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Assessment of genetically modified maize MON 89034 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-015)
Following the submission of application EFSA-GMO-RX-015 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA, the EFSA Panel on Genetically Modified Organisms (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant genetically modified maize MON 89034, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 89034 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-015 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034
Shock wave lithotripsy for a renal stone in a tetraplegic patient as a trigger for life-threatening posterior reversible encephalopathy syndrome
Shock wave lithotripsy (SWL) is considered a non-invasive treatment for urinary stones and usually advocated for frail patients with spinal cord injury (SCI). We report a life-threatening complication, called posterior reversible encephalopathy syndrome (PRES), in a tetraplegic person who underwent SWL for a small renal stone. Based on our experience, we recommend performing SWL with caution in SCI patients and in tertiary referral hospitals that can promptly manage similar severe complications
Safety and efficacy of the maximum tolerated dose of givinostat in polycythemia vera: a two-part Phase Ib/II study
Squeezing Phase Diffusion
We address the use of optical parametric oscillator (OPO) to counteract phase diffusion, and demonstrate phase-noise reduction for coherent signals traveling through a suitably tuned OPO. In particular, we theoretically and experimentally show that there is a threshold value on the phase noise, above which OPO can be exploited to "squeeze" phase noise. The threshold depends on the energy of the input coherent state, and on the relevant parameters of the OPO, i.e., gain and input-output and crystal loss rates
Structural requirements of benzofuran derivatives dehydro-δ-and dehydro-ε-viniferin for antimicrobial activity against the foodborne pathogen listeria monocytogenes
In a recent study, we investigated the antimicrobial activity of a collection of resveratrol-derived monomers and dimers against a series of foodborne pathogens. Out of the tested molecules, dehydro-\u3b4-viniferin and dehydro-\u3b5-viniferin emerged as the most promising derivatives. To define the structural elements essential to the antimicrobial activity against the foodborne pathogen L. monocytogenes Scott A as a model Gram-positive microorganism, the synthesis of a series of simplified benzofuran-containing derivatives was carried out. The systematic removal of the aromatic moieties of the parent molecules allowed a deeper insight into the most relevant structural features affecting the activity. While the overall structure of compound 1 could not be altered without a substantial loss of antimicrobial activity, the structural simplification of compound 2 (minimal inhibitory concentration (MIC) 16 \u3bc\ub5g/mL, minimal bactericidal concentration (MBC) >512 \u3bc\ub5g/mL) led to the analogue 7 with increased activity (MIC 8 \u3bc\ub5g/mL, MBC 64 \u3bc\ub5g/mL)
Berberine and Tinospora cordifolia exert a potential anticancer effect on colon cancer cells by acting on specific pathways
Berberine (BBR) is a natural active principle with potential antitumor activity. The compound targets multiple cell signaling pathways, including proliferation, differentiation, and epithelial\u2013mesenchymal transition. The aim of this study was to elucidate the mechanisms behind the anticancer activity of BBR by comparing the effects of purified BBR with those of the extract of Tinospora cordifolia, a medicinal plant that produces this metabolite. The expression levels of a panel of 44 selected genes in human colon adenocarcinoma (HCA-7) cell line were quantified by real-time polymerase chain reaction (PCR). BBR treatment resulted in a time- and dose-dependent down regulation of 33 genes differently involved in cell cycle, differentiation, and epithelial\u2013mesenchymal transition. The trend was confirmed across the two types of treatment, the two time points, and the different absolute dosage of BBR. These findings suggest that the presence of BBR in T. cordifolia extract significantly contributes to its antiproliferative activity
Effect of body mass and physical activity at younger age on the risk of prostatic enlargement and erectile dysfunction : Results from the 2018 #Controllati survey
Objective: Overweight and low physical activity (PA) increase the risk of prostatic enlargement and erectile dysfunction (ED). Less clear is the role of these factors at young age on the lifelong risk. Materials and methods: During June 2018 the Italian Society of Urologists organized the month of Male Urologic Prevention "#Controllati". Men aged 18 years or more were invited to attend urologic centers for a visit and counselling about urologic/andrologic conditions. Each participating man underwent a physical examination and was asked about urologic symptoms, sexual activity and possible related problems. Results: We analyzed data from 2786 men, aged 55.1 years (SD 10.9, range 19-97). A total of 710 (25.5%) subjects had a diagnosis of prostatic enlargement and 632 (22.7%) of DE. Overweight/obese men were at increased risk of prostatic enlargement and ED with corresponding odds ratio (0R) in comparison with normal or underweight men, being respectively 1.18 (95% Confidence Interval (CI) 1.00-1.44) and 1.69 (95% CI 1.39-2.05). The OR of prostatic enlargement in comparison with men reporting at age 25 a BMI < 25.0 was 1.22 (95% CI 1.01-1.51) for men with a BMI at 25 years of age 65 25; the corresponding OR value for ED was 1.17 (0.92- 1.48). Considering total PA at diagnosis, the OR of prostatic enlargement in comparison with no or low PA, was 0.69 (95%CI 0.55-0.86) for men reporting moderate PA and 0.75 (95%CI 0.58-0.98) for those reporting intense PA. When we considered PA at 25 years of age, the OR of subsequent diagnosis of prostatic enlargement, in comparison with men reporting no/low PA at 25 years of age was 0.81 (95%CI 0.63-1.04) for men reporting moderate PA and 0.70 (95%CI 0.52-0.99) for those reporting intense PA. Conclusions: These findings underline the utility of encouraging healthy lifestyle habits among young men in order to reduce the subsequent risk of prostatic enlargement and ED
Mechanical transients initiated by ramp stretch and release to P0 in frog muscle fibers
Single fibers from the tibialis muscle of Rana temporaria were subjected to ramp stretches during tetanic stimulation at a sarcomere length of ~2 \u3bcm. Immediately after the stretch, or after different time delays, the active fiber was released against a constant force equal to the isometric force (P0) exerted immediately before the stretch. Four phases were detected after release: 1) an elastic recoil of the fiber's undamped elements, 2) a transient rapid shortening, 3) a marked reduction in the velocity of shortening (often to 0), and 4) an apparently steady shortening (sometimes absent). Increasing the amplitude of the stretch from ~2 to 10% of the fiber rest length led to an increase in phase 2 shortening from ~5 to 10 nm per half-sarcomere. Phase 2 shortening increased further (up to 14 nm per half-sarcomere) if a time interval of 5-10 ms was left between the end of large ramp stretches and release to P0. After 50- to 100-ms time intervals, shortening occurred in two steps of ~5 nm per half-sarcomere each. These findings suggest that phase 2 is due to charging, during and after the stretch, of a damped element, which can then shorten against P0 in at least two steps of ~5 nm/half sarcomere each
Blinatumomab compared with standard of care for the treatment of adult patients with relapsed/refractory Philadelphia chromosome–positive B-precursor acute lymphoblastic leukemia
Background: A single-arm, phase 2 trial demonstrated the efficacy and safety of blinatumomab, a bispecific T-cell\u2013engaging antibody construct, in patients with relapsed/refractory (r/r) Philadelphia chromosome\u2013positive (Ph+) acute lymphoblastic leukemia (ALL), a rare hematologic malignancy with limited treatment options. This study compared outcomes with blinatumomab with those of a historical control treated with the standard of care (SOC). Methods: The blinatumomab trial enrolled adult patients with Ph+ ALL who were r/r to at least 1 second-generation tyrosine kinase inhibitor (n = 45). Propensity score analysis (PSA) was used to compare outcomes with blinatumomab with those of an external cohort of similar patients receiving SOC chemotherapy (n = 55). The PSA mitigated confounding variables between studies by adjusting for imbalances in the age at diagnosis and start of treatment, sex, duration from diagnosis to most recent treatment, prior allogeneic hematopoietic stem cell transplantation, prior salvage therapy, and number of salvage therapies. Bayesian data augmentation was applied to improve power to 80% with data from a phase 3 blinatumomab study in r/r Philadelphia chromosome\u2013negative ALL. Results: In the PSA, the rate of complete remission or complete remission with partial hematologic recovery was 36% for blinatumomab and 25% for SOC, and this resulted in an odds ratio of 1.54 (95% confidence interval [CI], 0.61-3.89) or 1.70 (95% credible interval [CrI], 0.94-2.94) with Bayesian data augmentation. Overall survival favored blinatumomab over SOC, with a hazard ratio of 0.81 (95% CI, 0.57-1.14) or 0.77 (95% CrI, 0.61-0.96) with Bayesian data augmentation. Conclusions: These results further support blinatumomab as a treatment option for patients with r/r Ph+ ALL