103 research outputs found

    GC/MS analysis of morning glory seeds freely in commerce: can they be considered "herbal highs"?

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    Abstract Background The so-called "herbal highs" are substances derived from natural plants with effects on the central nervous system. Lisergamide, ergine or LSA is the basis of different types of drugs, which are in seeds of Ipomoea violacea, also known as Morning Glory, and other seeds. In our study we analysed the presence of lysergic acid amide (LSA) in seeds of Ipomoea violacea seized by the Italian Police, in others purchased through the Internet, and in other varieties of Ipomoea sold for ornamental purposes, to assess whether the actual consumption of ornamental seeds could contain hallucinogenic doses of LSA. Methods The analyses were conducted at the Laboratory of Forensic Toxicology of the Section of Legal Medicine of the University of Perugia, using GC/MSD system. For analysis, 300 mg of seeds (~8 seeds) from each specimen were chosen. Results Analysis revealed that 300 mg of Ipomoea violacea seeds resulting from police seizures, equivalent to approximately 8 seeds, contained a percentage of LSA equal to 0.062%. This finding is in agreement with what was indicated in literature, as the ingestion of 250 seeds would lead to a dose of approximately 6 mg of LSA, capable of provoking hallucinogenic effects. The analysis of 300 mg of Ipomoea Rubrocerulea seeds bought on the commercial marketdetected an average concentration of LSA of 0.011%. The Ipomoea mix contained a concentration of LSA about 10 times lower than that of seized Morning Glory seeds. Conclusion Seeds bought on the commercial market contained doses of LSA capable of provoking hallucinogenic effects. In the absence of data on the toxicity resulting from the ingestion of seeds for ornamental purposes, we believe that further research on the actual safety of ornamental seeds is necessary

    Negative pressure wound therapy versus healing by secondary intention in pressure ulcers

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    Pressure ulcers are a highly prevalent source of morbidity with an equally high incidence of up to 38.0\% amongst different categories of healthcare institutions. Therefore, the management and therapeutic approach toward these often hospital- or facility-acquired problems remain critical aspects of long-term care. Negative pressure wound therapy (NPWT) has proven effective in addressing the barriers to pressure ulcer healing including increasing blood flow to previously ischemic wound areas by generating subatmospheric pressure which vacuums in circulation. The objective of this study was to compare negative pressure wound therapy (NPWT) versus surgical wounds healing by secondary intention (SWHSI). A systematic literature search was conducted using the PubMed and Scopus search engine up until the 20 Th January 2017 including the terms: "negative pressure wound therapy" and "pressure ulcers". In this systematic review, six randomized controlled trials were included. NPWT is deemed appropriate and effective method and widely used by clinicians to promote the healing of wounds and ulcers of different etiology. The heterogeneity found in individual trials regarding the inclusion criteria, therapeutic procedures, the criteria and methods of outcome evaluation, however, did not allow for a data evaluation with statistically valid conclusions. It is reasonable to assume that their subset of patients with pressure ulcers that can be effectively treated with NPWT, with optimal results and good cost-benefit ratio, also with respect to the quality of life

    Ilioinguinal nerve neurectomy is better than preservation in lichtenstein hernia repair. A systematic literature review and meta-analysis

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    Objective This study aimed to evaluate the incidence of chronic groin pain (primary outcome) and alterations of sensitivity (secondary outcome) after Lichtenstein inguinal hernia repair, comparing neurectomy with ilioinguinal nerve preservation surgery. Summary background data The exact cause of chronic groin postoperative pain after mesh inguinal hernia repair is usually unclear. Section of the ilioinguinal nerve (neurectomy) may reduce postoperative chronic pain. Methods We followed PRISMA guidelines to identify randomized studies reporting comparative outcomes of neurectomy versus ilioinguinal nerve preservation surgery during Lichtenstein hernia repairs. Studies were identified by searching in PubMed, Scopus, and Web of Science from April 2020. The protocol for this systematic review and meta-analysis was submitted and accepted from PROSPERO: CRD420201610. Results In this systematic review and meta-analysis, 16 RCTs were included and 1550 patients were evaluated: 756 patients underwent neurectomy (neurectomy group) vs 794 patients underwent ilioinguinal nerve preservation surgery (nerve preser- vation group). All included studies analyzed Lichtenstein hernia repair. The majority of the new studies and data comes from a relatively narrow geographic region; other bias of this meta-analysis is the suitability of pooling data for many of these studies. A statistically significant percentage of patients with prosthetic inguinal hernia repair had reduced groin pain a 6 months after surgery at 8.94% (38/425) in the neurectomy group versus 25.11% (113/450) in the nerve preservatio group [relative risk (RR) 0.39, 95% confidence interval (CI) 0.28–0.54; Z = 5.60 (P 0.00001)]. Neurectomy did no significantly increase the groin paresthesia 6 months after surgery at 8.5% (30/353) in the neurectomy group versu 4.5% (17/373) in the nerve preservation group [RR 1.62, 95% CI 0.94–2.80; Z = 1.74 (P = 0.08)]. At 12 months afte surgery, there is no advantage of neurectomy over chronic groin pain; no significant differences were found in th 12-month postoperative groin pain rate at 9% (9/100) in the neurectomy group versus 17.85% (20/112) in the inguina nerve preservation group [RR 0.50, 95% CI 0.24–1.05; Z = 1.83 (P = 0.07)]. One study (115 patients) reported dat about paresthesia at 12 months after surgery (7.27%, 4/55 in neurectomy group vs. 5%, 3/60 in nerve preservatio group) and results were not significantly different between the two groups [RR 1.45, 95% CI 0.34, 6.21;Z = 0.5 (P = 0.61)]. The subgroup analysis of the studies that identified the IIN showed a significant reduction of the 6th mont evaluation of pain in both groups and confirmed the same trend in favor of neurectomy reported in the previous overal analysis: statistically significant reduction of pain 6 months after surgery at 3.79% (6/158) in the neurectomy grou versus 14.6% (26/178) in the nerve preservation group [RR 0.28, 95% CI 0.13–0.63; Z = 3.10 (P = 0.002)]. Conclusion Ilioinguinal nerve identification in Lichtenstein inguinal hernia repair is the fundamental step to reduce or avoid postoperative pain. Prophylactic ilioinguinal nerve neurectomy seems to offer some advantages concerning pain in the first 6th month postoperative period, although it might be possible that the small number of cases contributed to the insignificancy regarding paresthesia and hypoesthesia. Nowadays, prudent surgeons should discuss with patients and their families the uncertain benefits and the potential risk of neurectomy before performing the hernioplasty

    BRCA1 and BRCA2 mutations in central and southern Italian patients.

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    Protein truncation test (PTT) and single-strand conformation polymorphism (SSCP) assay were used to scan the BRCA1 and BRCA2 genes in 136 unrelated Italian breast/ovarian cancer patients. In the sample tested, BRCA1 and BRCA2 equally contributed to site-specific breast cancer patients who reported one to two breast cancer-affected first-/ second-degree relative(s) or who were diagnosed before age 40 years in the absence of a family history of breast/ovarian cancer. BRCA1 and BRCA2 mutations were mostly found in patients with disease diagnosis before and after age 50 years, respectively. Moreover, in cases with familial clustering of site-specific breast cancer, BRCA1 mostly accounted for tumours diagnosed before age 40 years and BRCA2 for tumours diagnosed after age 50 years. The BRCA1 and BRCA2 mutation spectrum was consistent with a lack of significant founder effects in the sample of patients studied

    BRCA1 and BRCA2 mutations in central and southern Italian patients

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    INTRODUCTION: Germline BRCA1 and BRCA2 mutations account for most hereditary breast/ovarian cancers and are associated with male breast cancer. Furthermore, constitutional mutations in these genes may occur in breast/ovarian cancer patients that do not meet stringent criteria of autosomal-dominant predisposition. The relevance of BRCA1 and BRCA2 mutations in such patients is still debated. OBJECTIVES: We sought to determine the impact of BRCA1 and BRCA2 mutations in a population of patients from central and southern Italy. We analyzed the BRCA1 and BRCA2 coding regions in 136 unrelated probands: 117 females with breast/ovarian cancer and 19 males with breast cancer. This population of patients was mostly representative of cases who are at risk for hereditary susceptibility, but who do not meet stringent criteria of autosomal-dominant predisposition. METHODS: Probands, subclassified as follows, were consecutively recruited depending on informed consent from patients attending breast cancer clinics in Rome and Naples. Selection criteria for females were as follows: breast cancer with breast cancer family history [one to two first-/second-degree relative(s), n = 55]; breast cancer diagnosed before age 40 years (no breast/ovarian cancer family history, n = 28); bilateral breast cancer (regardless of age and family history, n =10); breast cancer associated with gastrointestinal, pancreatic or uterine cancers [synchronous/metachronous or in first-degree relative(s), n = 9]; breast or ovarian cancer with family history of breast-ovarian/ovarian cancer (at least 1 first-/ second-degree relative, n = 10); and ovarian cancer with no breast/ovarian cancer family history (n = 5). Males with breast cancer were recruited regardless of age and family history. BRCA1 exon 11 and BRCA2 exons 10 and 11 were screened by PTT. Coding BRCA1 exons 2, 3, 5-10 and 12-24 and BRCA2 exons 2-9 and 12-27 were screened by SSCP. Primers are listed in Table 1. In 27 cases, analyzed by PTT along the entire BRCA1 coding sequence, BRCA1 SSCP analysis was limited to exons 2, 5, 20 and 24. Mutations were verified by sequence analysis on two independent blood samples. RESULTS: Deleterious germline BRCA1/BRCA2 mutations were detected in 11 out of 136 cases (8%). Only three BRCA2 mutations were novel. One BRCA2 mutation recurred in two unrelated probands. Table 2 shows the mutations and data concerning carriers and their families. Table 3 shows correlations between BRCA1/BRCA2 mutations and sex, age at disease diagnosis and familial clustering of breast/ovarian cancer in the total patient population. Table 4 shows the proportions of BRCA1 and BRCA2 mutations in females with site-specific breast and breast-ovarian/ovarian cancer. Table 5 shows the frequency of BRCA1/BRCA2 mutations in males. BRCA1 and BRCA2 mutations, respectively, accounted for four out of 68 (6%) and one out of 68 (1%) cases diagnosed before age 50 years, and for one out of 68 (1%) and five out of 68 (7%) cases diagnosed after age 50 years. BRCA1 mutations were found in five out of 117 females (4%) and in none of 19 males (0%), and BRCA2 mutations were found in four out of 117 females (3%) and in two out of 19 males (10%). The proportions of BRCA1 and BRCA2 mutations coincided in site-specific female breast cancers (four out of 102; ie 4% each). BRCA1 and BRCA2 equally contributed to female breast cancers, with no familial clustering in those diagnosed before age 40 years (one out of 28; 4% each), and to female breast cancers, all ages, with familial clustering in one to two relatives (three out of 55; ie 5% each). In the latter subset of cases, BRCA1 mostly accounted for tumours diagnosed before age 40 years (two out of eight; 25%), and BRCA2 for tumours diagnosed after age 50 years (three out of 34; 9%). Regardless of family history, the respective contributions of BRCA1 and BRCA2 to site-specific female breast cancers diagnosed before age 40 years were 8% (three out of 36) and 3% (one out of 36). One BRCA1 mutation was detected among the 15 female probands from breast-ovarian/ovarian cancer families (7%). Among male breast cancers, BRCA2 mutations were identified in one out of five (20%) cases with family history and in one out of 14 (7%) apparently sporadic cases. No BRCA1 or BRCA2 mutations were found in female probands with nonfamilial bilateral breast cancer (10 cases) or in those with breast cancer associated with gastrointestinal, pancreatic or uterine cancers, synchronous/metachronous or in first-degree relative(s) (nine cases). These cases were all diagnosed after age 40 years. DISCUSSION: Our results indicate a lack of relevant founder effects for BRCA1- and BRCA2-related disease in the sample of patients studied, which is consistent with other Italian studies and with ethnical and historical data. Overall, the contribution of BRCA1 and BRCA2 to breast/ovarian cancer in Italian patients appears to be less significant than in patients from communities with founder mutations. The present study is in agreement with direct estimates on other outbred populations, indicating that 7-10% of all female breast cancers that occur in patients aged under 40 years are due to BRCA1/BRCA2. We found that BRCA1 and BRCA2 equally contributed to site-specific breast cancers who had one/two breast cancer-affected first-/second-degree relative(s) or who were diagnosed within age 40 years in the absence of family history. This is consistent with recent data that indicated that the respective frequencies of BRCA1 and BRCA2 mutations are comparable in early onset breast cancer. Considering the total population of patients analyzed here, however, BRCA1 and BRCA2 mutations were mostly found in cases with disease diagnosis before and after age 50 years, respectively. Moreover, in cases with familial clustering of site-specific breast cancer, BRCA1 mostly accounted for tumours diagnosed before age 40 years, and BRCA2 for tumours diagnosed after age 50 years. This is in agreement with a trend, which has been observed in other populations, for the proportion of cases with BRCA2 mutations to increase, and the proportion with mutations in BRCA1 to decrease, as the age at cancer onset increases. As in other studies, the frequency of BRCA1/BRCA2 mutations taken together was lower than the estimated frequencies at comparable ages for all susceptibility alleles derived from the Contraceptive and Steroid Hormones (CASH) study. The discrepancy between direct data deriving from BRCA1/BRCA2 mutational analysis and CASH estimates could be due to several factors, including contribution of gene(s) other than BRCA1/BRCA2, differences between populations and relative insensitivity of mutational screening. Only BRCA1 mutations were found in breast/ovarian and site-specific ovarian cancer families. BRCA2, but not BRCA1 mutations were found in the male breast cancers. The overall proportion of males with BRCA2 mutations was high when compared with data from other studies on outbred populations, but was low compared with data from populations with founder effects. The present results should be regarded as an approximation, because the following types of mutation are predicted to escape detection by the screening strategy used: mutations in noncoding regions; missense mutations within BRCA1 exon 11 and BRCA2 exons 10 and 11; large gene deletions; and mutations within the first and last 180 nucleotides of the amplicons analyzed by PTT

    Effectiveness of Radiomic ZOT Features in the Automated Discrimination of Oncocytoma from Clear Cell Renal Cancer

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    Background: Benign renal tumors, such as renal oncocytoma (RO), can be erroneously diagnosed as malignant renal cell carcinomas (RCC), because of their similar imaging features. Computer-aided systems leveraging radiomic features can be used to better discriminate benign renal tumors from the malignant ones. The purpose of this work was to build a machine learning model to distinguish RO from clear cell RCC (ccRCC). Method: We collected CT images of 77 patients, with 30 cases of RO (39%) and 47 cases of ccRCC (61%). Radiomic features were extracted both from the tumor volumes identified by the clinicians and from the tumor’s zone of transition (ZOT). We used a genetic algorithm to perform feature selection, identifying the most descriptive set of features for the tumor classification. We built a decision tree classifier to distinguish between ROs and ccRCCs. We proposed two versions of the pipeline: in the first one, the feature selection was performed before the splitting of the data, while in the second one, the feature selection was performed after, i.e., on the training data only. We evaluated the efficiency of the two pipelines in cancer classification. Results: The ZOT features were found to be the most predictive by the genetic algorithm. The pipeline with the feature selection performed on the whole dataset obtained an average ROC AUC score of 0.87 ± 0.09. The second pipeline, in which the feature selection was performed on the training data only, obtained an average ROC AUC score of 0.62 ± 0.17. Conclusions: The obtained results confirm the efficiency of ZOT radiomic features in capturing the renal tumor characteristics. We showed that there is a significant difference in the performances of the two proposed pipelines, highlighting how some already published radiomic analyses could be too optimistic about the real generalization capabilities of the models

    Position statement on the Joint ITA–NIST–USPTO collaboration initiative regarding standards : notice of public listening and request for comments

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    On 11th September 2023, the US Patent and Trademark Office (USPTO), the International Trade Administration (ITA), and the National Institute for Standards and Technology (NIST) called for stakeholder input on the current state of U.S. firm participation in standard-setting, and the ability of U.S. industry to readily adopt standards to grow and compete, especially as they relate to the standardisation of critical and emerging technologies. The Centre for a Digital Society (CDS) of the European University Institute (EUI) is thankful for the opportunity to offer its comments. We would like to express our view on the legislative proposal of the European Commission (EC) for a Regulation on Standard Essential Patents (hereinafter, the Regulation) as it relates to question no. 1 of the Request for Comments on the impact of foreign IPR policies on US leadership and participation in international standard setting. Furthermore, concerning question no. 9 on possible standard-essential patents (SEP) transparency measures, we highlight the possibility of improving the USPTO patent register already in place

    Position statement on the European Commission’s proposal for a SEPs regulation

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    On 27th April 2023, the European Commission published a proposal for a Regulation on Standard Essential Patents (hereinafter, SEPs Regulation) and allowed the public to provide feedback. The Centre for a Digital Society (CDS) of the European University Institute (EUI) is thankful for the opportunity to offer its comments and make suggestions on the proposed Regulation. Our team of researchers has significant research, policy and training experience in the areas of intellectual property, telecommunications regulation, standardisation and EU competition policy. In this Position Statement, we caution against adopting the proposed SEPs Regulation in its current form and suggest adopting guidance under Arts. 101 and 102 TFEU to clarify how SEP licensing should occur not to breach EU competition law. In the sub-optimal scenario where EU institutions would continue to pursue an immediate regulatory intervention, we provide substantial suggestions in an attempt to improve the current proposal of SEPs Regulation and limit certain negative consequences. Our constructive criticism aims to be a catalyst for the debate in the legislative process about the appropriate SEP licensing framework
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