24 results on '"Savy S"'
Search Results
2. Duration of preclinical, prodromal, and dementia stages of Alzheimer's disease in relation to age, sex, and APOE genotype
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Vermunt, L., Sikkes, S. A. M., van den Hout, A., Handels, R., Bos, I., van der Flier, W. M., Kern, S., Ousset, P. -J., Maruff, P., Skoog, I., Verhey, F. R. J., Freund-Levi, Y., Tsolaki, M., Wallin, A. K., Olde Rikkert, M., Soininen, H., Spiru, L., Zetterberg, H., Blennow, K., Scheltens, P., Muniz-Terrera, G., Visser, P. J., Vellas, B., Reynish, E., Ousset, P. J., Andrieu, S., Burns, A., Pasquier, F., Frisoni, G., Salmon, E., Michel, J. P., Zekry, D. S., Boada, M., Dartigues, J. F., Olde-Rikkert, M. G. M., Rigaud, A. S., Winblad, B., Malick, A., Sinclair, A., Frolich, L., Ribera, C., Touchon, J., Robert, P., Salva, A., Waldemar, G., Bullock, R., Rodriguez, G., Jones, R. W., Stiens, G., Stoppe, G., Eriksdotter Jonhagen, M., Cherubini, A., Lage, P. M., Gomez-Isla, T., Camus, V., Aguera-Morales, E., Lopez, F., Savy, S., Cantet, C., Coley, N., Psychiatrie & Neuropsychologie, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Med Staf Spec Psychiatrie (9), Neurology, Amsterdam Neuroscience - Neurodegeneration, NCA - neurodegeneration, APH - Personalized Medicine, APH - Methodology, Epidemiology and Data Science, Clinical Neuropsychology, and Zekry Berger, Dina Selma
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0301 basic medicine ,Apolipoprotein E ,Oncology ,Male ,NATIONAL INSTITUTE ,MILD COGNITIVE IMPAIRMENT ,Neurology ,Alzheimer`s disease Donders Center for Medical Neuroscience [Radboudumc 1] ,Time Factors ,Epidemiology ,Apolipoprotein E4 ,Disease ,RECOMMENDATIONS ,0302 clinical medicine ,Cerebrospinal fluid ,Genotype ,Longitudinal Studies ,Apolipoprotein E4/genetics ,Stage (cooking) ,Progression ,Health Policy ,Cognitive Dysfunction/pathology ,NEURODEGENERATION ,Alzheimer's disease ,Preclinical ,3. Good health ,PREVALENCE ,Psychiatry and Mental health ,Disease Progression ,lipids (amino acids, peptides, and proteins) ,Female ,ASSOCIATION WORKGROUPS ,APOE ,medicine.medical_specialty ,Amyloid ,Multistate model ,BETA-AMYLOID 1-42 ,Prodromal Symptoms ,tau Proteins ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,Sex Factors ,Developmental Neuroscience ,SDG 3 - Good Health and Well-being ,Alzheimer Disease ,Internal medicine ,mental disorders ,medicine ,Dementia ,Humans ,Biomarkers/cerebrospinal fluid ,Cognitive Dysfunction ,Alleles ,Aged ,Disease duration ,DECLINE ,business.industry ,tau Proteins/cerebrospinal fluid ,Alzheimer Disease/genetics/pathology ,medicine.disease ,Institutional repository ,Clinical setting ,030104 developmental biology ,Prodromal ,Positron-Emission Tomography ,ddc:618.97 ,RISK-FACTORS ,DIAGNOSTIC GUIDELINES ,Neurology (clinical) ,Geriatrics and Gerontology ,business ,030217 neurology & neurosurgery ,Biomarkers - Abstract
Introduction: We estimated the age-specific duration of the preclinical, prodromal, and dementia stages of Alzheimer's disease (AD) and the influence of sex, setting, apolipoprotein E (APOE) genotype, and cerebrospinal fluid tau on disease duration.Methods: We performed multistate modeling in a combined sample of 6 cohorts (n = 3268) with death as the end stage and estimated the preclinical, prodromal, and dementia stage duration.Results: The overall AD duration varied between 24 years (age 60) and 15 years (age 80). For individuals presenting with preclinical AD, age 70, the estimated preclinical AD duration was 10 years, prodromal AD 4 years, and dementia 6 years. Male sex, clinical setting, APOE epsilon 4 allele carriership, and abnormal cerebrospinal fluid tau were associated with a shorter duration, and these effects depended on disease stage.Discussion: Estimates of AD disease duration become more accurate if age, sex, setting, APOE, and cerebrospinal fluid tau are taken into account. This will be relevant for clinical practice and trial design. (C) 2019 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.
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- 2019
3. Physical Activity and Amyloid-β Brain Levels in Elderly Adults with Intact Cognition and Mild Cognitive Impairment
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de Souto Barreto, Philipe, Andrieu, Sandrine, Payoux, Pierre, Demougeot, Laurent, Rolland, Yves, Vellas, Bruno, Gillette-Guyonnet, Sophie, Carrié, Isabelle, Brigitte, Lauréane, Faisant, Catherine, Lala, Françoise, Delrieu, Julien, Combrouze, Emeline, Badufle, Carole, Zueras, Audrey, Cantet, Christelle, Gardette, Virginie, Morin, Christophe, Kan, Gabor Abellan Van, Dupuy, Charlotte, Caillaud, Céline, Ousset, Pierre-Jean, Willis, Sherry, Belleville, Sylvie, Gilbert, Brigitte, Fontaine, Francine, Dartigues, Jean-François, Marcet, Isabelle, Delva, Fleur, Foubert, Alexandra, Cerda, Sandrine, Cuffi, Marie-Noëlle, Costes, Corinne, Rouaud, Olivier, Manckoundia, Patrick, Quipourt, Valérie, Marilier, Sophie, Franon, Evelyne, Bories, Lawrence, Pader, Marie-Laure, Basset, Marie-France, Lapoujade, Bruno, Faure, Valérie, Tong, Michael Li Yung, Malick-Loiseau, Christine, Cazaban-Campistron, Evelyne, Desclaux, Françoise, Blatge, Colette, Dantoine, Thierry, Laubarie-Mouret, Cécile, Saulnier, Isabelle, Clément, Jean-Pierre, Picat, Marie-Agnès, Bernard-Bourzeix, Laurence, Willebois, Stéphanie, Désormais, Iléana, Cardinaud, Noëlle, Bonnefoy, Marc, Livet, Pierre, Rebaudet, Pascale, Gédéon, Claire, Burdet, Catherine, Terracol, Flavien, Pesce, Alain, Roth, Stéphanie, Chaillou, Sylvie, Louchart, Sandrine, Sudres, Kristelle, Lebrun, Nicolas, Barro-Belaygues, Nadège, Touchon, Jacques, Bennys, Karim, Gabelle, Audrey, Romano, Aurélia, Touati, Lynda, Marelli, Cécilia, Pays, Cécile, Robert, Philippe, Duff, Franck Le, Gervais, Claire, Gonfrier, Sébastien, Gasnier, Yves, Bordes, Serge, Begorre, Danièle, Carpuat, Christian, Khales, Khaled, Lefebvre, Jean-François, Idrissi, Samira Misbah El, Skolil, Pierre, Salles, Jean-Pierre, Dufouil, Carole, Lehéricy, Stéphane, Chupin, Marie, Mangin, Jean-François, Bouhayia, Ali, Allard, Michèle, Ricolfi, Frédéric, Dubois, Dominique, Martel, Marie Paule Bonceour, Cotton, François, Bonafé, Alain, Chanalet, Stéphane, Hugon, Françoise, Bonneville, Fabrice, Cognard, Christophe, Chollet, François, Voisin, Thierry, Peiffer, Sophie, Hitzel, Anne, Zanca, Michel, Monteil, Jacques, Darcourt, Jacques, Molinier, Laurent, Derumeaux, Hélène, Costa, Nadège, Vincent, Christian, Perret, Bertrand, Vinel, Claire, Savy, S, and Coley, N
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- 2015
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4. A Longitudinal Study of Transitions Between Informal and Formal Care in Alzheimer Disease Using Multistate Models in the European ICTUS Cohort
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Vellas, B., Reynish, E., Ousset, P.J., Andrieu, S., Burns, A., Pasquier, F., Frisoni, G., Salmon, E., Michel, J.P., Zekry, D.S., Boada, M., Dartigues, J.F., Olde-Rikkert, M.G.M., Rigaud, A.S., Winblad, B., Malick, A., Sinclair, A., Frölich, L., Scheltens, P., Ribera, C., Touchon, J., Robert, P., Salva, A., Waldmar, G., Bullock, R., Costa-Tsolaki, M., Rodriguez, G., Spiru, L., Jones, R.W., Stiens, G., Stoppe, G., Eriksdotter Jönhagen, M., Cherubini, A., Lage, P.M., Gomez-Isla, T., Camus, V., Agüera-Morales, E., Lopez, F., Savy, S., Cantet, C., Coley, N., Coley, Nicola, Gallini, Adeline, Garès, Valérie, Gardette, Virginie, and Andrieu, Sandrine
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- 2015
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5. Observations of the Creation of Hot Plasma in Solar Flares
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Savy, S. K., Uchida, Yutaka, editor, Kosugi, Takeo, editor, and Hudson, Hugh S., editor
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- 1996
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6. Predicting the Rate of Cognitive Decline in Alzheimer Disease
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Canevelli, Marco, Kelaiditi, Eirini, Del Campo, Natalia, Bruno, Giuseppe, Vellas, Bruno, Cesari, Matteo, Vellas, B., Reynish, E., Ousset, P. J., Andrieu, S., Burns, A., Pasquier, F., Frisoni, G., Salmon, E., Michel, J. P., Zekry, D. S., Boada, M., Dartigues, J. F., Olde Rikkert, M. G. M., Rigaud, A. S., Winblad, B., Malick, A., Sinclair, A., Frölich, L., Scheltens, P., Ribera, C., Touchon, J., Robert, P., Salva, A., Waldmar, G., Bullock, R., Costa Tsolaki, M., Rodriguez, G., Spiru, L., Jones, R. W., Stiens, G., Stoppe, G., Eriksdotter Jönhagen, M., Cherubini, A., Lage, P. M., Gomez Isla, T., Camus, V., Agüera Morales, E., Lopez, F., Savy, S., Cantet, C., Coley, N., Neurology, and Amsterdam Neuroscience - Neurodegeneration
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Male ,Aging ,medicine.medical_specialty ,Cognitive decline ,Neuropsychological Tests ,Prediction models ,Alzheimer disease ,Longitudinal studies ,Clinical Psychology ,Gerontology ,Geriatrics and Gerontology ,Psychiatry and Mental Health ,03 medical and health sciences ,0302 clinical medicine ,Alzheimer Disease ,Negatively associated ,Internal medicine ,medicine ,Humans ,Cognitive Dysfunction ,Prospective Studies ,Cognitive impairment ,Prospective cohort study ,Aged ,Mini–Mental State Examination ,030214 geriatrics ,medicine.diagnostic_test ,business.industry ,Cognition ,medicine.disease ,Multinomial logistic regression analysis ,Psychiatry and Mental health ,Disease Progression ,Female ,Alzheimer's disease ,business ,030217 neurology & neurosurgery - Abstract
Background: Different rates of cognitive progression have been observed among Alzheimer disease (AD) patients. The present study aimed at evaluating whether the rate of cognitive worsening in AD may be predicted by widely available and easy-to-assess factors. Methods: Mild to moderate AD patients were recruited in the ICTUS study. Multinomial logistic regression analysis was performed to measure the association between several sociodemographic and clinical variables and 3 different rates of cognitive decline defined by modifications (after 1 year of follow-up) of the Mini Mental State Examination (MMSE) score: (1) "slow" progression, as indicated by a decrease in the MMSE score ≤1 point; (2) "intermediate" progression, decrease in the MMSE score between 2 and 5 points; and (3) "rapid" progression, decrease in the MMSE score ≥6 points. Results: A total of 1005 patients were considered for the present analyses. Overall, most of the study participants (52%) exhibited a slow cognitive course. Higher ADAS-Cog scores at baseline were significantly associated with both "intermediate" and "rapid" decline. Conversely, increasing age was negatively associated with "rapid" cognitive worsening. Conclusions: A slow progression of cognitive decline is common among AD patients. The influence of age and baseline cognitive impairment should always be carefully considered when designing AD trials and defining study populations.
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- 2016
7. SOFT X-RAY PRE-FLARE EMISSION STUDIED IN YOHKOH-SXT IMAGES
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Fárník, F. and Savy, S. K.
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- 1998
8. A Longitudinal Study of Transitions Between Informal and Formal Care in Alzheimer Disease Using Multistate Models in the European ICTUS Cohort
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Coley, Nicola, primary, Gallini, Adeline, additional, Garès, Valérie, additional, Gardette, Virginie, additional, Andrieu, Sandrine, additional, Vellas, B., additional, Reynish, E., additional, Ousset, P.J., additional, Andrieu, S., additional, Burns, A., additional, Pasquier, F., additional, Frisoni, G., additional, Salmon, E., additional, Michel, J.P., additional, Zekry, D.S., additional, Boada, M., additional, Dartigues, J.F., additional, Olde-Rikkert, M.G.M., additional, Rigaud, A.S., additional, Winblad, B., additional, Malick, A., additional, Sinclair, A., additional, Frölich, L., additional, Scheltens, P., additional, Ribera, C., additional, Touchon, J., additional, Robert, P., additional, Salva, A., additional, Waldmar, G., additional, Bullock, R., additional, Costa-Tsolaki, M., additional, Rodriguez, G., additional, Spiru, L., additional, Jones, R.W., additional, Stiens, G., additional, Stoppe, G., additional, Eriksdotter Jönhagen, M., additional, Cherubini, A., additional, Lage, P.M., additional, Gomez-Isla, T., additional, Camus, V., additional, Agüera-Morales, E., additional, Lopez, F., additional, Savy, S., additional, Cantet, C., additional, and Coley, N., additional
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- 2015
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9. Les essais cliniques simulés : des avancées récentes
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Savy, N., primary, Savy, S., additional, and Andrieu, S., additional
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- 2014
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10. R162: Approche méthodologique du recrutement de patients
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Savy, N., primary, Mijoule, G., additional, and Savy, S., additional
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- 2010
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11. Shrinkage of Coronal X-Ray Loops
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Wang, J., primary, Shibata, K., additional, Nitta, N., additional, Slater, G. L., additional, Savy, S. K., additional, and Ogawara, Y., additional
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- 1997
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12. Impulsive X-Ray Brightenings in Solar Flares
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Savy, S. K.
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- 1996
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13. Comprehensive perioperative blood management in patients undergoing elective bypass cardiac surgery: Benefit effect of health care education and systematic correction of iron deficiency and anemia on red blood cell transfusion.
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Charbonneau H, Savy S, Savy N, Pasquié M, Mayeur N, Angles O, Balech V, Berthelot AL, Croute-Bayle M, Decramer I, Duterque D, Julien V, Mallet L, M'rini M, Quedreux JF, Richard B, Sidobre L, Taillefer L, Thibaud A, Abouliatim I, Berthoumieu P, Garcia O, Soula P, Vahdat O, Breil C, Brunel P, and Sciacca G
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- Humans, Male, Female, Prospective Studies, Aged, Middle Aged, Anemia, Iron-Deficiency prevention & control, Hematinics administration & dosage, Anemia therapy, Quality Improvement, Iron Deficiencies, Cardiac Surgical Procedures adverse effects, Retrospective Studies, Iron administration & dosage, France, Length of Stay statistics & numerical data, Erythrocyte Transfusion statistics & numerical data, Elective Surgical Procedures adverse effects, Perioperative Care methods, Cardiopulmonary Bypass adverse effects
- Abstract
Study Objective: The aim of this study was to investigate the efficacy of a two-step patient blood management (PBM) program in red blood cell (RBC) transfusion requirements among patients undergoing elective cardiopulmonary bypass (CPB) surgery., Design: Prospective, non-randomized, two-step protocol design., Setting: Cardiac surgery department of Clinique Pasteur, Toulouse, France., Patients: 897 patients undergoing for elective CPB surgery., Interventions: We conducted a two-steps protocol: PBMe and PBMc. PBMe involved a short quality improvement program for health care workers, while PBMc introduced a systematic approach to pre- and postoperative correction of deficiencies, incorporating iron injections, oral vitamins, and erythropoiesis-stimulating agents., Measurements: The PBM program's effectiveness was evaluated through comparison with a pre-PBM retrospective cohort after propensity score matching. The primary objective was the proportion of patients requiring RBC transfusions during their hospital stay. Secondary objectives were also analyzed., Main Results: After matching, 343 patients were included in each group. Primary outcomes were observed in 35.7% (pre-PBM), 26.7% (PBMe), and 21.1% (PBMc) of patients, resulting in a significant reduction (40.6%) in the overall RBC transfusion rate. Both the PBMe and PBMc groups exhibited significantly lower risks of RBC transfusion compared to the pre-PBM group, with adjusted odds ratios of 0.59 [95% CI 0.44-0.79] and 0.44 [95% CI 0.32-0.60], respectively. Secondary endpoints included reductions in transfusions exceeding 2 units, total RBC units transfused, administration of allogeneic blood products, and total bleeding volume recorded on Day 1. There were no significant differences noted in mortality rates or the duration of hospital stays., Conclusions: This study suggests that health care education and systematic deficiency correction are associated with reduced RBC transfusion rates in elective CPB surgery. However, further randomized, controlled studies are needed to validate these findings and refine their clinical application., Competing Interests: Declaration of competing interest All the authors declare no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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14. Striving for equitable vaccination coverage: Leveraging rapid coverage and community assessments during the COVID-19 pandemic to reach missed populations in Cambodia.
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R Mugali R, Ip H, Zikusooka A, Vong L, Bou S, Kros S, and Vandine O
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Amid the global response to the COVID-19 pandemic, Cambodia emerges as a notable exemplar, boasting a remarkable vaccination rate of 91% of its population by the end of 2021. This success can be attributed to a multifaceted approach encompassing strong governmental leadership, robust vaccine management, and effective risk communication. Despite notable success, challenges persisted in reaching unvaccinated segments of the population. Rapid Coverage and Community assessments (RCCAs) supported by UNICEF were deployed in 2022 and 2023 to support Government efforts in expanding vaccination reach to missed populations and bolster COVID-19 booster doses. RCCAs were conducted across 8 provinces, assessing 13,547 individuals from 87 low-coverage communes to identify not vaccinated people and understand their barriers. Overall, only seven percent missed any dose of C-19 vaccine, Disabilities and lack of education correlated with higher rates of zero doses (20.8% and 17.8%, respectively), with concerns about personal health conditions (25%) and adverse effects (10%) cited as top reasons for non-vaccination. RCCAs, differing from routine monitoring, utilized purposive sampling to identify barriers to vaccine access and uptake. Findings informed adaptive strategies by government and partners to enhance outreach in low-coverage areas. The RCCAs played a crucial role at the local level in ensuring vaccinations reached overlooked populations, providing innovative solutions and supporting UNICEF's national strategies. By the end of 2022, Cambodia achieved a high subnational coverage, contributing to a national coverage of 95% for primary doses and nearly 70% for the first booster for everyone above three years old. RCCAs also fostered local coordination, facilitating resource sharing, and coordinated action for more effective local outreach and community trust. Integration of RCCAs into national immunization programs is recommended to develop targeted outreach for underserved populations, including zero-dose children and communities. Cambodia's adaptation of RCCAs during the pandemic offers valuable insights into identifying and engaging missed populations, highlighting the importance of community involvement and targeted interventions for future pandemic preparedness, and achieving more equitable health outcomes in the longer-term., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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15. Investigating the Cognitive Style of Patients With Substance Use Disorder: A Cross-Sectional Study.
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Chawla S, Kazmi SS, Singh A, and Singh G
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Background The causal attributions we make to the events in our lives reflect our Cognitive Style. The use of substances can be precipitated by stressful life events, and substance use can be a result of maladaptive coping to alleviate negative effects in stressful situations. So, individuals with substance dependence may infer situations differently. The inferences made about the cause of these stressful events can give an understanding of their cognition and can further help in therapeutic interventions. Purpose The present study aims to assess the cognitive style of young patients with substance use disorder. Methods A cross-sectional research design was used and a total of 50 participants were chosen through purposive sampling from the in-patient departments of Psychiatric Hospitals and De-addiction centers. The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) was used to assess the specific substances used by the patients and the Cognitive Style Questionnaire-Short form (CSQ-SF) was used to assess the negative cognitive style of the patients. Results Results revealed a more negative cognitive style among young patients with Dual Substance Use than patients with Multiple Substance Use, indicating that patients with Substance Use Disorder tend to attribute stressful events to causes like internal (because of self), global (applicable to all domains of life) and stable (consistent), as well as the negative consequences (leading to other bad things) and self-worth implications (something wrong in self)., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Chawla et al.)
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- 2024
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16. Renal replacement therapy in patients on extracorporeal membrane oxygenation support: Who and how.
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Worku B, Khin S, Gaudino M, Gambardella I, Iannacone E, Ebrahimi H, Savy S, Voevidko L, Oribabor C, Hadjiangelis N, Desiraju B, and Gulkarov I
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- Humans, Renal Replacement Therapy, Retrospective Studies, Acute Kidney Injury, Extracorporeal Membrane Oxygenation
- Abstract
Patients undergoing extracorporeal membrane oxygenation (ECMO) support frequently develop renal failure requiring renal replacement therapy (RRT). RRT may be performed via a dialysis catheter based approach or via the ECMO circuit. We describe our experience with both techniques. A total of 68 patients undergoing ECMO support at our institution were retrospectively analyzed. Predictors of renal failure requiring RRT were determined. Patients undergoing RRT via a dialysis catheter were compared with those undergoing RRT via the ECMO circuit. 10 of the 68 patients required RRT support prior to ECMO. Of the remaining 58 patients, 25 (43%) required new RRT support on ECMO. Lower albumin levels and postcardiotomy shock were predictive of new renal failure requiring RRT on ECMO. RRT performed via the ECMO circuit demonstrated similar efficacy as via a dialysis catheter. Outcomes were much worse for patients requiring new RRT on ECMO support, with a doubling of the length of ECMO support and less that one-third the survival rate of patients not requiring RRT on ECMO support. New renal failure requiring RRT occurs in nearly one-half of patients on ECMO support, with poor outcomes. RRT may be performed via the ECMO circuit with similar efficacy as via a dialysis catheter.
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- 2021
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17. Attitudes of at-risk older adults about prevention of cardiovascular disease and dementia using eHealth: a qualitative study in a European context.
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Akenine U, Barbera M, Beishuizen CR, Fallah Pour M, Guillemont J, Rosenberg A, Coley N, Mangialasche F, Salo L, Savy S, Pols AJ, Andrieu S, Richard E, Soininen H, Moll van Charante E, and Kivipelto M
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- Aged, Attitude, Finland, France, Humans, Netherlands, Qualitative Research, Cardiovascular Diseases prevention & control, Dementia prevention & control, Telemedicine
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Objectives: Prevention of cardiovascular disease (CVD) and dementia is a key health priority among older adults. Understanding individuals' attitudes to, the prevention of these conditions, particularly when delivered through novel eHealth tools, could help in designing effective prevention programmes. The aim of the study was to explore the attitudes of older adults at increased risk of CVD and dementia regarding engagement in eHealth self-management prevention programmes, and to describe the facilitators and barriers., Design: A qualitative research approach was used. Data were collected through eight focus groups in Finland, France and the Netherlands. Data were analysed following the principles of grounded theory., Setting and Participants: Forty-four community-dwellers aged 65+ at risk of CVD were recruited from a previous trial cohort in Finland, and through general practices in France and the Netherlands., Results: The study identified three categories: access to reliable information, trust in the healthcare providers and burden and stigma of dementia. A core category was also identified: the interactive process of the three categories influencing engagement in self-management prevention programme. The categories were interconnected through an interactive process and influenced by the local healthcare culture and context which shaped them differently, becoming either facilitators or barriers to engage in eHealth self-management prevention programmes., Conclusions: The study emphasises the importance of considering the interactions between the identified categories in this study, grounded in the local healthcare culture and context in further developments of eHealth self-management interventions that aim to prevent CVD and dementia., Trial Registration Number: ISRCTN48151589., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)
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- 2020
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18. Using Poisson-gamma model to evaluate the duration of recruitment process when historical trials are available.
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Minois N, Lauwers-Cances V, Savy S, Attal M, Andrieu S, Anisimov V, and Savy N
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- Clinical Trials, Phase III as Topic, Computer Simulation, Humans, Models, Statistical, Monte Carlo Method, Multiple Myeloma therapy, Research Design, Clinical Trials as Topic methods, Patient Selection, Poisson Distribution
- Abstract
At the design of clinical trial operation, a question of a paramount interest is how long it takes to recruit a given number of patients. Modelling the recruitment dynamics is the necessary step to answer this question. Poisson-gamma model provides very convenient, flexible and realistic approach. This model allows predicting the trial duration using data collected at an interim time with very good accuracy. A natural question arises: how to evaluate the parameters of recruitment model before the trial begins? The question is harder to handle as there are no recruitment data available for this trial. However, if there exist similar completed trials, it is appealing to use data from these trials to investigate feasibility of the recruitment process. In this paper, the authors explore the recruitment data of two similar clinical trials (Intergroupe Francais du Myélome 2005 and 2009). It is shown that the natural idea of plugging the historical rates estimated from the completed trial in the same centres of the new trial for predicting recruitment is not a relevant strategy. In contrast, using the parameters of a gamma distribution of the rates estimated from the completed trial in the recruitment dynamic model of the new trial provides reasonable predictive properties with relevant confidence intervals. Copyright © 2017 John Wiley & Sons, Ltd., (Copyright © 2017 John Wiley & Sons, Ltd.)
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- 2017
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19. How to deal with the Poisson-gamma model to forecast patients' recruitment in clinical trials when there are pauses in recruitment dynamic?
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Minois N, Savy S, Lauwers-Cances V, Andrieu S, and Savy N
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Recruiting patients is a crucial step of a clinical trial. Estimation of the trial duration is a question of paramount interest. Most techniques are based on deterministic models and various ad hoc methods neglecting the variability in the recruitment process. To overpass this difficulty the so-called Poisson-gamma model has been introduced involving, for each centre, a recruitment process modelled by a Poisson process whose rate is assumed constant in time and gamma-distributed. The relevancy of this model has been widely investigated. In practice, rates are rarely constant in time, there are breaks in recruitment (for instance week-ends or holidays). Such information can be collected and included in a model considering piecewise constant rate functions yielding to an inhomogeneous Cox model. The estimation of the trial duration is much more difficult. Three strategies of computation of the expected trial duration are proposed considering all the breaks, considering only large breaks and without considering breaks. The bias of these estimations procedure are assessed by means of simulation studies considering three scenarios of breaks simulation. These strategies yield to estimations with a very small bias. Moreover, the strategy with the best performances in terms of prediction and with the smallest bias is the one which does not take into account of breaks. This result is important as, in practice, collecting breaks data is pretty hard to manage.
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- 2017
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20. Healthy Ageing Through Internet Counselling in the Elderly: the HATICE randomised controlled trial for the prevention of cardiovascular disease and cognitive impairment.
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Richard E, Jongstra S, Soininen H, Brayne C, Moll van Charante EP, Meiller Y, van der Groep B, Beishuizen CR, Mangialasche F, Barbera M, Ngandu T, Coley N, Guillemont J, Savy S, Dijkgraaf MG, Peters RJ, van Gool WA, Kivipelto M, and Andrieu S
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- Aged, Aged, 80 and over, Cost-Benefit Analysis, Female, Finland, France, Humans, Internet statistics & numerical data, Life Style, Male, Netherlands, Prospective Studies, Research Design, Risk Factors, Self-Management, Cardiovascular Diseases prevention & control, Cognitive Dysfunction prevention & control, Counseling methods, Healthy Aging
- Abstract
Introduction: Cardiovascular disease and dementia share a number of risk factors including hypertension, hypercholesterolaemia, smoking, obesity, diabetes and physical inactivity. The rise of eHealth has led to increasing opportunities for large-scale delivery of prevention programmes encouraging self-management. The aim of this study is to investigate whether a multidomain intervention to optimise self-management of cardiovascular risk factors in older individuals, delivered through an coach-supported interactive internet platform, can improve the cardiovascular risk profile and reduce the risk of cardiovascular disease and cognitive decline., Methods and Analysis: HATICE is a multinational, multicentre, prospective, randomised, open-label blinded end point (PROBE) trial with 18 months intervention. Recruitment of 2600 older people (≥65 years) at increased risk of cardiovascular disease will take place in the Netherlands, Finland and France. Participants randomised to the intervention condition will have access to an interactive internet platform, stimulating self-management of vascular risk factors, with remote support by a coach. Participants in the control group will have access to a static internet platform with basic health information.The primary outcome is a composite score based on the average z-score of the difference between baseline and 18 months follow-up values of systolic blood pressure, low-density-lipoprotein and body mass index. Main secondary outcomes include the effect on the individual components of the primary outcome, the effect on lifestyle-related risk factors, incident cardiovascular disease, mortality, cognitive functioning, mood and cost-effectiveness., Ethics and Dissemination: The study was approved by the medical ethics committee of the Academic Medical Center in Amsterdam, the Comité de Protection des Personnes Sud Ouest et Outre Mer in France and the Northern Savo Hospital District Research Ethics Committee in Finland.We expect that data from this study will result in a manuscript published in a peer-reviewed clinical open access journal., Trial Registration Number: ISRCTN48151589., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)
- Published
- 2016
- Full Text
- View/download PDF
21. Models for patients' recruitment in clinical trials and sensitivity analysis.
- Author
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Mijoule G, Savy S, and Savy N
- Subjects
- Bayes Theorem, Humans, Multicenter Studies as Topic, Poisson Distribution, Research Design statistics & numerical data, Clinical Trials as Topic, Models, Statistical, Patient Selection
- Abstract
Taking a decision on the feasibility and estimating the duration of patients' recruitment in a clinical trial are very important but very hard questions to answer, mainly because of the huge variability of the system. The more elaborated works on this topic are those of Anisimov and co-authors, where they investigate modelling of the enrolment period by using Gamma-Poisson processes, which allows to develop statistical tools that can help the manager of the clinical trial to answer these questions and thus help him to plan the trial. The main idea is to consider an ongoing study at an intermediate time, denoted t(1). Data collected on [0,t(1)] allow to calibrate the parameters of the model, which are then used to make predictions on what will happen after t(1). This method allows us to estimate the probability of ending the trial on time and give possible corrective actions to the trial manager especially regarding how many centres have to be open to finish on time. In this paper, we investigate a Pareto-Poisson model, which we compare with the Gamma-Poisson one. We will discuss the accuracy of the estimation of the parameters and compare the models on a set of real case data. We make the comparison on various criteria : the expected recruitment duration, the quality of fitting to the data and its sensitivity to parameter errors. We discuss the influence of the centres opening dates on the estimation of the duration. This is a very important question to deal with in the setting of our data set. In fact, these dates are not known. For this discussion, we consider a uniformly distributed approach. Finally, we study the sensitivity of the expected duration of the trial with respect to the parameters of the model : we calculate to what extent an error on the estimation of the parameters generates an error in the prediction of the duration.
- Published
- 2012
- Full Text
- View/download PDF
22. In vitro culture and expansion of human limbal epithelial cells.
- Author
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Mariappan I, Maddileti S, Savy S, Tiwari S, Gaddipati S, Fatima A, Sangwan VS, Balasubramanian D, and Vemuganti GK
- Subjects
- Amnion, Culture Media, Humans, Cell Culture Techniques, Epithelium, Corneal cytology
- Abstract
Limbal stem cells (LSCs) have an important role in the maintenance of the corneal surface epithelium, and autologous cultured limbal epithelial cell transplantations have contributed substantially to the treatment of the visually disabling condition known as LSC deficiency. In this protocol, we describe a method of establishing human limbal epithelial cell cultures by a feeder-free explant culture technique using a small limbal biopsy specimen and human amniotic membrane (hAM) as the culture substrate. This protocol is free of animal-derived products and involves the use of human recombinant growth factors. In addition, the recombinant cell dissociation enzyme TrypLE is used to replace trypsin and autologous serum replaces FBS. It takes approximately 2 weeks to establish a confluent monolayer from which approximately 3 x 10(6) cells can be harvested. This procedure can be adopted for both basic research purposes and clinical applications.
- Published
- 2010
- Full Text
- View/download PDF
23. Tips before you take that new job.
- Author
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Guthrie S
- Subjects
- Humans, Job Application, Personnel Selection statistics & numerical data, Personnel Turnover statistics & numerical data, Physician Assistants
- Published
- 2009
- Full Text
- View/download PDF
24. Bacteriological analysis of street foods in Pune.
- Author
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Chumber SK, Kaushik K, and Savy S
- Subjects
- Adult, Educational Status, Female, Humans, Hygiene, India epidemiology, Male, Middle Aged, Food Contamination, Food Handling, Food Microbiology
- Abstract
This study aimed to analyze the bacteriological profile of street foods sold in various parts of Pune city. A total of 75 randomly collected food samples were included in the study. Samples were processed for the presence of bacterial pathogens only. 88% of the food samples analyzed confirmed the presence of bacterial pathogens, indicating the need for stricter implementation of food sanitation practices to reduce the possible risk of transmission of infection on consumption of these foods. Other aspects related to the trade of street foods in the city like the age and sex profile of food vendors, educational status and the hygienic aspects involved in the preparation, selling and consumption of these items were also reviewed.
- Published
- 2007
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