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    Second-generation colon capsule endoscopy compared with colonoscopy
    (2011) Carretero, C. (Cristina); Costamagna, G. (Guido); Galmiche, J.P. (Jean-Paul); Toth, E. (Ervin); Johansson, G.W. (Gabriele Wurn); Petruzziello, L. (Lucio); Hassan, C. (Cesare); Muñoz-Navas, M. (Miguel); Gossum, A. (Andre) van; Nemeth, A. (Artur); Delvaux, M. (Michel); Fockens, P. (Paul); Sacher-Huvelin, S. (Sylvie); Frederic, M. (Muriel); Aminejab, L. (Leila); Neuhaus, H. (Horst); Spada, C. (Cristiano); Riccioni, M.E. (Maria Elena); Deviere, J. (Jacques); Dekker, E. (Evelien); Wientjes, C.A. (Caroline A.); Prieto-Frías, C. (Cesár); Coron, E. (Emmanuel); Mayershofer, R. (Rupert); Gay, G. (Gerard); Cesaro, P. (Paola)
    Background Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system. Objective To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy. Design and Setting Prospective, multicenter trial including 8 European sites. Patients This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed. Intervention CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day. Main Outcome Measurements CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed. Results Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients. Limitations Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients. Conclusion In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.
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    Split-dose sodium picosulfate–magnesium citrate colonoscopy preparation achieves lower residual gastric volume with higher cleansing effectiveness than a previous-day regimen
    (2016) Carretero, C. (Cristina); Herraiz, M. T. (María Teresa); Riva, S. (Susana) de la; Angós, R. (Ramón); Lopez-Olaondo, L. (Luis); Muñoz-Navas, M. (Miguel); Alzina, A. (Alejandra); Prieto-Frías, C. (Cesár); Betes, M.T. (María Teresa)
    Background and Aims It is known that sodium picosulfate–magnesium citrate (SPMC) bowel preparations are effective, well tolerated and safe, and that split-dosing is more effective for colon cleansing than previous-day regimens. Anesthetic guidelines consider that residual gastric fluid is independent of clear liquid fasting times. However, reluctance to use split-dosing persists. This may be due to limited data on residual gastric fluid volumes (RGFVs) and split-dosing bowel preparations, and that these may not be perceived as standard clear liquids. Furthermore, no studies are available on RGFV/residual gastric fluid pH (RGFpH) and SPMC. We aimed to evaluate the cleansing effectiveness and the RGFV/RGFpH achieved after an SPMC split-dosing regimen compared with a SPMC previous-day regimen. Methods This was a single-center observational study. A total of 328 outpatients scheduled for simultaneous EGD and colonoscopy and following a split-dosing or previous-day regimen of SPMC were included. We prospectively measured colon cleanliness by using the Ottawa Bowel Preparation Scale, RGFV, and RGFpH. Results Ottawa Bowel Preparation Scale scores for overall, right, mid-colon, and colon fluid were significantly better in the split-dosing group. In the split-dosing group, the 3- to 4-hour fasting time consistently achieved the best cleansing quality. RGFV was significantly lower in the split-dosing group (11.09 vs 18.62, P < .001). No significant differences in RGFpH were detected. Conclusions Split-dosing SPMC provides higher colon cleansing quality with lower RGFVs than previous-day SPMC regimens. SPMC in split-dosing acts exactly as a standard clear liquid acts, and thus anesthetic guidelines on this issue may be applied with no concerns.
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    Role of capsule endoscopy in suspected celiac disease: A European multi-centre study
    (2017) Carretero, C. (Cristina); Valle-Muñoz, J. (Julio); Herrerías-Gutiérrez, J. M. (Juan Manuel); Sanjuan-Acosta, M. (Mileidis); Gonzalez-Suarez, B. (Begoña); Juanmartiñena-Fernández, J.F. (José Francisco); Luján-Sanchís, M. (Marisol); Rosa, B. (Bruno); González-Vázquez, S. (Santiago); Jiménez-García, V. A. (Victoria Alejandra); Argüelles-Arias, F. (Federico); Borque-Barrera, P. (Pilar); Elli, L. (Luca); Fernandez-Urien, I. (Ignacio); Sempere-García-Argüelles, J. (Javier); Alonso-Lázaro, N. (Noelia); Xavier, S. (Sofía); Egea-Valenzuela, J. (Juan); Ruano-Díaz, L. (Lucía); Pérez-Cuadrado-Martínez, E. (Enrique); Pons-Beltran, V. (Vicente); García-Lledó, J. (Javier); Sánchez-Ceballos, F. (Francisco); Prieto-Frías, C. (Cesár); Branchi, F. (Federica); Pérez-Cuadrado-Robles, E. (Enrique); López-Higueras, A. (Antonio)
    METHODS This is a multi-centre, observational, analytical, retrospective study. A total of 163 patients with suspicion of celiac disease (CD) (mean age = 46.4 ± 17.3 years, 68.1% women) who underwent CE from 2003 to 2015 were included. Patients were divided into four groups: seronegative CD with atrophy (Group-I, n = 19), seropositive CD without atrophy (Group-II, n = 39), contraindication to gastroscopy (Group-III, n = 6), seronegative CD without atrophy, but with a compatible context (Group-IV, n = 99). DY, TI and the safety of CE were analysed. RESULTS The overall DY was 54% and the final diagnosis was villous atrophy (n = 65, 39.9%), complicated CD (n = 12, 7.4%) and other enteropathies (n = 11, 6.8%; 8 Crohn’s). DY for groups I to IV was 73.7%, 69.2%, 50% and 44.4%, respectively. Atrophy was located in duodenum in 24 cases (36.9%), diffuse in 19 (29.2%), jejunal in 11 (16.9%), and patchy in 10 cases (15.4%). Factors associated with a greater DY were positive serology (68.3% vs 49.2%, P = 0.034) and older age (P = 0.008). On the other hand, neither sex nor clinical presentation, family background, positive histology or HLA status were associated with DY. CE results changed the therapeutic approach in 71.8% of the cases. Atrophy was associated with a greater TI (92.3% vs 45.3%, P < 0.001) and 81.9% of the patients responded to diet. There was one case of capsule retention (0.6%). Agreement between CE findings and subsequent histology was 100% for diagnosing normal/other conditions, 70% for suspected CD and 50% for complicated CD. CONCLUSION CE has a high DY in cases of suspicion of CD and it leads to changes in the clinical course of the disease. CE is safe procedure with a high degree of concordance with histology and it helps in the differential diagnosis of CD.
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    EchoBrush may be superior to standard EUS-guided FNA in the evaluation of cystic lesions of the pancreas
    (2011) Lozano, M.D. (María Dolores); Álvarez-Cienfuegos, J. (Javier); Subtil, J.C. (José Carlos); Echeveste, J.I. (José I.); Labiano, T. (Tania); Idoate, M.A. (Miguel Ángel); Prieto-Frías, C. (Cesár); Betes, M.T. (María Teresa)
    BACKGROUND: Cystic lesions of the pancreas are being detected with increasing frequency. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is one of the most precise methods of diagnosis but still has limited accuracy. A new, through-the-needle cytologic brush system (EchoBrush; Cook Medical, Bloomington, Ind) has been approved for use during EUS evaluation of cystic pancreatic lesions. METHODS: Data from 127 EUS-FNAs of pancreatic cystic lesions were analyzed to compare the cytologic yield of EchoBrush with conventional EUS-FNA. An attending cytopathologist was present on site to assess specimen adequacy in all the cases. Diagnostic yields of both procedures, as well as related adverse events, were recorded. Statistical analysis was performed with the SPSS 15.0 version software (SPSS, Chicago, Ill). RESULTS: A total of 127 cystic lesions of the pancreas from 120 patients (42 men and 78 women, mean age of 62.17 ± 12.17 years) were included in the study. Mean size of lesions was 23.58 ± 21.69 mm. Adequacy of the samples and diagnostic yield were higher using EchoBrush. In 80 (63 %) cases, conventional EUS-FNA was performed, whereas in 47 (37%), we used EchoBrush. Diagnostic material was obtained in 85.1% (40 of 47) of cases using EchoBrush and in 66.3% (53 of 80) with conventional EUS-FNA. (P < .05). There were very few clinically relevant complications related to EUS-FNA and EUS-EchoBrush techniques. CONCLUSIONS: This study suggests that cytological specimens from pancreatic cystic lesions obtained using EchoBrush at the time of EUS are superior to conventional EUS-FNA mainly because of the higher yield of epithelial cells. Larger studies are needed to compare both methods. Cancer (Cancer Cytopathol) 2011. © 2011 American Cancer Society.
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    Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria
    (Elsevier, 2016) Omachi, T.A. (Theodore A.); Zazzali, J.L. (James L.); Rosén, K. (Karin); Khalil, S. (Sam); Kaplan, A.P. (Allen .P); Trzaskoma, B. (Benjamin); Bernstein, J.A. (Jonathan A.); Raimundo, K. (Karina); Ferrer-Cardona, M. (Marta); Antonova, E. (Evgeniya)
    Background: Few data are available that describe response patterns in patients with chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) treated with omalizumab. Objective: We sought to describe response patterns by using data from the 3 pivotal omalizumab CIU/CSU trials. Methods: Every 4 weeks, randomized patients received dosing with placebo or 75, 150, or 300 mg of omalizumab (ASTERIA I: n = 318, 24 weeks; ASTERIA II: n = 322, 12 weeks) or placebo or 300 mg of omalizumab (GLACIAL: n = 335, 24 weeks). Response was defined as well-controlled urticaria (weekly Urticaria Activity Score [UAS7] ≤ 6) or complete response (UAS7 = 0). Results: Response rates were dose dependent and highest with 300 mg of omalizumab. Some patients responded early (before week 4). At week 12, a higher proportion of patients treated with 300 mg of omalizumab reported a UAS7 ≤ 6 (26.0% [75 mg of omalizumab], 40.0% [150 mg of omalizumab], 51.9% [300 mg of omalizumab], and 11.3% [placebo] for ASTERIA I; 26.8% [75 mg of omalizumab], 42.7% [150 mg of omalizumab], 65.8% [300 mg of omalizumab], and 19.0% [placebo] for ASTERIA II; and 52.4% [300 mg of omalizumab] and 12.0% [placebo] for GLACIAL) or a UAS7 = 0 (11.7% [75 mg of omalizumab], 15.0% [150 mg of omalizumab], 35.8% [300 mg of omalizumab], and 8.8% [placebo] for ASTERIA I; 15.9% [75 mg of omalizumab], 22.0% [150 mg of omalizumab], 44.3% [300 mg of omalizumab], and 5.1% [placebo] for ASTERIA II; and 33.7% [300 mg of omalizumab] and 4.8% [placebo] for GLACIAL). In patients receiving 300 mg of omalizumab with 24 weeks of treatment, median time to achieve a UAS7 ≤ 6 was 6 weeks (ASTERIA I and GLACIAL) and median time to achieve a UAS7 = 0 was 12 or 13 weeks (ASTERIA I and GLACIAL, respectively). Some patients who achieved well-controlled urticaria or complete response sustained response throughout the treatment period. Conclusion: Benefits of omalizumab treatment were evident early (before week 4) in some patients and persisted to week 24. Use of 300 mg of omalizumab demonstrated best results in controlling CIU/CSU symptoms.
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    Omalizumab efficacy in cases of chronic spontaneous urticaria is not explained by the inhibition of sera activity in effector cells
    (Nature Publishing Group, 2017) Serrano-Candelas, E. (Eva); Gastaminza, G. (Gabriel); Audicana, M.T. (María T.); Martínez-Aranguren, R. (Rubén); Bartra, J. (Joan); Martín, M. (Margarita); Algorta, J. (Jaime); Vega, O. (Olga); Ferrer-Cardona, M. (Marta); Nuñez-Cordoba, J.M. (Jorge M.); Valero-Santiago, A. (Antonio)
    Omalizumab (OmAb) is a humanized anti-IgE antibody approved for the treatment of chronic spontaneous urticaria (CSU). OmAb's mechanism of action is known to include actions on free IgE and on pre-bound IgE. However, OmAb is equally and rapidly effective against autoimmune and non-autoimmune urticaria where IgE involvement is not clear, suggesting the involvement of additional mechanisms of action. In this study, we sought to investigate the ability of OmAb to inhibit mast cell and basophil degranulation induced by sera from CSU patients. For this purpose, we performed a comparison between the in vitro incubation of sera from CSU patients treated with OmAb and the in vivo administration of OmAb in a clinical trial. We found that OmAb added in vitro to sera from CSU patients did not modify the ability of the sera to induce cell degranulation. Similarly, the sera from patients treated with OmAb in the context of the clinical trial who had a good clinical outcome maintained the capacity to activate mast cells and basophils. Thus, we conclude that the beneficial activity of OmAb does not correlate with the ability of patient sera to induce cell degranulation.
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    Improvement of drug prescribing in acute kidney injury with a nephrotoxic drug alert system
    (BMJ, 2019) Idoate, A. (Antonio); Garcia-Fernandez, N. (Nuria); Aquerreta, I. (Irene); Arias-Pou, P. (Paloma)
    Electronic alert systems have shown their capacity for improving the detection of acute kidney injury (AKI). The aim of this study was to design and implement a clinical decision support system (CDSS) for improving drug selection and reducing nephrotoxic drug use in patients with AKI.
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    Infection burden and immunological responses are equivalent for polymeric and metallic implant materials in vitro and in a murine model of fracture-related infection
    (Wiley, 2018) Zeiter, S. (Stephan); Richards, R. G. (R. Geoff); Rochford, E. T. J. (Edward Thomas James); Sabaté-Brescó, M. (Marina); Moriarty, T. F. (T. Fintan); O'Mahony, L. (Liam); Ziegler, M. (Mario); Kluge, K. (Katharina); Poulsson, A. (Alexandra)
    The development of an infection is a major complication for some patients with implanted biomaterials. Whether the material or surface composition of the used biomaterial influences infection has not been directly compared for key biomaterials currently in use in human patients. We conducted a thorough in vitro and in vivo investigation using titanium (Ti) and polyether-ether-ketone (PEEK) as both commercially available and as modified equivalents (surface polished Ti, and oxygen plasma treated PEEK). Complement activation and cytokine secretion of cell of the immune system was assessed in vitro for all materials in the absence and presence of bacterial stimulants. In a follow-up in vivo study, we monitored bacterial infection associated with clinically available and standard Ti and PEEK inoculated with Staphylococcus aureus. Complement activation was affected by material choice in the absence of bacterial stimulation, although the material based differences were largely lost upon bacterial stimulation. In the in vivo study, the bacterial burden, histological response and cytokine secretion suggests that there is no significant difference between both PEEK and Ti. In conclusion, the underlying material has a certain impact in the absence of bacterial stimulation, however, in the presence of bacterial stimulation, bacteria seem to dictate the responses in a manner that overshadows the influence of material surface properties.
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    Circulating miRNAs in girls with abdominal obesity: miR-221-3p as a biomarker of response to weight loss interventions
    (Wiley, 2015) Milagro-Yoldi, F.I. (Fermín Ignacio); Azcona-SanJulián, M.C. (Mª Cristina); Silveira-Assmann, T. (Taís); Alonso-Pedrero, L. (Lucía); Marti, A. (Amelia); Ojeda-Rodríguez, A. (Ana)
    Background: Recent studies have associated several microRNAs (miRNAs) with childhood obesity and energy homeostasis, suggesting that an individual miRNA profile could be used as an early predictor to estimate the response to weight loss interventions in the design of precision nutrition. Objective: To investigate associations between the expression of circulating adiposity-related miRNAs and the response to a weight loss intervention. Methods: A total of 51 Spanish girls (age 7-16 years) with abdominal obesity underwent 8 weeks of a multidisciplinary intervention for weight loss. Participants were stratified into two groups in accordance with changes in body mass index (BMI) standard deviation score: low-responders (LR) and high-responders (HR). The expression of 39 circulating miRNAs (c-miRNAs) was evaluated in plasma of all subjects before the intervention. Results: Six miRNAs were differentially expressed between LR and HR. However, after adjustment for Tanner stage, the association was maintained only for miR-126-3p and miR-221-3p with a higher expression in HR group compared to LR group. After the intervention, miR-221-3p expression decreased in all subjects with a significant difference in the change within groups. However, changes in miR-126-3p levels were not significant. The expression of miR-221-3p was positively correlated with body weight, BMI and waist circumference, and negatively correlated with quantitative insulin sensitivity check index. Conclusions: Bioinformatic analysis evidenced that miR-221-3p participates in several obesity-related pathways, and more interestingly, this miRNA targets several candidate genes to childhood obesity according to DisGeNet database. Thus, miR-221-3p could be used for predicting the response to a multidisciplinary intervention for weight loss in young girls.
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    Multicenter Study of the Psychometric Properties of the New Demoralization Scale (DS-II) in Spanish-Speaking Advanced Cancer Patients
    (Elsevier, 2019) Santesteban, Y. (Yolanda); Centeno, C. (Carlos); Arantzamendi-Solabarrieta, M. (María); López-Fidalgo, J. (Jesús); Consigli, S. (Sara); Belar, A. (Alazne); Martínez, M. (Marina); Rodríguez-Núñez, A. (Alfredo)
    Context. Demoralization is a state of existential distress in patients with advanced illness, typically with coping difficulties, feelings of loss of sense, and purpose in life and despair, among other things. The New Demoralization Scale (DS-II) is an evaluation tool for this syndrome, which has recently been reformulated on a shorter scale. Objectives. The objective of this study was to obtain a Spanish version of the DS-II and to assess its psychometric properties in advanced cancer patients in Spain and a number of Latin American countries. Methods. Following a translationeback translation process, a validation study and a confirmatory analysis using structural equation models with their corresponding latent constructs were undertaken. Patients completed the DS-II in Spanish (DS-II (es)), the Hospital Anxiety and Depression Scale, and the Edmonton Symptom Assessment Systemerevised. Reliability was studied according to internal consistency; construct validity and concurrent validity with the Hospital Anxiety and Depression Scale and the Edmonton Symptom Assessment Systemerevised; discriminant validity using the Karnofsky Performance Status scale; and feasibility, with response ratio and required time. Cutoff points were established, and sensitivity and specificity were studied. Results. The DS-II (es) was obtained. One hundred fifty patients completed the validation study. The confirmatory analysis showed coherence, and all items correlated positively with their subscales and with the overall scale. Cronbach’s alpha for the DS-II (es) was 0.88, for the sense and purpose subscale 0.83, and for the coping ability 0.79. Demoralization correlated significantly with emotional distress (rho 1⁄4 0.73, P < 0.001). The tool distinguished between patients with diverse functional levels (rho 1⁄4 0.319, P 1⁄4 0.001). Cutoff points at 10 and 20 out of 32 were established. The scale showed high sensitivity (81.97%) and specificity (80.90%). The prevalence of demoralization was 33% in our sample. Conclusion. The Spanish version of the new Kissane DS-II demoralization scale has shown to be valid, reliable, and feasible with adequate psychometric properties. J Pain Symptom Manage 2019;57:627e634. 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.