6, Page(s) 399–402

Title translation	Multidisciplinary research in emergency medicine.
Language	Spanish
Publishing date	2015
Publishing country	Spain
Document type	Journal Article
ZDB-ID	2127173-2
ISSN	2386-5857 ; 1137-6821
ISSN (online)	2386-5857
ISSN	1137-6821
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Article ; Online: Comparison of cardiovascular disease and cancer prevalence between Mediterranean and north European middle-aged populations (The Cilento on Ageing Outcomes Study and The Malmö Offspring Study).

Melander, Olle / Antonini, Paola / Ottosson, Filip / Brunkwall, Louise / Gallo, Widet / Nilsson, Peter M / Orho-Melander, Marju / Pacente, Gaetano / D'Arena, Giovanni / Di Somma, Salvatore

Internal and emergency medicine

2021 Volume 16, Issue 6, Page(s) 1567–1572

Abstract: Mediterranean diet protects from both cardiovascular disease (CVD) and cancer. In the 1960s, Ancel Keys defined the concept of Mediterranean diet in the South Italian region of Cilento and proposed it as a key factor for healthy ageing in the region. The ...

Abstract	Mediterranean diet protects from both cardiovascular disease (CVD) and cancer. In the 1960s, Ancel Keys defined the concept of Mediterranean diet in the South Italian region of Cilento and proposed it as a key factor for healthy ageing in the region. The aim of the current study was to compare the prevalence of CVD and cancer between a middle-aged population from Cilento and those of a Northern European population from Malmö, Sweden. We clinically characterized two middle-aged (50-67 years of age) population-based samples from Cilento (n = 809) and Malmö (n = 1025), Sweden, respectively. Logistic regression was used to calculate odds ratios (95% confidence interval) for disease prevalence in Malmö versus Cilento inhabitants adjusted for age and sex (model 1) and adjusted for all cardiometabolic risk factors (model 2). The prevalence of hypertension, current smoking, diabetes mellitus and levels of body mass index and triglycerides were lower, whereas HDL-cholesterol was higher in Malmö than in Cilento. LDL-cholesterol was higher and estimated glomerular filtration rate was lower in Malmö than in Cilento. The odds ratio for cardiovascular disease in Malmö versus Cilento inhabitants was 1.13 (0.69-1.87) (P = 0.62) in model 1, whereas it was significantly elevated in model 2 [2.03 (1.14-3.60) (P = 0.016)]. Moreover, the odds ratio for cancer in Malmö versus Cilento was 2.78 (1.81-4.27) (P < 0.001) in model 1 and 3.11 (1.97-4.92) (P < 0.001) in model 2. The higher odds of CVD and cancer in Malmö versus Cilento, when risk factors were accounted for, suggests the existence of unknown protective factors in Cilento.
MeSH term(s)	Aged ; Cardiovascular Diseases/diet therapy ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/prevention & control ; Diet, Mediterranean/statistics & numerical data ; Female ; Humans ; Italy/epidemiology ; Linear Models ; Male ; Middle Aged ; Neoplasms/diet therapy ; Neoplasms/epidemiology ; Neoplasms/prevention & control ; Prevalence ; Risk Factors ; Surveys and Questionnaires ; Sweden/epidemiology
Language	English
Publishing date	2021-01-30
Publishing country	Italy
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2454173-4
ISSN	1970-9366 ; 1828-0447
ISSN (online)	1970-9366
ISSN	1828-0447
DOI	10.1007/s11739-020-02625-4
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Article ; Online: Cognitive Health of Nonagenarians in Southern Italy: A Descriptive Analysis from a Cross-Sectional, Home-Based Pilot Study of Exceptional Longevity (Cilento Initiative on Aging Outcomes Or CIAO).

Pizza, Vincenzo / Antonini, Paola / Marino, Rosella / D'Arena, Giovanni / Lucibello, Serena Grazia / Rizzo, Marianna / Brenner, David A / Jeste, Dilip V / Somma, Salvatore Di

Medicina (Kaunas, Lithuania)

2020 Volume 56, Issue 5

Abstract: ... ...

Abstract	Background
MeSH term(s)	Aged, 80 and over ; Aging/physiology ; Cognitive Dysfunction/diagnosis ; Cognitive Dysfunction/epidemiology ; Cross-Sectional Studies ; Female ; Home Care Services/statistics & numerical data ; Humans ; Italy/epidemiology ; Longevity/physiology ; Male ; Neuropsychological Tests ; Pilot Projects
Language	English
Publishing date	2020-05-05
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2188113-3
ISSN	1648-9144 ; 1010-660X
ISSN (online)	1648-9144
ISSN	1010-660X
DOI	10.3390/medicina56050218
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Article ; Online: Study of loneliness and wisdom in 482 middle-aged and oldest-old adults: a comparison between people in Cilento, Italy and San Diego, USA.

Jeste, Dilip V / Di Somma, Salvatore / Lee, Ellen E / Nguyen, Tanya T / Scalcione, Mara / Biaggi, Alice / Daly, Rebecca / Liu, Jinyuan / Tu, Xin / Ziedonis, Douglas / Glorioso, Danielle / Antonini, Paola / Brenner, David

Aging & mental health

2020 Volume 25, Issue 11, Page(s) 2149–2159

Abstract: Objectives: There has been growing research interest in loneliness and wisdom in recent decades, but no cross-cultural comparisons of these constructs using standardized rating measures in older adults, especially the oldest-old. This was a cross- ... ...

Abstract	Objectives: There has been growing research interest in loneliness and wisdom in recent decades, but no cross-cultural comparisons of these constructs using standardized rating measures in older adults, especially the oldest-old. This was a cross-sectional study of loneliness and wisdom comparing middle-aged and oldest-old adults in Cilento, Italy and San Diego, United States. Method: We examined loneliness and wisdom, using the UCLA Loneliness Scale Version 3 (UCLA-3) and San Diego Wisdom Scale (SD-WISE), respectively, in four subject groups: adults aged 50-65 and those ≥90 years from Cilento, Italy ( Results: After controlling for education, there were no significant group differences in levels of loneliness, while on SD-WISE the Cilento ≥90 group had lower scores compared to the other three groups. There was a strong inverse correlation between loneliness and wisdom in each of the four subject groups. Loneliness was negatively associated while wisdom was positively associated with general health, sleep quality, and happiness in most groups, with varying levels of significance. Conclusion: These results largely support cross-cultural validity of the constructs of loneliness and wisdom, and extend previous findings of strong inverse correlations between these two entities. Loneliness has become a growing public health problem, and the results of our study suggest that wisdom could be a protective factor against loneliness, although alternative explanations are also possible. Research on interventions to reduce loneliness by enhancing wisdom in older adults is needed.
MeSH term(s)	Aged ; Aged, 80 and over ; Cross-Sectional Studies ; Happiness ; Humans ; Italy ; Loneliness ; Middle Aged ; Protective Factors ; United States
Language	English
Publishing date	2020-10-01
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1474804-6
ISSN	1364-6915 ; 1360-7863
ISSN (online)	1364-6915
ISSN	1360-7863
DOI	10.1080/13607863.2020.1821170
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