Publications by authors named "Federica Guaraldi"

99 Publications

Adherence to and early adverse events of COVID-19 vaccine in a cohort of 600 Italian breastfeeding and pregnant physicians.

Hum Vaccin Immunother 2022 Aug 9:2106747. Epub 2022 Aug 9.

Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, Italy.

Pregnant and breastfeeding women (PBW) have been excluded from COVID-19 vaccine registry and the majority of post-marketing trials, despite the recognized increased risk of severe infections and complications. The lack of efficacy and safety data prevented the formulation of specific indications/guidelines for vaccination and could have also contributed to increased vaccine hesitancy (VH) in PBW. The aim of this cross-sectional study is to assess the rate and predictors of VH, and early adverse events (AEFI) following COVID-19 vaccine in PBW with a cross-sectional study. In January 2021, a purposely designed questionnaire was administered to 600 PBW part of a Facebook group of physicians, immunized with two doses of Comirnaty®. Thirty-eight (29%) pregnant women and 13 (2.8%) breastfeeders were hesitant. The only statistically significant negative predictor of COVID-19 VH appeared to be having had the flu shot in 2020/2021 (OR: 0.35; 95% CI: 0.13-0.97;  = .044). Approximately 27% of PBW reported hesitancy toward the 2020/2021 season influenza vaccine. Among the vaccinated subjects, 51.6% of pregnant and 75.2% of breastfeeding women reported at least one symptom after the first, and 82.4% and 81.6%, respectively, after the second dose. Nausea/vomiting, fatigue, headache and arthralgia/myalgia were the most common symptoms; dizziness, shivering, syncope and limb paresthesia were rarely reported. Among infants of breastfeeding mothers, six experienced fever, five rash and four moderate and self-limiting diarrhea. Preliminary data on mRNA COVID-19 vaccine in PBW and in their infants are reassuring since AEFI, although frequent, are typically mild and similar to those occurring in the general population, and in PBW after other vaccines. Larger studies with longer follow-up after vaccination are strongly recommended to develop recommendations in these patients.
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http://dx.doi.org/10.1080/21645515.2022.2106747DOI Listing
August 2022

Obesity and COVID-19 in Children and Adolescents: Reciprocal Detrimental Influence-Systematic Literature Review and Meta-Analysis.

Int J Environ Res Public Health 2022 Jun 21;19(13). Epub 2022 Jun 21.

IRCCS Istituto delle Scienze Neurologiche di Bologna, 40126 Bologna, Italy.

The dramatic lifestyle changes forced by COVID-19-related lockdown promoted weight gain, with a stronger impact on obese subjects, at higher risk of severe infection. The PubMed database was searched to identify original studies assessing: (1) the extent and risk factors of lockdown-induced weight increase; and (2) the impact of obesity on the risk of hospital admission in children and adolescents. A systematic literature review and meta-analyses were performed. Twenty out of 13,986 identified records were included. A significant weight increase was reported in the majority of subjects, with no apparent gender or age differences. It was induced by a higher consumption of hypercaloric/hyperglycemic/junk food and/or the reduction of physical activity, often associated with an altered sleep-wake cycle. On the other hand, obesity increased the risk of hospitalization (OR = 4.38; 95% C.I. 1.46-13.19; = 0.009; = 96%) as compared to the normal weight population. COVID-19 and obesity represent epidemic conditions with reciprocal detrimental impact. Urgent public health interventions, targeting the various age and social strata, and involving governmental authorities, health care personnel, teachers and families are warranted to increase awareness and actively promote healthy lifestyles to contrast pediatric obesity and its detrimental consequences at a global level.
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http://dx.doi.org/10.3390/ijerph19137603DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9266144PMC
June 2022

Uric acid, genetic scores and renal disease: merge to separate?

J Clin Endocrinol Metab 2022 Jun 14. Epub 2022 Jun 14.

Department of Medical and Surgical Sciences., IRCCS S.Orsola-University of Bologna, Bologna, Italy.

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http://dx.doi.org/10.1210/clinem/dgac364DOI Listing
June 2022

Infra-Temporal and Pterygo-Palatine Fossae Tumors: A Frontier in Endoscopic Endonasal Surgery-Description of the Surgical Anatomy of the Approach and Report of Illustrative Cases.

Int J Environ Res Public Health 2022 05 25;19(11). Epub 2022 May 25.

Programma Neurochirurgia Ipofisi-Pituitary Unit, IRCCS Istituto delle Scienze Neurologiche di Bologna, 40139 Bologna, Italy.

Infratemporal and pterygopalatine fossae (ITF and PPF) represent two complex paramedian skull base areas, which can be defined as jewelry boxes, containing a large number of neurovascular and osteomuscular structures of primary importance. They are in close communication with many craniofacial areas, such as nasal/paranasal sinuses, orbit, middle cranial fossa, and oral cavities. Therefore, they can be involved by tumoral, infective or inflammatory lesions spreading from these spaces. Moreover, they can be the primary site of the development of some primitive tumors. For the deep-seated location of ITF and PPF lesions and their close relationship with the surrounding functional neuro-vascular structures, their surgery represents a challenge. In the last decades, the introduction of the endoscope in skull base surgery has favored the development of an innovative anterior endonasal approach for ITF and PPF tumors: the transmaxillary-pterygoid, which gives a direct and straightforward route for these areas. It has demonstrated that it is effective and safe for the treatment of a large number of benign and malignant neoplasms, located in these fossae, avoiding extensive bone drilling, soft tissue demolition, possibly unaesthetic scars, and reducing the risk of neurological deficits. However, some limits, especially for vascular tumors or lesions with lateral extension, are still present. Based on the experience of our multidisciplinary team, we present our operative technique, surgical indications, and pre- and post-operative management protocol for patients with ITF and PPF tumors.
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http://dx.doi.org/10.3390/ijerph19116413DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9180479PMC
May 2022

Sexual and Reproductive Health and Education of Adolescents during COVID-19 Pandemic, Results from "Come Te La Passi?"-Survey in Bologna, Italy.

Int J Environ Res Public Health 2022 04 23;19(9). Epub 2022 Apr 23.

Department of Biomedical and Neuromotor Sciences, University of Bologna, 40138 Bologna, Italy.

Social distancing measures adopted to face the COVID-19 pandemic had a detrimental impact on adolescent education and their interaction with peers and adults, secondary to the limitation of school and recreational activities, with repercussions on social and sexual life. The "Come te la passi?" ("How is it going?") study, performed in the Metropolitan City of Bologna (Italy), aimed at investigating the type of information sources adopted by adolescents for their sexual and reproductive health (SRH) knowledge and education, the age of their sexual debut, and the way in which the COVID-19 pandemic affected their relationships and sexual life in order to help local health care professionals and educators designing SRH education programs. A purposely designed online survey was administered during the COVID-19 pandemic to 378 high school students (age > 14 yo) in July 2021. Based on the study results, the most common source of SRH education was the web, followed by peers (friends). A total of 61.3% of 17-year-olds already had sexual intercourse, and 90% of 15-year-olds had experienced romantic or sexual attraction. For 58.2% of the adolescents, the COVID-19 pandemic had negative effects on their relationships/sexual life. The current research emphasizes the need to involve health care professionals and educators in structured programs to promote SRH education tailored to adolescents' needs and started from early ages.
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http://dx.doi.org/10.3390/ijerph19095147DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9102478PMC
April 2022

Bilateral antererior circulation stroke: A rare but threatening consequence of pituitary apoplexy. Case report and systematic literature review.

Neuroradiol J 2022 Mar 27:19714009221083146. Epub 2022 Mar 27.

Programma Neurochirurgia Ipofisi- Pituitary Unit, 419170IRCCS Istituto delle Scienze Neurologiche di Bologna, Italy.

Background: Brain stroke is a rare, life-threatening condition associated with pituitary apoplexy (PA), resulting from direct arterial occlusion due to mechanical compression secondary to the sudden enlargement of the pituitary adenoma, or to vessel vasospasm, induced by tumor hemorrhage.

Case Report: We report the case of a 64-year-old woman with PA complicated by bilateral anterior circulation stroke due to critical stenosis of both anterior cerebral arteries (ACA). Despite the quick surgical decompression and consequent blood flow restoration, the neurological conditions of the patient did not improve and she died 18 days later. Ten other cases of anterior circulation stroke due to PA were retrieved in a systematic review of literature. Clinical and neuroradiological features of these patients and treatment outcome were assessed to suggest the most proper management.

Conclusion: The onset of neurological symptoms suggestive for brain stroke in patients with PA requires performing an emergency Magnetic Resonance Imaging (MRI), including Diffusion-weighted and angiographic MR-sequences. The role of surgery in these cases is debated, however, transsphenoidal adenomectomy would permit us to decompress the ACA and restore blood flow in their territories. Although the prognosis of PA-induced anterior circulation stroke is generally poor, a timely diagnosis and treatment would be paramount for improving patient outcome.
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http://dx.doi.org/10.1177/19714009221083146DOI Listing
March 2022

Machine learning-based clinical outcome prediction in surgery for acromegaly.

Endocrine 2022 Feb 12;75(2):508-515. Epub 2021 Oct 12.

Machine Intelligence in Clinical Neuroscience (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, University of Zurich, Zurich, Switzerland.

Purpose: Biochemical remission (BR), gross total resection (GTR), and intraoperative cerebrospinal fluid (CSF) leaks are important metrics in transsphenoidal surgery for acromegaly, and prediction of their likelihood using machine learning would be clinically advantageous. We aim to develop and externally validate clinical prediction models for outcomes after transsphenoidal surgery for acromegaly.

Methods: Using data from two registries, we develop and externally validate machine learning models for GTR, BR, and CSF leaks after endoscopic transsphenoidal surgery in acromegalic patients. For the model development a registry from Bologna, Italy was used. External validation was then performed using data from Zurich, Switzerland. Gender, age, prior surgery, as well as Hardy and Knosp classification were used as input features. Discrimination and calibration metrics were assessed.

Results: The derivation cohort consisted of 307 patients (43.3% male; mean [SD] age, 47.2 [12.7] years). GTR was achieved in 226 (73.6%) and BR in 245 (79.8%) patients. In the external validation cohort with 46 patients, 31 (75.6%) achieved GTR and 31 (77.5%) achieved BR. Area under the curve (AUC) at external validation was 0.75 (95% confidence interval: 0.59-0.88) for GTR, 0.63 (0.40-0.82) for BR, as well as 0.77 (0.62-0.91) for intraoperative CSF leaks. While prior surgery was the most important variable for prediction of GTR, age, and Hardy grading contributed most to the predictions of BR and CSF leaks, respectively.

Conclusions: Gross total resection, biochemical remission, and CSF leaks remain hard to predict, but machine learning offers potential in helping to tailor surgical therapy. We demonstrate the feasibility of developing and externally validating clinical prediction models for these outcomes after surgery for acromegaly and lay the groundwork for development of a multicenter model with more robust generalization.
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http://dx.doi.org/10.1007/s12020-021-02890-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8816764PMC
February 2022

Hesitant or Not Hesitant? A Systematic Review on Global COVID-19 Vaccine Acceptance in Different Populations.

Vaccines (Basel) 2021 Aug 6;9(8). Epub 2021 Aug 6.

Unit of Hygiene, Department of Biomedical and Neuromotor Sciences, Public Health and Medical Statistics, University of Bologna, 40126 Bologna, Italy.

Vaccination currently appears to be the only strategy to contain the spread of COVID-19. At the same time, vaccine hesitancy (VH) could limit its efficacy and has, therefore, attracted the attention of Public Health Systems. This systematic review aimed at assessing anti-COVID-19 vaccine acceptance rates worldwide and at identifying populations more prone to vaccine hesitancy, for which specific interventions should be planned. PubMed database was searched using a purposely formulated string. One hundred out of the 9243 studies retrieved were considered pertinent and thus included in the analyses. VH rate was analyzed according to patient geographical origin, ethnicity, age, study setting, and method used for data collection; data from specific populations were separately analyzed. Overall, this study demonstrated significant differences in terms of VH in the general population and in the specific subgroups examined according to geographical, demographic factors, as well as associated comorbidities, underlining the need for purposely designed studies in specific populations from the different countries, to design targeted programs aimed at increasing awareness for confidence and complacency toward COVID-19 vaccines.
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http://dx.doi.org/10.3390/vaccines9080873DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8402447PMC
August 2021

Mass Immunization and Vaccine Hesitancy in Children and Their Families: A Long and Winding Road Ahead to Address without a Second Thought.

Vaccines (Basel) 2021 Jul 6;9(7). Epub 2021 Jul 6.

Pituitary Unit, IRCCS Istituto delle Scienze Neurologiche di Bologna, 40126 Bologna, Italy.

In 2019, vaccine hesitancy (VH), defined by the SAGE working group as "delay in acceptance or refusal of vaccination despite availability of vaccination services" [...].
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http://dx.doi.org/10.3390/vaccines9070752DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8309981PMC
July 2021

Rate and Predictors of Hesitancy toward SARS-CoV-2 Vaccine among Type 2 Diabetic Patients: Results from an Italian Survey.

Vaccines (Basel) 2021 May 4;9(5). Epub 2021 May 4.

Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, 40126 Bologna, Italy.

Vaccine hesitancy (VH) has been identified as one of the major health concerns of our time by the World Health Organization. It may prove especially detrimental in the light of the ongoing SARS-CoV-2 pandemic, as vaccination campaigns still represent the primary strategy against the detrimental consequences of the pandemic. Among patients suffering from type 2 diabetes mellitus (DB), who are particularly vulnerable to COVID-19, VH might represent an even more serious threat. Therefore, our study focuses on identifying potential determinants of VH among patients with type 2 diabetes. Study participants ( = 1176) filled in a two-section online self-administered questionnaire, answering questions regarding demographic and anamnestic data, as well as their intention to accept any vaccination against COVID-19. Some possible reasons underlying VH were investigated as well. An overall hesitancy rate of 14.2% was registered. Data showed how older age, male gender, higher education level, and having been vaccinated for seasonal influenza in 2020-2021 were associated with a significantly higher propensity to receive the COVID-19 vaccine. On the contrary, having experienced adverse effects following past vaccinations was a negative predictor. In addition to confirming an array of predictors of VH, we found a worryingly high prevalence of VH among diabetics, who have been shown to be particularly exposed to severe COVID-19 and death. These findings may be useful in planning targeted action toward acceptance improvement and enhancing the efficacy of vaccination campaigns.
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http://dx.doi.org/10.3390/vaccines9050460DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147990PMC
May 2021

Would Parents Get Their Children Vaccinated Against SARS-CoV-2? Rate and Predictors of Vaccine Hesitancy According to a Survey over 5000 Families from Bologna, Italy.

Vaccines (Basel) 2021 Apr 10;9(4). Epub 2021 Apr 10.

Unit of Hygiene, Department of Biomedical and Neuromotor Sciences, Public Health and Medical Statistics, University of Bologna, 40126 Bologna, Italy.

In the near future, COVID-19 vaccine efficacy trials in larger cohorts may offer the possibility to implement child and adolescent vaccination. The opening of the vaccination for these strata may play a key role in order to limit virus circulation, infection spreading towards the most vulnerable subjects, and plan safe school reopening. Vaccine hesitancy (VH) could limit the ability to reach the coverage threshold required to ensure herd immunity. The aim of this study was to investigate the prevalence and determinants of VH among parents/guardians toward a potentially available COVID-19 vaccination for children and adolescents. An online survey was performed in parents/guardians of children aged <18 years old, living in Bologna. Overall, 5054 questionnaires were collected. A vast majority (60.4%) of the parents/guardians were inclined to vaccinate, while 29.6% were still considering the opportunity, and 9.9% were hesitant. Highest vaccine hesitancy rates were detected in female parents/guardians of children aged 6-10 years, ≤29 years old, with low educational level, relying on information found in the web/social media, and disliking mandatory vaccination policies. Although preliminary, these data could help in designing target strategies to implement adherence to a vaccination campaign, with special regard to web-based information.
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http://dx.doi.org/10.3390/vaccines9040366DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8069076PMC
April 2021

Fecal Microbiota Transplantation in Allogeneic Hematopoietic Stem Cell Transplantation Recipients: A Systematic Review.

J Pers Med 2021 Feb 4;11(2). Epub 2021 Feb 4.

Pediatric Oncology and Hematology "Lalla Seràgnoli", Pediatric Unit-IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.

The disruption of gut microbiota eubiosis has been linked to major complications in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients. Various strategies have been developed to reduce dysbiosis and related complications. Fecal microbiota transplantation (FMT) consists of the infusion of fecal matter from a healthy donor to restore impaired intestinal homeostasis, and could be applied in the allo-HSCT setting. We conducted a systematic review of studies addressing the use of FMT in allo-HSCT patients. In the 23 papers included in the qualitative synthesis, FMT was used for the treatment of recurrent infections or as a therapeutic strategy for steroid-resistant gut aGvHD. FMT was also performed with a preventive aim (e.g., to decolonize from antibiotic-resistant bacteria). Additional knowledge on the biological mechanisms underlying clinical findings is needed in order to employ FMT in clinical practice. There is also concern regarding the administration of microbial consortia in immune-compromised patients with altered gut permeability. Therefore, the safety profile and efficacy of the procedure must be determined to better assess the role of FMT in allo-HSCT recipients.
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http://dx.doi.org/10.3390/jpm11020100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7913807PMC
February 2021

Management of sellar and parasellar tumors becoming symptomatic during pregnancy: a practical algorithm based on multi-center experience and systematic literature review.

Pituitary 2021 Apr 17;24(2):269-283. Epub 2020 Nov 17.

Pituitary Unit, IRCCS Istituto Delle Scienze Neurologiche di Bologna, Via Altura, 3, 40139, Bologna, Italy.

Introduction: Sellar/parasellar tumors (SPTs) very rarely become symptomatic during pregnancy. No specific guidelines exist for their management, that is extremely challenging as mother and fetus health can be jeopardized.

Materials And Methods: Data of patients with SPTs becoming symptomatic during pregnancy treated at two Italian referral Centers were retrospectively collected. Systematic literature review was also performed.

Results: Our series consisted of 6 cases, 3 meningiomas, 1 ACTH-secreting adenoma, 1 pituicytoma and 1 craniopharyngioma. Mean age at presentation was 33.6 ± 6.0 years. Five patients complained of visual disturbances, associated with headache in one case, that occurred between gestation week (GW) 22 and 34. In 5 cases, pregnancy was uneventful with the delivery of a healthy baby between GW 33 and 35, followed by endoscopic surgical tumor exeresis (n = 4) or proton bean therapy (n = 1). Another patient presented with stigmata typical of Cushing's syndrome and rapidly worsening pre-eclampsia, that required pregnancy interruption and adenomectomy. Based on personal and literature cases, a practical algorithm was proposed to help clinicians dealing with these patients.

Conclusions: SPTs becoming symptomatic in pregnancy deserve careful monitoring and multidisciplinary management. Overall, wait-and-see approach is suggested, reserving surgery to patients with rapidly progressive/life-threatening situations, significant risk of permanent neurological impairment or malignant lesions.
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http://dx.doi.org/10.1007/s11102-020-01107-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7966198PMC
April 2021

Association of Clinicopathological Features With Outcome in Chondrosarcomas of the Head and Neck.

Otolaryngol Head Neck Surg 2021 04 15;164(4):807-814. Epub 2020 Sep 15.

Service of Anatomic Pathology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Objective: The aim of this study is to assess the association between clinical and radiological features as well as of isocitrate dehydrogenase 1 and 2 ( 1,2) mutations with outcome in head and neck chondrosarcomas.

Study Design: Retrospective study.

Setting: Tertiary referral center.

Methods: Clinical, histological, and molecular data of patients with head and neck chondrosarcomas treated by surgery were collected.

Results: Forty-six patients were included. The mean age at diagnosis was 56 years (range, 17-78). The tumor originated from the skull base (52.2%), facial bones (28.2%), or laryngotracheal area (19.6%). At last follow-up (median 52.5 months), 38 patients were alive, 30 of which were disease free, whereas 8 had died, 4 of disease progression and 4 of other causes. Fourteen (30.4%) had local recurrence and 2 (4.3%) had lung metastasis. All cases were negative for cytokeratin AE1/AE3, brachyury, and IDH1 at immunohistochemistry, while Sanger sequencing identified IDH1/2 point mutations, typically IDH1 R132C, in 9 (37.5%) tumors arising from the skull base. Margin infiltration on the surgical specimen negatively affected the outcome, whereas no correlation was identified with mutation status.

Conclusions: An adequate margin positively affects survival. mutation status does not affect patient outcome.
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http://dx.doi.org/10.1177/0194599820957271DOI Listing
April 2021

Machine learning-based prediction of outcomes of the endoscopic endonasal approach in Cushing disease: is the future coming?

Neurosurg Focus 2020 06;48(6):E5

1Pituitary Unit, Center for the Diagnosis and Treatment of Hypothalamic-Pituitary Diseases, IRCCS Institute of Neurological Sciences of Bologna.

Objective: Machine learning (ML) is an innovative method to analyze large and complex data sets. The aim of this study was to evaluate the use of ML to identify predictors of early postsurgical and long-term outcomes in patients treated for Cushing disease (CD).

Methods: All consecutive patients in our center who underwent surgery for CD through the endoscopic endonasal approach were retrospectively reviewed. Study endpoints were gross-tumor removal (GTR), postsurgical remission, and long-term control of disease. Several demographic, radiological, and histological factors were assessed as potential predictors. For ML-based modeling, data were randomly divided into 2 sets with an 80% to 20% ratio for bootstrapped training and testing, respectively. Several algorithms were tested and tuned for the area under the curve (AUC).

Results: The study included 151 patients. GTR was achieved in 137 patients (91%), and postsurgical hypersecretion remission was achieved in 133 patients (88%). At last follow-up, 116 patients (77%) were still in remission after surgery and in 21 patients (14%), CD was controlled with complementary treatment (overall, of 131 cases, 87% were under control at follow-up). At internal validation, the endpoints were predicted with AUCs of 0.81-1.00, accuracy of 81%-100%, and Brier scores of 0.035-0.151. Tumor size and invasiveness and histological confirmation of adrenocorticotropic hormone (ACTH)-secreting cells were the main predictors for the 3 endpoints of interest.

Conclusions: ML algorithms were used to train and internally validate robust models for all the endpoints, giving accurate outcome predictions in CD cases. This analytical method seems promising for potentially improving future patient care and counseling; however, careful clinical interpretation of the results remains necessary before any clinical adoption of ML. Moreover, further studies and increased sample sizes are definitely required before the widespread adoption of ML to the study of CD.
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http://dx.doi.org/10.3171/2020.3.FOCUS2060DOI Listing
June 2020

Testosterone Deficiency and Risk of Cognitive Disorders in Aging Males.

World J Mens Health 2021 Jan 1;39(1):9-18. Epub 2020 Apr 1.

Endocrinology Unit, Department of Experimental, Clinical and Biomedical Sciences, University of Florence, Florence, Italy.

Cognitive impairment and dementia are predicted to undergo a dramatic increase in the following years with more than 131.5 million people being affected by 2030. Although vascular diseases play the most important role in the pathogenesis of memory impairment in aging men, some pre-clinical and clinical evidence has suggested a possible contribution of the age-dependent reduction of testosterone (T). In this paper we have summarized and discussed all the information derived from available animal and experimental studies. In addition, we meta-analyzed data rising from all randomized placebo controlled trials (RCTs) published so far. Only limited preclinical and clinical evidence can support a possible contribution of T in the pathogenesis of the age-dependent impairment of cognitive functions. In addition, our meta-analysis did not support the use of T replacement therapy for the improvement of several cognitive domains analyzed including attention/working memory, executive function, language, verbal memory, visual memory, visuomotor ability, and visuospatial ability. However, it is important to recognize that the vast majority of available RCTs included mixed populations of subjects with eugonadism and hypogonadism preventing any final conclusion being drawn on these issues.
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http://dx.doi.org/10.5534/wjmh.200017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7752509PMC
January 2021

A practical algorithm to predict postsurgical recurrence and progression of pituitary neuroendocrine tumours (PitNET)s.

Clin Endocrinol (Oxf) 2020 07 5;93(1):36-43. Epub 2020 May 5.

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Objective: Pituitary neuroendocrine tumours (PitNET)s can be aggressive, thus presenting local invasion, postsurgical recurrence and/or resistance to treatment, responsible for significant morbidity. The study aimed at identifying prognostic factors of postsurgical outcome using data-driven classification of patients.

Design: Retrospective observational study.

Methods: Clinicopathological and radiological data of patients with PitNET treated via endoscopic endonasal surgery were collected. Tumour recurrence/progression and progression-free survival were assessed by classification tree analysis (CTA) and Kaplan-Meier curves, respectively. Histological subtype, cavernous/sphenoid sinus invasion, mitosis, Ki-67, p53, Trouillas' grading, degree of tumour exeresis and postsurgery disease activity were also evaluated.

Results: A total of 1066 (466 gonadotroph, 287 somatotroph, 148 lactotroph, 157 corticotroph and 8 thyrotroph) tumours were included; 21.7% invaded the cavernous/sphenoid sinus. Based on Trouillas' classification, 64.3% were grade 1a, 14.2% 1b, 16.1% 2a, and 5.4% 2b; 18.3% had >2/10 HPF mitoses, 24.9% had Ki-67 ≥3%; 15.8% were positive for p53. Exeresis was radical in 81.2% of the cases. Median follow-up was 59.2 months. At last evaluation, 79.4% of the patients were cured; 20.6% had disease persistence, controlled by medical treatment in 18.3% of them. Disease recurrence/progression was recorded in 10.9% of the cases. CTA identified 5 distinct patient subgroups with different risk of disease recurrence/progression. Grade 2 of the Trouillas' grading, >2/10 HPF mitoses, Ki-67 ≥3%, p53 protein expression (P < .001), tumour invasion (P = .002) and ACTH-subtype (P = .003) were identified as risk factors of disease recurrence/progression.

Conclusions: The combined evaluation of Trouillas' grading, proliferation indexes and immunohistochemistry appears promising in the prediction of surgical outcome in PitNET.
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http://dx.doi.org/10.1111/cen.14197DOI Listing
July 2020

Endoscopic approaches to orbital lesions: case series and systematic literature review.

J Neurosurg 2020 Jan 3:1-13. Epub 2020 Jan 3.

1Center for the Diagnosis and Treatment of Hypothalamic-Pituitary Diseases, Pituitary Unit, and.

Objective: Surgical treatment of orbital lesions is challenging because complex approaches with a high risk of postoperative sequelae are required. Recently, minimally invasive endoscopic approaches through endonasal (EEA) and transpalpebral (ETP) routes have been proposed. The objective of this study was to assess outcomes of EEA and ETP in the authors' series of patients with orbital lesions.

Methods: Data from all patients who underwent operations for an orbital tumor through an endoscopic approach at the authors' institution from 2002 to 2018 were retrospectively collected. All patients underwent preoperative MRI and ophthalmological evaluation, which was repeated 3 months after surgery and then at regular follow-up intervals. A systematic review of the literature was also performed using Medline, Embase, and Web of Science databases.

Results: The series includes 23 patients (14 males); the mean patient age was 48 ± 23.9 years. Most of the lesions were intraconal (n = 19, 83%). The more frequent histotype was cavernous hemangioma (n = 5, 22%). Exophthalmos was the most common symptom (21 of 23 patients). EEA was performed in 16 cases (70%) and ETP in 7 (30%). The aim of the surgery was achieved in 94% of the cases after an EEA (successful biopsy in 5 of 6 cases and radical resection in all 10 remaining patients), and in 86% after an ETP (successful biopsy in 2 cases and radical tumor resection in 4 of 5 cases). Complications consisted of 3 cases (13%) of transitory diplopia. One recurrence (4%) was observed at follow-up (mean 59 ± 55 months).

Conclusions: The EEA and ETP have demonstrated to be safe and effective for tumors located respectively in medial and lateral quadrants, permitting one to approach orbital lesions endoscopically at 360°. Innovative surgical tools, including intraoperative ultrasonography, may be useful to potentially reduce surgical morbidity. Larger series are needed to validate these preliminary suggestions.
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http://dx.doi.org/10.3171/2019.10.JNS192138DOI Listing
January 2020

Peculiar pathological, radiological and clinical features of skull-base de-differentiated chordomas. Results from a referral centre case-series and literature review.

Histopathology 2020 Apr 10;76(5):731-739. Epub 2020 Mar 10.

Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, Italy.

Aims: De-differentiated chordoma is an uncommon and incompletely characterised aggressive neoplasm. Only a few cases originating from the skull base have been reported.

Methods And Results: All consecutive cases of skull-base de-differentiated chordomas treated surgically in a referral centre from January 1990 to June 2019 were retrospectively evaluated to assess peculiar pathological, radiological and clinical features. Patient data were retrieved from paper and electronic records. Six cases (two male, four female; mean age at surgery = 46 years, range = 35-64), treated surgically at our institution were identified. Transformation to de-differentiated chordomas occurred after radiation therapy in three cases (mean = 13.6 years after treatment, range = 5-25), two during tumour progression, while one was de-novo. Magnetic resonance imaging and surgical examination revealed the presence of two different tumour components, corresponding to the conventional and de-differentiated portion on histological examination. The de-novo case presented a PIK3CA mutation. DNA methylation analysis revealed consistent epigenetic changes in TERT, MAGEA11 and UXT. Prognosis was poor, as five of six patients died after surgery and radiation therapy, with a mean overall survival of 29 months (range = 11-52).

Conclusions: Skull-base de-differentiated chordomas are extremely rare and aggressive neoplasms with characteristic magnetic resonance imaging, surgical and histological features. Therefore, an early and accurate histological diagnosis is of paramount relevance. Molecular analysis appears promising to define mechanisms involved in tumour de-differentiation.
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http://dx.doi.org/10.1111/his.14024DOI Listing
April 2020

Outcome of Endoscopic Endonasal Surgery in Pediatric Craniopharyngiomas.

World Neurosurg 2020 Feb 17;134:e277-e288. Epub 2019 Oct 17.

Division of Pediatric Neurosurgery, Department of Neurosurgery, Bellaria Hospital, Bologna, Italy.

Background: In the last years, few reports have shown the feasibility of the endoscopic endonasal approach (EEA) for craniopharyngiomas in pediatric patients. For these tumors, recent studies have suggested less aggressive surgery, favoring the preservation of the patient's quality of life.

Objective: The aim of this study was to assess the outcome of the EEA in a large series with specific attention on the long-term functional sequelae.

Materials: All consecutive pediatric craniopharyngiomas operated on through this approach since 2000 were included in the study. Preoperative and postoperative operative clinical, radiologic, and pathologic features were retrieved from patient records (mean follow-up, 72 ± 67 months).

Results: The series included 25 patients (12 female; mean age, 8.9 ± 4.1 years). Most of the tumors presented with a supradiaphragmatic extension (88%). Removal was radical in 23 patients (92%). Complications consisted of 6 cerebrospinal fluid leaks (24%). One patient (4%) died of postoperative respiratory complications. Most patients (92%) developed panhypopituitarism and visual disturbances normalized or improved in 6 patients (43%). At follow-up, 9 patients (36%) were overweight/obese (6 were already overweight before surgery). The tumor recurrence rate was 19%.

Conclusions: EEA can be an effective approach for midline craniopharyngiomas in children older than 3 years. It gives a satisfactory exposure of the suprasellar region and an adequate assessment of the brain-tumor interface. Its main limitations are age-related anatomic features of nasal/paranasal sinuses and the risk of cerebrospinal fluid leak.
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http://dx.doi.org/10.1016/j.wneu.2019.10.039DOI Listing
February 2020

Activation of pituitary axis according to underlying critical illness and its effect on outcome.

J Crit Care 2019 12 6;54:22-29. Epub 2019 Jul 6.

Anestesiologia e Rianimazione, Dipartimento di Scienze e Biotecnologie Medico Chirurgiche, Università di Roma La Sapienza, Roma, Italy. Electronic address:

Purpose: Critical illness is a life threatening condition inducing a severe acute physical stress. The aim of the study was to investigate the activation of pituitary axis early after ICU admission in patients with critical illnesses of different etiology and its association with outcome.

Materials And Methods: Patients admitted for acute respiratory distress syndrome (ARDS), severe traumatic brain injury (TBI), subarachnoid hemorrhage (SAH) and neurocritically ill patients at the moment of brain death (BD) diagnosis were included in the present post-hoc analysis. On day 1, 2-3 and 4-5 after admission the following pituitary axes were assessed: hypothalamic-pituitary-adrenal, hypothalamic-pituitary-thyroid, somatotroph, prolactin and copeptin. ICU mortality was used as outcome measure.

Results: One hundred-thirteen critical ill patients were studied. Thyroid axis suppression and activation of copeptin axis were the most frequent pituitary hormone alterations, present in almost 60% of patients. Activation of the hypothalamic pituitary adrenal axis was a predictor of ICU mortality independently from the underlying critical illness [OR 3.952 (C.I.95% 1.129-13.838)].

Conclusions: Pituitary axis function is frequently altered early after ICU admission, the magnitude of hormonal response being different according to the underlying critical illness. The activation of the hypothalamic pituitary adrenal axis was a strong predictor of ICU mortality.
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http://dx.doi.org/10.1016/j.jcrc.2019.07.006DOI Listing
December 2019

Parosteal osteosarcoma: a monocentric retrospective analysis of 195 patients.

Hum Pathol 2019 09 23;91:11-18. Epub 2019 May 23.

Department of Pathology, IRCCS Rizzoli Orthopedic Institute, Bologna, Italy. Electronic address:

Parosteal osteosarcoma is a low-grade malignant bone tumor that can undergo dedifferentiation. The aim of this study was to analyze clinicopathologic features associated with clinical outcome in a large cohort of patients. Patients consecutively treated for parosteal osteosarcoma at Rizzoli Orthopedic Institute from 1900 to 2018 were reviewed and analyzed. Clincopathologic data of 195 patients with parosteal osteosarcoma were analyzed. Age at diagnosis ranged from 9 to 75 years (median 31). Median follow-up time was 150 months (range, 3-720). The most common tumor locations were femur (61.5%), humerus (15.9%) and tibia (12.8%). Wide surgical margins were achieved in 125 (64.1%) patients. Medullary involvement was present in 69 (35.4%) cases. Dedifferentiation occurred in 48 (24.6%) patients. Forty-five patients developed recurrence (23.1%; median time to recurrence of 36 months). At last follow-up, 155 (79.5%) patients were alive and without evidence of disease, 8 (4.1%) were alive with active disease, 23 (11.8%) died from disease, and 9 (4.6%) from unrelated causes. Patients with dedifferentiated parosteal osteosarcoma had worse 5-year (65% versus 96%) and 10-year survival (60% versus 96%) when compared to conventional tumors (P < .001). Wide surgical margins had positive impact on both disease-free (P < .001) and overall survival (P = .036). Medullary involvement, age at presentation and tumor size had no impact on survival. Dedifferentiation is the most important factor that negatively impacts clinical outcome. Surgical aim is to ensure radical removal with wide surgical margins to improve disease-free survival.
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http://dx.doi.org/10.1016/j.humpath.2019.05.009DOI Listing
September 2019

Anti-Hypothalamus and Anti-Pituitary Auto-antibodies in ROHHAD Syndrome: Additional Evidence Supporting an Autoimmune Etiopathogenesis.

Horm Res Paediatr 2019 30;92(2):124-132. Epub 2019 Apr 30.

Genetics and Rare Diseases Research Division, Bambino Gesù Children's Hospital, Rome, Italy.

Background: Rapid-onset Obesity with Hypothalamic dysfunction, Hypoventilation and Autonomic Dysregulation (ROHHAD) is a very rare and complex pediatric syndrome characterized by altered hypothalamic thermal regulation, pain threshold, and respiratory control, hyperphagia with rapid weight gain and, often, hypothalamic-pituitary dysfunction. Its etiopathogenesis remains undetermined. We investigated the presence of alterations to target genes and hypothalamic-pituitary autoimmunity in a patient with -ROHHAD syndrome.

Methods: A 3-year-old girl presenting with obesity after rapid weight gain was diagnosed with ROHHAD syndrome based on clinical features and abnormal biochemical and functional testing results. Because of worsening of rapid symptoms and demonstration of oligoclonal bands on cerebrospinal fluid (CSF) analysis, she was treated with plasmapheresis, methylprednisolone, anti-CD20 monoclonal antibodies, and azathioprine. Despite initial partial clinical improvement, the patient soon died of cardiorespiratory arrest. Post-mortem, whole exome sequencing, high-resolution comparative genomic hybridization array, and optimized indirect immunofluorescence (IIF) analysis were performed on blood and CSF.

Results: No putative causative genomic variants compatible with dominant or recessive inheritance nor clinically significant structural rearrangement were detected. IIF on serum and CSF demonstrated the presence of anti-pituitary and anti-hypothalamus autoantibodies.

Conclusions: These findings support the involvement of autoimmunity in ROHHAD syndrome. However, response to immunosuppressive treatment was only transient and the patient died. Further cases are required to define the complex disease pathogenesis.
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http://dx.doi.org/10.1159/000499163DOI Listing
May 2020

Impact of Metabolically Healthy Obesity in Patients with Andrological Problems.

J Sex Med 2019 Jun 5;16(6):821-832. Epub 2019 Apr 5.

Endocrinology Unit, Medical Department, Azienda USL, Maggiore-Bellaria Hospital, Bologna, Italy. Electronic address:

Background: Although the pathogenic role of metabolically complicated obesity (MCO) in erectile dysfunction (ED), major adverse cardiovascular events (MACE), and male infertility has been widely studied, that of metabolically healthy obesity (MHO) has been poorly investigated.

Aim: To assess the role of MHO in the pathogenesis of ED, prediction of MACE, and male reproductive health.

Methods: A consecutive series of 4,945 men (mean age, 50.5 ± 13.5 years) with sexual dysfunction (SD) (cohort 1) and 231 male partners of infertile couples (mean age, 37.9 ± 9.1 years; cohort 2) were studied. A subset of men with SD (n = 1,687) was longitudinally investigated to evaluate MACE. All patients underwent clinical, biochemical, erectile function, and flaccid penile color Doppler ultrasound (PCDU) assessment. Infertile men also underwent scrotal and transrectal ultrasound; semen analysis, including interleukin (IL-) 8; and prostatitis-like symptom assessment. MHO was defined as body mass index >30 kg/m with high-density lipoprotein cholesterol level >40 mg/dL and absence of diabetes or hypertension. The rest of the obesity sample was defined as MCO. MHO or MCO were compared with the rest of the sample, defined as normal weight (NW) individuals.

Outcomes: Clinical, biochemical, erectile, and PCDU assessment in MHO, MCO and NW men in both cohorts; longitudinal MACE incidence assessment in cohort 1.

Results: In cohort 1, 816 men (16.5%) were obese, 181 (3.7%) were MHO, and 635 (12.8%) were MCO. In cohort 2, 68 men (28.4%) were obese, 19 (8.2%) were MHO, and 49 (21.2%) were MCO. After adjusting for confounders, in both samples, the men with MHO and MCO had lower total testosterone levels and worse PCDU parameters compared with the NW men. However, only MCO men had worse erectile function compared with NW men. In the longitudinal study, both MHO and MCO men independently had a higher incidence of MACE compared with NW men (P < .05 for both). In cohort 2, MHO and MCO men had a larger prostate volume, and MCO men also had higher ultrasound and biochemical (IL-8) features of prostatic inflammation compared with NW men, but no differences in prostatitis-like symptoms or seminal parameters.

Clinical Implications: MHO men should be considered at high cardiovascular risk like MCO men and followed-up for erectile dysfunction and prostate abnormalities overtime.

Strengths & Limitations: The study simultaneously examined several endpoints with validated instruments within 2 different male populations, 1 with SD and 1 with infertility. As for limitations, there is no consensus in the scientific community regarding the definition of MHO, and the results are derived from patients with SD or infertility, which could have different characteristics than the general male population.

Conclusion: MHO is associated with subclinical ED, increased cardiovascular risk, and prostate enlargement. Lotti F, Rastrelli G, Maseroli E, et al. Impact of Metabolically Healthy Obesity in Patients with Andrological Problems. J Sex Med 2019:16;821-832.
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http://dx.doi.org/10.1016/j.jsxm.2019.03.006DOI Listing
June 2019

Testosterone Replacement Therapy for Sexual Symptoms.

Sex Med Rev 2019 07 22;7(3):464-475. Epub 2019 Feb 22.

Endocrinology Unit, Medical Department, Azienda Usl, Maggiore-Bellaria Hospital, Bologna, Italy. Electronic address:

Background: Several data have clearly shown that the endocrine system-and androgens in particular-play a pivotal role in regulating all the steps involved in the male sexual response cycle. Accordingly, testosterone (T) replacement therapy (TRT) represents a cornerstone of pharmacologic management of hypogonadal subjects with erectile dysfunction.

Aim: The aim of this review is to summarize all the available evidence supporting the role of T in the regulation of male sexual function and to provide a comprehensive summary regarding the sexual outcomes of TRT in patients complaining of sexual dysfunction.

Methods: A comprehensive PubMed literature search was performed.

Main Outcome Measure: Specific analysis of preclinical and clinical evidence on the role of T in regulating male sexual function was performed. In addition, available evidence supporting the role of TRT on several sexual outcomes was separately investigated.

Results: T represents an important modulator of male sexual response function. However, the role of T in sexual functioning is less evident in epidemiologic studies because other factors, including organic, relational, and intrapsychic determinants, can orchestrate their effect independently from the state of androgens. Nonetheless, it is clear that TRT can ameliorate several aspects of sexual functioning, including libido, erectile function, and overall sexual satisfaction. Conversely, data on the role of TRT in improving orgasmic function are more conflicting. Finally, further controlled studies are needed to investigate the combination of TRT and PDE5 inhibitors.

Conclusion: Positive effects of TRT are observed only in the presence of a hypogonadal status (ie, total T < 12 nmol/L). In addition, TRT alone can be effective in restoring only milder forms of erectile dysfunction, whereas the combined therapy with other drugs is required when more severe vascular damage is present. Rastrelli G, Guaraldi F, Reismann Y, et al. Testosterone Replacement Therapy for Sexual Symptoms. Sex Med Rev 2019;7:464-475.
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http://dx.doi.org/10.1016/j.sxmr.2018.11.005DOI Listing
July 2019

Endoscopic endonasal approach to primitive Meckel's cave tumors: a clinical series.

Acta Neurochir (Wien) 2018 12 31;160(12):2349-2361. Epub 2018 Oct 31.

Department of Neurosurgery, DIBINEM, University of Bologna, Bologna, Italy.

Introduction: Recently, an alternative endoscopic endonasal approach to Meckel's cave (MC) tumors has been proposed. To date, few studies have evaluated the results of this route. The aim of our study was to evaluate long-term surgical and clinical outcome associated with this technique in a cohort of patients with intrinsic MC tumors.

Methods: All patients with MC tumors treated at out institution by endoscopic endonasal approach (EEA) between 2002 and 2016 were included. Patients underwent brain MRI, CT angiography, and neurological evaluation before surgery. Complications were considered based on the surgical records. All examinations were repeated after 3 and 12 months, then annually. The median follow-up was of 44.1 months (range 16-210).

Results: The series included 8 patients (4 F): 5 neuromas, 1 meningioma, 1 chondrosarcoma, and 1 epidermoid cyst. The median age at treatment was 54.5 years (range 21-70). Three tumors presented with a posterior fossa extension. Radical removal of the MC portion of the tumor was achieved in 7 out of 8 cases. Two patients developed a permanent and transitory deficit of the sixth cranial nerve, respectively. No tumor recurrence was observed at follow-up.

Conclusion: In this preliminary series, the EEA appeared an effective and safe approach to MC tumors. The technique could be advantageous to treat tumors located in the antero-medial aspects of MC displacing the trigeminal structures posteriorly and laterally. A favorable index of an adequate working space for this approach is represented by the ICA medialization, while tumor extension to the posterior fossa represents the main limitation to radical removal of this route.
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http://dx.doi.org/10.1007/s00701-018-3708-4DOI Listing
December 2018

The Endoscopic Endonasal Management of Anterior Skull Base Meningiomas.

J Neurol Surg B Skull Base 2018 Oct 27;79(Suppl 4):S300-S310. Epub 2018 Aug 27.

Center of Pituitary and Endoscopic Skull Base Surgery, IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

 The endoscopic endonasal approach (EEA) might seem an "unnatural" route for intradural lesions such as meningiomas. The aim of this study is to critically revise our management of anterior skull base meningiomas to consider, in what cases it may be advantageous.  Each consecutive case of anterior skull base meningioma operated on through an EEA or combined endoscopic-transcranial approach at our institution, between 2003 and 2017, have been included. Tumors were classified on the basis of their location and intra or extracranial extension. Follow-up consisted of an MRI (magnetic resonance imaging) and a clinical examination 3 months after the surgery and then repeated annually.  Fifty-seven patients were included. The most common location was the tuberculum sellae (62%), followed by olfactory groove (14%), planum sphenoidale (12%), and frontal sinus (12%). Among these, 65% were intracranial, 7% were extracranial, and 28% both intra and extracranial. Radical removal was achieved in 44 cases (77%). Complications consisted in 10 CSF (cerebrospinal fluid) leaks (17.6%), 1 overpacking (1.7%), and 1 asymptomatic brain ischemia (1.7%). Visual acuity and campimetric deficits improved respectively in 67 and 76% of patients. Recurrence rate was of 14%.  EEA presents many advantages in selected cases of anterior skull base meningioma. However, it is hampered by the relevant risk of CSF leak. We consider that it could be advantageous for planum/tuberculum sellae tumors. Conversely, for olfactory groove or frontal sinus meningiomas, it can be indicated for tumors with extracranial extension, while its role is still debatable for purely intracranial forms as considering our surgical results, it could be advantageous for midline planum/tuberculum sellae tumors. Conversely, it can be of first choice for olfactory groove or frontal sinus meningiomas with extracranial extension, while its role for purely intracranial forms is still debatable.
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http://dx.doi.org/10.1055/s-0038-1669463DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133667PMC
October 2018

Myasthenia gravis imitating pituitary apoplexy in macroprolactinoma.

Hormones (Athens) 2018 Sep 2;17(3):423-426. Epub 2018 Jun 2.

Center for the Diagnosis and Treatment of Hypothalamic-Pituitary Disorders (Pituitary Unit), IRCCS Institute of Neurological Sciences of Bologna, Via Altura, 3, 40141, Bologna, Italy.

Myasthenia gravis (MG) is an autoimmune disease affecting neuromuscular transmission that manifests with muscle weakness and typically involves the eye muscles, often producing diplopia and ptosis. Recent studies suggest that hyperprolactinaemia may have a role in the development of MG, although its association with prolactinoma is extremely rare. We report the unusual case of a 71-year-old male affected with macroprolactinoma, who presented at our Center 2 weeks after starting cabergoline treatment because of acute onset of headache, diplopia, and ptosis. On admission, he presented with drowsiness, dropped head, swallowing impairment and bilateral ptosis, which rapidly worsened. Based on clinical manifestation and history, emergency surgery was performed on suspicion of pituitary apoplexy (PA), the typical complication occurring in patients with macroadenomas who present these symptoms. No pituitary haemorrhage was found. The symptoms initially resolved after surgery, but soon returned and worsened day by day, especially in the evening, despite the increase of cortisone replacement doses. MG was thus suspected and confirmed by the detection of antibodies to the acetylcholine receptor. Pyridostigmine was started with prompt improvement of neurological symptoms. In conclusion, although very rare, MG should be considered in the differential diagnosis of patients with macroprolactinomas and suggestive neurological symptoms in order to provide early and appropriate treatment. The role of hyperprolactinaemia in MG onset and evolution is also discussed.
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http://dx.doi.org/10.1007/s42000-018-0036-2DOI Listing
September 2018

Effect of short-term hazelnut consumption on DNA damage and oxidized LDL in children and adolescents with primary hyperlipidemia: a randomized controlled trial.

J Nutr Biochem 2018 07 20;57:206-211. Epub 2018 Mar 20.

Department of Public Health and Pediatric Sciences, University of Turin, Turin, Italy.

Children with primary hyperlipidemia are prone to develop premature atherosclerosis, possibly associated with increased oxidative stress. Nutritional therapy is the primary strategy in the treatment of hyperlipidemia and associated conditions. Dietary interventions with bioactive-rich foods, such as nuts, may contribute to the modulation of both lipid profile and the oxidative/antioxidant status. Our study aimed to assess the impact of a dietary intervention with hazelnuts on selected oxidative stress markers in children and adolescents with primary hyperlipidemia. A single-blind, 8-week, randomized, controlled, three-arm, parallel-group study was performed. Children and adolescents diagnosed with primary hyperlipidemia (n=60) received dietary guidelines and were randomized into three groups: group 1 received hazelnuts with skin (HZN+S), and group 2 hazelnuts without skin (HZN-S), at equivalent doses (15-30 g/day, based on body weight); group 3 (controls) received only dietary recommendations (no nuts). At baseline and after 8 weeks, plasma oxidized low-density lipoprotein (ox-LDL) concentrations, oxidative levels of DNA damage in PBMCs and potential correlation with changes in serum lipids were examined. A reduction of endogenous DNA damage by 18.9%±51.3% (P=.002) and 23.1%±47.9% (P=.007) was observed after HZN+S and HZN-S, respectively. Oxidatively induced DNA strand breaks decreased by 16.0%±38.2% (P=.02) following HZN+S treatment. Ox-LDL levels did not change after HZN+S intervention but positively correlated with total cholesterol and LDL cholesterol. A short-term hazelnut intervention improves cell DNA protection and resistance against oxidative stress but not ox-LDL in hyperlipidemic pediatric patients. The trial was registered at ISRCTN.com, ID no. ISRCTN12261900.
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http://dx.doi.org/10.1016/j.jnutbio.2018.03.012DOI Listing
July 2018
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