Academic literature on the topic '628.168 36'

ABSTRACT Introduction: The spectrum of various complications in critically ill Guillain–Barre syndrome (GBS) and its effect on the prognosis is lacking in literature. This study aimed at enumerating the complications in such a cohort and their significance in the prognosis and mortality. Materials and Methods: Retrospective case record analysis of all consecutive mechanically ventilated patients of GBS in neurology Intensive Care Unit (ICU) of a tertiary care institute for 10 years was done. Demographic, laboratory, and treatment details and outcome parameters were recorded. Results: Among the 173 patients were 118 men and 55 women (2.1:1), aged 1–84 years. The average number of ICU complications per patient was 6.8 ± 1.8 (median = 7, range = 1–12). The most common complication was tracheobronchitis (128). Other pulmonary complications were found in 36 patients. The next was metabolic hyponatremia (115) hypokalemia (67), hypocalcemia (13), stress hyperglycemia (10), hyperkalemia (8), hypernatremia (9). Sepsis (40), UTI (47), dysautonomia (27), hypoalbuminemia (76), anemia (75), seizures (8), paralytic ileus (5), bleeding (4), anoxic encephalopathy (3), organ failures (12), deep vein thrombosis (7), and drug rashes (1) were also noted. The complications, considered significant in causing death, Hughes scale ≤ 3 at discharge, prolonged mechanical ventilation (>21 days) and hospitalization (>36 days) were pneumonia, hyponatremia, hypokalemia, urinary infection, tracheobronchial infections, hypoalbuminemia, sepsis, anemia dysautonomia. Conclusion: Active monitoring and appropriate and early intervention by the clinician will improve the quality of life of these patients and reduce the cost of prolonged mechanical ventilation and ICU stay.

Összefoglaló. Bevezetés: A magyarországi vesetranszplantáció 2013 óta az Eurotransplant (ET) keretein belül zajlik. A debreceni vesetranszplantációs centrumhoz évente kb. 200 kadáverdonorvese-felajánlás érkezik, melyek 37%-a kerül a megismert adatok alapján elfogadásra. Nem minden elfogadott vese kerül beültetésre, aminek számos oka lehet. Célkitűzés: A debreceni szakmai gyakorlat elemzése és bemutatása reprezentatív mintán. Módszer: A debreceni centrumhoz 2016. november és 2020. március között 624 vesefelajánlás érkezett. A felajánlott vesék 37%-a (n = 229) került előzetesen elfogadásra, később az elfogadott vesék 63%-a (n = 144) került beültetésre. Centrumunkban az ún. ’standard criteria’, azaz tökéletes minőségű donorvesék szignifikánsan magasabb arányban kerültek elfogadásra, majd beültetésre, mint az ’extended criteria’, azaz kompromisszummal vállalhatók. Az elfogadott és nem elfogadott veséket vizsgálva a KDPI (kidney donor profile index) és a KDRI (kidney donor risk index) értéke szignifikánsan magasabb volt az elutasított donorok esetében (p<0,001). Eredmények: Elemeztük, hogy a felajánlott, de a centrum által nem beültetett donorveséket más ET-centrumban elfogadták-e. Látható, hogy a felajánlott 624 donorvese közül 144 Debrecenben, 313 pedig más ET-centrumban került beültetésre, viszont 167 vese beültetése egyik ET-centrumban sem történt meg (discarded organ). A 36–85 KDPI-értékkel rendelkező csoportból került beültetésre a legtöbb donorvese (180 vese) más ET-centrumban. A Debrecenben beültetett kadáverdonor-vesék KDPI- és KDRI-értéke szignifikánsan alacsonyabb volt a nekünk felajánlott, majd máshol beültetett vesékhez képest. Következtetés: Összességében elmondható, hogy a debreceni centrumban a magas rizikócsoportba tartozó donorszervek elutasításra kerültek, miközben más centrumban a nagy részüket beültették. Ez alapján a 36–85 KDPI-értékű csoport a transzplantációs esetszám bővítésének lehetséges forrása a recipiens ismeretében. Orv Hetil. 2021; 162(26): 1022–1028. Summary. Introduction: Kidney transplantation in Hungary is carried out via Eurotransplant (ET). Our centre in Debrecen receives around 200 kidney offers a year, of which 37% are accepted. Not all accepted kidneys are transplanted, which can be a result of a number of causes. Obejctive: A debreceni szakmai gyakorlat elemzése és bemutatása reprezentatív mintán. Method: Between November 2016 and March 2020, the centre of Debrecen received 624 kidney offers. 37% (n = 229) of the offered kidneys got preliminarily accepted, of which 63% (n = 144) were transplanted later. In our centre, standard criteria donor kidneys were accepted and transplanted in significantly higher rate, than extended criteria donor kidneys. Looking at accepted and rejected kidneys, KDPI and KDRI values were significantly higher in the case of the refused ones (p<0.001). Results: Part of our assessment is to analyze whether kidneys offered to and refused by us got accepted in other transplant centres. In the examined period, of the 624 kidneys offered to our centre 144 were transplanted in Debrecen, 313 were transplanted in other ET centres, while 167 were not transplanted at all (discarded organ). The majority of transplanted kidneys in other ET centres had KDPI values between 36 and 85 (180 kidneys.) KDPI and KDRI values of kidneys transplanted in our centre were significantly lower than those that were offered to us, but got transplanted elsewhere. Conclusion: To summarize, we can say that high-risk donor organs are refused in the transplant centre of Debrecen, while the majority of them are being transplanted in other centres. Based on this, kidneys of KDPI value between 36 and 85 are a possible source of expanding the number of transplantations, with regards to the recipient. Orv Hetil. 2021; 162(26): 1022–1028.

We previously showed that sustained exposure to febrile-range hyperthermia (FRH) for 24 h caused an increase in circulating granulocyte colony-stimulating factor (G-CSF) levels and a peripheral neutrophilia in mice (Hasday J, Garrison A, Singh I, Standiford T, Ellis G, Rao S, He JR, Rice P, Frank M, Goldblum S, and Viscardi R. Am J Pathol 162: 2005–2017, 2003). In this study, we utilized a conscious temperature-clamped mouse model to analyze the kinetics of G-CSF expression and peripheral neutrophil expansion and the contributions of FRH-induced G-CSF expression, glucocorticoid generation, and catecholamine-induced neutrophil demargination. In conscious mice housed at an ambient temperature of 34.5°C, core temperature rapidly equilibrated at 39.5–40°C. Peripheral neutrophil counts increased 2-fold after 24-h exposure to hyperthermia, peaked at 3.6-fold baseline levels after 36-h exposure to FRH, and returned to baseline levels after 42 h of sustained hyperthermia. Plasma G-CSF levels were increased by 6.8-fold after 24 h and peaked at 40-fold baseline levels after 36 h in the hyperthermic mice. Plasma corticosterone levels peaked at 3.3-fold baseline levels after 30-h sustained hyperthermia and returned to baseline by 42 h. Immunoneutralization of G-CSF blocked FRH-induced peripheral neutrophilia, but blockade of the glucocorticoid receptor with mifepristone failed to modify FRH-induced neutrophilia. Epinephrine induced similar increases in peripheral blood absolute neutrophil counts in euthermic mice (2.2-fold increase) and mice exposed to FRH for 36 h (1.8-fold increase). Collectively, these data suggest that FRH-induced expression of G-CSF drives the sustained peripheral neutrophilia that occurs during sustained (36 h) hyperthermia, whereas glucocorticoid generation and catecholamine-induced demargination play little role in this response.

The effect of fasting for 12, 36 and 72 h was studied in twenty-nine healthy subjects (seventeen women and twelve men). Measurements were made of cardiovascular variables, metabolic rate, respiratory exchange ratio, plasma metabolites, insulin, thyroid hormones and catecholamines. During starvation there were no significant changes in blood pressure, whilst heart rate (beatslmin) increased at 36 h and remained elevated after 72 h (12 h 625 (SE 1.8), 36 h 68.0 (SE 1.9), 72 h 69 2 (SE 1.8);P< 0.001). Forearm blood flow(FBF),increased progressively from 3.32 (SE 0.20) to 6.21(SE0.46) m1/100 ml per min (P< 0.001). Resting metabolic rate (kJ/min) was significantly increased after 36 h of starvation (12 h 4 60 (SE 0.14), 36 h 4 88 (SE 0.13),P< 0.001), but was not significantly different from the 12 h value after 72 h (72 h 4.72(SE0.15)P= 0.06). The respiratory exchange ratio fell progressively from 0.80 to 076 to 0.72 (P< 0.001). Blood glucose fell, whilst plasma glycerol and β-hydroxybutyrate rose and plasma lactate did not change. Plasma insulin and free triiodothyronine fell during starvation. Plasma adrenaline and noradrenaline were unchanged at 36 h, but were significantly increased after 72 h. Both sexes showed a similar pattern of response to starvation, although absolute values of blood pressure, forearm blood flow, metabolic rate and plasma catecholamines were higher in men than women. Acute starvation produces profound cardiovascular and metabolic changes which are not explained by the accompanying hormonal changes.

Introduction: Focused attention meditation is the voluntary focusing of attention on a chosen object in a sustained fashion, whose objective is to develop attentional and emotional regulatory skills./objective: We investigated the effect of a six-week focused attention meditation training on a discrimination task with emotional distractors by comparing participants’ discriminability and bias before and after training. Method: College students were randomly assigned to either focused meditation (N=35), progressive relaxation (N=37), or control groups (N=28). 120 neutral and 120 emotional - negative and arousing – pictures (9º x 12º), flanked by two peripheral bars (0.3º x 0.3º), equidistant from the centre of the picture (9º), were equally and randomly distributed and displayed among three blocks, one with low attentional (LA) and two with high attentional demand (HA). Participants indicated if bars were parallel or not by pressing one of two buttons. In LA and HA conditions, respectively, bars differed with 90º and 6º in half of the trials. Trials started with a fixation cross (1500ms) followed by the pictures and bars (200ms). Next, a chessboard remained on the screen until a response was given or for 2000ms. Results: Mixed-design ANOVAs showed no discriminability difference across groups (meditation=26; relaxation=24; control=24) pre-post training; only task difficulty affected discriminability [F(1,68) = 739.8, p < .001; LA > HA]. Response bias was affected by difficulty [F(1,68) = 81.2, p < .001; LA < HA], and testing session [F(1,68) = 23.1, p < .001; pre > post]. Additionally, there was a significant difficulty × session × group interaction [F(2,68) = 4.02, p = .02]: meditation (M = .58, SE =.36) and relaxation (M = .65, SE =.36) presented a reduction in response bias relative to control (M = .69, SE =.37), but only after training in the HA condition (p < 0.05). Conclusion: The reduction in response bias suggests that meditation and relaxation can affect decision making in a difficult perceptual discrimination task. Meditation showed the highest bias reduction, consistent with previous results linking meditation to attention and monitoring processes.

Electrochemotherapy (ECT) is a local ablative treatment that is based on the reversible electroporation and intracellular accumulation of hydrophilic drug molecules, which greatly increases their cytotoxicity. In mucosal head and neck cancer (HNC), experience with ECT is limited due to the poor accessibility of tumors. In order to review the experience with ECT in mucosal HNC, we undertook a systematic review of the literature. In 22 articles, published between 1998 and 2020, 16 studies with 164 patients were described. Curative and palliative intent treatment were given to 36 (22%) and 128 patients (78%), respectively. The majority of tumors were squamous cell carcinomas (79.3%) and located in the oral cavity (62.8%). In the curative intent group, complete response after one ECT treatment was achieved in 80.5% of the patients, and in the palliative intent group, the objective (complete and partial) response rate was 73.1% (31.2% and 41.9%). No serious adverse events were reported during or soon after ECT and late effects were rare (19 events in 17 patients). The quality-of-life assessments did not show a significant deterioration at 12 months post-ECT. Provided these preliminary data are confirmed in randomized controlled trials, ECT may be an interesting treatment option in selected patients with HNC not amenable to standard local treatment.

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively neutralises interleukin (IL)-17A and IL-17F, is a potential therapeutic option in ankylosing spondylitis (AS).Objectives:To report 48-week (wk) patient-reported outcomes (PROs) in patients (pts) with AS treated with BKZ in a phase 2b dose-ranging study (BE-AGILE;NCT02963506).Methods:Pts with active AS (Bath AS Disease Activity Index [BASDAI] ≥4; spinal pain ≥4 [0–10]), fulfilling modified New York criteria (central reading), and inadequate response/intolerance to NSAIDs were randomised according to the study design (Figure 1). PROs included spinal pain, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), Bath AS Functional Index (BASFI), Medical Outcomes Study (MOS) Sleep Problems Index II and AS Quality of Life questionnaire (ASQoL). Efficacy is reported for pts initially randomised to placebo (PBO) or BKZ 160/320 mg every 4 weeks (Q4W); treatment-emergent adverse events (TEAEs) are reported for pts who received ≥1 dose of study drug (Safety Set).Results:Of 303 pts, 181 were randomised to PBO or BKZ 160/320 Q4W mg at Wk 0; 179/181 completed Wk 12 and 161/181 completed Wk 48. At Wk 12, improvements in pain, fatigue, morning stiffness, BASFI, sleep and ASQoL were greater in BKZ pts vs PBO pts. Responses were further improved or maintained to Wk 48, with no meaningful differences between BKZ 160 mg and 320 mg (Table 1). Serious TEAEs occurred in 13/303 (4.3%) pts (Table 2), which included 2 major adverse cardiac events considered not related to study drug. Oral candidiasis occurred in 16 (5.3%) pts.Table 1.PRO efficacy endpoints to Week 48 (multiple imputation)Mean (SD)WkPBO – BKZ 160 mg(n=24)PBO – BKZ 320 mg(n=36)BKZ 160 mg(n=58)BKZ 320 mg(n=61)Spinal pain06.9 (1.4)7.0 (1.9)6.6 (2.0)7.3 (1.5)CfB12-1.5 (1.6)-0.7 (1.7)-2.6 (2.2)-3.6 (2.4)48-3.7 (2.0)-3.7 (2.6)-3.8 (2.4)-4.7 (2.1)Fatigue06.4 (1.7)6.8 (1.6)6.4 (1.7)6.4 (1.9)CfB12-0.7 (2.5)-1.0 (1.7)-2.1 (2.2)-2.1 (2.5)48-2.7 (2.2)-2.8 (2.4)-3.1 (2.1)-3.3 (2.4)Morning stiffness06.9 (1.7)6.7 (2.0)6.5 (1.8)6.6 (2.1)CfB12-1.5 (1.7)-1.1 (1.5)-2.8 (2.0)-3.4 (2.7)48-3.9 (2.2)-3.6 (2.4)-3.9 (2.2)-4.4 (2.4)BASFI05.8 (1.8)5.5 (2.2)5.5 (2.2)5.9 (2.0)CfB12-1.0 (2.1)-0.3 (1.7)-1.7 (1.8)-2.2 (2.0)48-2.9 (2.2)-2.4 (2.2)-2.5 (2.0)-2.9 (2.2)MOS Sleep Problems Index II045.5 (8.1)45.3 (7.9)46.9 (7.5)47.2 (9.4)CfB122.1 (8.3)1.8 (6.8)5.6 (6.7)6.8 (7.5)487.6 (8.7)8.0 (9.1)6.5 (6.1)8.0 (7.9)ASQoL08.4 (4.7)9.2 (4.7)8.4 (4.3)8.7 (4.3)CfB12-1.3 (5.5)-1.3 (3.7)-3.5 (4.3)-4.6 (4.8)48-4.2 (5.6)-5.3 (5.6)-4.9 (4.1)-5.4 (4.8)CfB: change from baselineTable 2.Overview of TEAEs to Week 48 (Safety Set; N=303)n (%)BKZ 160 mg(n=149)BKZ 320 mg(n=150)All BKZ [a](N=303)Any TEAE103 (69.1)122 (81.3)235 (77.6)Drug-related TEAEs48 (32.2)54 (36.0)110 (36.3)Serious TEAEs5 (3.4)6 (4.0)13 (4.3)Discontinuations due to TEAEs7 (4.7)10 (6.7)20 (6.6)[a] Includes TEAEs for 16 and 64 mg BKZConclusion:Pts with active AS demonstrated rapid and sustained improvements in PROs, sleep and quality of life over 48 wks of BKZ treatment. BKZ was generally well tolerated with no unexpected safety findings versus previous studies.Acknowledgments:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim, Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Mary Katherine Farmer Employee of: UCB Pharma, Dominique Baeten Employee of: UCB Pharma, Nadine Goldammer Employee of: UCB Pharma, Jason Coarse Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma

Abstract Partnering with a Medicaid Home and Community Based waiver, we tests implementation strategies on adoption and sustainability of a model of care to support aging-in-place, intervening on individual capabilities and the home environment. Knowledge-to-Action model underpins the 2-arm (usual care + internal facilitation versus additive external facilitation) 3-year randomized (sites) trial statewide using an implementation strategy bundle (relationship/coalition/team building; education; interdisciplinary care/coordination; facilitation; and audit/feedback). Consolidated Framework for Implementation Research guides examining characteristics (site/RN-OT-SW/beneficiary), clinician attitude/self-efficacy, leadership/readiness to implement, and policy on adoption and sustainability; and intervention impact on beneficiary outcomes. Linear models will be used to analyze fidelity, Poisson and bootstrapping gage adoption, sustainability, fidelity, and level of facilitation. Champions (internal facilitators/supervisors; N=57) were engaged and 33.3% (n=19) completed online training (1.5 hours; 7.0 [SD 2.3] understood role; 6.8 [SD 1.8] would use training: 1-10 [lo-hi]); 100% (N=19) attended monthly coalition-building meetings. RN-OT-SWs were recruited (mail); 608 of 685 (88.8%) consented and completed online education (5.5 hours; Certified). Policymakers included quality incentives in contracts (10/1/2019) with sites for >95% certified RN-OT-SWs. Beneficiaries (N=12,000) were recruited (mail); 5% (n=608) did not participate (16.1% [n=98] poor cognition; 11.5% [n=70] nursing home/assisted living; 7.1% [n=43] no needs; 5.9% [n=36] too sick; 5.2% [n=32] many caregivers; 5.1% [n=31] inability to improve]; no English/hospitalized/other). Stages of Implementation Completion and fidelity data (September/October) will be reported. Adoption of models of care to support aging-in-place in Medicaid settings are a challenge, and this research harnesses a network (university/policymaker/supervisors/waiver sites-clinicians/beneficiaries) to improve care for vulnerable older adults.

Abstract Introduction: Solid organ transplant recipients may receive calcineurin inhibitor therapy for years without lethal consequences. Severe aplastic anemia is a cellular immunological rejection of hematopoiesis that is amenable to calcineurin-based immunosuppressive therapy. A general guideline exists to discontinue immuno-suppressive therapy following a complete response or after 4-6 months, despite a relapse rate of 30-50% and often less than optimal choices for second-line treatment. Anecdotal conversions from late and/or lengthy partial remissions to complete responses prompted this single-institutional retrospective analysis of patients who received extended calcineurin inhibition (ECI). Objective: To assess outcomes of extended cyclosporine therapy (greater than six months) in patients with aplastic anemia with one of the following circumstances: (1) no matched sibling bone marrow donor; (2) relative contraindication to a second course of intensive immunosuppressive therapy; or, (3) not able to access a promising investigational protocol. Design, Setting, and Patients: Fifty patients with severe aplastic anemia treated at Indiana University Melvin and Bren Simon Cancer Center between 1994 and 2014 were screened. Treatment groups included extended calcineurin inhibitor (n=16) and matched sibling-donor (MRD) bone marrow transplantation (BMT, n=9). Patients who received matched unrelated (MUD) BMT or supportive care or those with missing data were excluded from analysis. Methods: After an initial treatment with anti-thymocyte globulin, glucocortico-steroids and calcineurin inhibition, patients who received MRD-BMT were compared to those who received ECI. Changes in hemoglobin (Hb), white blood cell (WBC) and platelet (Plt) counts were monitored and survival rates were analyzed for the two groups. Results: Median follow-up was 93 months. Table 1 describes improvements in cell counts with ECI and BMT over 6 months, 12 months, 24 months and 36 months. Survival for ECI group was 87.5% versus 88.9% for patients undergoing BMT, p-value 0.759. Conclusion: Patients with severe aplastic anemia who received MRD-BMT had a more rapid improvement in Hb, WBC and plt counts compared to those who received ECI. However, the difference of improvement in Hb, WBC and plt counts at 36 months and survival between these two groups was not statistically different. Table 1: ECI BMT p-value WBC Improvement at 6 months 1.1 k/cumm 1.5 k/cumm 0.629 WBC Improvement at 12 months 0.9 k/cumm 2.9 k/cumm 0.034 WBC Improvement at 24 months 1.0 k/cumm 3.0 k/cumm 0.023 WBC Improvement at 36 months 1.8 k/cumm 3.2 k/cumm 0.289 Hb Improvement at 6 months 2.0 GM/dl 5.8 GM/dl 0.002 Hb Improvement at 12 months 2.0 GM/dl 6.8 GM/dl 0.001 Hb Improvement at 24 months 2.5 GM/dl 7.1 GM/dl 0.012 Hb Improvement at 36 months 3.3 GM/dl 7.0 GM/dl 0.130 Plt improvement at 6 months 25 k/cumm 151 k/cumm 0.001 Plt improvement at 12 months 37 k/cumm 172 k/cumm 0.007 Plt improvement at 24 months 45 k/cumm 164 k/cumm 0.010 Plt improvement at 36 months 54 k/cumm 167 k/cumm 0.078 Disclosures No relevant conflicts of interest to declare.

Object There is significant practice variation and considerable uncertainty among payers and other major stakeholders as to whether many surgical treatments are effective in actual US spine practice. The aim of this study was to establish a multicenter cooperative research group and demonstrate the feasibility of developing a registry to assess the efficacy of common lumbar spinal procedures using prospectively collected patient-reported outcome measures. Methods An observational prospective cohort study was conducted at 13 US academic and community sites. Unselected patients undergoing lumbar discectomy or single-level fusion for spondylolisthesis were included. Patients completed the 36-item Short-Form Survey Instrument (SF-36), Oswestry Disability Index (ODI), and visual analog scale (VAS) questionnaires preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: 125 patients with lumbar disc herniation, and 35 with lumbar spondylolisthesis. All patient data were entered into a secure Internet-based data management platform. Results Of 249 patients screened, there were 198 enrolled over 1 year. The median age of the patients was 45.0 years (49% female) for lumbar discectomy (n = 148), and 58.0 years (58% female) for lumbar spondylolisthesis (n = 50). At 30 days, 12 complications (6.1% of study population) were identified. Ten patients (6.8%) with disc herniation and 1 (2%) with spondylolisthesis required reoperation. The overall follow-up rate for the collection of patient-reported outcome data over 1 year was 88.3%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, VAS, and SF-36 scores (p ≤ 0.0002), which persisted over the 1-year follow-up period (p < 0.0001). By the 1-year follow-up evaluation, more than 80% of patients in each cohort who were working preoperatively had returned to work. Conclusions It is feasible to build a national spine registry for the collection of high-quality prospective data to demonstrate the effectiveness of spinal procedures in actual practice. Clinical trial registration no.: 01220921 (ClinicalTrials.gov).

AbstractUnruptured brain AVMs (bAVMs) remain a controversial subject for practicing neurosurgeons, especially in the light of ARUBA and other observational studies. This retrospective study aims to analyze our experience with unruptured bAVMs to see whether it is beneficial in the long-term and how it corresponds to large literature trials. The study comprised 160 adult patients with unruptured bAVMs surgically treated in Burdenko NMC (Moscow) in 2009–2017. Mean age: 33.4 ± 10лет. Clinical presentations were: seizures in 99 (61.9%), chronical headaches—49 (30.6%), ischemic symptoms—4 (2.5%), asymptomatic in 8 (5%) patients. Spetzler-Martin scale: I—18 pt. (11.3%), II—71 pt. (44.4%), III—60 pt. (37.5%), IV—11 pt. (6.8%). Good outcomes (mRS = 0–2) at discharge were achieved in 149 (93.1%), satisfactory (mRS—3)—9 (5.6%). Follow-up was complete for 97 (60.6%) patients, mean—59.3 (13–108 month). Excellent outcomes (mRS = 0–1) reached in 94.8%. For epilepsy patients, Engel I outcome was found in 50 (84.8%); for chronic headaches, 43 (66.1%) patients reported improvement. Postoperative visual field defects were followed in 22 of 55 (40%), complete recovery was reported in 6 (27%) and partial recovery in 8 (36%) patients. Overall, our results support the conclusion that surgery for low-grade bAVMs (S-M I–II) is a beneficial, low-risk option.

Article 4(16) (Definition of ‘main establishment’) (see too recital 36); Article 4(22) (Definition of ‘supervisory authority concerned’) (see also recital 36); Article 4(23) (Definition of ‘cross-border processing’); Article 4(24) (Definition of ‘relevant and reasoned objection’) (see too recital 124); Article 50 (International cooperation for the protection of personal data) (see too recitals 102 and 116); Article 55 (Competence of the supervisory authorities) (see too recitals 122 and 128); Article 56 (Competence of the lead supervisory authority) (see also recitals 124–128); Article 57(1)(g) (Supervisory authorities’ task to cooperate with other supervisory authorities) (see too recitals 123 and 133); Article 58 (Powers of supervisory authorities) (see too recitals 122 and 129); Article 61 (Mutual assistance) (see too recitals 123 and 133); Article 62 (Joint operations of supervisory authorities) (see too recital 134); Article 63 (Consistency mechanism) (see too recitals 13, 136 and 138); Article 64 (Opinion of the Board) (see also recitals 135–136); Article 65 (Dispute resolution by the Board) (see too recitals 136 and 143); and Article 66 (Urgency procedure) (see too recitals 137–138).

Article 4(21) (Definition of a supervisory authority); Article 28(8) (Adoption of processors’ standard contractual clauses); Article 36(2) (Prior consultation) (see too recitals 84 and 94); Articles 40(1), (5) and 41(3) (Codes of conduct) (see too recital 98); Article 42(1), (5), (7) and 43(1) (Certification) (see too recital 100); Article 46(2)(d), (3) and (4) (Standard data protection clauses for data transfers) (see too recitals 108–109); Article 47 (Approval of binding corporate rules); Article 50 (International cooperation for the protection of personal data) (see too recitals 104 and 116); Article 58 (Powers) (see too recitals 129, 148 and 150); Article 59 (Activity reports); Article 60 (Cooperation between supervisory authorities); Article 61 (Mutual assistance between supervisory authorities); Article 62 (Joint operations of supervisory authorities); Article 70 (Tasks of the Board, including promotion of cooperation between supervisory authorities; contribution to activities of the Board); Article 77 (Complaint handling and investigations) (see too recital 141); Article 83 (Administrative fines) (see too recital 148).

Article 4(21) (Definition of a supervisory authority); Article 36 (Advisory and other powers concerning prior consultation, national legislative measures and mandatory prior consultation or authorisation) (see too recital 94); Article 50 (Supervisory authorities to take steps to provide international mutual assistance in enforcement, including through investigative assistance) (see too recital 116); Article 52 (Exercise of powers with complete independence) (see too recital 117); Article 55 (Competence with regard to the exercise of powers, competence over public bodies) (see too recitals 122, 128 and 131); Article 57 (Tasks of supervisory authorities) (see too recitals 122, 123, 132 and 133); Articles 60(2) and 61 (Mutual assistance) (see too recital 133); Article 62 (Joint operations of supervisory authorities, including joint investigations and conferring of powers) (see too recitals 130 and 134); Article 90 (Possibility for Member States to adopt specific rules to set out supervisory authorities’ powers) (see too recital 164).

Platelet-PA-Inhibitors can be released by thrombin, Col laaen( Col) and others.If they are physiologically important,inhibition of their release might facilitate thrombolysis.Intrinsic PA were tested in euclobulins (eug)of PPP and PPP+Washed platelets(WP) ,with and without aspirinf ASA) .treated with UK,SK and Col(20 atfd l2uo/ml) Results(mm2)were:euaPPP:232+78;+3×106WP/ul:217+71;+10%7ul:188+/5 +2×106MP/ul: 157+69:With UK:eugPPP:283+76;+3×l0517P/ul :234+69;+106 WP/ul :172+55;+2×l(PWP/ul :154+48; With SK:euoPPP:303+99;+3×l05WP/ul 252+65;+1067P/ul:203+68;+2×106UP/ul: 174+85;Wi th Col (20ug/ml) :eur PPP:234+97;+3×105WP/ul:160+63;+106WP/ul:141+73;+2×l06WP/ul:129+81; +2×106WP/ul+ASA: 105+31;Wi th Col uc/ml) :euaPPP:230+56;+3×l05NP/ul: 160+52;+106WP/ul:139+44;+2×106wp/ul:126+21;+2×106WP/ul+ASA:118+28. EugPPP+l/P showed lower lysis area.Col induced more decrease of lysis area in euc with WP.ASA did not modify this effect.UK and SK produced higher lysis area only in euoPPP.No difference was observed between high and low doses of Col-effect upon WP.Combined treatment of eucPPP+WP+Col, with UK and SK showed:(mm2):UK-treated eugPPP+2×106WP/ul+Col(29ug/ml):134+25;+ASA and Col(20ug/ml):115+65;+Col(2uc/ml):157+50;+ASA and Col(2uo/ml):133+49; SK-treated eupPPP+2×106WP/ul:+Col(20uo/ml):144+49;+ASA and Col(20ug/ml):128+ 60;+Co1(2ug/ml):173+66;+ASA and Col(2ug/ml):142+36.Col (20ug/ml) produced slight lower lysis area of UK and SK-treated eugPPP+WP. (p:ns). ASA did not modify this effect.Col (2uc/ml) did not produce changes in lysis area of UK and SK-treated eupPPP +WP. ASA produced slight lower lysis area(p:ns).Conclusion: high dosis of Col could release anti UK,anti SK and intrinsic PA-inhibitors from platelets;low dosis of Col could only release fntrinsic PA-inhibi tors. It suggests that anti UK and anti SK release might be triggered by stronger stimuli than intrinsic PA inhibitors.ASA could not inhibit any inhibitors release.We must consider that PA-inhibi tors could be released by different metabolic pathways other than cyclooxygenase pathway.

A cohort study was performed to determine the postnatal development of the coagulation system in the “healthy” premature infant. Mothers were approached for consent and a total of 132 premature infants were entered into the study. The group consisted of 64 infants with gestational ages of 34-36 weeks (prem 1) and 68 infants whose gestational age was 33 weeks or less (prem 2). Demographic information and a 2 ml blood sample were obtained on days 1, 5, 30, 90, and 180. Plasma was fractionated and stored at −70°C for batch assaying of the following tests: screening tests, PT, APTT; factor assays (biologic (B)); fibrinogen, II, V, VII, VIII:C, IX, X, XI, XII, prekallikrein, high molecular weight kininogen, XIII (immunologic (I)); inhibitors (I), antithrombin III, aα2-antiplasmin, α2-macroglobulin, α-anti-trypsin, Cl esterase inhibitor, protein C, protein S, and the fibrinolytic system (B); plasminogen. We have previously reported an identical study for 118 full term infants. The large number of premature and full term infants studied at varying time points allowed us to determine the following: 1) coagulation tests vary with the gestational age and postnatal age of the infant; 2) each factor has a unique postnatal pattern of maturation; 3) near adult values are achieved by 6 months of age; 4) premature infants have a more rapid postnatal development of the coagulation system compared to the full term infant; and 5) the range of reference values for two age groups of premature infants has been established for each of the assays. These reference values will provide a basis for future investigation of specific hemorrhagic and thrombotic problems in the newborn infant.