Some studies observed a benefit of Parkinson's disease (PD) patients after treatment with safinamide in some non-motor symptoms (NMSs). The aim of this study was to analyze the effectiveness of ...safinamide on NMS burden in PD. SAFINONMOTOR (an open-label study of the effectiveness of safinamide on non-motor symptoms in Parkinson's disease patients) is a prospective open-label single-arm study conducted in five centers from Spain. The primary efficacy outcome was the change from baseline (V1) to the end of the observational period (6 months) (V4) in the non-motor symptoms scale (NMSS) total score. Between May/2019 and February/2020 50 patients were included (age 68.5 ± 9.12 years; 58% females; 6.4 ± 5.1 years from diagnosis). At 6 months, 44 patients completed the follow-up (88%). The NMSS total score was reduced by 38.5% (from 97.5 ± 43.7 in V1 to 59.9 ± 35.5 in V4;
< 0.0001). By domains, improvement was observed in sleep/fatigue (-35.8%;
= 0.002), mood/apathy (-57.9%;
< 0.0001), attention/memory (-23.9%;
= 0.026), gastrointestinal symptoms (-33%;
= 0.010), urinary symptoms (-28.3%;
= 0.003), and pain/miscellaneous (-43%;
< 0.0001). Quality of life (QoL) also improved with a 29.4% reduction in the PDQ-39SI (from 30.1 ± 17.6 in V1 to 21.2 ± 13.5 in V4;
< 0.0001). A total of 21 adverse events in 16 patients (32%) were reported, 5 of which were severe (not related to safinamide). Dyskinesias and nausea were the most frequent (6%). Safinamide is well tolerated and improves NMS burden and QoL in PD patients with severe or very severe NMS burden at 6 months.
Background and objective: Pain is a frequent and disabling symptom in Parkinson’s disease (PD) patients. Our aim was to analyze the effectiveness of safinamide on pain in PD patients from the ...SAFINONMOTOR (an open-label study of the effectiveness of SAFInamide on NON-MOTOR symptoms in Parkinson´s disease patients) study. Material and Methods: SAFINONMOTOR is a prospective open-label single-arm study conducted in five centers from Spain. In this analysis, a secondary objective of the study, the score in the KPPS (King´s Parkinson´s Disease Pain Scale) at V1 (baseline) and V4 (6 months ± 1 month) were compared. Wilcoxon´s rank sum test was performed to test the changes from V1 to V4. Results: Forty-four (88%) out of 50 PD patients (age 68.5 ± 9.12 years; 58% women; 6.4 ± 5.1 years from diagnosis) completed the study. The KPPS total score was reduced by 43.6% (from 40.04 ± 36.18 in V1 to 22.60 ± 21.42 in V4; p < 0.0001). By domains, improvement was observed in musculoskeletal (−35.9%; p = 0.009), fluctuation-related (−51.7%; p = 0.020), nocturnal (−46.1%; p = 0.001), discoloration and/or edema/swelling (−50.4%; p = 0.009) and radicular pain (−40.1%; p = 0.048). A total of 21 adverse events in 11 patients (22%) were reported, five being severe, but not related to safinamide. Conclusion: Safinamide is well tolerated and improves pain in PD patients at 6 months. Future studies are necessary to analyze the possible beneficial effect of safinamide on pain in PD patients.
Our main objective was to determine the evolution of IgG and IgA antibodies directed against SARS-CoV-2 protein S in the blood of lactating women and in breast milk.
A cohort of 110 uninfected and ...vaccinated breastfeeding women was followed-up for 6 months at the Marqués de Valdecilla University Hospital, Spain, in 2020. An additional group of 23 breastfeeding mothers who had no previously documented infection and had not been vaccinated against SARS-CoV-2 were included as a control group. The antibodies in blood and breast milk and their evolution at 6 months post-vaccination were analysed.
One hundred ten breastfeeding mothers were included; 70 women (63.6%) were vaccinated with two doses of BNT162b2, 20 women (18.2%) received two doses of mRNA-1273, and 20 women (18.2%) received a single dose of ChAdOx1-S. No evidence of differences between concentrations of antibodies was found according to the type of vaccine, with the exception of serum IgA antibodies, which was higher in women vaccinated with mRNA-1273: mean 95%CI: 0.05 AU/mL 0.03,0.06 with mRNA-1273, 0.02 AU/mL 0.01,0.03 with BNT162b2 and 0.01 AU/mL 0.00,0.03 with ChAdOx1-S, ANOVA p value = 0.03. The lack of difference between vaccines was also found when anti-S1 specific IgG in serum and breast milk were measured.
In lactating women vaccinated against COVID-19, anti-SARS-CoV-2 antibodies can be detected in both serum and breastmilk 6 months after receiving the second dose, although their concentrations decreased when compared with concentrations reached immediately after vaccination.
The fabrication of three-dimensional (3D) nanostructures within optical materials is currently a highly sought-after capability. Achieving nanoscale structuring of media within its inner volume in 3D ...and with free design flexibility, high accuracy and precision is a development yet to be demonstrated. In this work, a 3D laser nanolithography technique is developed which allows producing mm-long hollow nanopores inside solid-state laser crystals and with a high degree of control of pore cross-sectional aspect ratio and size. We report an in-depth study on the formation of pores both within the non-thermal regime at which temperature is fast dissipated after each laser pulse, and for a thermally controlled regime using pulse-bursts which facilitate the formation of pores with highly circular shapes down to 1.1. We demonstrate this process for a wide range of speeds, pulse repetition rates and pulse energies, thus opening the door to a much more useful nanofabrication technique for nanophotonics. Finally, we also report the change in index of refraction that is produced at the nanoscale obtaining a positive index contrast of ∼3%. The work therefore provides a promising path towards reliable 3D nanostructuring of solid-state laser media for the flexible fabrication of large and complex structures with features sizes from the nanoscale up to the mm-scale. Moreover, due to the embedded, seamless, and monolithic nature of this technology, and since YAG crystals can sustain temperatures of up to 1900 °C and are highly chemically inert and erosion resistant, we anticipate its direct application in harsh environments.
Depression is frequent in Parkinson’s disease (PD) patients, but the evidence for many antidepressant agents to treat it in PD is insufficient. The aim of the present prospective open-label ...single-arm study (VOPARK, an open-label study of the effectiveness and safety of VOrtioxetine in PARKinson’s disease patients with depression) was to analyze the effectiveness of vortioxetine on depressive symptoms in PD patients with major depression. The primary efficacy outcome was the change from baseline (VB) at the end of the observational period (12 weeks ± 14 days; V12w) in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score. At VB, all patients had a HAM-D17 total score ≥16. A total of 30 patients (age 66.23 ± 10.27; 73.3% males) were included between February 2021 (first patient, 12/FEB/21) and March 2022 (last patient, 14/MAR/22). At 12 weeks, 27 patients completed the follow-up (90%). The total HAM-D17 total score was reduced by 52.7% (from 21.5 ± 4.75 at VB to 10.44 ± 7.54 at V12w; Cohen’s effect size = −2.5; p < 0.0001) and the response and remission rates were 50% and 43.3%, respectively. Apathy (Apathy Scale; p < 0.0001), cognition (PD-Cognitive Rating Scale; p = 0.007), fatigue (Fatigue Severity Scale; p = 0.014), and quality of life (PDQ-39 (p = 0.001) and EUROHIS-QOL8 (p < 0.0001)) improved at 3 weeks as well. A total of 11 adverse events in 10 patients (33.3%) were reported, one of which was severe (vomiting related to vortioxetine with full recovery after drug withdrawal). Vortioxetine was safe and well tolerated and improved depressive symptoms and other non-motor symptoms in PD patients.
•Polygenic risk score was computed for alcohol consumption (drinks per week).•PCA applied to nine psychiatric PRS to estimate the general psychopatology factor (polygenic p).•Both risk scores ...associated with alcohol dependence, contributing additively to risk.•The polygenic p remains associated in the subset of non-comorbid patients.•The polygenic p is mainly manifested as alcohol dependence in some patients.
High alcohol consumption and alcohol dependence are only partly genetically correlated and they differ considerably in their correlations with other traits. The existence of genetic correlation among alcohol dependence and psychiatric disorders may be attributed to the presence of a general psychopathology factor, the p factor. This study investigates the relationship of polygenic risk to general psychopathology and to high alcohol consumption on alcohol dependence.
Participants were 524 alcohol-dependent patients and 729 controls. Polygenic risk scores (PRS) were computed for alcohol consumption (drinks per week) and nine psychiatric disorders. Principal component analysis (PCA) applied to the psychiatric PRS was used to calculate the first principal component as a proxy of the polygenic p factor.
Both the polygenic p factor and the drinks per week PRS were associated with alcohol dependence in our sample. Both variables are only weakly correlated, contributing additively to the risk for alcohol dependence. Sensitivity analyses showed that the polygenic p factor was also associated with alcohol dependence in the subset of patients without any psychiatric or substance use comorbidity.
Polygenic risk for alcohol dependence can be split at least into two components, involved in general psychopathology and high alcohol consumption. The first component of PCA based on PRS for different psychiatric disorders allows estimation of the contribution of the polygenic p factor to alcohol dependence. The pleiotropic effects of genetic variants across psychiatric disorders are mainly manifested as alcohol dependence in some patients.
Breastfeeding mothers were excluded from the clinical trials conducted for vaccines against SARS-CoV-2. Since the start of the vaccination, some doubts have arisen regarding its compatibility with ...breastfeeding. The aim of this study was to analyse the presence of anti-SARS-CoV-2 antibodies in breast milk and serum (IgG and IgA) of vaccinated breastfeeding women. The main variables of the observational study were: adverse related events after vaccination and determination of the presence of IgG and IgA isotypes antibodies in serum and in breast milk of vaccinated women against the SARS-CoV-2 antigens. Results: 110 breastfeeding mothers were included; 70 women (63.6%) were vaccinated with two doses of BNT162b2, 20 women (18.2%) with two doses of mRNA-1273, and 20 women (18.2%) with a single dose of ChAdOx1-S. Regarding adverse reactions and vaccine safety, 38 women had no adverse reactions; 20 (18.2%) had general malaise or adenopathies; 10 (9.1%) had a headache; and 7 (6.4%) had fever. When analysing IgG antibodies, significantly higher levels of antibodies were found in serum and breast milk from mothers vaccinated with BNT162b2 or mRNA-1273 vs. ChAdOx1-S (p < 0.001 and p = 0.001, respectively). Analysing IgA antibodies, significant differences were found when comparing mean values in serum from mothers vaccinated with BNT162b2 or mRNA-1273 vs. ChAdOx1-S (0.12, 0.16, and 0.02, respectively; p < 0.001) and breast milk of mothers vaccinated when comparing BNT16b2 vs. ChAdOx1-S. All vaccinated breastfeeding mothers had serum anti-S1 IgG antibodies in response to vaccination against SARS-CoV-2, regardless of the commercial vaccine administered. Conclusions: the anti-SARS-CoV-2 vaccines were well tolerated by the mothers and the breastfed infant. In addition, breastfeeding mothers offer their infants IgA and IgG isotype antibodies directed against SARS-CoV-2 protein S in breast milk.
Background: The Work Ability Index (WAI) is an instrument that measures work ability. The wide dispersion of the WAI internationally has led to its adaptation for use in different countries. This ...study aimed to evaluate the psychometric properties of the Spanish version of the WAI. Methods: A methodological design was used over an opportunistic sample of 233 workers in the aeronautical industry in Spain. Reliability was evaluated through internal consistency. Factorial validity, known groups, and convergent validity were tested. Results: The Cronbach's alpha and item-total correlation indicated an adequate internal consistency. The confirmatory factor analysis, performed to evaluate the factorial validity, found adequate fit indices for a two-factor solution with a high correlation between the factors. Factor 1, "Subjectively estimated work ability and resources", was composed of 3 subscales and factor 2, "Ill-health-related", of 2 subscales. Subscales 4 and 6 had loading in both factors. Workers under 45 years of age obtained higher significant scores than older ones. Convergent validity was also evidenced since WAI was highly correlated with self-assessment of health status. Conclusions: The Spanish version of the WAI has shown evidence of reliability and validity in this study, supporting its use in individual and collective health surveillance by occupational health professionals. The factorial solution that was found has previously been reported in another international context. However, further research is needed to resolve the discrepancies detected in the role of some subscales between other national and international studies.
Understanding hydrological processes controlling stream chemistry and quantifying solute concentrations over time is crucial for estimating future alterations of water quality due to land use or ...climate change impacts, as well as for setting preventive or remedial actions. In the current study, soluble sodium (Na+), potassium (K+), calcium (Ca2+), and magnesium (Mg2+) concentrations and loads were assessed in waters from two small catchments located at different distances to the sea (9 km Valiñas and 30 km Abelar) in NW Spain from 2003 to 2016. Solute concentrations were determined using spectrometric techniques, while streamflow data were employed for estimating loads. Moreover, concentration-discharge relations were calculated for each solute and catchment. The average concentrations of soluble Na+, K+, Ca2+ and Mg2+ were, respectively, 16.5, 2.6, 7.9 and 4.1 mg L−1 in Valiñas, and 8.2, 0.9, 2.9 and 3.4 mg L−1 in Abelar, although variability among samplings was high. The four soluble ions showed a dilution pattern in Valiñas, whereas in Abelar Na+ tended to a chemostatic behavior and K+ and Ca2+ were positively related to streamflow. In conclusion, the dominant processes controlling these relationships are local and depend on catchment characteristics such as land use (including slurry applications in Abelar), distance to the sea, and vegetation cover.
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