134 results on '"Sala, Margarita"'
Search Results
102. Selection of candidates with HCC for transplantation in the MELD era
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Sala, Margarita, primary, Varela, Maria, additional, and Bruix, Jordi, additional
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- 2004
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103. MRI angiography is superior to helical CT for detection of HCC prior to liver transplantation: An explant correlation
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Burrel, Marta, primary, Llovet, Josep M., additional, Ayuso, Carmen, additional, Iglesias, Carmela, additional, Sala, Margarita, additional, Miquel, Rosa, additional, Caralt, Teresa, additional, Ayuso, Juan Ramon, additional, Solé, Manel, additional, Sanchez, Marcelo, additional, Brú, Concepció, additional, and Bruix, Jordi, additional
- Published
- 2003
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104. p27Kip1 is an independent predictor of recurrence after surgical resection in patients with small hepatocellular carcinoma
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Armengol, Carolina, primary, Boix, Loreto, additional, Bachs, Oriol, additional, Solé, Manel, additional, Fuster, Josep, additional, Sala, Margarita, additional, Llovet, Josep M, additional, Rodés, Juan, additional, and Bruix, Jordi, additional
- Published
- 2003
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- View/download PDF
105. Contrast‐enhanced power Doppler sonography and helical computed tomography for assessment of vascularity of small hepatocellular carcinomas before and after percutaneous ablation
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Vilana, Ramon, primary, Llovet, Josep M., additional, Bianchi, Luis, additional, Sanchez, Marcelo, additional, Pagés, Mario, additional, Sala, Margarita, additional, Gilabert, Rosa, additional, Nicolau, Carlos, additional, Garcia, Angeles, additional, Ayuso, Carmen, additional, Bruix, Jordi, additional, and Bru, Concepció, additional
- Published
- 2003
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106. Nonsurgical treatment of hepatocellular carcinoma
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Llovet, Josep M., primary, Sala, Margarita, additional, and Bruix, Jordi, additional
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- 2000
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107. Randomized controlled trial of interferon treatment for advanced hepatocellular carcinoma
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Llovet, Josep M., primary, Sala, Margarita, additional, Castells, Lluís, additional, Suarez, Yanette, additional, Vilana, Ramon, additional, Bianchi, Lluís, additional, Ayuso, Carmen, additional, Vargas, Víctor, additional, Rodés, Joan, additional, and Bruix, Jordi, additional
- Published
- 2000
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108. Natural history of untreated nonsurgical hepatocellular carcinoma: Rationale for the design and evaluation of therapeutic trials
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Llovet, Josep M., primary, Bustamante, Javier, additional, Castells, Antoni, additional, Vilana, Ramon, additional, Ayuso, Maria Del Carmen, additional, Sala, Margarita, additional, Brú, Concepció, additional, Rodés, Joan, additional, and Bruix, Jordi, additional
- Published
- 1999
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109. Initial response to percutaneous ablation predicts survival in patients with hepatocellular carcinoma.
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Sala, Margarita, Llovet, Josep M., Vilana, Ramon, Bianchi, Lluís, Solé, Manel, Ayuso, Carmen, Brú, Concepció, and Bruix, Jordi
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- 2004
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110. Increased risk of tumor seeding after percutaneous radiofrequency ablation for single hepatocellular carcinoma.
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Llovet, Josep M., Vilana, Ramon, Brú, Concepció, Bianchi, Lluís, Salmeron, Joan Manuel, Boix, Loreto, Ganau, Sergi, Sala, Margarita, Pagès, Mario, Ayuso, Carmen, Solé, Manel, Rodés, Joan, and Bruix, Jordi
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- 2001
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111. Undetected asymptomatic alcoholic cirrhosis underlies the diagnosis of hepatocellular carcinoma (HCC) out of surveillance programs in Spain. Analysis of 720 cases in 74 centers
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Rodriguez-Lope, Carlos, Elisa Reig, Maria, Matilla, Ana, Teresa Ferrer, Maria, Duenas, Eva, Minguez, Beatriz, Castroagudin, Javier F., Ortiz, Inmaculada, Pascual, Sonia, Luis Lledo, Jose, Gallego, Adolfo, Arenas, Juan I., Aracil, Carles, Forne, Montserrat, Munoz, Carolina, Pons, Fernando, Sala, Margarita, Inarrairaegui, Mercedes, Martin-Ilahi, Marta, Andreu, Victoria, Garre, Carmen, Rendon, Paloma, Fuentes, Javier, Crespo, Javier, Manuel Rodriguez, Bruix, Jordi, and Varela, Maria
112. Extrahepatic Autoimmune Comorbidities in Patients with Primary Biliary Cholangitis. Lack of Association with Prognosis and Therapeutic Response to Ursodeoxycholic Acid
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Reig, Anna, Llovet, Laura Patricia, Romero-Gomez, Manuel, Albillos, Agustin, Royuela, Federico Manuel Saez, Fabrega, Emilio, Salmeron, Francisco Javier, Gallego, Adolfo, Horta, Diana, Carrion, Jose Antonio, Andrade, Raul J., Sala, Margarita, Castano, Andres, Gomez-Dominguez, Elena, Conde, Isabel, Conde, Marta Hernandez, Chahri, Nadia, Estevez, Pamela, Diago, Moises, Gonzalez, Jesus M., and Albert Pares
113. A multicenter international study of sorafenib treatment in patients with hepatocellular carcinoma and chronic kidney disease undergoing hemodialysis
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Diaz-Gonzalez, Alvaro, Sanduzzi-Zamparelli, Marco, Gomes Da Fonseca, Leonardo, Di Costanzo, Giovan Giuseppe, Alves, Rogerio, Iavarone, Massimo, Leal, Cassia Regina G., Sacco, Rodolfo, Matilla, Ana M., Hernandez Guerra, Manuel, Aballay Soteras, Gabriel Alejandro, Marcus, Worns, Pinter, Matthias, Varela, Maria, Ladekarl, Morten, Chagas, Aline Lopes, Minguez, Beatriz, Arenas Ruiz-Tapiador, Juan Ignacio, Granito, Alessandro, Sanchez, Yolanda, Rojas, Angela, Rodriguez Lope, Carlos, Mario Alvares-da-Silva, Pascual, Sonia, Rimassa, Lorenza, Luis Lledo, Jose, Huertas, Carlos, Sangro, Bruno, Giannini, Edoardo Giovanni, Delgado, Manuel, Vergara Gomez, Mercedes, Perello, Christie, Lue, Alberto, Sala, Margarita, Gallego Moya, Adolfo, Coll, Susana, Hernaez Alsina, Tania, Pinero, Federico, Pereira, Gustavo, Callado Franca, Alex Vianey, Marin, Juan, Margarita Anders, Maria, Mello, Vivianne, Del Mar Lozano, Maria, Nault, Jean Charles, Maria Menendez, Jose, Garcia Juarez, Ignacio, Bruix, Jordi, Reig, Maria, Diaz-Gonzalez, A, Sanduzzi-Zamparelli, M, da Fonseca, L, Costanzo, GG, Alves, R, Iavarone, M, Leal, CRG, Sacco, R, Matilla, AM, Guerra, M, Soteras, GA, Marcus, W, Pinter, M, Varela, M, Ladekarl, M, Chagas, AL, Minguez, B, Ruiz-Tapiador, JI, Granito, A, Sanchez, Y, Rojas, A, De Lope, C, Alvares-Da-Silva, MR, Pascual, S, Rimassa, L, Lledo, J, Huertas, C, Sangro, B, Giannini, EG, Delgado, M, Gomez, MV, Perello, C, Lue, A, Sala, M, Moya, AG, Coll, S, Alsina, TH, Pinero, F, Pereira, G, Franca, AV, Marin, J, Anders, MM, Mello, V, Lozano, MD, Nault, JC, Menendez, JM, Juarez, IG, Bruix, J, and Reig, M
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Hepatocellular carcinoma, sorafenib, sorafenib, hemodialysis
114. Definition of a 3-Protein Signature to Stratify Hepatoblastoma Patients According to Their Prognosis
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Garrido, Marta, Guerra, Laura, Simon, Marina, Azkargorta, Mikel, Nonell, Lara, Lopez-Santamaria, Manuel, Mateos, Maria E., Belendez, Cristina, Plaza, Diego, Hernandez, Francisco, Mendiola, Marta, Ojanguren, Isabel, Childs, Margaret, Piotr Czauderna, Maibach, Rudolf, Morland, Bruce, Buendia, Marie A., Elortza, Felix, Planas, Ramon, Sarrias, Maria R., Sala, Margarita, and Armengol, Carolina
115. 1250 Predictors of drop-out and survival of patients with hepatocellular carcinoma candidates for liver transplantation
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Llovet, Josep M., Sala, Margarita, Fuster, Josep, Navasa, Miquel, Pons, Fernando, Solé, Manel, Ayuso, Carmen, Rimola, Antoni, García-Valdecasas, Juan Carlos, and Bruix, Jordi
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- 2003
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116. Eating Disorders, Addictions, and Substance Use Disorders: Research, Clinical, and Treatment Perspectives, edited by Timothy D. Brewerton and Amy Baker Dennis.
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Sala, Margarita
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SELF-destructive behavior , *NONFICTION , *DRUG addiction , *EATING disorders , *SUBSTANCE abuse - Published
- 2015
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117. ACUTE PANCREATITIS AFTER LONG-TERM 5-AMINOSALICYLIC ACID THERAPY.
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Fernández, Javier, Sala, Margarita, Panés, Julián, Feu, Faust, Navarro, Salvador, and Terés, Josep
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PANCREATITIS ,THERAPEUTICS ,PATIENTS ,ULCERATIVE colitis ,ACIDS - Abstract
Acute pancreatitis is a known, although rare, complication of mesalamine treatment. This complication typically appears within the first days or weeks after initiation of therapy. We describe two cases of acute pancreatitis that occurred after long term mesalamine therapy for ulcerative colitis. A rechallenge, performed in both patients, confirmed the diagnosis of mesalamine-induced pancreatitis. These case reports provide evidence that 5-aminosalicylic acid may induce acute pancreatitis after long term treatment. [ABSTRACT FROM AUTHOR]
- Published
- 1997
118. Time association between hepatitis C therapy and hepatocellular carcinoma emergence in cirrhosis: Relevance of non-characterized nodules.
- Author
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Mariño, Zoe, Darnell, Anna, Lens, Sabela, Sapena, Victor, Díaz, Alba, Belmonte, Ernest, Perelló, Christie, Calleja, Jose Luis, Varela, Maria, Rodriguez, Manuel, Rodriguez de Lope, Carlos, Llerena, Susana, Torras, Xavier, Gallego, Adolfo, Sala, Margarita, Morillas, Rosa María, Minguez, Beatriz, Llaneras, Jordi, Coll, Susana, and Carrion, José Antonio
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HEPATITIS C , *HEPATOCELLULAR carcinoma - Abstract
Graphical abstract Highlights • The risk of HCC in patients with HCV cirrhosis treated with DAAs persists despite viral cure. • The presence of indeterminate nodules before starting DAA is associated with a 3 times greater risk of HCC. • A time association between DAA therapy and developing HCC reflects increased short-term HCC risk. • DAA therapy elicits a mechanism that primes the emergence of HCC early during follow-up. Background & Aims Despite direct-acting antivirals being highly effective at eradicating hepatitis C virus infection, their impact on the development of hepatocellular carcinoma (HCC) remains controversial. We analyzed the clinical and radiological outcome of cirrhotic patients treated with interferon-free regimens to estimate the risk of developing HCC. Methods This was a retrospective multicenter study focusing on cirrhotic patients treated with direct-acting antivirals until December 2016. Clinical and radiologic characteristics were collected before the start of antiviral therapy, at follow-up and at HCC development. Diagnosis of HCC was centrally validated and its incidence was expressed as HCC/100 person-years. Results A total of 1,123 patients were included (60.6% males, 83.8% Child-Pugh A) and 95.2% achieved a sustained virologic response. Median time of follow-up was 19.6 months. Seventy-two patients developed HCC within a median of 10.3 months after starting antiviral treatment. HCC incidence was 3.73 HCC/100 person-years (95% CI 2.96–4.70). Baseline liver function, alcohol intake and hepatic decompensation were associated with a higher risk of HCC. The relative risk was significantly increased in patients with non-characterized nodules at baseline 2.83 (95% CI 1.55–5.16) vs. absence of non-characterized nodules. When excluding these patients, the risk remained increased. Conclusion These data expose a clear-cut time association between interferon-free treatment and HCC. The mechanisms involved in the increased risk of HCC emergence in the short term require further investigation. Lay summary In this cohort of cirrhotic patients, interferon-free therapies achieved a high rate of sustained virologic response (>95%); however, we reported a risk of de novo hepatocellular carcinoma of 3.73 per 100 person-years and a clear-cut time association with antiviral therapy. The time association between starting direct-acting antivirals and developing hepatocellular carcinoma, together with the association with the presence of non-characterized nodules at baseline ultrasound, suggests that antiviral therapy elicits a mechanism (probably immune-related) that primes the growth and clinical recognition of hepatocellular carcinoma early during follow-up. As a result, short-term liver cancer risk is significantly increased. [ABSTRACT FROM AUTHOR]
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- 2019
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119. Improving prediction of eating-related behavioral outcomes with zero-sensitive regression models.
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Schaumberg, Katherine, Reilly, Erin E., Anderson, Lisa M., Gorrell, Sasha, Wang, Shirley B., and Sala, Margarita
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COMPULSIVE eating , *EATING disorders , *LAXATIVES , *VOMITING , *REGRESSION analysis - Abstract
Objective: Outcome variables gauging the frequency of specific disordered eating behaviors (e.g., binge eating, vomiting) are common in the study of eating and health behaviors. The nature of such data presents several analytical challenges, which may be best addressed through the application of underutilized statistical approaches. While zero-sensitive models are well-supported by methodologists, application of these models has yet to gain traction among a widespread audience of researchers who study eating-related behaviors. The current study examined several approaches to predicting count-based behaviors, including zero-sensitive (i.e., zero-inflated and hurdle) regression models.Method: Exploration of alternative models to predict eating-related behaviors occurred in two parts. In Part 1, participants (N = 524; 54% female) completed the Eating Disorder Examination-Questionnaire and Daily Stress Inventory. We considered the theoretical basis and practical utility of several alternative approaches for predicting the frequency of binge eating and compensatory behaviors, including ordinary least squares (OLS), logistic, Poisson, negative binomial, and zero-sensitive models. In Part 2, we completed Monte Carlo simulations comparing negative binomial, zero-inflated negative binomial, and negative binomial hurdle models to further explore when these models are most useful.Results: Traditional OLS regression models were generally a poor fit for the data structure. Zero-sensitive models, which are not limited to traditional distribution assumptions, were preferable for predicting count-based outcomes. In the data presented, zero-sensitive models were useful in modeling behaviors that were relatively rare (laxative use and vomiting, 9.7% endorsed) along with those that were somewhat common (binge eating, 33.4% endorsed; driven exercise, 40.7% endorsed). Simulations indicated missing data, sample size, and the number of zeros may impact model fit.Discussion: Zero-sensitive approaches hold promise for answering key questions about the presence and frequency of common eating-related behaviors and improving the specificity of relevant statistical models. The current manuscript provides practical guidance to aid the use of these models when studying eating-related behaviors. [ABSTRACT FROM AUTHOR]- Published
- 2018
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120. p27Kip1 is an independent predictor of recurrence after surgical resection in patients with small hepatocellular carcinoma
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Armengol, Carolina, Boix, Loreto, Bachs, Oriol, Solé, Manel, Fuster, Josep, Sala, Margarita, Llovet, Josep M., Rodés, Juan, and Bruix, Jordi
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CANCER relapse , *CELLULAR control mechanisms , *LIVER cancer - Abstract
Background/Aims: Alterations in p27Kip1 (p27) and cyclin E (cycE) expression are found in tumors and are related to poor prognosis. This study assesses the role of these cell cycle regulators in the development of recurrence after surgical resection in 46 cirrhotic patients (age: 61.3±7 years, 30 males, 44 Child–Pugh''s A, 30 HCV-positive) with small hepatocellular carcinoma (HCC, size: 3.1±1.5 cm, 40 solitary at pathological examination).Methods: p27 and cycE expression in tumoral and non-tumoral liver were analyzed by Western blot (WB). p27 was also assessed by immunohistochemistry (IHC).Results: Tumor p27 underexpression (50% decreased vs. non-tumoral liver) occurred in 12 cases. Throughout follow-up, 26 patients developed recurrence, which was significantly higher in patients with p27 underexpression than in those without (3-year recurrence: 80 vs. 44%, respectively, P=0.026). IHC showed concordant inverse findings: 13 tumors showed high p27 staining that was related to lower recurrence rate (P=0.019). Multivariate analysis identified p27 measured by WB as an improved predictor of recurrence (OR: 3.09, 95% CI: 1.26–7.08, P=0.016). By contrast, cycE, increased in 66% of the tumors, had no impact on recurrence but was associated to poor differentiation (P=0.015) and microvascular invasion (P=0.016).Conclusions: p27 underexpression is frequent in relatively early stages of HCC and constitutes an independent predictor of recurrence after surgical resection. [Copyright &y& Elsevier]
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- 2003
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121. Development and initial testing of mindful journey: a digital mindfulness-based intervention for promoting recovery from Substance use disorder.
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Roos CR, Kiluk B, Carroll KM, Bricker JB, Mun CJ, Sala M, Kirouac M, Stein E, John M, Palmer R, DeBenedictis A, Frisbie J, Haeny AM, Barry D, Fucito LM, Bowen S, Witkiewitz K, and Kober H
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- Adult, Humans, Motivation, Ambulatory Care, Mindfulness methods, Mobile Applications, Substance-Related Disorders therapy
- Abstract
Background/objectives: There is a great unmet need for accessible adjunctive interventions to promote long-term recovery from substance use disorder (SUD). This study aimed to iteratively develop and test the initial feasibility and acceptability of Mindful Journey, a novel digital mindfulness-based intervention for promoting recovery among individuals with SUD., Patients/materials: Ten adults receiving outpatient treatment for SUD., Methods: Phase 1 ( n = 5) involved developing and testing a single introductory digital lesson. Phase 2 included a separate sample ( n = 5) and involved testing all 15 digital lessons (each 30- to 45-minutes) over a 6-week period, while also receiving weekly brief phone coaching for motivational/technical support., Results: Across both phases, quantitative ratings (rated on a 5-point scale) were all at or above a 4 (corresponding with 'agree') for key acceptability dimensions, such as usability, understandability, appeal of visual content, how engaging the content was, and helpfulness for recovery. Additionally, in both phases, qualitative feedback indicated that participants particularly appreciated the BOAT (Breath, Observe, Accept, Take a Moment) tool for breaking down mindfulness into steps. Qualitative feedback was used to iteratively refine the intervention. For example, based on feedback, we added a second core mindfulness tool, the SOAK (Stop, Observe, Appreciate, Keep Curious), and we added more example clients and group therapy videos. In Phase 2, 4 out of 5 participants completed all 15 lessons, providing initial evidence of feasibility. Participants reported that the phone coaching motivated them to use the app. The final version of Mindful Journey was a smartphone app with additional features, including brief on-the-go audio exercises and a library of mindfulness practices. Although, participants used these additional features infrequently., Conclusions: Based on promising initial findings, future acceptability and feasibility testing in a larger sample is warranted. Future versions might include push notifications to facilitate engagement in the additional app features.
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- 2024
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122. Outcomes and factors associated with relapse of vaccine-induced liver injury after SARS CoV-2 immunization: A nationwide study.
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Barreira-Díaz A, Riveiro-Barciela M, Fernández-Bonilla EM, Bernal V, Castiella A, Casado-Martín M, Delgado C, Londoño MC, Díaz-González Á, Pérez-Medrano I, Conthe A, Sala M, Mateos B, Gómez-Camarero J, Antón-Conejero D, Pozo-Calzada CD, Cuenca F, Villagrasa-Vilella A, and Salcedo M
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- Humans, Female, Male, Middle Aged, Retrospective Studies, Prospective Studies, Chemical and Drug Induced Liver Injury etiology, SARS-CoV-2, Aged, Adult, Immunization, Secondary, Risk Factors, Liver Transplantation, Immunosuppressive Agents adverse effects, COVID-19 Vaccines adverse effects, Recurrence, COVID-19 prevention & control, COVID-19 epidemiology
- Abstract
Introduction and Objectives: Different patterns of liver injury have been reported in association with the SARS-CoV-2 vaccines. The aim of this study was to describe a nationwide cohort of patients with SARS CoV-2 vaccine-induced liver injury, focusing on treatment and the evolution after further booster administration., Patients and Methods: multicentre, retrospective-prospective study, including subjects who developed abnormal liver tests within 90 days after administration of SARS-CoV-2 vaccination., Results: 47 cases were collected: 17 after prime dose and 30 after booster. Age was 57 years, 30 (63.8 %) were female, and 7 (14.9 %) had a history of prior autoimmune hepatitis (AIH). Most cases were non-severe, though 9 (19.1 %) developed acute liver injury or failure (ALF). Liver injury tended to be more severe in those presenting after a booster (p=0.084). Pattern of liver injury was hepatocellular (80.9 %), mixed (12.8 %) and 3 (6.4 %) cholestatic. Liver biopsy was performed on 33 patients; 29 showed findings of AIH. Forty-one (87.2 %) patients received immunosuppressants, mostly corticosteroids (35/41). One required liver transplantation and another died due to ALF. Immunosuppression was discontinued in 6/41 patients without later rebound. Twenty-five subjects received at least one booster and 7 (28.0 %) relapsed from the liver injury, but all were non-severe. Recurrence was less frequent among patients on immunosuppressants at booster administration (28.6 % vs. 88.9 %, p=0.007)., Conclusions: SARS CoV-2 vaccine-induced liver injury is heterogeneous but mostly immune-mediated. Relapse of liver injury after re-exposure to vaccine is frequent (28.0 %) but mild. Immunosuppression at booster administration is associated with a lower risk of liver injury., Competing Interests: Conflicts of interest None., (Copyright © 2024 Fundación Clínica Médica Sur, A.C. Published by Elsevier España, S.L.U. All rights reserved.)
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- 2024
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123. Unpacking differences in post-exercise affective experiences between physically underactive and active individuals.
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Sala M, Rosenfield D, and Baldwin AS
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- Humans, Emotions, Fatigue psychology, Exercise Test, Affect physiology, Exercise psychology
- Abstract
Background: Affective response to exercise (i.e., how individuals feel during- and post-exercise) as well as post-behavioral evaluations of affective experiences with exercise (i.e., reflecting on the experience after engaging in exercise) may be important determinants of regular exercise., Purpose: We compared post-exercise affective response and post-behavioral evaluations of exercise between a physically active and underactive group. Physically active (n = 32) and underactive (n = 25) participants completed a 10-minute treadmill bout of vigorous exercise and reported affective valence, positive activated affect, negative activated affect, calmness, fatigue and relief at various points during and/or after the bout., Results: As expected, both groups reported an improvement in affective valence immediately post-exercise (ps < 0.001). This improvement in affective valence was associated with a concurrent decrease in negative affect (ps < 0.05) for the physically underactive group and was only associated with a concurrent increase in positive affect (ps < 0.02) for the active group. There were significant differences between physically active and underactive groups in pre-post exercise changes in positive activated affect (ps < 0.005). The underactive group reported greater relief than the active group at all-post exercise time-points (ps < 0.05)., Conclusions: These findings have implications for understanding post-exercise affective response and post-behavioral evaluations of exercise and for interventions directed at influencing the post-exercise affective response and behavioral evaluations of exercise in physically underactive individuals., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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124. Outcome of liver cancer patients with SARS-CoV-2 infection: An International, Multicentre, Cohort Study.
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Muñoz-Martínez S, Sapena V, Forner A, Bruix J, Sanduzzi-Zamparelli M, Ríos J, Bouattour M, El-Kassas M, Leal CRG, Mocan T, Nault JC, Alves RCP, Reeves HL, da Fonseca L, García-Juárez I, Pinato DJ, Varela M, Alqahtani SA, Alvares-da-Silva MR, Bandi JC, Rimassa L, Lozano M, González Santiago JM, Tacke F, Sala M, Anders M, Lachenmayer A, Piñero F, França A, Guarino M, Elvevi A, Cabibbo G, Peck-Radosavljevic M, Rojas Á, Vergara M, Braconi C, Pascual S, Perelló C, Mello V, Rodríguez-Lope C, Acevedo J, Villani R, Hollande C, Vilgrain V, Tawheed A, Ferguson Theodoro C, Sparchez Z, Blaise L, Viera-Alves DE, Watson R, Carrilho FJ, Moctezuma-Velázquez C, D'Alessio A, Iavarone M, and Reig M
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- COVID-19 Testing, Cohort Studies, Cross-Sectional Studies, Humans, Retrospective Studies, SARS-CoV-2, COVID-19 complications, Carcinoma, Hepatocellular, Liver Neoplasms
- Abstract
Background & Aims: Information about the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients with liver cancer is lacking. This study characterizes the outcomes and mortality risk in this population., Methods: Multicentre retrospective, cross-sectional, international study of liver cancer patients with SARS-CoV-2 infection registered between February and December 2020. Clinical data at SARS-CoV-2 diagnosis and outcomes were registered., Results: Two hundred fifty patients from 38 centres were included, 218 with hepatocellular carcinoma (HCC) and 32 with intrahepatic cholangiocarcinoma (iCCA). The median age was 66.5 and 64.5 years, and 84.9% and 21.9% had cirrhosis in the HCC and iCCA cohorts respectively. Patients had advanced cancer stage at SARS-CoV-2 diagnosis in 39.0% of the HCC and 71.9% of the iCCA patients. After a median follow-up of 7.20 (IQR: 1.84-11.24) months, 100 (40%) patients have died, 48% of the deaths were SARS-CoV-2-related. Forty (18.4%) HCC patients died within 30-days. The death rate increase was significantly different according to the BCLC stage (6.10% [95% CI 2.24-12.74], 11.76% [95% CI 4.73-22.30], 20.69% [95% CI 11.35-31.96] and 34.52% [95% CI 17.03-52.78] for BCLC 0/A, B, C and D, respectively; p = .0017). The hazard ratio was 1.45 (95% CI 0.49-4.31; p = .5032) in BCLC-B versus 0/A, and 3.13 (95% CI 1.29-7.62; p = .0118) in BCLC-C versus 0/A in the competing risk Cox regression model. Nineteen out of 32 iCCA (59.4%) died, and 12 deaths were related to SARS-CoV-2 infection., Conclusions: This is the largest cohort of liver cancer patients infected with SARS-CoV-2. It characterizes the 30-day mortality risk of SARS-CoV-2 infected patients with HCC during this period., (© 2022 The Authors. Liver International published by John Wiley & Sons Ltd.)
- Published
- 2022
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125. State body dissatisfaction predicts momentary positive and negative affect but not weight control behaviors: an ecological momentary assessment study.
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Sala M, Linde JA, Crosby RD, and Pacanowski CR
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- Ecological Momentary Assessment, Female, Health Behavior, Humans, Students, Body Dissatisfaction, Feeding and Eating Disorders
- Abstract
Purpose: Body dissatisfaction is ubiquitous in our society and leads to eating disorders. Longitudinal research suggests that higher body dissatisfaction predicts higher negative affect and unhealthy weight control behaviors over time. However, no study has assessed how body dissatisfaction impacts affect and weight control behaviors in the moment. In the current study, we examined the momentary relationships between body dissatisfaction, affect and weight control behaviors using ecological momentary assessment., Methods: Female college students (N = 67) completed measures of state body dissatisfaction, affect, and weight control behaviors across fourteen days using ecological momentary assessment., Results: Greater body dissatisfaction significantly predicted lower subsequent positive affect and higher subsequent negative affect, but positive and negative affect did not predict subsequent body dissatisfaction. Daily average body dissatisfaction was not significantly associated with daily engagement in either healthy or unhealthy weight control behaviors., Conclusion: Short-term negative effects of body dissatisfaction on affect were apparent. Targeting body dissatisfaction may be important for improving affect., Level of Evidence: Level IV, multiple time series without intervention., (© 2020. Springer Nature Switzerland AG.)
- Published
- 2021
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126. Assessing the impact of COVID-19 on liver cancer management (CERO-19).
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Muñoz-Martínez S, Sapena V, Forner A, Nault JC, Sapisochin G, Rimassa L, Sangro B, Bruix J, Sanduzzi-Zamparelli M, Hołówko W, El Kassas M, Mocan T, Bouattour M, Merle P, Hoogwater FJH, Alqahtani SA, Reeves HL, Pinato DJ, Giorgakis E, Meyer T, Villadsen GE, Wege H, Salati M, Mínguez B, Di Costanzo GG, Roderburg C, Tacke F, Varela M, Galle PR, Alvares-da-Silva MR, Trojan J, Bridgewater J, Cabibbo G, Toso C, Lachenmayer A, Casadei-Gardini A, Toyoda H, Lüdde T, Villani R, Matilla Peña AM, Guedes Leal CR, Ronzoni M, Delgado M, Perelló C, Pascual S, Lledó JL, Argemi J, Basu B, da Fonseca L, Acevedo J, Siebenhüner AR, Braconi C, Meyers BM, Granito A, Sala M, Rodríguez-Lope C, Blaise L, Romero-Gómez M, Piñero F, Gomez D, Mello V, Pinheiro Alves RC, França A, Branco F, Brandi G, Pereira G, Coll S, Guarino M, Benítez C, Anders MM, Bandi JC, Vergara M, Calvo M, Peck-Radosavljevic M, García-Juárez I, Cardinale V, Lozano M, Gambato M, Okolicsanyi S, Morales-Arraez D, Elvevi A, Muñoz AE, Lué A, Iavarone M, and Reig M
- Abstract
Background & Aims: The coronavirus disease 2019 (COVID-19) pandemic has posed unprecedented challenges to healthcare systems and it may have heavily impacted patients with liver cancer (LC). Herein, we evaluated whether the schedule of LC screening or procedures has been interrupted or delayed because of the COVID-19 pandemic., Methods: An international survey evaluated the impact of the COVID-19 pandemic on clinical practice and clinical trials from March 2020 to June 2020, as the first phase of a multicentre, international, and observational project. The focus was on patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma, cared for around the world during the first COVID-19 pandemic wave., Results: Ninety-one centres expressed interest to participate and 76 were included in the analysis, from Europe, South America, North America, Asia, and Africa (73.7%, 17.1%, 5.3%, 2.6%, and 1.3% per continent, respectively). Eighty-seven percent of the centres modified their clinical practice: 40.8% the diagnostic procedures, 80.9% the screening programme, 50% cancelled curative and/or palliative treatments for LC, and 41.7% modified the liver transplantation programme. Forty-five out of 69 (65.2%) centres in which clinical trials were running modified their treatments in that setting, but 58.1% were able to recruit new patients. The phone call service was modified in 51.4% of centres which had this service before the COVID-19 pandemic (n = 19/37)., Conclusions: The first wave of the COVID-19 pandemic had a tremendous impact on the routine care of patients with liver cancer. Modifications in screening, diagnostic, and treatment algorithms may have significantly impaired the outcome of patients. Ongoing data collection and future analyses will report the benefits and disadvantages of the strategies implemented, aiding future decision-making., Lay Summary: The coronavirus disease 2019 (COVID-19) pandemic has posed unprecedented challenges to healthcare systems globally. Herein, we assessed the impact of the first wave pandemic on patients with liver cancer and found that routine care for these patients has been majorly disrupted, which could have a significant impact on outcomes., Competing Interests: SM.-M.: Speaker fees from Bayer and travel funding from 10.13039/100004326Bayer and 10.13039/501100014382Eisai. V.S.: Travel grants from 10.13039/100004326Bayer. A.F.: Lecture fees from Bayer, Gilead and MSD; consultancy fees from Bayer, AstraZeneca, Roche and Guerbert. J-C.N.: Received research grant from 10.13039/100004326Bayer for Inserm UMR1138. L.R.: Reports receiving consulting fees from Amgen, ArQule, AstraZeneca, Basilea, Bayer, Celgene, Eisai, Exelixis, Hengrui, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi; lectures fees from AbbVie, Amgen, Eisai, Gilead, Incyte, Ipsen, Lilly, Roche, Sanofi; travel fees from Ipsen; and institutional research funding from Agios, ARMO BioSciences, 10.13039/100004325AstraZeneca, BeiGene, 10.13039/501100003769Eisai, 10.13039/100010544Exelixis, 10.13039/100006591Fibrogen, Incyte, 10.13039/501100014382Ipsen, 10.13039/100004312Lilly, 10.13039/100007054MSD, 10.13039/100004337Roche. B.S.: Reports consultancy fees from Adaptimmune, AstraZeneca, Bayer, BMS, BTG, Eli Lilly, Ipsen, Novartis, Merck, Roche, Sirtex Medical, Terumo; and research grants from 10.13039/100002491BMS and Sirtex Medical. J. Bruix: Consultancy: AbbVie, ArQule, Astra, Basilea, Bayer, BMS, Daiichi Sankyo, GlaxoSmithKline, Gilead, Kowa, Lilly, Medimune, Novartis, Onxeo, Polaris, Quirem, Roche, Sanofi-Aventis, Sirtex, Terumo/Grants: 10.13039/100004326Bayer and 10.13039/501100014382Ipsen. M.S.Z.: Received speaker fees and travel grants from 10.13039/100004326Bayer and 10.13039/100014869BTG, 10.13039/100007054MSD. M.B.: Consultant and Advisory Board for: Bayer Pharma, Ipsen, BMS, Eisai, Roche, AstraZeneca, Sirtex Medical. D.J.P.: Received lecture fees from ViiV Healthcare and Bayer Healthcare and travel expenses from BMS and Bayer Healthcare; consulting fees for Mina Therapeutics, EISAI, Roche, and AstraZeneca; received research funding (to institution) from MSD and BMS. T.M.: Consultancy: Eisai, Roche, BTG, Ipsen, Bayer, Adaptimmune. Research funding: Bayer, BTG. H.W.: Served as speaker for Bayer, Eisai, and Ipsen, and as a consultant for Bayer, Eisai, Lilly, BMS, Roche, and Ipsen. B.M.: Consultancy: Bayer-Shering Pharma /Speaker fees: Eisai, MSDG. C. Consultancy fees from Bayer, Ipsen. P.R.G.: Bayer, BMS, MSD, AstraZeneca, Adaptimmune, Sirtex, Lilly Ipsen, Roche, Eisai. M.R.A.S.: Has received Research grants, advisory board or speaker fees for 10.13039/100006483AbbVie, 10.13039/100004326Bayer, Biolab, Intercept, 10.13039/501100014382Ipsen, 10.13039/100008799Gilead, 10.13039/100009947MSD, 10.13039/100004336Novartis, and 10.13039/100004337Roche. J.T.: Has received research grants from 10.13039/100004337Roche and 10.13039/501100014382Ipsen. He has received speaker and consulting honoraria from AstraZeneca, Amgen, Bayer Healthcare, Bristol Myers-Squibb, Eisai, Ipsen, Merck Serono, Merck Sharp & Dome, Lilly Imclone, and Roche. J. Bridgewater: Consultancy Bayer, BMS, Incyte, Taiho, Roche, MSD and Merck Serono. Research funding from Incyte. G.C.: Consultancy fees from Bayer, Ipsen. A.L.: Consultancy CAScination, Advisory Board Neuwave and Histosonics. H.T.: Speaker fees from AbbVie, Gilead, MSD, and Bayer. R.V.: Research grant from 10.13039/100006483Abbvie. A.M.M.P.: Speaker honorarium from Bayer, BMS, Boston Scientific and EISAI. Consulting honorarium from Bayer, AstraZeneca and EISAI. Advisory honorarium from Bayer, AstraZeneca and EISAI. Grants from 10.13039/100004326Bayer and 10.13039/100008497Boston Scientific. M.D.: Has received consulting and training fees from Bayer and Eisai. B.B.: Reports Consultancy for GenMab (paid to Institution); Advisory Boards for Roche (paid to Institution), Eisai Europe Limited (paid to Institution), research grant from 10.13039/100006436Celgene Ltd (paid to Institution), Speakers Bureau for Eisai Europe Limited (paid to Institution), Travel and registration for Congress from Bayer. L.d.F.: Lectures fees from BMS, Roche and Bayer. B.M.M.: Advisory/Speaker: Amgen, AstraZeneca, Bayer, BMS, Eisai, Ipsen, Merck, Roche, Sanoffi Genzyme, Taiho. Expert Testimony: Eisai, Roche. Travel: Eisai, Merck. Research: Sillajen (Individual); AstraZeneca, H3/Eisai, Galera, GSK, Exelixis (Institution). M.S.: Travel/ accommodation/meeting expenses: Bayer. Eisai. Speaker fees: Bayer. C.R.L.: Travel grants from 10.13039/100004326Bayer. M.R-G.: Reports grants from Intercept, grants from 10.13039/100005564Gilead-Sciences, personal fees from Shionogi, personal fees from Alfa-Wasserman, personal fees from Prosciento, personal fees from Kaleido, personal fees from Novonrdisk, personal fees from MSD, personal fees from BMS, personal fees from Allergan, personal fees from Boehriger-Ingelheim, personal fees from Zydus, personal fees from Intercept Pharma, personal fees from Gilead-Sciences, outside the submitted work. F.P.: Disclosures: Received speaker honoraria from Bayer, Roche, LKM-Biotoscana, RAFFO. Research Grants from INC Argentinean 10.13039/100013137National Institute of Corrections, 10.13039/100004337Roche. V.M.: Lectures sponsored by Bayer. G.B.: Advisory board Eli-Lilly and Incyte. M. Vergara: Travel grants from 10.13039/100004326Bayer, 10.13039/100008799Gilead, 10.13039/100009947MSD and 10.13039/100006483Abbvie. Lectures sponsored by Gilead, Abbvie, Intercept, and MSD. M.L.: Lectures and educational presentations: Abbvie. Travel/accommodation, meeting expenses covered by Bayer, Gilead, Abbvie. M.I.: Received speaker honoraria from Bayer, Gilead Sciences, BMS, Janssen, Ipsen, MSD, BTG-Boston Scientific, AbbVie, EISAI, and was consultant for BTG-Boston Scientific, Bayer, and Guerbet. M.R.: Consultancy: Bayer-Schering Pharma, BMS, Roche, Ipsen, AstraZeneca, Lilly, BTG/Paid conferences: Bayer-Schering Pharma, BMS, Gilead, Lilly/Research Grants: 10.13039/100004326Bayer-Schering Pharma, 10.13039/501100014382Ipsen. Please refer to the accompanying ICMJE disclosure forms for further details., (© 2021 The Authors.)
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- 2021
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127. Affect and engagement in healthy and unhealthy weight control behaviors in college women: An ecological momentary assessment study.
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Sala M, Linde JA, Crosby RD, and Pacanowski CR
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- Feeding Behavior, Female, Health Behavior, Humans, Universities, Ecological Momentary Assessment, Feeding and Eating Disorders
- Abstract
Purpose: The relationships between momentary affect and weight control behaviors have been extensively studied in samples of individuals with eating disorders, but we do not know that the established relationships translate to healthy college women. The current study examined the relationship between affect and weight control behaviors in healthy college women., Method: Female college students (N = 67) completed measures of negative affect, positive affect, healthy weight control behaviors, and unhealthy weight control behaviors across fourteen days using ecological momentary assessment., Results: Average daily negative affect was inversely associated with daily engagement in unhealthy weight control behaviors, but was not associated with healthy weight control behaviors. Average daily positive affect was not associated with daily engagement in healthy or unhealthy weight control behaviors., Conclusion: Negative affect was inversely associated with engagement in unhealthy weight control behaviors in this female undergraduate sample. Future studies should continue to elucidate the differences in the relationships in samples of individuals with ED psychopathology vs. healthy samples., (Copyright © 2020. Published by Elsevier Ltd.)
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- 2021
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128. Diagnostic, clinical, and personality correlates of food anxiety during a food exposure in patients diagnosed with an eating disorder.
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Levinson CA, Sala M, Murray S, Ma J, Rodebaugh TL, and Lenze EJ
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- Anorexia Nervosa therapy, Bulimia Nervosa therapy, Day Care, Medical, Depressive Disorder, Major psychology, Feeding and Eating Disorders psychology, Feeding and Eating Disorders therapy, Humans, Implosive Therapy, Obsessive-Compulsive Disorder psychology, Perfectionism, Stress Disorders, Post-Traumatic psychology, Anorexia Nervosa psychology, Anxiety psychology, Bulimia Nervosa psychology, Food, Meals psychology, Personality
- Abstract
Background: Eating disorders are characterized by high levels of anxiety, especially while eating. However, little is known about anxiety experienced during meals and specifically what other variables may impact such anxiety., Objective: We sought to further quantify and understand the relationship between food anxiety, eating disorders, and related correlates (e.g., comorbid diagnoses, personality)., Methods: In the current study [N = 42 participants diagnosed with an eating disorder (n = 36 participants with anorexia nervosa)], we quantified anxiety before, during, and after a meal using data from a food exposure session in a partial hospital eating disorder center. We examined diagnostic, personality, and clinical factors as correlates of food anxiety., Results: Participants were more likely to experience higher food anxiety if they had a current diagnosis of major depression, obsessive-compulsive disorder, or post-traumatic stress disorder (PTSD). Concern over mistakes was the strongest and most consistent correlate of food anxiety regardless of time during the meal that anxiety was assessed. Other significant correlates were fear of positive evaluation, social appearance anxiety, BMI, and trust., Conclusions: These findings show how diagnoses, perfectionism (concern over mistakes), and other correlates relate to anxiety during meals. Food exposure interventions may benefit from personalizations that address these factors., Level of Evidence: IV Evidence from a randomized control trial, but from the first session before effects of the design would be present.
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- 2019
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129. Affect, reward, and punishment in anorexia nervosa: a narrative overview.
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Sala M, Egbert AH, Lavender JM, and Goldschmidt AB
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- Anorexia Nervosa psychology, Humans, Affect physiology, Models, Psychological, Punishment, Reward
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Introduction: Anorexia nervosa (AN) is a serious psychiatric disorder that is difficult to treat and often follows a protracted course. A number of theoretical models have been proposed for the etiology and maintenance of AN. Two domains that have received substantial attention in the literature on AN are affect and reward/punishment processes. However, despite an overlap in the nature and implications of these processes, studies of AN addressing these constructs have typically investigated them independently., Purpose: The purpose of this narrative review is to integrate the literature on the role of affect, reward, and punishment in AN., Method: We provide a focused narrative overview of the literature relating to the affect, reward, and punishment in AN via a synthesis of recent reviews and meta-analyses., Results: We first describe several prominent affect and reward/punishment-based conceptualizations of AN, followed by a brief overview of the existing empirical literature in these domains., Conclusion: We provide a critical discussion of the disparate nature of these literatures in AN, including associated limitations. We then conclude with an extensive discussion of directions for future research that integrate the study of affect and reward/punishment processes in AN., Level of Evidence: Level V, narrative review.
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- 2018
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130. Meal and snack-time eating disorder cognitions predict eating disorder behaviors and vice versa in a treatment seeking sample: A mobile technology based ecological momentary assessment study.
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Levinson CA, Sala M, Fewell L, Brosof LC, Fournier L, and Lenze EJ
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- Adolescent, Adult, Anxiety psychology, Cell Phone, Ecological Momentary Assessment, Feeding and Eating Disorders psychology, Female, Humans, Male, Young Adult, Cognition physiology, Eating psychology, Feeding Behavior psychology, Feeding and Eating Disorders diagnosis, Snacks psychology
- Abstract
Individuals with eating disorders experience high anxiety when eating, which may contribute to the high relapse rates seen in the eating disorders. However, it is unknown if specific cognitions associated with such anxiety (e.g., fears of gaining weight) may lead to engagement in eating disorder behaviors (e.g., weighing oneself). Participants (N = 66) recently treated at a residential eating disorder facility and diagnosed with an eating disorder (primarily anorexia nervosa; n = 40; 60.6%) utilized a mobile application to answer questions about mealtime cognitions, anxiety, and eating disorder behaviors four times a day for one week. Hierarchical linear models using cross-lag analyses identified that there were quasi-causal (and sometimes reciprocal) within-person relationships between specific eating disorder cognitions and subsequent eating disorder behaviors. These cognitions predicted higher anxiety during the next meal and eating disorder pathology at one-month follow-up. Interventions personalized to target these specific cognitions in real time might reduce eating disorder relapse., (Copyright © 2018 Elsevier Ltd. All rights reserved.)
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- 2018
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131. HEPACONTROL. A program that reduces early readmissions, mortality at 60 days, and healthcare costs in decompensated cirrhosis.
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Morales BP, Planas R, Bartoli R, Morillas RM, Sala M, Casas I, Armengol C, and Masnou H
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- Aged, Emergency Service, Hospital statistics & numerical data, Female, Humans, Incidence, Kaplan-Meier Estimate, Liver Cirrhosis therapy, Male, Middle Aged, Patient Discharge, Prospective Studies, Retrospective Studies, Risk Factors, Spain epidemiology, Time Factors, Health Care Costs statistics & numerical data, Liver Cirrhosis economics, Liver Cirrhosis mortality, Monitoring, Physiologic methods, Patient Readmission statistics & numerical data
- Abstract
Background & Aims: Decompensated cirrhosis patients have an elevated incidence of early readmission, mortality and economic burden. The aims of HEPACONTROL were to reduce early readmission and to evaluate its impact on mortality and emergency department visits., Patients and Methods: Quasi-experimental study with control group which compared two cohorts of patients discharged after being admitted for cirrhosis-related complications. A prospective cohort (n=80), who followed the HEPACONTROL program, which began with a follow-up examination seven days after discharge at the Hepatology Unit Day Hospital and a retrospective cohort of patients (n=112), who had been given a standard follow-up. Outcome variables that were compared between both groups were early readmission rates, the number of emergency department visits post-discharge, financial costs and mortality., Results: The rate of early readmission was lower in the group with HEPACONTROL (11.3% vs 29.5%; P=.003). Also, the mean number of visits to the emergency department post-discharge (1.10±1.64 vs 1.71±2.36; P=.035), mortality at 60days (3.8% vs 14.3%; P=.016), and the cost of early readmission were all lower compared with the group with standard follow-up (P=.029)., Conclusions: HEPACONTROL decreases the incidence of early readmission the rate of emergency department visits and mortality at 60days in patients with decompensated cirrhosis, and it is cost-effective., (Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)
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- 2018
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132. Translating self-persuasion into an adolescent HPV vaccine promotion intervention for parents attending safety-net clinics.
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Baldwin AS, Denman DC, Sala M, Marks EG, Shay LA, Fuller S, Persaud D, Lee SC, Skinner CS, Wiebe DJ, and Tiro JA
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- Adolescent, Adult, Feasibility Studies, Female, Health Knowledge, Attitudes, Practice, Health Promotion, Humans, Interviews as Topic, Male, Middle Aged, Patient Acceptance of Health Care psychology, Qualitative Research, Vaccination, Papillomavirus Infections prevention & control, Papillomavirus Vaccines administration & dosage, Parents psychology, Persuasive Communication, Safety-net Providers
- Abstract
Objective: Self-persuasion is an effective behavior change strategy, but has not been translated for low-income, less educated, uninsured populations attending safety-net clinics or to promote human papillomavirus (HPV) vaccination. We developed a tablet-based application (in English and Spanish) to elicit parental self-persuasion for adolescent HPV vaccination and evaluated its feasibility in a safety-net population., Methods: Parents (N=45) of age-eligible adolescents used the self-persuasion application. Then, during cognitive interviews, staff gathered quantitative and qualitative feedback on the self-persuasion tasks including parental decision stage., Results: The self-persuasion tasks were rated as easy to complete and helpful. We identified six question prompts rated as uniformly helpful, not difficult to answer, and generated non-redundant responses from participants. Among the 33 parents with unvaccinated adolescents, 27 (81.8%) reported deciding to get their adolescent vaccinated after completing the self-persuasion tasks., Conclusions: The self-persuasion application was feasible and resulted in a change in parents' decision stage. Future studies can now test the efficacy of the tablet-based application on HPV vaccination., Practice Implications: The self-persuasion application facilitates verbalization of reasons for HPV vaccination in low literacy, safety-net settings. This self-administered application has the potential to be more easily incorporated into clinical practice than other patient education approaches., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)
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- 2017
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133. [Therapeutic decisions in the treatment of hepatocellular carcinoma and patterns of sorafenib use. Results of the international observational GIDEON trial in Spain].
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Turnes J, Díaz R, Hernandez-Guerra M, Gómez M, Castells L, Bustamante J, Espinosa MD, Fernández-Castroagudín J, Serrano T, Rendón P, Andrade R, Salgado M, Arenas J, Vergara M, Sala M, Polo BA, Granizo IM, Gonzálvez ML, and Viudez A
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- Aged, Aged, 80 and over, Antineoplastic Agents adverse effects, Carcinoma, Hepatocellular therapy, Combined Modality Therapy, Diarrhea chemically induced, Disease Progression, Disease-Free Survival, Dose-Response Relationship, Drug, Fatigue chemically induced, Female, Hand-Foot Syndrome etiology, Humans, Liver Neoplasms therapy, Male, Middle Aged, Niacinamide adverse effects, Niacinamide therapeutic use, Phenylurea Compounds adverse effects, Prospective Studies, Protein Kinase Inhibitors adverse effects, Salvage Therapy, Severity of Illness Index, Sorafenib, Spain, Treatment Outcome, Antineoplastic Agents therapeutic use, Carcinoma, Hepatocellular drug therapy, Liver Neoplasms drug therapy, Niacinamide analogs & derivatives, Phenylurea Compounds therapeutic use, Protein Kinase Inhibitors therapeutic use
- Abstract
Introduction: GIDEON is a non-interventional, prospective, international study that evaluated the safety of sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in daily clinical practice, including Child-Pugh B patients., Objectives: To analyze data collected in Spain on the safety and efficacy of sorafenib and treatment patterns., Methods: Data were collected during follow-up on demographic and disease characteristics, the initial dose used, treatment-emergent adverse events (AEs) and dose modifications. Overall survival was evaluated, as well as time to disease progression. Efficacy and safety were analyzed according to the Child-Pugh classification and the initial dose., Results: We included 143 patients from 19 Spanish hospitals. A total of 24.5% of the patients were Child-Pugh B. An initial dose of 400 mg/12 h was used in 90.9% of patients. In Child-Pugh A patients, dose modifications occurred more frequently and the treatment duration was longer. The incidence of AEs and drug-related AEs were similar in Child-Pugh A and B patients, although serious AEs were more frequent in Child-Pugh B patients. The most common AEs were diarrhea, fatigue and hand-foot skin reactions. The median overall survival was 384 days and was higher in Child-Pugh A patients (593 vs. 211 days in Child-Pugh B). The median time to disease progression was 177 days, similar in both subgroups., Conclusion: The safety profile of sorafenib in Spanish patients with unresectable HCC is independent of liver function. Child-Pugh status does not seem to influence the approach to sorafenib dosage or time to progression but does seem to be a strong prognostic factor for survival., (Copyright © 2015. Published by Elsevier Espana.)
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- 2015
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134. Treatment of hepatocellular carcinoma: is there an optimal strategy?
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Varela M, Sala M, Llovet JM, and Bruix J
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- Chemoembolization, Therapeutic, Clinical Trials as Topic, Combined Modality Therapy, Disease Progression, Humans, Liver Transplantation, Palliative Care, Carcinoma, Hepatocellular therapy, Liver Neoplasms therapy
- Abstract
The incidence of hepatocellular carcinoma is increasing worldwide and now it accounts for as many as 1 million deaths annually, representing the third cause of cancer-related death. Surveillance programmes in the population at risk, namely cirrhotic patients, aim to detect tumours at an early stage when benefit from effective therapy may be provided. Patients with early tumours (single tumours measuring less than 5 cm or with less than 3 nodules measuring less than 3 cm in size) constitute the early stage category. These patients may be treated with surgical resection, transplantation, or percutaneous ablation, and the 5-year survival rate will exceed 50%. Patients with more advanced disease constitute the intermediate-advanced stage. Intermediate stage includes individuals without cancer-related symptoms and absence of vascular invasion and/or extrahepatic spread. They may achieve a 50% survival rate at 3 years that can be expanded by transarterial chemoembolization. Symptomatic patients with more advanced disease have a survival rate of less than 20% at 3 years. In this group of patients the efficacy of new agents should be assessed in phase II trials or randomized controlled trials versus no treatment to determine the impact of any therapy on survival. Finally, patients with end-stage disease with heavily impaired liver function (Child-Pugh class C) or severe physical impairment (performance status 3-4) die within 6 months and should receive only symptomatic treatment.
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- 2003
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