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Since the multicomponent meningococcal B vaccine introduction, the Apulian Regional Health Authority implemented postmarketing surveillance program, as provided by Italian laws. From National Pharmacovigilance Network, we selected 4CMenB AEFIs reported in Apulia from 01 January 2014 to 31 December 2019, while the number of 4 cMen B doses administered per year was obtained from the regional immunization database (GIAVA). For each subject who experienced an adverse event following meningococcal B vaccine (AEFIs), a predefined form was filled in. A total of 214 AEFIs (26.5 × 100.000 doses) were reported after any dose of MenB-4 c vaccination of which 58/214 (27.1%) were classified as serious (7.2 × 100,000 doses), 145/214 (67.8%) as not serious (180 × 100,000 doses), and 11/214 (5.1%) as undefined (1.3 × 100,000 doses). The average age of subjects who experimented and AEFI was 30 months. The majority of serious AEFIs were reported in 2- to 11-month-old children (44/57; 77.2%). A total of 31/58 (3.8 × 100,000 doses; 53.4%) serious AEFIs were reported as having a ‘consistent causal association’ with vaccination. Of these, fever/hyperpyrexia was reported in 21/31 (2.6 × 100,000 doses; 67.7%); hypotonic-hyporesponsive episode was reported in 7/31 (0.9 × 100,000 doses [add %-age]) and was the most frequent adverse event with neurological symptoms. A total of 13/31 (41.9%) serious AEFIs classified as ‘consistent causal association’ were reported after the first dose of 4cMenB, of these 5/13 (38.5%) children did not complete the vaccination schedule. Our data seemed to confirm, in a large population, the a good safety profile of the universal mass vaccination with 4CMENB.

Abstract The neuromodulation induced by neurofeedback training (NFT) remains a matter of debate. Investigating the modulation of brain activity specifically associated with NF requires controlling for multiple factors, such as reward, performance, congruency between task and targeted brain activity. This can be achieved using sham feedback (FB) control condition, equating all aspects of the experiment but the link between brain activity and FB. We aimed at investigating the modulation of individual alpha EEG activity induced by NFT in a double-blind, randomized, sham-controlled study. Forty-eight healthy participants were assigned to either NF (n = 25) or control (n = 23) group and performed alpha upregulation training (over 12 weeks) with a wearable EEG device. Participants of the NF group received FB based on their individual alpha activity. The control group received the auditory FB of participants of the NF group. An increase of alpha activity across training sessions was observed in the NF group only (p

Large stratospheric balloons are the easiest access to near space. Large long duration balloons (LDBs) can float in the stratosphere for weeks collecting measurements (e.g., astrophysical or geophysical data) or samples (e.g., contaminants, volcanic ash, micrometeorites). The recovery of data media and samples is a common problem in this type of experiment because direct radio communication becomes useless when the balloon crosses the horizon, and satellite links are too slow and expensive. For this reason, physical recovery of the payload is mandatory to obtain experimental results, which is a difficult task, especially in polar regions. The goal of HERMES (HEmera Returning MESsenger) is to allow researchers to obtain experimental data prior to payload recovery. HERMES is a system equipped with an autonomous glider capable of physically transporting data and samples from the stratosphere to a recovery point on the ground. The glider is installed on the balloon payload via a remotely controlled release system and is connected to the main computer to store a copy of the scientific data and to receive the geographic coordinates of the recovery point. This allows scientists to obtain experimental results before recovering the payload. The article describes HERMES and the first experimental flight of the entire system, which was conducted at Esrange Space Center (Kiruna, Sweden) in July 2022.

Although the vaccination of healthcare workers (HCWs) is considered essential for preventing influenza circulation in the hospital setting, vaccination coverage (VC) in this group remains low. Among the reasons cited by HCWs is a lack of time to attend the vaccination clinic. For the 2018/2019 influenza season, active (on-site) influenza vaccination was offered directly in 44 operative units (OUs) of the Bari Policlinico hospital (50 OUs, 3,397 HCWs). At the same time, the hospital granted the HCW access to the vaccination clinic during October and December 2018. VC achieved among HCWs of Bari Policlinico during the 2018/2019 influenza season was then analyzed, and the results compared with those of the 2017/18 season. During the 2018/19 season, VC was 20.4% (n = 798) and thus higher than the 14.2% of the 2017/18 season (+6.2%). The highest VC was among physicians (33.4%), followed by other HCWs (23.8%), auxiliary staff (8.6%), and nurses (7.2%). Overall, 284 (36.5%) HCWs were vaccinated at on-site sessions. Multivariate analysis showed that vaccination uptake was associated with male gender and with work in OU where vaccination was actively offered. On the other hand, being a nurse or auxiliary staff member and working in the surgical area were deterrents. Although VC remained unsatisfactory, active on-site vaccination proved to be an important strategy to improve vaccination compliance, increasing 44% compared to the previous season. Nonetheless, mandatory vaccination directed by public health institutions may be the only way to reach a minimum level of coverage.

The diagnosis of apathy, one of the most common behavioral changes after acquired brain injury (ABI), is important for improving clinical understanding and treatment of persons with ABI. The main aim of this study was to determine the possible role of apathy in conflict monitoring, by using choice reaction time tasks. Methods: We examined behavioral responses of conflict monitoring during three different flanker tasks in 10 severe ABI patients with or without diagnosis of apathy (3 M, mean age = 56.60; 3 M, mean age ± SD = 58.60, respectively), and 15 healthy controls (9 M, mean age = 54.46) Reaction times (RTs), accuracy, and global index of performance (GIP) were analyzed for each task. Results: Only apathetic ABI patients showed a significant difference from healthy subjects (p-value ≤ 0.001), while the performance of patients without apathy was not significantly different from that of healthy controls (p-value = 0.351). Healthy participants had higher accuracy in comparison to both ABI patients with (p < 0.001) and without (p-value = 0.038) apathy, whilst slower RTs were shown by ABI patients without apathy in comparison to both healthy subjects (p-value = 0.045) and apathetic ABI patients (p-value = 0.022). Only patients with apathy exhibited a significantly higher number of missing trials (p-value = 0.001). Conclusions: Our results may suggest a potential link between apathy following severe ABI and conflict monitoring processes, even though further investigations with larger sample size are needed.

Background: The management of difficult-to-treat periocular basal cell carcinoma becomes very challenging in cases of delayed diagnosis, leading to the development of locally advanced basal cell carcinoma. Objective: The aim of this study was to evaluate the outcomes of Hedgehog pathway inhibitors (vismodegib and sonidegib) treatment in patients affected by periocular locally advanced basal cell carcinoma. We focused on the common adverse events and their correlation with the administration schedule in order to determine a management protocol specific for the periocular area. Methods: This observational prospective study included a single-center case series with patients who were histologically confirmed to have periocular or orbital locally advanced basal cell carcinoma, treated with Hedgehog pathway inhibitors. Results: All patients benefitted in terms of regression or stabilization of the neoplasm. In the first months of treatment, the HPIs were well tolerated, and the first important side effects appeared after about 5 months of continuous use of the drug. Conclusion: These data could lead to a new type of therapeutic scheme where neoadjuvant therapy could be followed by pulse therapy as an adjuvant to surgery.

Since the influenza season 2018/19, the Italian Ministry of Health recommended a dose of cell-based quadrivalent vaccine (Flucelvax Tetra) for HCWs (healthcare workers), because this vaccine seemed more efficacious in the prevention of AH3N2 virus. Due to the lack of pre-registration data, the safety profile of this new vaccine must be investigated in post-marketing surveillance. The aim of our study is to evaluate, through a post-marketing active surveillance program developed during the 2019/20 influenza season, any Adverse Events Following Immunization (AEFIs) that happened in the 7 days after immunization with Flucelvax Tetra. The study was carried out in a sample of HCWs of Policlinico General University-Hospital (Apulia, South Italy). AEFIs were classified as ‘serious’ or ‘not serious’ according to the WHO (World Health Organization) guidelines; the WHO causality assessment algorithm was applied to classify serious AEFIs. A total of 741 HCWs were enrolled, and 430 AEFIs (reporting rate: 58.0 (95%CI: 54.4–61.6) × 100 enrolled) were recorded. Of these, 429 of 430 (99.8%; reporting rate: 57.8 (95%CI: 54.2–61.5) × 100 enrolled) were classified as not serious and one (0.2%; reporting rate: 0.13 (0.03–0.75) × 100 enrolled) was classified as serious. Local reactions were the adverse reaction reported most frequently (88%); regarding the serious AEFI, causality assessment excluded the causal link with the administration of the vaccine. All the AEFIs resolved without sequelae. Flucelvax Tetra showed a profile of high safety. Due to their characteristics of greater sensitivity than passive surveillance, active surveillance programs can be useful in defining the safety profiles of a given vaccine/drug in certain population subgroups.

Background Nasal reconstruction is one of the most difficult challenges for the head and neck surgeon, especially in the case of complex full thickness defects following malignant skin tumor resection. Full-thickness defects require demanding multi-step reconstruction. Methods Seven patients underwent surgical reconstruction of full-thickness nasal defects with a bi-pedicled forehead flap shaped appropriately to the defect. Patients were aged between 58 and 86 years, with a mean age of 63.4 years. All of the tumors were excised using traditional surgery, and in 4 of the patients, reconstruction was performed simultaneously following negativity of fresh frozen sections of the margins under general anesthesia. Results Nasal reconstruction was well accepted by all of the patients suffering non-melanoma skin tumors with acceptable cosmetic outcomes. The heart-shaped forehead flap was harvested in cases of subtotal involvement of the nasal pyramid, while smaller defects were reconstructed with a wing-shaped flap. No cartilaginous or osseous support was necessary. Conclusions This bi-pedicled forehead flap was a valid, versatile, and easy-to-implement alternative to microsurgery or multi-step reconstruction. The flap is the best indication for full-thickness nasal defects but can also be indicated for other complex facial defects in the orbital (exenteratio orbitae), zygomatic, and cheek area, for which the availability of a flap equipped with two thick and hairless lobes can be a valuable resource.

BackgroundA thinned anterolateral thigh (ALT) flap is often harvested to achieve optimal skin resurfacing. Several techniques have been described to thin an ALT flap including an adipocutaneous flap, an adipofascial flap and delayed debulking.MethodsBy systematically reviewing all of the available literature in English and French, the present manuscript attempts to identify the common surgical indications, complications and donor site morbidity of the adipofascial variant of the ALT flap. The studies were identified by performing a systematic search on Medline, Ovid, EMBASE, the Cochrane Database of Systematic Reviews, Current Contents, PubMed, Google, and Google Scholar.ResultsThe study selection process was adapted from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and 15 articles were identified using the study inclusion criteria. These articles were then reviewed for author name(s), year of publication, flap dimensions and thickness following defatting, perforator type, type of transfer, complications, thinning technique, number of cases with a particular area of application and donor site morbidity.ConclusionsThe adipofascial variant of the ALT flap provides tissue to fill large defects and improve pliability. Its strong and safe blood supply permits adequate immediate or delayed debulking without vascular complications. The presence of the deep fascia makes it possible to prevent sagging by suspending and fixing the flap for functional reconstructive purposes (e.g., the intraoral cavity). Donor site morbidity is minimal, and thigh deformities can be reduced through immediate direct closure or liposuction and direct closure. A safe blood supply was confirmed by the rate of secondary flap debulking.

BackgroundThe aim of this investigation was to systematically review the current literature to provide the best data for indications, outcomes, survival, and complication rates of pedicled propeller perforator flaps for upper body defects.MethodsA comprehensive literature review for articles published from January 1991 to December 2011 was performed using the PubMed, Medline, and Cochrane Databases. Articles without available full-text, single case reports or papers with excessive missing data were excluded. Papers reporting pedicle-perforator (propeller) flaps used for lower extremity reconstruction were excluded from meta-analysis.ResultsFrom the initial 1,736 studies our search yielded, 343 studies qualified for the second stage of selection. Of 117 full-text reports screened, 41 studies, met the definitive inclusion and exclusion criteria. Of the selected 41 articles, 26 were case series, original papers or retrospective reviews and were included, whereas 15 were case report papers and therefore were excluded. Two hundred ninety-five propeller flaps were reported to have been used in a total of 283 patients. Indications include repair of trauma-induced injuries, post-trauma revision surgery, cancer resection, chronic infection, pressure sores, and chronic ulcers with a major complication rate (3.3%) comparable to that of free flaps. No specific exclusion criteria for the procedure were presented in the studies reviewed.ConclusionsPedicled propeller flaps are a versatile and safe reconstructive option that are easy and quick to raise and that provide unlimited clinical solutions because of the theoretical possibility of harvesting them based on any perforator chosen among those classified in the body.

Background:The aim of research was to study spiral family implant by finite element analysis (FEA) inserted in different bone qualities connected with abutments of different angulations. Methods:The biomechanical behaviour of 4.2 × 13 mm dental implants, connecting screw, straight and 15° and 25° angulated abutments subjected to static loads, in contact with high and poor bone qualities was evaluated by FEA. Results: The lowest stress value was found in the system composed by implants and straight abut-ments loaded with a vertical force, while the highest stress value was found in implants with 15° angulated abutment loaded with an angulated force. In addition, we found the lower the bone quality, the higher the distribution of the stress within the bone. Conclusion: Spiral family implants can be used successfully in low bone quality but applying a straight force is recommended.

Background: Orbital blowout fractures can be managed by several surgical specialties including plastic and maxillofacial surgery, otolaryngology, and ophthalmology. Recommendations for surgical fracture repair depend on a combination of clinical and imaging studies to evaluate muscle/nerve entrapment and periorbital tissue herniation. Methods: The aim of this study was to verify the applicability of regional anesthesia when repairing orbital floor fractures. A retrospective chart review was performed for isolated orbital floor fractures treated at the Department of Maxillofacial Surgery in Florence between May 2011 and July 2012. The study included 135 patients who met the inclusion criteria: 96 subjects were male (71%) and 39 were female (29%). The mean age was 45.3 years, ranging from 16 to 77 years. Results: The results revealed that isolated anterior orbital floor fractures can be safely repaired under regional and local anesthesia. Regional and local anesthesia should be combined with intravenous sedation when the fracture involves the posterior floor. The surgical outcome was comparable to the outcome achieved under general anesthesia. There was a lower rate of surgical revisions due to concealed malposition or entrapment of the inferior rectus muscle (19% vs 22%). However, this result was not statistically significant (P > 0.05). Conclusions: There are several advantages to surgically repairing isolated orbital floor fractures under regional and local anesthesia that include the following: surgeons can check the surgical outcome (enophthalmos and extrinsic ocular muscles function) intraoperatively, thereby reducing the reoperation rate; patient discomfort due to general anesthesia is eliminated; and the hospital stay is reduced, thus decreasing overall healthcare costs.