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Sample records for multicenter european study

  1. Adjunctive corticosteroid therapy for Pneumocystis carinii pneumonia in AIDS: a randomized European multicenter open label study

    DEFF Research Database (Denmark)

    Nielsen, T L; Eeftinck Schattenkerk, J K; Jensen, B N

    1992-01-01

    Fifty-nine human immunodeficiency virus type-1-infected patients with a microscopically proven first episode of moderate to severe Pneumocystis carinii pneumonia (PCP) were enrolled into a randomized European multicenter study. The effect of adjunctive corticosteroid (CS) therapy was assessed on (a...

  2. Determinants of Patient-Physician Discordance in Global Assessment in Psoriatic Arthritis: A Multicenter European Study.

    Science.gov (United States)

    Desthieux, Carole; Granger, Benjamin; Balanescu, Andra Rodica; Balint, Peter; Braun, Jürgen; Canete, Juan D; Heiberg, Turid; Helliwell, Philip S; Kalyoncu, Umut; Kvien, Tore K; Kiltz, Uta; Niedermayer, Dora; Otsa, Kati; Scrivo, Rossana; Smolen, Josef; Stamm, Tanja A; Veale, Douglas J; de Vlam, Kurt; de Wit, Maarten; Gossec, Laure

    2016-12-20

    Patient-physician discordance in global assessment of disease activity concerns one-third of patients, but what does it reflect? We aimed to assess patient-physician discordance in psoriatic arthritis (PsA) and patient-reported domains of health (physical and psychological) associated with discordance. We analyzed the PsAID (Psoriatic Arthritis Impact of Disease), a cross-sectional, multicenter European study of patients with PsA according to expert opinion. Patient global assessment (PGA) and physician global assessment (PhGA) were rated on a 0-10 numeric rating scale. Discordance was defined as the difference (PGA-PhGA) and as the absolute difference |PGA-PhGA| ≥3 points. Determinants of PGA-PhGA were assessed by a stepwise multivariate linear regression among 12 physical and psychological aspects of impact: pain, skin problems, fatigue, ability to work/leisure, functional incapacity, feeling of discomfort, sleep disturbance, anxiety/fear, coping, embarrassment/shame, social participation, and depressive affects. In 460 patients (mean ± SD age 50.6 ± 12.9 years, 52.2% female, mean ± SD disease duration 9.5 ± 9.5 years, mean ± SD Disease Activity Index for Psoriatic Arthritis score 30.8 ± 32.4, and 40.4% undergoing treatment with biologic agents), the mean ± SD PGA was higher than the mean PhGA, with a mean absolute difference of 1.9 ± 1.8 points. Discordance defined by |PGA-PhGA| ≥3 of 10 concerned 134 patients (29.1%), and 115 patients (85.8% of the patients with discordance) had PGA>PhGA. Higher fatigue (β = 0.14), lower self-perceived coping (β = 0.23), and impaired social participation (β = 0.16) were independently associated with a higher difference (PGA-PhGA). Discordance concerned 29.1% of these patient/physician dyads, mainly by PGA>PhGA. Factors associated with discordance were psychological rather than physical domains of health. Discordance was more frequent in patients in remission, indicating

  3. European Maxillofacial Trauma (EURMAT) in children: a multicenter and prospective study

    NARCIS (Netherlands)

    Boffano, P.; Roccia, F.; Zavattero, E.; Dediol, E.; Uglešić, V.; Kovačič, Ž.; Vesnaver, A.; Konstantinović, V.S.; Petrović, M.; Stephens, J.; Kanzaria, A.; Bhatti, N.; Holmes, S.; Pechalova, P.F.; Bakardjiev, A.G.; Malanchuk, V.A.; Kopchak, A.V.; Galteland, P.; Mjøen, E.; Skjelbred, P.; Grimaud, F.; Fauvel, F.; Longis, J.; Corre, P.; Løes, S.; Lekven, N.; Laverick, S.; Gordon, P.; Tamme, T.; Akermann, S.; Karagozoglu, K.H.; Kommers, S.C.; Meijer, B.; Forouzanfar, T.

    2015-01-01

    Objective The aim of this study is to present and discuss the results of a European multicentre prospective study about pediatric maxillofacial trauma epidemiology during a year. Study Design The following data were recorded: gender, age, etiology, site of fracture, date of injury. Of the 3396 patie

  4. Multicenter European Prevalence Study of Neurocognitive Impairment and Associated Factors in HIV Positive Patients

    DEFF Research Database (Denmark)

    Haddow, Lewis J; Laverick, Rosanna; Daskalopoulou, Marina

    2017-01-01

    We conducted a cross-sectional study in 448 HIV positive patients attending five European outpatient clinics to determine prevalence of and factors associated with neurocognitive impairment (NCI) using computerized and pen-and-paper neuropsychological tests. NCI was defined as a normalized Z score...

  5. Serotonin transporter 5HTTLPR polymorphism and affective disorders: no evidence of association in a large European multicenter study.

    Science.gov (United States)

    Mendlewicz, Julien; Massat, Isabelle; Souery, Daniel; Del-Favero, Jurgen; Oruc, Lilijana; Nöthen, Markus M; Blackwood, Douglas; Muir, Walter; Battersby, Sharon; Lerer, Beny; Segman, Ronen H; Kaneva, Radka; Serretti, Alessandro; Lilli, Roberta; Lorenzi, Christian; Jakovljevic, Miro; Ivezic, Sladana; Rietschel, Marcella; Milanova, Vihra; Van Broeckhoven, Christine

    2004-05-01

    The available data from preclinical and pharmacological studies on the role of the serotonin transporter (5-HTT) support the hypothesis that a dysfunction in brain serotonergic system activity contributes to the vulnerability to affective disorders (AD). 5-HTT is the major site of serotonin reuptake into the presynaptic neuron, and it has been shown that the polymorphic repeat polymorphism in the 5-HTT promotor region (5-HTTLPR) may affect gene-transcription activity. 5-HTT maps to chromosome 17 at position 17q11.17-q12, and the 5-HTTLPR polymorphisms have been extensively investigated in AD with conflicting results. The present study tested the genetic contribution of the 5-HTTLPR polymorphism in a large European multicenter case-control sample, including 539 unipolar (UPAD), 572 bipolar patients (BPAD), and 821 controls (C). Our European collaboration has led to efforts to optimize a methodology that attenuates some of the major limitations of the case-control association approach. No association was found with primary psychiatric diagnosis (UPAD and BPAD) and with phenotypic traits (family history of AD, suicidal attempt, and presence of psychotic features). Our negative findings are not attributable to the lack of statistical power, and may contribute to clarify the role of 5-HTTLPR polymorphism in AD.

  6. A prospective multicenter European study on flexible ureterorenoscopy for the management of renal stone

    Science.gov (United States)

    Berardinelli, Francesco; Proietti, Silvia; Cindolo, Luca; Pellegrini, Fabrizio; Peschechera, Roberto; Derek, Hennessey; Dalpiaz, Orietta; Schips, Luigi; Giusti, Guido

    2016-01-01

    ABSTRACT Purpose The aim of this study was to describe the outcomes and the complications of retrograde intrarenal surgery (RIRS) for renal stones in a multi-institutional working group. Materials and Methods From 2012 to 2014, we conducted a prospective study including all RIRS performed for kidney stones in 4 European centers. Demographic information, disease characteristics, and perioperative and postoperative data were gathered. Patients and stone data, procedure characteristics, results and safety outcomes were analyzed and compared by descriptive statistics. Complications were reported using the standardized Clavien system. Results Three hundred and fifty-six patients underwent 377 RIRS with holmium laser lithotripsy for renal stones. The RIRS was completed in all patients with a mean operative time of 63.5 min. The stone-free status was confirmed endoscopically and through fluoroscopic imaging after the first procedure in 73.6%. The second procedure was performed in twenty patients (5.6%) achieving an overall stone free rate of 78.9%. The overall complication rate was 15.1%. Intra-operative and post-operative complications were seen in 24 (6.7%) and 30 (8.4%) cases, respectively. Conclusions RIRS is a minimally invasive procedure with good results in terms of stone-free and complications rate. PMID:27286110

  7. Sexual behavior of gender-dysphoric individuals before gender-confirming interventions: a European multicenter study.

    Science.gov (United States)

    Cerwenka, Susanne; Nieder, Timo O; Cohen-Kettenis, Peggy; De Cuypere, Griet; Haraldsen, Ira R Hebold; Kreukels, Baudewijntje P C; Richter-Appelt, Hertha

    2014-01-01

    A transsexual course of development that starts before puberty (early onset) or during or after puberty, respectively (late onset), may lead to diverse challenges in coping with sexual activity. The authors explored the sexual behavior of 380 adult male-to-female and female-to-male individuals diagnosed according to DSM-IV-TR criteria who had not yet undergone gender-confirming interventions. Data originated from the European Network for the Investigation of Gender Incongruence Initiative, conducted in Belgium, Germany, The Netherlands, and Norway. Information on outcome variables was collected using self-administered questionnaires at first clinical presentation. Compared with late-onset male-to-females, early-onset individuals tended to show sexual attraction toward males more frequently (50.5%), involve genitals less frequently in partner-related sexual activity, and consider penile sensations and orgasm as more negative. Early-onset female-to-males predominantly reported sexual attraction toward females (84.0%), whereas those with a late-onset more frequently showed other sexual attractions (41.7%). The study (a) shows that early- and late-onset male-to-females differ considerably with regard to coping strategies involving their body during sexual relations and (b) reveals initial insights into developmental pathways of late-onset female-to-males.

  8. Biological monitoring and questionnaire for assessing exposure to ethylenebisdithiocarbamates in a multicenter European field study.

    Science.gov (United States)

    Fustinoni, S; Campo, L; Liesivuori, J; Pennanen, S; Vergieva, T; van Amelsvoort, Lgpm; Bosetti, C; Van Loveren, H; Colosio, C

    2008-09-01

    This study deals with pesticide exposure profile in some European countries with a specific focus on ethylenebisdithiocarbamates (EBDC). In all, 55 Bulgarian greenhouse workers, 51 Finnish potato farmers, 48 Italian vineyard workers, 42 Dutch floriculture farmers, and 52 Bulgarian zineb producers entered the study. Each group was matched with a group of not occupationally exposed subjects. Exposure data were gained through self-administered questionnaires and measuring ethylenethiourea (ETU) in two spot urine samples collected, respectively, before the beginning of seasonal exposure (T0), and after 30 days, at the end of the exposure period (T30). Controls underwent a similar protocol. Study agriculture workers were involved in mixing and loading pesticides, application of pesticide mixture with mechanical or manual equipments, re-entry activities, and cleaning equipments. Chemical workers were involved in synthesis, quality controls, and packing activities. The number of pesticides to whom these subjects were exposed varied from one (zineb production) to eight (potato farmers). The use of personal protective devices was variegate and regarded both aerial and dermal penetration routes. EBDC exposure, assessed by T30 urinary ETU, was found to follow the order: greenhouse workers, zineb producers, vineyard workers, potato farmers, floriculture farmers with median levels of 49.6, 23.0, 11.8, 7.5, and 0.9 microg/g creatinine; the last group having ETU at the same level of controls (approximately 0.5 microg/g creatinine). Among agriculture workers, pesticide application, especially using manual equipment, seems to be the major determinant in explaining internal dose. Although the analysis of self-administered questionnaires evidenced difficulties especially related to lack and/or poor quality of reported data, biological monitoring confirms to be a powerful tool in assessing pesticide exposure.

  9. Endovascular Treatment of Visceral Aneurysms and Pseudoaneurysms: Long-term Outcomes from a Multicenter European Study

    Energy Technology Data Exchange (ETDEWEB)

    Spiliopoulos, Stavros, E-mail: stavspiliop@upatras.gr; Sabharwal, Tarun [Guy' s and St Thomas' Hospitals NHS Trust, Department of Interventional Radiology (United Kingdom); Karnabatidis, Dimitrios [Patras University Hospital, Department of Diagnostic and Interventional Radiology (Greece); Brountzos, Elias [Attikon University Hospital, 2nd Radiology Department (Greece); Katsanos, Konstantinos [Patras University Hospital, Department of Diagnostic and Interventional Radiology (Greece); Krokidis, Miltiadis; Gkoutzios, Panagiotis [Guy' s and St Thomas' Hospitals NHS Trust, Department of Interventional Radiology (United Kingdom); Siablis, Dimitrios [Patras University Hospital, Department of Diagnostic and Interventional Radiology (Greece); Adam, Andreas [Guy' s and St Thomas' Hospitals NHS Trust, Department of Interventional Radiology (United Kingdom)

    2012-12-15

    Purpose: To investigate the percutaneous endovascular management of visceral aneurysms (VA) and visceral pseudoaneurysms (VPA) treated in three European interventional radiology departments. Methods: Patient archives from the department's databases were examined and retrospectively analyzed. Patients diagnosed between 2000 and 2010 with VA and/or VPA, confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography and treated exclusively with percutaneous endovascular methods, were included in the study. The study's primary end points were procedural technical success, target lesion reintervention rate, and periprocedural mortality rate. Secondary end points included major and minor complications rates. Results: The medical records of 54 patients (41 male, mean age 55 {+-} 18.1 years) with 58 VAs or VPAs and treated with various percutaneous endovascular therapeutic modalities were analyzed. In total, 21 VAs (mean diameter 49.4 {+-} 21 mm, range 20-100 mm) and 37 VPAs (mean diameter 25.1 {+-} 14.6 mm, range 8-60 mm) were treated. Procedural technical success was achieved in 100% of the cases, while target lesion reintervention rate was 6.1% (2 of 33) and 14.2% (3 of 21) in the VPA and VA groups, respectively. Mean clinical follow-up period was 19.1 {+-} 21.4 months. Overall periprocedural mortality rate was 3% (1 of 33) in the VPA group and 0% (0 of 21) in the VA group. Conclusion: Percutaneous endovascular treatment of VAs and VPAs is safe and effective with low morbidity and mortality. There is a small but significant reintervention rate, particularly for true aneurysms; dedicated follow-up imaging is recommended. Successful aneurysm exclusion was achieved in all cases with a second procedure.

  10. European multicenter study on antimicrobial resistance in bacteria isolated from companion animal urinary tract infections

    DEFF Research Database (Denmark)

    Marques, Cátia; Gama, Luís Telo; Belas, Adriana

    2016-01-01

    of antimicrobial resistant bacteria causing urinary tract infection (UTI) in companion animals in Europe. The antimicrobial susceptibility of 22 256 bacteria isolated from dogs and cats with UTI was determined. Samples were collected between 2008 and 2013 from 16 laboratories of 14 European countries...

  11. Histological and clinical findings in patients with post-transplantation and classical encapsulating peritoneal sclerosis: a European multicenter study.

    Directory of Open Access Journals (Sweden)

    Joerg Latus

    Full Text Available Encapsulating peritoneal sclerosis (EPS commonly presents after peritoneal dialysis has been stopped, either post-transplantation (PT-EPS or after switching to hemodialysis (classical EPS, cEPS. The aim of the present study was to investigate whether PT-EPS and cEPS differ in morphology and clinical course.In this European multicenter study we included fifty-six EPS patients, retrospectively paired-matched for peritoneal dialysis (PD duration. Twenty-eight patients developed EPS after renal transplantation, whereas the other twenty-eight patients were classical EPS patients. Demographic data, PD details, and course of disease were documented. Peritoneal biopsies of all patients were investigated using histological criteria.Eighteen patients from the Netherlands and thirty-eight patients from Germany were included. Time on PD was 78(64-95 in the PT-EPS and 72(50-89 months in the cEPS group (p>0.05. There were no significant differences between the morphological findings of cEPS and PT-EPS. Podoplanin positive cells were a prominent feature in both groups, but with a similar distribution of the podoplanin patterns. Time between cessation of PD to the clinical diagnosis of EPS was significantly shorter in the PT-EPS group as compared to cEPS (4(2-9 months versus 23(7-24 months, p<0.001. Peritonitis rate was significantly higher in cEPS.In peritoneal biopsies PT-EPS and cEPS are not distinguishable by histomorphology and immunohistochemistry, which argues against different entities. The critical phase for PT-EPS is during the first year after transplantation and therefore earlier after PD cessation then in cEPS.

  12. Left-Sided Reoperations After Arterial Switch Operation: A European Multicenter Study.

    Science.gov (United States)

    Vida, Vladimiro L; Zanotto, Lorenza; Zanotto, Lucia; Stellin, Giovanni; Padalino, Massimo; Sarris, Georges; Protopapas, Eleftherios; Prospero, Carol; Pizarro, Christian; Woodford, Edward; Tlaskal, Thomas; Berggren, Hakan; Kostolny, Martin; Omeje, Ikenna; Asfour, Boulos; Kadner, Alexander; Carrel, Thierry; Schoof, Paul H; Nosal, Matej; Fragata, Josè; Kozłowski, Michał; Maruszewski, Bohdan; Vricella, Luca A; Cameron, Duke E; Sojak, Vladimir; Hazekamp, Mark; Salminen, Jukka; Mattila, Ilkka P; Cleuziou, Julie; Myers, Patrick O; Hraska, Viktor

    2017-09-01

    We sought to report the frequency, types, and outcomes of left-sided reoperations (LSRs) after an arterial switch operation (ASO) for patients with D-transposition of the great arteries (D-TGA) and double-outlet right ventricle (DORV) TGA-type. Seventeen centers belonging to the European Congenital Heart Surgeons Association (ECHSA) contributed to data collection. We included 111 patients who underwent LSRs after 7,951 ASOs (1.4%) between January 1975 and December 2010. Original diagnoses included D-TGA (n = 99) and DORV TGA-type (n = 12). Main indications for LSR were neoaortic valve insufficiency (n = 52 [47%]) and coronary artery problems (CAPs) (n = 21 [19%]). Median age at reoperation was 8.2 years (interquartile range [IQR], 2.9-14 years). Seven patients died early after LSRs (6.3%); 4 patients with D-TGA (5.9%) and 3 patients with DORV TGA-type (25%) (p = 0.02). Median age at last follow-up was 16.1 years (IQR, 9.9-21.8 years). Seventeen patients (16%) required another reoperation, which was more frequent in patients with DORV- TGA type (4 of 9 [45%]) than in patients with D-TGA (13 of 95 [14%]). Late death occurred in 4 patients (4 of 104 [3.8%]). The majority of survivors were asymptomatic at last clinical examination (84 of 100 [84%]). Reoperations for residual LSRs are infrequent but may become necessary late after an ASO, predominantly for neoaortic valve insufficiency and CAPs. Risk at reoperation is not negligible, and DORV TGA-type anatomy, as well as procedures on the coronary arteries, were significantly associated with a higher morbidity and a lower overall survival. Recurrent reoperations after LSRs may be required. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  13. Rufinamide for refractory focal seizures: an open-label, multicenter European study.

    Science.gov (United States)

    Coppola, Giangennaro; Zamponi, Nelia; Kluger, Gerhard; Mueller, Arndt; Anna Rita, Mazzotta; Parisi, Pasquale; Isone, Claudia; Santoro, Elena; Curatolo, Paolo; Verrotti, Alberto

    2013-01-01

    The present study aimed to assess the efficacy and tolerability of rufinamide as adjunctive drug for the treatment of a large series of children, adolescents and adults with refractory cryptogenic or symptomatic focal epilepsy. Patients were recruited in a prospective, add-on, open-label treatment study from six Italian and one German centers for pediatric and adolescent epilepsy care. Inclusion criteria were: (1) age 3 years or more; (2) diagnosis of cryptogenic or symptomatic focal epilepsy refractory to at least three previous antiepileptic drugs (AEDs), alone or in combination; (3) more than one seizure per month in the last 6 months; (4) use of at least one other AED, but no more than three, at baseline; (5) informed consent from parents and/or caregivers. Sixty-eight patients (40 males, 28 females), aged between 3 and 63 years (mean 19.9 years, median 16.0)±SD 12.58, with cryptogenic (28 pts, 41.2%) or symptomatic focal epilepsy (40 pts, 58.8%), were recruited in the study. After a mean follow-up period of 10.4±10.29 months, twenty-two patients (32.3%) had a 50-99% seizure reduction, and none became seizure-free. Twelve patients (17.6%) had a 25-49% seizure decrease, while in 30 (44.1%) seizure frequency was unchanged. A seizure worsening was reported in 5 patients (7.3%). A better response to rufinamide occurred in frontal lobe seizures (51.6%) and secondary generalized tonic-clonic seizures (50%). Rufinamide was effective against focal-onset seizures, particularly in the treatment of secondary generalized frontal lobe seizures. Copyright © 2012 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  14. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  15. Predicting sickness impact profile at six months after stroke: further results from the European multi-center CERISE study

    NARCIS (Netherlands)

    Stummer, C.A.; Verheyden, G.; Putman, K.; Jenni, W.; Schupp, W.; Wit, L. De

    2015-01-01

    PURPOSE: To develop prognostic models and equations for predicting participation at six months after stroke. METHODS: This European prospective cohort study recruited 532 consecutive patients from four rehabilitation centers. Participation was assessed at six months after stroke with the Sickness

  16. Laboratory diagnosis of endophthalmitis: comparison of microbiology and molecular methods in the European Society of Cataract & Refractive Surgeons multicenter study and susceptibility testing.

    Science.gov (United States)

    Seal, David; Reischl, Udo; Behr, Anke; Ferrer, Consuelo; Alió, Jorge; Koerner, Roland J; Barry, Peter

    2008-09-01

    To investigate and compare the use of molecular biology with the use of traditional Gram stain and organism culture for the laboratory diagnosis of postoperative endophthalmitis. Twenty-four ophthalmology units together with 9 microbiology laboratories and 2 European reference molecular biology laboratories. A prospective randomized partially masked multicenter cataract surgery study recruited 16 603 patients. This resulted in 29 cases of presumed postoperative endophthalmitis. Gram stain and culture were performed in the local laboratory according to agreed protocols. Samples of aqueous and/or vitreous were transported to the first referenced molecular biology laboratory (Regensburg, Germany) for polymerase chain reaction (PCR) testing, and an extracted aliquot of DNA was then referred to the second laboratory (Alicante, Spain) for PCR. Of the 29 who presented with presumed postoperative endophthalmitis, 20 were classified as proven infective endophthalmitis with positive Gram stain, culture, or PCR. Fourteen patients were culture-positive; all but 1 of these was also positive by PCR. Six patients were positive by PCR but negative by Gram stain or culture. Nine patients were negative by both microbiology and PCR testing. Use of molecular biology technique increased the laboratory rate of identifying the pathogen by 20%, confirming the technique is very useful for the endophthalmitis specimen. Samples of both aqueous and vitreous should be collected and stored at -20 degrees C for PCR at the time of the diagnostic taps.

  17. Risk of upper aerodigestive tract cancer and type of alcoholic beverage: a European multicenter case-control study.

    LENUS (Irish Health Repository)

    Marron, Manuela

    2012-07-01

    The general relationship between cancers of the upper aerodigestive tract (UADT) and alcohol drinking is established. Nevertheless, it is uncertain whether different types of alcoholic beverages (wine, beer and liquor) carry different UADT cancer risks. Our study included 2,001 UADT cancer cases and 2,125 controls from 14 centres in 10 European countries. All cases were histologically or cytologically confirmed squamous cell carcinomas. Controls were frequency matched by sex, age and centre. Logistic regression models were used to estimate odds ratios (OR) and 95 % confidence intervals (95 %CI) adjusted for age, sex, centre, education level, vegetable and fruit intake, tobacco smoking and alcohol drinking, where appropriate. Risk of beverage-specific alcohol consumption were calculated among \\'pure drinker\\' who consumed one beverage type exclusively, among \\'predominant drinkers\\' who consumed one beverage type to more than 66 % and among \\'mixed drinkers\\' who consumed more than one beverage type to similar proportions. Compared to never drinkers and adjusted for cumulative alcohol consumption, the OR and 95 %CI for wine, beer and liquor drinking, respectively, were 1.24 (0.86, 1.78), 1.54 (1.05, 2.27) and 0.94 (0.53, 1.64) among \\'pure drinkers\\' (p value for heterogeneity across beverage types = 0.306), 1.05 (0.76,1.47), 1.25 (0.87,1.79) and 1.43 (0.95, 2.16) among \\'predominant drinkers\\' (p value = 0.456), and 1.09 (0.79, 1.50), 1.20 (0.88, 1.63) and 1.12 (0.82, 1.53) among \\'mixed drinkers\\' (p value = 0.889). Risk of UADT cancer increased with increasing consumption of all three alcohol beverage types. Our findings underscore the strong and comparable carcinogenic effect of ethanol in wine, beer and liquor on organs of the UADT.

  18. Histological and clinical findings in patients with post-transplantation and classical encapsulating peritoneal sclerosis: A European multicenter study

    NARCIS (Netherlands)

    J. Latus (Joerg); S.M. Habib (Meelad); D. Kitterer (Daniel); M.R. Korte (Mario); C. Ulmer (Christoph); P. Fritz (Peter); S. Davies (Simon); M. Lambie (Mark); M.D. Alscher (M. Dominik); M.G.H. Betjes (Michiel); S. Segerer (Stephan); N. Braun (Niko)

    2014-01-01

    textabstractBackground: Encapsulating peritoneal sclerosis (EPS) commonly presents after peritoneal dialysis has been stopped, either post-transplantation (PT-EPS) or after switching to hemodialysis (classical EPS, cEPS). The aim of the present study was to investigate whether PT-EPS and cEPS differ

  19. Assault-related maxillofacial injuries: the results from the European Maxillofacial Trauma (EURMAT) multicenter and prospective collaboration

    NARCIS (Netherlands)

    Boffano, P.; Roccia, F.; Zavattero, E.; Dediol, E.; Uglešić, V.; Kovačič, Ž.; Vesnaver, A.; Konstantinović, V.S.; Petrović, M.; Stephens, J.; Kanzaria, A.; Bhatti, N.; Holmes, S.; Pechalova, P.F.; Bakardjiev, A.G.; Malanchuk, V.A.; Kopchak, A.V.; Galteland, P.; Mjøen, E.; Skjelbred, P.; Bertin, H.; Marion, F.; Guiol, J.; Corre, P.; Løes, S.; Lekven, N.; Laverick, S.; Gordon, P.; Tamme, T.; Akermann, S.; Karagozoglu, K.H.; Kommers, S.C.; Forouzanfar, T.

    2015-01-01

    Objective The aim of this study is to present and discuss the demographic characteristics and patterns of assault-related maxillofacial fractures as reported by a European multicenter prospective study. Study Design Demographic and injury data were recorded for each patient who was a victim of an as

  20. Original Paper Multicenter study on antibiotic susceptibility ...

    African Journals Online (AJOL)

    Multicenter study on antibiotic susceptibility/resistance trends in the western region of Cameroon ... This would be achieved with State support to public and private institutions. ... because of lack or insufficient knowledge on microbial life and ...

  1. Sentinel node biopsy in head and neck squamous cell cancer: 5-year follow-up of a European multicenter trial

    DEFF Research Database (Denmark)

    Alkureishi, Lee W T; Ross, Gary L; Shoaib, Taimur

    2010-01-01

    Sentinel node biopsy (SNB) may represent an alternative to elective neck dissection for the staging of patients with early head and neck squamous cell carcinoma (HNSCC). To date, the technique has been successfully described in a number of small single-institution studies. This report describes...... the long-term follow-up of a large European multicenter trial evaluating the accuracy of the technique....

  2. Self-Care for Common Colds by Primary Care Patients: A European Multicenter Survey on the Prevalence and Patterns of Practices—The COCO Study

    Science.gov (United States)

    Thielmann, Anika; Gerasimovska-Kitanovska, Biljana; Koskela, Tuomas H.; Mevsim, Vildan; Petrazzuoli, Ferdinando; Petek-Šter, Marija; Lingner, Heidrun; Hoffman, Robert D.; Tekiner, Selda; Chambe, Juliette; Edirne, Tamer; Hoffmann, Kathryn; Pirrotta, Enzo; Uludağ, Ayşegül; Kreitmayer Pestic, Sanda; Zielinski, Andrzej; Guede Fernández, Clara

    2016-01-01

    Background. Patients use self-care to relieve symptoms of common colds, yet little is known about the prevalence and patterns across Europe. Methods/Design. In a cross-sectional study 27 primary care practices from 14 countries distributed 120 questionnaires to consecutive patients (≥18 years, any reason for consultation). A 27-item questionnaire asked for patients' self-care for their last common cold. Results. 3,074 patients from 27 European sites participated. Their mean age was 46.7 years, and 62.5% were females. 99% of the participants used ≥1 self-care practice. In total, 527 different practices were reported; the age-standardized mean was 11.5 (±SD 6.0) per participant. The most frequent self-care categories were foodstuffs (95%), extras at home (81%), preparations for intestinal absorption (81%), and intranasal applications (53%). Patterns were similar across all sites, while the number of practices varied between and within countries. The most frequent single practices were water (43%), honey (42%), paracetamol (38%), oranges/orange juice (38%), and staying in bed (38%). Participants used 9 times more nonpharmaceutical items than pharmaceutical items. The majority (69%) combined self-care with and without proof of evidence, while ≤1% used only evidence-based items. Discussion. This first cross-national study on self-care for common colds showed a similar pattern across sites but quantitative differences. PMID:27738443

  3. Occupational noise, smoking, and a high body mass index are risk factors for age-related hearing impairment and moderate alcohol consumption is protective: a European population-based multicenter study.

    NARCIS (Netherlands)

    Fransen, E.; Topsakal, V.; Hendrickx, J.J.; Laer, L. van; Huyghe, J.R.; Eyken, E. van; Lemkens, N.; Hannula, S.; Maki-Torkko, E.; Jensen, M.; Demeester, K.; Tropitzsch, A.; Bonaconsa, A.; Mazzoli, M.; Espeso, A.; Verbruggen, K.; Huyghe, J.; Huygen, P.L.M.; Kunst, S.; Manninen, M.; Diaz-Lacava, A.; Steffens, M.; Wienker, T.F.; Pyykko, I.; Cremers, C.W.R.J.; Kremer, H.; Dhooge, I.; Stephens, D.; Orzan, E.; Pfister, M.; Bille, M.; Parving, A.; Sorri, M.; Heyning, P. van de; Camp, G. van

    2008-01-01

    A multicenter study was set up to elucidate the environmental and medical risk factors contributing to age-related hearing impairment (ARHI). Nine subsamples, collected by nine audiological centers across Europe, added up to a total of 4,083 subjects between 53 and 67 years. Audiometric data (pure-t

  4. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument.

    Science.gov (United States)

    Muysoms, Filip E; Vanlander, Aude; Ceulemans, Robrecht; Kyle-Leinhase, Iris; Michiels, Maarten; Jacobs, Ivo; Pletinckx, Pieter; Berrevoet, Frederik

    2016-11-01

    There is an increasing interest in patient-reported outcome measurement to evaluate hernia operations. Several hernia-specific quality of life (QoL) scales have been proposed, but none are constructed for preoperative assessment. The European Registry for Abdominal Wall Hernias (EuraHS) proposed the short, 9-question EuraHS-QoL instrument for assessment pre- and postoperatively. The EuraHS-QoL was evaluated in a prospective, multicenter validation study alongside the Visual Analogue Scale, Verbal Rating Scale, and Carolina Comfort Scale (https://clinicaltrials.gov; NCT01936584). We included 101 patients undergoing unilateral laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh. Clinical follow-up at 12 months was 87% complete. The EuraHS-QoL score shows good internal consistency (Cronbach's α ≥ .90), good test-retest reliability (Spearman correlation coefficient r ≥ 0.72), and high correlation for pain with the Visual Analogue Scale, the Verbal Rating Scale, the Carolina Comfort Scale pain scale (r between 0.64 and 0.86), and for restriction of activity with the Carolina Comfort Scale movement scale (r between 0.65 and 0.79). Our results show significant improvement in quality of life at 3 weeks compared with preoperative and further significant improvement at 12 months (P 75%) or with a 95%) in the majority of the patients. The EuraHS-QoL instrument is a short and valid patient-reported outcome measurement following groin hernia repair. Laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh results in a favorable outcome and significant improvement of quality of life compared with the preoperative assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. A multicenter study confirms CD226 gene association with systemic sclerosis-related pulmonary fibrosis

    NARCIS (Netherlands)

    Bossini-Castillo, L.; Simeon, C.P.; Beretta, L.; Broen, J.C.A.; Vonk, M.C.; Rios-Fernandez, R.; Espinosa, G.; Carreira, P.; Camps, M.T.; Castillo, M.J.; Gonzalez-Gay, M.A.; Beltran, E.; Carmen Freire, M.; Narvaez, J.; Tolosa, C.; Witte, T.; Kreuter, A.; Schuerwegh, A.J.; Hoffmann-Vold, A.M.; Hesselstrand, R.; Lunardi, C.; Laar, J.M. van; Chee, M.M.; Herrick, A.; Koeleman, B.P.; Denton, C.P.; Fonseca, C.; Radstake, T.R.D.J.; Martin, J.; Spanish Scleroderma, G.

    2012-01-01

    INTRODUCTION: CD226 genetic variants have been associated with a number of autoimmune diseases and recently with systemic sclerosis (SSc). The aim of this study was to test the influence of CD226 loci in SSc susceptibility, clinical phenotypes and autoantibody status in a large multicenter European

  6. A multicenter study confirms CD226 gene association with systemic sclerosis-related pulmonary fibrosis

    NARCIS (Netherlands)

    Bossini-Castillo, L.; Simeon, C.P.; Beretta, L.; Broen, J.C.A.; Vonk, M.C.; Rios-Fernandez, R.; Espinosa, G.; Carreira, P.; Camps, M.T.; Castillo, M.J.; Gonzalez-Gay, M.A.; Beltran, E.; Carmen Freire, M.; Narvaez, J.; Tolosa, C.; Witte, T.; Kreuter, A.; Schuerwegh, A.J.; Hoffmann-Vold, A.M.; Hesselstrand, R.; Lunardi, C.; Laar, J.M. van; Chee, M.M.; Herrick, A.; Koeleman, B.P.; Denton, C.P.; Fonseca, C.; Radstake, T.R.D.J.; Martin, J.; Spanish Scleroderma, G.

    2012-01-01

    INTRODUCTION: CD226 genetic variants have been associated with a number of autoimmune diseases and recently with systemic sclerosis (SSc). The aim of this study was to test the influence of CD226 loci in SSc susceptibility, clinical phenotypes and autoantibody status in a large multicenter European

  7. Implementation of departmental quality strategies is positively associated with clinical practice: results of a multicenter study in 73 hospitals in 7 European countries.

    NARCIS (Netherlands)

    Suñol, R.; Wagner, C.; Arah, O.A.; Kristensen, S.; Pfaff, H.; Klazinga, N.; Thompson, C.A.; Wang, A.; DerSarkissian, M.; Bartels, P.; Michel, P.; Groene, O.

    2015-01-01

    Background: Given the amount of time and resources invested in implementing quality programs in hospitals, few studies have investigated their clinical impact and what strategies could be recommended to enhance its effectiveness. Objective: To assess variations in clinical practice and explore

  8. Preoperative high-resolution magnetic resonance imaging can identify good prognosis stage I, II, and III rectal cancer best managed by surgery alone: a prospective, multicenter, European study.

    Science.gov (United States)

    Taylor, Fiona G M; Quirke, Philip; Heald, Richard J; Moran, Brendan; Blomqvist, Lennart; Swift, Ian; Sebag-Montefiore, David J; Tekkis, Paris; Brown, Gina

    2011-04-01

    To assess local recurrence, disease-free survival, and overall survival in magnetic resonance imaging (MRI)-predicted good prognosis tumors treated by surgery alone. The MERCURY study reported that high-resolution MRI can accurately stage rectal cancer. The routine policy in most centers involved in the MERCURY study was primary surgery alone in MRI-predicted stage II or less and in MRI "good prognosis" stage III with selective avoidance of neoadjuvant therapy. Data were collected prospectively on all patients included in the MERCURY study who were staged as MRI-defined "good" prognosis tumors. "Good" prognosis included MRI-predicted safe circumferential resection margins, with MRI-predicted T2/T3a/T3b (less than 5 mm spread from muscularis propria), regardless of MRI N stage. None received preoperative or postoperative radiotherapy. Overall survival, disease-free survival, and local recurrence were calculated. Of 374 patients followed up in the MERCURY study, 122 (33%) were defined as "good prognosis" stage III or less on MRI. Overall and disease-free survival for all patients with MRI "good prognosis" stage I, II and III disease at 5 years was 68% and 85%, respectively. The local recurrence rate for this series of patients predicted to have a good prognosis tumor on MRI was 3%. The preoperative identification of good prognosis tumors using MRI will allow stratification of patients and better targeting of preoperative therapy. This study confirms the ability of MRI to select patients who are likely to have a good outcome with primary surgery alone.

  9. Patch testing with fragrances: results of a multicenter study of the European Environmental and Contact Dermatitis Research Group with 48 frequently used constituents of perfumes

    DEFF Research Database (Denmark)

    Frosch, P J; Pilz, B; Andersen, Klaus Ejner

    1995-01-01

    ), citronellol (1) and amyl salicylate (1)). The remaining 41 fragrances were negative. 28 irritant or doubtful reactions on day 3/4 were observed to a total of 19 FF materials (more than 1 reaction: 5% citronellol (2), 1% amyl salicylate (2), 1% isononyl acetate (3), 0.1% musk xylol (2), 1% citral (2), and 1...... products, 3. soaps) of 400 commercial products on the US market had been determined. In a pilot study on a total of 1069 patients in 11 centres, the appropriate test concentration and vehicle were examined. For most fragrances, 1% and 5% were chosen, and petrolatum proved to be the best vehicle...

  10. Patch testing with fragrances: results of a multicenter study of the European Environmental and Contact Dermatitis Research Group with 48 frequently used constituents of perfumes

    DEFF Research Database (Denmark)

    Frosch, P J; Pilz, B; Andersen, Klaus Ejner

    1995-01-01

    The objective of this study was to determine the frequency of reactivity to a series of commonly used fragrances in dermatological patients. A total of 48 fragrances (FF) were chosen, based on the publication of Fenn in 1989 in which the top 25 constituents of 3 types (1. perfumes, 2. household...... mix (FM) and its 8 constituents. In patients with a positive reaction to any of the 48 FF, a careful history with regard to past or present reactions to perfumed products was taken. A total of 1323 patients were tested in 11 centres. The 8% FM was positive in 89 patients (8.3% of 1072 patients...

  11. Multilayered epithelium at the gastroesophageal junction is a marker of gastroesophageal reflux disease: data from a prospective Central European multicenter study (histoGERD trial).

    Science.gov (United States)

    Langner, Cord; Wolf, Eva-Maria; Plieschnegger, Wolfgang; Geppert, Michael; Wigginghaus, Bernd; Höss, Gabriele M; Eherer, Andreas; Schneider, Nora I; Rehak, Peter; Vieth, Michael

    2014-04-01

    Multilayered epithelium is defined as hybrid epithelium with characteristics of both squamous and columnar epithelia. Our aim was to evaluate the clinicopathological significance of the lesion by relating its presence to various histological and clinical and/or endoscopic features indicating gastroesophageal reflux disease (GERD). A total of 1,071 individuals participated in a prospective cross-sectional study (576 females and 495 males; median age 53 years). Biopsy material was systematically sampled from the gastroesophageal junction. The histological diagnosis of esophagitis was made according to the Esohisto consensus guidelines. The endoscopic diagnosis of esophagitis was made according to the modified Los Angeles classification and the diagnosis of Barrett's esophagus according to Prague's C & M criteria, respectively. Multilayered epithelium was identified in 103 (9.6 %) individuals, frequently within or adjacent to the ducts of esophageal glands. Its presence was associated with increasing age (p epithelium was associated with features of the squamous epithelium indicating GERD, particularly intercellular space dilation (p = 0.005), and presence of cardiac mucosa (epithelium was observed in about every tenth individual undergoing upper gastrointestinal endoscopy. The association with histological and clinical features indicating GERD advocates the lesion as a promising new marker for reflux esophagitis. The association with cardiac mucosa and Barrett's esophagus suggests multilayered epithelium to be an intermediate step in the development of columnar metaplasia and, ultimately, Barrett's esophagus.

  12. [Multicenter paragliding accident study 1990].

    Science.gov (United States)

    Lautenschlager, S; Karli, U; Matter, P

    1992-01-01

    During the period from 1.1.90 until 31.12.90, 86 injuries associated with paragliding were analyzed in a prospective study in 12 different Swiss hospitals with reference to causes, patterns, and frequencies. The injuries showed a mean score of over 2 and were classified as severe. Most frequent spine injuries (36%) and lesions of the lower extremity (35%) with a high risk of the ankles were diagnosed. One accident was fatal. 60% of the accidents happened during landing, 26% during launching and 14% during flight. Half of the pilots were affected during their primary training course. Most accidents were caused by inflight error of judgement--especially incorrect estimation of wind conditions--and further the choice of unfavourable landing sites. In contrast to previous injury-reports, only one equipment failure could be noted, but often the equipment was not corresponding with the experience and the weight of the pilot. To reduce the frequency of paragliding-injuries an accurate choice of equipment and an increased attention to environmental factors is mandatory. Furthermore an education-program regarding the attitude and intelligence of the pilot should be included in training courses.

  13. Coordination of international multicenter studies: governance and administrative structure

    Directory of Open Access Journals (Sweden)

    Bangdiwala Shrikant I.

    2003-01-01

    Full Text Available A well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. The organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented. The elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration. The experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (WorldSAFE, illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators.

  14. Invasive aspergillosis: results of multicenter study

    Directory of Open Access Journals (Sweden)

    N. N. Klimko

    2014-09-01

    Full Text Available We present the results of a multicenter study of 445 patients with “proven” and “probable” invasive aspergillosis (EORTC/MSG, 2008. Invasive aspergillosis usually occurs in patients with hematological malignancies (88 %, main underlying diseases were acute myeloid and acute lymphoblastic leukemia. The risk factors: prolonged agranulocytosis (64 %, cytostatic chemotherapy (57 %, corticosteroid treatment (45 %, and allogeneic hematopoietic stem cells transplantation (29 %. The pathogens – A. fumigatus (42 %, A. niger (33 %, and A. flavus (21 %. The main site of infection were lungs (86 %. 12 week overall survival was 83 %. Bronchoscopy use for the early diagnosis (p = 0.01, adequatetherapy with voriconazole (p = 0.002 and secondary antifungal prophylaxis (p = 0.0003 were positive prognostic factors for survival of patients with invasive aspergillosis.

  15. Histopathological evaluation of thrombus in patients presenting with stent thrombosis. A multicenter European study: a report of the prevention of late stent thrombosis by an interdisciplinary global European effort consortium†

    Science.gov (United States)

    Riegger, Julia; Byrne, Robert A.; Joner, Michael; Chandraratne, Sue; Gershlick, Anthony H.; ten Berg, Jurrien M.; Adriaenssens, Tom; Guagliumi, Giulio; Godschalk, Thea C.; Neumann, Franz-Josef; Trenk, Dietmar; Feldman, Laurent J.; Steg, Philippe Gabriel; Desmet, Walter; Alfonso, Fernando; Goodall, Alison H.; Wojdyla, Roman; Dudek, Dariusz; Philippi, Vanessa; Opinaldo, Sheryl; Titova, Anna; Malik, Nikesh; Cotton, James; Jhagroe, Darshni A.; Heestermans, Antonius A.C.M.; Sinnaeve, Peter; Vermeersch, Paul; Valina, Christian; Schulz, Christian; Kastrati, Adnan; Massberg, Steffen

    2016-01-01

    Background Stent thrombosis (ST) is a rare but serious complication following percutaneous coronary intervention. Analysis of thrombus composition from patients undergoing catheter thrombectomy may provide important insights into the pathological processes leading to thrombus formation. We performed a large-scale multicentre study to evaluate thrombus specimens in patients with ST across Europe. Methods Patients presenting with ST and undergoing thrombus aspiration were eligible for inclusion. Thrombus collection was performed according to a standardized protocol and specimens were analysed histologically at a core laboratory. Serial tissue cross sections were stained with haematoxylin–eosin (H&E), Carstairs and Luna. Immunohistochemistry was performed to identify leukocyte subsets, prothrombotic neutrophil extracellular traps (NETs), erythrocytes, platelets, and fibrinogen. Results Overall 253 thrombus specimens were analysed; 79 (31.2%) from patients presenting with early ST, 174 (68.8%) from late ST; 79 (31.2%) were from bare metal stents, 166 (65.6%) from drug-eluting stents, 8 (3.2%) were from stents of unknown type. Thrombus specimens displayed heterogeneous morphology with platelet-rich thrombus and fibrin/fibrinogen fragments most abundant; mean platelet coverage was 57% of thrombus area. Leukocyte infiltrations were hallmarks of both early and late ST (early: 2260 ± 1550 per mm2 vs. late: 2485 ± 1778 per mm2; P = 0.44); neutrophils represented the most prominent subset (early: 1364 ± 923 per mm2 vs. late: 1428 ± 1023 per mm2; P = 0.81). Leukocyte counts were significantly higher compared with a control group of patients with thrombus aspiration in spontaneous myocardial infarction. Neutrophil extracellular traps were observed in 23% of samples. Eosinophils were present in all stent types, with higher numbers in patients with late ST in sirolimus-and everolimus-eluting stents. Conclusion In a large-scale study of histological thrombus analysis from

  16. Acute necrotizing pancreatitis: a multicenter study.

    Science.gov (United States)

    Fernández-Cruz, L; Navarro, S; Valderrama, R; Sáenz, A; Guarner, L; Aparisi, L; Espi, A; Jaurietta, E; Marruecos, L; Gener, J

    1994-04-01

    A multicenter study of acute necrotizing pancreatitis (ANP) classified in accordance with the Balthazar criteria (grades D and E), has been performed in 12 teaching hospitals. A total of 233 patients were reviewed, and the mortality rate was 26.6%. The most common etiology was biliary pancreatitis (45.5%). Among the complications, shock, renal insufficiency, pulmonary insufficiency and hemorrhagic gastritis were associated with a mortality rate of 51-66%. Diffuse fluid collections were associated with a higher mortality rate (26.8%) than localized fluid collections (14.5%). In 106 patients with gallstone pancreatitis, early surgery was performed in 17, and 5 patients (29.4%) died. No mortality was observed in 32 patients with delayed surgery. Sphincterotomy was performed in 13 patients, and 4 (30.7%) died. Early surgery (necrosectomy and closed peritoneal lavage) was undertaken in 75 patients, with a mortality rate of 39%. In conclusion, the morbidity and mortality rates of ANP can be improved with proper monitoring, adequate supportive care and the judicious use of surgery based on clinical and morphological findings.

  17. Pirating European Studies

    Directory of Open Access Journals (Sweden)

    Natalia Timus

    2016-08-01

    Full Text Available Open Science has gained a lot of attention not only within the academic community but also among policy-makers. Some international publishers have been active in moving towards open access publications and research data, but, overall, modest results have been achieved so far. In this context, the digital piracy engines emerge as vital actors in disseminating and determining the impact of research. This study examines the Sci-Hub downloads data in order to uncover patterns of piracy in European Studies research. We identify journals and the subjects of articles that have been pirated the most. We also study the geographical distribution of download requests. The analysis reveals that the readers are mostly interested in subjects reflecting the current major European challenges, specifically populism and the economic crisis. Both developing countries as well as the ‘old’ EU members are active in illegal downloads.

  18. [Inguinofemoral hernia: multicenter study of surgical techniques].

    Science.gov (United States)

    Porrero, José L; Sánchez-Cabezudo, Carlos; Bonachía, Oscar; López-Buenadicha, Adolfo; Sanjuánbenito, Alfonso; Hidalgo, Manuel

    2005-07-01

    The present study was performed by the Spanish Association of surgeons through its abdominal wall and sutures section. The aim was to determine the current situation of inguinofemoral hernias in Spain and was based on an anonymous multicenter study with the participation of various national hospitals. Fifty general surgery departments in distinct surgical centers throughout Spain responded to an anonymous survey in 2000. The survey gathered data on anesthetic features, surgical techniques and complications in the treatment of inguinofemoral hernias. Sixty-six percent of hospital centers had a specific abdominal wall unit and 24% performed laparoscopic hernia surgery. Prosthetic techniques (especially Lichtenstein) were the most frequently used in the treatment of primary inguinal hernia (72%) and recurrent hernia (100%). The most frequently used prosthetic material was polypropylene mesh (76%). Only 28% of the departments surveyed performed anatomic techniques in the repair of primary inguinal hernia (Shouldice and Bassini). The most frequent treatment for femoral hernia was the Lichtenstein "plug" (78%). Sixty-eight percent of the centers surveyed performed regional anesthesia, 18% used general anesthesia and only 14% used local anesthesia with sedation. Severe complications were found in 20% of departments. Clinical postoperative follow-up was performed in 96% of the centers and telephone follow-up was used in 4%. The recurrence rate was 1.2% for primary inguinal hernia, 2.7% for recurrent inguinal hernia and 0.3% for femoral hernia. In Spain the most commonly used surgical technique in the treatment of inguinal hernia is Lichtenstein hernioplasty under spinal anesthesia and with polypropylene prosthesis. The Lichtenstein plug is the most commonly used technique in the treatment of femoral hernia.

  19. Multicenter observational prehospital resuscitation on helicopter study.

    Science.gov (United States)

    Holcomb, John B; Swartz, Michael D; DeSantis, Stacia M; Greene, Thomas J; Fox, Erin E; Stein, Deborah M; Bulger, Eileen M; Kerby, Jeffrey D; Goodman, Michael; Schreiber, Martin A; Zielinski, Martin D; O'Keeffe, Terence; Inaba, Kenji; Tomasek, Jeffrey S; Podbielski, Jeanette M; Appana, Savitri N; Yi, Misung; Wade, Charles E

    2017-07-01

    at any time point, although only 10% of the high-risk sample were able to be matched. Because of the unexpected imbalance in systolic blood pressure, Glasgow Coma Scale, and Injury Severity Score between systems with and without blood products on helicopters, matching was limited, and the results of this study are inconclusive. With few units transfused to each patient and small outcome differences between groups, it is likely large, multicenter, randomized studies will be required to detect survival differences in this important population. Level II.

  20. Infliximab-induced autoantibodies: a multicenter study.

    Science.gov (United States)

    Vaz, João Luiz Pereira; Fernandes, Vander; Nogueira, Felipe; Arnóbio, Adriano; Levy, Roger A

    2016-02-01

    The purpose of this study was to assess autoantibody incidence in patients treated with infliximab for various diseases, and the development of autoimmune diseases using a multicenter, longitudinal, open-label, phase IV observational study. All patients received anti-tumor necrosis factor (anti-TNF) according to local treatment guidelines. The autoantibodies assessed before and after infliximab treatment were ANA, anti-Sm, anti-dsDNA, anticardiolipin IgM/IgG, anti-Scl70, anti-centromere B, anti-chromatin, anti-ribosomal P, anti-Sm-RNP, anti-RNP A, anti-RNP 68 kD, anti-La/SSB, anti-Ro/SSA 52 kD and 60 kD, and anti-Jo1. ANA was determined by indirect immunofluorescence on HEp-2 cells (INOVA); the remaining was assessed using BioPlexTM 2200. The Fisher exact test, Wilcoxon test, and the McNemar were used when appropriate.Two hundred eighty-six patients were included (139 with rheumatoid arthritis, 77 with ankylosing spondylitis, 29 with inflammatory bowel disease, 27 with psoriatic arthritis, and 14 with psoriasis), 167 females and 119 males, with mean age of 46.3 years. Subjects received at least five infusions of infliximab (6-month treatment). A significant difference was observed in antinuclear antibody (ANA) detection between samplings (p = 0.001). Among patients that had ANA before treatment (n = 92), six became ANA-negative, 48 had increased titers, 29 maintained, and nine decreased titers after treatment; a total of 186 patients had a positive ANA after treatment. Fine speckled nuclear pattern was most commonly observed (both before and after infliximab treatment). The number of patients with anti-dsDNA had a statistically significant increase (p = 0.003). No significant differences were noted for anticardiolipin and the remaining autoantibodies tested. Among the 286 patients included in the study, only one (0.35 %) showed clinical signs of drug-induced lupus, presenting elevated ANA and anti-dsDNA titers that normalized once treatment was

  1. Allogeneic stem cell transplantation after reduced-intensity conditioning in patients with myelofibrosis: a prospective, multicenter study of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation.

    NARCIS (Netherlands)

    Kroger, N.; Holler, E.; Kobbe, G.; Bornhauser, M.; Schwerdtfeger, R.; Baurmann, H.; Nagler, A.; Bethge, W.; Stelljes, M.; Uharek, L.; Wandt, H.; Burchert, A.; Corradini, P.; Schubert, J.; Kaufmann, Martin; Dreger, P.; Wulf, G.G.; Einsele, H.; Zabelina, T.; Kvasnicka, H.M.; Thiele, J.; Brand, R.; Zander, A.R.; Niederwieser, D.; Witte, T.J.M. de

    2009-01-01

    From 2002 to 2007, 103 patients with primary myelofibrosis or postessential thrombocythemia and polycythemia vera myelofibrosis and a median age of 55 years (range, 32-68 years) were included in a prospective multicenter phase 2 trial to determine efficacy of a busulfan (10 mg/kg)/fludarabine (180 m

  2. Multicenter study with a direct acoustic cochlear implant

    NARCIS (Netherlands)

    Lenarz, T.; Zwartenkot, J.W.; Stieger, C.; Schwab, B.; Mylanus, E.A.M.; Caversaccio, M.; Kompis, M.; Snik, A.F.M.; D'Hondt, C.; Mojallal, H.

    2013-01-01

    OBJECTIVE: To confirm the clinical efficacy and safety of a direct acoustic cochlear implant. STUDY DESIGN: Prospective multicenter study. SETTING: The study was performed at 3 university hospitals in Europe (Germany, The Netherlands, and Switzerland). PATIENTS: Fifteen patients with severe-to-profo

  3. Lateralization in cluster headache: a Nordic multicenter study

    DEFF Research Database (Denmark)

    Meyer, Eva Laudon; Laurell, Katarina; Artto, Ville

    2009-01-01

    A slight predominance of cluster pain on the right side has been reported in several studies. The aim of this large retrospective Nordic multicenter study was to estimate the prevalence of right- and left-sided pain in cluster headache (CH) patients with side-locked pain, the prevalence of side...

  4. Neurophysiology versus clinical genetics in Rett syndrome: A multicenter study.

    Science.gov (United States)

    Halbach, Nicky; Smeets, Eric E; Julu, Peter; Witt-Engerström, Ingegerd; Pini, Giorgio; Bigoni, Stefania; Hansen, Stig; Apartopoulos, Flora; Delamont, Robert; van Roozendaal, Kees; Scusa, Maria F; Borelli, Paolo; Candel, Math; Curfs, Leopold

    2016-09-01

    Many studies have attempted to establish the genotype-phenotype correlation in Rett syndrome (RTT). Cardiorespiratory measurements provide robust objective data, to correlate with each of the different clinical phenotypes. It has important implications for the management and treatment of this syndrome. The aim of this study was to correlate the genotype with the quantitative cardiorespiratory data obtained by neurophysiological measurement combined with a clinical severity score. This international multicenter study was conducted in four European countries from 1999 to 2012. The study cohort consisted of a group of 132 well-defined RTT females aged between 2 and 43 years with extended clinical, molecular, and neurophysiological assessments. Diagnosis of RTT was based on the consensus criteria for RTT and molecular confirmation. Genotype-phenotype analyses of clinical features and cardiorespiratory data were performed after grouping mutations by the same type and localization or having the same putative biological effect on the MeCP2 protein, and subsequently on eight single recurrent mutations. A less severe phenotype was seen in females with CTS, p.R133C, and p.R294X mutations. Autonomic disturbances were present in all females, and not restricted to nor influenced by one specific group or any single recurrent mutation. The objective information from non-invasive neurophysiological evaluation of the disturbed central autonomic control is of great importance in helping to organize the lifelong care for females with RTT. Further research is needed to provide insights into the pathogenesis of autonomic dysfunction, and to develop evidence-based management in RTT. © 2016 Wiley Periodicals, Inc.

  5. Prevalence of smell loss in Parkinson's disease - A multicenter study

    NARCIS (Netherlands)

    Haehner, A.; Boesveldt, S.; Berendse, H.W.; Mackay-Sim, A.; Fleischman, J.; Silburn, P.A.; Johnston, A.N.; Mellick, G.D.; Herting, B.; Reichmann, H.; Hummel, T.

    2009-01-01

    Previous data on the prevalence of olfactory dysfunction in Parkinson's disease (PD) range from 45% to 90%. The present multicenter study aimed to provide data on the prevalence of smell loss in a large sample of PD patients from three independent populations. Olfactory sensitivity was tested in 400

  6. Cabergoline for Cushing's disease: a large retrospective multicenter study.

    Science.gov (United States)

    Ferriere, A; Cortet, C; Chanson, P; Delemer, B; Caron, P; Chabre, O; Reznik, Y; Bertherat, J; Rohmer, V; Briet, C; Raingeard, I; Castinetti, F; Beckers, A; Vroonen, L; Maiter, D; Cephise-Velayoudom, F L; Nunes, M L; Haissaguerre, M; Tabarin, A

    2017-03-01

    The efficacy of cabergoline in Cushing's disease (CD) is controversial. The aim of this study was to assess the efficacy and tolerability of cabergoline in a large contemporary cohort of patients with CD. We conducted a retrospective multicenter study from thirteen French and Belgian university hospitals. Sixty-two patients with CD received cabergoline monotherapy or add-on therapy. Symptom score, biological markers of hypercortisolism and adverse effects were recorded. Twenty-one (40%) of 53 patients who received cabergoline monotherapy had normal urinary free cortisol (UFC) values within 12 months (complete responders), and five of these patients developed corticotropic insufficiency. The fall in UFC was associated with significant reductions in midnight cortisol and plasma ACTH, and with clinical improvement. Compared to other patients, complete responders had similar median baseline UFC (2.0 vs 2.5xULN) and plasma prolactin concentrations but received lower doses of cabergoline (1.5 vs 3.5 mg/week, P 12 months), cabergoline was withdrawn in 28% of complete responders because of treatment escape or intolerance. Overall, sustained control of hypercortisolism was obtained in 23% of patients for 32.5 months (19-105). Nine patients on steroidogenesis inhibitors received cabergoline add-on therapy for 19 months (1-240). Hypercortisolism was controlled in 56% of these patients during the first year of treatment with cabergoline at 1.0 mg/week (0.5-3.5). About 20-25% of CD patients are good responders to cabergoline therapy allowing long-term control of hypercortisolism at relatively low dosages and with acceptable tolerability. No single parameter, including the baseline UFC and prolactin levels, predicted the response to cabergoline. © 2017 European Society of Endocrinology.

  7. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years.

    LENUS (Irish Health Repository)

    Rolfs, Arndt

    2011-01-01

    Stroke in the young has not been thoroughly investigated with most previous studies based on a small number of patients from single centers. Furthermore, recent reports indicate that Fabry disease may be a significant cause for young stroke. The primary aim of our study was to determine the prevalence of Fabry disease in young stroke patients, while the secondary aim was to describe patterns of stroke in young patients.

  8. RANDOMIZED EUROPEAN MULTICENTER TRIAL OF SURFACTANT REPLACEMENT THERAPY FOR SEVERE NEONATAL RESPIRATORY-DISTRESS SYNDROME - SINGLE VERSUS MULTIPLE DOSES OF CUROSURF

    NARCIS (Netherlands)

    SPEER, CP; ROBERTSON, B; CURSTEDT, T; HALLIDAY, HL; COMPAGNONE, D; GEFELLER, O; HARMS, K; HERTING, E; MCCLURE, G; REID, M; TUBMAN, R; HERIN, P; NOACK, G; KOK, J; KOPPE, J; VANSONDEREN, L; LAUFKOTTER, E; KOHLER, W; BOENISCH, H; ALBRECHT, K; HANSSLER, L; HAIM, M; OETOMO, SB; Okken, Albert; ALTFELD, PC; GRONECK, P; KACHEL, W; RELIER, JP; WALTI, H

    1992-01-01

    There is now convincing evidence that the severity of neonatal respiratory distress syndrome can be reduced by surfactant replacement therapy; however, the optimal therapeutic regimen has not been defined. This randomized European multicenter trial was designed to determine whether the beneficial ef

  9. [IDEFICS: a multicenter European project on diet- and lifestyle-related disorders in children].

    Science.gov (United States)

    Bammann, Karin; Peplies, Jenny; Pigeot, Iris; Ahrens, Wolfgang

    2007-03-15

    The environment of children has drastically changed in Europe during the last decades as reflected in unhealthy dietary habits and a sedentary lifestyle. Nutrition obviously plays a part in the development of overweight and obesity in childhood. However, dietary factors and physical activity are also involved in the development of metabolic syndrome, diabetes, cardiovascular diseases, osteoporosis, and postural deformities like scoliosis. To stop the resulting epidemic of diet- and lifestyle-induced morbidity, efficient evidence-based approaches are needed. These issues are the focus of IDEFICS (Identification and prevention of dietary- and lifestyle-induced health effects in children and infants), an Integrated Project within the 6th framework program of the European Commission. The IDEFICS consortium comprises 24 research centers and small or medium enterprises across Europe. One part of IDEFICS will investigate the etiology of selected diet- and lifestyle-related diseases in 2- to 10-year-old children. The impact of sensory perception and other internal and external triggers of children's food choices and consumer behavior will be studied in this context. Another part of IDEFICS will develop and evaluate strategies for the primary prevention of diet- and lifestyle-related diseases. The results of the project shall contribute to the development of harmonized European guidelines on diet and lifestyle for health promotion and disease prevention in children.

  10. Segmentation of age-related white matter changes in a clinical multi-center study

    DEFF Research Database (Denmark)

    Dyrby, Tim B.; Rostrup, E.; Baare, W.F.C.;

    2008-01-01

    Age-related white matter changes (WMC) are thought to be a marker of vascular pathology, and have been associated with motor and cognitive deficits. In the present study, an optimized artificial neural network was used as an automatic segmentation method to produce probabilistic maps of WMC......) pruning method in the training stage. Six optimized neural networks were produced to investigate the impact of different input information on WMC segmentation. The automatic segmentation method was applied to MR scans of 362 non-demented elderly subjects from 11 centers in the European multi-center study...... Leukoaraiosis And Disability (LADIS). Semi-manually delineated WMC were used for validating the segmentation produced by the neural networks. The neural network segmentation demonstrated high consistency between subjects and centers, making it a promising technique for large studies. For WMC volumes less than...

  11. Primary hepatic lymphoma: a retrospective, multicenter Rare Cancer Network study

    Directory of Open Access Journals (Sweden)

    Gamze Ugurluer

    2016-10-01

    Full Text Available Primary hepatic lymphoma (PHL is a rare malignancy. We aimed to assess the clinical profile, outcome and prognostic factors in PHL through the Rare Cancer Network (RCN. A retrospective analysis of 41 patients was performed. Median age was 62 years (range, 23- 86 years with a male-to-female ratio of 1.9:1.0. Abdominal pain or discomfort was the most common presenting symptom. Regarding B-symptoms, 19.5% of patients had fever, 17.1% weight loss, and 9.8% night sweats. The most common radiological presentation was multiple lesions. Liver function tests were elevated in 56.1% of patients. The most common histopathological diagnosis was diffuse large B-cell lymphoma (65.9%. Most of the patients received Chop-like (cyclophosphamide, doxorubicin, vincristine, and prednisone regimens; 4 patients received radiotherapy (dose range, 30.6-40.0 Gy. Median survival was 163 months, and 5- and 10-year overall survival rates were 77 and 59%, respectively. The 5- and 10-year disease-free and lymphoma-specific survival rates were 69, 56, 87 and 70%, respectively. Multivariate analysis revealed that fever, weight loss, and normal hemoglobin level were the independent factors influencing the outcome. In this retrospective multicenter RCN study, patients with PHL had a relatively better prognosis than that reported elsewhere. Multicenter prospective studies are still warranted to establish treatment guidelines, outcome, and prognostic factors.

  12. Primary Hepatic Lymphoma: A Retrospective, Multicenter Rare Cancer Network Study

    Science.gov (United States)

    Ugurluer, Gamze; Miller, Robert C.; Li, Yexiong; Thariat, Juliette; Ghadjar, Pirus; Schick, Ulrike; Ozsahin, Mahmut

    2016-01-01

    Primary hepatic lymphoma (PHL) is a rare malignancy. We aimed to assess the clinical profile, outcome and prognostic factors in PHL through the Rare Cancer Network (RCN). A retrospective analysis of 41 patients was performed. Median age was 62 years (range, 23-86 years) with a male-to-female ratio of 1.9:1.0. Abdominal pain or discomfort was the most common presenting symptom. Regarding B-symptoms, 19.5% of patients had fever, 17.1% weight loss, and 9.8% night sweats. The most common radiological presentation was multiple lesions. Liver function tests were elevated in 56.1% of patients. The most common histopathological diagnosis was diffuse large B-cell lymphoma (65.9%). Most of the patients received Chop-like (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimens; 4 patients received radiotherapy (dose range, 30.6-40.0 Gy). Median survival was 163 months, and 5- and 10-year overall survival rates were 77 and 59%, respectively. The 5- and 10-year disease-free and lymphoma-specific survival rates were 69, 56, 87 and 70%, respectively. Multivariate analysis revealed that fever, weight loss, and normal hemoglobin level were the independent factors influencing the outcome. In this retrospective multicenter RCN study, patients with PHL had a relatively better prognosis than that reported elsewhere. Multicenter prospective studies are still warranted to establish treatment guidelines, outcome, and prognostic factors. PMID:27746888

  13. Should we use laparoscopic adrenalectomy for metastases? Scandinavian multicenter study

    DEFF Research Database (Denmark)

    Marangos, Irina Pavlik; Kazaryan, Airazat M; Rosseland, Arne R;

    2009-01-01

    carcinoma, 5 lung carcinoma, 4 melanoma, and 1 hepatocellular metastases. The resection margin was not free in one case (3.7%). The median hospital stay was 2 (1-21) days. The median length of survival was 29 +/- 2.1 months for all patients. CONCLUSION: Laparoscopic adrenalectomy for metastases is feasible......INTRODUCTION: Laparoscopic adrenalectomy for metastases is considered controversial. Multicenter retrospective study was performed to gain new knowledge in this issue. MATERIALS AND METHODS: From January 1997 till November 2008, 41 adrenalectomies were performed during follow-up of the patients...... operated for malignant tumors. The median age was 64 (52-77) years. Metastases were confirmed in 31/41 cases. Metastatic lesions were further studied and to define factors influencing on survival, patients were divided to sub-groups of metachronous/synchronous, tumor origin and tumor size. RESULTS...

  14. Functional correlates of cognitive dysfunction in multiple sclerosis: A multicenter fMRI Study.

    Science.gov (United States)

    Rocca, Maria A; Valsasina, Paola; Hulst, Hanneke E; Abdel-Aziz, Khaled; Enzinger, Christian; Gallo, Antonio; Pareto, Debora; Riccitelli, Gianna; Muhlert, Nils; Ciccarelli, Olga; Barkhof, Frederik; Fazekas, Franz; Tedeschi, Gioacchino; Arévalo, Maria J; Filippi, Massimo

    2014-12-01

    In this multicenter study, we applied functional magnetic resonance imaging (fMRI) to define the functional correlates of cognitive dysfunction in patients with multiple sclerosis (MS). fMRI scans during the performance of the N-back task were acquired from 42 right-handed relapsing remitting (RR) MS patients and 52 sex-matched right-handed healthy controls, studied at six European sites using 3.0 Tesla scanners. Patients with at least two abnormal (<2 standard deviations from the normative values) neuropsychological tests at a standardized evaluation were considered cognitively impaired (CI). FMRI data were analyzed using the SPM8 software, modeling regions showing load-dependent activations/deactivations with increasing task difficulty. Twenty (47%) MS patients were CI. During the N-back load condition, compared to controls and CI patients, cognitively preserved (CP) patients had increased recruitment of the right dorsolateral prefrontal cortex. As a function of increasing task difficulty, CI MS patients had reduced activations of several areas located in the fronto-parieto-temporal lobes as well as reduced deactivations of regions which are part of the default mode network compared to the other two groups. Significant correlations were found between abnormal fMRI patterns of activations and deactivations and behavioral measures, cognitive performance, and brain T2 and T1 lesion volumes. This multicenter study supports the theory that a preserved fMRI activity of the frontal lobe is associated with a better cognitive profile in MS patients. It also indicates the feasibility of fMRI to monitor disease evolution and treatment effects in future studies.

  15. Epidemiology, severity classification, and outcome of moderate and severe traumatic brain injury: a prospective multicenter study

    NARCIS (Netherlands)

    Andriessen, T.M.J.C.; Horn, J.; Franschman, G.; Naalt, J. van der; Haitsma, I.; Jacobs, B.; Steyerberg, E.W.; Vos, P.E.

    2011-01-01

    Changes in the demographics, approach, and treatment of traumatic brain injury (TBI) patients require regular evaluation of epidemiological profiles, injury severity classification, and outcomes. This prospective multicenter study provides detailed information on TBI-related variables of 508 moderat

  16. Epidemiology, Severity Classification, and Outcome of Moderate and Severe Traumatic Brain Injury: A Prospective Multicenter Study

    NARCIS (Netherlands)

    T.M.J.C. Andriessen; J. Horn; G. Franschman; J. van der Naalt; I. Haitsma; B. Jacobs; E.W. Steyerberg; P.E. Vos

    2011-01-01

    Changes in the demographics, approach, and treatment of traumatic brain injury (TBI) patients require regular evaluation of epidemiological profiles, injury severity classification, and outcomes. This prospective multicenter study provides detailed information on TBI-related variables of 508 moderat

  17. A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder

    NARCIS (Netherlands)

    Chouinard, G; Saxena, B; Belanger, MC; Ravindran, A; Bakish, D; Beauclair, L; Morris, P; Nair, NPV; Manchanda, R; Reesal, R; Remick, R; O'Neill, MC

    1999-01-01

    Background: Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors. In a 12-week randomized, multicenter, double-blind trial, the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in

  18. Consensus strategy to quantitate malignant cells in myeloma patients is validated in a multicenter study

    NARCIS (Netherlands)

    Willems, P; Verhagen, O; Segeren, C; Veenhuizen, P; Guikema, J; Wiemer, E; Groothuis, L; Buitenweg-de Jong, T; Kok, H; Bloem, A; Bos, N; Vellenga, E; Mensink, E; Sonneveld, P; van der Schoot, HLE; Raymakers, R

    2000-01-01

    Recently the Belgium-Dutch Hematology-Oncology group initiated a multicenter study to evaluate whether myeloma patients treated with intensive chemotherapy benefit from additional peripheral stem cell transplantation. To determine treatment response accurately, we decided to quantitate malignant cel

  19. Epidemiology, Severity Classification, and Outcome of Moderate and Severe Traumatic Brain Injury : A Prospective Multicenter Study

    NARCIS (Netherlands)

    Andriessen, Teuntje M. J. C.; Horn, Janneke; Franschman, Gaby; van der Naalt, Joukje; Haitsma, Iain; Jacobs, Bram; Steyerberg, Ewout W.; Vos, Pieter E.

    2011-01-01

    Changes in the demographics, approach, and treatment of traumatic brain injury (TBI) patients require regular evaluation of epidemiological profiles, injury severity classification, and outcomes. This prospective multicenter study provides detailed information on TBI-related variables of 508 moderat

  20. New Predictive Hematologic Parameters in Chronic Rhinosinusitis: A Multicenter Study

    Directory of Open Access Journals (Sweden)

    Beyhan Yilmaz

    2016-12-01

    Full Text Available INTRODUCTION: Our aim was to investigate whether Neutrophil-Lymphocyte Ratio (NLR, Platelet-Lymphocyte Ratio (PLR and Mean Platelet Volume parameters (MPV may be utilized as inflammatory markers of chronic rhinosinusitis with nasal polyps (CRSwNP and without nasal polyps (CRSsNP. METHODS: This retrospective multicenter study was performed on 647 patients who were underwent endoscopic sinus surgery. Clinical and preoperative laboratory data of patients were screened retrospectively. The study and control groups were compared for the parameters NLR, PLR, MPV, neutrophils, lymphocytes, and platelets. RESULTS: Of the 647 patients, 313 were in the CRSwNP group, 334 were in the CRSsNP group. There were 93 individuals in the control group. NLR and PLR levels were significantly higher in study groups compared to control group (p < 0.001. But no statistically significant differences were identified between CRSwNP group and CRSsNP group in terms of NLR, PLR, MPV levels. DISCUSSION AND CONCLUSION: We speculate that high NLR and PLR values may be useful inflammatory indicator for CRSwNP and CRSsNP groups. We believe these parameters will have increasing clinical use in the future on treatment options and prognosis.

  1. European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay

    DEFF Research Database (Denmark)

    Krintus, Magdalena; Kozinski, Marek; Boudry, Pascal

    2014-01-01

    high sensitive cardiac troponin I (hs-cTnI) assay and its 99th percentile upper reference limit (URL). METHODS: Laboratories from nine European countries evaluated the ARCHITECT STAT high sensitive troponin I (hs-TnI) immunoassay on the ARCHITECT i2000SR/i1000SR immunoanalyzers. Imprecision, limit...... hs-cTnI assay and contemporary cTnI assay at 99th percentile cut-off was found to be 95%. TnI was detectable in 75% and 57% of the apparently healthy population using the lower (1.1 ng/L) and upper (1.9 ng/L) limit of the LoD range provided by the ARCHITECT STAT hs-TnI package insert, respectively....... The 99th percentile values were gender dependent. CONCLUSIONS: The new ARCHITECT STAT hs-TnI assay with improved analytical features meets the criteria of high sensitive Tn test and will be a valuable diagnostic tool....

  2. Serum calcium concentration and prostate cancer risk: a multicenter study.

    Science.gov (United States)

    Salem, Sepehr; Hosseini, Mostafa; Allameh, Farzad; Babakoohi, Shahab; Mehrsai, Abdolrasoul; Pourmand, Gholamreza

    2013-01-01

    This study sought to further evaluate the possible effects of serum calcium level on prostate cancer (PC) risk, with considering the age, body mass index (BMI), and sex steroid hormones. Using data from a prospective multicenter study, serum calcium concentration, as well as thorough demographic and medical characteristics, were determined in 194 cases with newly diagnosed, clinicopathologically confirmed PC and 317 controls, without any malignant disease, admitted to the same network of hospitals. Serum total and ionized calcium levels were categorized into tertiles. Multivariate logistic regression model was used to estimate odds ratios (OR) and corresponding 95% confidence intervals (CI) after adjustment for major potential confounders, including age, BMI, smoking, alcohol, education, occupation, marital status, family history of PC, and sex hormones level. The mean serum calcium level (±SD) in case and control groups was 9.22 (±0.46) mg/dl and 9.48 (±0.51) mg/dl, respectively (P < 0.001). After adjustment for mentioned confounders, a significant trend of decreasing risk was found for serum total calcium concentration (OR = 0.27, 95% CI = 0.12-0.59, comparing the highest with the lowest tertile) and ionized calcium (OR = 0.25, 95% CI = 0.10-0.58). An increase of 1 mg/dl in serum calcium level was associated with a significant decrease in PC risk (OR = 0.52; 95% CI = 0.34-0.76). Our findings reveal the inverse association between serum total and ionized concentrations and PC risk, which supports the hypothesis that calcium may protect against PC. Furthermore, no evidence was found regarding age, BMI, and sex steroid hormones to modify the association between serum calcium and PC risk.

  3. Divorce and Severity of Coronary Artery Disease: A Multicenter Study

    Directory of Open Access Journals (Sweden)

    Amin Daoulah

    2017-01-01

    Full Text Available The association between marital status and coronary artery disease (CAD is supported by numerous epidemiological studies. While divorce may have an adverse effect on cardiac outcomes, the relationship between divorce and severe CAD is unclear. We conducted a multicenter, observational study of consecutive patients undergoing coronary angiography during the period between April 1, 2013, and March 30, 2014. Of 1,068 patients, 124 (12% were divorced. Divorce was more frequent among women (27% compared to men (6%. Most divorced patients had been divorced only once (49%, but a subset had been divorced 2 (38% or ≥3 (12% times. After adjusting for baseline differences, there was no significant association between divorce and severe CAD in men. In women, there was a significant adjusted association between divorce and severe MVD (OR 2.31 [1.16, 4.59] or LMD (OR 5.91 [2.19, 15.99]. The modification of the association between divorce and severe CAD by gender was statistically significant for severe LMD (Pinteraction 0.0008 and marginally significant for CAD (Pinteraction 0.05. Among women, there was a significant adjusted association between number of divorces and severe CAD (OR 2.4 [95% CI 1.2, 4.5], MVD (OR 2.0 [95% CI 1.4, 3.0], and LMD (OR 3.4 [95% CI 1.9, 5.9]. In conclusion, divorce, particularly multiple divorces, is associated with severe CAD, MVD, and LMD in women but not in men.

  4. UDRIVE : the European naturalistic driving study.

    NARCIS (Netherlands)

    Eenink, R.G. Barnard, Y. Baumann, M. Augros, X. & Utesch, F.

    2014-01-01

    UDRIVE is the first large-scale European Naturalistic Driving Study on cars, trucks and powered two wheelers. The acronym stands for “European naturalistic Driving and Riding for Infrastructure & Vehicle safety and Environment”. Naturalistic driving can be defined as a study undertaken to provide in

  5. UDRIVE : the European naturalistic driving study.

    NARCIS (Netherlands)

    Eenink, R.G. Barnard, Y. Baumann, M. Augros, X. & Utesch, F.

    2014-01-01

    UDRIVE is the first large-scale European Naturalistic Driving Study on cars, trucks and powered two wheelers. The acronym stands for “European naturalistic Driving and Riding for Infrastructure & Vehicle safety and Environment”. Naturalistic driving can be defined as a study undertaken to provide in

  6. Multicenter follow-up study of ankle fracture surgery

    Institute of Scientific and Technical Information of China (English)

    XU Hai-lin; WANG Gang; WANG Guang-lin; WU Xin-bao; LIU Li-min; LI Xuan; ZHANG Dian-ying; FU Zhong-guo; WANG Tian-bing; ZHANG Pei-xun; JIANG Bao-guo; SHEN Hui-liang

    2012-01-01

    Background Few data on ankle fractures in China from large multicenter epidemiological and clinical studies are available.The aim of this research was to evaluate the epidemiological features and surgical outcomes of ankle fractures by reviewing 235 patients who underwent ankle fracture surgery at five hospitals in China.Methods This study included patients who underwent ankle fracture surgery at five Chinese hospitals from January 2000 to July 2009.Age,gender,mechanism of injury,Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture type,fracture pattern,length of hospital stay and treatment outcome were recorded.Statistical analyses were conducted using SPSS software.The American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale,visual analogue scale (VAS),and arthritis scale were used to evaluate outcome.Results Of 235 patients with ankle fractures,105 were male with an average age of 37.8 years and 130 were female with an average age of 47.3 years.The average follow-up period was 55.7 months.There were significant differences in the ratios of patients in different age groups between males and females,and in mechanisms of injury among different age groups.There were also significant differences in the length of hospital stay among different fracture types and mechanisms of injury.In healed fractures,the average AOFAS ankle-hindfoot score was 95.5,with an excellence rate of 99.6%,the average VAS score was 0.17,and the average arthritis score was 0.18.Movement of the injured ankle was significantly different to that of the uninjured ankle.There were no significant differences between AO fracture types,fracture patterns or follow-up periods and AOFAS score,but there were some significant differences between these parameters and ankle joint movements,pain VAS score and arthritis score.Conclusions Ankle fractures occur most commonly in middle-aged and young males aged 20-39 years and in elderly females aged 50-69 years.The most common mechanisms of

  7. [Enterococcal endocarditis: a multicenter study of 76 cases].

    Science.gov (United States)

    Martínez-Marcos, Francisco Javier; Lomas-Cabezas, José Manuel; Hidalgo-Tenorio, Carmen; de la Torre-Lima, Javier; Plata-Ciézar, Antonio; Reguera-Iglesias, José María; Ruiz-Morales, Josefa; Márquez-Solero, Manuel; Gálvez-Acebal, Juan; de Alarcón-González, Arístides

    2009-12-01

    Although enterococci occupy the third position among microorganisms producing infectious endocarditis (IE) following streptococci and Staphylococcus aureus, few multicenter studies have provided an in-depth analysis of enterococcal IE. Description of the characteristics of 76 cases of enterococcal left-sided infectious endocarditis (LSIE) (native: 59, prosthetic: 17) retrieved from the database of the Cardiovascular Infections Study Group of the Andalusian Society of Infectious Diseases, with emphasis on the comparison with non-enterococcal LSIE. Enterococci were the causal agent in 76 of the 696 episodes of LSIE (11%). Compared with non-enterococcal LSIE, enterococcal LSIE was more commonly seen in patients older than 65 (47.4% vs. 27.6%, P<0.0005), and those with chronic diseases (75% vs. 54.6%, P<0.001), calcified valves (18.6% vs. 10%, P<0.05), and previous urinary (30.3% vs. 2.1%, P<0.00001) or abdominal (10.5% vs. 3.1%, P<0.01) infections, and produced a higher rate of relapses (6.6% vs. 2.3%, P<0.05). Enterococcal LSIE was associated with fewer peripheral vascular or skin manifestations (14.5% vs. 27.1%, P<0.05) and fewer immunological phenomena (10.5% vs. 24%, P<0.01). Among the total of patients with enterococcal LSIE, 36.8% underwent valve surgery during hospitalization. In-hospital mortality was 32.9% for enterococcal LSIE, 9.3% for viridans group streptococci (VGS) LSIE and 48.6% for S. aureus LSIE (enterococci vs VGS: P<0.0001; enterococci vs S. aureus: P=0.02). Enterococcal LSIE patients treated with the combination of a penicillin or vancomycin plus an aminoglycoside (n=60) and those treated with ampicillin plus ceftriaxone (n=6) showed similar in-hospital mortality (26.7% vs 33.3%, P=0.66). High-level resistance to gentamicin was detected in 5 of 38 episodes of enterococcal LSIE (13.1%). Enterococcal LSIE appears in patients with well-defined clinical characteristics, and causes few peripheral vascular or skin manifestations and few immunological

  8. Mycobacterium tuberculosis pyrazinamide resistance determinants: a multicenter study.

    Science.gov (United States)

    Miotto, Paolo; Cabibbe, Andrea M; Feuerriegel, Silke; Casali, Nicola; Drobniewski, Francis; Rodionova, Yulia; Bakonyte, Daiva; Stakenas, Petras; Pimkina, Edita; Augustynowicz-Kopeć, Ewa; Degano, Massimo; Ambrosi, Alessandro; Hoffner, Sven; Mansjö, Mikael; Werngren, Jim; Rüsch-Gerdes, Sabine; Niemann, Stefan; Cirillo, Daniela M

    2014-10-21

    Pyrazinamide (PZA) is a prodrug that is converted to pyrazinoic acid by the enzyme pyrazinamidase, encoded by the pncA gene in Mycobacterium tuberculosis. Molecular identification of mutations in pncA offers the potential for rapid detection of pyrazinamide resistance (PZA(r)). However, the genetic variants are highly variable and scattered over the full length of pncA, complicating the development of a molecular test. We performed a large multicenter study assessing pncA sequence variations in 1,950 clinical isolates, including 1,142 multidrug-resistant (MDR) strains and 483 fully susceptible strains. The results of pncA sequencing were correlated with phenotype, enzymatic activity, and structural and phylogenetic data. We identified 280 genetic variants which were divided into four classes: (i) very high confidence resistance mutations that were found only in PZA(r) strains (85%), (ii) high-confidence resistance mutations found in more than 70% of PZA(r) strains, (iii) mutations with an unclear role found in less than 70% of PZA(r) strains, and (iv) mutations not associated with phenotypic resistance (10%). Any future molecular diagnostic assay should be able to target and identify at least the very high and high-confidence genetic variant markers of PZA(r); the diagnostic accuracy of such an assay would be in the range of 89.5 to 98.8%. Importance: Conventional phenotypic testing for pyrazinamide resistance in Mycobacterium tuberculosis is technically challenging and often unreliable. The development of a molecular assay for detecting pyrazinamide resistance would be a breakthrough, directly overcoming both the limitations of conventional testing and its related biosafety issues. Although the main mechanism of pyrazinamide resistance involves mutations inactivating the pncA enzyme, the highly diverse genetic variants scattered over the full length of the pncA gene and the lack of a reliable phenotypic gold standard hamper the development of molecular diagnostic

  9. The morbidity of laparoscopic radical cystectomy: analysis of postoperative complications in a multicenter cohort by the European Association of Urology (EAU)-Section of Uro-Technology.

    Science.gov (United States)

    Albisinni, Simone; Oderda, Marco; Fossion, Laurent; Varca, Virginia; Rassweiler, Jens; Cathelineau, Xavier; Chlosta, Piotr; De la Taille, Alexandre; Gaboardi, Franco; Piechaud, Thierry; Rimington, Peter; Salomon, Laurent; Sanchez-Salas, Rafael; Stolzenburg, Jens-Uwe; Teber, Dogu; Van Velthoven, Roland

    2016-02-01

    To analyze postoperative complications after laparoscopic radical cystectomy (LRC) and evaluate its risk factors in a large prospective cohort built by the ESUT across European centers involved in minimally invasive urology in the last decade. Patients were prospectively enrolled, and data were retrospectively analyzed. Only oncologic cases were included. There were no formal contraindications for LRC: Also patients with locally advanced tumors (pT4a), serious comorbidities, and previous major abdominal surgery were enrolled. All procedures were performed via a standard laparoscopic approach, with no robotic assistance. Early and late postoperative complications were graded according to the modified Clavien-Dindo classification. Multivariate logistic regression was performed to explore possible risk factors for developing complications. A total of 548 patients were available for final analysis, of which 258 (47%) experienced early complications during the first 90 days after LRC. Infectious, gastrointestinal, and genitourinary were, respectively, the most frequent systems involved. Postoperative ileus occurred in 51/548 (9.3%) patients. A total of 65/548 (12%) patients underwent surgical re-operation, and 10/548 (2%) patients died in the early postoperative period. Increased BMI (p = 0.024), blood loss (p = 0.021), and neoadjuvant treatment (p = 0.016) were significantly associated with a greater overall risk of experiencing complications on multivariate logistic regression. Long-term complications were documented in 64/548 (12%), and involved mainly stenosis of the uretero-ileal anastomosis or incisional hernias. In this multicenter, prospective, large database, LRC appears to be a safe but morbid procedure. Standardized complication reporting should be encouraged to evaluate objectively a surgical procedure and permit comparison across studies.

  10. Chasing the Effects of Pre-Analytical Confounders - A Multicenter Study on CSF-AD Biomarkers

    DEFF Research Database (Denmark)

    Leitão, Maria João; Baldeiras, Inês; Herukka, Sanna-Kaisa

    2015-01-01

    play an important role in the reliable measurement of these biomarkers across laboratories. AIM: In this study, we aim to surpass the efforts from previous studies, by employing a multicenter approach to assess the impact of less studied CSF pre-analytical confounders in AD-biomarkers quantification...

  11. Multicenter Study of Posaconazole Therapeutic Drug Monitoring: Exposure-Response Relationship and Factors Affecting Concentration

    OpenAIRE

    Dolton, Michael J; Ray, John E.; Chen, Sharon C.-A.; Ng, Kingsley; Pont, Lisa; McLachlan, Andrew J

    2012-01-01

    Posaconazole has an important role in the prophylaxis and salvage treatment of invasive fungal infections (IFIs), although poor and variable bioavailability remains an important clinical concern. Therapeutic drug monitoring of posaconazole concentrations has remained contentious, with the use of relatively small patient cohorts in previous studies hindering the assessment of exposure-response relationships. This multicenter retrospective study aimed to investigate relationships between posaco...

  12. Optimizing the definition of intrauterine growth restriction: the multicenter prospective PORTO Study.

    LENUS (Irish Health Repository)

    Unterscheider, Julia

    2013-04-01

    The objective of the Prospective Observational Trial to Optimize Pediatric Health in Intrauterine Growth Restriction (IUGR) (PORTO Study), a national prospective observational multicenter study, was to evaluate which sonographic findings were associated with perinatal morbidity and mortality in pregnancies affected by growth restriction, originally defined as estimated fetal weight (EFW) <10th centile.

  13. Performance of Ultrasound in the Diagnosis of Gout in a Multi-Center Study

    DEFF Research Database (Denmark)

    Ogdie, Alexis; Taylor, William J; Neogi, Tuhina

    2017-01-01

    OBJECTIVES: To examine the performance of ultrasound for the diagnosis of gout using presence of monosodium urate (MSU) crystals as the gold standard. METHODS: We analyzed data from the Study for Updated Gout Classification Criteria (SUGAR), a large, multi-center observational cross-sectional study...

  14. Conditions for exercising residents' voting rights in long-term care residences: a prospective multicenter study.

    Science.gov (United States)

    Bosquet, Antoine; El Massioui, Farid; Mahé, Isabelle

    2015-01-01

    To assess voting conditions in long-term care settings, we conducted a multicenter survey after the 2009 European elections in France. A questionnaire about voting procedures and European elections was proposed in 146 out of 884 randomized facilities. Sixty-four percent of facilities answered the questionnaire. Four percent of residents voted (national turnout: 40%), by proxy (58%) or at polling places (42%). Abstention related to procedural issues was reported in 32% of facilities. Sixty-seven percent of establishments had voting procedures, and 53% declared that they assessed residents' capacity to vote. Assistance was proposed to residents for voter registration, for proxy voting, and for voting at polling places, respectively, in 33%, 87%, and 80% of facilities. This survey suggests that residents may be disenfranchised and that more progress should be made to protect the voting rights of residents in long-term care facilities.

  15. LDL oxidative modification and carotid atherosclerosis : Results of a multicenter study

    NARCIS (Netherlands)

    Nyyssonen, K.; Kurl, S.; Karppi, J.; Nurmi, T.; Baldassarre, D.; Veglia, F.; Rauramaa, R.; de Faire, U.; Hamsten, A.; Smit, A. J.; Mannarino, E.; Humphries, S. E.; Giral, P.; Grossi, E.; Tremoli, E.

    2012-01-01

    Objective: Serum LDL conjugated diene concentration is a marker of oxidative modification of LDL. We investigated the relationship between LDL conjugated dienes and cross-sectional subclinical atherosclerosis assessed by carotid IMT in high-risk subjects of a multicenter study. Methods: Serum LDL co

  16. Outcome of HCV/HIV-coinfected liver transplant recipients: a prospective and multicenter cohort study.

    NARCIS (Netherlands)

    Miro, J.M.; Montejo, M.; Castells, L.; Rafecas, A.; Moreno, S.; Aguero, F.; Abradelo, M.; Miralles, P.; Torre-Cisneros, J.; Pedreira, J.D.; Cordero, E.; Rosa, G. De; Moyano, B.; Moreno, A.; Perez, I.; Rimola, A.; Barrera, P.

    2012-01-01

    Eighty-four HCV/HIV-coinfected and 252-matched HCV-monoinfected liver transplant recipients were included in a prospective multicenter study. Thirty-six (43%) HCV/HIV-coinfected and 75 (30%) HCV-monoinfected patients died, with a survival rate at 5 years of 54% (95% CI, 42-64) and 71% (95% CI, 66 to

  17. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study

    DEFF Research Database (Denmark)

    Giovannini, Marc; Thomas, Botelberge; Erwan, Bories

    2009-01-01

    AIM: To evaluate the ability of endoscopic ultrasound (EUS) elastography to distinguish benign from malignant pancreatic masses and lymph nodes. METHODS: A multicenter study was conducted and included 222 patients who underwent EUS examination with assessment of a pancreatic mass (n = 121) or lym...

  18. Simplified Therapeutic Intervention Scoring System : The TISS-28 items - Results from a multicenter study

    NARCIS (Netherlands)

    Miranda, DR; deRijk, A; Schaufeli, W

    Objectives: To validate a simplified version of the Therapeutic Intervention Scoring System, the TISS-28, and to determine the association of TISS-28 with the time spent on scored and nonscored nursing activities. Design: Prospective, multicenter study. Setting: Twenty-two adult medical, surgical,

  19. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  20. Crossroads in European Union Studies

    DEFF Research Database (Denmark)

    Lynggaard, Kennet; Löfgren, Karl; Manners, Ian James

    2015-01-01

    Over the past two decades the educational practices within EU studies have been challenged by the lack of comprehensive texts on research strategy, design and method useful for study programmes. Since the ‘comparative turn’ of the 1990s, where we saw a shift towards applying theories, analytical ...

  1. Cytomegalovirus Infection following Kidney Transplantation: a Multicenter Study of 3065 Cases

    OpenAIRE

    2012-01-01

    Background: Cytomegalovirus (CMV) infection is a common complication following kidney transplantation. Objective: To assess the incidence and risk factors of CMV infection among renal transplant recipients. Methods: In a retrospective multicenter study, 3065 renal transplant recipients from 17 transplant centers of Iran were studied between April 2008 and January 2011. Kidney transplant patients were routinely monitored by sequential blood samples drawn for use in the CMV-pp65 antigenemia ass...

  2. Crossroads in European Union Studies

    DEFF Research Database (Denmark)

    Lynggaard, Kennet; Löfgren, Karl; Manners, Ian James

    2015-01-01

    Over the past two decades the educational practices within EU studies have been challenged by the lack of comprehensive texts on research strategy, design and method useful for study programmes. Since the ‘comparative turn’ of the 1990s, where we saw a shift towards applying theories, analytical ...... the past weaknesses of methodology meet the future challenges of a new research agenda on Europe....

  3. An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence

    DEFF Research Database (Denmark)

    Lose, Gunnar; Sørensen, Helle Christina; Axelsen, Susanne Maigaard

    2010-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence....

  4. Participation of a coordinating center pharmacy in a multicenter international study.

    Science.gov (United States)

    Jeon, Jihyun Esther; Mighty, Janet; Lane, Karen; McBee, Nichol; Majkowski, Ryan; Mayo, Steven; Hanley, Daniel

    2016-11-15

    The activities of a coordinating center pharmacy (CCP) supporting a multicenter, international clinical trial are described. Serving in a research support role comparable to that of a commercial clinical trial supply company, a CCP within the Johns Hopkins Hospital Investigational Drug Service (JHH IDS) uses its management expertise and infrastructure to support multicenter trials, such as the recently completed Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage, Phase III (CLEAR III) trial. The role of the CCP staff in supporting the CLEAR III trial was overall investigational product (IP) management through coordination of IP-related operations to ensure high-quality care for study participants at study sites in the United States and abroad. For the CLEAR III trial, the CCP coordinated IP supply activities; provided education to site pharmacists; developed study-specific documents, including pharmacy manuals; communicated with trial stakeholders, including third-party IP distributors; monitored treatment assignments; and performed quality assurance monitoring to ensure compliance with institutional, state, federal, and international regulations regarding IP procurement and storage. Acting as a CCP for a multicenter international study poses a number of operational challenges while providing opportunities for the CCP to contribute to research of global importance and enrich the skill sets of its personnel. The development and implementation of the CCP at JHH IDS for the CLEAR III trial included several responsibilities, such as IP supply management, communication, and database, regulatory, and finance management. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  5. Prospective Multicenter Study of the Impact of Carbapenem Resistance on Mortality in Pseudomonas aeruginosa Bloodstream Infections

    OpenAIRE

    2012-01-01

    The impact of antimicrobial resistance on clinical outcomes is the subject of ongoing investigations, although uncertainty remains about its contribution to mortality. We investigated the impact of carbapenem resistance on mortality in Pseudomonas aeruginosa bacteremia in a prospective multicenter (10 teaching hospitals) observational study of patients with monomicrobial bacteremia followed up for 30 days after the onset of bacteremia. The adjusted influence of carbapenem resistance on mortal...

  6. Clinical Characteristics of Microscopic Colitis in Korea: Prospective Multicenter Study by KASID

    OpenAIRE

    2011-01-01

    Background/Aims Microscopic colitis (MC) encompasses collagenous and lymphocytic colitis and is characterized by chronic diarrhea. In cases of MC, colonic mucosae are macroscopically normal, and diagnostic histopathological features are observed only upon microscopic examination. We designed a prospective multicenter study to determine the clinical features, pathological distribution in the colon and prevalence of MC in Korea. Methods We prospectively enrolled patients having watery diarrhea ...

  7. The Association of Obesity with Walking Independent of Knee Pain: The Multicenter Osteoarthritis Study

    OpenAIRE

    White, Daniel K.; Tuhina Neogi; Yuqing Zhang; David Felson; Michael LaValley; Jingbo Niu; Michael Nevitt; Cora E Lewis; James Torner; K. Douglas Gross

    2012-01-01

    Practice guidelines recommend addressing obesity for people with knee OA, however, the association of obesity with walking independent of pain is not known. We investigated this association within the Multicenter Osteoarthritis Study, a cohort of older adults who have or are at high risk of knee OA. Subjects wore a StepWatch to record steps taken over 7 days. We measured knee pain from a visual analogue scale and obesity by BMI. We examined the association of obesity with walking using lin...

  8. A Multicenter Study of Volumetric Computed Tomography for Staging Malignant Pleural Mesothelioma.

    Science.gov (United States)

    Rusch, Valerie W; Gill, Ritu; Mitchell, Alan; Naidich, David; Rice, David C; Pass, Harvey I; Kindler, Hedy L; De Perrot, Marc; Friedberg, Joseph

    2016-10-01

    Standard imaging modalities are inaccurate in staging malignant pleural mesothelioma (MPM). Single-institution studies suggest that volumetric computed tomography (CT) is more accurate but labor intensive. We established a multicenter network to test interobserver variability, accuracy (relative to pathologic stage), and the prognostic significance of semiautomated volumetric CT. Six institutions electronically submitted to an established multicenter database clinical and pathologic data for patients with MPM who had operations. Institutional radiologists reviewed preoperative CT scans for quality and then submitted by electronic network (AG Mednet, www.agmednet.com) to the biostatistical center. Two reference radiologists blinded to clinical data performed semiautomated tumor volume calculations using Vitrea Enterprise 6.0 software (Vital Images, Minnetonka, MN) and then submitted readings to the biostatistical center. Study end points included feasibility of the network, interobserver variability for volumetric CT, correlation of tumor volume to pTN stages, and overall survival (OS). Of 164 patients, the CT scans for 129 were analyzable and read by reference radiologists. Most tumors were less than 500 cm(3). A small bias was observed between readers because one provided consistently larger measurements than the other (mean difference, 47.9; p = .0027), but for 80%, the absolute difference was 200 cm(3) or less. Spearman correlation between readers was 0.822. Volume correlated with pTN stages and OS, best defined by three groups with average volumes of 91.2, 245.3, and 511.3 cm(3) associated with median OS of 37, 18, and 8 months, respectively. For the first time, a multicenter network was established and initial correlations of tumor volume with pTN stages and OS are shown. A larger multicenter international study is planned to confirm the results and refine correlations. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights

  9. LORIS: A web-based data management system for multi-center studies.

    Directory of Open Access Journals (Sweden)

    Samir eDas

    2012-01-01

    Full Text Available LORIS (Longitudinal Online Research and Imaging System is a modular and extensible web-based data management system that integrates all aspects of a multi-center study: from heterogeneous data acquisition (imaging, clinical, behavior, genetics to storage, processing and ultimately dissemination. It provides a secure, user-friendly, and streamlined platform to automate the flow of clinical trials and complex multi-center studies. A subject-centric internal organization allows researchers to capture and subsequently extract all information, longitudinal or cross-sectional, from any subset of the study cohort. Extensive error-checking and quality control procedures, security, data management, data querying and administrative functions provide LORIS with a triple capability (i continuous project coordination and monitoring of data acquisition (ii data storage/cleaning/querying, (iii interface with arbitrary external data processing pipelines. LORIS is a complete solution that has been thoroughly tested through the full life cycle of a multi-center longitudinal project# and is now supporting numerous neurodevelopment and neurodegeneration research projects internationally.

  10. LORIS: a web-based data management system for multi-center studies.

    Science.gov (United States)

    Das, Samir; Zijdenbos, Alex P; Harlap, Jonathan; Vins, Dario; Evans, Alan C

    2011-01-01

    Longitudinal Online Research and Imaging System (LORIS) is a modular and extensible web-based data management system that integrates all aspects of a multi-center study: from heterogeneous data acquisition (imaging, clinical, behavior, and genetics) to storage, processing, and ultimately dissemination. It provides a secure, user-friendly, and streamlined platform to automate the flow of clinical trials and complex multi-center studies. A subject-centric internal organization allows researchers to capture and subsequently extract all information, longitudinal or cross-sectional, from any subset of the study cohort. Extensive error-checking and quality control procedures, security, data management, data querying, and administrative functions provide LORIS with a triple capability (1) continuous project coordination and monitoring of data acquisition (2) data storage/cleaning/querying, (3) interface with arbitrary external data processing "pipelines." LORIS is a complete solution that has been thoroughly tested through a full 10 year life cycle of a multi-center longitudinal project and is now supporting numerous international neurodevelopment and neurodegeneration research projects.

  11. Clinical presentation of intralabyrinthine schwannomas: a multicenter study of 110 cases.

    Science.gov (United States)

    Dubernard, Xavier; Somers, Thomas; Veros, Konstantinos; Vincent, Christophe; Franco-Vidal, Valérie; Deguine, Olivier; Bordure, Philippe; Linder, Thomas; Lescanne, Emmanuel; Ayache, Denis; Mondain, Michel; Schmerber, Sébastien; Dahmani-Causse, Myriam; Truy, Eric; Darrouzet, Vincent

    2014-10-01

    To describe the presentation of intralabyrinthine schwannomas (ILSs). Retrospective multicenter study involving 12 European skull base surgery tertiary referral centers. One hundred ten patients with the diagnosis of ILS, either labyrinth confined or extending into the internal auditory meatus for less than 50% of their volume. Data collected were age, sex, nature and timing of presenting symptoms, hearing (according to the AAO-HNS grading system), results of vestibular tests (caloric tests and cervical vestibular-evoked myogenic potentials [c-VEMPs]), and tumor localization. Presenting symptoms and laboratory test results were studied according to the extension of the lesion into the cochlea (C) and vestibule (V), on one hand, and according to unifocal (L1) or plurifocal (L2) extension into the labyrinth, on the other. Intracochlear type was more common (50%) than vestibular (19.1%) and more diffuse forms (30.9%). The mean delay for diagnosis was long (72.5 mo; SD, 76.6). Mean age was 53.9 years (SD, 13.2). Deafness was the most common symptom (77.8 dB HL [SD, 33.6], with only 24.6% of patients keeping viable hearing. Caloric tests (65.5% of patients) were abnormal in 77.8% of cases. c-VEMPs were abnormal in 65.7% of the 36 cases analyzed. In V forms, hearing was significantly better (class A + B in 21.1% in C and 45.8% in V forms) (p = 0.03), and vestibular function was more altered (C: 57%, V: 100%, p = 0.0009*). L2 forms were diagnosed later (L1: 59.1 mo, L2: 104.5 mo; p = 0.004*) and were associated more frequently with a dead ear (L1: 13.1%, L2: 41.2%, p = 0.002*) than L1 forms. This series, which is the largest in the literature, demonstrates that even very small and localized ILSs heavily compromise labyrinthine functions.

  12. CONSCIOUSNESS, CONNECTEDNESS AND INTRAOPERATIVE UNRESPONSIVENESS STUDY (CONSCIOUS) : A PROSPECTIVE INTERNATIONAL MULTICENTER COHORT STUDY OF THE ISOLATED FOREARM TECHNIQUE FOLLOWING INTUBATION

    NARCIS (Netherlands)

    Sanders, Robert; Raz, A; Absalom, Anthony; Mashour, George; Bonhomme, V.; Coburn, Marc; Sleigh, J. W.

    2016-01-01

    BACKGROUND: Prior data from the isolated forearm technique (IFT) following noxious stimuli suggest that the incidence of response to command may approach 40% under anesthesia 1,2 . We conducted an international, multicenter, pragmatic study of the IFT to establish the incidence of responsiveness fol

  13. Assessment of risk factors for candidemia in non-neutropenic patients hospitalized in Internal Medicine wards: A multicenter study.

    Science.gov (United States)

    Falcone, M; Tiseo, G; Tascini, C; Russo, A; Sozio, E; Raponi, G; Rosin, C; Pignatelli, P; Carfagna, P; Farcomeni, A; Luzzati, R; Violi, F; Menichetti, F; Venditti, M

    2017-06-01

    An increasing prevalence of candidemia has been reported in Internal Medicine wards (IMWs). The aim of our study was to identify risk factors for candidemia among non-neutropenic patients hospitalized in IMWs. A multicenter case-control study was performed in three hospitals in Italy. Patients developing candidemia (cases) were compared to patients without candidemia (controls) matched by age, time of admission and duration of hospitalization. A logistic regression analysis identified risk factors for candidemia, and a new risk score was developed. Validation was performed on an external cohort of patients. Overall, 951 patients (317 cases of candidemia and 634 controls) were included in the derivation cohort, while 270 patients (90 patients with candidemia and 180 controls) constituted the validation cohort. Severe sepsis or septic shock, recent Clostridium difficile infection, diabetes mellitus, total parenteral nutrition, chronic obstructive pulmonary disease, concomitant intravenous glycopeptide therapy, presence of peripherally inserted central catheter, previous antibiotic therapy and immunosuppressive therapy were factors independently associated with candidemia. The new risk score showed good area under the curve (AUC) values in both derivation (AUC 0.973 95% CI 0.809-0.997, pcandidemia. A new risk score with a good performance could facilitate the identification of candidates to early antifungal therapy. Copyright © 2017 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  14. Open, multicenter study to evaluate the tolerability and efficacy of Echinaforce Forte tablets in athletes.

    Science.gov (United States)

    Schoop, Ronald; Büechi, Samuel; Suter, Andy

    2006-01-01

    This open, multicenter study investigated the tolerability and efficacy of a new tablet formulation of Echinacea purpurea extract (Echinaforce Forte; A. Vogel, Bioforce AG, Roggwil, Switzerland) in 80 subjects actively involved in sports. Most investigators (97.5%) rated the treatment as having "very good" or "good" tolerability. About 75% of patients and investigators rated its efficacy during a common cold as "very good" or "good," and 71% of subjects were free of cold episodes. This study is the first to suggest that Echinaforce is effective in the prophylaxis, as well as the treatment, of the common cold in persons who actively participate in sports.

  15. Mass Spectrometry Imaging of Biological Tissue: An Approach for Multicenter Studies

    Energy Technology Data Exchange (ETDEWEB)

    Rompp, Andreas; Both, Jean-Pierre; Brunelle, Alain; Heeren, Ronald M.; Laprevote, Olivier; Prideaux, Brendan; Seyer, Alexandre; Spengler, Bernhard; Stoeckli, Markus; Smith, Donald F.

    2015-03-01

    Mass spectrometry imaging has become a popular tool for probing the chemical complexity of biological surfaces. This led to the development of a wide range of instrumentation and preparation protocols. It is thus desirable to evaluate and compare the data output from different methodologies and mass spectrometers. Here, we present an approach for the comparison of mass spectrometry imaging data from different laboratories (often referred to as multicenter studies). This is exemplified by the analysis of mouse brain sections in five laboratories in Europe and the USA. The instrumentation includes matrix-assisted laser desorption/ionization (MALDI)-time-of-flight (TOF), MALDI-QTOF, MALDIFourier transform ion cyclotron resonance (FTICR), atmospheric-pressure (AP)-MALDI-Orbitrap, and cluster TOF-secondary ion mass spectrometry (SIMS). Experimental parameters such as measurement speed, imaging bin width, and mass spectrometric parameters are discussed. All datasets were converted to the standard data format imzML and displayed in a common open-source software with identical parameters for visualization, which facilitates direct comparison of MS images. The imzML conversion also allowed exchange of fully functional MS imaging datasets between the different laboratories. The experiments ranged from overview measurements of the full mouse brain to detailed analysis of smaller features (depending on spatial resolution settings), but common histological features such as the corpus callosum were visible in all measurements. High spatial resolution measurements of AP-MALDI-Orbitrap and TOF-SIMS showed comparable structures in the low-micrometer range. We discuss general considerations for planning and performing multicenter studies in mass spectrometry imaging. This includes details on the selection, distribution, and preparation of tissue samples as well as on data handling. Such multicenter studies in combination with ongoing activities for reporting guidelines, a common

  16. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD)...

  17. Establishing a multicenter longitudinal clinical cohort Study in ...

    African Journals Online (AJOL)

    ... clinical cohort Study in Ethiopia: Advanced Clinical Monitoring of Antiretroviral Treatment Project. ... Ethiopian Journal of Health Sciences ... Using similar recruitment procedures, a total of 120 children were enrolled in each of retrospective ...

  18. Multicenter Case-Control Study on Restless Legs Syndrome in Multiple Sclerosis: the REMS Study

    Science.gov (United States)

    Manconi, Mauro; Ferini-Strambi, Luigi; Filippi, Massimo; Bonanni, Enrica; Iudice, Alfonso; Murri, Luigi; Gigli, Gian Luigi; Fratticci, Lara; Merlino, Giovanni; Terzano, Giovanni; Granella, Franco; Parrino, Liborio; Silvestri, Rosalia; Aricò, Irene; Dattola, Vincenzo; Russo, Giovanna; Luongo, Carmela; Cicolin, Alessandro; Tribolo, Antonella; Cavalla, Paola; Savarese, Mariantonietta; Trojano, Maria; Ottaviano, Salvatore; Cirignotta, Fabio; Simioni, Valentina; Salvi, Fabrizio; Mondino, Fiorella; Perla, Franco; Chinaglia, Giorgia; Zuliani, Cristina; Cesnik, Edward; Granieri, Enrico; Placidi, Fabio; Palmieri, Maria Giuseppina; Manni, Raffaele; Terzaghi, Michele; Bergamaschi, Roberto; Rocchi, Raffaele; Ulivelli, Monica; Bartalini, Sabina; Ferri, Raffaele; Fermo, Salvatore Lo; Ubiali, Emilio; Viscardi, Massimo; Rottoli, Mariarosa; Nobili, Lino; Protti, Alessandra; Ferrillo, Franco; Allena, Marta; Mancardi, Gianluigi; Guarnieri, Biancamaria; Londrillo, Francesco

    2008-01-01

    Study objectives: To verify the existence of a symptomatic form of restless legs syndrome (RLS) secondary to multiple sclerosis (MS) and to identify possible associated risk factors. Design: Prospective, multicenter, case-control epidemiologic survey. Settings: Twenty sleep centers certified by the Italian Association of Sleep Medicine. Patients: Eight hundred and sixty-one patients affected by MS and 649 control subjects. Interventions: N/A. Measures and results: Data regarding demographic and clinical factors, presence and severity of RLS, the results of hematologic tests, and visual analysis of cerebrospinal magnetic resonance imaging studies were collected. The prevalence of RLS was 19% in MS and 4.2% in control subjects, with a risk to be affected by RLS of 5.4 (95%confidence interval: 3.56–8.26) times greater for patients with MS than for control subjects. In patients with MS, the following risk factors for RLS were significant: older age; longer MS duration; the primary progressive MS form; higher global, pyramidal, and sensory disability; and the presence of leg jerks before sleep onset. Patients with MS and RLS more often had sleep complaints and a higher intake of hypnotic medications than patients with MS without RLS. RLS associated with MS was more severe than that of control subjects. Conclusions: RLS is significantly associated with MS, especially in patients with severe pyramidal and sensory disability. These results strengthen the idea that the inflammatory damage correlated with MS may induce a secondary form of RLS. As it does in idiopathic cases, RLS has a significant impact on sleep quality in patients with MS; therefore, it should be always searched for, particularly in the presence of insomnia unresponsive to treatment with common hypnotic drugs. Citation: Manconi M; Ferini-Strambi L; Filippi M; Bonanni E; Iudice A; Murri L; Gigli GL; Fratticci L; Merlino G; Terzano G; Granella F; Parrino L; Silvestri R; Aricò I; Dattola V; Russo G; Luongo

  19. Sexual functioning of people with rheumatoid arthritis : a multicenter study

    NARCIS (Netherlands)

    van Berlo, W.T.M.; van de Wiel, H.B.M.; Taal, E.; Rasker, J.J.; Schultz, W.C.M.W.; van Rijswijk, M.H.

    2007-01-01

    The objective of this study is to compare men and women with rheumatoid arthritis (RA) to controls regarding sexual motivation, activity, satisfaction, and specific sexual problems, and to determine the correlation of physical aspects of the disease with sexual functioning. Questionnaire for screeni

  20. Sexual functioning of people with rheumatoid arthritis: a multicenter study

    NARCIS (Netherlands)

    Berlo, van Willy T.M.; Wiel, van de Harry B.M.; Taal, Erik; Rasker, Johannes J.; Weijmar Schultz, Willibrord C.M.; Rijswijk, van Martin H.

    2007-01-01

    The objective of this study is to compare men and women with rheumatoid arthritis (RA) to controls regarding sexual motivation, activity, satisfaction, and specific sexual problems, and to determine the correlation of physical aspects of the disease with sexual functioning. Questionnaire for screeni

  1. Geriatric rehabilitation of lower limb amputees: a multicenter study.

    NARCIS (Netherlands)

    Eijk, M.S. van; Linde, H. van der; Buijck, B.I.; Zuidema, S.U.; Koopmans, R.T.C.M.

    2012-01-01

    PURPOSE: The aim of this study was to determine factors independently associated with successful rehabilitation of patients with lower limb amputation in skilled nursing facilities (SNFs). METHODS: All patients admitted to one of the 11 participating SNFs were eligible. Multidisciplinary teams colle

  2. Geriatric rehabilitation of lower limb amputees : a multicenter study

    NARCIS (Netherlands)

    Eijk, Monica Spruit-van; van der Linde, Harmen; Buijck, Bianca I; Zuidema, Sytse U; Koopmans, Raymond T C M

    2012-01-01

    PURPOSE: The aim of this study was to determine factors independently associated with successful rehabilitation of patients with lower limb amputation in skilled nursing facilities (SNFs). METHODS: All patients admitted to one of the 11 participating SNFs were eligible. Multidisciplinary teams colle

  3. Pegaferon in hepatitis C: Results of a Multicenter Study

    OpenAIRE

    Jabbari, Hossain; Zamani, Farhad; Hatami, Khadijeh; Sheikholeslami, Arghavan; Fakharzadeh, Elham; Shahzamani, Kiana; Zamini, Hedye; Merat, Shahin; Malekzadeh, Reza; Sharfi, Amir Houshang

    2011-01-01

    BACKGROUND Chronic hepatitis C (CHC) is a major contributor to cirrhosis and hepatocellular carcinoma and major global public health problem that causes mortality in both developed and developing countries.For the past decade, treatment with pegylated interferon (peg interferon α) and ribavirin (RBV) has been associated with rates of sustained virologic response of ≤ 66% among patients with hepatitis C virus (HCV) infection. In this study, we report the response rate of Iranian treatment-naïv...

  4. [HCV and HBV prevalence in hemodialyzed pediatric patients. Multicenter study].

    Science.gov (United States)

    Cañero-Velasco, M C; Mutti, J E; Gonzalez, J E; Alonso, A; Otegui, L; Adragna, M; Antonuccio, M; Laso, M; Montenegro, M; Repetto, L; Brandi, M; Canepa, J; Baimberg, E

    1998-01-01

    Hemodialized pediatric patients are a risk population for the hepatitis B and C virus infection. The aim of this paper was to study the serum prevalence of HBV and HCV infection in hemodialized children. We study 61 pediatric patients at hemodialisis, 12 on renal transplant, range between 2 and 20 years old (mean: 12.9 years), 23 male and 38 female. The specific anti-HCV IgC were measured by enzyme immunoassay (ELISA Abbott) and confirmed by LIA-TEK (Organon). The anti-HBV were measured by ELISA Abbott and transaminases by cinetic method (ASAT: 29 UI/L and ALT: 33 UI/L). The 19.7% of studied children were HCV (+) and 29.5% were HBV (+), 38.9% of them were HbsAg (+) and 50% anti-HBs (+). The HCV and HBV infection was more elevated in relation to the transfusion number and the hemodilisis time. The elevation of ALT/ASAT activity isn't a right infection index for HCV and HBV in this children.

  5. Characteristics of rheumatoid arthritis in Algeria: a multicenter study.

    Science.gov (United States)

    Slimani, Samy; Abbas, Abdelmalek; Ben Ammar, Amina; Kebaili, Djemaa; Ali, El Hadi; Rahal, Fadia; Khamari, Mohamed Choukri; Baltache, Ayada; Khider, Imene; Chiheub, Riad; Khelif, Khireddine; Akbi, Sabrina; Rahmani, Salima; Dahou-Makhloufi, Chafia; Brahimi-Mazouni, Nadjia; Abtroun-Benmadi, Sabira; Ladjouze-Rezig, Aicha

    2014-09-01

    The aim of this study was to compare the epidemiology of rheumatoid arthritis (RA) in North Africa to that of Western countries. We have enrolled in a cross-sectional study all consecutive patients presenting with the diagnosis of RA according to the 1987 ACR criteria, and during a 5-month period, patients were included in 11 centers across northern Algeria. Demographics, clinical data, and health assessment questionnaires (HAQ) were collected for each patient. We have estimated means, standard deviations, and 95 % confidence intervals for all parameters. Of the 249 patients (213 females and 36 males) enrolled in the study, 10 (4 %) had juvenile onset of the disease. The mean age was 50.1 ± 14.5 years, and the mean duration of RA was 8.4 ± 7.8 years. In terms of comorbidities, 18.9 % of patients reported hypertension and 5.2 % had diabetes. The mean DAS28 at inclusion was 4.3 (95 % CI 4.1-4.5); 14.0 % were in remission (DAS28 ≤ 2.6). The mean HAQ score was 0.81 ± 0.82. Rheumatoid factor was positive in 78.5 % of cases, and anti-citrullinated protein/peptide antibodies, when measured, was positive in 69.0 % of cases. Seronegative patients were older and had a relatively less severe disease. For treatment, 89.7 % of patients were taking disease-modifying anti-rheumatic drugs and only 4 % were taking biologics (rituximab); 90.8 % of patients were taking glucocorticoids, and none of the patients satisfied the recommended calcium intake guidelines. RA in Algeria is more common in women. Compared to reports from Western countries, RA in Algeria appears to be less aggressive, with more dominant seronegative oligoarthritis forms. The remission rate is comparable to that of Western populations.

  6. Riyadh Mother and Baby Multicenter Cohort Study: The Cohort Profile.

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    Hayfaa Wahabi

    Full Text Available To assess the effects of non-communicable diseases, such as diabetes, hypertension and obesity, on the mother and the infant.A multicentre cohort study was conducted in three hospitals in the city of Riyadh in Saudi Arabia. All Saudi women and their babies who delivered in participating hospitals were eligible for recruitment. Data on socio-demographic characteristics in addition to the maternal and neonatal outcomes of pregnancy were collected. The cohort demographic profile was recorded and the prevalence of maternal conditions including gestational diabetes, pre-gestational diabetes, hypertensive disorders in pregnancy and obesity were estimated.The total number of women who delivered in participating hospitals during the study period was 16,012 of which 14,568 women participated in the study. The mean age of the participants was 29 ± 5.9 years and over 40% were university graduates. Most of the participants were housewives, 70% were high or middle income and 22% were exposed to secondhand smoke. Of the total cohort, 24% were married to a first cousin. More than 68% of the participants were either overweight or obese. The preterm delivery rate was 9%, while 1.5% of the deliveries were postdate. The stillbirth rate was 13/1000 live birth. The prevalence of gestational diabetes was 24% and that of pre-gestational diabetes was 4.3%. The preeclampsia prevalence was 1.1%. The labour induction rate was 15.5% and the cesarean section rate was 25%.Pregnant women in Saudi Arabia have a unique demographic profile. The prevalence of obesity and diabetes in pregnancy are among the highest in the world.

  7. Temperamental characteristics in childhood migraine without aura: a multicenter study

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    Esposito M

    2013-08-01

    Full Text Available Maria Esposito,1 Rosa Marotta,2 Beatrice Gallai,3 Lucia Parisi,4 Giuseppina Patriciello,1 Serena Marianna Lavano,2 Giovanni Mazzotta,5 Michele Roccella,4 Marco Carotenuto11Center for Childhood Headache, Clinic of Child and Adolescent Neuropsychiatry, Department of Mental Health, Physical and Preventive Medicine, Second University of Naples, Naples, Italy; 2Department of Psychiatry, "Magna Graecia" University of Catanzaro, Catanzaro, Italy; 3Unit of Child and Adolescent Neuropsychiatry, University of Perugia, Perugia, Italy; 4Child Neuropsychiatry, Department of Psychology, University of Palermo, Palermo, Italy; 5Unit of Child and Adolescent Neuropsychiatry, AUSL Umbria 2, Terni, ItalyBackground: Children with migraine seem to be more anxious, sensitive, deliberate, cautious, fearful, vulnerable to frustration, tidy, and less physically enduring than comparisons. To the best our knowledge no studies about the temperamental and the characterial dimension aspects in childhood migraine was conducted. Therefore, the aim of the present study was to describe the temperamental and character aspects in a sample of children affected by migraine without aura (MoA and their relationship with clinical aspects of MoA such as frequency, duration, and severity of attacks.Materials and methods: In our study, 486 children affected by MoA (239 male, 247 female aged 7–12 years, (mean 10.04 ± 2.53 years and 518 typical developing children comparable for age (P = 0.227 and sex (P = 0.892 were enrolled to assess their temperamental characteristics. The mothers of all subjects filled out the Junior Temperament and Character Inventory: Parent Version.Results: Children affected by migraine show a higher prevalence of harm avoidance and persistence temperamental domains (P < 0.001 and significantly lower prevalence of the self-directedness character trait (P = 0.023 with respect to the comparisons, according to Cloninger's model. The Spearman rank correlation analysis

  8. Stereotactic radiosurgery for idiopathic glossopharyngeal neuralgia: an international multicenter study.

    Science.gov (United States)

    Kano, Hideyuki; Urgosik, Dusan; Liscak, Roman; Pollock, Bruce E; Cohen-Inbar, Or; Sheehan, Jason P; Sharma, Mayur; Silva, Danilo; Barnett, Gene H; Mathieu, David; Sisterson, Nathaniel D; Lunsford, L Dade

    2016-12-01

    OBJECTIVE The goal of this study was to evaluate the outcomes of Gamma Knife stereotactic radiosurgery (SRS) when used for patients with intractable idiopathic glossopharyngeal neuralgia. METHODS Six participating centers of the International Gamma Knife Research Foundation identified 22 patients who underwent SRS for intractable glossopharyngeal neuralgia between 1998 and 2015. The median patient age was 60 years (range 34-83 years). The median duration of symptoms before SRS was 46 months (range 1-240 months). Three patients had unsuccessful prior surgical procedures, including microvascular decompression (MVD) (n = 2) and balloon compression (n = 1). The radiosurgical target was the glossopharyngeal meatus. The median maximum dose was 80 Gy. RESULTS The median follow-up was 45 months after SRS (range 6-120 months). Twelve patients (55%) had neuralgia provided lasting pain reduction in 55% of patients after 1 or 2 SRS procedures. Patients who had a poor response or pain recurrence may require additional procedures such as repeat SRS, MVD, nerve blocks, or nerve section. No patient developed changes in vocal cord function or swallowing disorders after SRS in this study.

  9. Pediatric neurofibromatosis 1 and parental stress: a multicenter study

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    Esposito M

    2014-01-01

    Full Text Available Maria Esposito,1 Rosa Marotta,2 Michele Roccella,3 Beatrice Gallai,4 Lucia Parisi,3 Serena Marianna Lavano,2 Marco Carotenuto1 1Clinic of Child and Adolescent Neuropsychiatry, Department of Mental Health, Physical and Preventive Medicine, Second University of Naples, Naples, Italy; 2Department of Psychiatry, "Magna Graecia" University of Catanzaro, Catanzaro, Italy; 3Child Neuropsychiatry, Department of Psychology, University of Palermo, Palermo, Italy; 4Unit of Child and Adolescent Neuropsychiatry, University of Perugia, Perugia, Italy Background: Neurofibromatosis 1 (NF1 is a complex and multifaceted neurocutaneous syndrome with many and varied comorbidities. The literature about the prevalence and degree of maternal stress and the impact of NF1 in the parent–child interaction is still scant. The aim of this study was to evaluate the prevalence of maternal stress in a large pediatric sample of individuals affected by NF1. Methods: Thirty-seven children (19 boys, 18 girls of mean age 7.86±2.94 (range 5–11 years affected by typical NF1 and a control group comprising 405 typically developing children (207 boys, 198 girls; mean age 8.54±2.47 years were included in this study. To assess parental stress, the mothers of all individuals (NF1 and comparisons filled out the Parenting Stress Index-Short Form test. Results: The two study groups were comparable for age (P=0.116, gender (P=0.886, and body mass index adjusted for age (P=0.305. Mothers of children affected by NF1 reported higher mean Parenting Stress Index-Short Form scores on the Parental Distress domain (P<0.001, Difficult Child domain (P<0.001, and Total Stress domain than the mothers of typically developing children (controls (P<0.001. No significant differences between the two groups were found for the Parent-Child Dysfunctional Interaction domain (P=0.566 or Defensive Responding domain scores (P=0.160. Conclusion: NF1 is considered a multisystemic and complex disease, with many

  10. Serious gaming and voluntary laparoscopic skills training: a multicenter study.

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    Verdaasdonk, E G G; Dankelman, J; Schijven, M P; Lange, J F; Wentink, M; Stassen, L P S

    2009-01-01

    This study assesses the issue of voluntary training of a standardized online competition (serious gaming) between surgical residents. Surgical residents were invited to join a competition on a virtual reality (VR) simulator for laparoscopic motor skills. A final score was calculated based on the task performance of three exercises and was presented to all the participants through an online database on the Internet. The resident with the best score would win a lap-top computer. During three months, 31 individuals from seven hospitals participated (22 surgical residents, 3 surgeons and six interns). A total of 777 scores were logged in the database. In order to out-perform others some participants scheduled themselves voluntarily for additional training. More attempts correlated with higher scores. The serious gaming concept may enhance voluntary skills training. Online data capturing could facilitate monitoring of skills progression in surgical trainees and enhance (VR) simulator validation.

  11. Late prematurity in twins: a Polish multicenter study.

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    Kosinska-Kaczynska, Katarzyna; Szymusik, Iwona; Bomba-Opon, Dorota; Madej, Anna; Oleszczuk, Jan; Patro-Malysza, Jolanta; Marciniak, Beata; Breborowicz, Grzegorz; Drews, Krzysztof; Seremak-Mrozikiewicz, Agnieszka; Szymankiewicz, Marta; Zimmer, Mariusz; Pomorski, Michal; Olejek, Anita; Slawska, Helena; Wielgos, Mirosław

    2014-10-01

    The study aimed at investigating the impact of late prematurity (LPT) on neonatal outcome in twins and neonatal morbidity and mortality within LPT with regard to the completed weeks of gestation. The study was conducted in six tertiary obstetric departments from different provinces of Poland (Warsaw, Lublin, Poznan, Wroclaw, Bytom). It included 465 twin deliveries in the above centers in 2012. A comparative analysis of maternal factors, the course of pregnancy and delivery and neonatal outcome between LPT (34 + 0-36 + 6 weeks of gestation) and term groups (completed 37 weeks) was performed. The neonatal outcome included short-term morbidities. The analysis of neonatal complication rates according to completed gestational weeks was carried out. Out of 465 twin deliveries 213 (44.8%) were LPT and 156 (33.55%) were term. There were no neonatal deaths among LPT and term twins. One-third of LPT newborns suffered from respiratory disorders or required antibiotics, 40% had jaundice requiring phototherapy, and 30% were admitted to NICU. The analysis of neonatal morbidity with regard to each gestational week at delivery showed that most analyzed complications occurred less frequently with the advancing gestational age, especially respiratory disorders and NICU admissions. The only two factors with significant influence on neonatal morbidity rate were neonatal birth weight (OR = 0.43, 95% CI = 0.2-0.9, p = .02) and gestational age at delivery (OR = 0.62, 95% CI = 0.5-0.8, p twins. Gestational age and neonatal birth weight seem to play a crucial role in neonatal outcome in twins.

  12. Integrating surgery and radiology in one suite: a multicenter study.

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    ten Cate, Gerben; Fosse, Erik; Hol, Per Kristian; Samset, Eigil; Bock, Richard W; McKinsey, James F; Pearce, Benjamin J; Lothert, Mark

    2004-09-01

    The study was performed to evaluate the performance of digital fixed-mounted angiographic C-arm systems in the operating room as used by surgeons, cardiologists, and interventional radiologists. An observational study in the operating room was performed, along with a structured questionnaire and semi-structured interviews. Twenty interventions were observed at 5 sites. Workflow was analyzed. Integration of high-end angiographic imaging equipment in the operating room enables image-guided surgery with high-quality images, on-table quality assessment of surgical procedures, and "one-stop shopping" procedures. Integrated suites were run by surgery as well as radiology departments, and are used for a variety of procedures, including vascular, cardiothoracic, open surgical, percutaneous, and combined procedures. Operation of the angiographic system and its user interface design were not considered ideal for operating room use. Limited patient accessibility was observed, sometimes leading to uncomfortable positions for the operating physicians. Certain procedures, such as tibial artery surgery, were difficult to perform, owing to lack of accessories. Patient transfer was considered inadequate. Cleaning of the system was rated as poor. Operating room use puts an even higher demand on reliability of the system. Integration of digital angiographic systems into operating rooms has produced opportunities for new treatments and offers a superior solution for interdisciplinary work among surgeons, cardiologists, and radiologists. However, the context of use differs radically from that in the traditional radiologic examination room; the environment, users, and procedures are all different. Integration of imaging methods into the operating room can be more successful if special operating room conditions are taken into account by medical systems manufacturers.

  13. Pigmented villonodular synovitis: a retrospective multicenter study of 237 cases.

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    Xie, Guo-ping; Jiang, Nan; Liang, Chang-xiang; Zeng, Jian-chun; Chen, Zhi-yuan; Xu, Qian; Qi, Rui-zhen; Chen, Yi-rong; Yu, Bin

    2015-01-01

    To review clinical characteristics of pigmented villonodular synovitis (PVNS) in China. Electronic medical records (EMR) of four Chinese institutes were queried for patients with histologically proven PVNS between January 2005 and February 2014. Their data were collected including gender, age at diagnosis, clinical presentation, affected site, symptom duration, comorbidities, treatment strategy, recurrence and routine laboratories. A total of 237 patients with biopsy-proven PVNS were investigated. The gender ratio was 1.35 for a female predominance (101 males and 136 females). The average age was 36 years (range, 2 to 83 years). The median delay from initial clinical symptom to diagnosis was 18 months. Main affected areas were the knee (73.84%) and the hip (18.14%). Forty patients had a clear history of joint trauma. Six patients were concurrently diagnosed with PVNS and avascular necrosis (AVN). Five patients suffered from PVNS following implantation of orthopaedic devices including artificial prosthesis, plate and wire. One hundred and twenty-nine patients underwent arthroscopic synovectomy and 108 open synovectomy. Altogether 48 patients (26 males and 22 females) had recurrence of disease. The relapse rate was 24% (knee) and 6.98% (hip), 20.93% (open surgery) and 19.44% (arthroscopy), respectively. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) rate were elevated in 45.83% and 38.41% of the patients respectively. To our knowledge, this study is the largest sample size of PVNS patients reported as well as the largest sample of PVNS with concurrent AVN reported to date. Our outcomes suggest that PVNS shows a female predominance, occurs mostly between 20-40 years and favors the knee and hip. Recurrence is frequent, particularly in the knee. Serum ESR and CRP may be elevated in some patients. Additionally, the present study supports the theory of an association between PVNS and orthopedic surgery, which is not limited to joint replacement.

  14. Giant cell arteritis: a multicenter observational study in Brazil

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    Alexandre Wagner Silva de Souza

    2013-01-01

    Full Text Available OBJECTIVE: To describe demographic features, disease manifestations and therapy in patients with giant cell arteritis from referral centers in Brazil. METHODS: A retrospective cohort study was performed on 45 giant cell arteritis patients from three university hospitals in Brazil. Diagnoses were based on the American College of Rheumatology classification criteria for giant cell arteritis or temporal artery biopsy findings. RESULTS: Most patients were Caucasian, and females were slightly more predominant. The frequencies of disease manifestations were as follows: temporal headache in 82.2%, neuro-ophthalmologic manifestations in 68.9%, jaw claudication in 48.9%, systemic symptoms in 44.4%, polymyalgia rheumatica in 35.6% and extra-cranial vessel involvement in 17.8% of cases. Aortic aneurysms were observed in 6.6% of patients. A comparison between patients with biopsy-proven giant cell arteritis and those without temporal artery biopsies did not yield significant differences in disease manifestations. All patients were treated with oral prednisone, and intravenous methylprednisolone was administered to nearly half of the patients. Methotrexate was the most commonly used immunosuppressive agent, and low-dose aspirin was prescribed to the majority of patients. Relapses occurred in 28.9% of patients, and aspirin had a protective effect against relapses. Females had higher prevalences of polymyalgia rheumatica, systemic manifestations and jaw claudication, while permanent visual loss was more prevalent in men. CONCLUSIONS: Most of the clinical features of Brazilian giant cell arteritis patients were similar to those found in other studies, except for the high prevalence of neuro-ophthalmic manifestations and permanent blindness in the Brazilian patients. Aspirin had a protective effect on relapses.

  15. Pigmented villonodular synovitis: a retrospective multicenter study of 237 cases.

    Directory of Open Access Journals (Sweden)

    Guo-ping Xie

    Full Text Available To review clinical characteristics of pigmented villonodular synovitis (PVNS in China.Electronic medical records (EMR of four Chinese institutes were queried for patients with histologically proven PVNS between January 2005 and February 2014. Their data were collected including gender, age at diagnosis, clinical presentation, affected site, symptom duration, comorbidities, treatment strategy, recurrence and routine laboratories.A total of 237 patients with biopsy-proven PVNS were investigated. The gender ratio was 1.35 for a female predominance (101 males and 136 females. The average age was 36 years (range, 2 to 83 years. The median delay from initial clinical symptom to diagnosis was 18 months. Main affected areas were the knee (73.84% and the hip (18.14%. Forty patients had a clear history of joint trauma. Six patients were concurrently diagnosed with PVNS and avascular necrosis (AVN. Five patients suffered from PVNS following implantation of orthopaedic devices including artificial prosthesis, plate and wire. One hundred and twenty-nine patients underwent arthroscopic synovectomy and 108 open synovectomy. Altogether 48 patients (26 males and 22 females had recurrence of disease. The relapse rate was 24% (knee and 6.98% (hip, 20.93% (open surgery and 19.44% (arthroscopy, respectively. Erythrocyte sedimentation rate (ESR and C-reactive protein (CRP rate were elevated in 45.83% and 38.41% of the patients respectively.To our knowledge, this study is the largest sample size of PVNS patients reported as well as the largest sample of PVNS with concurrent AVN reported to date. Our outcomes suggest that PVNS shows a female predominance, occurs mostly between 20-40 years and favors the knee and hip. Recurrence is frequent, particularly in the knee. Serum ESR and CRP may be elevated in some patients. Additionally, the present study supports the theory of an association between PVNS and orthopedic surgery, which is not limited to joint replacement.

  16. EBM in primary care: a qualitative multicenter study in Spain.

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    Calderón, Carlos; Sola, Iván; Rotaeche, Rafael; Marzo-Castillejo, Mèrce; Louro-González, Arturo; Carrillo, Ricard; González, Ana-Isabel; Alonso-Coello, Pablo

    2011-08-09

    Evidence based medicine (EBM) has made a substantial impact on primary care in Spain over the last few years. However, little research has been done into family physicians (FPs)' attitudes related to EBM. The present study investigates FPs' perceptions of EBM in the primary care context. This study used qualitative methodology. Information was obtained from 8 focus groups composed of 67 FPs from 47 health centers in 4 autonomous regions in Spain. Intentional sampling considered participants' previous education in EBM, and their experience as tutors in family medicine or working groups' members of the Spanish Society of Family Practice. Sociological discourse analysis was used with the support of the MAXqda software. Results were validated by means of triangulation among researchers and contrast with participants. Findings were grouped into three main areas: 1) The tug-of-war between the "science" of EBM and "experience" in the search for good clinical practice in primary care; 2) The development of EBM sensemaking as a reaction to contextual factors and interests; 3) The paradox of doubt and trust in the new EBM experts.The meaning of EBM was dynamically constructed within the primary care context. FPs did not consider good clinical practice was limited to the vision of science that EBM represents. Its use appeared to be conditioned by several factors that transcended the common concept of barriers. Along with concerns about its objectivity, participants showed a tendency to see EBM as the use of simplified guidelines developed by EBM experts. The identification of science with EBM and its recognition as a useful but insufficient tool for the good clinical practice requires rethinking new meanings of evidence within the primary care reality. Beyond the barriers related to accessing and putting into practice the EBM, its reactive use can determine FPs' questions and EBM development in a direction not always centred on patients' needs. The questioning of experts

  17. EBM in primary care: a qualitative multicenter study in Spain

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    Calderón Carlos

    2011-08-01

    Full Text Available Abstract Background Evidence based medicine (EBM has made a substantial impact on primary care in Spain over the last few years. However, little research has been done into family physicians (FPs' attitudes related to EBM. The present study investigates FPs' perceptions of EBM in the primary care context. Methods This study used qualitative methodology. Information was obtained from 8 focus groups composed of 67 FPs from 47 health centers in 4 autonomous regions in Spain. Intentional sampling considered participants' previous education in EBM, and their experience as tutors in family medicine or working groups' members of the Spanish Society of Family Practice. Sociological discourse analysis was used with the support of the MAXqda software. Results were validated by means of triangulation among researchers and contrast with participants. Results Findings were grouped into three main areas: 1 The tug-of-war between the "science" of EBM and "experience" in the search for good clinical practice in primary care; 2 The development of EBM sensemaking as a reaction to contextual factors and interests; 3 The paradox of doubt and trust in the new EBM experts. The meaning of EBM was dynamically constructed within the primary care context. FPs did not consider good clinical practice was limited to the vision of science that EBM represents. Its use appeared to be conditioned by several factors that transcended the common concept of barriers. Along with concerns about its objectivity, participants showed a tendency to see EBM as the use of simplified guidelines developed by EBM experts. Conclusions The identification of science with EBM and its recognition as a useful but insufficient tool for the good clinical practice requires rethinking new meanings of evidence within the primary care reality. Beyond the barriers related to accessing and putting into practice the EBM, its reactive use can determine FPs' questions and EBM development in a direction not

  18. Pain during medical abortion: a multicenter study in France.

    Science.gov (United States)

    Saurel-Cubizolles, Marie-Josèphe; Opatowski, Marion; David, Philippe; Bardy, Françoise; Dunbavand, Annabel

    2015-11-01

    To compare the level of pain reported by women by dose of mifepristone, 200 or 600mg, and describe the main factors related to the pain level in the 5 days after a medical abortion. Observational study in 11 medical centers in France between October 2013 and September 2014. The protocols were 200 or 600mg orally mifepristone on day 1 of the medical abortion and 400, 600 or 800μg orally misoprostol on day 3. Women returned a questionnaire that they completed during 5 days following the abortion; pain was recorded on a visual analog scale (0-10) daily. 453 women were included; the mean age was 29 years (range 18-49 years). Pain was greater with 200 than 600mg mifepristone: 33% of women reported a pain level of ≥8 on day 3 with 200mg as compared with 16% with 600mg. This difference remained after controlling for age, gestational age, gravidity, usual painful menstruation and misoprostol dose. Percentages of symptoms as vomiting or diarrhea were also lower with 600mg mifépristone than 200mg. The mean pain severity experienced by women undergoing medical abortion is high; it is higher with a regimen of 200mg mifepristone. The findings emphasize the need to improve analgesic strategies and invite to opt for a protocol of 600mg instead of 200mg mifepristone. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. Management of cholelithiasis in Italian children: A national multicenter study

    Science.gov (United States)

    Corte, Claudia Della; Falchetti, Diego; Nebbia, Gabriella; Calacoci, Marisa; Pastore, Maria; Francavilla, Ruggiero; Marcellini, Matilde; Vajro, Pietro; Iorio, Raffaele

    2008-01-01

    AIM: To evaluate the management of Italian children with cholelithiasis observed at Pediatric and Surgical Departments linked to Italian Society of Pediatric Gastroenterology Hepatology and Nutrition. METHODS: One-hundred-eighty children (90 males, median age at diagnosis 7.3 years; range, 0-18 years) with echographic evidence of cholelithiasis were enrolled in the study; the data were collected by an anonymous questionnaire sent to participating centers. RESULTS: One hundred seventeen patients were treated with ursodeoxycholic acid; in 8 children dissolution of gallstones was observed, but the cholelithiasis recurred in 3 of them. Sixty-five percent of symptomatic children treated became asymptomatic. Sixty-four patients were treated with cholecystectomy and in only 2 cases a postoperative complication was reported. Thirty-four children received no treatment and were followed with clinical and echographic controls; in no case the development of complications was reported. CONCLUSION: The therapeutic strategies were extremely heterogeneous. Ursodeoxycholic acid was ineffective in dissolution of gallstones but it had a positive effect on the symptoms. Laparoscopic cholecystectomy was confirmed to be an efficacy and safe treatment for pediatric gallstones. PMID:18322952

  20. Seizures in Preterm Neonates: A Multicenter Observational Cohort Study.

    Science.gov (United States)

    Glass, Hannah C; Shellhaas, Renée A; Tsuchida, Tammy N; Chang, Taeun; Wusthoff, Courtney J; Chu, Catherine J; Cilio, M Roberta; Bonifacio, Sonia L; Massey, Shavonne L; Abend, Nicholas S; Soul, Janet S

    2017-07-01

    The purpose of this study was to characterize seizures among preterm neonates enrolled in the Neonatal Seizure Registry, a prospective cohort of consecutive neonates with seizures at seven pediatric centers that follow the American Clinical Neurophysiology Society's neonatal electroencephalography monitoring guideline. Of 611 enrolled neonates with seizures, 92 (15%) were born preterm. Seizure characteristics were evaluated by gestational age at birth for extremely preterm (preterm (28 to preterm (32 to preterm neonates. Hypothermia therapy was utilized in 15 moderate to late preterm subjects with encephalopathy. The presence of subclinical seizures, monotherapy treatment failure, and distribution of seizure burden (including status epilepticus) was similar in preterm and term neonates. However, exclusively subclinical seizures occurred more often in preterm than term neonates (24% vs 14%). Phenobarbital was the most common initial medication for all gestational age groups, and failure to respond to an initial loading dose was 63% in both preterm and term neonates. Mortality was similar among the three preterm gestational age groups; however, preterm mortality was more than twice that of term infants (35% vs 15%). Subclinical seizures were more common and mortality was higher for preterm than term neonates. These data underscore the importance of electroencephalographic monitoring and the potential for improved management in preterm neonates. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Multicenter study on caries risk assessment in Japanese adult patients.

    Science.gov (United States)

    Arino, Masumi; Ataru, Ito; Fujiki, Shozo; Sugiyama, Seiichi; Hayashi, Mikako

    2015-10-01

    This study was conducted to identify significant risk factors for the onset and the accumulation of new caries in adult patients undergoing regular preventive therapy. The data of 732 patients from nine Japanese general dental practices were retrospectively analyzed. Classification and regression tree (CART) analysis was applied to develop a caries prediction model using the following patient parameters: age, number of teeth with caries experience (DMFT), levels of mutans streptococci (SM) and lactobacilli (LB), saliva flow rate and buffer capacity, and compliance with a preventive program. Poisson regression analysis was conducted to identify factors affecting caries accumulation within three years. CART analysis identified patients at high risk for primary caries with an odds ratio of 3.08 (95%CI, 1.55-5.79; p=0.0018) according to SM levels and compliance; and those for secondary caries with an odds ratio of 3.69 (95%CI, 2.29-5.91; pcaries was affected by compliance (pcaries was affected by DMFT (pcaries development in individual adult patients. Cariogenic bacteria are important factors for both the onset and accumulation of primary and secondary caries. Participation in a regular preventive program limits the onset and the accumulation of primary caries in adult patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Reliability of Radiographic Assessments of Adolescent Midshaft Clavicle Fractures by the FACTS Multicenter Study Group.

    Science.gov (United States)

    Li, Ying; Donohue, Kyna S; Robbins, Christopher B; Pennock, Andrew T; Ellis, Henry B; Nepple, Jeffrey J; Pandya, Nirav; Spence, David D; Willimon, Samuel Clifton; Heyworth, Benton E

    2017-09-01

    There is a recent trend toward increased surgical treatment of displaced midshaft clavicle fractures in adolescents. The primary purpose of this study was to evaluate the intrarater and interrater reliability of clavicle fracture classification systems and measurements of displacement, shortening, and angulation in adolescents. The secondary purpose was to compare 2 different measurement methods for fracture shortening. This study was performed by a multicenter study group conducting a prospective, comparative, observational cohort study of adolescent clavicle fractures. Eight raters evaluated 24 deidentified anteroposterior clavicle radiographs selected from patients 10-18 years of age with midshaft clavicle fractures. Two clavicle fracture classification systems were used, and 2 measurements for shortening, 1 measurement for superior-inferior displacement, and 2 measurements for fracture angulation were performed. A minimum of 2 weeks after the first round, the process was repeated. Intraclass correlation coefficients were calculated. Good to excellent intrarater and interrater agreement was achieved for the descriptive classification system of fracture displacement, direction of angulation, presence of comminution, and all continuous variables, including both measurements of shortening, superior-inferior displacement, and degrees of angulation. Moderate agreement was achieved for the Arbeitsgemeinschaft für Osteosynthesefragen classification system overall. Mean shortening by 2 different methods were significantly different from each other (P < 0.0001). Most radiographic measurements performed by investigators in a multicenter, prospective cohort study of adolescent clavicle fractures demonstrated good-to-excellent intrarater and interrater reliability. Future consensus on the most accurate and clinically appropriate measurement method for fracture shortening is critical.

  3. Critical Pertussis Illness in Children, A Multicenter Prospective Cohort Study

    Science.gov (United States)

    Berger, John T.; Carcillo, Joseph A.; Shanley, Thomas P.; Wessel, David L.; Clark, Amy; Holubkov, Richard; Meert, Kathleen L.; Newth, Christopher J.L.; Berg, Robert A.; Heidemann, Sabrina; Harrison, Rick; Pollack, Murray; Dalton, Heidi; Harvill, Eric; Karanikas, Alexia; Liu, Teresa; Burr, Jeri S.; Doctor, Allan; Dean, J. Michael; Jenkins, Tammara L.; Nicholson, Carol E.

    2013-01-01

    Objective Pertussis persists in the United States despite high immunization rates. The present report characterizes the presentation and acute course of critical pertussis by quantifying demographic data, laboratory findings, clinical complications, and critical care therapies required among children requiring admission to the pediatric intensive care unit (PICU). Design Prospective cohort study. Setting Eight PICUs comprising the Eunice Kennedy Shriver National Institute for Child Health and Human Development Collaborative Pediatric Critical Care Research Network and 17 additional PICUs across the United States. Patients Eligible patients had laboratory confirmation of pertussis infection, were < 18 years of age, and died in the PICU or were admitted to the PICU for at least 24 hours between June 2008 and August 2011. Interventions None. Measurements and Main Results 127 patients were identified. Median age was 49 days, and 105 (83%) patients were < 3 months of age. Fifty-five (43%) required mechanical ventilation. Twelve (9.4%) died during initial hospitalization. Pulmonary hypertension was found in 16 patients (12.5%), and was present in 75% of patients who died, compared with 6% of survivors (p< 0.001). Median white blood cell count (WBC) was significantly higher in those requiring mechanical ventilation (p<0.001), those with pulmonary hypertension (p<0.001) and non-survivors (p<0.001). Age, sex and immunization status did not differ between survivors and non-survivors. Fourteen patients received leukoreduction therapy (exchange transfusion (12), leukopheresis (1) or both (1)). Survival benefit was not apparent. Conclusions Pulmonary hypertension may be associated with mortality in pertussis critical illness. Elevated WBC is associated with the need for mechanical ventilation, pulmonary hypertension, and mortality risk. Research is indicated to elucidate how pulmonary hypertension, immune responsiveness, and elevated WBC contribute to morbidity and mortality

  4. Liver retransplantation in adults: the largest multicenter Italian study.

    Directory of Open Access Journals (Sweden)

    Umberto Maggi

    Full Text Available This study is the largest Italian survey on liver retransplantations (RET. Data report on 167 adult patients who received 2 grafts, 16 who received 3 grafts, and one who received 4 grafts over a 11 yr period.There was no statistically significant difference in graft survival after the first or the second RET (52, 40, and 29% vs 44, 36, and 18% at 1,5,and 10 yr, respectively: Log-Rank test, p = 0.30.Survivals at 1, 5, and 10 years of patients who underwent 2 (n = 151 or 3 (n = 15 RETs, were 65, 48,and 39% vs 59, 44, and 30%, respectively (p = 0.59.Multivariate analysis of survival showed that only the type of graft (whole vs reduced was associated with a statistically significant difference (HR = 3.77, Wald test p = 0. 05; the donor age appeared to be a relevant factor as well, although the difference was not statistically significant (HR = 1.91, Wald test p = 0.08.Though late RETs have better results on long term survival relative to early RETs, no statistically significant difference can be found in early results, till three years after RET.Considering late first RETs (interval>30 days from previous transplantation with whole grafts the difference in graft survival in RETs due to HCV recurrence (n = 17 was not significantly different from RETs due to other causes (n = 53 (65-58 and 31% vs 66-57 and 28% respectively at 1-5 and 10 years, p = 0.66.

  5. Recognition of Delirium in Postoperative Elderly Patients: A Multicenter Study.

    Science.gov (United States)

    Numan, Tianne; van den Boogaard, Mark; Kamper, Adriaan M; Rood, Paul J T; Peelen, Linda M; Slooter, Arjen J C

    2017-09-01

    To evaluate to what extent delirium experts agree on the diagnosis of delirium when independently assessing exactly the same information and to evaluate the sensitivity of delirium screening tools in routine daily practice of clinical nurses. Prospective observational longitudinal study. Three medical centers in the Netherlands. Elderly postoperative adults (n = 167). A researcher examined participants daily (Postoperative Day 1-3) for delirium using a standardized cognitive assessment and interview including the Delirium Rating Scale Revised-98 as global impression without any cut-off values that was recorded on video. Two delirium experts independently evaluated the videos and clinical information from the last 24 hours in the participants' record and classified each assessment as delirious, possibly delirious, or not delirious. Interrater agreement between the delirium experts was determined using weighted Cohen's kappa. When there was no consensus, a third expert was consulted. Final classification was based on median score and compared with the results of the Confusion Assessment Method for Intensive Care Unit and Delirium Observation Scale that clinical nurses administered. Four hundred twenty-four postoperative assessments of 167 participants were included. The overall kappa was 0.61 (95% confidence interval = 0.53-0.68). There was no agreement between the experts for 89 (21.0%) assessments and a third delirium expert was needed for the final classification. Delirium screening that nurses performed detected 32% of the assessments that the experts diagnosed as (possibly) delirious. There was considerable disagreement in classification of delirium by experts who independently assessed exactly the same information, showing the difficulty of delirium diagnosis. Furthermore, the sensitivity of daily delirium screening by clinical nurses was poor. Future research should focus on development of objective instruments to diagnose delirium. © 2017, Copyright the

  6. Survey on treatments for primary headaches in 13 specialized juvenile Headache Centers: The first multicenter Italian study.

    Science.gov (United States)

    Toldo, Irene; Rattin, Martina; Perissinotto, Egle; De Carlo, Debora; Bolzonella, Barbara; Nosadini, Margherita; Rossi, Livia Nicoletta; Vecchio, Angelo; Simonati, Alessandro; Carotenuto, Marco; Scalas, Cinzia; Sciruicchio, Vittorio; Raieli, Vincenzo; Mazzotta, Giovanni; Tozzi, Elisabetta; Valeriani, Massimiliano; Cianchetti, Carlo; Balottin, Umberto; Guidetti, Vincenzo; Sartori, Stefano; Battistella, Pier Antonio

    2017-05-01

    could be used more frequently as first or almost second choice for treating migraine attack in adolescents. Non-pharmacological preventive treatments are recommended by some pediatric guidelines as first-line interventions for primary headaches and their use should be implemented in clinical practice. Prospective multicenter studies based on larger series are warranted to better understand the best treatment strategies for young people with primary headaches. Copyright © 2016 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

  7. [Risk factors for contact lens-related microbial keratitis: A multicenter case-control study].

    Science.gov (United States)

    Becmeur, P H; Abry, F; Bourcier, T; Meyer, N; Sauer, A

    2017-03-01

    Currently, the most feared complication by ophthalmologists of contact lens (CL) wear is microbial keratitis (MK), even though its incidence remains low. It is also a significant financial burden for society. This study aimed to identify the risk factors for CL-related MK especially with regard to hygiene and pattern of use, in a large, prospective, multicenter, case-control study. A multicenter retrospective case-control study was designed. The CL-related MK subpopulation (case) was compared with healthy CL wearers (control) using a 52-item anonymous questionnaire designed to determine subject demographics, lens wear history, lens type and disinfection solution, fitting, patient education, hygiene and maintenance of contact lenses, and patient history. Univariate logistic regression analysis was performed to compare both groups. The study included 497 cases and 364 controls. The risk factors associated with the greatest increased odds of CL-related MK were as follows: extended wear (OR=2.96 [1.65-5.33], Pcase replacement (OR=3.95 [2.28-6.82] Pcase maintenance. The knowledge of these risks factors incentivizes action at all levels to reduce the incidence of MK, from the prescriber to the patient, including the type of CL, case and contact lens solution. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  8. A multicenter study of the clinical features of allergic rhinitis in central China.

    Science.gov (United States)

    Chen, Jianjun; Zhao, Yan; Li, Bin; Zhang, Quanming; Wan, Lijia; Liu, Jun; Tian, Xingde; Li, Guoyi; Zhou, Jie; Zhang, Long; Wang, Pengju; Cheng, Qi; Liang, Jianwei; Zhao, Ping; He, Jingpei; Lou, Zhihong; Lu, Haitao; Zhou, Yi; Zhang, Yuanfen; Chen, Xiangjun; Pan, Fangming; Zhang, Zhimao; Zeng, Ligang; He, Benchao; Zeng, Ying; Xu, Xiaoyan; Kong, Weijia

    2014-01-01

    Several epidemiological surveys of allergic rhinitis (AR) have been conducted in China. However, the clinical features of AR are still not clear enough. The aim of the current study was to perform a multicenter investigation to evaluate the clinical features of AR in China. A multicenter investigation was performed in 13 allergy centers in central China. A disease-related questionnaire was completed by each patient themselves or with guardian assistance after the diagnosis of AR. The clinical features of AR and allergen profile were analyzed. Eleven thousand four patients who were diagnosed with AR were recruited in this study. The percentages of classification of AR according to the Allergic Rhinitis and Its Impact on Asthma guidelines were 9.7% intermittent mild (IM), 3.1% persistent mild (PM), 33.9% intermittent moderate-severe (IMS), and 53.3% persistent moderate-severe (PMS). There were 61.6 and 42.2% AR patients who had concomitant ocular or lower respiratory symptoms in clinic. The occurrence of ocular and lower respiratory symptoms was found to be gradually increased from IM, PM, and IMS to PMS. Cold air and temperature change were the two most common factors triggering the nasal symptoms. Dermatophagoides pteronyssinus and Dermatophagoides farinae were the most important allergens of central China. This study has contributed to a better understanding of clinical features of AR in China.

  9. Report on the use of sampling frames in European studies

    NARCIS (Netherlands)

    Scherpenzeel, A.; Maineri, Angelica; Bristle, Johanna; Pflüger, Senta-Melissa; Mindarova, Ilziya; Butt, Sarah; Zins, Stefan; Emery, Tom; Luijkx, R.

    2017-01-01

    Obtaining good probability samples is a key challenge for European cross-national studies in order to represent the population. This report gives an overview of the sampling frames which are used in countries participating in the four cross-European surveys cooperating in SERISS: the European Social

  10. Evaluation of a graphic interface to control a robotic grasping arm: a multicenter study.

    Science.gov (United States)

    Laffont, Isabelle; Biard, Nicolas; Chalubert, Gérard; Delahoche, Laurent; Marhic, Bruno; Boyer, François C; Leroux, Christophe

    2009-10-01

    Laffont I, Biard N, Chalubert G, Delahoche L, Marhic B, Boyer FC, Leroux C. Evaluation of a graphic interface to control a robotic grasping arm: a multicenter study. Grasping robots are still difficult to use for persons with disabilities because of inadequate human-machine interfaces (HMIs). Our purpose was to evaluate the efficacy of a graphic interface enhanced by a panoramic camera to detect out-of-view objects and control a commercialized robotic grasping arm. Multicenter, open-label trial. Four French departments of physical and rehabilitation medicine. Control subjects (N=24; mean age, 33y) and 20 severely impaired patients (mean age, 44y; 5 with muscular dystrophies, 13 with traumatic tetraplegia, and 2 others) completed the study. None of these patients was able to grasp a 50-cL bottle without the robot. Participants were asked to grasp 6 objects scattered around their wheelchair using the robotic arm. They were able to select the desired object through the graphic interface available on their computer screen. Global success rate, time needed to select the object on the screen of the computer, number of clicks on the HMI, and satisfaction among users. We found a significantly lower success rate in patients (81.1% vs 88.7%; chi(2)P=.017). The duration of the task was significantly higher in patients (71.6s vs 39.1s; Probotic arms for disabled people, with numerous potential applications in daily life.

  11. The reliability of echocardiographic left ventricular wall motion index to identify high-risk patients for multicenter studies

    DEFF Research Database (Denmark)

    Gislason, Gunnar H; Gadsbøll, Niels; Quinones, Miguel A

    2006-01-01

    overall agreement for identifying patients with severe impairment of LV function. This not only underscores the value of LV-WMI as a useful tool for selecting high-risk patients to be included in multicenter studies but also serves to warn against the use of rigid cutoff values for WMI in the treatment......OBJECTIVE: To study whether the use of echocardiographic left ventricular (LV) wall motion index (WMI) is a dependable parameter for identifying patients with LV dysfunction to be enrolled in multicenter trials. METHODS: Videotaped echocardiographic examinations from 200 randomly selected patients...

  12. Multi-Center Genetic Study of Hypertension: The Family Blood Pressure Program (FBPP)

    National Research Council Canada - National Science Library

    The FBPP Investigators

    2002-01-01

    The Family Blood Pressure Program (FBPP) consists of 4 independently established multicenter networks of investigators who have complementary approaches to the genetics of blood pressure levels and hypertension...

  13. A multicenter study of neurocognition in children with hypertension: methods, challenges, and solutions.

    Science.gov (United States)

    Lande, Marc B; Adams, Heather R; Kupferman, Juan C; Hooper, Stephen R; Szilagyi, Peter G; Batisky, Donald L

    2013-01-01

    Hypertensive adults demonstrate decreased performance on neurocognitive testing compared with that of normotensive controls. There is now emerging, preliminary evidence that children with hypertension also manifest neurocognitive differences when compared with normotensive controls, findings postulated to potentially represent early signs of hypertensive target organ damage to the brain. However, reports in children to date have been limited to database and single-center studies. We have established an ongoing, prospective, multicenter study of neurocognition in children with primary hypertension. This article outlines the study methods, with particular attention to the unique challenges in this area of clinical research. We highlight aspects of the study design that are specifically designed as solutions to these challenges.

  14. Automated telecommunication to obtain longitudinal follow-up in a multicenter cross-sectional COPD study.

    Science.gov (United States)

    Stewart, Jeffrey I; Moyle, Sarah; Criner, Gerard J; Wilson, Carla; Tanner, Ron; Bowler, Russell P; Crapo, James D; Zeldin, Robert K; Make, Barry J; Regan, Elizabeth A; For The Copdgene Investigators

    2012-08-01

    It can be challenging to maintain longitudinal follow-up of subjects in clinical studies. COPDGene is a multicenter, observational study designed to identify genetic factors associated with COPD and to characterize COPD-related phenotypes. To obtain follow-up data on patient's vital status and outcomes, the COPDGene Longitudinal Follow-up (LFU) Program was developed to supplement its parent study. We used a telecommunication system that employed automated telephone contact or web-based questions to obtain longitudinal follow-up data in our subjects. A branching questionnaire asked about exacerbations, new therapies, smoking status, development of co-morbid conditions, and general health status. Study coordinators contacted subjects who did not respond to one of the automated methods. We enrolled 10,383 subjects in the COPDGene study. As of August 29, 2011, 7,959 subjects completed 19,955 surveys. On the first survey, 68.8% of subjects who completed their survey did so by electronic means, while 31.3% required coordinator phone follow-up. On each subsequent survey the number of subjects who completed their survey by electronic means increased, while the number of subjects who required coordinator follow-up decreased. Despite many of the patients in the cohort being chronically ill and elderly, there was broad acceptance of the system with over half the cohort using electronic response methods. The COPDGene LFU Study demonstrated that telecommunications was an effective way to obtain longitudinal follow-up of subjects in a large multicenter study. Web-based and automated phone contacts are accepted by research subjects and could serve as a model for LFU in future studies.

  15. Tree-structured survival analysis of patients with Pseudomonas aeruginosa bacteremia: A multicenter observational cohort study.

    Science.gov (United States)

    Yoon, Young Kyung; Kim, Hyun Ah; Ryu, Seong Yeol; Lee, Eun Jung; Lee, Mi Suk; Kim, Jieun; Park, Seong Yeon; Yang, Kyung Sook; Kim, Shin Woo

    2017-02-01

    This study aimed to construct a prediction algorithm, which is readily applicable in the clinical setting, to determine the mortality rate for patients with P. aeruginosa bacteremia. A multicenter observational cohort study was performed retrospectively in seven university-affiliated hospitals in Korea from March 2012 to February 2015. In total, 264 adult patients with monomicrobial P. aeruginosa bacteremia were included in the analyses. Among the predictors independently associated with 30-day mortality in the Cox regression model, Pitt bacteremia score >2 and high-risk source of bacteremia were identified as critical nodes in the tree-structured survival analysis. Particularly, the empirical combination therapy was not associated with any survival benefit in the Cox regression model compared to the empirical monotherapy. This study suggests that determining the infection source and evaluating the clinical severity are critical to predict the clinical outcome in patients with P. aeruginosa bacteremia.

  16. Long-term efficacy and safety of pramipexole in advanced Parkinson's disease: results from a European multicenter trial.

    Science.gov (United States)

    Möller, J Carsten; Oertel, Wolfgang H; Köster, Jürgen; Pezzoli, Gianni; Provinciali, Leandro

    2005-05-01

    A double-blind, placebo-controlled study with a subsequent open-label phase was conducted in 354 patients with Parkinson's disease (PD) and motor fluctuations under individually adjusted therapy with levodopa. During the double-blind phase 174 patients received pramipexole and 180 placebo. In agreement with previous studies, pramipexole treatment improved UPDRS sum scores of parts II and III by 30% and off times by approximately 2.5 hours per day. Differences between the treatment groups became significant at a daily dose of 0.75 mg of pramipexole dihydrochloride. We, furthermore, performed post hoc analyses with respect to resting tremor and depression. Patients with pronounced resting tremor derived a clear benefit from pramipexole treatment compared with placebo. In addition, pramipexole significantly improved the subitems motivation/initiative and depression in a subpopulation with increased Unified Parkinson's Disease Rating Scale I scores at the time of inclusion. There were 262 patients who were subsequently enrolled into the open-label study featuring a maximum duration of up to 57 months. Statistical analysis revealed good long-term efficacy and tolerability of pramipexole. Overall, only a low prevalence of somnolence was found. In summary, this study provides additional level I evidence of the usefulness of pramipexole, suggests a particular tremorlytic and a possible antidepressant action of this compound, and addresses for the first time its efficacy and safety during long-term administration in advanced PD.

  17. Multicenter case-control study on restless legs syndrome in multiple sclerosis: the REMS study.

    Science.gov (United States)

    Manconi, Mauro; Ferini-Strambi, Luigi; Filippi, Massimo; Bonanni, Enrica; Iudice, Alfonso; Murri, Luigi; Gigli, Gian Luigi; Fratticci, Lara; Merlino, Giovanni; Terzano, Giovanni; Granella, Franco; Parrino, Liborio; Silvestri, Rosalia; Aricò, Irene; Dattola, Vincenzo; Russo, Giovanna; Luongo, Carmela; Cicolin, Alessandro; Tribolo, Antonella; Cavalla, Paola; Savarese, Mariantonietta; Trojano, Maria; Ottaviano, Salvatore; Cirignotta, Fabio; Simioni, Valentina; Salvi, Fabrizio; Mondino, Fiorella; Perla, Franco; Chinaglia, Giorgia; Zuliani, Cristina; Cesnik, Edward; Granieri, Enrico; Placidi, Fabio; Palmieri, Maria Giuseppina; Manni, Raffaele; Terzaghi, Michele; Bergamaschi, Roberto; Rocchi, Raffaele; Ulivelli, Monica; Bartalini, Sabina; Ferri, Raffaele; Lo Fermo, Salvatore; Ubiali, Emilio; Viscardi, Massimo; Rottoli, Mariarosa; Nobili, Lino; Protti, Alessandra; Ferrillo, Franco; Allena, Marta; Mancardi, Gianluigi; Guarnieri, Biancamaria; Londrillo, Francesco

    2008-07-01

    To verify the existence of a symptomatic form of restless legs syndrome (RLS) secondary to multiple sclerosis (MS) and to identify possible associated risk factors. Prospective, multicenter, case-control epidemiologic survey. Twenty sleep centers certified by the Italian Association of Sleep Medicine. Eight hundred and sixty-one patients affected by MS and 649 control subjects. N/A. Data regarding demographic and clinical factors, presence and severity of RLS, the results of hematologic tests, and visual analysis of cerebrospinal magnetic resonance imaging studies were collected. The prevalence of RLS was 19% in MS and 4.2% in control subjects, with a risk to be affected by RLS of 5.4 (95%confidence interval: 3.56-8.26) times greater for patients with MS than for control subjects. In patients with MS, the following risk factors for RLS were significant: older age; longer MS duration; the primary progressive MS form; higher global, pyramidal, and sensory disability; and the presence of leg jerks before sleep onset. Patients with MS and RLS more often had sleep complaints and a higher intake of hypnotic medications than patients with MS without RLS. RLS associated with MS was more severe than that of control subjects. RLS is significantly associated with MS, especially in patients with severe pyramidal and sensory disability. These results strengthen the idea that the inflammatory damage correlated with MS may induce a secondary form of RLS. As it does in idiopathic cases, RLS has a significant impact on sleep quality in patients with MS; therefore, it should be always searched for, particularly in the presence of insomnia unresponsive to treatment with common hypnotic drugs.

  18. Myocardial infarct size and mortality depend on the time of day-a large multicenter study.

    Directory of Open Access Journals (Sweden)

    Stephane Fournier

    Full Text Available Different studies have shown circadian variation of ischemic burden among patients with ST-Elevation Myocardial Infarction (STEMI, but with controversial results. The aim of this study was to analyze circadian variation of myocardial infarction size and in-hospital mortality in a large multicenter registry.This retrospective, registry-based study was based on data from AMIS Plus, a large multicenter Swiss registry of patients who suffered myocardial infarction between 1999 and 2013. Peak creatine kinase (CK was used as a proxy measure for myocardial infarction size. Associations between peak CK, in-hospital mortality, and the time of day at symptom onset were modelled using polynomial-harmonic regression methods.6,223 STEMI patients were admitted to 82 acute-care hospitals in Switzerland and treated with primary angioplasty within six hours of symptom onset. Only the 24-hour harmonic was significantly associated with peak CK (p = 0.0001. The maximum average peak CK value (2,315 U/L was for patients with symptom onset at 23:00, whereas the minimum average (2,017 U/L was for onset at 11:00. The amplitude of variation was 298 U/L. In addition, no correlation was observed between ischemic time and circadian peak CK variation. Of the 6,223 patients, 223 (3.58% died during index hospitalization. Remarkably, only the 24-hour harmonic was significantly associated with in-hospital mortality. The risk of death from STEMI was highest for patients with symptom onset at 00:00 and lowest for those with onset at 12:00.As a part of this first large study of STEMI patients treated with primary angioplasty in Swiss hospitals, investigations confirmed a circadian pattern to both peak CK and in-hospital mortality which were independent of total ischemic time. Accordingly, this study proposes that symptom onset time be incorporated as a prognosis factor in patients with myocardial infarction.

  19. Spanish Multicenter Normative Studies (NEURONORMA Project): norms for verbal fluency tests.

    Science.gov (United States)

    Peña-Casanova, Jordi; Quiñones-Ubeda, Sonia; Gramunt-Fombuena, Nina; Quintana-Aparicio, María; Aguilar, Miquel; Badenes, Dolors; Cerulla, Noemí; Molinuevo, José Luis; Ruiz, Eva; Robles, Alfredo; Barquero, Maria Sagrario; Antúnez, Carmen; Martínez-Parra, Carlos; Frank-García, Anna; Fernández, Manuel; Alfonso, Verónica; Sol, Josep M; Blesa, Rafael

    2009-06-01

    Lexical fluency tests are frequently used in clinical practice to assess language and executive function. As part of the Spanish multicenter normative studies (NEURONORMA project), we provide age- and education-adjusted norms for three semantic fluency tasks (animals, fruit and vegetables, and kitchen tools), three formal lexical tasks (words beginning with P, M, and R), and three excluded letter fluency tasks (excluded A, E, and S). The sample consists of 346 participants who are cognitively normal, community dwelling, and ranging in age from 50 to 94 years. Tables are provided to convert raw scores to age-adjusted scaled scores. These were further converted into education-adjusted scaled scores by applying regression-based adjustments. The current norms should provide clinically useful data for evaluating elderly Spanish people. These data may also be of considerable use for comparisons with other international normative studies. Finally, these norms should help improve the interpretation of verbal fluency tasks and allow for greater diagnostic accuracy.

  20. Effect of medication reconciliation on unintentional medication discrepancies in acute hospital admissions of elderly adults: A multicenter study

    NARCIS (Netherlands)

    Bemt, P.M.L.A. van den; Schrieck-De Loos, E.M. van der; Linden, C. van der; Theeuwes, A.M.L.J.; Pol, A.G.

    2013-01-01

    Objectives To investigate the effect of pharmacy-based medication reconciliation on the frequency of unintentional medication discrepancies in acutely admitted individuals aged 65 and older. Design Multicenter intervention study with pre-post design. Setting Twelve Dutch hospitals. Participants One

  1. An international multicenter study on the effectiveness of a denture adhesive in maxillary dentures using disposable gnathometers

    NARCIS (Netherlands)

    de Baat, Cees; van 't Hof, Martin; van Zeghbroeck, Lieve; Ozcan, Mutlu; Kalk, Warner

    No consensus has been achieved on whether denture adhesives are beneficial adjuncts in denture-wearers management. The purpose of this international multicenter study was to determine objectively the effect of a denture adhesive (Kukident) on the retention of complete maxillary dentures using

  2. An international multicenter study on the effectiveness of a denture adhesive in maxillary dentures using disposable gnathometers.

    NARCIS (Netherlands)

    Baat, C. de; Hof, M.A. van 't; Zeghbroeck, L. van; Ozcan, M.; Kalk, W.

    2007-01-01

    No consensus has been achieved on whether denture adhesives are beneficial adjuncts in denture-wearers management. The purpose of this international multicenter study was to determine objectively the effect of a denture adhesive (Kukident) on the retention of complete maxillary dentures using

  3. Sulfasalazine in the treatment of juvenile chronic arthritis - A randomized, double-blind, placebo-controlled, multicenter study

    NARCIS (Netherlands)

    Fiselier, TJW; Franssen, MJAM; Zwinderman, AH; ten Cate, R; van Suijlekom-Smit, LWA; van Luijk, WHJ; van Soesbergen, RM; Wulffraat, NM; Oostveen, JCM; Kuis, W; Dijkstra, PF; van Ede, CFP; Dijkmans, BAC

    1998-01-01

    Objective. To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA). Methods. we conducted a 24-week randomized, placebo-controlled, double-blind, multicenter study of patients with active JCA of both oligoarticular and polyarticula

  4. Risk Factors for Borderline Personality Disorder in Treatment Seeking Patients with a Substance Use Disorder : An International Multicenter Study

    NARCIS (Netherlands)

    Wapp, Manuela; van de Glind, Geurt; van Emmerik-van Oortmerssen, Katelijne; Dom, Geert; Verspreet, Sofie; Carpentier, Pieter Jan; Ramos-Quiroga, Josep Antoni; Skutle, Arvid; Bu, Eli-Torlid; Franck, Johan; Konstenius, Maija; Kaye, Sharlene; Demetrovics, Zsolt; Barta, Csaba; Fatseas, Melina; Auriacombe, Marc; Johnson, Brian; Faraone, Stephen V.; Levin, Frances R.; Allsop, Steve; Carruthers, Susan; Schoevers, Robert A.; Koeter, Maarten W. J.; van den Brink, Wim; Moggi, Franz

    2015-01-01

    Borderline personality disorder (BPD) and substance use disorders (SUDs) often co-occur, partly because they share risk factors. In this international multicenter study, risk factors for BPD were examined for SUD patients. In total, 1,205 patients were comprehensively examined by standardized interv

  5. Intracranial Aneurysms Treated with Coil Placement: Test Characteristics of Follow-up MR Angiography-Multicenter Study

    NARCIS (Netherlands)

    J.D. Schaafsma; B.K. Velthuis; C.B.L.M. Majoie; R. van den Berg; P.A. Brouwer; F. Barkhof; O. Eshghi; G.A.P. de Kort; R.T.H. Lo; T.D. Witkamp; M.E.S. Sprengers; M.A. van Walderveen; J.C. Bot; E. Sanchez; W.P. Vandertop; J. van Gijn; E. Buskens; Y. van der Graaf; G.J.E. Rinkel

    2010-01-01

    Purpose: To determine the test characteristics of magnetic resonance (MR) angiography in the assessment of occlusion of aneurysms treated with coil placement. Materials and Methods: This was an ethics committee-approved multicenter study. Written informed consent was obtained in 311 patients with 34

  6. Alcohol Consumption among University Students in North Rhine-Westphalia, Germany--Results from a Multicenter Cross-Sectional Study

    Science.gov (United States)

    Akmatov, Manas K.; Mikolajczyk, Rafael T.; Meier, Sabine; Kramer, Alexander

    2011-01-01

    Objective: To assess alcohol use and problem drinking among university students in the German Federal State of North Rhine-Westphalia (NRW) and to examine the associated factors. Method: A multicenter cross-sectional study was conducted in 16 universities in 2006-2007 in NRW by a standardized questionnaire and 3,306 students provided information…

  7. Effect of medication reconciliation on unintentional medication discrepancies in acute hospital admissions of elderly adults: A multicenter study

    NARCIS (Netherlands)

    Bemt, P.M.L.A. van den; Schrieck-De Loos, E.M. van der; Linden, C. van der; Theeuwes, A.M.L.J.; Pol, A.G.

    2013-01-01

    Objectives To investigate the effect of pharmacy-based medication reconciliation on the frequency of unintentional medication discrepancies in acutely admitted individuals aged 65 and older. Design Multicenter intervention study with pre-post design. Setting Twelve Dutch hospitals. Participants One

  8. SEROPREVALENCE OF ANTIBODIES TO THE HUMAN-IMMUNODEFICIENCY-VIRUS IN DIALYSIS WORKERS - RESULTS OF A MULTICENTER STUDY

    NARCIS (Netherlands)

    BERLYNE, G; KACZMAREK, RG; HAMBURGER, S; HAMILTON, P; MOORE, RM; CHARNEY, AN; KAHN, T; GRUBER, M; KAUFMAN, CE; GOFFINET, J; BERNARD, MA

    1992-01-01

    The Center for Devices and Radiological Health, in collaboration with the Department of Veterans Affairs Medical Center, Brooklyn, N.Y., conducted a multi-center, multi-institutional study of the seroprevalence of antibodies to the human immunodeficiency virus (HIV) among dialysis workers. Seven dia

  9. Alcohol Consumption among University Students in North Rhine-Westphalia, Germany--Results from a Multicenter Cross-Sectional Study

    Science.gov (United States)

    Akmatov, Manas K.; Mikolajczyk, Rafael T.; Meier, Sabine; Kramer, Alexander

    2011-01-01

    Objective: To assess alcohol use and problem drinking among university students in the German Federal State of North Rhine-Westphalia (NRW) and to examine the associated factors. Method: A multicenter cross-sectional study was conducted in 16 universities in 2006-2007 in NRW by a standardized questionnaire and 3,306 students provided information…

  10. Clinical characteristics and predictors of mortality in cirrhotic patients with candidemia and intra-abdominal candidiasis: a multicenter study.

    Science.gov (United States)

    Bassetti, Matteo; Peghin, Maddalena; Carnelutti, Alessia; Righi, Elda; Merelli, Maria; Ansaldi, Filippo; Trucchi, Cecilia; Alicino, Cristiano; Sartor, Assunta; Toniutto, Pierluigi; Wauters, Joost; Laleman, Wim; Tascini, Carlo; Menichetti, Francesco; Luzzati, Roberto; Brugnaro, Pierluigi; Mesini, Alessio; Raviolo, Stefania; De Rosa, Francesco G; Lagunes, Leonel; Rello, Jordi; Dimopoulos, George; Colombo, Arnaldo L; Nucci, Marcio; Vena, Antonio; Bouza, Emilio; Muñoz, Patricia; Tumbarello, Mario; Losito, Raffaella; Martin-Loeches, Ignacio; Viscoli, Claudio

    2017-04-01

    The aim of the study was to describe the characteristics of cirrhotic patients with candidemia and intra-abdominal candidiasis (IAC) and to evaluate the risk factors associated with 30-day mortality. A multicenter multinational retrospective study including all consecutive episodes of candidemia and IAC in adult patients with liver cirrhosis in 14 European hospitals during the period 2011-2013 was performed. A total of 241 episodes (169 candidemia, 72 IAC) were included. Most Candida infections were acquired in hospital (208, 86.3%), mainly in the intensive care unit (ICU) (121, 50.2%). At clinical presentation, fever was seen in 60.6% of episodes (146/241) and septic shock in 34.9% (84/241). C. albicans was the most common species (found in 131 episodes, 54.4%), followed by C. glabrata (35, 14.5%) and C. parapsilosis (34, 14.1%). Overall, the 30-day mortality was 35.3%. Multivariable analysis identified candidemia (OR 2.2, 95% CI 1.2-4.5) and septic shock (OR 3.2, 95% CI 1.7-6) as independent factors associated with 30-day mortality. Adequate antifungal treatment (OR 0.4, 95% CI 0.3-0.9) was associated with survival benefit. A shift towards increasing prevalence of C. glabrata and C. parapsilosis species in patients with liver disease was documented. Candidemia and IAC were associated with significant mortality in cirrhotic patients. Thirty-day mortality was associated with candidemia and severe clinical presentation, whereas adequate antifungal treatment improved the prognosis.

  11. The European multicenter trial on the safety and efficacy of guided oblique lumbar interbody fusion (GO-LIF

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    Birkenmaier Christof

    2010-09-01

    Full Text Available Abstract Background Because of the implant-related problems with pedicle screw-based spinal instrumentations, other types of fixation have been tried in spinal arthrodesis. One such technique is the direct trans-pedicular, trans-discal screw fixation, pioneered by Grob for spondylolisthesis. The newly developed GO-LIF procedure expands the scope of the Grob technique in several important ways and adds security by means of robotic-assisted navigation. This is the first clinical trial on the GO-LIF procedure and it will assess safety and efficacy. Methods/Design Multicentric prospective study with n = 40 patients to undergo single level instrumented spinal arthrodesis of the lumbar or the lumbosacral spine, based on a diagnosis of: painful disc degeneration, painful erosive osteochondrosis, segmental instability, recurrent disc herniation, spinal canal stenosis or foraminal stenosis. The primary target criteria with regards to safety are: The number, severity and cause of intra- and perioperative complications. The number of significant penetrations of the cortical layer of the vertebral body by the implant as recognized on postoperative CT. The primary target parameters with regards to feasibility are: Performance of the procedure according to the preoperative plan. The planned follow-up is 12 months and the following scores will be evaluated as secondary target parameters with regards to clinical improvement: VAS back pain, VAS leg pain, Oswestry Disability Index, short form - 12 health questionnaire and the Swiss spinal stenosis questionnaire for patients with spinal claudication. The secondary parameters with regards to construct stability are visible fusion or lack thereof and signs of implant loosening, implant migration or pseudarthrosis on plain and functional radiographs. Discussion This trial will for the first time assess the safety and efficacy of guided oblique lumbar interbody fusion. There is no control group, but the results, the

  12. Antibiotic prescription patterns in Spanish cystic fibrosis patients: results from a national multicenter study

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    Concepción Prados

    2017-05-01

    Full Text Available Objective: Information about antibiotic prescription patterns for cystic fibrosis (CF patients and, specifically, about inhaled treatment strategies for their management is lacking in Spain due to the absence of a national patient registry. In this study we present data about antibiotic prescription in the Spanish CF context that were obtained in a multicenter study, being inhaled treatment strategies the special focus of this work.Methods: Twenty-four specialized CF units (12 adult, 12 pediatric from 17 tertiary- care hospitals covering all Spanish Autonomous Communities provided sputa and clinical data from 15 consecutive patients. Data about antibiotic and non-antibiotic therapies prescribed to these patients during the year prior inclusion (2013 were retrospectively collected.Results: The multicenter study included 341 CF patients from all age groups and clinical status. The prevalence of oral, inhaled and intravenous therapies was 89% (n = 302, 80% (n = 273 and 31% (n = 105, respectively. The most prevalent oral agents were ciprofloxacin (n = 177, 59%, cotrimoxazole (n = 109, 36% and amoxicillin-clavulanate (n = 99, 33%, whereas ceftazidime (n = 53, 50%, tobramycin (n = 43, 41% and meropenem (n = 41, 49% were the most prevalent intravenous ones. Two or more different inhaled antibiotics were administered to 67 patients (24%, 51 of them receiving 2 drugs continuously in alternating schemes. Nebulization of intravenous specific antibiotics was common (n = 39 and, in some cases, was used for maintenance purposes.Conclusions: These results show that the treatment of CF patients is evolving more rapidly than clinical consensus guidelines. Clinical trials evaluating new specific inhaled combinations and new alternative treatment regimes of the existing ones are needed.

  13. Multicenter study of Blount disease in Japan by the Japanese Pediatric Orthopaedic Association.

    Science.gov (United States)

    Inaba, Yutaka; Saito, Tomoyuki; Takamura, Kazuyuki

    2014-01-01

    In order to investigate the epidemiology and features of Blount disease in Japan, the Japanese Pediatric Orthopaedic Association conducted a multicenter study on Blount disease in 2003. Questionnaires were sent to 1,350 training hospitals of the Japanese Orthopaedic Association. This study included those with stage I or II diagnosed between 1990 and 2002 and those with stage III or higher diagnosed between 1980 and 2002 based on the Langenskiöld classification. The questionnaire items included age at diagnosis, sex, presence or absence of a family history of bowlegs, past history of trauma, birthplace, age when starting to walk, height and weight at the initial presentation, laterality of the affected knee, disease types (infantile or adolescent), treatments, and plain radiographic findings. The results for 212 patients with 296 affected knees were obtained. The disease types were infantile in 190 patients with 270 affected knees and adolescent in 22 patients with 26 affected knees. There were more girls among cases with both types. Among the infantile-type cases, there were more patients with bilaterally affected knees; however, in the adolescent-type cases, there were more patients with unilaterally affected knees. Patients with either type tended to be obese at diagnosis. There was little difference in age at which patients with either type started to walk, compared with the mean age for the general population. Conservative treatment was applied to most infantile-type cases in stage I or II, whereas surgery was performed in all but one of those with stage III or IV of the disease. Most adolescent-type cases underwent surgery. This was the first multicenter study on Blount disease in Japan. Among 296 knees, the majority of these knees had stage I or II Blount disease. Very few cases had stage III or higher disease, and there were 35 knees with the infantile type and 19 with the adolescent type in the 23 years from 1980 through 2002.

  14. Cancer in Crohn's Disease patients treated with infliximab: a long-term multicenter matched pair study.

    Science.gov (United States)

    Biancone, Livia; Petruzziello, Carmelina; Orlando, Ambrogio; Kohn, Anna; Ardizzone, Sandro; Daperno, Marco; Angelucci, Erika; Castiglione, Fabiana; D'Incà, Renata; Zorzi, Francesca; Papi, Claudio; Meucci, Gianmichele; Riegler, Gabriele; Sica, Giuseppe; Rizzello, Fernando; Mocciaro, Filippo; Onali, Sara; Calabrese, Emma; Cottone, Mario; Pallone, Francesco

    2011-03-01

    The long-term risk of neoplasia in Crohn's disease (CD) patients treated with infliximab is undefined. The aim was to assess, in a multicenter, matched-pair study, whether infliximab use in CD is associated with an increased frequency of neoplasia in the long term. A multicenter, long-term, matched-pair study was conducted in 12 referral inflammatory bowel disease (IBD) centers. An initial cohort of 808 CD patients, including 404 infliximab-treated (CD-IFX) and 404 matched CD controls never treated with infliximab (CD-C) studied from 1999 to 2004, was followed up for an additional 4 years (2004-2008). Cases and controls were matched for: sex, age (±5 years), CD site, follow-up (±5 years), immunosuppressant use, and CD duration (±5 years). From 1999 to 2008 the frequency and characteristics of neoplasia were compared between CD-IFX and CD-C. In 2008, 591 patients (304 CD-IFX, 287 CD-C) were in follow-up. Matched couples included 442 patients: 221 CD-IFX and 221 CD-C (median follow-up, months: 72, range 48-114 versus 75, range 44-114). From 1999 to 2008 the frequency of neoplasia among the 591 patients did not differ between CD-IFX (12/304; 3.94%) and CD-C (12/287; 4.19%; P = 0.95). A comparable frequency of neoplasia was also observed between the 221 matched couples (CD-IFX: 8/221; 3.61% versus CD-C: 9/221; 4.07%; P = 1). No specific histotype of cancer appeared associated with infliximab use. The frequency of neoplasia was comparable in an adult population of CD patients treated or not with infliximab, matched for clinical variables and followed up for a median of 6 years. Copyright © 2010 Crohn's & Colitis Foundation of America, Inc.

  15. Use of Standardized, Quantitative Digital Photography in a Multicenter Web-based Study

    Science.gov (United States)

    Molnar, Joseph A.; Lew, Wesley K.; Rapp, Derek A.; Gordon, E. Stanley; Voignier, Denise; Rushing, Scott; Willner, William

    2009-01-01

    Objective: We developed a Web-based, blinded, prospective, randomized, multicenter trial, using standardized digital photography to clinically evaluate hand burn depth and accurately determine wound area with digital planimetry. Methods: Photos in each center were taken with identical digital cameras with standardized settings on a custom backdrop developed at Wake Forest University containing a gray, white, black, and centimeter scale. The images were downloaded, transferred via the Web, and stored on servers at the principal investigator's home institution. Color adjustments to each photo were made using Adobe Photoshop 6.0 (Adobe, San Jose, Calif). In an initial pilot study, model hands marked with circles of known areas were used to determine the accuracy of the planimetry technique. Two-dimensional digital planimetry using SigmaScan Pro 5.0 (SPSS Science, Chicago, Ill) was used to calculate wound area from the digital images. Results: Digital photography is a simple and cost-effective method for quantifying wound size when used in conjunction with digital planimetry (SigmaScan) and photo enhancement (Adobe Photoshop) programs. The accuracy of the SigmaScan program in calculating predetermined areas was within 4.7% (95% CI, 3.4%–5.9%). Dorsal hand burns of the initial 20 patients in a national study involving several centers were evaluated with this technique. Images obtained by individuals denying experience in photography proved reliable and useful for clinical evaluation and quantification of wound area. Conclusion: Standardized digital photography may be used quantitatively in a Web-based, multicenter trial of burn care. This technique could be modified for other medical studies with visual endpoints. PMID:19212431

  16. [Results of the multicenter prospective study of cerebrolysin safety and efficacy in acute stroke].

    Science.gov (United States)

    Skwortsova, V I; Stakhovskaia, L V; Shamalov, N A; Kerbikov, O B

    2006-01-01

    The multicenter prospective study of cerebrolysin safety and efficacy included 277 patients with ischemic stroke aged 55-85 years, who received therapy within 12 h from the disease development. Cerebrolysin was used in dosage 10 ml daily along with concomitant standard basic treatment during 10 days after stroke onset in 138 patients. A control group comprised 139 patients who received basic treatment only. A quantitative analysis of the dynamics of neurological deficit revealed the accelerated improvement by NIHSS score, modified Rankin score and Barthel index in the cerebrolysin group on days 10 and 28 (pcerebrolysin within the first 3h after stroke onset comparing to those treated within 6-12h. The trial demonstrated cerebrolysin safety and good tolerability in treatment of ischemic stroke in the carotid artery territory as well as its favorable clinical effect.

  17. [Auranofin in the treatment of chronic polyarthritis. Results of an open multicenter study].

    Science.gov (United States)

    Siegmeth, W

    1984-01-01

    Auranofin (Ridaura SK and F 39 162) was tested in an open multicenter study with regard to its anti-inflammatory effect in 166 patients suffering from rheumatoid arthritis. The time for treatment lasted for one or two years. The therapeutic effect of the drug was judged by its influence on pain, joint swelling, morning stiffness, grip strength, blood-sedimentation rate and rheumatoid factor etc. The serum gold concentration was measured regularly. With Auranofin the majority of the patients achieved a lasting improvement of the condition. The therapeutical effect was observed gradually. Side-effects were frequent but removal from the therapy was rare. Most of the side-effects were diarrhea, rash, pruritus and conjunctivitis. Regular laboratory controls revealed in some cases toxic organic reactions.

  18. Treatment of primary headache in children: a multicenter hospital-based study in France.

    Science.gov (United States)

    Cuvellier, Jean-Christophe; Donnet, Anne; Guégan-Massardier, Evelyne; Nachit-Ouinekh, Fatima; Parain, Dominique; Vallée, Louis

    2009-12-01

    The aim of this 6-month, prospective, multicenter study of 398 children and adolescents with primary headaches was to collect data on headache treatment in neuropediatric departments. Treatments were compared before and after consultation. Prior to consultation, the acute treatments that had been prescribed most frequently were paracetamol (82.2% of children) and non-steroidal anti-inflammatory drugs treatment (53.5%); 10.3% had received a prophylactic treatment. No differences in either acute or prophylactic treatment with respect to headache diagnosis were observed. After the neuropediatric consultation, paracetamol was replaced by a non-steroidal anti-inflammatory drug in about three-quarters of cases and by triptan in about one-quarter of cases. The number of children prescribed a prophylactic treatment nearly doubled, whereas there was a 5-fold and 23-fold increase in psychotherapy and relaxation training, respectively, between pre-referral and referral. We conclude that specific treatments were underused for primary headache.

  19. Clinical Characteristics of Microscopic Colitis in Korea: Prospective Multicenter Study by KASID

    Science.gov (United States)

    Baek, Dae Hyun; Kim, Won Ho; Kim, Joo Sung; Yang, Suk-Kyun; Jung, Sung-Ae; Jang, Byung Ik; Choi, Chnag Hwan; Han, Dong Soo; Kim, Young-Ho; Chung, Yong Woo; Kim, Sang Woo; Kim, You Sun

    2011-01-01

    Background/Aims Microscopic colitis (MC) encompasses collagenous and lymphocytic colitis and is characterized by chronic diarrhea. In cases of MC, colonic mucosae are macroscopically normal, and diagnostic histopathological features are observed only upon microscopic examination. We designed a prospective multicenter study to determine the clinical features, pathological distribution in the colon and prevalence of MC in Korea. Methods We prospectively enrolled patients having watery diarrhea no more than 3 times a day between March 2008 and February 2009. We obtained patient histories and performed colonoscopies with random biopsies at each colon segment. Results A total of 100 patients with chronic diarrhea were enrolled for a normal colonoscopy and stool exam. MC was observed in 22 patients (22%) (M:F 1.2:1; mean age, 47.5 years). Of those 22 patients, 18 had lymphocytic colitis and 4 had collagenous colitis. The entire colon was affected in only 3 cases (13.6%), the ascending colon in 6 cases (27.2%), the transverse colon in 3 cases (13.6%), and the left colon in 3 cases (13.6%). More than 2 segments were affected in 7 cases (31.8%). Nonsteroidal anti-inflammatory drug-associated MCs were observed in 4 cases (18.2%), 3 of which showed improved diarrhea symptoms following discontinuation of the medication. Frequently associated symptoms were abdominal pain and weight loss. Autoimmune diseases were observed in 4 cases (18.2%). Half of the 22 patients with MC improved with conservative care by loperamide or probiotics. Conclusions In a prospective multicenter study of Korean patients with chronic diarrhea, the frequency of MC was found to be approximately 20%, similar to the percentage observed in Western countries. Therefore, the identification of MC is important for the adequate management of Korean patients with chronic diarrhea. PMID:21814598

  20. Assessment of the New 2012 EULAR/ACR Clinical Classification Criteria for Polymyalgia Rheumatica: A Prospective Multicenter Study.

    Science.gov (United States)

    Ozen, Gulsen; Inanc, Nevsun; Unal, Ali Ugur; Bas, Seda; Kimyon, Gezmis; Kisacik, Bunyamin; Onat, Ahmet Mesut; Murat, Sadiye; Keskin, Havva; Can, Meryem; Mengi, Alperen; Cakir, Necati; Balkarli, Ayse; Cobankara, Veli; Yilmaz, Neslihan; Yazici, Ayten; Dogru, Atalay; Sahin, Mehmet; Sahin, Ali; Gok, Kevser; Senel, Soner; Pamuk, Omer Nuri; Yilmaz, Sema; Bayindir, Ozun; Aksu, Kenan; Cagatay, Yonca; Akyol, Lutfi; Sayarlioglu, Mehmet; Yildirim-Cetin, Gozde; Yasar-Bilge, Sule; Yagci, Ilker; Aydin, Sibel Zehra; Alibaz-Oner, Fatma; Atagunduz, Pamir; Direskeneli, Haner

    2016-05-01

    To assess the performance of the new 2012 provisional European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) polymyalgia rheumatica (PMR) clinical classification criteria in discriminating PMR from other mimicking conditions compared with the previous 5 diagnostic criteria in a multicenter prospective study. Patients older than 50 years, presenting with new-onset bilateral shoulder pain with elevated acute-phase reactants (APR), were assessed for the fulfillment of the new and old classification/diagnostic criteria sets for PMR. At the end of the 1-year followup, 133 patients were diagnosed with PMR (expert opinion) and 142 with non-PMR conditions [69 rheumatoid arthritis (RA)]. Discriminating capacity, sensitivity, and specificity of the criteria sets were estimated. Discriminating capacity of the new clinical criteria for PMR from non-PMR conditions and RA as estimated by area under the curve (AUC) were good with AUC of 0.736 and 0.781, respectively. The new criteria had a sensitivity of 89.5% and a specificity of 57.7% when tested against all non-PMR cases. When tested against all RA, seropositive RA, seronegative RA, and non-RA control patients, specificity changed to 66.7%, 100%, 20.7%, and 49.3%, respectively. Except for the Bird criteria, the 4 previous criteria had lower sensitivity and higher specificity (ranging from 83%-93%) compared with the new clinical criteria in discriminating PMR from all other controls. The new 2012 EULAR/ACR clinical classification criteria for PMR is highly sensitive; however, its ability to discriminate PMR from other inflammatory/noninflammatory shoulder conditions, especially from seronegative RA, is not adequate. Imaging and other modifications such as cutoff values for APR might increase the specificity of the criteria.

  1. Profile of Nigerians with diabetes mellitus - Diabcare Nigeria study group (2008: Results of a multicenter study

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    Sunday Chinenye

    2012-01-01

    Full Text Available Background: Diabetes Mellitus is the commonest endocrine-metabolic disorder in Nigeria similar to the experience in other parts of the world. The aim was to assess the clinical and laboratory profile, and evaluate the quality of care of Nigerian diabetics with a view to planning improved diabetes care. Materials and Methods: In a multicenter study across seven tertiary health centers in Nigeria, the clinical and laboratory parameters of diabetic out-patients were evaluated. Clinical parameters studied include type of diabetes, anthropometry, and blood pressure (BP status, chronic complications of diabetes, and treatment types. Laboratory data assessed included fasting plasma glucose (FPG, 2-h post-prandial (2-HrPP glucose, glycated hemoglobin (HbA1c, urinalysis, serum lipids, electrolytes, urea, and creatinine. Results: A total of 531 patients, 209 (39.4% males and 322 (60.6% females enrolled. The mean age of the patients was 57.1 ± 12.3 years with the mean duration of diabetes of 8.8 ± 6.6 years. Majority (95.4% had type 2 diabetes mellitus (DM compared to type 1 DM (4.6%, with P < 0.001. The mean FPG, 2-HrPP glucose, and HbA1c were 8.1 ± 3.9 mmol/L, 10.6 ± 4.6 mmol/L, and 8.3 ± 2.2%, respectively. Only 170 (32.4% and 100 (20.4% patients achieved the ADA and IDF glycemic targets, respectively. Most patients (72.8% did not practice self-monitoring of blood glucose. Hypertension was found in 322 (60.9%, with mean systolic BP 142.0 ± 23.7 mmHg, and mean diastolic BP 80.7 ± 12.7 mmHg. Diabetic complications found were peripheral neuropathy (59.2%, retinopathy (35.5%, cataracts (25.2%, cerebrovascular disease (4.7%, diabetic foot ulcers (16.0%, and nephropathy (3.2%. Conclusion: Most Nigerian diabetics have suboptimal glycemic control, are hypertensives, and have chronic complications of DM. Improved quality of care and treatment to target is recommended to reduce diabetes-related morbidity and mortality.

  2. Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus

    DEFF Research Database (Denmark)

    Simmons, David; Jelsma, Judith G M; Galjaard, Sander

    2015-01-01

    OBJECTIVE: Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. RESEARCH DESIGN AND METHODS...

  3. European contribution to the study of ROS

    DEFF Research Database (Denmark)

    Egea, Javier; Fabregat, Isabel; Frapart, Yves M

    2017-01-01

    The European Cooperation in Science and Technology (COST) provides an ideal framework to establish multi-disciplinary research networks. COST Action BM1203 (EU-ROS) represents a consortium of researchers from different disciplines who are dedicated to providing new insights and tools for better u...

  4. Solid organ transplantation after allogeneic hematopoietic stem cell transplantation: a retrospective, multicenter study of the EBMT

    DEFF Research Database (Denmark)

    Koenecke, C; Hertenstein, B; Schetelig, J;

    2010-01-01

    To analyze the outcome of solid organ transplantation (SOT) in patients who had undergone allogeneic hematopoietic stem cell transplantation (HSCT), a questionnaire survey was carried out within 107 European Group of Blood and Marrow Transplantation centers. This study covered HSCT between 1984...

  5. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study

    Science.gov (United States)

    Lee, Woo Hyun; Kim, Dong-Kyu; Kim, Sung Wan; Kim, Young Hyo; Nam, Jung Gwon; Park, Seok-Won; Park, Chan-Soon; Bae, Woo Yong; Yeo, Nam-Kyung; Won, Tae-Bin; Lee, Seung Hoon; Lee, Tae-Hoon; Lee, Hyoung Joo; Kim, Sang-Wook; Jeong, Sung-Wook; Choi, Jeong-Seok; Han, Doo Hee; Choi, Ji Ho

    2015-01-01

    Background/Objective There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA) with those of power-assisted adenoidectomy. Study Design Prospective multi-institutional study. Methods Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C) or without cauterization (PAA-C) due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated. Results A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females) were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1) CA (n = 116); (2) PAA+C (n = 153); and (3) PAA-C (n = 119). Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001) and degree of intraoperative bleeding was significantly less (P < 0.001) compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016). Conclusions This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding. PMID:26267337

  6. Linking Public Administration and Law Studies within European Union

    Directory of Open Access Journals (Sweden)

    Mihaela V. Cărăuşan

    2012-05-01

    Full Text Available The year 1987 represented for us, scholars, the turning point for the Europeanization of highdegree studies. The European Region Action Scheme for the Mobility of University Students (ERASMUS isa European Union student exchange program which has proved its utility in the last two decade. The publicadministration and law studies are two of the fields of studies which have benefited from the ERASMUSProgramme. In this respect we will try to learn the lesson of internationalization from the European contactthrough ERASMUS programme. The ‘win win’ for students is not just in the increase of knowledge in thearea of administrative sciences and law, but also in the share of cultures. The ERASMUS gives students abetter sense of what it means to be a European citizen. In addition, many employers highly value such aperiod abroad, which increases the students’ employability and job prospects.

  7. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Jeong-Whun Kim

    Full Text Available There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA with those of power-assisted adenoidectomy.Prospective multi-institutional study.Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C or without cauterization (PAA-C due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated.A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1 CA (n = 116; (2 PAA+C (n = 153; and (3 PAA-C (n = 119. Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001 and degree of intraoperative bleeding was significantly less (P < 0.001 compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016.This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding.

  8. Anti-ribosomal P antibody: a multicenter study in childhood-onset systemic lupus erythematosus patients.

    Science.gov (United States)

    Valões, C C M; Molinari, B C; Pitta, A C G; Gormezano, N W S; Farhat, S C L; Kozu, K; Sallum, A M E; Appenzeller, S; Sakamoto, A P; Terreri, M T; Pereira, R M R; Magalhães, C S; Ferreira, J C O A; Barbosa, C M; Gomes, F H; Bonfá, E; Silva, C A

    2017-04-01

    Objectives Anti-ribosomal P protein (anti-P) autoantibodies are highly specific for systemic lupus erythematosus (SLE). However, the evaluation of this autoantibody in childhood-onset SLE (cSLE) populations has been limited to a few small series, hampering the interpretation of the clinical and laboratorial associations. Therefore, the objective of this multicenter cohort study was to evaluate demographic, clinical/laboratorial features, and disease damage score in cSLE patients with and without the presence of anti-P antibody. Methods This was a retrospective multicenter study performed in 10 pediatric rheumatology services of São Paulo state, Brazil. Anti-P antibodies were measured by ELISA in 228 cSLE patients. Results Anti-P antibodies were observed in 61/228 (27%) cSLE patients. Frequencies of cumulative lymphadenopathy (29% vs. 15%, p = 0.014), acute confusional state (13% vs. 5%, p = 0.041), mood disorder (18% vs. 8%, p = 0.041), autoimmune hemolytic anemia (34% vs. 15%, p = 0.001), as well as presence of anti-Sm (67% vs. 40%, p = 0.001), anti-RNP (39% vs. 21%, p = 0.012) and anti-Ro/SSA antibodies (43% vs. 25%, p = 0.016) were significantly higher in cSLE patients with anti-P antibodies compared to those without these autoantibodies. A multiple regression model revealed that anti-P antibodies were associated with autoimmune hemolytic anemia (odds ratio (OR) = 2.758, 95% confidence interval (CI): 1.304-5.833, p = 0.008) and anti-Sm antibody (OR = 2.719, 95% CI: 1.365-5.418, p = 0.004). The SLICC/ACR damage index was comparable in patients with and without anti-P antibodies ( p = 0.780). Conclusions The novel association of anti-P antibodies and autoimmune hemolytic anemia was evidenced in cSLE patients and further studies are necessary to determine if anti-P titers may vary with this hematological manifestation.

  9. Predictors of wound infection in elective colorectal surgery. Multicenter observational case-control study.

    Science.gov (United States)

    Fraccalvieri, Doménico; Kreisler Moreno, Esther; Flor Lorente, Blas; Torres García, Antonio; Muñoz Calero, Alberto; Mateo Vallejo, Francisco; Biondo, Sebastiano

    2014-01-01

    The aim of this study is to evaluate the usefulness of Vicryl Plus(®) suture in reducing the rate of postoperative wound infection in elective colorectal surgery. A prospective case-control multicenter study with 480 patients undergoing elective colorectal surgery was performed between 2006 and 2007. Patients were divided in 2 groups of equal sample size: group 1, closure of the abdominal wall using Vicryl Plus(®) and group 2 where PDS II(®) was used. The study involved 5 hospitals in the Spanish State. Wound infection was classified into superficial and deep. All patients diagnosed of wound infection during the hospital stay and up to 30 days after discharge were studied. For the statistical analysis Chi-square test and Fisher exact were used for bivariate analysis and logistic regression model for multivariate analysis. Wound infection rates were significantly lower in group 1: 14.6 vs. 29.2. Multivariate analysis showed that risk of wound infection was higher in patients with cancer, lung disease, anemia, operative time greater than 2 h, lack of second dose intra-operative prophylactic antibiotic and laparotomy closure with PDS suture II(®). The use of suture coated with triclosan can be an effective prophylactic tool in reducing wound infection rate in patients undergoing elective colorectal surgery. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  10. "Burnout in Medical Oncology Fellows: a Prospective Multicenter Cohort Study in Brazilian Institutions".

    Science.gov (United States)

    Cubero, Daniel I G; Fumis, Renata Rego Lins; de Sá, Thiago Hérick; Dettino, Aldo; Costa, Felipe Osório; Van Eyll, Brigitte M R H Adam; Beato, Carlos; Peria, Fernanda Maris; Mota, Augusto; Altino, José; Azevedo, Sérgio Jobim; da Rocha Filho, Duílio Reis; Moura, Melba; Lessa, Álvaro Edson Ramos; Del Giglio, Auro

    2016-09-01

    Burnout syndrome is a common occurrence among oncologists. Doctors enrolled in residency programs in clinical oncology are exposed to similar risk factors; however, few data are available in this population. This study assessed the occurrence of burnout and associated factors among first-year residents at Brazilian institutions. The present prospective, multicenter, cohort study was conducted with doctors enrolled in residency programs in clinical oncology at Brazilian institutions affiliated with the public health system. The participants answered a sociodemographic questionnaire, the Maslach Burnout Inventory (MBI), Lipp's Stress Inventory, and the Beck Depression Inventory (BDI), upon admission to the program and 6 and 12 months later. Of 37 eligible residency programs in 2009, 11 (30.6 %) agreed to participate in the study. Fifty-four residents, representing 100 % of new admissions to the participating institutions, were included. Most of the participants met the criteria for severe burnout upon admission to the residency programs (emotional exhaustion in 49.0 % and depersonalization in 64.7 %). The scores on MBI domains emotional exhaustion and depersonalization increased significantly (p burnout increased to 88 % at the end of that first year. The present study found a high prevalence of burnout among doctors enrolled in residency programs in clinical oncology at Brazilian institutions. A large fraction of the participants met the criteria for burnout syndrome upon admission to the program, which suggests that the problem began during the course of the previous residency program in internal medicine.

  11. ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): study methodology, recruitment, and baseline demographic and disease characteristics.

    Science.gov (United States)

    Mitsumoto, Hiroshi; Factor-Litvak, Pam; Andrews, Howard; Goetz, Raymond R; Andrews, Leslie; Rabkin, Judith G; McElhiney, Martin; Nieves, Jeri; Santella, Regina M; Murphy, Jennifer; Hupf, Jonathan; Singleton, Jess; Merle, David; Kilty, Mary; Heitzman, Daragh; Bedlack, Richard S; Miller, Robert G; Katz, Jonathan S; Forshew, Dallas; Barohn, Richard J; Sorenson, Eric J; Oskarsson, Bjorn; Fernandes Filho, J Americo M; Kasarskis, Edward J; Lomen-Hoerth, Catherine; Mozaffar, Tahseen; Rollins, Yvonne D; Nations, Sharon P; Swenson, Andrea J; Shefner, Jeremy M; Andrews, Jinsy A; Koczon-Jaremko, Boguslawa A

    2014-06-01

    Abstract In a multicenter study of newly diagnosed ALS patients without a reported family history of ALS, we are prospectively investigating whether markers of oxidative stress (OS) are associated with disease progression. Methods utilize an extensive structured telephone interview ascertaining environmental, lifestyle, dietary and psychological risk factors associated with OS. Detailed assessments were performed at baseline and at 3-6 month intervals during the ensuing 30 months. Our biorepository includes DNA, plasma, urine, and skin. Three hundred and fifty-five patients were recruited. Subjects were enrolled over a 36-month period at 16 sites. To meet the target number of subjects, the recruitment period was prolonged and additional sites were included. Results showed that demographic and disease characteristics were similar between 477 eligible/non-enrolled and enrolled patients, the only difference being type of health insurance among enrolled patients. Sites were divided into three groups by the number of enrolled subjects. Comparing these three groups, the Columbia site had fewer 'definite ALS' diagnoses. This is the first prospective, interdisciplinary, in-depth, multicenter epidemiological investigation of OS related to ALS progression and has been accomplished by an aggressive recruitment process. The baseline demographic and disease features of the study sample are now fully characterized.

  12. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence

    DEFF Research Database (Denmark)

    Toozs-Hobson, Philip; Al-Singary, Waleed; Fynes, Michelle

    2012-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence....

  13. A Multicenter Phase II Study of Erlotinib and Sorafenib in Chemotherapy-Naive Patients with Advanced Non-Small Cell Lung Cancer

    NARCIS (Netherlands)

    Lind, Joline S. W.; Dingemans, Anne-Marie C.; Groen, Harry J. M.; Thunnissen, Frederik B.; Bekers, Otto; Heideman, Danielle A. M.; Honeywell, Richard J.; Giovannetti, Elisa; Peters, Godefridus J.; Postmus, Pieter E.; van Suylen, Robert Jan; Smit, Egbert F.

    2010-01-01

    Purpose: This multicenter, phase II study evaluates the efficacy and safety of erlotinib, an epidermal growth factor receptor (EGFR) inhibitor, plus sorafenib, a multityrosine kinase inhibitor against vascular endothelial growth factor receptors, in patients with previously untreated advanced

  14. Delay in the administration of appropriate antimicrobial therapy in Staphylococcus aureus bloodstream infection : A prospective multicenter hospital-based cohort study

    NARCIS (Netherlands)

    Kaasch, A. J.; Rieg, S.; Kuetscher, J.; Brodt, H. -R.; Widmann, T.; Herrmann, M.; Meyer, C.; Welte, T.; Kern, P.; Haars, U.; Reuter, S.; Huebner, I.; Strauss, R.; Sinha, B.; Brunkhorst, F. M.; Hellmich, M.; Faetkenheuer, G.; Kern, W. V.; Seifert, H.

    2013-01-01

    Early broad-spectrum antimicrobial treatment reduces mortality in patients with septic shock. In a multicenter, prospective observational study, we explored whether delayed appropriate antimicrobial therapy (AAT) influences outcome in Staphylococcus aureus bloodstream infection (SAB). Two hundred an

  15. Multicenter study of posaconazole therapeutic drug monitoring: exposure-response relationship and factors affecting concentration.

    Science.gov (United States)

    Dolton, Michael J; Ray, John E; Chen, Sharon C-A; Ng, Kingsley; Pont, Lisa; McLachlan, Andrew J

    2012-11-01

    Posaconazole has an important role in the prophylaxis and salvage treatment of invasive fungal infections (IFIs), although poor and variable bioavailability remains an important clinical concern. Therapeutic drug monitoring of posaconazole concentrations has remained contentious, with the use of relatively small patient cohorts in previous studies hindering the assessment of exposure-response relationships. This multicenter retrospective study aimed to investigate relationships between posaconazole concentration and clinical outcomes and adverse events and to assess clinical factors and drug interactions that may affect posaconazole concentrations. Medical records were reviewed for patients who received posaconazole and had ≥1 concentration measured at six hospitals in Australia. Data from 86 patients with 541 posaconazole concentrations were included in the study. Among 72 patients taking posaconazole for prophylaxis against IFIs, 12 patients (17%) developed a breakthrough fungal infection; median posaconazole concentrations were significantly lower than in those who did not develop fungal infection (median [range], 289 [50 to 471] ng/ml versus 485 [0 to 2,035] ng/ml; P posaconazole concentration was a significant predictor of breakthrough fungal infection via binary logistic regression (P posaconazole exposure, including coadministration with proton pump inhibitors, metoclopramide, phenytoin or rifampin, and the H(2) antagonist ranitidine (P posaconazole exposure (P posaconazole concentrations are common and are associated with breakthrough fungal infection, supporting the utility of monitoring posaconazole concentrations to ensure optimal systemic exposure.

  16. Italian Multicenter Cross-Sectional Study (AISAG) on light smoking and allergic diseases in adults.

    Science.gov (United States)

    Lombardi, C; Passalacqua, G

    2016-03-01

    Allergic rhinitis, allergic dermatitis, and food allergy are extremely common diseases and are frequently associated to each other and to asthma. Smoking is a potential risk factor for these conditions, but so far, results from individual studies have been conflicting. On the basis of these contradictory data in the literature we have carried out a multicenter cross-sectional study to evaluate the relationship between some allergic conditions and exposure or not to active light smoking. The study was carried out between May 2013 and November 2013 in 22 different Italian hospitals. Patients with respiratory and/or food allergy, and aged 18 years and over, visited at Allergy Outpatient Clinics, were invited to participate. A total of 1586 allergic patients (21.6% smokers) with a mean age of 39.2 years (standard deviation, SD = 15.1) were included. We demonstrated that the prevalence of tobacco smoking was higher in patients with food allergy and in asthmatic patients in stage III-IV. But no other statistical differences were found at univariate analysis. The sensitization patterns of non-smokers and smokers were similar. Furthermore, tobacco smoking was associated with higher risk of food allergy and lower risk of asthma. Moreover, tobacco smoking was an independent risk factor for persistent respect to intermittent rhinitis, and for asthma GINA stage III-IV with respect to stage I-II.

  17. Neutrophil Gelatinase Associated Lipocalin (NGAL) in Leptospirosis Acute Kidney Injury: A Multicenter Study in Thailand.

    Science.gov (United States)

    Srisawat, Nattachai; Praditpornsilpa, Kearkiat; Patarakul, Kanitha; Techapornrung, Malee; Daraswang, Tinnapop; Sukmark, Theerapon; Khositrangsikun, Kamol; Fakthongyoo, Apinya; Oranrigsupak, Petchdee; Praderm, Laksamon; Suwattanasilpa, Ummarit; Peerapornratana, Sadudee; Loahaveeravat, Passisd; Suwachittanont, Nattachai; Wirotwan, Thaksa-on; Phonork, Chayanat; Kumpunya, Sarinya; Tiranathanagul, Khajohn; Chirathaworn, Chintana; Eiam-ong, Somchai; Tungsanga, Kriang; Sitprija, Visith; Kellum, John A; Townamchai, Natavudh

    2015-01-01

    AKI is one of the most serious complications of leptospirosis, an important zoonosis in the tropics. Recently, NGAL, one of the novel AKI biomarkers, is extensively studied in various specific settings such as sepsis, cardiac surgery, and radiocontrast nephropathy. In this multicenter study, we aimed to study the role of NGAL as an early marker and an outcome predictor of leptospirosis associated AKI. Patients who presented with clinical suspiciousness of leptospirosis were prospectively enrolled in 9 centers from August 2012 to November 2014. The first day of enrollment was the first day of clinical suspicious leptospirosis. Blood and urine samples were serially collected on the first three days and day 7 after enrollment. We used three standard techniques (microscopic agglutination test, direct culture, and PCR technique) to confirm the diagnosis of leptospirosis. KDIGO criteria were used for AKI diagnosis. Recovery was defined as alive and not requiring dialysis during hospitalization or maintaining maximum KDIGO stage at hospital discharge. Of the 221 recruited cases, 113 cases were leptospirosis confirmed cases. Thirty seven percent developed AKI. Median uNGAL and pNGAL levels in those developing AKI were significantly higher than in patients not developing AKI [253.8 (631.4) vs 24.1 (49.6) ng/ml, p leptospirosis associated AKI. However, both of them did not show the potential role to be the predictor of renal recovery in this specific setting.

  18. Risk factors for death during pulmonary tuberculosis treatment in Korea: a multicenter retrospective cohort study.

    Science.gov (United States)

    Kwon, Yong-Soo; Kim, Yee Hyung; Song, Jae-Uk; Jeon, Kyeongman; Song, Junwhi; Ryu, Yon Ju; Choi, Jae Chol; Kim, Ho Cheol; Koh, Won-Jung

    2014-09-01

    The data regarding risk factors for death during tuberculosis (TB) treatment are inconsistent, and few studies examined this issue in Korea. The purpose of this study was to evaluate baseline prognostic factors for death during treatment of adult patients with pulmonary TB in Korea. A multicenter retrospective cohort study of 2,481 patients who received TB treatment at eight hospitals from January 2009 to December 2010 was performed. Successful treatment included cure (1,129, 45.5%) and treatment completion (1,204, 48.5%) in 2,333 patients (94.0%). Unsuccessful treatment included death (85, 3.4%) and treatment failure (63, 2.5%) occurred in 148 patients (6.0%). In multivariate analysis, male sex, anemia, dyspnea, chronic heart disease, malignancy, and intensive care unit (ICU) admission were significant risk factors for death during TB treatment. Therefore, male sex, anemia, dyspnea, chronic heart disease, malignancy, and ICU admission could be baseline prognostic factors for death during treatment of adult patients with pulmonary TB in Korea.

  19. Evolution of adolescent idiopathic scoliosis: results of a multicenter study at 20 years' follow-up.

    Science.gov (United States)

    Pesenti, S; Jouve, J-L; Morin, C; Wolff, S; Sales de Gauzy, J; Chalopin, A; Ibnoulkhatib, A; Polirsztok, E; Walter, A; Schuller, S; Abelin-Genevois, K; Leroux, J; Lechevallier, J; Kabaj, R; Mary, P; Fuentes, S; Parent, H; Garin, C; Bin, K; Peltier, E; Blondel, B; Chopin, D

    2015-09-01

    To date there is no consensus on therapeutic indications in adolescent idiopathic scoliosis (AIS) with curvature between 30° and 60° at the end of growth. The objective of this study was to assess outcome in patients with moderate AIS. A multicenter retrospective study was conducted. Inclusion criteria were: Cobb angle, 30-60° at end of growth; and follow-up > 20 years. The data collected were angular values in adolescence and at last follow-up, and quality of life scores at follow-up. A total of 258 patients were enrolled: 100 operated on in adolescence, 116 never operated on, and 42 operated on in adulthood. Mean follow-up was 27.8 years. Cobb angle progression significantly differed between the 3 groups: 3.2° versus 8.8° versus 23.6°, respectively; P scoliosis, the risk of progression to ≥ 20° was significantly higher for initial Cobb angle > 35° (OR=4.278, P=0.002). There were no significant differences in quality of life scores. Patients operated on in adolescence showed little radiological progression, demonstrating the efficacy of surgical treatment for curvature greater than 50°. Curvature greater than 40° was progressive and may require surgery in adulthood. Lumbar scoliosis showed greater potential progression than thoracic scoliosis in adulthood, requiring fusion as of 35° angulation. IV, retrospective study. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  20. Acceptance of living liver donation among medical students: A multicenter stratified study from Spain

    Science.gov (United States)

    Ríos, Antonio; López-Navas, Ana Isabel; López-López, Ana Isabel; Gómez, Francisco Javier; Iriarte, Jorge; Herruzo, Rafael; Blanco, Gerardo; Llorca, Francisco Javier; Asunsolo, Angel; Sánchez-Gallegos, Pilar; Gutiérrez, Pedro Ramón; Fernández, Ana; de Jesús, María Teresa; Martínez-Alarcón, Laura; Lana, Alberto; Fuentes, Lorena; Hernández, Juan Ramón; Virseda, Julio; Yelamos, José; Bondía, José Antonio; Hernández, Antonio Miguel; Ayala, Marco Antonio; Ramírez, Pablo; Parrilla, Pascual

    2016-01-01

    AIM: To analyze the attitude of Spanish medical students toward living liver donation (LLD) and to establish which factors have an influence on this attitude. METHODS: Study type: A sociological, interdisciplinary, multicenter and observational study. Study population: Medical students enrolled in Spain (n = 34000) in the university academic year 2010-2011. Sample size: A sample of 9598 students stratified by geographical area and academic year. Instrument used to measure attitude: A validated questionnaire (PCID-DVH RIOS) was self-administered and completed anonymously. Data collection procedure: Randomly selected medical schools. The questionnaire was applied to each academic year at compulsory sessions. Statistical analysis: Student´s t test, χ2 test and logistic regression analysis. RESULTS: The completion rate was 95.7% (n = 9275). 89% (n = 8258) were in favor of related LLD, and 32% (n = 2937) supported unrelated LLD. The following variables were associated with having a more favorable attitude: (1) age (P = 0.008); (2) sex (P mutilation of the body after donation (P < 0.001). CONCLUSION: Spanish medical students have a favorable attitude toward LLD. PMID:27433093

  1. Outcomes and demostration of cranial firearm injuries: A multicenter retrospective study.

    Science.gov (United States)

    Çınar, Kadir; Seçer, Mehmet; Alagöz, Fatih; Ulutaş, Murat; Uçkun, Özhan Merzuk; Yıldırım, Ali Erdem; Gürçay, Ahmet Gürhan; Güvenç, Yahya; Çelik, Haydar; Narin, Fırat

    2015-07-01

    Cranial firearm injuries (CFAI) are associated with significant morbidity and mortality.This study was aimed to determine the factors affecting mortality of CFAI cases managed in our institution by a retrospective analysis of CT scans and clinical data. This multicenter retrospective study examined two hundred and nineteen patients presenting to neurosurgery clinics after CFAI between January 2012 and November 2014. Age, sex, Glasgow Coma Score (GCS), CT findings, and mortality and morbidity rates of the patients were analyzed to determine the factors affecting mortality. Mean age of the study population was 24.19±12.25 years, 85.8% of them were male. The most common CT findings were fracture (100%), intracranial hemorrhage (61.2%), and an intracranially located foreign body (44.3%). A cranial operation was performed in 64.8% of the victims. Mean GCS on admission was 8±3.9, which increased in survivors (p<0.05). CFAIs are associated with increased mortality and morbidity. We determined that many factors affected morbidity and mortality rates, and patient age, presence of intracranial hemorrhage, GCS, and treatment protocols were significantly associated with mortality.

  2. The Anti-Osteoporotic Drug Preferences of Physiatrists: A Multicenter Descriptive Study

    Directory of Open Access Journals (Sweden)

    Yeşim Gökçe Kutsal

    2012-08-01

    Full Text Available Aim: The purpose of this multicenter descriptive study is to determine the preferences of physiatrists in our country for anti-osteoporotic drugs in patients with primary and secondary osteoporosis. Materials and Methods: This study was carried out in 10 provinces of Turkey. The diagnosis of osteoporosis was based on World Health Organization criteria using dual-energy x-ray absorptiometry. Patients with a spine and/or hip T-score ≤-2.5 were considered as osteoporotic. 714 patients over 18 years old with primary or secondary osteoporosis were included in the study. In addition to socio-demographic characteristics and chronic use of medications and/or additional systemic diseases that cause secondary osteoporosis were questioned and antiosteoporotic drugs that are recommended by their physicians were recorded.Results: The physicians’ preferred vitamin D and calcium as the prior treatment both in primary and secondary osteoporosis. The most commonly used anti-osteoporotic agent was alendronate from the biphosphonate group. It was followed by ibandronate, risedronate, strontium ranelate, calcitonin, zoledronate, raloxifene, parathyroid hormone (PTH and hormone replacement therapy (HRT in the primary osteoporosis and risedronate, ibandronate, calcitonin, strontium ranelate, zoledronate, PTH, HRT and raloxifene in the secondary osteoporosis, respectively. Conclusion: The physician should choose the most suitable treatment for the patient based on fracture risk, medical history, previous treatments for osteoporosis, concomitant diseases, treatment-induced risks and benefits, and the relation between financial cost and potential benefit. (Turkish Journal of Osteoporosis 2012;18: 42-6

  3. Incidence of Malignancy after Living Kidney Transplantation: A Multicenter Study from Iran

    Science.gov (United States)

    Einollahi, Behzad; Rostami, Zohreh; Nourbala, Mohammad Hossein; Lessan-Pezeshki, Mahboob; Simforoosh, Naser; Nemati, Eghlim; Pourfarziani, Vahid; Beiraghdar, Fatemeh; Nafar, Mohsen; Pour-Reza-Gholi, Fatemeh; Mazdeh, Mitra Mahdavi; Amini, Manochehr; Ahmadpour, Pedram; Makhdoomi, Khadijeh; Ghafari, Ali; Ardalan, Mohammad Reza; Khosroshahi, Hamid Taebi; Oliaei, Farshid; Shahidi, Shahrzad; Abbaszadeh, Shahin; Fatahi, Mohammad Reza; Hiedari, Fatemeh; Makhlogh, Atehieh; Azmandian, Jalal; Samimagham, Hamid Reza; Shahbazian, Heshmatollah; Nazemian, Fatemeh; Naghibi, Massih; Khosravi, Masoud; Monfared, Ali; Mosavi, Seyed Majid; Ahmadi, Javad; Jalalzadeh, Mojgan

    2012-01-01

    Malignancy is a common complication after renal transplantation. However, limited data are available on post-transplant malignancy in living kidney transplantation. Therefore, we made a plan to evaluate the incidence and types of malignancies, association with the main risk factors and patient survival in a large population of living kidney transplantation. We conducted a large retrospective multicenter study on 12525 renal recipients, accounting for up to 59% of all kidney transplantation in Iran during 22 years follow up period. All information was collected from observation of individual notes or computerized records for transplant patients. Two hundred and sixty-six biopsy-proven malignancies were collected from 16 Transplant Centers in Iran; 26 different type of malignancy categorized in 5 groups were detected. The mean age of patients was 46.2±12.9 years, mean age at tumor diagnosis was 50.8±13.2 years and average time between transplantation and detection of malignancy was 50.0±48.4 months. Overall tumor incidence in recipients was 2%. Kaposis' sarcoma was the most common type of tumor. The overall mean survival time was 117.1 months (95% CI: 104.9-129.3). In multivariate analysis, the only independent risk factor associated with mortality was type of malignancy. This study revealed the lowest malignancy incidence in living unrelated kidney transplantation. PMID:22712025

  4. Incidence of Malignancy after Living Kidney Transplantation: A Multicenter Study from Iran

    Directory of Open Access Journals (Sweden)

    Behzad Einollahi, Zohreh Rostami, Mohammad Hossein Nourbala, Mahboob Lessan-Pezeshki, Naser Simforoosh, Eghlim Nemati, Vahid Pourfarziani, Fatemeh Beiraghdar, Mohsen Nafar, Fatemeh Pour-Reza-Gholi, Mitra Mahdavi Mazdeh, Manochehr Amini, Pedram Ahmadpour,

    2012-01-01

    Full Text Available Malignancy is a common complication after renal transplantation. However, limited data are available on post-transplant malignancy in living kidney transplantation. Therefore, we made a plan to evaluate the incidence and types of malignancies, association with the main risk factors and patient survival in a large population of living kidney transplantation. We conducted a large retrospective multicenter study on 12525 renal recipients, accounting for up to 59% of all kidney transplantation in Iran during 22 years follow up period. All information was collected from observation of individual notes or computerized records for transplant patients. Two hundred and sixty-six biopsy-proven malignancies were collected from 16 Transplant Centers in Iran; 26 different type of malignancy categorized in 5 groups were detected. The mean age of patients was 46.2±12.9 years, mean age at tumor diagnosis was 50.8±13.2 years and average time between transplantation and detection of malignancy was 50.0±48.4 months. Overall tumor incidence in recipients was 2%. Kaposis' sarcoma was the most common type of tumor. The overall mean survival time was 117.1 months (95% CI: 104.9-129.3. In multivariate analysis, the only independent risk factor associated with mortality was type of malignancy. This study revealed the lowest malignancy incidence in living unrelated kidney transplantation.

  5. A multicenter study of cellulite treatment with a variable emission radio frequency system.

    Science.gov (United States)

    van der Lugt, Claudia; Romero, Carmen; Ancona, Dvora; Al-Zarouni, Marwan; Perera, Joanet; Trelles, Mario A

    2009-01-01

    Radio frequency (RF) systems have been reported as producing electrothermally mediated and subcutaneous effects. The present study evaluates a new approach to treat cellulite with a bipolar RF device. The buttocks of 50 patients were treated, 10 from each of five multinational centers with a novel bipolar RF technology set at 6 J/cm(3), which changes its frequency between 0.6 and 2.4 MHz according to impedance of tissue. Twelve weekly sessions were given for 12 minutes on each buttock, with a treatment end point of 42 degrees C external skin temperature. Cellulite changes and tissue condition were assessed before and immediately after the first session, before the final 12th session, and 2 months thereafter. The patient Satisfaction Index was recorded. Objective evaluation involved clinical photography, three-dimensional optical skin surface measurement, and histological findings. Almost all patients noted improvement of cellulite and body silhouette at the final session, which slightly decreased at the 2-month assessment. Improved skin appearance was objectively detected. Histological findings following the first session showed reactive edema and lysis of adipocyte membranes, possibly implicated in the final effects achieved. The RF technology used in the present multicenter study improved the general aspect of skin and cellulite, with high patient Satisfaction Index. Maintenance sessions might lead to even better and longer-lasting results.

  6. Risk Factors for Malnutrition among Older Adults in the Emergency Department: A Multicenter Study.

    Science.gov (United States)

    Burks, Collin E; Jones, Christopher W; Braz, Valerie A; Swor, Robert A; Richmond, Natalie L; Hwang, Kay S; Hollowell, Allison G; Weaver, Mark A; Platts-Mills, Timothy F

    2017-08-01

    Among older adults, malnutrition is common, often missed by healthcare providers, and influences recovery from illness or injury. To identify modifiable risk factors associated with malnutrition in older patients. Prospective cross-sectional multicenter study. 3 EDs in the South, Northeast, and Midwest. Non-critically ill, English-speaking adults aged ≥65 years. Random time block sampling was used to enroll patients. The ED interview assessed malnutrition using the Mini Nutritional Assessment Short-Form. Food insecurity and poor oral health were assessed using validated measures. Other risk factors examined included depressive symptoms, limited mobility, lack of transportation, loneliness, and medication side effects, qualified by whether the patient reported the risk factor affected their diet. The population attributable risk proportion (PARP) for malnutrition was estimated for each risk factor. In our sample (n = 252), the prevalence of malnutrition was 12%. Patient characteristics associated with malnutrition included not having a college degree, being admitted to the hospital, and residence in an assisted living facility. Of the risk factors examined, the PARPs for malnutrition were highest for poor oral health (54%; 95% CI 16%, 78%), food insecurity (14%; 95% CI 3%, 31%), and lack of transportation affecting diet (12%; 95% CI 3%, 28%). Results of this observational study identify multiple modifiable factors associated with the problem of malnutrition in older adults. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  7. Complications of Microwave Ablation for Liver Tumors: Results of a Multicenter Study

    Energy Technology Data Exchange (ETDEWEB)

    Livraghi, Tito, E-mail: lalivra@tin.it [IRCCS Istituto Clinico Humanitas, Department of Interventional Radiology (Italy); Meloni, Franca, E-mail: meloni@yahoo.it [San Gerardo Hospital, Department of Radiology (Italy); Solbiati, Luigi, E-mail: lusolbia@tin.it [Azienda Ospedaliera di Busto Arsizio, Department of Interventional Radiology (Italy); Zanus, Giorgio, E-mail: zanus@unipd.it [Azienda Universita di Padova, General Surgery and Organ Transplantation (Italy); Collaboration: For the Collaborative Italian Group using AMICA system

    2012-08-15

    Purpose: New technologies for microwave ablation (MWA) have been conceived, designed to achieve larger areas of necrosis compared with radiofrequency ablation (RFA). The purpose of this study was to report complications by using this technique in patients with focal liver cancer. Methods: Members of 14 Italian centers used a 2.45-GMHz generator delivering energy through a cooled miniature-choke MW antenna and a standardized protocol for follow-up. They completed a questionnaire regarding number and type of deaths, major and minor complications and side effects, and likelihood of their relationship to the procedure. Enrollment included 736 patients with 1.037 lesions: 522 had hepatocellular carcinoma with cirrhosis, 187 had metastases predominantly from colorectal cancer, and 27 had cholangiocellular carcinoma. Tumor size ranged from 0.5 to 10 cm. In 13 centers, the approach used was percutaneous, in 4 videolaparoscopic, and in 3 laparotomic. Results: No deaths were reported. Major complications occurred in 22 cases (2.9%), and minor complications in 54 patients (7.3%). Complications of MWA do not differ from those RFA, both being based on the heat damage. Conclusion: Results of this multicenter study confirmed those of single-center experiences, indicating that MWA is a safe procedure, with no mortality and a low rate of major complications. The low rate of complications was probably due to precautions adopted, knowing in advance possible risk conditions, on the basis of prior RFA experience.

  8. Molecular Profiling-Selected Therapy for Treatment of Advanced Pancreaticobiliary Cancer: A Retrospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Ron Epelbaum

    2015-01-01

    Full Text Available This multicenter cohort study assessed the impact of molecular profiling (MP on advanced pancreaticobiliary cancer (PBC. The study included 30 patients treated with MP-guided therapy after failing ≥1 therapy for advanced PBC. Treatment was considered as having benefit for the patient if the ratio between the longest progression-free survival (PFS on MP-guided therapy and the PFS on the last therapy before MP was ≥1.3. The null hypothesis was that ≤15% of patients gain such benefit. Overall, ≥1 actionable (i.e., predictive of response to specific therapies biomarker was identified/patient. Immunohistochemistry (the most commonly used method for guiding treatment decisions identified 1–6 (median: 4 actionable biomarkers per patient. After MP, patients received 1–4 (median: 1 regimens/patient (most commonly, FOLFIRI/XELIRI. In a decision-impact analysis, of the 27 patients for whom treatment decisions before MP were available, 74.1% experienced a treatment decision change in the first line after MP. Twenty-four patients were evaluable for clinical outcome analysis; in 37.5%, the PFS ratio was ≥1.3. In one-sided exact binomial test versus the null hypothesis, P = 0.0015; therefore, the null hypothesis was rejected. In conclusion, our analysis demonstrated the feasibility, clinical decision impact, and potential clinical benefits of MP-guided therapy in advanced PBC.

  9. [Multicenter Clinical Study of Vibrant Soundbridge in Japan: Analysis of Subjective Questionnaires].

    Science.gov (United States)

    Kumakawa, Kozo; Kanzaki, Sho; Usami, Shin-ichi; Iwasaki, Satoshi; Yamanaka, Noboru; Doi, Katsumi; Naito, Yasushi; Gyo, Kiyofumi; Tono, Tetsuya; Takahashi, Haruo; Kanda, Yukihiko

    2015-11-01

    The Vibrant Soundbridge (VSB) is an active middle ear implant with the Floating Mass Transducer (FMT). We performed a multicenter study to study the efficacy of the VSB by means of "the 10 Questionnaire on Hearing 2002" and "the APHAB questionnaire" at 13 hospitals between 2011 and 2013. In all, 23 patients with mixed or conductive hearing loss received VSB implantation by the round window placement technique. These individuals were generally unable to use, or gained little from conventional hearing aids or bone conduction hearing aids. Two questionnaires were administrated before the surgery and 20 weeks after the VSB implantation. Scores on every item of "the 10 Questionnaire on Hearing 2002" showed significant improvement under noise after VSB implantation. On the APHAB, the scores for Ease of Communication, Reverberation, and Background subscales improved significantly after the VSB implantation, while the score for the Aversiveness subscale alone failed to show a positive improvement from the inexperience to the new sound. Analysis of the responses to these subjective questionnaires revealed better results after VSB implantation as compared to the preoperative data. In conclusion, RW vibroplasty with the use of VSB provided subjective benefit in patients with conductive and mixed hearing loss.

  10. Multicenter Study of Brain Volume Abnormalities in Children and Adolescent-Onset Psychosis

    Science.gov (United States)

    Reig, Santiago; Parellada, Mara; Castro-Fornieles, Josefina; Janssen, Joost; Moreno, Dolores; Baeza, Inmaculada; Bargalló, Nuria; González-Pinto, Ana; Graell, Montserrat; Ortuño, Felipe; Otero, Soraya; Arango, Celso; Desco, Manuel

    2011-01-01

    The goal of the study is to determine the extent of structural brain abnormalities in a multicenter sample of children and adolescents with a recent-onset first episode of psychosis (FEP), compared with a sample of healthy controls. Total brain and lobar volumes and those of gray matter (GM), white matter, and cerebrospinal fluid (CSF) were measured in 92 patients with a FEP and in 94 controls, matched for age, gender, and years of education. Male patients (n = 64) showed several significant differences when compared with controls (n = 61). GM volume in male patients was reduced in the whole brain and in frontal and parietal lobes compared with controls. Total CSF volume and frontal, temporal, and right parietal CSF volumes were also increased in male patients. Within patients, those with a further diagnosis of “schizophrenia” or “other psychosis” showed a pattern similar to the group of all patients relative to controls. However, bipolar patients showed fewer differences relative to controls. In female patients, only the schizophrenia group showed differences relative to controls, in frontal CSF. GM deficit in male patients with a first episode correlated with negative symptoms. Our study suggests that at least part of the GM deficit in children and adolescent-onset schizophrenia and in other psychosis occurs before onset of the first positive symptoms and that, contrary to what has been shown in children-onset schizophrenia, frontal GM deficits are probably present from the first appearance of positive symptoms in children and adolescents. PMID:20478821

  11. Undernutrition, risk of malnutrition and obesity in gastroenterological patients: A multicenter study

    Institute of Scientific and Technical Information of China (English)

    Massimiliano Rizzi; Silvia Mazzuoli; Nunzia Regano; Rosa Inguaggiato; Margherita Bianco; Gioacchino Leandro; Elisabetta Bugianesi; Donatella Noè; Nicoletta Orzes; Paolo Pallini; Maria Letizia Petroni; Gianni Testino; Francesco William Guglielmi

    2016-01-01

    AIM: To investigate the prevalence of undernutrition, risk of malnutrition and obesity in the Italian gastroenterological population. METHODS: The Italian Hospital Gastroenterology Association conducted an observational, cross-sectional multicenter study. Weight, weight loss, and body mass index were evaluated. Undernutrition was defined as unintentional weight loss > 10% in the last threesix months. Values of Malnutrition Universal Screening Tool(MUST) > 2, NRS-2002 > 3, and Mini Nutritional Assessment(MNA) from 17 to 25 identified risk of malnutrition in outpatients, inpatients and elderly patients, respectively. A body mass index ≥ 30 indicated obesity. Gastrointestinal pathologies were categorized into acute, chronic and neoplastic diseases. RESULTS: A total of 513 patients participated in the study. The prevalence of undernutrition was 4.6% in outpatients and 19.6% in inpatients. Moreover, undernutrition was present in 4.3% of the gastrointestinal patients with chronic disease, 11.0% of those with acute disease, and 17.6% of those with cancer. The risk of malnutrition increased progressively and significantly in chronic, acute and neoplastic gastrointestinal diseases in inpatients and the elderly population. Logistical regression analysis confirmed that cancer was a risk factor for undernutrition(OR = 2.7; 95%CI: 1.2-6.44, P = 0.02). Obesity and overweight were more frequent in outpatients. CONCLUSION: More than 63% of outpatients and 80% of inpatients in gastroenterological centers suffered from significant changes in body composition and required specific nutritional competence and treatment.

  12. Kinetic and Related Determinants of Plasma Triglyceride Concentration in Abdominal Obesity: Multicenter Tracer Kinetic Study.

    Science.gov (United States)

    Borén, Jan; Watts, Gerald F; Adiels, Martin; Söderlund, Sanni; Chan, Dick C; Hakkarainen, Antti; Lundbom, Nina; Matikainen, Niina; Kahri, Juhani; Vergès, Bruno; Barrett, P Hugh R; Taskinen, Marja-Riitta

    2015-10-01

    Patients with obesity and diabetes mellitus have increased risk of cardiovascular disease. A major cause is an atherogenic dyslipidemia related primarily to elevated plasma concentrations of triglyceride-rich lipoproteins. The aim of this study was to clarify determinants of plasma triglyceride concentration. We focused on factors that predict the kinetics of very-low density lipoprotein 1 (VLDL1) triglycerides. A multicenter study using dual stable isotopes (deuterated leucine and glycerol) and multicompartmental modeling was performed to elucidate the kinetics of triglycerides and apoB in VLDL1 in 46 subjects with abdominal obesity and additional cardiometabolic risk factors. Results showed that plasma triglyceride concentrations were dependent on both the secretion rate (r=0.44, Ptriglycerides and VLDL1-apoB. Liver fat mass was independently and directly associated with secretion rates of VLDL1-triglycerides (r=0.56, Ptriglycerides (r=0.48, Ptriglyceride concentrations in abdominal obesity are determined by the kinetics of VLDL1 subspecies, catabolism being mainly dependent on apoC-III concentration and secretion on liver fat content. Reduction in liver fat and targeting apoC-III may be an effective approach for correcting triglyceride metabolism atherogenic dyslipidemia in obesity. © 2015 American Heart Association, Inc.

  13. Quadriceps Weakness, Patella Alta and Structural Features of Patellofemoral Osteoarthritis: The Multicenter Osteoarthritis Study

    Science.gov (United States)

    Stefanik, Joshua J.; Guermazi, Ali; Zhu, Yanyan; Zumwalt, Ann C.; Gross, K. Douglas; Clancy, Margaret; Lynch, John A.; Segal, Neil A.; Lewis, Cora E.; Roemer, Frank W.; Powers, Christopher M.; Felson, David T.

    2011-01-01

    Objective To determine the relationship between quadriceps weakness and cartilage damage and bone marrow lesions (BMLs) in the patellofemoral joint (PFJ), and if this relationship is modified by patella alta. Methods The Multicenter Osteoarthritis (MOST) Study is a cohort study of persons aged 50–79 years with or at risk for knee OA. Concentric knee extensor strength was measured using an isokinetic dynamometer. Patella alta was measured using the Insall-Salvati ratio (ISR) on the lateral radiograph, and cartilage damage and bone marrow lesions (BMLs) were graded on MRI in the PFJ. We determined the association between quadriceps weakness with cartilage damage and BMLs in the PFJ among those knees with (ISR≥1.2) and without patella alta (ISRpatella alta in the lateral PFJ. Conclusion Quadriceps weakness was associated with PFJ cartilage damage and BMLs. While both patella alta and quadriceps weakness are associated with PFJ damage, the combination of the two was not associated with more damage than either of these factors alone. PMID:21702087

  14. Reliability of Semiautomated Computational Methods for Estimating Tibiofemoral Contact Stress in the Multicenter Osteoarthritis Study

    Directory of Open Access Journals (Sweden)

    Donald D. Anderson

    2012-01-01

    Full Text Available Recent findings suggest that contact stress is a potent predictor of subsequent symptomatic osteoarthritis development in the knee. However, much larger numbers of knees (likely on the order of hundreds, if not thousands need to be reliably analyzed to achieve the statistical power necessary to clarify this relationship. This study assessed the reliability of new semiautomated computational methods for estimating contact stress in knees from large population-based cohorts. Ten knees of subjects from the Multicenter Osteoarthritis Study were included. Bone surfaces were manually segmented from sequential 1.0 Tesla magnetic resonance imaging slices by three individuals on two nonconsecutive days. Four individuals then registered the resulting bone surfaces to corresponding bone edges on weight-bearing radiographs, using a semi-automated algorithm. Discrete element analysis methods were used to estimate contact stress distributions for each knee. Segmentation and registration reliabilities (day-to-day and interrater for peak and mean medial and lateral tibiofemoral contact stress were assessed with Shrout-Fleiss intraclass correlation coefficients (ICCs. The segmentation and registration steps of the modeling approach were found to have excellent day-to-day (ICC 0.93–0.99 and good inter-rater reliability (0.84–0.97. This approach for estimating compartment-specific tibiofemoral contact stress appears to be sufficiently reliable for use in large population-based cohorts.

  15. [Snow board accidents. Multicenter Swiss snow board study 1992/93 with the cooperation of the bfu].

    Science.gov (United States)

    Campell, L; Soklic, P; Ziegler, W; Matter, P; Fenner, A; Noesberger, B; Rigo, M

    1993-01-01

    Snowboarding has become increasingly popular in recent years. A prospective multicenter study was therefore performed during the winter 1992/93. 345 injuries were analysed and compared with 305 healthy snowboarders on the slopes. Preliminary results show predominantly injuries of the upper extremity comparative to those suffered from alpine skiing. Protection of the hand and wrist is recommended as well as an instruction for a special technique for falling as measurements for accident prevention.

  16. Antibiotic use in infants in the first year of life in five European countries

    NARCIS (Netherlands)

    Stam, Jose; van Stuijvenberg, Margriet; Grueber, Christoph; Mosca, Fabio; Arslanoglu, Sertac; Chirico, Gaetano; Braegger, Christian P.; Riedler, Josef; Boehm, Guenther; Sauer, Pieter J. J.

    2012-01-01

    Aim: To assess in infants the number of illness episodes treated with antibiotics and prescription rates in five European countries. Methods: This study was embedded in a multicenter nutritional intervention study and was conducted in five European countries. Infants were followed until 1 year of ag

  17. Antibiotic use in infants in the first year of life in five European countries

    NARCIS (Netherlands)

    Stam, Jose; van Stuijvenberg, Margriet; Grueber, Christoph; Mosca, Fabio; Arslanoglu, Sertac; Chirico, Gaetano; Braegger, Christian P.; Riedler, Josef; Boehm, Guenther; Sauer, Pieter J. J.

    Aim: To assess in infants the number of illness episodes treated with antibiotics and prescription rates in five European countries. Methods: This study was embedded in a multicenter nutritional intervention study and was conducted in five European countries. Infants were followed until 1 year of

  18. Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic Cadazolid in Patients with Clostridium difficile Infection.

    Science.gov (United States)

    Louie, Thomas; Nord, Carl Erik; Talbot, George H; Wilcox, Mark; Gerding, Dale N; Buitrago, Martha; Kracker, Hilke; Charef, Pascal; Cornely, Oliver A

    2015-10-01

    Cadazolid, a novel fluoroquinolone-oxazolidinone antibiotic, exhibits potent in vitro activity against Clostridium difficile, including the epidemic BI/NAP1/027 strain. This multicenter, randomized, double-blind, active reference group, phase 2 study evaluated the efficacy and safety of oral cadazolid in treatment of adult patients with C. difficile infection (CDI). Eligible patients with first occurrence/first recurrence of CDI were randomized 1:1:1:1 to 250, 500, or 1,000 mg cadazolid twice daily (BID) or oral 125 mg vancomycin four times daily (QID) for 10 days. The primary endpoint was clinical cure at test of cure (48 ± 24 h after the end of treatment; modified intent-to-treat population), defined as resolution of diarrhea with no further CDI treatment required. Secondary endpoints included recurrence rate, sustained clinical response (clinical cure without recurrence), and time to diarrhea resolution. Of 84 patients enrolled, 20, 22, 20, and 22 received 250, 500, or 1,000 mg cadazolid BID or 125 mg vancomycin QID, respectively. The primary endpoint was achieved in 76.5% (80% confidence interval [CI], 58.4, 89.3), 80.0% (63.9, 91.0), 68.4% (51.1, 82.5), and 68.2% (52.3, 81.3) of patients, respectively. There was no evidence of a cadazolid dosage-dependent response. Each dosage of cadazolid resulted in a lower recurrence rate than with vancomycin (18.2 to 25.0% versus 50%). Consequently, higher sustained clinical response rates were observed with cadazolid (46.7 to 60.0%) than with vancomycin (33.3%). The times to diarrhea resolution were similar for cadazolid and vancomycin. Cadazolid was well tolerated, with no safety signal observed. The results of this phase 2 study support further clinical development of cadazolid. (This study has been registered in the United States at ClinicalTrials.gov under registration no. NCT01222702 and in Europe with the European Medicines Agency under registration no. EUDRA-CT 2010-020941-29.).

  19. European birth cohort studies on asthma and atopic diseases

    DEFF Research Database (Denmark)

    Keil, T; Kulig, M; Simpson, A;

    2006-01-01

    BACKGROUND: The Global Allergy and Asthma European Network (GA2LEN) is a consortium of 26 leading European research centres committed to establish a European research area of excellence in the field of allergy and asthma. AIM: One of the GA2LEN work packages was designed to identify and compare...... asthma and atopic diseases. Data were collected by visiting most of the participating research teams and interviewing all relevant study personnel. For each study, the type of objective/subjective outcome parameters and potentially influential factors were recorded precisely for every time point during...... the existing European birth cohort studies on asthma and atopic diseases. The present review compares their subjective and objective outcomes as well as exposure variables. METHODS: A common database was established to assess study characteristics of observational birth cohort studies designed to examine...

  20. Multicenter Study of Prevalence of Nontuberculous Mycobacteria in Patients with Cystic Fibrosis in France ▿

    Science.gov (United States)

    Roux, Anne-Laure; Catherinot, Emilie; Ripoll, Fabienne; Soismier, Nathalie; Macheras, Edouard; Ravilly, Sophie; Bellis, Gil; Vibet, Marie-Anne; Le Roux, Evelyne; Lemonnier, Lydie; Gutierrez, Cristina; Vincent, Véronique; Fauroux, Brigitte; Rottman, Martin; Guillemot, Didier; Gaillard, Jean-Louis

    2009-01-01

    We performed a multicenter prevalence study of nontuberculous mycobacteria (NTM) involving 1,582 patients (mean age, 18.9 years; male/female ratio, 1.06) with cystic fibrosis in France. The overall NTM prevalence (percentage of patients with at least one positive culture) was 6.6% (104/1,582 patients), with prevalences ranging from 3.7% (in the east of France) to 9.6% (in the greater Paris area). Mycobacterium abscessus complex (MABSC; 50 patients) and Mycobacterium avium complex (MAC; 23 patients) species were the most common NTM, and the only ones associated with fulfillment of the American Thoracic Society bacteriological criteria for NTM lung disease. The “new” species, Mycobacterium bolletii and Mycobacterium massiliense, accounted for 40% of MABSC isolates. MABSC species were isolated at all ages, with a prevalence peak between 11 and 15 years of age (5.8%), while MAC species reached their highest prevalence value among patients over 25 years of age (2.2%). PMID:19846643

  1. Arthroscopic repair of peripheral avulsions of the triangular fibrocartilage complex of the wrist: a multicenter study.

    Science.gov (United States)

    Corso, S J; Savoie, F H; Geissler, W B; Whipple, T L; Jiminez, W; Jenkins, N

    1997-02-01

    A multicenter study to assess arthroscopic reconstruction of the peripheral attachment of the triangular fibrocartilage complex was undertaken. A total of 44 patients (45 wrists) from three institutions were reviewed. Twenty-seven of the 45 wrists had associated injuries, including distal radius fracture (4), partial or complete rupture of the scapholunate (7), lunotriquetral (9), ulnocarpal (2), or radiocarpal (2) ligaments. There were two fractured ulnar styloids and one scapholunate accelerated collapse (SLAC) wrist deformity. The peripheral tears were repaired using a zone-specific repair kit. The patients were immobilized in a munster cast, allowing elbow flexion and extension, but no pronation or supination for 4 weeks, followed by 2 to 4 weeks in a short arm cast or VersaWrist splint. All patients were reexamined independently 1 to 3 years postoperatively by a physician, therapist, and registered nurse. The results were graded according to the Mayo modified wrist score. Twenty-nine of the 45 wrists were rated excellent. 12 good, 1 fair, and 3 poor. Overall, 42 of the 45 patients (93%) rated as satisfactory and returned to sports or work activities. One patient had chronic pain, and two patients had ulnar nerve symptoms, although motion was normal in all, and their grip strength was at least 75% of the opposite hand. Arthroscopic repair of peripheral tears of the triangular fibrocartilage complex (TFCC) is a satisfactory method of repairing these injuries.

  2. Value of Chest Radiographic Pattern in RSV Disease of the Newborn: A Multicenter Retrospective Cohort Study

    Directory of Open Access Journals (Sweden)

    Américo Gonçalves

    2012-01-01

    Full Text Available Respiratory syncytial virus (RSV lower respiratory tract infection is the most common viral respiratory infection in infants. Several authors have sought to determine which risk factors are the best predictors for severe RSV disease. Our aim was to evaluate if a specific chest radiographic pattern in RSV disease can predict the disease severity. We conducted a multicenter retrospective cohort study in term and preterm neonates with confirmed lower respiratory tract RSV infection, admitted to neonatal intensive care units (NICU from 2000 to 2010. To determine which factors independently predicted the outcomes, multivariate logistic regression analysis was performed. A total of 259 term and preterm neonates were enrolled. Patients with a consolidation pattern on the chest radiograph at admission (n=101 had greater need for invasive mechanical ventilation (OR: 2.5; P=.015, respiratory support (OR: 2.3; P=.005, supplemental oxygen (OR: 3.0; P=.008, and prolonged stay in the NICU (>7 days (OR: 1.8; P=.025. Newborns with a consolidation pattern on admission chest radiograph had a more severe disease course, with greater risk of invasive mechanical ventilation, respiratory support, supplemental oxygen, and prolonged hospitalization.

  3. Multicenter study on adult growth hormone level in postoperative pituitary tumor patients.

    Science.gov (United States)

    Cheng, Jing-min; Gu, Jian-wen; Kuang, Yong-qin; Ma, Yuan; Xia, Xun; Yang, Tao; Lu, Min; He, Wei-qi; Sun, Zhi-yong; Zhang, Yan-chao

    2015-03-01

    The objective of this study is to observe the adult growth hormone level in postoperative pituitary tumor patients of multi-centers, and explore the change of hypophyseal hormones in postoperative pituitary tumor patients. Sixty patients with pituitary tumor admitted during March, 2011-March, 2012 were selected. Postoperative hypophyseal hormone deficiency and the change of preoperative, intraoperative, and postoperative growth hormone levels were recorded. Growth hormone hypofunction was the most common hormonal hypofunction, which took up to 85.0 %. Adrenocortical hormone hypofunction was next to it and accounted for 58.33 %. GH + ACTH + TSH + Gn deficiency was the most common in postoperative hormone deficiency, which took up to 40.00 %, and GH + ACTH + TSH + Gn + AVP and GH deficiencies were next to it and accounted for 23.33 and 16.67 %, respectively. The hormone levels in patients after total pituitary tumor resection were significantly lower than those after partial pituitary tumor resection, and the difference was statistically significant; growth hormone and serum prolactin levels after surgery in two groups were decreased, and the difference was statistically significant. The incidence rate of growth hormone deficiency in postoperative pituitary tumor patients is high, which is usually complicated with deficiency of various hypophyseal hormones. In clinical, we should pay attention to the levels of the hypopnyseal hormones, and take timely measures to avoid postoperative complications.

  4. Rheumatic fever: a multicenter study in the State of São Paulo

    Directory of Open Access Journals (Sweden)

    Silva Carlos Henrique Martins da

    1999-01-01

    Full Text Available Rheumatic fever is still the most commonly seen rheumatic disease in Brazilian pediatric rheumatology clinics. It remains a significant health problem since subsequent cardiac sequelae represent one of the most important causes of chronic heart disease in children. We reviewed the clinical manifestations of rheumatic fever in 786 patients, followed at seven pediatric rheumatology clinics in the state of São Paulo, Brazil. All patients were diagnosed according to revised Jones' criteria. Regarding major criteria, 396 (50.4% children exhibited carditis, 453 (57.6% polyarthritis, 274 (34.8% chorea, 13 (1.6% erythema marginatum, and 12 (1.5% subcutaneous nodules. Valvular lesions documented by echocardiography in the absence of accompanying auscultatory findings were found in 144 (18.3% patients. Migratory polyarthritis was observed in 290 (64.0% patients with articular involvement. Documented previous streptococcal infection assessed by serum antistreptolysin (ASO titers occurred in 531 (67.5% patients. Even though prophylaxis with benzathine penicillin was recommended to all patients, recurrent attacks were observed in 147 (18.7%. We emphasize the high frequency of chorea, silent carditis and recurrences in our series as well as the variable clinical presentation of arthritis in rheumatic fever. Multicenter studies should be encouraged to improve our understanding of the clinical features of rheumatic diseases in children and adolescents.

  5. The Association of Obesity with Walking Independent of Knee Pain: The Multicenter Osteoarthritis Study

    Directory of Open Access Journals (Sweden)

    Daniel K. White

    2012-01-01

    Full Text Available Practice guidelines recommend addressing obesity for people with knee OA, however, the association of obesity with walking independent of pain is not known. We investigated this association within the Multicenter Osteoarthritis Study, a cohort of older adults who have or are at high risk of knee OA. Subjects wore a StepWatch to record steps taken over 7 days. We measured knee pain from a visual analogue scale and obesity by BMI. We examined the association of obesity with walking using linear regression adjusting for pain and covariates. Of 1788 subjects, the mean steps/day taken was 8872.9±3543.4. Subjects with a BMI ≥35 took 3355 fewer steps per day independent of knee pain compared with those with a BMI ≤25 (95% CI −3899, −2811. BMI accounted for 9.7% of the variability of walking while knee pain accounted for 2.9%. BMI was associated with walking independent of knee pain.

  6. [Trauma-related disorders in patients with borderline personality disorders. Results of a multicenter study].

    Science.gov (United States)

    Sack, M; Sachsse, U; Overkamp, B; Dulz, B

    2013-05-01

    There is current controversy about the diagnostic overlap between personality disorders and trauma-related disorders. Applying a multicenter study design, trauma-related disorders were investigated via interview assessment in 136 patients with borderline personality disorder (BPD) in 5 specialized treatment centers. Additionally a spectrum of psychological symptoms and prevalence of lifetime traumatic experiences were assessed by questionnaire measures. Diagnostic overlap between BPD and PTSD was found to be high (79%) as well as the overlap of BPD with complex PTSD (55%) and severe dissociative disorders (41%). Including neglect and emotional violence as trauma categories, an extremely high prevalence of lifetime traumatic experiences was reported (96%). Experiences of sexual violence were reported by 48% of all female and 28% of all male patients. Severe forms of physical violence were reported by 65% of all patients. BPD patients with severe psychopathology show a high comorbidity with trauma-related disorders including dissociative disorders. This association has to be taken into account when planning psychological treatment.

  7. Health care providers underestimate symptom intensities of cancer patients: A multicenter European study

    NARCIS (Netherlands)

    Laugsand, E.A.; Sprangers, M.A.G.; Bjordal, K.; Skorpen, F.; Kaasa, S.; Klepstad, P.

    2010-01-01

    ABSTRACT: BACKGROUND: Many patients with advanced cancer depend upon health care providers for symptom assessment. The extent of agreement between patient and provider symptom assessments and the association of agreement with demographic- and disease-related factors was examined. METHODS: This

  8. Adjunctive corticosteroid therapy for Pneumocystis carinii pneumonia in AIDS: a randomized European multicenter open label study

    DEFF Research Database (Denmark)

    Nielsen, T L; Eeftinck Schattenkerk, J K; Jensen, B N

    1992-01-01

    ) survival to discharge, (b) need for mechanical ventilation, and (c) survival at day 90. CS was given within 24 h of standard therapy as intravenous methylprednisolone 2 mg/kg body weight daily for 10 days. All patients received cotrimoxazole as standard treatment. Inclusion criteria were a PaO2 less than 9...

  9. Pressure ulcer incidence in Dutch and German nursing homes: design of a prospective multicenter cohort study

    Directory of Open Access Journals (Sweden)

    Lohrmann Christa

    2011-04-01

    Full Text Available Abstract Background Pressure ulcers are a common and serious health care problem in all health care settings. Results from annual national pressure ulcer prevalence surveys in the Netherlands and Germany reveal large differences in prevalence rates between both countries over the past ten years, especially in nursing homes. When examining differences in prevalence and incidence rates, it is important to take into account all factors associated with the development of pressure ulcers. Numerous studies have identified patient related factors, as well as nursing related interventions as risk factors for the development of pressure ulcers. Next to these more process oriented factors, also structural factors such as staffing levels and staff quality play a role in the development of pressure ulcers. This study has been designed to investigate the incidence of pressure ulcers in nursing homes in the Netherlands and Germany and to identify patient related factors, nursing related factors and structural factors associated with pressure ulcer development. The present article describes the protocol for this study. Methods/design A prospective multicenter study is designed in which a cohort of newly admitted nursing home residents in 10 Dutch and 11 German nursing homes will be followed for a period of 12 weeks. Data will be collected by research assistants using questionnaires on four different levels: resident, staff, ward, and nursing home. Discussion The results of the study will provide information on the incidence of pressure ulcers in Dutch and German nursing homes. Furthermore, information will be gathered on the influence of patient related factors, nursing related factors and structural factors on the incidence of pressure ulcers. The present article describes the study design and addresses the study's strengths and weaknesses.

  10. Fraser syndrome : epidemiological study in a European population

    NARCIS (Netherlands)

    Barisic, Ingeborg; Odak, Ljubica; Loane, Maria; Garne, Ester; Wellesley, Diana; Calzolari, Elisa; Dolk, Helen; Addor, Marie-Claude; Arriola, Larraitz; Bergman, Jorieke; Bianca, Sebastiano; Boyd, Patricia A; Draper, Elizabeth S; Gatt, Miriam; Haeusler, Martin; Khoshnood, Babak; Latos-Bielenska, Anna; McDonnell, Bob; Pierini, Anna; Rankin, Judith; Rissmann, Anke; Queisser-Luft, Annette; Verellen-Dumoulin, Christine; Stone, David; Tenconi, Romano

    2013-01-01

    Fraser syndrome is a rare autosomal recessive disorder characterized by cryptophthalmos, cutaneous syndactyly, laryngeal, and urogenital malformations. We present a population-based epidemiological study using data provided by the European Surveillance of Congenital Anomalies (EUROCAT) network of bi

  11. European Liaisons? A study on European bi-national marriages in Belgium

    NARCIS (Netherlands)

    Koelet, S.; de Valk, H.A.G.

    2014-01-01

    European bi-national marriages as a special case of interethnic unions have received relatively little attention in research. Existing studies on interethnic marriage mainly orient on union formation among non-western migrants and in particular intermarriages between the majority group and non-weste

  12. Multicenter study differentiated thyroid carcinoma (MSDS). Diminished acceptance of adjuvant external beam radiotherapy.

    Science.gov (United States)

    Biermann, M; Pixberg, M K; Schuck, A; Heinecke, A; Köpcke, W; Schmid, K W; Dralle, H; Willich, N; Schober, O

    2003-12-01

    The Multicenter Study Differentiated Thyroid Carcinoma (MSDS) is an ongoing study in Germany, Austria, and Switzerland on the clinical benefit of adjuvant external beam radiotherapy (RTx) for locally invasive differentiated thyroid carcinoma (DTC) in TNM stages pT4 pN0/1/x M0/x (5th ed. 1997). MSDS was designed as a prospective randomized trial. Patients receive thyroidectomy, radioiodine therapy (RIT) to ablate the thyroid remnant, and TSH-suppressive L-thyroxine therapy with or without RTx after documented elimination of cervical iodine-131 uptake (http://msds-studie.uni-muenster.de). 311 patients were enrolled between January 2000 and March 2003. 279 patients met the trial's inclusion criteria. 45 consented to randomization, of whom 17 were randomized into treatment arm A (RTx) and 18 into arm B (no RTx). Advised by the trial's independent Data Monitoring and Safety Committee, the MSDS steering committee decided to terminate randomization in April 2003 and continue MSDS as a prospective cohort study. 23 of the 234 patients in the observation arm of the trial were prescribed RTx by their physicians. Thus, 14% of the trial cohort were randomized or assigned to receive RTx (in-tention-to-treat analysis). In contrast, at least 44% of all patients with pT4 papillary DTC in Germany in the nation-wide PCES study underwent RTx in 1996 (p <0.001, chi(2)-test). Acceptance of external beam RTx as a treatment modality for DTC has receded to a degree that accrual of a sufficient number of patients for a randomized trial has been impossible. Observation of the trial cohort is continued in order to assess clinical event rates with and without RTx and chronic RTx toxicity.

  13. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

    Directory of Open Access Journals (Sweden)

    Reinaldo Menezes Martins

    2004-12-01

    Full Text Available The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang® were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70% met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the protocol were newborn infants (566, children 1 to 10 years old (484, adolescents from 11 to 19 years (740, adults from 20 to 30 years (568, and adults from 31 to 40 years (396. Vaccine was administered in three doses on the schedule 0, 1, and 6 months (newborn infants, adolescents, and adults or 0, 1, and 7 months (children. Vaccine dose was intramuscular 10 µg (infants, children, and adolescents or 20 µg (adults. Percent seroprotection (assumed when anti-HBs titers were > 10mIU/ml and geometric mean titer (mIU/ml were: newborn infants, 93.7% and 351.1 (Butang® and 97.5% and 1530.6 (Engerix B®; children, 100% and 3600.0 (Butang® and 97.7% and 2753.1 (Engerix B®; adolescents, 95.1% and 746.3 (Butang® and 96% and 1284.3 (Engerix B®; adults 20-30 years old, 91.8% and 453.5 (Butang® and 95.5% and 1369.0 (Engerix B®; and adults 31-40 years old, 79.8% and 122.7 (Butang® and 92.4% and 686.2 (Engerix B®. There were no severe adverse events following either vaccine. The study concluded that Butang® was equivalent to Engerix B® in children, and less immunogenic but acceptable for use in newborn infants, adolescents, and young adults.

  14. Blood Reference Intervals for Preterm Low-Birth-Weight Infants: A Multicenter Cohort Study in Japan

    Science.gov (United States)

    Inoue, Hirosuke; Kusuda, Takeshi; Kang, Dongchon; Ichihara, Kiyoshi; Nakashima, Naoki; Ihara, Kenji; Ohga, Shouichi; Hara, Toshiro

    2016-01-01

    Preterm low-birth-weight infants remain difficult to manage based on adequate laboratory tests. The aim of this study was to establish blood reference intervals (RIs) in those newborns who were admitted to and survived in the neonatal intensive care unit (NICU). A multicenter prospective study was conducted among all infants admitted to 11 affiliated NICUs from 2010 to 2013. The clinical information and laboratory data were registered in a network database designed for this study. The RIs for 26 items were derived using the parametric method after applying the latent abnormal values exclusion method. The influence of birth weight (BW) and gestational age (GA) on the test results was expressed in terms of the standard deviation ratio (SDR), as SDRBW and SDRGA, respectively. A total of 3189 infants were admitted during the study period; 246 were excluded due to a lack of blood sampling data, and 234 were excluded for chromosomal abnormalities (n = 108), congenital anomalies requiring treatment with surgical procedures (n = 76), and death or transfer to another hospital (n = 50). As a result, 2709 infants were enrolled in this study. Both the SDRGA and SDRBW were above 0.4 in the test results for total protein (TP), albumin (ALB), alanine aminotransferase (ALT), and red blood cells (RBC); their values increased in proportion to the BW and GA. We derived 26 blood RIs for infants who were admitted to NICUs. These RIs should help in the performance of proper clinical assessments and research in the field of perinatal-neonatal medicine. PMID:27552225

  15. Essential competencies in prescribing: A first european cross-sectional study among 895 final-year medical students.

    Science.gov (United States)

    Brinkman, D J; Tichelaar, J; Schutte, T; Benemei, S; Böttiger, Y; Chamontin, B; Christiaens, T; Likic, R; Maˇiulaitis, R; Marandi, T; Monteiro, E C; Papaioannidou, P; Pers, Y M; Pontes, C; Raskovic, A; Regenthal, R; Sanz, E J; Tamba, B I; Wilson, K; Vries, Tp de; Richir, M C; Agtmael, Ma van

    2017-02-01

    European medical students should have acquired adequate prescribing competencies before graduation, but it is not known whether this is the case. In this international multicenter study, we evaluated the essential knowledge, skills, and attitudes in clinical pharmacology and therapeutics (CPT) of final-year medical students across Europe. In a cross-sectional design, 26 medical schools from 17 European countries were asked to administer a standardized assessment and questionnaire to 50 final-year students. Although there were differences between schools, our results show an overall lack of essential prescribing competencies among final-year students in Europe. Students had a poor knowledge of drug interactions and contraindications, and chose inappropriate therapies for common diseases or made prescribing errors. Our results suggest that undergraduate teaching in CPT is inadequate in many European schools, leading to incompetent prescribers and potentially unsafe patient care. A European core curriculum with clear learning outcomes and assessments should be urgently developed. © 2016 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of The American Society for Clinical Pharmacology and Therapeutics.

  16. A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

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    Verleisdonk Egbert JMM

    2011-06-01

    Full Text Available Abstract Background Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF, or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation. Methods/Design The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36. Discussion The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are

  17. Over- and undersupply in home care: a representative multicenter correlational study.

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    Lahmann, Nils A; Suhr, Ralf; Kuntz, Simone; Kottner, Jan

    2015-04-01

    Quality assurance and funding of care become a major challenge against the background of demographic changes in western societies. The primary aim of the study was to identify possible misclassification, respectively over and undersupply of care by comparing the Barthel Index of clients of home care service with the level of care (Stage 0, I, II, III) according to the statutory German long-term care insurance. In 2012, a multi-center point prevalence study of 878 randomly selected clients of 100 randomly selected home care services across Germany was conducted. According to a standardized study protocol, demographics, the Barthel Index and the nurses' professional judgment-whether a client requires more nursing care-were assessed. Associations of the Barthel items and professional judgment were analyzed using univariate (Chi-square) and multivariate (logistic regression and classification-regression-tree-models) statistics. In each level of care, the Barthel Index showed large variability e.g. in level II ranging from 0 to 100 points. Multivariate logistic regression regarding possible under- and oversupply revealed occasionally fecal incontinence (2.1; 95 % CI 1.2-3.7), urinary incontinence (2.0; 95 % CI 1.1-3.6), feeding (1.7; 95 % CI 1.0-2.9), immobility (0.2; 95 % CI 0.1-0.6) and to be female (1.8; 95 % CI 1.2-2.6) to be statistically significantly associated. The variability in Barthel Index in each level of care found in this study indicated a large general misclassification of home care clients according to their actual need of care. Professional caregivers identified occasional incontinence, help with eating and drinking and mobility (especially in female clients) as areas of possible under- and oversupply of care. The statutory German long-term care insurance classification should be modified according to the above finding to increase the quality of care in home care clients.

  18. Health care utilization in patients with gout: a prospective multicenter cohort study.

    Science.gov (United States)

    Singh, Jasvinder A; Bharat, Aseem; Khanna, Dinesh; Aquino-Beaton, Cleopatra; Persselin, Jay E; Duffy, Erin; Elashoff, David; Khanna, Puja P

    2017-05-31

    All published studies of health care utilization in gout have been cross-sectional to date, and most used a patient-reported diagnosis of gout. Our objective was to assess health care utilization and its predictors in patients with physician-confirmed gout in a prospective cohort study. In a multi-center prospective cohort study of U.S. veterans with rheumatologist-confirmed gout (N = 186; two centers), we assessed patient self-reported overall and gout-specific health care utilization with the Gout Assessment Questionnaire (GAQ) every 3-months for a 9-month period. Comparisons were made using the student's t test or the chi-square, Wilcoxon rank sum test or Fisher exact test, as appropriate. Mixed effects Poisson regression was used to assess potential correlates of gout-related health care utilization. Mean age was 64.6 years, 98% were men, 13% Hispanic or Latino, 32% were African-American, 6% did not graduate high school, mean serum urate was 8.3 and mean Deyo-Charlson score was 3.1. During the past year, mean gout-related visits were as follows: rheumatologist, 1.5; primary care physician, 2 visits; ≥1 inpatient visits, 7%; ≥1 ER visits, 26%; and urgent care/walk-in visit, 33%. In longitudinal analyses, African-American race and gout flares in the last 3 months were associated with significantly higher rate ratio of gout-related outpatient visits. African-American race and lack of college education were associated with significantly higher rate ratio for gout-related urgent visits and overnight stays. African-American race and recent gout flares were associated with higher outpatient utilization and African-American race and no college education with higher urgent or inpatient utilization. Future studies should examine whether modifiable predictors of utilization can be targeted to reduce healthcare utilization in patients with gout.

  19. The Burden of Spine Fractures in India: A Prospective Multicenter Study.

    Science.gov (United States)

    Aleem, Ilyas S; DeMarco, Dylan; Drew, Brian; Sancheti, Parag; Shetty, Vijay; Dhillon, Mandeep; Foote, Clary J; Bhandari, Mohit

    2017-06-01

    Prospective cohort study. The objectives of this study were (1) to determine the characteristics of patients sustaining spinal trauma in India and (2) to explore the association between patient or injury characteristics and outcomes after spinal trauma. In affiliation with the ongoing INternational ORthopaedic MUlticentre Study (INORMUS), 192 patients with spinal injuries were recruited during an 8-week period (November 2011 to June 2012) from 14 hospitals in India and followed for 30-days. The primary outcome was a composite of mortality, complications, and reoperation. This was regressed on a set of 13 predictors in a multiple logistic regression model. Most patients were middle-aged (mean age = 51.0 years; median age = 55.5 years; range = 18.0 to 72.0 years), male (60.4%), injured from falls (72.4%), and treated in a private setting (59.9%). Fractures in the lumbar region (51.0%) were most common, followed by thoracic (30.7%) and cervical (18.2%). More than 1 in 5 (21.6%) patients experienced a treatment delay greater than 24 hours, and 36.5% arrived by ambulance. Thirty-day mortality and complication rates were 2.6% and 10.0%, respectively. Care in the public hospital system (odds ratio [OR] = 6.7, 95% CI = 1.1-41.6), chest injury (OR = 11.1, 95% CI = 1.8-66.9), and surgical intervention (OR = 4.8, 95% CI = 1.2-19.6) were independent predictors of major complications. Treatment in the public health care system, increased severity of injury, and surgical intervention were associated with increased risk of major complications following spinal trauma. The need for a large-scale, prospective, multicenter study taking into account spinal stability and neurologic status is feasible and warranted.

  20. Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

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    Oliveira Sérgio A

    2007-01-01

    Full Text Available Abstract Background Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. Method/Design We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum. For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. Discussion Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271

  1. Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas.

    Science.gov (United States)

    Stamos, Michael J; Snyder, Michael; Robb, Bruce W; Ky, Alex; Singer, Marc; Stewart, David B; Sonoda, Toyooki; Abcarian, Herand

    2015-03-01

    Although interest in sphincter-sparing treatments for anal fistulas is increasing, few large prospective studies of these approaches have been conducted. The study assessed outcomes after implantation of a synthetic bioabsorbable anal fistula plug. A prospective, multicenter investigation was performed. The study was conducted at 11 colon and rectal centers. Ninety-three patients (71 men; mean age, 47 years) with complex cryptoglandular transsphincteric anal fistulas were enrolled. Exclusion criteria included Crohn's disease, an active infection, a multitract fistula, and an immunocompromised status. Draining setons were used at the surgeon's discretion. Patients had follow-up evaluations at 1, 3, 6, and 12 months postoperatively. The primary end point was healing of the fistula, defined as drainage cessation plus closure of the external opening, at 6 and 12 months. Secondary end points were fecal continence, duration of drainage from the fistula, pain, and adverse events during follow-up. Thirteen patients were lost to follow-up and 21 were withdrawn, primarily to undergo an alternative treatment. The fistula healing rates at 6 and 12 months were 41% (95% CI, 30%-52%; total n = 74) and 49% (95% CI, 38%-61%; total n = 73). Half the patients in whom a previous treatment failed had healing. By 6 months, the mean Wexner score had improved significantly (p = 0.0003). By 12 months, 93% of patients had no or minimal pain. Adverse events included 11 infections/abscesses, 2 new fistulas, and 8 total and 5 partial plug extrusions. The fistula healed in 3 patients with a partial extrusion. The study was nonrandomized and had relatively high rates of loss to follow-up. Implantation of a synthetic bioabsorbable fistula plug is a reasonably efficacious treatment for complex transsphincteric anal fistulas, especially given the simplicity and low morbidity of the procedure.

  2. Who Donates Their Body to Science? An International, Multicenter, Prospective Study

    Science.gov (United States)

    Cornwall, Jon; Perry, Gary F.; Louw, Graham; Stringer, Mark D.

    2012-01-01

    The altruistic act of body donation provides a precious resource for both teaching and researching human anatomy. However, relatively little is known about individuals who donate their bodies to science (donors), and in particular whether donors in different geographical locations share similar characteristics. A multicenter prospective survey of…

  3. Early-Stage Primary Bone Lymphoma: A Retrospective, Multicenter Rare Cancer Network (RCN) Study

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    Cai Ling [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland); Sun Yat-sen University Cancer Center, Guangzhou, Guangdong (China); Stauder, Michael C. [Mayo Clinic, Rochester, MN (United States); Zhang Yujing [Sun Yat-sen University Cancer Center, Guangzhou, Guangdong (China); Poortmans, Philip [Verbeeten Institute, Tilburg (Netherlands); Li Yexiong [Cancer Hospital, Chinese Academy of Medical Sciences, Beijing (China); Constantinou, Nicolaos [Theagenio Cancer Hospital, Thessaloniki, Macedonia (Greece); Thariat, Juliette [Centre Anti-Cancereux Antoine-Lacassagne, Nice, Cote d' Azur (France); Kadish, Sidney P. [University of Massachusetts Medical School, Worcester, MA (United States); Nguyen, Tan Dat [Institut Jean-Godinot, Reims, Champagne-Ardenne (France); Kirova, Youlia M. [Institut Curie, Paris (France); Ghadjar, Pirus [Inselspital, Bern University Hospital, and University of Bern (Switzerland); Weber, Damien C. [Hopitaux Universitaires de Geneve (Switzerland); Bertran, Victoria Tuset [Hospital Universitari Germans Trias i Pujol, Barcelona (Spain); Ozsahin, Mahmut [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland); Mirimanoff, Rene-Olivier, E-mail: Rene-Olivier.Mirimanoff@chuv.ch [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland)

    2012-05-01

    Purpose: Primary bone lymphoma (PBL) represents less than 1% of all malignant lymphomas. In this study, we assessed the disease profile, outcome, and prognostic factors in patients with Stages I and II PBL. Patients and Methods: Thirteen Rare Cancer Network (RCN) institutions enrolled 116 consecutive patients with PBL treated between 1987 and 2008 in this study. Eighty-seven patients underwent chemoradiotherapy (CXRT) without (78) or with (9) surgery, 15 radiotherapy (RT) without (13) or with (2) surgery, and 14 chemotherapy (CXT) without (9) or with (5) surgery. Median RT dose was 40 Gy (range, 4-60). The median number of CXT cycles was six (range, 2-8). Median follow-up was 41 months (range, 6-242). Results: The overall response rate at the end of treatment was 91% (complete response [CR] 74%, partial response [PR] 17%). Local recurrence or progression was observed in 12 (10%) patients and systemic recurrence in 17 (15%). The 5-year overall survival (OS), lymphoma-specific survival (LSS), and local control (LC) were 76%, 78%, and 92%, respectively. In univariate analyses (log-rank test), favorable prognostic factors for OS and LSS were International Prognostic Index (IPI) score {<=}1 (p = 0.009), high-grade histology (p = 0.04), CXRT (p = 0.05), CXT (p = 0.0004), CR (p < 0.0001), and RT dose >40 Gy (p = 0.005). For LC, only CR and Stage I were favorable factors. In multivariate analysis, IPI score, RT dose, CR, and CXT were independently influencing the outcome (OS and LSS). CR was the only predicting factor for LC. Conclusion: This large multicenter retrospective study confirms the good prognosis of early-stage PBL treated with combined CXRT. An adequate dose of RT and complete CXT regime were associated with better outcome.

  4. HER2 status in ovarian carcinomas: a multicenter GINECO study of 320 patients.

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    Marianne Tuefferd

    Full Text Available BACKGROUND: Despite a typically good response to first-line combination chemotherapy, the prognosis for patients with advanced ovarian cancer remains poor because of acquired chemoresistance. The use of targeted therapies such as trastuzumab may potentially improve outcomes for patients with ovarian cancer. HER2 overexpression/amplification has been reported in ovarian cancer, but the exact percentage of HER2-positive tumors varies widely in the literature. In this study, HER2 gene status was evaluated in a large, multicentric series of 320 patients with advanced ovarian cancer, including 243 patients enrolled in a multicenter prospective clinical trial of paclitaxel/carboplatin-based chemotherapy. METHODOLOGY/PRINCIPAL FINDINGS: The HER2 status of primary tumors and metastases was evaluated by both immunohistochemistry (IHC and fluorescence in situ hybridization (FISH analysis of paraffin-embedded tissue on conventional slides. The prognostic impact of HER2 expression was analyzed. HER2 gene was overexpressed and amplified in 6.6% of analyzed tumors. Despite frequent intratumoral heterogeneity, no statistically significant difference was detected between primary tumors and corresponding metastases. CONCLUSIONS/SIGNIFICANCE: Our results show that the decision algorithm usually used in breast cancer (IHC as a screening test, with equivocal results confirmed by FISH is appropriate in ovarian cancer. In contrast to previous series, HER2-positive status did not influence outcome in the present study, possibly due to the fact that patients in our study received paclitaxel/carboplatin-based chemotherapy. This raises the question of whether HER2 status and paclitaxel sensitively are linked.

  5. Cytomegalovirus Infection following Kidney Transplantation: a Multicenter Study of 3065 Cases

    Science.gov (United States)

    Einollahi, B.

    2012-01-01

    Background: Cytomegalovirus (CMV) infection is a common complication following kidney transplantation. Objective: To assess the incidence and risk factors of CMV infection among renal transplant recipients. Methods: In a retrospective multicenter study, 3065 renal transplant recipients from 17 transplant centers of Iran were studied between April 2008 and January 2011. Kidney transplant patients were routinely monitored by sequential blood samples drawn for use in the CMV-pp65 antigenemia assay, and for hematological and biochemistry tests. Results: 63% of studied patients were males; the mean±SD age of participants was 38±15 years. The majority of cases (81%) received a kidney from a living unrelated donor (LURD), 9% from living related donor (LRD), and 10% from deceased donors. 671 patients experienced CMV viremia. The incidence of CMV infection was 21.9% (95% CI: 20.4%–23.4%). The rate was higher in the first 6 months after transplantation (p<0.001); in recipients with higher level of cyclosporine (p<0.001); in those with lower hemoglobin concentration (p=0.02); patients with elevated ALT (p<0.001); those with increased fasting blood sugar (p=0.005); recipients with dyslipidemia (p<0.05); deceased kidney recipients (p=0.006); and patients with kidney graft impairment (p=0.01). In multivariate regression analysis, time since kidney transplantation (p<0.001) and renal allograft failure (p<0.001) were the only risk factors associated with CMV infection. Conclusions: CMV infection was a common complication in the first 6 months of kidney transplantation, particularly among patients with kidney graft impairment. PMID:25013626

  6. Major dietary factors and prostate cancer risk: a prospective multicenter case-control study.

    Science.gov (United States)

    Salem, Sepehr; Salahi, Mona; Mohseni, Mona; Ahmadi, Hamed; Mehrsai, Abdolrasoul; Jahani, Yunes; Pourmand, Gholamreza

    2011-01-01

    The association between diet and prostate cancer (PC) risk, although suggestive, still remains largely elusive particularly in the Asian population. This study sought to further evaluate the possible effects of different dietary factors on risk of PC in Iran. Using data from a prospective hospital-based multicenter case-control study, dietary intakes of red meat, fat, garlic, and tomato/tomato products, as well as thorough demographic and medical characteristics, were determined in 194 cases with the newly diagnosed, clinicopathologically confirmed PC and 317 controls, without any malignant disease, admitted to the same network of hospitals. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were obtained after adjustment for major potential confounders, including age, body mass index, smoking, alcohol, education, occupation, family history of PC, and total dietary calories. Comparing the highest with the lowest tertile, a significant trend of increasing risk with more frequent consumption was found for dietary fat (OR: 1.79, 95% CI: 1.71-4.51), whereas inverse association was observed for tomato/tomato products (OR: 0.33, 95% CI: 0.16-0.65). A nonsignificant increase in PC risk was revealed for dietary red meat (OR: 1.69, 95% CI: 0.93-3.06). For garlic consumption, a borderline reduction in risk was observed (OR: 0.58, 95% CI: 0.32-1.01; P = 0.05). In conclusion, our study supports the hypothesis that total fat may increase PC risk and tomatoes/tomato products and garlic may protect patients against PC.

  7. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  8. Hours of television viewing and sleep duration in children: a multicenter birth cohort study.

    Science.gov (United States)

    Marinelli, Marcella; Sunyer, Jordi; Alvarez-Pedrerol, Mar; Iñiguez, Carmen; Torrent, Maties; Vioque, Jesús; Turner, Michelle C; Julvez, Jordi

    2014-05-01

    This study used longitudinal data to examine potential associations between hours of television viewing and sleep duration in children. To examine the association between hours of television viewing and sleep duration in preschool and school-aged children. Longitudinal, multicenter study among birth cohorts in Menorca, Sabadell, and Valencia from the Spanish Infancia y Medio Ambiente (environment and childhood) project. The study sample included 1713 children (468 from Menorca, 560 from Sabadell, and 685 from Valencia). Parent-reported child television viewing duration measured in hours per day at 2 and 4 years of age in Sabadell and Valencia and at 6 and 9 years of age in Menorca. Parent-reported child sleep duration measured in hours per day at 2 and 4 years of age in Sabadell and Valencia and at 6 and 9 years of age in Menorca. In cross-sectional analysis, children with longer periods of television viewing reported at baseline (≥ 1.5 hours per day) had shorter sleep duration. Longitudinally, children with reported increases in television viewing duration over time (from <1.5 to ≥ 1.5 hours per day) had a reduction in sleep duration at follow-up visits. Results were similar when examining television viewing duration as a continuous variable, with each 1 hour per day of increased viewing decreasing sleep duration at follow-up visits (β = -0.11; 95% CI, -0.18 to -0.05). Associations were similar when television viewing duration was assessed during weekends and after adjusting for potential intermediate factors (child executive function and attention-deficit/hyperactivity disorder symptoms) and confounders (child physical activity level, parental mental health status, maternal IQ, and maternal marital status). Children spending longer periods watching television had shorter sleep duration. Changes in television viewing duration were inversely associated with changes in sleep duration in longitudinal analysis. Parents should consider avoiding long periods of

  9. Pediatric drug-related problems: a multicenter study in four French-speaking countries.

    Science.gov (United States)

    Prot-Labarthe, Sonia; Di Paolo, Ermindo R; Lavoie, Annie; Quennery, Stefanie; Bussières, Jean-François; Brion, Françoise; Bourdon, Olivier

    2013-04-01

    Pediatric intensive care patients represent a population at high risk for drug-related problems. There are few studies that compare the activity of clinical pharmacists between countries. To describe the drug-related problems identified and interventions by four pharmacists in a pediatric cardiac and intensive care unit. Four pediatric centers in France, Quebec, Switzerland and Belgium. This was a six-month multicenter, descriptive and prospective study conducted from August 1, 2009 to January 31, 2010. Drug-related problems and clinical interventions were compiled from four pediatric centers in France, Quebec, Switzerland and Belgium. Data on patients, drugs, intervention, documentation, approval and estimated impact were compiled. Number and type of drug-related problems encountered in a large pediatric inpatient population. A total of 996 interventions were recorded: 238 (24 %) in France, 278 (28 %) in Quebec, 351 (35 %) in Switzerland and 129 (13 %) in Belgium. These interventions targeted 270 patients (median 21 months old, 53 % male): 88 (33 %) in France, 56 (21 %) in Quebec, 57 (21 %) in Switzerland and 69 (26 %) in Belgium. The main drug-related problems were inappropriate administration technique (29 %), untreated indication (25 %) and supra-therapeutic dose (11 %). The pharmacists' interventions were mostly optimizing the mode of administration (22 %), dose adjustment (20 %) and therapeutic monitoring (16 %). The two major drug classes that led to interventions were anti-infectives for systemic use (23 %) and digestive system and metabolism drugs (22 %). Interventions mainly involved residents and all clinical staff (21 %). Among the 878 (88 %) proposed interventions requiring physician approval, 860 (98 %) were accepted. This descriptive study illustrates drug-related problems and the ability of clinical pharmacists to identify and resolve them in pediatric intensive care units in four French-speaking countries.

  10. CEUS Time Intensity Curves in the Differentiation Between Leydig Cell Carcinoma and Seminoma: A Multicenter Study.

    Science.gov (United States)

    Drudi, F M; Valentino, M; Bertolotto, M; Malpassini, F; Maghella, F; Cantisani, V; Liberatore, M; De Felice, C; D'Ambrosio, F

    2016-04-01

    Ultrasound (US) is the main imaging technique in the assessment of testicular masses, as it has proved to be highly accurate in the visualization of these pathologies. Identification of a Leydig cell tumor is essential since the lesion is benign in 90% of cases. The aim of this multicenter study is to assess the effectiveness of contrast-enhanced ultrasound (CEUS) in differentiating Leydig cell tumors from seminoma using qualitative and quantitative features. From February 2011 to December 2013, 31 patients (mean age: 34 years; range: 25 - 52) were recruited for this prospective study. Three of them were monorchid. Therefore, a total of 59 testicles were assessed. All patients underwent grayscale US, color Doppler ultrasound (CDUS), CEUS and orchiectomy. The paired one-tailed Student's t-test was carried out to differentiate between Leydig cell tumors and seminomas. 31 lesions suspicious for malignancy were hypoechoic on grayscale US while they did not show a typical pattern on CDUS. CEUS qualitative analysis, based on contrast enhancement pattern, during the arterial and venous phases, did not allow discrimination of Leydig cell tumors from seminoma. Quantitative analysis of time-intensity curves (TICs) demonstrated that only three parameters presented statistical significance, i. e. wash-in rate (WiR) p = 0.014, peak enhancement (PE) p = 0.001 and time to peak (TTP) p = 0.003. The vascular bed of a Leydig cell tumor is wider and the blood flow velocity is higher than that of a seminoma due to more regular neovascularization. In contrast, a seminoma presents large areas of necrosis due to irregular neovascularization. This explains the different PE and WiR values. Further studies involving larger patient populations are mandatory to confirm these encouraging preliminary results. © Georg Thieme Verlag KG Stuttgart · New York.

  11. Assessment of thromboprophylaxis in medical patients hospitalized in Andalusia. A multicenter study.

    Science.gov (United States)

    Navarro Puerto, M A; Medrano Ortega, F J; Izquierdo Guerrero, R; Calderón Sandubete, E; Buzón-Barrera, M L; Marín-León, I

    2015-04-01

    Hospitalized patients are a population at risk for venous thromboembolism (VTE). The PRETEMED-2007 clinical practice guidelines help identify high-risk medical patients who are suited to thromboprophylaxis. These guidelines therefore provide a standard for prophylaxis in such patients. We evaluated the risk of VTE and the adjustment of thromboprophylaxis to the standards of the PRETEMED-2007 guidelines in patients hospitalized in internal medicine departments. An observational, cross-sectional multicenter study was performed in 2010 in 16 hospitals in Andalusia and included 20 consecutive patients per center. The study variables were age, sex, risk factors for VTE and hemorrhage, the risk-adjusted PRETEMED of VTE, adjustment of thromboembolic prophylaxis at admission and at discharge and hospital mortality. The study included 293 patients (57.8% men) with a mean age of 69 (±15) years. The most common triggers for VTE were acute severe infection (27.3%) and neoplasia (16.4%). Some 43.4% of the patients presented a risk of hemorrhage. The risk of VTE at admission and discharge was high in 47.8% and 31% and moderate in 8.2% and 10.6%, respectively. A total of 91.7% and 17.3% of the patients underwent prophylaxis with low-molecular-weight heparin on admission and at discharge, respectively. The prescription was appropriate for 59.9% of the patients at admission (overutilization 38.4%, underutilization 1.7%) and for 74.7% at discharge (overutilization 5.4%, underutilization 19.9%). The adjustment was greater in patients older than 60 years and with greater hemorrhagic risk. For 60% of the patients admitted to the departments of internal medicine in Andalusia, the thromboprophylaxis was appropriate. The inadequacy of thromboprophylaxis (40%) is mostly due to overutilization. These results suggest significant space for improvement. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  12. Topical corticosteroid abuse on the face: A prospective, multicenter study of dermatology outpatients

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    Abir Saraswat

    2011-01-01

    Full Text Available Background: Abuse of topical corticosteroids (TC, especially over the face, is prevalent worldwide, including in India. Data about the magnitude of this problem in our country is lacking. Aims: The aims of this study were to ascertain the demographics, magnitude and clinical features of TC misuse on the face in the dermatology outpatient department (OPD attendees in order to raise awareness about this problem and to analyze its causes. Methods: This was a prospective multicenter questionnaire-based clinical study conducted at 12 dermatology centers nationwide. Patients with relevant facial dermatoses reporting to the investigator were asked about their current use of over-the-counter topical formulations and a structured questionnaire applied in case the same was confirmed to be TC. Results: A total of 2926 patients with facial dermatoses were screened, of which 433 (14.8% were using TC. TC was used as a fairness/general purpose cream or aftershave in 126 (29% and in 104 (24% for acne. Steroid combinations were used by 258 (59.6%. Potent and super-potent TC were significantly (P = 0.05 more frequently used by the rural/suburban population. The younger age groups used more potent formulations. A non-physician recommendation for TC use was obtainable in 257 (59.3% patients. Of these, 232 (90.3% were for potent/super-potent steroids. Among 176 physician prescriptions, 78 (44.3% were from non-dermatologists. All non-physician prescriptions and 146 (83% physician prescriptions for TC were inappropriately refilled. Adverse effects were seen in 392 (90.5% TC users. Acne/exacerbation of acne was the most common adverse effect. Conclusions: TC misuse in patients with facial dermatoses is quite common, and most of this use is unwarranted. Use as a fairness cream is the most common indication in this cohort. Limitations: This was an OPD-based study and, therefore, it may or may not accurately reflect the community data.

  13. Antecedents of organizational citizenship behavior among Iranian nurses: a multicenter study.

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    Taghinezhad, Fakhredin; Safavi, Mahboobe; Raiesifar, Afsaneh; Yahyavi, Sayed Hossein

    2015-10-08

    Organizational citizenship behavior (OCB) improves efficiency and employees' participation and generally provides a good ambiance. This study was conducted to determine the role of job satisfaction (JS), organizational commitment (OC) and procedural justice (PJ) in explaining OCB among nurses working in fifteen educational-treatment centers in Tehran-Iran, to provide guidelines for health care managers' further understanding of how to encourage citizenship behavior among nurses. In this multi-center descriptive-correlational study 373 nurses were evaluated through a Multi-stage cluster sampling method after obtaining approval from the Ethics Committee of Islamic Azad University, Tehran Medical Branch and Tehran University of Medical Sciences Research Deputy. Nurses who signed the informed consent and holding a bachelor or master degree, having a minimum one year of job experience and not having organizational management position during the questionnaire distribution were included in the study. In order to collect data, Demographic questionnaire, Podsakoff et al. (Leadersh Q 1(2):107-142, 1990) OCB questionnaire, OC questionnaire, Aelterman et al. (Educ Stud 33(3):285-297, 2007) JS questionnaire and PJ questionnaire were used. These questionnaires were translated into Persian and content validity was confirmed by an expert group; their reliability was calculated by the internal consistency Cronbach alpha coefficient and it was satisfied. Data were analyzed by descriptive statistics, Comparative mean tests, correlation coefficient and multiple-regression in the SPSS software version 11. The general mean and all five aspects of OCB that ranked higher than 3 were evaluated in a "quite desired" state. The mean for perceived procedural justice, the general mean for JS and the mean of general grade for OC from the nurses' was in "quite desired" state. Finding from multiple regression indicated that OC and PJ exhibit about 19 % of OCB variance totally which is

  14. Appropriateness guidelines and predictive rules to select patients for upper endoscopy: a nationwide multicenter study.

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    Buri, Luigi; Hassan, Cesare; Bersani, Gianluca; Anti, Marcello; Bianco, Maria Antonietta; Cipolletta, Livio; Di Giulio, Emilio; Di Matteo, Giovanni; Familiari, Luigi; Ficano, Leonardo; Loriga, Pietro; Morini, Sergio; Pietropaolo, Vincenzo; Zambelli, Alessandro; Grossi, Enzo; Intraligi, Marco; Buscema, Massimo

    2010-06-01

    Selecting patients appropriately for upper endoscopy (EGD) is crucial for efficient use of endoscopy. The objective of this study was to compare different clinical strategies and statistical methods to select patients for EGD, namely appropriateness guidelines, age and/or alarm features, and multivariate and artificial neural network (ANN) models. A nationwide, multicenter, prospective study was undertaken in which consecutive patients referred for EGD during a 1-month period were enrolled. Before EGD, the endoscopist assessed referral appropriateness according to the American Society for Gastrointestinal Endoscopy (ASGE) guidelines, also collecting clinical and demographic variables. Outcomes of the study were detection of relevant findings and new diagnosis of malignancy at EGD. The accuracy of the following clinical strategies and predictive rules was compared: (i) ASGE appropriateness guidelines (indicated vs. not indicated), (ii) simplified rule (>or=45 years or alarm features vs. <45 years without alarm features), (iii) logistic regression model, and (iv) ANN models. A total of 8,252 patients were enrolled in 57 centers. Overall, 3,803 (46%) relevant findings and 132 (1.6%) new malignancies were detected. Sensitivity, specificity, and area under the receiver-operating characteristic curve (AUC) of the simplified rule were similar to that of the ASGE guidelines for both relevant findings (82%/26%/0.55 vs. 88%/27%/0.52) and cancer (97%/22%/0.58 vs. 98%/20%/0.58). Both logistic regression and ANN models seemed to be substantially more accurate in predicting new cases of malignancy, with an AUC of 0.82 and 0.87, respectively. A simple predictive rule based on age and alarm features is similarly effective to the more complex ASGE guidelines in selecting patients for EGD. Regression and ANN models may be useful in identifying a relatively small subgroup of patients at higher risk of cancer.

  15. Oral propranolol therapy for infantile hemangiomas beyond the proliferation phase: a multicenter retrospective study.

    Science.gov (United States)

    Zvulunov, Alex; McCuaig, Catherine; Frieden, Ilona J; Mancini, Anthony J; Puttgen, Kate B; Dohil, Magdalene; Fischer, Gayle; Powell, Julie; Cohen, Bernard; Ben Amitai, Dan

    2011-01-01

    Pharmacological therapies for infantile hemangiomas were considered effective only during the proliferative phases. Recently reported beneficial effects of propranolol may extend beyond the proliferative phase of infantile hemangiomas. The purpose of the study was to assess the effect of oral propranolol therapy for infantile hemangiomas beyond the proliferative phase of these lesions. Members of the Society for Pediatric Dermatology were invited to participate in a multicenter retrospective study. Only children with infantile hemangiomas with documented cessation of lesions' growth or those older than 12 months of age were eligible for the study. Clinical and demographic information and digital photographs before, at the start, and following the treatment were collected. Scaled panels of photographs were distributed among preselected experienced pediatric dermatologists. Visual analog scale was used to assess photographs for each case. Paired t-test was used for statistical analyses. Data on 49 eligible patients from eight pediatric dermatology centers was collected. Seven cases were excluded because of insufficient photographic documentation. The age of the patients at the start of propranolol therapy ranged 7 to 120 months (mean 28 mos, median 22 mos). The duration of propranolol therapy ranged 1 to 8 months (mean 3.6 mos). The mean visual analog scale score before the treatment was 6.8 ± 2.15, and mean reduction in the visual analog scale score at the assessment was 2.6 ± 1.74 (p < 0.001). The rate of visual analog scale reduction was 0.4 per month before the start of the therapy, while this rate was accelerated to 0.9 per months following the therapy (p < 0.001). No significant side effects were reported. We conclude that propranolol is effective in infantile hemangiomas, including post-proliferative phase, and should be considered as the first-line therapy in that setting.

  16. Clinical evaluation of the use of a multifunctional remotely controlled insulin pump: multicenter observational study.

    Science.gov (United States)

    Boizel, Robert; Pinget, Michel; Lachgar, Karim; Parkin, Christopher G; Grulet, Hervé; Guillon-Metz, Françoise; Weissmann, Joerg

    2014-11-01

    Current insulin pumps now feature advanced functions for calculating insulin dosages, delivering insulin and analyzing data, however, the perceived usefulness of these functions in clinical settings has not been well studied. We assessed the use and patient perceptions of an insulin delivery system (Accu-Chek® Combo, Roche Diagnostics, Mannheim, Germany) that combines an insulin pump and a handheld multifunctional blood glucose meter with integrated remote control functions. This prospective, observational, multicenter study enrolled 74 type 1 diabetes patients within 13 weeks after starting use of the pump system. At 4 to 24 weeks, investigators collected usage data from the latest 14-day period. Seventy-two patients completed the evaluation, aged 39 ± 15 years, diabetes duration 16 ± 13 years, HbA1c 8.3 ± 1.6%. At follow-up, 62 (86.1%) patients used the remote control for ≥50% of all boluses, 20 (27.8%) used the bolus advisor for ≥50% of all boluses, and 42 (58.3%) viewed at least 1 of the e-logbook reports. More than 95% of users appraised the functions as easy-to-use and useful; median scores from VAS (0 = useless to 100 = indispensable) ranged from 72 to 85. A high percentage of study patients used the system's advanced features, especially the remote control feature for bolusing. Overall, patients assessed the functions as useful and easy to use. Results support the implementation of these smart capabilities in further insulin pump developments. © 2014 Diabetes Technology Society.

  17. A prospective, multicenter study of pharmacist activities resulting in medication error interception in the emergency department.

    Science.gov (United States)

    Patanwala, Asad E; Sanders, Arthur B; Thomas, Michael C; Acquisto, Nicole M; Weant, Kyle A; Baker, Stephanie N; Merritt, Erica M; Erstad, Brian L

    2012-05-01

    The primary objective of this study is to determine the activities of pharmacists that lead to medication error interception in the emergency department (ED). This was a prospective, multicenter cohort study conducted in 4 geographically diverse academic and community EDs in the United States. Each site had clinical pharmacy services. Pharmacists at each site recorded their medication error interceptions for 250 hours of cumulative time when present in the ED (1,000 hours total for all 4 sites). Items recorded included the activities of the pharmacist that led to medication error interception, type of orders, phase of medication use process, and type of error. Independent evaluators reviewed all medication errors. Descriptive analyses were performed for all variables. A total of 16,446 patients presented to the EDs during the study, resulting in 364 confirmed medication error interceptions by pharmacists. The pharmacists' activities that led to medication error interception were as follows: involvement in consultative activities (n=187; 51.4%), review of medication orders (n=127; 34.9%), and other (n=50; 13.7%). The types of orders resulting in medication error interceptions were written or computerized orders (n=198; 54.4%), verbal orders (n=119; 32.7%), and other (n=47; 12.9%). Most medication error interceptions occurred during the prescribing phase of the medication use process (n=300; 82.4%) and the most common type of error was wrong dose (n=161; 44.2%). Pharmacists' review of written or computerized medication orders accounts for only a third of medication error interceptions. Most medication error interceptions occur during consultative activities. Copyright © 2011. Published by Mosby, Inc.

  18. Diagnostic accuracy of the Eurotest for dementia: a naturalistic, multicenter phase II study

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    Frank Ana

    2006-04-01

    Full Text Available Abstract Background Available screening tests for dementia are of limited usefulness because they are influenced by the patient's culture and educational level. The Eurotest, an instrument based on the knowledge and handling of money, was designed to overcome these limitations. The objective of this study was to evaluate the diagnostic accuracy of the Eurotest in identifying dementia in customary clinical practice. Methods A cross-sectional, multi-center, naturalistic phase II study was conducted. The Eurotest was administered to consecutive patients, older than 60 years, in general neurology clinics. The patients' condition was classified as dementia or no dementia according to DSM-IV diagnostic criteria. We calculated sensitivity (Sn, specificity (Sp and area under the ROC curves (aROC with 95% confidence intervals. The influence of social and educational factors on scores was evaluated with multiple linear regression analysis, and the influence of these factors on diagnostic accuracy was evaluated with logistic regression. Results Sixteen neurologists recruited a total of 516 participants: 101 with dementia, 380 without dementia, and 35 who were excluded. Of the 481 participants who took the Eurotest, 38.7% were totally or functionally illiterate and 45.5% had received no formal education. Mean time needed to administer the test was 8.2+/-2.0 minutes. The best cut-off point was 20/21, with Sn = 0.91 (0.84–0.96, Sp = 0.82 (0.77–0.85, and aROC = 0.93 (0.91–0.95. Neither the scores on the Eurotest nor its diagnostic accuracy were influenced by social or educational factors. Conclusion This naturalistic and pragmatic study shows that the Eurotest is a rapid, simple and useful screening instrument, which is free from educational influences, and has appropriate internal and external validity.

  19. Multicenter Study of Viral Etiology and Relapse in Hospitalized Children with Bronchiolitis

    Science.gov (United States)

    Hasegawa, Kohei; Mansbach, Jonathan M.; Teach, Stephen J.; Fisher, Erin S.; Hershey, Daniel; Koh, Joyce Y.; Clark, Sunday; Piedra, Pedro A.; Sullivan, Ashley F.; Camargo, Carlos A.

    2014-01-01

    Background It is unclear whether the infectious etiology of severe bronchiolitis affects short-term outcomes, such as post-hospitalization relapse. We tested the hypothesis that children hospitalized with rhinovirus (RV) bronchiolitis, either as a sole pathogen or in combination with respiratory syncytial virus (RSV), are at increased risk of relapse. Methods We performed a 16-center, prospective cohort study of hospitalized children age bronchiolitis. During the winters of 2007 to 2010, researchers collected clinical data and nasopharyngeal aspirates from study participants; the aspirates were tested using real-time polymerase chain reaction. The primary outcome was bronchiolitis relapse (urgent bronchiolitis visit or scheduled visit at which additions to the bronchiolitis medications were made) during the 2 weeks after hospital discharge. Results Among 1836 enrolled children with 2-week follow-up data, the median age was 4 months and 60% were male. Overall, 48% had sole RSV infection, 8% had sole RV infection, and 13% had RSV/RV co-infection. Compared with children with sole RSV infection, and adjusting for 10 demographic and clinical characteristics and clustering of patients within hospitals, children with sole RV infection did not differ in their likelihood of relapse (OR, 0.99; 95%CI, 0.52–1.90; P=0.98), whereas those with RSV/RV co-infection were more likely to have relapse (OR, 1.54; 95%CI, 1.03–2.30; P=0.03). Conclusions In this prospective, multicenter, multiyear study of children hospitalized with bronchiolitis, we found that RSV/RV co-infection was independently associated with a higher likelihood of bronchiolitis relapse. Present data support the concept that the infectious etiology of severe bronchiolitis affects short-term outcomes. PMID:24577039

  20. Axial Globe Position Measurement: A Prospective Multicenter Study by the International Thyroid Eye Disease Society.

    Science.gov (United States)

    Bingham, Chad M; Sivak-Callcott, Jennifer A; Gurka, Matthew J; Nguyen, John; Hogg, Jeffery P; Feldon, Steve E; Fay, Aaron; Seah, Lay-Leng; Strianese, Diego; Durairaj, Vikram D; Uddin, Jimmy; Devoto, Martin H; Harris, Matheson; Saunders, Justin; Osaki, Tammy H; Looi, Audrey; Teo, Livia; Davies, Brett W; Elefante, Andrea; Shen, Sunny; Realini, Tony; Fischer, William; Kazim, Michael

    2016-01-01

    Identify a reproducible measure of axial globe position (AGP) for multicenter studies on patients with thyroid eye disease (TED). This is a prospective, international, multicenter, observational study in which 3 types of AGP evaluation were examined: radiologic, clinical, and photographic. In this study, CT was the modality to which all other methods were compared. CT AGP was measured from an orthogonal line between the anterior lateral orbital rims to the cornea. All CT measurements were made at a single institution by 3 individual clinicians. Clinical evaluation was performed with exophthalmometry. Three clinicians from each clinical site assessed AGP with 3 different exophthalmometers and horizontal palpebral width using a ruler. Each physician made 3 separate measurements with each type of exophthalmometer not in succession. All photographic measurements were made at a single institution. AGP was measured from lateral photographs in which a standard marker was placed at the anterior lateral orbital rim. Horizontal and vertical palpebral fissure were measured from frontal photographs. Three trained readers measured 3 separate times not in succession. Exophthalmometry and photography method validity was assessed by agreement with CT (mean differences calculation, intraclass correlation coefficients [ICCs], Bland-Altman figures). Correlation between palpebral fissure and CT AGP was assessed with Pearson correlation. Intraclinician and interclinician reliability was evaluated using ICCs. Sixty-eight patients from 7 centers participated. CT mean AGP was 21.37 mm (15.96-28.90 mm) right and 21.22 mm (15.87-28.70 mm) left (ICC 0.996 and 0.995). Exophthalmometry AGP fell between 18 mm and 25 mm. Intraclinician agreement across exophthalmometers was ideal (ICC 0.948-0.983). Agreement between clinicians was greater than 0.85 for all upright exophthalmometry measurements. Photographic mean AGP was 20.47 mm (10.92-30.88 mm) right and 20.30 mm (8.61-28.72

  1. A multicenter, double-blind, randomized, placebo-controlled comparison of nocturnal roxatidine in the treatment of active duodenal ulcer disease. Multicenter Roxatidine Cooperative Study Group.

    Science.gov (United States)

    Gilinsky, N H; Bright-Asare, P; Cobert, B L; Fitch, D D; Lanza, F L; Kerr, R M; Savitsky, J P

    1992-07-01

    This multicenter randomized, double-blind, 4-wk study compared the new H2-receptor antagonistic roxatidine (R) to placebo (P) for treatment of endoscopically diagnosed active duodenal ulcer disease. Subjects were evaluated after 2 and 4 wk of treatment. Those whose ulcer was unhealed at 2 wk received 2 more weeks of treatment before final evaluation. Ulcer healing (endoscopically determined) with roxatidine was more effective than placebo at both wk 0-2 (R = 33.9%, P = 21.9%, p = 0.018) and wk 2-4 (R = 68.2%, P = 29.7%, p less than 0.001), with an overall 4-wk effectiveness of 78.9% compared to 44.8% (p less than 0.001). At the end of treatment, average maximum ulcer diameter diminished 83% in R and 50% in P (p less than 0.001). Roxatidine was also more effective than placebo in decreasing abdominal pain (p less than 0.001), decreasing the number of antacid tablets taken for pain relief (p less than 0.001), improving dyspeptic symptoms (p less than 0.001), and permitting return to a normal routine for subjects with previous illness-imposed restrictions on work and/or other daily activities. The profile of laboratory values and adverse experiences demonstrated roxatidine to be safe and well-tolerated. The efficacy of roxatidine as evaluated by the healing rate of duodenal ulcer and reduction in abdominal pain emphasize its value as an addition to the family of H2-receptor antagonists.

  2. Tumor immunoscintigraphy by means of radiolabeled monoclonal antibodies: Multicenter studies of the Italian National Research Council--Special Project Biomedical Engineering

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    Siccardi, A.G. (Universita di Milano (Italy))

    1990-02-01

    Four radioimmunopharmaceuticals ({sup 99m}Tc- and 111In-labeled anti-melanoma and {sup 111}In- and {sup 131}I-labeled anti-carcinoembryonic antigen F(ab')2 fragments derived from monoclonal antibodies 225.28S and F023C5) were developed by means of a collaborative effort coordinated by the Italian National Research Council, Special Project Biomedical Engineering. After appropriate pilot studies, the radioimmunopharmaceuticals, prepared by Sorin Biomedica (Saluggia, Italy), were distributed to 31 Nuclear Medicine departments in Italy and in 10 other European countries within the framework of three immunoscintigraphy multicenter studies. A total of 1245 patients were studied, 898 of whom carried 1725 documented tumor lesions; 1596 of 2193 tumor lesions (468 of which were previously unknown) were imaged by immunoscintigraphy in 785 of 990 lesion-bearing patients. Among the occult lesions, 173 were imaged in 92 patients admitted to the study as lesion-free patients. The results have been analyzed in terms of the reliability, reproducibility, and diagnostic usefulness of the method and of each immunoradiopharmaceutical.

  3. Capturing patients' experiences to change Parkinson's disease care delivery: a multicenter study.

    Science.gov (United States)

    van der Eijk, Martijn; Faber, Marjan J; Post, Bart; Okun, Michael S; Schmidt, Peter; Munneke, Marten; Bloem, Bastiaan R

    2015-11-01

    Capturing patients' perspectives has become an essential part of a quality of care assessment. The patient centeredness questionnaire for PD (PCQ-PD) has been validated in The Netherlands as an instrument to measure patients' experiences. This study aims to assess the level of patient centeredness in North American Parkinson centers and to demonstrate the PCQ-PD's potential as a quality improvement instrument. 20 Parkinson Centers of Excellence participated in a multicenter study. Each center asked 50 consecutive patients to complete the questionnaire. Data analyses included calculating case mix-adjusted scores for overall patient centeredness (scoring range 0-3), six subscales (0-3), and quality improvement (0-9). Each center received a feedback report on their performance. The PCQ-PD was completed by 972 PD patients (median 50 per center, range 37-58). Significant differences between centers were found for all subscales, except for emotional support (p < 0.05). The information subscale (mean 1.62 SD 0.62) and collaboration subscale (mean 2.03 SD 0.58) received the lowest experience ratings. 14 centers (88 %) who returned the evaluation survey claimed that patient experience scores could help to improve the quality of care. Nine centers (56 %) utilized the feedback to change specific elements of their care delivery process. PD patients are under-informed about critical care issues and experience a lack of collaboration between healthcare professionals. Feedback on patients' experiences facilitated Parkinson centers to improve their delivery of care. These findings create a basis for collecting patients' experiences in a repetitive fashion, intertwined with existing quality of care registries.

  4. Long-term outcomes in primary spinal osteochondroma: a multicenter study of 27 patients

    Science.gov (United States)

    Sciubba, Daniel M.; Macki, Mohamed; Bydon, Mohamad; Germscheid, Niccole M.; Wolinsky, Jean-Paul; Boriani, Stefano; Bettegowda, Chetan; Chou, Dean; Luzzati, Alessandro; Reynolds, Jeremy J.; Szövérfi, Zsolt; Zadnik, Patti; Rhines, Laurence D.; Gokaslan, Ziya L.; Fisher, Charles G.; Varga, Peter Paul

    2016-01-01

    OBJECT Clinical outcomes in patients with primary spinal osteochondromas are limited to small series and sporadic case reports. The authors present data on the first long-term investigation of spinal osteochondroma cases. METHODS An international, multicenter ambispective study on primary spinal osteochondroma was performed. Patients were included if they were diagnosed with an osteochondroma of the spine and received surgical treatment between October 1996 and June 2012 with at least 1 follow-up. Perioperative prognostic variables, including patient age, tumor size, spinal level, and resection, were analyzed in reference to long-term local recurrence and survival. Tumor resections were compared using Enneking appropriate (EA) or Enneking inappropriate surgical margins. RESULTS Osteochondromas were diagnosed in 27 patients at an average age of 37 years. Twenty-two lesions were found in the mobile spine (cervical, thoracic, or lumbar) and 5 in the fixed spine (sacrum). Twenty-three cases (88%) were benign tumors (Enneking tumor Stages 1–3), whereas 3 (12%) exhibited malignant changes (Enneking tumor Stages IA–IIB). Sixteen patients (62%) underwent en bloc treatment—that is, wide or marginal resection—and 10 (38%) underwent intralesional resection. Twenty-four operations (92%) followed EA margins. No one received adjuvant therapy. Two patients (8%) experienced recurrences: one in the fixed spine and one in the mobile spine. Both recurrences occurred in latent Stage 1 tumors following en bloc resection. No osteochondroma-related deaths were observed. CONCLUSIONS In the present study, most patients underwent en bloc resection and were treated as EA cases. Both recurrences occurred in the Stage 1 tumor cohort. Therefore, although benign in character, osteochondromas still require careful management and thorough follow-up. PMID:25793467

  5. Epidemiology of acute kidney injury in Hungarian intensive care units: a multicenter, prospective, observational study

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    Bencsik Gabor

    2011-09-01

    Full Text Available Abstract Background Despite the substantial progress in the quality of critical care, the incidence and mortality of acute kidney injury (AKI continues to rise during hospital admissions. We conducted a national, multicenter, prospective, epidemiological survey to evaluate the importance of AKI in intensive care units (ICUs in Hungary. The objectives of this study were to determine the incidence of AKI in ICU patients; to characterize the differences in aetiology, illness severity and clinical practice; and to determine the influencing factors of the development of AKI and the patients' outcomes. Methods We analysed the demographic, morbidity, treatment modality and outcome data of patients (n = 459 admitted to ICUs between October 1st, 2009 and November 30th, 2009 using a prospectively filled in electronic survey form in 7 representative ICUs. Results The major reason for ICU admission was surgical in 64.3% of patients and medical in the remaining 35.7%. One-hundred-twelve patients (24.4% had AKI. By AKIN criteria 11.5% had Stage 1, 5.4% had Stage 2 and 7.4% had Stage 3. In 44.0% of patients, AKI was associated with septic shock. Vasopressor treatment, SAPS II score, serum creatinine on ICU admission and sepsis were the independent risk factors for development of any stage of AKI. Among the Stage 3 patients (34 50% received renal replacement therapy. The overall utilization of intermittent renal replacement therapy was high (64.8%. The overall in-hospital mortality rate of AKI was 49% (55/112. The ICU mortality rate was 39.3% (44/112. The independent risk factors for ICU mortality were age, mechanical ventilation, SOFA score and AKI Stage 3. Conclusions For the first time we have established the incidence of AKI using the AKIN criteria in Hungarian ICUs. Results of the present study confirm that AKI has a high incidence and is associated with high ICU and in-hospital mortality.

  6. Multicenter study of endoscopic preoperative biliary drainage for malignant distal biliary obstruction

    Science.gov (United States)

    Sasahira, Naoki; Hamada, Tsuyoshi; Togawa, Osamu; Yamamoto, Ryuichi; Iwai, Tomohisa; Tamada, Kiichi; Kawaguchi, Yoshiaki; Shimura, Kenji; Koike, Takero; Yoshida, Yu; Sugimori, Kazuya; Ryozawa, Shomei; Kakimoto, Toshiharu; Nishikawa, Ko; Kitamura, Katsuya; Imamura, Tsunao; Mizuide, Masafumi; Toda, Nobuo; Maetani, Iruru; Sakai, Yuji; Itoi, Takao; Nagahama, Masatsugu; Nakai, Yousuke; Isayama, Hiroyuki

    2016-01-01

    AIM: To determine the optimal method of endoscopic preoperative biliary drainage for malignant distal biliary obstruction. METHODS: Multicenter retrospective study was conducted in patients who underwent plastic stent (PS) or nasobiliary catheter (NBC) placement for resectable malignant distal biliary obstruction followed by surgery between January 2010 and March 2012. Procedure-related adverse events, stent/catheter dysfunction (occlusion or migration of PS/NBC, development of cholangitis, or other conditions that required repeat endoscopic biliary intervention), and jaundice resolution (bilirubin level < 3.0 mg/dL) were evaluated. Cumulative incidence of jaundice resolution and dysfunction of PS/NBC were estimated using competing risk analysis. Patient characteristics and preoperative biliary drainage were also evaluated for association with the time to jaundice resolution and PS/NBC dysfunction using competing risk regression analysis. RESULTS: In total, 419 patients were included in the study (PS, 253 and NBC, 166). Primary cancers included pancreatic cancer in 194 patients (46%), bile duct cancer in 172 (41%), gallbladder cancer in three (1%), and ampullary cancer in 50 (12%). The median serum total bilirubin was 7.8 mg/dL and 324 patients (77%) had ≥ 3.0 mg/dL. During the median time to surgery of 29 d [interquartile range (IQR), 30-39 d]. PS/NBC dysfunction rate was 35% for PS and 18% for NBC [Subdistribution hazard ratio (SHR) = 4.76; 95%CI: 2.44-10.0, P < 0.001]; the pig-tailed tip was a risk factor for PS dysfunction. Jaundice resolution was achieved in 85% of patients and did not depend on the drainage method (PS or NBC). CONCLUSION: PS has insufficient patency for preoperative biliary drainage. Given the drawbacks of external drainage via NBC, an alternative method of internal drainage should be explored. PMID:27076764

  7. Reference equations for the six-minute walk distance based on a Brazilian multicenter study.

    Science.gov (United States)

    Britto, Raquel R; Probst, Vanessa S; de Andrade, Armele F Dornelas; Samora, Giane A R; Hernandes, Nidia A; Marinho, Patrícia E M; Karsten, Marlus; Pitta, Fabio; Parreira, Veronica F

    2013-01-01

    It is important to include large sample sizes and different factors that influence the six-minute walking distance (6MWD) in order to propose reference equations for the six-minute walking test (6 MWT). To evaluate the influence of anthropometric, demographic, and physiologic variables on the 6 MWD of healthy subjects from different regions of Brazil to establish a reference equation for the Brazilian population. In a multicenter study, 617 healthy subjects performed two 6 MWTs and had their weight, height, and body mass index (BMI) measured, as well as their physiologic responses to the test. Delta heart rate (∆HR), perceived effort, and peripheral oxygen saturation were calculated by the difference between the respective values at the end of the test minus the baseline value. Walking distance averaged 586 ± 106 m, 54 m greater in male compared to female subjects (p<0.001). No differences were observed among the 6 MWD from different regions. The quadratic regression analysis considering only anthropometric and demographic data explained 46% of the variability in the 6 MWT (p<0.001) and derived the equation: 6 MWD(pred)=890.46-(6.11 × age)+(0.0345 × age(2))+(48.87 × gender)-(4.87 × BMI). A second model of stepwise multiple regression including ∆HR explained 62% of the variability (p<0.0001) and derived the equation: 6 MWD(pred)=356.658-(2.303 × age)+(36.648 × gender)+(1.704 × height)+(1.365×∆HR). The equations proposed in this study, especially the second one, seem adequate to accurately predict the 6 MWD for Brazilians.

  8. Latarjet Procedure for Anterior Shoulder Instability Due to Tramadol-Induced Seizures: A Multicenter Study.

    Science.gov (United States)

    Khater, Ahmad Hany; Sobhy, Mohamed H; Said, Hatem G; Kandil, Ahmed; Reda, Walid; Seifeldin, Ahmed Fouad; Moustafa, Ramez; Elassal, Maher A; Kamel, Ezzat M

    2016-04-01

    Seizures, commonly due to epilepsy, are known to cause shoulder instability. Tramadol addiction has recently been found to induce seizures in patients who exceed the recommended dose. Because of the easy accessibility and low cost of tramadol, an increasingly alarming phenomenon of tramadol abuse has been demonstrated in recent years. The purpose of this multicenter study was to investigate shoulder instability resulting from tramadol-induced seizure (TIS) as well as to recommended management for such shoulder instability. The hypothesis was that TIS leads to anterior shoulder dislocations with major bony defects, which favors bony reconstructive procedures as a suitable method of treatment. Case series; Level of evidence, 4. This prospective case series study was conducted on 73 patients (78 shoulders) who presented with anterior shoulder dislocations and a clear history of tramadol abuse. The mean age of the patients was 26.8 years, and the mean number of dislocations was 14. The mean duration of addiction was 17 months, with a mean dose of 752 mg of tramadol hydrochloride per day. Glenoid and humeral bone loss ranged from 15% to 35% and from 15% to 40%, respectively. The mean follow-up period was 28 months. All patients underwent an open Latarjet procedure. Postoperative mean Rowe score and American Shoulder and Elbow Surgeons score at final follow-up (24 months) improved significantly from 20 to 84 and from 44 to 91, respectively (P Latarjet procedure is recommended for these patients, after control of addiction, and provides 95% satisfaction at midterm follow-up. © 2016 The Author(s).

  9. Association between 24-h urinary sodium excretion and obesity in Korean adults: A multicenter study.

    Science.gov (United States)

    Nam, Ga Eun; Kim, Seon Mee; Choi, Mi-Kyeong; Heo, Young-Ran; Hyun, Tai-Sun; Lyu, Eun-Soon; Oh, Se-Young; Park, Hae-Ryun; Ro, Hee-Kyong; Han, Kyungdo; Lee, Yeon Kyung

    2017-09-01

    The aim of this study was to explore the association between sodium intake, as assessed by 24-h urinary sodium excretion, and various obesity parameters among South Korean adults. The associations of 24-h urinary sodium excretion and sodium intake calculated from the dietary questionnaire with obesity parameters also were compared. This multicenter, cross-sectional study analyzed data of 640 healthy adults from eight provinces in South Korea. Obesity was assessed by body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR). Mean 24-h urinary sodium excretion was calculated from repeatedly collected 24-h urine samples. Participants' dietary intake was assessed by 24-h dietary recall interview on the days before 24-h urine collection. In both sexes, the means of all anthropometric measurements tended to increase proportionally with 24-h urinary sodium excretion quartiles, regardless of adjustment. Men in the highest quartile (Q4) of 24-h urinary sodium excretion had increased odds of obesity (as assessed by BMI, WC, WHR, and WHtR) compared with men in the three lower quartiles (Q1-Q3) of 24-h urinary sodium excretion. Women in Q4 of 24-h urinary sodium excretion exhibited a higher chance of general obesity and abdominal obesity. Sodium intake calculated from the dietary questionnaire was not significantly associated with obesity in either sex. In Korean adults, there was a positive association between higher sodium intake as assessed by 24-h urinary sodium excretion and obesity independent of energy intake. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China.

    Science.gov (United States)

    Xia, Liangyu; Chen, Ming; Liu, Min; Tao, Zhihua; Li, Shijun; Wang, Liang; Cheng, Xinqi; Qin, Xuzhen; Han, Jianhua; Li, Pengchang; Hou, Li'an; Yu, Songlin; Ichihara, Kiyoshi; Qiu, Ling

    2016-03-01

    A nationwide multicenter study was conducted in the China to explore sources of variation of reference values and establish reference intervals for 28 common biochemical analytes, as a part of the International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits (IFCC/C-RIDL) global study on reference values. A total of 3148 apparently healthy volunteers were recruited in 6 cities covering a wide area in China. Blood samples were tested in 2 central laboratories using Beckman Coulter AU5800 chemistry analyzers. Certified reference materials and value-assigned serum panel were used for standardization of test results. Multiple regression analysis was performed to explore sources of variation. Need for partition of reference intervals was evaluated based on 3-level nested ANOVA. After secondary exclusion using the latent abnormal values exclusion method, reference intervals were derived by a parametric method using the modified Box-Cox formula. Test results of 20 analytes were made traceable to reference measurement procedures. By the ANOVA, significant sex-related and age-related differences were observed in 12 and 12 analytes, respectively. A small regional difference was observed in the results for albumin, glucose, and sodium. Multiple regression analysis revealed BMI-related changes in results of 9 analytes for man and 6 for woman. Reference intervals of 28 analytes were computed with 17 analytes partitioned by sex and/or age. In conclusion, reference intervals of 28 common chemistry analytes applicable to Chinese Han population were established by use of the latest methodology. Reference intervals of 20 analytes traceable to reference measurement procedures can be used as common reference intervals, whereas others can be used as the assay system-specific reference intervals in China.

  11. Hospital admissions for hypertensive crisis in the emergency departments: a large multicenter Italian study.

    Science.gov (United States)

    Pinna, Giuliano; Pascale, Claudio; Fornengo, Paolo; Arras, Sebastiana; Piras, Carmela; Panzarasa, Pietro; Carmosino, Gianpaolo; Franza, Orietta; Semeraro, Vincenzo; Lenti, Salvatore; Pietrelli, Susanna; Panzone, Sergio; Bracco, Christian; Fiorini, Roberto; Rastelli, Giovanni; Bergandi, Daniela; Zampaglione, Bruno; Musso, Roberto; Marengo, Claudio; Santoro, Giancarlo; Zamboni, Sergio; Traversa, Barbara; Barattini, Maddalena; Bruno, Graziella

    2014-01-01

    Epidemiological data on the impact of hypertensive crises (emergencies and urgencies) on referral to the Emergency Departments (EDs) are lacking, in spite of the evidence that they may be life-threatening conditions. We performed a multicenter study to identify all patients aged 18 years and over who were admitted to 10 Italian EDs during 2009 for hypertensive crises (systolic blood pressure ≥220 mmHg and/or diastolic blood pressure ≥120 mmHg). We classified patients as affected by either hypertensive emergencies or hypertensive urgencies depending on the presence or the absence of progressive target organ damage, respectively. Logistic regression analysis was then performed to assess variables independently associated with hypertensive emergencies with respect to hypertensive urgencies. Of 333,407 patients admitted to the EDs over the one-year period, 1,546 had hypertensive crises (4.6/1,000, 95% CI 4.4-4.9), and 23% of them had unknown hypertension. Hypertensive emergencies (n = 391, 25.3% of hypertensive crises) were acute pulmonary edema (30.9%), stroke (22.0%,), myocardial infarction (17.9%), acute aortic dissection (7.9%), acute renal failure (5.9%) and hypertensive encephalopathy (4.9%). Men had higher frequency than women of unknown hypertension (27.9% vs 18.5%, phypertensive patients, a larger proportion of men than women reported not taking anti-hypertensive drug (12.6% among men and 9.4% among women (phypertensive emergencies than urgencies (OR = 1.34, 95% CI 1.06-1.70), independently of presenting symptoms, creatinine, smoking habit and known hypertension. This study shows that hypertensive crises involved almost 5 out of 1,000 patients-year admitted to EDs. Sex differences in frequencies of unknown hypertension, compliance to treatment and risk of hypertensive emergencies might have implications for public health programs.

  12. One-step surgical placement of Brånemark implants: a prospective multicenter clinical study.

    Science.gov (United States)

    Becker, W; Becker, B E; Israelson, H; Lucchini, J P; Handelsman, M; Ammons, W; Rosenberg, E; Rose, L; Tucker, L M; Lekholm, U

    1997-01-01

    This prospective longitudinal multicenter study evaluated the clinical outcomes after placement and restoration of one-step Brånemark implants into the maxillae and mandibles of completely and partially edentulous patients. Six surgical treatment centers participated in this study, in which 135 implants were placed into 63 adult patients. All implants were stable after placement. The majority of implants were placed into type B bone with minimal jaw resorption and type 2 bone quality. After implant placement, standard transmucosal healing abutments were firmly placed. The average amount of time between implant placement and prosthetic abutment connection was 170 days in the maxillae and 147 days in the mandibles. To evaluate crestal bone changes caused by implant placement, a periodontal probe was used to measure midbuccally from the top of the implant cylinder to the alveolar crest; in 29 patients, 54 midbuccal bone crest sites were remeasured following prosthetic abutment connection. Crestal bone changes in mandibles and maxillae were statistically and clinically insignificant. Six implants were lost prior to loading and one implant has not been restored. No implants or restorations were lost after loading. At 1 year, the implant success rate was 95.6%. Mesiodistal radiographic measurements from 34 patients were averaged, and changes from prosthetic abutment connection to, on average, 12 months follow-up were compared. The radiographs, which were digitalized, measured from the bottom of the implant cylinder to the most coronal bone in contact with implant thread. For mandibular implants, the mean radiographic bone level at prosthetic abutment connection was 1.07 mm; after loading, it was 1.35 mm. For maxillary implants, the mean radiographic bone height at prosthetic abutment connection was 1.16 mm; after loading, it was 1.36 mm. These changes were not statistically significant. The 1-year outcomes from this patient series indicate that one-step Br

  13. Lumbar spinal stenosis associated with peripheral arterial disease: a prospective multicenter observational study.

    Science.gov (United States)

    Uesugi, Kazuhide; Sekiguchi, Miho; Kikuchi, Shin-ichi; Kanayama, Masahiro; Takahashi, Kazuhisa; Chiba, Kazuhiro; Doita, Minoru; Toribatake, Yasumitsu; Matsuo, Hiroshi; Yonenobu, Kazuo; Matsuyama, Yukihiro; Konno, Shin-Ichi

    2012-11-01

    Intermittent claudication is a common symptom of both lumbar spinal stenosis (LSS) and peripheral arterial disease (PAD) in middle-aged and elderly people. However, the prevalence and clinical characteristics of LSS with PAD (LSSPAD) have not been investigated in a multicenter study. The aim of this study was to investigate the prevalence and clinical characteristics of LSS associated with PAD. 570 patients diagnosed with LSS using a clinical diagnostic support tool and MRI at 64 facilities were enrolled. We evaluated each patient's medical history, physical findings, ankle brachial index, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) score, and the Short Form 36 (SF-36) score. Statistical analyses were performed to compare LSSPAD patients and LSS patients without PAD using the t test, Mann-Whitney's U test, and multivariate recurrence analysis. p values of <0.05 were considered statistically significant. The LSSPAD group comprised 38 patients (6.7 %); 20 (3.5 %) had pre-diagnosised PAD while 18 (3.2 %) had undetected PAD. The clinical characteristics of these patients were advanced age, diabetes, and a history of ischemic heart disease and cerebrovascular disorder. 570 patients enrolled, and 448 (78.6 %) of those patients were followed up at three months after enrollment. Pain in buttocks and legs improved less in the LSSPAD group than in the LSS group (p < 0.05). Improvements in the "general health" score in SF-36 were lower in the LSSPAD group than in the LSS group (p < 0.05). Advanced age, diabetes, and a history of cerebrovascular disorder and ischemic heart disease were associated with LSSPAD. Because LSSPAD patients show less improvement in QOL than patients with LSS but without PAD do, clinicians should consider the coexistence of PAD in LSS patients.

  14. Outcomes after operations for anal fistula: results of a prospective, multicenter, regional study.

    Science.gov (United States)

    Hall, Jason F; Bordeianou, Liliana; Hyman, Neil; Read, Thomas; Bartus, Christine; Schoetz, David; Marcello, Peter W

    2014-11-01

    There are various surgical techniques used treat anal fistulas. The adoption and success rates of newer techniques have not been clearly established. The purpose of this study was to determine the healing rate after operations for anal fistulas in New England colorectal surgery practices. We conducted a retrospective review of a prospectively collected database. The study was conducted at colorectal surgery practices in New England. A prospective, multicenter registry was created by the New England Society of Colon and Rectal Surgeons. Surgeons were invited to collect data prospectively regarding patients operated on for anal fistulas between January 1, 2011, and August 1, 2013. Fistula classification, surgical intervention, continence scores, and healing were determined by the treating surgeon. Operation for anal fistula was performed. We measured the proportion of patients with healed fistulas at 3 months. Sixteen surgeons submitted data regarding 240 operations for fistula with curative intent. Mean patient age was 45 ± 14 years. A total of 158 patients (66%) were men, and 110 (46%) had undergone an anorectal operation. Twenty-nine (12%) had Crohn's disease. The healing rates of fistulotomy, advancement flap, and fistula plugs at 3 months were 94% (95% CI, 89-97), 60% (95% CI, 33-77), and 20% (95% CI, 5-50). The healing rate of the ligation of intersphincteric fistula tract procedure at 3 months was 79% (95% CI, 65-88). Hospital site was the only variable associated with healing (p fistula tract procedures had higher healing rates at 3 months (p anal fistulas in our region. Fistulotomy continues to have excellent results. There has been enthusiastic early adoption of the ligation of intersphincteric fistula tract technique. Early healing rates after the ligation of intersphincteric fistula tract procedure appear to be excellent.

  15. Unmasking Glucose Metabolism Alterations in Stable Renal Transplant Recipients: A Multicenter Study

    Science.gov (United States)

    Delgado, Patricia; Diaz, Juan Manuel; Silva, Irene; Osorio, José M.; Osuna, Antonio; Bayés, Beatriz; Lauzurica, Ricardo; Arellano, Edgar; Campistol, Jose Maria; Dominguez, Rosa; Gómez-Alamillo, Carlos; Ibernon, Meritxell; Moreso, Francisco; Benitez, Rocio; Lampreave, Ildefonso; Porrini, Esteban; Torres, Armando

    2008-01-01

    Background and objectives: Emerging information indicates that glucose metabolism alterations are common after renal transplantation and are associated with carotid atheromatosis. The aims of this study were to investigate the prevalence of different glucose metabolism alterations in stable recipients as well as the factors related to the condition. Design, setting, participants, & measurements: A multicenter, cross-sectional study was conducted of 374 renal transplant recipients without pre- or posttransplantation diabetes. A standard 75-g oral glucose tolerance test was performed. Results: Glucose metabolism alterations were present in 119 (31.8%) recipients: 92 (24.6%) with an abnormal oral glucose tolerance test and 27 (7.2%) with isolated impaired fasting glucose. The most common disorder was impaired glucose tolerance (17.9%), and an abnormal oral glucose tolerance test was observed for 21.5% of recipients with a normal fasting glucose. By multivariate analysis, age, prednisone dosage, triglyceride/high-density lipoprotein cholesterol ratio, and β blocker use were shown to be factors related to glucose metabolism alterations. Remarkably, triglyceride levels, triglyceride/high-density lipoprotein cholesterol ratio, and the proportion of recipients with impaired fasting glucose were already higher throughout the first posttransplantation year in recipients with a current glucose metabolism alteration as compared with those without the condition. Conclusions: Glucose metabolism alterations are common in stable renal transplant recipients, and an oral glucose tolerance test is required for its detection. They are associated with a worse metabolic profile, which is already present during the first posttransplantation year. These findings may help planning strategies for early detection and intervention. PMID:18322043

  16. European Studies and Public Engagement: A Conceptual Toolbox

    Directory of Open Access Journals (Sweden)

    Andreas Müllerleile

    2014-11-01

    Full Text Available Journal of Contemporary European Research User Username Password Remember me Subscribe... Sign up for issue alerts Follow JCER on Twitter Font Size Make font size smaller Make font size default Make font size larger Journal Content Search Search Scope Browse By Issue By Author By Title Information For Readers For Authors For Librarians Journal Help Keywords CFSP Communication ESDP EU EU enlargement EU trade policy Energy, EU, External Policy Europe European Commission European Parliament European Union European integration Europeanisation First Enlargement Germany Liberty Lisbon Treaty Poland Russia Security teaching European studies The UACES Blog The Commission after the 2014 EP... Power shift? The EU’s pivot to Asia 100 Books on Europe to be Remembered For a Global European Studies? EU Member State Building in the... Open Journal Systems Home About Login Register Search Current Archives Announcements UACES Home > Vol 10, No 4 (2014 > Müllerleile European Studies and Public Engagement: A Conceptual Toolbox Andreas Müllerleile Abstract This article examines public engagement strategies for academics working in the field of European Studies. Should academics engage with the public? What are the most effective outreach strategies? And what are the implications for universities and departments? The article argues that engaging with the public should be considered an integral part for academics working on topics that relate to the European Union or European politics. The article has a theoretical and a practical dimension. The first part of the paper deals with the nature of public engagement, explaining why it is an important issue and how it differs from the mainstream understanding of public engagement. The practical part of the paper presents the idea of building an online presence through which academics can engage with the public debate both during periods of low issue salience and high issue salience. The final section includes a toolbox

  17. Determinants of mortality for adults with cystic fibrosis admitted in Intensive Care Unit: a multicenter study

    Directory of Open Access Journals (Sweden)

    Rabbat Antoine

    2006-01-01

    Full Text Available Abstract Background Intensive care unit (ICU admission of adults with cystic fibrosis (CF is controversial because of poor outcome. This appraisal needs re-evaluation following recent changes in both CF management and ICU daily practice. Objectives were to determine long-term outcome of adults with CF admitted in ICU and to identify prognostic factors. Methods Retrospective multicenter study of 60 ICU hospitalizations for 42 adult CF patients admitted between 2000 and 2003. Reason for ICU admission, ventilatory support provided and one-year survival were recorded. Multiple logistic analysis was used to determine predictors of mortality. Results Prior to ICU admission, all patients (mean age 28.1 ± 8 yr had a severe lung disease (mean FEV1 28 ± 12% predicted; mean PaCO2 47 ± 9 mmHg. Main reason for ICU hospitalization was pulmonary infective exacerbation (40/60. At admission, noninvasive ventilation was used in 57% of cases and was successful in 67% of patients. Endotracheal intubation was implemented in 19 episodes. Overall ICU mortality rate was 14%. One year after ICU discharge, 10 of the 28 survivors have been lung transplanted. Among recognized markers of CF disease severity, only the annual FEV1 loss was associated with a poor outcome (HR = 1.47 [1.18–1.85], p = 0.001. SAPSII (HR = 1.08 [1.03–1.12], p Conclusion Despite advanced lung disease, adult patients with CF admitted in ICU have high survival rate. Endotracheal intubation is associated with a poor prognosis and should be used as the last alternative. Although efforts have to be made in selecting patients with CF likely to benefit from ICU resources, ICU admission of these patients should be considered.

  18. [Critical reading of reports of educational research in teachers of IMSS. Multicenter study].

    Science.gov (United States)

    Leyva-González, Félix Arturo; Cacho-Salazar, Julio M; Degollado-Bardales, Lilia; Zavala-Arenas, Jesús Arturo; Angulo-Bernal, Sonia Elizabeth; Leyva-Salas, César Arturo; Orozco-Bisson, Gisele Victorine

    2011-01-01

    To determine the effect of an educational strategy promoting participation in the development of critical reading of educational research reports on professors of Educational Research and Teacher Education (CIEFD's). We performed an intervention study, multicenter professors (medical specialists) who enrolled in the courses: Diploma in teaching methodological level 1 and 2 (n = 46, n = 29, respectively) in the six CIEFD's (D.F. Siglo XXI, DF. La Raza, Nuevo León, Sonora, Puebla and Jalisco), in the period March to August 2007. A tool was built that assessed the variables critical appraisal of educational research reports, the construct validity, content and reliability was assessed by experts in education research. The educational strategy developed in the form of seminars, which were held three times a week in the Certification in teaching methodological level 1 and twice per week in the Certification Level 2 in teaching methodology duration per session: 6 h. The instrument was applied at the beginning and end of the course. In the two Graduates it was observed in the total group, an advance in the three indicators of critical reading, which was expressed with statistically significant differences; in the global score of the Diploma level 1 (final vs. initial measurement) the following mediums were observed: 36-67 (p = 0.0001); in the Diploma level 2, it was observed in its overall rating: 42-78 (p = 0.0001). This inquiry from the results observed some of theoretical approaches to mainstreaming participatory. An educational strategy promoting participation produced a breakthrough in the three indicators (to interpret, to judge and to formulate proposals) for critical reading of educational research reports.

  19. [French multicenter prospective epidemiologic study (ORLI Group) of allergic and lung diseases associated with nasal polyposis].

    Science.gov (United States)

    Crampette, L; Serrano, E; Klossek, J M; Rugina, M; Rouvier, P; Peynègre, R; Bébéar, J P; Stoll, D

    2001-01-01

    224 patients presenting with nasal polyposis (NP) were included in a french prospective multicenter study. NP was evaluated by nasal endoscopy and computed tomography. Allergic status was documented using skin prick-tests and/or specific IgE. Pneumologic assessment included spirometry with carbamyl-choline hyper-reactivity test or beta 2 mimetic broncho-dilation test. Minimal follow up period was 1 year. 45% of the whole population were considered as asthmatic. Asthma onset occurred before and after the NP onset in respectively 45.7%, 22.3% and 32% of cases; these two conditions started simultaneously in 32% of patients. Skin prick-tests and/or specific IgE were positive in 32.5% of cases. In most of the cases (80%), patients were polysensitized to house dust mite and/or pollens and/or animal danders and/or fungi. 31% of the population had idiosyncrasy, caused by drugs in general and especially aspirin in 44% of cases. The global population could be divided in two groups according to the occurrence of previous polypectomy or not. The group "polypectomy" and the group "no polypectomy" were similar regarding the frequency, the age of onset, the course and the severity of associated asthma. Familial history (parents, children, brothers and sisters) was of great interest: 58.7% of the patients had one (or more) relative suffering from NP, 43.6% of the patients had one (or more) relative suffering from asthma and 12.2% of the patients had one (or more) relative suffering from idiosyncrasy. These results support a genetic etiology for NP.

  20. Atypical manifestations of hepatitis A infection: a prospective, multicenter study in Korea.

    Science.gov (United States)

    Jung, Youn Mu; Park, Sang Jong; Kim, Jeong Sim; Jang, Je-Hyuck; Lee, Sang Hyub; Kim, Jin-Wook; Park, Young Min; Hwang, Seong Gyu; Rim, Kyu Sung; Kang, Sook-Kyoung; Lee, Hyun Seok; Yun, Hae Sun; Jee, Young Mee; Jeong, Sook-Hyang

    2010-08-01

    The clinical outcome of symptomatic hepatitis A and the incidence and clinical characteristics of atypical presentation of hepatitis A were studied using prospective, multicenter design. The atypical presentation included delayed anti-hepatitis A virus (HAV) immunoglobulin M (IgM) seroconversion defined as positive anti-HAV IgM on the repeated test within 7 days of hospital admission after the initially negative result, prolonged cholestasis, and acute kidney injury (AKI). A total of 595 patients with symptomatic hepatitis A requiring hospital admission were enrolled prospectively from September 2006 to August 2008 in four major hospitals in a Korean city with a population of approximately 1 million. Clinical outcomes of symptomatic hepatitis A showed a case fatality rate of 0.2%, and fulminant hepatitis in 0.5%. Delayed anti-HAV IgM seroconversion was found in 6.4%, and was significantly associated with shorter intervals from symptom onset to hospital admission, higher body mass index, and lower alanine aminotransferase (ALT) level at admission. Prolonged cholestasis was found in 4.7% of patients, and could be predicted by preexisting chronic hepatitis B viral infection, prolonged prothrombin time, and higher total bilirubin level. AKI was complicated in 1.5%, which could be predicted by lower albumin level, higher ALT level, and higher white blood cell (WBC) count. More than half of the patients required hemodialysis. Substantial occurrence of delayed anti-HAV IgM seroconversion, prolonged cholestasis, and AKI was confirmed with various predictable factors, which could be helpful for accurate diagnosis and management of hepatitis A patients. (c) 2010 Wiley-Liss, Inc.

  1. Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III).

    Science.gov (United States)

    Stein, Paul D; Chenevert, Thomas L; Fowler, Sarah E; Goodman, Lawrence R; Gottschalk, Alexander; Hales, Charles A; Hull, Russell D; Jablonski, Kathleen A; Leeper, Kenneth V; Naidich, David P; Sak, Daniel J; Sostman, H Dirk; Tapson, Victor F; Weg, John G; Woodard, Pamela K

    2010-04-06

    The accuracy of gadolinium-enhanced magnetic resonance pulmonary angiography and magnetic resonance venography for diagnosing pulmonary embolism has not been determined conclusively. To investigate performance characteristics of magnetic resonance angiography, with or without magnetic resonance venography, for diagnosing pulmonary embolism. Prospective, multicenter study from 10 April 2006 to 30 September 2008. 7 hospitals and their emergency services. 371 adults with diagnosed or excluded pulmonary embolism. Sensitivity, specificity, and likelihood ratios were measured by comparing independently read magnetic resonance imaging with the reference standard for diagnosing pulmonary embolism. Reference standard diagnosis or exclusion was made by using various tests, including computed tomographic angiography and venography, ventilation-perfusion lung scan, venous ultrasonography, d-dimer assay, and clinical assessment. Magnetic resonance angiography, averaged across centers, was technically inadequate in 25% of patients (92 of 371). The proportion of technically inadequate images ranged from 11% to 52% at various centers. Including patients with technically inadequate images, magnetic resonance angiography identified 57% (59 of 104) with pulmonary embolism. Technically adequate magnetic resonance angiography had a sensitivity of 78% and a specificity of 99%. Technically adequate magnetic resonance angiography and venography had a sensitivity of 92% and a specificity of 96%, but 52% of patients (194 of 370) had technically inadequate results. A high proportion of patients with suspected embolism was not eligible or declined to participate. Magnetic resonance pulmonary angiography should be considered only at centers that routinely perform it well and only for patients for whom standard tests are contraindicated. Magnetic resonance pulmonary angiography and magnetic resonance venography combined have a higher sensitivity than magnetic resonance pulmonary angiography

  2. Developmental outcomes of children with congenital diaphragmatic hernia: a multicenter prospective study.

    Science.gov (United States)

    Wynn, Julia; Aspelund, Gudrun; Zygmunt, Annette; Stolar, Charles J H; Mychaliska, George; Butcher, Jennifer; Lim, Foong-Yen; Gratton, Teresa; Potoka, Douglas; Brennan, Kate; Azarow, Ken; Jackson, Barbara; Needelman, Howard; Crombleholme, Timothy; Zhang, Yuan; Duong, Jimmy; Arkovitz, Marc S; Chung, Wendy K; Farkouh, Christiana

    2013-10-01

    To determine developmental outcomes and associated factors in patients with congenital diaphragmatic hernia (CDH) at 2 years of age. This is a multicenter prospective study of a CDH birth cohort. Clinical and socioeconomic data were collected. Bayley Scales of Infant Development (BSID-III) and Vineland Adaptive Behavior Scales (VABS-II) were performed at 2 years of age. BSID-III and VABS-II assessments were completed on 48 and 49 children, respectively. The BSID-III mean cognitive, language, and motor scores were significantly below the norm mean with average scores of 93 ± 15, 95 ± 16, and 95 ± 11. Ten percent (5/47) scored more than 2 standard deviations below the norm on one or more domains. VABS-II scores were similar to BSID-III scores with mean communication, daily living skills, social, motor, adaptive behavior scores of 97 ± 14, 94 ± 16, 93 ± 13, 97 ± 10, and 94 ± 14. For the BSID-III, supplemental oxygen at 28 days, a prenatal diagnosis, need for extracorporeal membrane oxygenation (ECMO) and exclusive tube feeds at time of discharge were associated with lower scores. At 2 years of age, history of hospital readmission and need for tube feeds were associated with lower scores. Lower socioeconomic status correlated with lower developmental scores when adjusted for significant health factors. CDH patients on average have lower developmental scores at 2 years of age compared to the norm. A need for ECMO, oxygen at 28 days of life, ongoing health issues and lower socioeconomic status are factors associated with developmental delays. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Anatomical Location of Pathology Is Predictive of Prolonged Fluoroscopy Time During ERCP: A Multicenter American Study.

    Science.gov (United States)

    Alkhatib, Amer A; Abdel Jalil, Ala A; Faigel, Douglas O; Pannala, Rahul; Crowell, Michael; Harrison, M E

    2015-06-01

    Different factors have been associated with prolonged fluoroscopy time (FT) during endoscopic retrograde cholangiopancreatography (ERCP). We hypothesize that FT depends on both the anatomical location of the pathology managed during ERCP and the complexity of the ERCP. Three centers participated in a retrospective multi-center cohort study. Data on patient demographics, ERCP complexity, and the location of pathology were collected. The relationships between FT and the location of pathology, ERCP complexity, patient demographics, and ERCP maneuvers, respectively, were analyzed. Prolonged FT was defined as a FT > 10 min. A total of 442 cases underwent ERCP in three different centers (301 cases, 76 cases, and 65 cases in centers A, B, and C, respectively) by six endoscopists. The median FT for all cases was 282 (range 8-3,516) s. Mean FT increased progressively according to anatomical location in the order extrahepatic cases {n = 298; mean FT 292 [95 % confidence interval (CI) 263-322] s}, pancreatic cases [n = 27; mean FT 359 (95 % CI 200-517) s], and intrahepatic cases [n = 117; mean FT 736 s (95 % CI 635-836) s]. Mean FT increased progressively with the complexity scale, with mean FT for Grade I, 218 (95 % CI 138-299) s; Grade II, 295 (95 % 261-329) s; Grade III, 586 (95 % CI 508-663) s; Grade IV, 636 (95 % CI 437-834) s. Multivariable analysis confirmed that prolonged FT was independently associated with anatomical location of the targeted pathology during ERCP-but not with ERCP complexity and endoscopy center. Prolonged FT during ERCP is associated most strongly with intrahepatic cases. FT can be used most effectively as a quality measure if it is stratified according to presence or absence of intrahepatic cases.

  4. Osteosarcoma of the spine: prognostic variables for local recurrence and overall survival, a multicenter ambispective study.

    Science.gov (United States)

    Dekutoski, Mark B; Clarke, Michelle J; Rose, Peter; Luzzati, Alessandro; Rhines, Laurence D; Varga, Peter P; Fisher, Charles G; Chou, Dean; Fehlings, Michael G; Reynolds, Jeremy J; Williams, Richard; Quraishi, Nasir A; Germscheid, Niccole M; Sciubba, Daniel M; Gokaslan, Ziya L; Boriani, Stefano

    2016-07-01

    OBJECTIVE Primary spinal osteosarcomas are rare and aggressive neoplasms. Poor outcomes can occur, as obtaining marginal margins is technically demanding; further Enneking-appropriate en bloc resection can have significant morbidity. The goal of this study is to identify prognostic variables for local recurrence and mortality in surgically treated patients diagnosed with a primary osteosarcoma of the spine. METHODS A multicenter ambispective database of surgically treated patients with primary spine osteosarcomas was developed by AOSpine Knowledge Forum Tumor. Patient demographic, diagnosis, treatment, perioperative morbidity, local recurrence, and cross-sectional survival data were collected. Tumors were classified in 2 cohorts: Enneking appropriate (EA) and Enneking inappropriate (EI), as defined by pathology margin matching Enneking-recommended surgical margins. Prognostic variables were analyzed in reference to local recurrence and survival. RESULTS Between 1987 and 2012, 58 patients (32 female patients) underwent surgical treatment for primary spinal osteosarcoma. Patients were followed for a mean period of 3.5 ± 3.5 years (range 0.5 days to 14.3 years). The median survival for the entire cohort was 6.7 years postoperative. Twenty-four (41%) patients died, and 17 (30%) patients suffered a local recurrence, 10 (59%) of whom died. Twenty-nine (53%) patients underwent EA resection while 26 (47%) patients underwent EI resection with a postoperative median survival of 6.8 and 3.7 years, respectively (p = 0.048). EI patients had a higher rate of local recurrence than EA patients (p = 0.001). Patient age, previous surgery, biopsy type, tumor size, spine level, and chemotherapy timing did not significantly influence recurrence and survival. CONCLUSIONS Osteosarcoma of the spine presents a significant challenge, and most patients die in spite of aggressive surgery. There is a significant decrease in recurrence and an increase in survival with en bloc resection (EA

  5. Multicenter study of pectus excavatum, final report: complications, static/exercise pulmonary function, and anatomic outcomes.

    Science.gov (United States)

    Kelly, Robert E; Mellins, Robert B; Shamberger, Robert C; Mitchell, Karen K; Lawson, M Louise; Oldham, Keith T; Azizkhan, Richard G; Hebra, Andre V; Nuss, Donald; Goretsky, Michael J; Sharp, Ronald J; Holcomb, George W; Shim, Walton K T; Megison, Stephen M; Moss, R Lawrence; Fecteau, Annie H; Colombani, Paul M; Cooper, Dan; Bagley, Traci; Quinn, Amy; Moskowitz, Alan B; Paulson, James F

    2013-12-01

    A multicenter study of pectus excavatum was described previously. This report presents our final results. Patients treated surgically at 11 centers were followed prospectively. Each underwent a preoperative evaluation with CT scan, pulmonary function tests, and body image survey. Data were collected about associated conditions, complications, and perioperative pain. One year after treatment, patients underwent repeat chest CT scan, pulmonary function tests, and body image survey. A subset of 50 underwent exercise pulmonary function testing. Of 327 patients, 284 underwent Nuss procedure and 43 underwent open procedure without mortality. Of 182 patients with complete follow-up (56%), 18% had late complications, similarly distributed, including substernal bar displacement in 7% and wound infection in 2%. Mean initial CT scan index of 4.4 improved to 3.0 post operation (severe >3.2, normal = 2.5). Computed tomography index improved at the deepest point (xiphoid) and also upper and middle sternum. Pulmonary function tests improved (forced vital capacity from 88% to 93%, forced expiratory volume in 1 second from 87% to 90%, and total lung capacity from 94% to 100% of predicted (p VO2 max during peak exercise increased by 10.1% (p = 0.015) and O2 pulse by 19% (p = 0.007) in 20 subjects who completed both pre- and postoperative exercise tests. There is significant improvement in lung function at rest and in VO2 max and O2 pulse after surgical correction of pectus excavatum, with CT index >3.2. Operative correction significantly reduces CT index and markedly improves the shape of the entire chest, and can be performed safely in a variety of centers. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  6. Prehospital and en route cricothyrotomy performed in the combat setting: a prospective, multicenter, observational study.

    Science.gov (United States)

    Barnard, Ed B G; Ervin, Alicia T; Mabry, Robert L; Bebarta, Vikhyat S

    2014-01-01

    Airway compromise is the third most common cause of potentially preventable combat death. Surgical cricothyrotomy is an infrequently performed but lifesaving airway intervention. There are limited published data on prehospital cricothyrotomy in civilian or military settings. Our aim was to prospectively describe the survival rate and complications associated with cricothyrotomy performed in the military prehospital and en route setting. The Life-Saving Intervention (LSI) study is a prospective, institutional review board-approved, multicenter trial examining LSIs performed in the prehospital combat setting. We prospectively recorded LSIs performed on patients in theater who were transported to six combat hospitals. Trained site investigators evaluated patients on arrival and recorded demographics, vital signs, and LSIs performed. LSIs were predefined and include cricothyrotomies, chest tubes, intubations, tourniquets, and other procedures. From the large dataset, we analyzed patients who had a cricothyrotomy performed. Hospital outcomes were cross-referenced from the Department of Defense Trauma Registry. Descriptive statistics or Wilcoxon test (nonparametric) were used for data comparisons; statistical significance was set at pcombat medic (pre-evacuation), and 18 by an evacuation helicopter medic. Combat-hospital outcome data were available for 26 patients, 13 (50%) of whom survived to discharge. The cricothyrotomy patients had more LSIs than noncricothyrotomy patients (four versus two LSIs per patient; pcombat, procedural success was higher than previously reported. In addition, the majority of cricothyrotomies were performed by the evacuation helicopter medic rather than the prehospital combat medic. Prehospital military medics should receive training in decision making and be provided with adjuncts to facilitate this lifesaving procedure. 2014.

  7. Shigella isolates from the global enteric multicenter study inform vaccine development.

    Science.gov (United States)

    Livio, Sofie; Strockbine, Nancy A; Panchalingam, Sandra; Tennant, Sharon M; Barry, Eileen M; Marohn, Mark E; Antonio, Martin; Hossain, Anowar; Mandomando, Inacio; Ochieng, John B; Oundo, Joseph O; Qureshi, Shahida; Ramamurthy, Thandavarayan; Tamboura, Boubou; Adegbola, Richard A; Hossain, Mohammed Jahangir; Saha, Debasish; Sen, Sunil; Faruque, Abu Syed Golam; Alonso, Pedro L; Breiman, Robert F; Zaidi, Anita K M; Sur, Dipika; Sow, Samba O; Berkeley, Lynette Y; O'Reilly, Ciara E; Mintz, Eric D; Biswas, Kousick; Cohen, Dani; Farag, Tamer H; Nasrin, Dilruba; Wu, Yukun; Blackwelder, William C; Kotloff, Karen L; Nataro, James P; Levine, Myron M

    2014-10-01

    Shigella, a major diarrheal disease pathogen worldwide, is the target of vaccine development. The Global Enteric Multicenter Study (GEMS) investigated burden and etiology of moderate-to-severe diarrheal disease in children aged Shigella was 1 of the 4 most common pathogens across sites and age strata. GEMS Shigella serotypes are reviewed to guide vaccine development. Subjects' stool specimens/rectal swabs were transported to site laboratories in transport media and plated onto xylose lysine desoxycholate and MacConkey agar. Suspect Shigella colonies were identified by biochemical tests and agglutination with antisera. Shigella isolates were shipped to the GEMS Reference Laboratory (Baltimore, MD) for confirmation and serotyping of S. flexneri; one-third of isolates were sent to the Centers for Disease Control and Prevention for quality control. Shigella dysenteriae and S. boydii accounted for 5.0% and 5.4%, respectively, of 1130 Shigella case isolates; S. flexneri comprised 65.9% and S. sonnei 23.7%. Five serotypes/subserotypes comprised 89.4% of S. flexneri, including S. flexneri 2a, S. flexneri 6, S. flexneri 3a, S. flexneri 2b, and S. flexneri 1b. A broad-spectrum Shigella vaccine must protect against S. sonnei and 15 S. flexneri serotypes/subserotypes. A quadrivalent vaccine with O antigens from S. sonnei, S. flexneri 2a, S. flexneri 3a, and S. flexneri 6 can provide broad direct coverage against these most common serotypes and indirect coverage against all but 1 (rare) remaining subserotype through shared S. flexneri group antigens. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

  8. Outcome of HCV/HIV-coinfected liver transplant recipients: a prospective and multicenter cohort study.

    Science.gov (United States)

    Miro, J M; Montejo, M; Castells, L; Rafecas, A; Moreno, S; Agüero, F; Abradelo, M; Miralles, P; Torre-Cisneros, J; Pedreira, J D; Cordero, E; de la Rosa, G; Moyano, B; Moreno, A; Perez, I; Rimola, A

    2012-07-01

    Eighty-four HCV/HIV-coinfected and 252-matched HCV-monoinfected liver transplant recipients were included in a prospective multicenter study. Thirty-six (43%) HCV/HIV-coinfected and 75 (30%) HCV-monoinfected patients died, with a survival rate at 5 years of 54% (95% CI, 42-64) and 71% (95% CI, 66 to 77; p = 0.008), respectively. When both groups were considered together, HIV infection was an independent predictor of mortality (HR, 2.202; 95% CI, 1.420-3.413 [p < 0.001]). Multivariate analysis of only the HCV/HIV-coinfected recipients, revealed HCV genotype 1 (HR, 2.98; 95% CI, 1.32-6.76), donor risk index (HR, 9.48; 95% CI, 2.75-32.73) and negative plasma HCV RNA (HR, 0.14; 95% CI, 0.03-0.62) to be associated with mortality. When this analysis was restricted to pretransplant variables, we identified three independent factors (HCV genotype 1, pretransplant MELD score and centers with <1 liver transplantation/year in HIV-infected patients) that allowed us to identify a subset of 60 (71%) patients with a similar 5-year prognosis (69%[95% CI, 54-80]) to that of HCV-monoinfected recipients. In conclusion, 5-year survival in HCV/HIV-coinfected liver recipients was lower than in HCV-monoinfected recipients, although an important subset with a favorable prognosis was identified in the former. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

  9. Acute renal failure according to the RIFLE and AKIN criteria: a multicenter study.

    Science.gov (United States)

    Salgado, G; Landa, M; Masevicius, D; Gianassi, S; San-Román, J E; Silva, L; Gimenez, M; Tejerina, O; Díaz-Cisneros, P; Ciccioli, F; do Pico, J L

    2014-01-01

    To determine the incidence of acute renal failure (ARF) in critically ill patients using the RIFLE and AKIN criteria. A prospective, multicenter observational study with a duration of one year from February 2010 was carried out. RIFLE and AKIN were employed using the urinary (UC) and creatinine criteria (CC) jointly and separately. Nine polyvalent Critical Care Units (CCUs) in Argentina. A total of 627 critical patients over 18 years of age were admitted to the CCU for more than 48h. inability to quantify diuresis, surgical instrumentation of the urinary tract, and need for renal support therapy (RST). Calculated hourly diuresis (CHD) was used to apply the UC. The incidence of ARF was 69.4% and 51.8% according to RIFLE and AKIN, respectively. UC detected ARF in 59.5% of cases, while CC identified ARF in 34.7% (RIFLE) and 25.3% (AKIN). The mortality rate was 40.9% and 44.6% according to RIFLE and AKIN respectively, was significantly higher than in patients without ARF, and increased with disease severity (Data processing: Excel, SQL and SPSS. Levene test, comparison of means with Student t and chi-squared, with 95% confidence interval). RIFLE identified more cases of ARF. UC proved more effective than CC. The presence of ARF and severity levels were correlated to mortality but not to days of stay in the CCU. Implementation of the unified CHD was useful for implementing UC and achieving comparable results. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

  10. Survey on the Treatment of Postherpetic Neuralgia in Korea; Multicenter Study of 1,414 Patients

    Science.gov (United States)

    Nahm, Francis Sahngun; Kim, Sang Hun; Kim, Hong Soon; Shin, Jin Woo; Yoo, Sie Hyeon; Yoon, Myung Ha; Lee, Doo Ik; Lee, Youn Woo; Lee, Jun Hak; Jeon, Young Hoon

    2013-01-01

    Background Postherpetic neuralgia (PHN) is a serious complication resulting from herpes zoster infections, and it can impair the quality of life. In order to relieve pain from PHN, various treatments, including pharmacological and interventional methods have been used. However, little information on the recommendations for the interventional treatment of PHN, along with a lack of nation-wide surveys on the current status of PHN treatment exists. This multicenter study is the first survey on the treatment status of PHN in Korea. Methods Retrospective chart reviews were conducted on the entire patients who visited the pain clinics of 11 teaching hospitals from January to December of 2011. Co-morbid disease, affected site of PHN, routes to pain clinic visits, parenteral/topical medications for treatment, drugs used for nerve block, types and frequency of nerve blocks were investigated. Results A total of 1,414 patients' medical records were reviewed. The most commonly affected site was the thoracic area. The anticonvulsants and interlaminar epidural blocks were the most frequently used pharmacological and interventional methods for PHN treatment. For the interval of epidural block, intervals of 5 or more-weeks were the most popular. The proportion of PHN patients who get information from the mass media or the internet was only 0.8%.The incidence of suspected zoster sine herpete was only 0.1%. Conclusions The treatment methods for PHN vary among hospitals. The establishment of treatment recommendation for PHN treatment is necessary. In addition, public relations activities are required in order to inform the patients of PHN treatments by pain clinicians. PMID:23342203

  11. Estimating cardiovascular risk in patients with type 2 diabetes: a national multicenter study in Brazil

    Directory of Open Access Journals (Sweden)

    Gomes Marilia B

    2009-10-01

    Full Text Available Abstract According to Brazilian National Data Survey diabetes is the fifth cause for hospitalization and is one of the ten major causes of mortality in this country. Aims to stratify the estimated cardiovascular risk (eCVR in a population of type 2 diabetics (T2DM according to the Framingham prediction equations as well as to determine the association between eCVR with metabolic and clinical control of the disease. Methods From 2000 to 2001 a cross-sectional multicenter study was conducted in 13 public out-patients diabetes/endocrinology clinics from 8 Brazilian cities. The 10-year risk of developing coronary heart disease (CHD was estimated by the prediction equations described by Wilson et al (Circulation 1998. LDL equations were preferably used; when patients missed LDL data we used total cholesterol equations instead. Results Data from 1382 patients (59.0% female were analyzed. Median and inter-quartile range (IQ of age and duration of diabetes were 57.4 (51-65 and 8.8 (3-13 years, respectively without differences according to the gender. Forty-two percent of these patients were overweight and 35.4% were obese (the prevalence of higher BMI and obesity in this T2DM group was significantly higher in women than in men; p 20% in 738 (53.4%, intermediate in 202 (14.6% and low in 442 (32% patients. Men [25.1(15.4-37.3] showed a higher eCVR than women [18.8 (12.4-27.9 p

  12. Nutrition-related risk indexes and long-term mortality in noncritically ill inpatients who receive total parenteral nutrition (prospective multicenter study).

    Science.gov (United States)

    Tapia, María José; Ocón, Julia; Cabrejas-Gómez, Carmen; Ballesteros-Pomar, María D; Vidal-Casariego, Alfonso; Arraiza-Irigoyen, Carmen; Olivares, Josefina; Conde-García, Ma Carmen; García-Manzanares, Álvaro; Botella-Romero, Francisco; Quílez-Toboso, Rosa P; Cabrerizo, Lucio; Rubio, Miguel A; Chicharro, Luisa; Burgos, Rosa; Pujante, Pedro; Ferrer, Mercedes; Zugasti, Ana; Petrina, Estrella; Manjón, Laura; Diéguez, Marta; Carrera, Ma José; Vila-Bundo, Anna; Urgelés, Juan Ramón; Aragón-Valera, Carmen; Sánchez-Vilar, Olga; Bretón, Irene; García-Peris, Pilar; Muñoz-Garach, Araceli; Márquez, Efren; del Olmo, Dolores; Pereira, José Luis; Tous, María C; Olveira, Gabriel

    2015-10-01

    Malnutrition in hospitalized patients is associated with an increased risk of death, in both the short and the long term. The purpose of this study was to determine which nutrition-related risk index predicts long-term mortality better (three years) in patients who receive total parenteral nutrition (TPN). This prospective, multicenter study involved noncritically ill patients who were prescribed TPN during hospitalization. Data were collected on Subjective Global Assessment (SGA), Nutritional Risk Index (NRI), Geriatric Nutritional Risk Index (GNRI), body mass index, albumin and prealbumin, as well as long-term mortality. Over the 1- and 3-year follow-up periods, 174 and 244 study subjects (28.8% and 40.3%) respectively, died. Based on the Cox proportional hazards survival model, the nutrition-related risk indexes most strongly associated with mortality were SGA and albumin (<2.5 g/dL) (after adjustment for age, gender, C-reactive protein levels, prior comorbidity, mean capillary blood glucose during TPN infusion, diabetes status prior to TPN, diagnosis, and infectious complications during hospitalization). The SGA and very low albumin levels are simple tools that predict the risk of long-term mortality better than other tools in noncritically ill patients who receive TPN during hospitalization. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  13. Clinical manifestations of colorectal cancer patients from a large multicenter study in Colombia.

    Science.gov (United States)

    Bohorquez, Mabel; Sahasrabudhe, Ruta; Criollo, Angel; Sanabria-Salas, María Carolina; Vélez, Alejandro; Castro, Jorge Mario; Marquez, Juan Ricardo; Mateus, Gilbert; Bolaños, Fernando; Panqueva, Cesar; Restrepo, Jose Ignacio; Puerta, Juan Dario; Murillo, Raul; Bravo, María Mercedes; Hernández, Gustavo; Rios, Angela; Prieto, Rodrigo; Tomlinson, Ian; Echeverry, Magdalena; Carvajal-Carmona, Luis G

    2016-10-01

    Colorectal cancer (CRC) is a major public health problem, and its incidence is rising in developing countries. However, studies characterizing CRC clinicopathological features in cases from developing countries are still lacking. The goal of this study was to evaluate clinicopathological and demographic features in one of the largest CRC studies in Latin America.The study involved over 1525 CRC cases recruited in a multicenter study in Colombia between 2005 and 2014 as part of ongoing genetic and epidemiological studies. We gathered clinicopathological data such as age at diagnosis, sex, body mass index, tobacco and alcohol consumption, family history of cancer, and tumor features including location, histological type, and stage. Statistical analyses were performed to test the association between age of onset, sex, and clinical manifestations.The average age at CRC diagnosis was 57.4 years, with 26.5% of cases having early-onset CRC (diagnosed by age 50 years). Most cases were women (53.2%; P = 0.009), 49.2% were overweight or obese, 49.1% were regular alcohol drinkers, 52% were smokers/former smokers, and 12.2% reported relatives with cancer. Most tumors in the study were located in the rectum (42.7%), were adenocarcinomas (91.5%), and had advanced stage (T3-T4, 79.8%). Comparisons by sex found that male cases were more likely to be obese (36.5% vs 31.1%; P = 0.001), less likely to have a family history of cancer (9.7% vs 15.3%; P = 0.016), and more likely to have advanced-stage tumors (83.9% vs 76.1%; P = 0.036). Comparisons by age of onset found that early-onset cases were more likely to be women (59.3% vs 51.0%; P = 0.005) and report a family history of cancer (17.4% vs 10.2%; P = 0.001).To our knowledge, our study is the largest report of clinicopathological characterization of Hispanic CRC cases, and we suggest that further studies are needed to understand CRC etiology in diverse Hispanic populations.

  14. Ideal cardiovascular health and inflammation in European adolescents: The HELENA study.

    Science.gov (United States)

    González-Gil, E M; Santabárbara, J; Ruiz, J R; Bel-Serrat, S; Huybrechts, I; Pedrero-Chamizo, R; de la O, A; Gottrand, F; Kafatos, A; Widhalm, K; Manios, Y; Molnar, D; De Henauw, S; Plada, M; Ferrari, M; Palacios Le Blé, G; Siani, A; González-Gross, M; Gómez-Martínez, S; Marcos, A; Moreno Aznar, L A

    2017-05-01

    Inflammation plays a key role in atherosclerosis and this process seems to appear in childhood. The ideal cardiovascular health index (ICHI) has been inversely related to atherosclerotic plaque in adults. However, evidence regarding inflammation and ICHI in adolescents is scarce. The aim is to assess the association between ICHI and inflammation in European adolescents. As many as 543 adolescents (251 boys and 292 girls) from the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) study, a cross-sectional multi-center study including 9 European countries, were measured. C-reactive protein (CRP), complement factors C3 and C4, leptin and white blood cell counts were used to compute an inflammatory score. Multilevel linear models and multilevel logistic regression were used to assess the association between ICHI and inflammation controlling by covariates. Higher ICHI was associated with a lower inflammatory score, as well as with several individual components, both in boys and girls (p < 0.01). In addition, adolescents with at least 4 ideal components of the ICHI had significantly lower inflammatory score and lower levels of the study biomarkers, except CRP. Finally, the multilevel logistic regression showed that for every unit increase in the ICHI, the probability of having an inflammatory profile decreased by 28.1% in girls. Results from this study suggest that a better ICHI is associated with a lower inflammatory profile already in adolescence. Improving these health behaviors, and health factors included in the ICHI, could play an important role in CVD prevention. Copyright © 2016 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

  15. Brazilian multicenter study on prevalence of preterm birth and associated factors

    Directory of Open Access Journals (Sweden)

    Guinsburg Ruth

    2010-05-01

    Full Text Available Abstract Background The occurrence of preterm birth remains a complex public health condition. It is considered the main cause of neonatal morbidity and mortality, resulting in a high likelihood of sequelae in surviving children. With variable incidence in several countries, it has grown markedly in the last decades. In Brazil, however, there are still difficulties to estimate its real occurrence. Therefore, it is essential to establish the prevalence and causes of this condition in order to propose prevention actions. This study intend to collect information from hospitals nationwide on the prevalence of preterm births, their associated socioeconomic and environmental factors, diagnostic and treatment methods resulting from causes such as spontaneous preterm labor, prelabor rupture of membranes, and therapeutic preterm birth, as well as neonatal results. Methods/Design This proposal is a multicenter cross-sectional study plus a nested case-control study, to be implemented in 27 reference obstetric centers in several regions of Brazil (North: 1; Northeast: 10; Central-west: 1; Southeast: 13; South: 2. For the cross sectional component, the participating centers should perform, during a period of six months, a prospective surveillance of all patients hospitalized to give birth, in order to identify preterm birth cases and their main causes. In the first three months of the study, an analysis of the factors associated with preterm birth will also be carried out, comparing women who have preterm birth with those who deliver at term. For the prevalence study, 37,000 births will be evaluated (at term and preterm, corresponding to approximately half the deliveries of all participating centers in 12 months. For the case-control study component, the estimated sample size is 1,055 women in each group (cases and controls. The total number of preterm births estimated to be followed in both components of the study is around 3,600. Data will be collected

  16. Energy and Protein in Critically Ill Patients with AKI: A Prospective, Multicenter Observational Study Using Indirect Calorimetry and Protein Catabolic Rate

    Science.gov (United States)

    Theilla, Miriam; Hellerman, Moran; Singer, Pierre; Maggiore, Umberto; Barbagallo, Maria; Regolisti, Giuseppe; Fiaccadori, Enrico

    2017-01-01

    The optimal nutritional support in Acute Kidney Injury (AKI) still remains an open issue. The present study was aimed at evaluating the validity of conventional predictive formulas for the calculation of both energy expenditure and protein needs in critically ill patients with AKI. A prospective, multicenter, observational study was conducted on adult patients hospitalized with AKI in three different intensive care units (ICU). Nutrient needs were estimated by different methods: the Guidelines of the European Society of Parenteral and Enteral Nutrition (ESPEN) for both calories and proteins, the Harris-Benedict equation, the Penn-State and Faisy-Fagon equations for energy. Actual energy and protein needs were repeatedly measured by indirect calorimetry (IC) and protein catabolic rate (PCR) until oral nutrition start, hospital discharge or renal function recovery. Forty-two patients with AKI were enrolled, with 130 IC and 123 PCR measurements obtained over 654 days of artificial nutrition. No predictive formula was precise enough, and Bland-Altman plots wide limits of agreement for all equations highlight the potential to under- or overfeed individual patients. Conventional predictive formulas may frequently lead to incorrect energy and protein need estimation. In critically ill patients with AKI an increased risk for under- or overfeeding is likely when nutrient needs are estimated instead of measured. PMID:28933744

  17. Denosumab is really effective in the treatment of osteoporosis secondary to hypogonadism in prostate carcinoma patients? A prospective randomized multicenter international study

    Science.gov (United States)

    Doria, Carlo; Leali, Paolo Tranquilli; Solla, Federico; Maestretti, Gianluca; Balsano, Massimo; Scarpa, Robero Mario

    2016-01-01

    Summary Introduction Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. The best defense against osteoporosis in prostate cancer is to identify patients with a high risk for fracture during the first clinical visit, select an effective anti-osteoporosis agent, and advise the patient to change his lifestyle and diet to prevent further bone loss. New agents include denosumab, a human monoclonal antibody that inhibits the RANK ligand (RANKL). RANKL promotes the formation, activity, and survival of osteoclasts and, thus, supports the breakdown of bone. Purpose This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT in prostate cancer patients in three European countries (Italy, France, Switzerland). Patients and methods In this 24-month observation study we enrolled 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer. All patients aged ≥55 years and had a dual-energy X-ray absorptiometry (DEXA) T-score osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures. PMID:28228781

  18. A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine

    OpenAIRE

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D.; Zava, Dario; Pinessi, Lorenzo

    2010-01-01

    The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1–3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment pe...

  19. Changes in Physician Decision Making after CT: A Prospective Multicenter Study in Primary Care Settings.

    Science.gov (United States)

    Pandharipande, Pari V; Alabre, Claude I; Coy, David L; Zaheer, Atif; Miller, Chad M; Herring, Maurice S; Tramontano, Angela C; Dowling, Emily C; Eisenberg, Jonathan D; Ashar, Bimal H; Halpern, Elkan F; Donelan, Karen; Gazelle, G Scott

    2016-12-01

    Purpose To determine the effect of computed tomography (CT) results on physician decision making in three common clinical scenarios in primary care. Materials and Methods This research was approved by the institutional review board (IRB) and was HIPAA compliant. All physicians consented to participate with an opt-in or opt-out mechanism; patient consent was waived with IRB approval. In this prospective multicenter observational study, outpatients referred by primary care providers (PCPs) for CT evaluation of abdominal pain, hematuria, or weight loss were identified. Prior to CT, PCPs were surveyed to elicit their leading diagnosis, confidence in that diagnosis (confidence range, 0%-100%), a rule-out diagnosis, and a management plan if CT were not available. Surveys were repeated after CT. Study measures were the proportion of patients in whom leading diagnoses and management changed (PCP management vs specialist referral vs emergency department transfer), median changes in diagnostic confidence, and the proportion of patients in whom CT addressed rule-out diagnoses. Regression analyses were used to identify associations between study measures and site and participant characteristics. Specifically, logistic regression analysis was used for binary study measures (change in leading diagnosis, change in management), and linear regression analysis was used for the continuous study measure (change in diagnostic confidence). Accrual began on September 5, 2012, and ended on June 28, 2014. Results In total, 91 PCPs completed pre- and post-CT surveys in 373 patients. In patients with abdominal pain, hematuria, or weight loss, leading diagnoses changed after CT in 53% (131 of 246), 49% (36 of 73), and 57% (27 of 47) of patients, respectively. Management changed in 35% (86 of 248), 27% (20 of 74), and 54% (26 of 48) of patients, respectively. Median absolute changes in diagnostic confidence were substantial and significant (+20%, +20%, and +19%, respectively; P ≤ .001 for

  20. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

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    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  1. Occupation and skin cancer: the results of the HELIOS-I multicenter case-control study

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    Gafà Lorenzo

    2007-07-01

    Full Text Available Abstract Background Non-melanoma skin cancer (NMSC is the most frequent tumour among Caucasian populations worldwide. Among the risk factors associated with this tumour, there are host-related factors and several environmental agents. A greater likelihood of high exposure to physical agents (with the exception of solar radiation and chemical agents depends on the work setting. Our objective is to evaluate the role of occupational exposures in NMSC, with special emphasis on risk factors other than solar radiation and skin type. Methods We analysed 1585 cases (1333 basal cell carcinoma (BCC and 183 squamous cell carcinoma (SCC and 1507 controls drawn from the Helios-I multicenter study. Odds ratios (OR and 95% confidence intervals (CI were estimated using logistic regression mixed models. Results For NMSC as a whole (both histological types, miners and quarrymen, secondary education teachers, and masons registered excess risk, regardless of exposure to solar radiation and skin type (OR 7.04, 95% CI 2.44–20.31; OR 1.75, 95% CI 1.05–2.89 and OR 1.54, 95% CI 1.04–2.27, respectively. Frequency of BCC proved higher among railway engine drivers and firemen (OR 4.55; 95% CI 0.96–21.57, specialised farmers (OR 1.65; 95% CI 1.05–2.59 and salesmen (OR 3.02; 95% CI 1.05–2.86, in addition to miners and quarrymen and secondary education teachers (OR 7.96; 95% CI 2.72–23.23 and OR 1.76; 95% CI 1.05–2.94 respectively. The occupations that registered a higher risk of SCC (though not of BCC were those involving direct contact with livestock, construction workers not elsewhere classified (OR 2.95, 95% CI 1.12–7.74, stationary engine and related equipment operators not elsewhere classified (OR 5.31, 95% CI 1.13–21.04 and masons (OR 2.55, 95% CI 1.36–4.78. Conclusion Exposure to hazardous air pollutants, arsenic, ionizing radiations and burns may explain a good part of the associations observed in this study. The Helios study affords an

  2. Early rehabilitation for severe acquired brain injury in intensive care unit: multicenter observational study.

    Science.gov (United States)

    Bartolo, Michelangelo; Bargellesi, Stefano; Castioni, Carlo A; Bonaiuti, Donatella; Antenucci, Roberto; Benedetti, Angelo; Capuzzo, Valeria; Gamna, Federica; Radeschi, Giulio; Citerio, Giuseppe; Colombo, Carolina; Del Casale, Laura; Recubini, Elena; Toska, Saimir; Zanello, Marco; D'Aurizio, Carlo; Spina, Tullio; Del Gaudio, Alredo; Di Rienzo, Filomena; Intiso, Domenico; Dallocchio, Giulia; Felisatti, Giovanna; Lavezzi, Susanna; Zoppellari, Roberto; Gariboldi, Valentina; Lorini, Luca; Melizza, Giovanni; Molinero, Guido; Mandalà, Giorgio; Pignataro, Amedeo; Montis, Andrea; Napoleone, Alessandro; Pilia, Felicita; Pisu, Marina; Semerjian, Monica; Pagliaro, Giuseppina; Nardin, Lorella; Scarponi, Federico; Zampolini, Mauro; Zava, Raffaele; Massetti, Maria A; Piccolini, Carlo; Aloj, Fulvio; Antonelli, Sergio; Zucchella, Chiara

    2016-02-01

    The increased survival after a severe acquired brain injury (sABI) raise the problem of making most effective the treatments in Intensive Care Unit (ICU)/Neurointensive Care Unit (NICU), also integrating rehabilitation care. Despite previous studies reported that early mobilization in ICU was effective in preventing complications and reducing hospital stay, few studies addressed the rehabilitative management of sABI patients in ICU/NICU. To collect clinical and functional data about the early rehabilitative management of sABI patients during ICU/NICU stay. Prospective, observational, multicenter study. Fourteen facilities supplied by intensive neurorehabilitation units and ICU/NICUs. Consecutive sABI patients admitted to ICU/NICU. Patients were evaluated at admission and then every 3-5 days. Clinical, functional and rehabilitative data, including Glasgow Coma Scale (GCS), Disability Rating Scale (DRS), The Rancho Los Amigos Levels of Cognitive Functioning Scale (LCF), Early Rehabilitation Barthel Index (ERBI), Glasgow Outcome scale (GOS) and Functional Independence Measure (FIM) were collected. One hundred and two patients (F/M 44/58) were enrolled. The mean duration of ICU stay was 24.7±13.9 days and the first rehabilitative evaluation occurred after 8.7±8.8 days. Regular postural changes and multijoint mobilization were prescribed in 63.7% and 64.7% cases, respectively. The mean session duration was 38±11.5 minutes. Swallowing evaluation was performed in 14.7% patients, psychological support was provided to 12.7% of patients' caregivers, while 17.6% received a psycho-educational intervention, and 28.4% were involved in interdisciplinary team meetings. The main discharge destinations were Severe Acquired Brain Injury rehabilitation units for 43.7%, intensive neurorehabilitation units for 20.7%. Data showed that early rehabilitation was not diffusely performed in sABI subjects in ICU/NICU and rehabilitative interventions were variable; one-third of subjects were

  3. Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study

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    Bockelbrink Angelina

    2010-07-01

    Full Text Available Abstract Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female were included. The most frequent diagnoses were hypertension (11.1%, breast cancer (3.5%, and heart failure (3.0%. In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic. The adjusted odds ratio (AOR for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79, treatment by an internist (AOR = 1.49; CI: 1.40-1.58, female patients (AOR = 1.35; CI: 1.27-1.43, cancer (AOR = 4.54; CI: 4.12-4.99, arthropathies (AOR = 1.36; CI: 1.19-1.55, or dorsopathies (AOR = 1.34; CI: 1.16-1.55 and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98. The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39, diabetes mellitus (AOR = 0.17; CI: 0

  4. Species distribution and susceptibility profile of yeasts isolated from blood cultures: results of a multicenter active laboratory-based surveillance study in Argentina.

    Science.gov (United States)

    Córdoba, Susana; Vivot, Walter; Bosco-Borgeat, Maria E; Taverna, Constanza; Szusz, Wanda; Murisengo, Omar; Isla, Guillermina; Davel, Graciela

    2011-01-01

    The Mycology Department of the Instituto Nacional de Enfermedades Infecciosas "Dr. C. Malbrán", conducted the Second National Multicenter Survey on Fungemia due to Yeasts in Argentina. The aim was to obtain updated data of the frequency of the causative species encountered and their in vitro susceptibility to seven antifungal agents. Yeast species were identified by micromorphological and biochemical studies. Antifungal susceptibility testing was performed by the reference microdilution method E.Def 7.1 of the European Committee on Antibiotic Susceptibility Testing (EUCAST). A total of 461 viable yeasts were identified. The most frequent species were: Candida albicans (38.4 %), Candida parapsilosis (26 %), Candida tropicalis (15.4 %) and Candida glabrata (4.3 %). Other uncommon species, such as Candida viswanathii (0.6 %), Candida haemulonii (0.4 %), Candida inconspicua (0.2 %) and Candida fermentati (0.2 %) were also isolated. Among the Candida spp., 5.4 % and 1.6 % were resistant to fluconazole and voriconazole, respectively. Itraconazole and caspofungin were the most efficient agents against all Candida spp. tested (MIC 8 mg/l), 75 % of Trichosporon spp., and 100 % of Rhodotorula spp., Geotrichum candidum, Saccharomyces cerevisiae. The global percentage of mortality was 20 %. The presence of uncommon species reinforces the need for performing continuous laboratory surveillance in order to monitor possible changes, not only in the epidemiological distribution of species, but also in the resistance to antifungal drugs.

  5. Risk and timing of biochemical recurrence in pT3aN0/Nx prostate cancer with positive surgical margin - A multicenter study.

    Science.gov (United States)

    Karl, Alexander; Buchner, Alexander; Tympner, Christiane; Kirchner, Thomas; Ganswindt, Ute; Belka, Claus; Ganzer, Roman; Wieland, Wolf; Eder, Fabian; Hofstädter, Ferdinand; Schilling, David; Sievert, Karl-Dietrich; Stenzl, Arnulf; Scharpf, Marcus; Fend, Falko; Vom Dorp, Frank; Rübben, Herbert; Schmid, Kurt Werner; Porres-Knoblauch, Daniel; Heidenreich, Axel; Hangarter, Birgit; Knüchel-Clarke, Ruth; Rogenhofer, Michael; Wullich, Bernd; Hartmann, Arndt; Comploj, Evi; Pycha, Armin; Hanspeter, Esther; Pehrke, Dirk; Sauter, Guido; Graefen, Markus; Gratzke, Christian; Stief, Christian; Wiegel, Thomas; Haese, Alexander

    2015-07-01

    Positive surgical margins (PSM) after radical prostatectomy have been shown to be associated with impaired outcome. In pT3pN0 patients with PSM either immediate radiotherapy or clinical and biological monitoring followed by salvage radiotherapy is recommended by the latest guidelines of the European Association of Urology. A retrospective, multicenter study of eight urological centers was conducted on 536 prostatectomy patients with pT3aN0/NxR1 tumors and no neoadjuvant/adjuvant therapy. A pathological re-review of all prostate specimens was performed. Association of clinical and pathological features with biochemical recurrence (BCR) was analyzed using univariate and multivariate analysis. With 48months median follow-up, BCR occurred in 39.7%. Preoperative PSA value, performance of pelvic lymph node dissection and Gleason score were significantly associated with BCR. In multivariate analysis, Gleason score was the only independent prognostic factor (p<0.001) for BCR. Five-year BCR-free survival rates were 74%, 70%, 38%, and 51% with Gleason score 6, 3+4=7a, 4+3=7b, and 8-10, respectively. In pT3aN0/NxR1 patients with no adjuvant/neoadjuvant treatment, Gleason Score permits independent prediction of the risk for BCR. These findings could help to estimate and discuss the individual risk for BCR with our patients on an individual basis. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  6. Prognostic power of abnormal cytogenetics for multiple myeloma:a multicenter study in China

    Institute of Scientific and Technical Information of China (English)

    LAI Yue-yun; FU Wei-ling; GUO Hai-ying; HOU Ming; HOU Jian; HU Yu; HU Xiao-tong; HU Xiao-mei; HUANG Li-qiang; JIN Jie; LI Jian-yong; HUANG Xiao-jun; LI Juan; Li Wei; LIANG Ying-min; LIU Ting; LIU Qi-fa; LIU Yan-hui; MAO Ping; OUYANG Jian; QIU Lu-gui; QIU Lin; CAI Zhen; SHAO Chun-kui; SHI Bin; SONG Yong-ping; SUN Zi-min; WANG Qi-shan; WANG Chun; WANG Jian-ming; WANG Yun-shan; WANG Zhao; WU Jian-bo; CAO Xiang-shan; WU Yin-xia; XIA Rui-xiang; XUE Yong-quan; YANG Bao-zhen; YANG Guang; YANG Zheng-lin; YU Li; YUAN Zhong; ZHANG Sheng; ZHANG Yin; CHEN Fang-ping; ZHAO Hong-guo; ZHAO Li; ZHOU Dao-bin; ZOU Shan-hua; ZHU Yun-feng; CHEN Xie-qun; CHEN Bao-an; FANG Mei-yun; FENG Jia-fu

    2012-01-01

    Background Chromosomal abnormalities have been shown to play an important prognostic role in multiple myeloma (MM).tnterphase fluorescence in situ hybridization (i-FISH) has been much more effective to identify cytogenetic aberrations in MM than conventional cytogenetic technique (CC).To clearly determine the cytogenetic features of Chinese MM patients and identify their prognostic implications,we designed a multicenter study based on i-FISH including 672 patients from 52 hospitals in China.Methods All 672 patients were systematically screened for the following genomic aberrations:del(13q).lgHrearrangement,del(p53) and 1q21 amplifications.Results The analysis showed that the chromosomal changes were detected in 22.1% patients by CC and in 82.3%patients by i-FISH.The most common abnormalities by CC were chromosome 1 aberrations (48.4%),-13/13q- (37.6%),hyperdiploidy (36.6%),hypodiploidy (30.1%) and lgH rearrangements (23.7%).The most frequent abnormalities by FISH was del(13q),which was found in 60.4% patients.whereas IgH rearrangement,1q21 amplification and p53 deletions were detected in 57.6%,49.0% and 34.7% cases.respectively.By statistical analysis.-13/13q- by CC was associated with low level of platelet (P=0.015).hyperdiploidy was associated with low level of serum albumin (P=0.028),and lgH rearrangement by FISH was associated with high level of β32 microglobulin (P=0.019).Moreover,1q21 amplification and del(p53) by FlSH conferred a high incidence of progressive disease (PD) after initial therapy.Metaphase detection of lgH rearrangements and chromosome 1 aberrations concurrently was associated with a short progression free survival (PFS)(P=0.036).No significant prognostic implications of other cytogenetic abnormalities were found associated with overall survival and PFS.Conclusions Chinese MM patients had similar cytogenetic abnormalities compared with the previous reported studies.However,the prognostic significance of FISH aberrations

  7. The costs in provision of haemodialysis in a developing country: A multi-centered study

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    Wijesinghe Aruna

    2011-09-01

    % reduction. Conclusions This multi-centered study demonstrated that the costs of haemodialysis in a developing country remained significantly lower compared to developed countries. However, it still places a significant burden on the health care sector, whilst possibility of further cost reduction exists.

  8. An international multicenter study on HIV-1 drug resistance testing by 454 ultra-deep pyrosequencing.

    Science.gov (United States)

    Simen, Birgitte B; Braverman, Michael S; Abbate, Isabella; Aerssens, Jeroen; Bidet, Yannick; Bouchez, Olivier; Gabriel, Christian; Izopet, Jacques; Kessler, Harald H; Stelzl, Evelyn; Di Giallonardo, Francesca; Schlapbach, Ralph; Radonic, Aleksander; Paredes, Roger; Recordon-Pinson, Patricia; Sakwa, James; St John, Elizabeth P; Schmitz-Agheguian, Gudrun G; Metzner, Karin J; Däumer, Martin P

    2014-08-01

    The detection of mutant spectra within the viral quasispecies is critical for therapeutic management of HIV-1 infections. Routine clinical application of ultrasensitive genotyping requires reproducibility and concordance within and between laboratories. The goal of the study was to evaluate a new protocol on HIV-1 drug resistance testing by 454 ultra-deep pyrosequencing (454-UDS) in an international multicenter study. Sixteen blinded HIV-1 subtype B samples were provided for 454-UDS as both RNA and cDNA with viral titers of 88,600-573,000 HIV-1 RNA copies/ml. Eight overlapping amplicons spanning protease (PR) codons 10-99 and reverse transcriptase (RT) codons 1-251 were generated using molecular barcoded primers. 454-UDS was performed using the 454 Life Sciences/Roche GS FLX platform. PR and RT sequences were analyzed using 454 Life Sciences Amplicon Variant Analyzer (AVA) software. Quantified variation data were analyzed for intra-laboratory reproducibility and inter-laboratory concordance. Routine population sequencing was performed using the ViroSeq HIV-1 genotyping system. Eleven laboratories and the reference laboratory 454 Life Sciences sequenced the HIV-1 sample set. Data presented are derived from seven laboratories and the reference laboratory since severe study protocol execution errors occurred in four laboratories leading to exclusion. The median sequencing depth across all sites was 1364 reads per position (IQR=809-2065). 100% of the ViroSeq-reported mutations were also detected by 454-UDS. Minority HIV-1 drug resistance mutations, defined as HIV-1 drug resistance mutations identified at frequencies of 1-25%, were only detected by 454-UDS. Analysis of 10 preselected majority and minority mutations were consistently found across sites. The analysis of drug-resistance mutations detected between 1 and 10% demonstrated high intra- and inter-laboratory consistency in frequency estimates for both RNA and prepared cDNA samples, indicating robustness of the

  9. Outcomes of stereotactic radiosurgery for foramen magnum meningiomas: an international multicenter study.

    Science.gov (United States)

    Mehta, Gautam U; Zenonos, Georgios; Patibandla, Mohana Rao; Lin, Chung Jung; Wolf, Amparo; Grills, Inga; Mathieu, David; McShane, Brendan; Lee, John Y; Blas, Kevin; Kondziolka, Douglas; Lee, Cheng-Chia; Lunsford, L Dade; Sheehan, Jason P

    2017-09-01

    OBJECTIVE Meningiomas are the most common benign extramedullary lesions of the foramen magnum; however, their optimal management remains undefined. Given their location, foramen magnum meningiomas (FMMs) can cause significant morbidity, and complete microsurgical removal can be challenging. Anterior and anterolateral FMMs carry greater risks with surgery, but they comprise the majority of these lesions. As an alternative to resection, stereotactic radiosurgery (SRS) has been used to treat FMMs in small case series. To more clearly define the outcomes of SRS and to delineate a rational management paradigm for these lesions, the authors analyzed the safety and efficacy of SRS for FMM in an international multicenter trial. METHODS Seven medical centers participating in the International Gamma Knife Research Foundation (IGKRF) provided data for this retrospective cohort study. Patients who were treated with Gamma Knife radiosurgery and whose clinical and radiological follow-up was longer than 6 months were eligible for study inclusion. Data from pre- and post-SRS radiological and clinical evaluations were analyzed. Stereotactic radiosurgery treatment variables were recorded. RESULTS Fifty-seven patients (39 females and 18 males, with a median age of 64 years) met the study inclusion criteria. Thirty-two percent had undergone prior microsurgical resection. Patients most frequently presented with cranial neuropathy (39%), headache (35%), numbness (32%), and ataxia (30%). Median pre-SRS tumor volume was 2.9 cm(3). Median SRS margin dose was 12.5 Gy (range 10-16 Gy). At the last follow-up after SRS, 49% of tumors were stable, 44% had regressed, and 7% had progressed. Progression-free survival rates at 5 and 10 years were each 92%. A greater margin dose was associated with a significantly increased likelihood of tumor regression, with 53% of tumors treated with > 12 Gy regressing. Fifty-two percent of symptomatic patients noted some clinical improvement. Adverse radiation

  10. Outcomes of Second Combination Antiretroviral Therapy Regimens Among HIV-Infected Persons in Clinical Care: A Multicenter Cohort Study

    OpenAIRE

    2013-01-01

    Data on the effectiveness of second-line combination antiretroviral therapy (cART) are limited. We evaluated virologic outcomes of second cART in a multicenter cohort collaboration. The study population initiated first and second modern cART between 1996 and 2010. The second cART required a switch in at least the anchor agent of first cART. We evaluated time to virologic failure of second cART and factors associated with greater risk of failure using multivariable Cox proportional hazards mod...

  11. A Prospective Multi-Center Observational Study of Children Hospitalized with Diarrhea in Ho Chi Minh City, Vietnam.

    OpenAIRE

    Thompson, CN; Phan, MV; Hoang, NV; Minh, PV; Vinh, NT; Thuy, CT; Nga, TT; Rabaa, MA; Duy, PT; Dung, TT; Phat, VV; Nga, TV; Tu, leTP; Tuyen, HT; K. Yoshihara

    2015-01-01

    : We performed a prospective multicenter study to address the lack of data on the etiology, clinical and demographic features of hospitalized pediatric diarrhea in Ho Chi Minh City (HCMC), Vietnam. Over 2,000 (1,419 symptomatic and 609 non-diarrheal control) children were enrolled in three hospitals over a 1-year period in 2009-2010. Aiming to detect a panel of pathogens, we identified a known diarrheal pathogen in stool samples from 1,067/1,419 (75.2%) children with diarrhea and from 81/609 ...

  12. Hospital admissions for hypertensive crisis in the emergency departments: a large multicenter Italian study.

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    Giuliano Pinna

    Full Text Available Epidemiological data on the impact of hypertensive crises (emergencies and urgencies on referral to the Emergency Departments (EDs are lacking, in spite of the evidence that they may be life-threatening conditions. We performed a multicenter study to identify all patients aged 18 years and over who were admitted to 10 Italian EDs during 2009 for hypertensive crises (systolic blood pressure ≥220 mmHg and/or diastolic blood pressure ≥120 mmHg. We classified patients as affected by either hypertensive emergencies or hypertensive urgencies depending on the presence or the absence of progressive target organ damage, respectively. Logistic regression analysis was then performed to assess variables independently associated with hypertensive emergencies with respect to hypertensive urgencies. Of 333,407 patients admitted to the EDs over the one-year period, 1,546 had hypertensive crises (4.6/1,000, 95% CI 4.4-4.9, and 23% of them had unknown hypertension. Hypertensive emergencies (n = 391, 25.3% of hypertensive crises were acute pulmonary edema (30.9%, stroke (22.0%,, myocardial infarction (17.9%, acute aortic dissection (7.9%, acute renal failure (5.9% and hypertensive encephalopathy (4.9%. Men had higher frequency than women of unknown hypertension (27.9% vs 18.5%, p<0.001. Even among known hypertensive patients, a larger proportion of men than women reported not taking anti-hypertensive drug (12.6% among men and 9.4% among women (p<0.001. Compared to women of similar age, men had higher likelihood of having hypertensive emergencies than urgencies (OR = 1.34, 95% CI 1.06-1.70, independently of presenting symptoms, creatinine, smoking habit and known hypertension. This study shows that hypertensive crises involved almost 5 out of 1,000 patients-year admitted to EDs. Sex differences in frequencies of unknown hypertension, compliance to treatment and risk of hypertensive emergencies might have implications for public health programs.

  13. Italian multicenter study on low-density lipoprotein apheresis Working Group 2009 survey.

    Science.gov (United States)

    Stefanutti, Claudia; Morozzi, Claudia; Di Giacomo, Serafina

    2013-04-01

    We present results of the second survey of the Italian Multicenter Study on Low-Density Lipoprotein Apheresis (IMSLDLa-WG/2). The study involved 18 centers in 2009, treating 66 males and 35 females, mean age 47 ± 18 years. Mean age for initiation of drug treatment before low-density lipoprotein apheresis (LDLa) was 31 ± 18 years, mean age to the first LDLa was 37 ± 20 years and average duration of treatment was 9 ± 6 years. The techniques used included direct adsorption of lipids, dextran sulfate cellulose adsorption, heparin-mediated low-density lipoprotein (LDL) precipitation, cascade filtration, and plasma exchange. The mean treated plasma/blood volumes/session were 3127 ± 518 mL and 8666 ± 1384 mL, respectively. The average plasma volume substituted was 3500 ± 300 mL. Lipid therapy before LDLa included ezetimibe, statins, ω-3 fatty acids and fenofibrate. Baseline mean LDL cholesterol (LDLC) levels were 386 ± 223 mg/dL. The mean before/after apheresis LDLC level decreased by 67% from 250 ± 108 mg/dL (P = 0.05 vs. baseline) to 83 ± 37 mg/dL (P = 0.001 vs. before). Baseline mean Lipoprotein(a) [Lp(a)] level was 179 ± 136 mg/dL. Mean before/after apheresis Lp(a) level decreased by 71% from 133 ± 120 mg/dL (P = 0.05 vs. baseline) to 39 ± 44 mg/dL (P = 0.001 vs. before). Major and minor side effects occurred in 27 and 62 patients, respectively. Among patients with coronary artery disease (CAD), 62.3% had coronary angiography and 50.4% coronary revascularization before LDLa. Single vessel, double vessel and triple vessel CAD occurred in 19 (30.1%), 15 (23.8%) and 29 (46%) patients, respectively. Both CAD and extra-CAD occurred in 41.5%, 39% had hypertension, 9.9% were smokers, 9.9% consumed alcohol and 42% were physically active. Ischemic cardiovascular events were not observed in any patient over 9 ± 6 years of treatment. Two centers have also treated 34 patients (females: 17/males 17; no. sessions: 36; average plasma volume treated: 3000 mL) for

  14. Gamma Knife radiosurgery for sellar and parasellar meningiomas: a multicenter study.

    Science.gov (United States)

    Sheehan, Jason P; Starke, Robert M; Kano, Hideyuki; Kaufmann, Anthony M; Mathieu, David; Zeiler, Fred A; West, Michael; Chao, Samuel T; Varma, Gandhi; Chiang, Veronica L S; Yu, James B; McBride, Heyoung L; Nakaji, Peter; Youssef, Emad; Honea, Norissa; Rush, Stephen; Kondziolka, Douglas; Lee, John Y K; Bailey, Robert L; Kunwar, Sandeep; Petti, Paula; Lunsford, L Dade

    2014-06-01

    Parasellar and sellar meningiomas are challenging tumors owing in part to their proximity to important neurovascular and endocrine structures. Complete resection can be associated with significant morbidity, and incomplete resections are common. In this study, the authors evaluated the outcomes of parasellar and sellar meningiomas managed with Gamma Knife radiosurgery (GKRS) both as an adjunct to microsurgical removal or conventional radiation therapy and as a primary treatment modality. A multicenter study of patients with benign sellar and parasellar meningiomas was conducted through the North American Gamma Knife Consortium. For the period spanning 1988 to 2011 at 10 centers, the authors identified all patients with sellar and/or parasellar meningiomas treated with GKRS. Patients were also required to have a minimum of 6 months of imaging and clinical follow-up after GKRS. Factors predictive of new neurological deficits following GKRS were assessed via univariate and multivariate analyses. Kaplan-Meier analysis and Cox multivariate regression analysis were used to assess factors predictive of tumor progression. The authors identified 763 patients with sellar and/or parasellar meningiomas treated with GKRS. Patients were assessed clinically and with neuroimaging at routine intervals following GKRS. There were 567 females (74.3%) and 196 males (25.7%) with a median age of 56 years (range 8-90 years). Three hundred fifty-five patients (50.7%) had undergone at least one resection before GKRS, and 3.8% had undergone prior radiation therapy. The median follow-up after GKRS was 66.7 months (range 6-216 months). At the last follow-up, tumor volumes remained stable or decreased in 90.2% of patients. Actuarial progression-free survival rates at 3, 5, 8, and 10 years were 98%, 95%, 88%, and 82%, respectively. More than one prior surgery, prior radiation therapy, or a tumor margin dose Gamma Knife radiosurgery provides a high rate of tumor control for patients with

  15. [Multicenter Ozurdex® assessment for diabetic macular edema: MOZART study].

    Science.gov (United States)

    Guigou, S; Hajjar, C; Parrat, E; Merite, P Y; Pommier, S; Matonti, F; Prost-Magnin, O; Meyer, F

    2014-06-01

    To evaluate the efficiency and safety of intravitreal implant of 0.7mg dexamathasone in visual impairment due to diabetic macular edema (DME). This was a retrospective, multicenter, study. Seventy-four patients, with a mean age of 65 years, followed for at least 6 months (mean follow-up: 9.8 months) were included in 5 French eye clinics (P 1.5 collective). The mean systolic blood pressure was 138mmHg and the mean HbA1c was 7.2%. We monitored 2 systemic parameters: blood pressure and glycemic balance. Best-corrected visual acuity (BCVA), central retinal thickness (CRT, Spectralis OCT), intraocular pressure (IOP) and cataract progression are studied at baseline and then at 1, 2, 4 and 6 months. The average CRT decrease was: 239μm at month 2 (M2) and 135μm at month 6 (M6). The mean improvement from baseline of BCVA is 8.5 letters at M2 and 7.6 letters at M6. A gain greater than 15 letters is found in 27% of patients at M6. For naive patients the BCVA is 71 letters versus 60 letters (P<0.05). Patients with a baseline CRT <500mmHg have a BCVA of 66 letters versus 57 letters (P<0.05). The mean rate injections was 1.2 at 6 months with an average of 5.4 months for reinjection. Ocular hypertension greater than 25mmHg, managed by topical treatment, is observed in 13.4% of patients. No glaucoma surgery was necessary. Dexamethasone has an anatomical and functional effectiveness in the treatment of DME. Outcomes for naive patients and lower CRT suggest that the duration of diabetes mellitus and previous treatments are negative factors of recovery. Side effects are rare and manageable. Ozurdex(®) seems to be a treatment for visual impairment due to DME with a favorable safety profile. Patient follow-up must be adapted to half-life of the product with a control before M1 (intraocular pressure) and before M5 (DME recurrence, BCVA). Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  16. Multicenter prospective study of magnetic resonance imaging prior to breast-conserving surgery for breast cancer

    Institute of Scientific and Technical Information of China (English)

    Liu Qian; Liu Yinhua; Xu Ling; Duan Xuening; Li Ting; Qin Naishan; Kang Hua

    2014-01-01

    Background This multicenter prospective study aimed to assess the utility of dynamic enhanced magnetic resonance imaging (MRI) prior to breast-conserving surgery for breast cancer.Methods The research subjects were drawn from patients with primary early resectable breast cancer treated in the breast disease centers of six three-level hospitals in Beijing from 1 January 2010 to 31 December 2012.The participants were allocated to a breast-conserving surgery group (breast-conserving group) or a total mastectomy group (total mastectomy group).Enhanced MRI was used to measure breast volume,longest diameter of tumor and tumor volume.The correlations between these measurements and those derived from histopathologic findings were assessed.The relationships between the success rate of breast-conserving surgery and MRI-and pathology-based measurement results were statistically analyzed in the breast-conserving group.Results The study included 461 cases in the total mastectomy group and 195 in the breast-conserving group.Allocation to these groups was based on clinical indications and patient preferences.The cut-off for concurrence between MRI-and pathology-based measurements of the longest diameter of tumor was set at 0.3 cm.In the total mastectomy group,the confidence interval for 95% concurrence of these measurements was 35.41%-44.63%.Correlation coefficients for MRI and histopathology-based measurements of breast volume,tumor volume and tumor volume/breast volume ratio were r=0.861,0.569,and 0.600,respectively (all P <0.001).In the breast-conserving group,with 0.30 cm taken as the cut-off for concurrence,the 95% confidence interval for MRI and pathology-based measurements of the longest diameter of tumor was 29.98%-44.01%.The subjective and objective success rates for breast-conserving surgery were 100% and 88.54%,respectively.Conclusions There were significant correlations between dynamic enhanced MRI-and histopathology-based measurements of the longest

  17. Nosocomial acquisition of methicillin-resistant Staphyloccocus aureus (MRSA and extended-spectrum beta-lactamase (ESBL Enterobacteriaceae in hospitalised patients: a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    De Angelis Giulia

    2012-03-01

    Full Text Available Abstract Background The risk of acquisition of antibiotic resistant-bacteria during or shortly after antibiotic therapy is still unclear and it is often confounded by scarce data on antibiotic usage. Primary objective of the study is to compare rates of acquisition of methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae in hospitalised patients, after starting antibiotic therapy. Methods/Design The study, running in three European hospitals, is a multicenter, prospective, longitudinal, observational cohort study funded from the European Community's Seventh Framework Programme [FP7/2007-2013] within the project 'Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria' (acronym SATURN. Nasal and rectal screening for methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae will be obtained at hospital admission, discharge, at antibiotic start (t0, within one hour and at the following intervals: day 3 (t1, 7 (t2, 15 (t3, and 30 (t4. Two nested case-control studies will be performed. The objective of the first study will be to define individual level of risk related to specific antibiotics. Patients acquiring methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae (cases will be compared with patients not acquiring antibiotic-resistant strains after starting antibiotic therapy (controls; ratio 1:4. To define the impact of antibiotics on new acquisition of target antibiotic-resistant bacteria, a second nested case-control study will be done (ratio 1:4. Control group will be selected among patients not receiving antibiotics, admitted in the same ward on the day of the corresponding case, with negative cultures at admission. Epidemiological, clinical and microbiological data will be prospective collected. Discussion The rationale of this study is to better

  18. Are Teachers Ready for CLIL? Evidence from a European Study

    Science.gov (United States)

    Pérez Cañado, María Luisa

    2016-01-01

    This article presents the outcomes of a European study on the main training needs which pre- and in-service teachers, teacher trainers, and coordinators consider they have in order to adapt to a bilingual education model. The macro-study has designed, validated and administered four sets of questionnaires to 706 informants across the whole of…

  19. Are Teachers Ready for CLIL? Evidence from a European Study

    Science.gov (United States)

    Pérez Cañado, María Luisa

    2016-01-01

    This article presents the outcomes of a European study on the main training needs which pre- and in-service teachers, teacher trainers, and coordinators consider they have in order to adapt to a bilingual education model. The macro-study has designed, validated and administered four sets of questionnaires to 706 informants across the whole of…

  20. Cutaneous Invasive Aspergillosis: Retrospective Multicenter Study of the French Invasive-Aspergillosis Registry and Literature Review.

    Science.gov (United States)

    Bernardeschi, Céline; Foulet, Francoise; Ingen-Housz-Oro, Saskia; Ortonne, Nicolas; Sitbon, Karine; Quereux, Gaëlle; Lortholary, Olivier; Chosidow, Olivier; Bretagne, Stéphane

    2015-07-01

    Invasive aspergillosis (IA) has poor prognosis in immunocompromised patients. Skin manifestations, when present, should contribute to an early diagnosis. The authors aimed to provide prevalence data and a clinical and histologic description of cutaneous manifestations of primary cutaneous IA (PCIA) and secondary CIA (SCIA) in a unique clinical series of IA and present the results of an exhaustive literature review of CIA. Cases of proven and probable IA with cutaneous manifestations were retrospectively extracted from those registered between 2005 and 2010 in a prospective multicenter aspergillosis database held by the National Reference Center for Invasive Mycoses and Antifungals, Pasteur Institute, France. Patients were classified as having PCIA (i.e., CIA without extracutaneous manifestations) or SCIA (i.e., disseminated IA). Among the 1,410 patients with proven or probable IA, 15 had CIA (1.06%), 5 PCIA, and 10 SCIA. Hematological malignancies were the main underlying condition (12/15). Patients with PCIA presented infiltrated and/or suppurative lesions of various localizations not related to a catheter site (4/5), whereas SCIA was mainly characterized by disseminated papules and nodules but sometimes isolated nodules or cellulitis. Histologic data were available for 11 patients, and for 9, similar for PCIA and SCIA, showed a dense dermal polymorphic inflammatory infiltrate, with the epidermis altered in PCIA only. Periodic acid Schiff and Gomori-Grocott methenamine silver nitrate staining for all but 2 biopsies revealed hyphae compatible with Aspergillus. Aspergillus flavus was isolated in all cases of PCIA, with Aspergillus fumigatus being the most frequent species (6/10) in SCIA. Two out 5 PCIA cases were treated surgically. The 3-month survival rate was 100% and 30% for PCIA and SCIA, respectively. Our study is the largest adult series of CIA and provides complete clinical and histologic data for the disease. Primary cutaneous IA should be recognized early

  1. Clinical presentation and visual status of retinitis pigmentosa patients: a multicenter study in southwestern Nigeria

    Directory of Open Access Journals (Sweden)

    Onakpoya OH

    2016-08-01

    Full Text Available Oluwatoyin Helen Onakpoya,1 Caroline Olufunlayo Adeoti,2 Tunji Sunday Oluleye,3 Iyiade Adeseye Ajayi,4 Timothy Majengbasan,4,5 Olayemi Kolawole Olorundare1 1Department of Ophthalmology, Obafemi Awolowo University Teaching Hospital, Ile-Ife, 2Department of Ophthalmology, Ladoke Akintola University of Technology Teaching Hospital, Osogbo, 3Department of Ophthalmology, University College Hospital, Ibadan, 4Department of Ophthalmology, University Teaching Hospital, Ado-Ekiti, 5Department of Ophthalmology, Federal Medical Centre, Ido-Ekiti, Nigeria Background: To review the visual status and clinical presentation of patients with retinitis pigmentosa (RP.Methodology: Multicenter, retrospective, and analytical review was conducted of the visual status and clinical characteristics of patients with RP at first presentation from January 2007 to December 2011. Main outcome measure was the World Health Organization’s visual status classification in relation to sex and age at presentation. Data analysis by SPSS (version 15 and statistical significance was assumed at P<0.05.Results: One hundred and ninety-two eyes of 96 patients with mean age of 39.08±18.5 years and mode of 25 years constituted the study population; 55 (57.3% were males and 41 (42.7% females. Loss of vision 67 (69.8% and night blindness 56 (58.3% were the leading symptoms. Twenty-one (21.9% patients had a positive family history, with RP present in their siblings 15 (71.4%, grandparents 11 (52.3%, and parents 4 (19.4%. Forty (41.7% were blind at presentation and 23 (24% were visually impaired. Blindness in six (15% patients was secondary to glaucoma. Retinal vascular narrowing and retinal pigmentary changes of varying severity were present in all patients. Thirty-five (36.5% had maculopathy, 36 (37.5% refractive error, 19 (20% lenticular opacities, and eleven (11.5% had glaucoma. RP was typical in 85 patients (88.5%. Older patients had higher rates of blindness at presentation (P=0

  2. Differential diagnosis of fetal hyperechogenic cystic kidneys unrelated to renal tract anomalies: A multicenter study.

    Science.gov (United States)

    Chaumoitre, K; Brun, M; Cassart, M; Maugey-Laulom, B; Eurin, D; Didier, F; Avni, E F

    2006-12-01

    To identify important factors in the differential diagnosis of renal cysts associated with hyperechogenic kidneys. This was a retrospective multicenter study. We identified 93 fetuses presenting between 1990 and 2002 with hyperechogenic kidneys and which had a diagnosis of nephropathy confirmed later. We analyzed retrospectively the prenatal ultrasound findings of those fetuses which were found sonographically to have renal cysts. Of the 93 fetuses presenting with hyperechogenic kidneys and with a later diagnosis of nephropathy, there were 28 with autosomal dominant polycystic kidney disease (ADPKD), 31 with autosomal recessive polycystic kidney disease (ARPKD), 11 with Bardet-Biedl syndrome, nine with Meckel-Gruber syndrome, six with Ivemark II syndrome, one with Jarcho-Levin syndrome, one with Beemer syndrome and one with Meckel-like syndrome. One third of the fetuses (30/93) had renal cysts. Cystic characteristics (size, location, number) were not very useful for diagnosis; more useful was diagnosis of an associated malformation. Three (11%) of the fetuses with ADPKD had cysts, as did nine (29%) of those with ARPKD, three (27%) of those with Bardet-Biedl syndrome, all (100%) of those with Meckel-Gruber syndrome, three (50%) of those with Ivemark II syndrome, and each of the three cases with other syndromes (Jarcho-Levin, Beemer and Meckel-like syndromes). None of the cases with trisomy 13 had cysts. There were no associated malformations in the 12 cases with renal cysts and polycystic kidney disease; the other 18 cases with renal cysts were associated with malformations that were often specific, such as polydactyly in Bardet-Biedl and Beemer syndromes, occipital defect and Dandy-Walker malformation in Meckel-Gruber or Meckel-Gruber-like syndromes, and thoracic and/or vertebral abnormalities in Jarcho-Levin and Beemer syndromes. Renal cysts associated with hyperechogenic kidneys are not rare. The clue to diagnosis is the demonstration of an associated

  3. Stability of R2* and quantitative susceptibility mapping of the brain tissue in a large scale multi-center study

    Science.gov (United States)

    Wang, Rongpin; Xie, Guangyou; Zhai, Maoxiong; Zhang, Zhongping; Wu, Bing; Zheng, Dandan; Hong, Nan; Jiang, Tao; Wen, Baohong; Cheng, Jingliang

    2017-01-01

    Multi-center studies are advantageous for enrolling participants of varying pathological and demographical conditions, and especially in neurological studies. Hence stability of the obtained quantitative R2* and susceptibility in multicenter studies is a key issue for their widespread applications. In this work, the stabilities of simultaneously obtained R2* and susceptibility are investigated and compared across 10 sites that are equipped with the same scanner and receiver coil, the same post-processing process was used to achieve consistent experiment setup. Two healthy adult volunteers (one male and female) participated in this study. High intraclass correlation coefficient was obtained for both susceptibility (0.94) and R2* (0.96). The coefficients of variance for all measurements obtained were smaller than 0.1, the largest variations of measurements in all the chosen ROIs fall within ±20% from the median value. Higher level of stability was obtained in R2* as compared to susceptibility at 1 mm resolution (P < 0.05) and at 1.5 mm (P < 0.01). PMID:28349957

  4. Research Strategies in European Union Studies

    DEFF Research Database (Denmark)

    Manners, Ian James; Lynggaard, Kennet; Löfgren, Karl

    2015-01-01

    The contributing chapters of this book all illustrate the richness and diversity of problem-driven research in EU studies. This concluding chapter draws together the insights of this rich diversity in order to move the study of research strategies beyond the dichotomies of the past towards a new ...... of demonstrating the methods and evidence used. A new agenda for research on Europe needs to acknowledge these weaknesses of the past and move beyond dichotomies towards greater awareness and openesss of the importance of research strategies, designs and methods.......The contributing chapters of this book all illustrate the richness and diversity of problem-driven research in EU studies. This concluding chapter draws together the insights of this rich diversity in order to move the study of research strategies beyond the dichotomies of the past towards a new...

  5. Research Methods in European Union Studies

    DEFF Research Database (Denmark)

    Research methods and designs from the social sciences and beyond can, and should, be applied in research directed at EU affairs. The purpose of this edited collection is twofold: (1) to provide a state-of-the-art examination of social science research methods in EU studies and (2) to provide...... innovative guidelines to the advancement of more inclusive and empirically sensitive research methods in EU studies....

  6. Central Nervous System Idiopathic Inflammatory Demyelinating Disorders in South Americans: A Descriptive, Multicenter, Cross-Sectional Study.

    Directory of Open Access Journals (Sweden)

    Regina Maria Papais-Alvarenga

    Full Text Available The idiopathic inflammatory demyelinating disease (IIDD spectrum has been investigated among different populations, and the results have indicated a low relative frequency of neuromyelitis optica (NMO among multiple sclerosis (MS cases in whites (1.2%-1.5%, increasing in Mestizos (8% and Africans (15.4%-27.5% living in areas of low MS prevalence. South America (SA was colonized by Europeans from the Iberian Peninsula, and their miscegenation with natives and Africans slaves resulted in significant racial mixing. The current study analyzed the IIDD spectrum in SA after accounting for the ethnic heterogeneity of its population. A cross-sectional multicenter study was performed. Only individuals followed in 2011 with a confirmed diagnosis of IIDD using new diagnostic criteria were considered eligible. Patients' demographic, clinical and laboratory data were collected. In all, 1,917 individuals from 22 MS centers were included (73.7% female, 63.0% white, 28.0% African, 7.0% Mestizo, and 0.2% Asian. The main disease categories and their associated frequencies were MS (76.9%, NMO (11.8%, other NMO syndromes (6.5%, CIS (3.5%, ADEM (1.0%, and acute encephalopathy (0.4%. Females predominated in all main categories. The white ethnicity also predominated, except in NMO. Except in ADEM, the disease onset occurred between 20 and 39 years old, early onset in 8.2% of all cases, and late onset occurred in 8.9%. The long-term morbidity after a mean disease time of 9.28±7.7 years was characterized by mild disability in all categories except in NMO, which was scored as moderate. Disease time among those with MS was positively correlated with the expanded disability status scale (EDSS score (r=0.374; p=<0.001. This correlation was not observed in people with NMO or those with other NMO spectrum disorders (NMOSDs. Among patients with NMO, 83.2% showed a relapsing-remitting course, and 16.8% showed a monophasic course. The NMO-IgG antibody tested using indirect

  7. Central Nervous System Idiopathic Inflammatory Demyelinating Disorders in South Americans: A Descriptive, Multicenter, Cross-Sectional Study

    Science.gov (United States)

    Papais-Alvarenga, Regina Maria; Vasconcelos, Claudia Cristina Ferreira; Carra, Adriana; de Castillo, Ibis Soto; Florentin, Sara; Diaz de Bedoya, Fernando Hamuy; Mandler, Raul; de Siervi, Luiza Campanella; Pimentel, Maria Lúcia Vellutini; Alvarenga, Marina Papais; Papais Alvarenga, Marcos; Grzesiuk, Anderson Kuntz; Gama Pereira, Ana Beatriz Calmon; Gomes Neto, Antonio Pereira; Velasquez, Carolina; Soublette, Carlos; Fleitas, Cynthia Veronica; Diniz, Denise Sisteroli; Armas, Elizabeth; Batista, Elizabeth; Hernandez, Freda; Pereira, Fernanda Ferreira Chaves da Costa; Siqueira, Heloise Helena; Cabeça, Hideraldo; Sanchez, Jose; Brooks, Joseph Bruno Bidin; Gonçalves, Marcus Vinicius; Barroso, Maria Cristina Del Negro; Ravelo, Maria Elena; Castillo, Maria Carlota; Ferreira, Maria Lúcia Brito; Rocha, Maria Sheila Guimarães; Parolin, Monica Koncke Fiuza; Molina, Omaira; Marinho, Patricia Beatriz Christino; Christo, Paulo Pereira; Brant de Souza, Renata; Pessanha Neto, Silvio; Camargo, Solange Maria das Graças; Machado, Suzana Costa; Neri, Vanderson Carvalho; Fragoso, Yara Dadalti; Alvarenga, Helcio; Thuler, Luiz Claudio Santos

    2015-01-01

    The idiopathic inflammatory demyelinating disease (IIDD) spectrum has been investigated among different populations, and the results have indicated a low relative frequency of neuromyelitis optica (NMO) among multiple sclerosis (MS) cases in whites (1.2%-1.5%), increasing in Mestizos (8%) and Africans (15.4%-27.5%) living in areas of low MS prevalence. South America (SA) was colonized by Europeans from the Iberian Peninsula, and their miscegenation with natives and Africans slaves resulted in significant racial mixing. The current study analyzed the IIDD spectrum in SA after accounting for the ethnic heterogeneity of its population. A cross-sectional multicenter study was performed. Only individuals followed in 2011 with a confirmed diagnosis of IIDD using new diagnostic criteria were considered eligible. Patients’ demographic, clinical and laboratory data were collected. In all, 1,917 individuals from 22 MS centers were included (73.7% female, 63.0% white, 28.0% African, 7.0% Mestizo, and 0.2% Asian). The main disease categories and their associated frequencies were MS (76.9%), NMO (11.8%), other NMO syndromes (6.5%), CIS (3.5%), ADEM (1.0%), and acute encephalopathy (0.4%). Females predominated in all main categories. The white ethnicity also predominated, except in NMO. Except in ADEM, the disease onset occurred between 20 and 39 years old, early onset in 8.2% of all cases, and late onset occurred in 8.9%. The long-term morbidity after a mean disease time of 9.28±7.7 years was characterized by mild disability in all categories except in NMO, which was scored as moderate. Disease time among those with MS was positively correlated with the expanded disability status scale (EDSS) score (r=0.374; p=<0.001). This correlation was not observed in people with NMO or those with other NMO spectrum disorders (NMOSDs). Among patients with NMO, 83.2% showed a relapsing-remitting course, and 16.8% showed a monophasic course. The NMO-IgG antibody tested using indirect

  8. Case study: Teaching European Active Citizenship (TEACh)-course, EU

    DEFF Research Database (Denmark)

    Milana, Marcella; Bernt Sorensen, Tore

    2007-01-01

    education. Among these projects, the Teaching European Active Citizenship (TEACh)-course was considered worth of a closer examination due to several reasons. Firstly, the course constitutes a follow-up of a Socrates research project which was co-financed by the European Commission within the same action....... The case study presented here is based on results from desk research and field work carried out over 9 months (autumn 2006-summer 2007). Data was collected by a combination of qualitative methods. The main source of information was participant observation at the TEACh course held in Milan (Italy...

  9. A 2-YEAR FOLLOW-UP OF BABIES ENROLLED IN A EUROPEAN MULTICENTER TRIAL OF PORCINE SURFACTANT REPLACEMENT FOR SEVERE NEONATAL RESPIRATORY-DISTRESS SYNDROME

    NARCIS (Netherlands)

    ROBERTSON, B; CURSTEDT, T; TUBMAN, R; STRAYER, D; BERGGREN, P; KOK, J; KOPPE, J; VANSONDEREN, L; HALLIDAY, H; MCCLURE, G; REID, M; OETEMO, SB; Okken, A; SPEER, C; SCHROTER, W; SVENNINGSEN, N; WALTI, H; RELIER, JP

    1992-01-01

    The postnatal growth, respiratory status and neurodevelopmental outcome of surviving babies enrolled in the first European multicentre trial of porcine surfactant (Curosurf) replacement for severe neonatal respiratory distress syndrome, were assessed at corrected ages of 1 and 2 years. Follow up rat

  10. A 10-year follow-up of the European multicenter trial of interferon beta-1b in secondary-progressive multiple sclerosis

    NARCIS (Netherlands)

    Kuhle, J.; Hardmeier, M.; Disanto, G.; Gugleta, K.; Ecsedi, M.; Lienert, C.; Amato, M. P.; Baum, K.; Buttmann, M.; Bayas, A.; Brassat, D.; Brochet, B.; Confavreux, C.; Edan, G.; Farkkila, M.; Fredrikson, S.; Frontoni, M.; D'Hooghe, M.; Hutchinson, M.; De Keyser, J.; Kieseier, B. C.; Kuempfel, T.; Rio, J.; Polman, C.; Roullet, E.; Stolz, C.; Vass, K.; Wandinger, K. P.; Kappos, L.

    2016-01-01

    Objectives: To explore long-term effects of treatment and prognostic relevance of variables assessed at baseline and during the European secondary progressive multiple sclerosis (SPMS) trial of interferon beta 1b (IFNB-1b). Methods: We assessed 362 patients (60% female; median age 41 years; Expanded

  11. Sexual function in adult patients with classic bladder exstrophy: A multicenter study.

    Science.gov (United States)

    Park, Weon; Zwink, Nadine; Rösch, Wolfgang H; Schmiedeke, Eberhard; Stein, Raimund; Schmidt, Dominik; Noeker, Meinolf; Jenetzky, Ekkehart; Reutter, Heiko; Ebert, Anne-Karoline

    2015-06-01

    The bladder exstrophy-epispadias complex (BEEC) comprises a spectrum of congenital anomalies that represents the severe end of urorectal malformations, and has a profound impact on continence as well as sexual and renal functions. The relation between severity of BEEC and its associated functional impairments, on one hand, and the resulting restrictions in quality of life and potential psychopathology determine the patients' outcome. It is important for improving further outcome to identify BEEC-related sources of distress in the long term. Genital function and sexuality becomes an important issue for adolescent and adult BEEC individuals. Hence, the present study focused on sexual function and psychological adaption in patients with BEEC. In a multicenter study 52 patients (13 females, 39 males) with classic bladder exstrophy (BE) with their bladders in use were assessed by a self-developed questionnaire about sexual function, and psychosexual and psychosocial outcome. The patients were born between 1948 and 1994 (median age 31 years). Twelve of 13 (92%) females and 25 of 39 (64%) males with classic BE had answered the questions on sexual function. Of these, 50% females and 92% males answered that they masturbated. Females had sexual intercourse more frequently. Six (50%) females affirmed dyspareunia whereas only two (8%) males reported pain during erection. Eight (67%) females specified having orgasms. Eighteen (72%) males were able to ejaculate. Two males and none of the females lived in a committed partnership (Figure). Two (15%) females and 13 (33%) males answered all psychosocial questions. The majority of these patients had concerns about satisfactory sexuality and lasting, happy partnerships. A minority of patients of both sexes were willing to answer psychosocial questions. Sexual activity and relationships of many adult BE patients seems to be impaired. Not surprisingly, sexual activity and awareness were different in males and females even in a multi

  12. Research Strategies in European Union Studies

    DEFF Research Database (Denmark)

    Manners, Ian James; Lynggaard, Kennet; Löfgren, Karl

    2015-01-01

    The contributing chapters of this book all illustrate the richness and diversity of problem-driven research in EU studies. This concluding chapter draws together the insights of this rich diversity in order to move the study of research strategies beyond the dichotomies of the past towards a new...... of demonstrating the methods and evidence used. A new agenda for research on Europe needs to acknowledge these weaknesses of the past and move beyond dichotomies towards greater awareness and openesss of the importance of research strategies, designs and methods....... agenda for research on Europe. The crisis gripping the EU in the 21st century is not just an economic crisis, it is a crisis of belief in the EU. Research on the EU is deeply implicated in this crisis, not least because of the questions it does not ask, but also because of the pereceived weakness...

  13. Solid organ transplantation after allogeneic hematopoietic stem cell transplantation: a retrospective, multicenter study of the EBMT

    DEFF Research Database (Denmark)

    Koenecke, C; Hertenstein, B; Schetelig, J

    2010-01-01

    To analyze the outcome of solid organ transplantation (SOT) in patients who had undergone allogeneic hematopoietic stem cell transplantation (HSCT), a questionnaire survey was carried out within 107 European Group of Blood and Marrow Transplantation centers. This study covered HSCT between 1984...... and 2007 in Europe. Forty-five SOT in 40 patients were reported. Fifteen liver, 15 renal, 13 lung, 1 heart and 1 skin transplantations were performed in 28 centers. Overall survival (OS) of patients after SOT was 78% at 5 years (95% confidence interval [CI], 64% to 92%). OS at 5 years was 100% for renal......, 71% (95% CI, 46% to 96%) for liver and 63% (95% CI, 23% to 100%) for lung transplant recipients. The 2-year-incidence of SOT failure was 20% (95% CI, 4% to 36%) in patients with graft-versus-host disease (GvHD) and 7% (95% CI, 0% to 21%) in patients without GvHD before SOT. The relapse incidence...

  14. Teacher Behavior and Student Outcomes : Results of a European Study

    NARCIS (Netherlands)

    Panayiotou, A.; Kyriakides, L.; Creemers, B.P.M.; McMahon, L.; Vanlaar, G.; Pfeifer, M.; Rekalidou, G.; Bren, M.

    2014-01-01

    This study investigates the extent to which the factors included in the dynamic model of educational effectiveness are associated with student achievement gains in six different European countries. At classroom level, the dynamic model refers to eight factors relating to teacher behavior in the clas

  15. Neonatal bleeding in haemophilia : a European cohort study

    NARCIS (Netherlands)

    Richards, M.; Lissalde, G. Lavigne; Combescure, C.; Batorova, A.; Dolan, G.; Fischer, K.; Klamroth, R.; Lambert, T.; Lopez-Fernandez, M.; Perez, R.; Rocino, A.; Fijnvandraat, K.

    2012-01-01

    Birth is the first haemostatic challenge for a child with haemophilia. Our aim was to examine the association between perinatal risk factors and major neonatal bleeding in infants with haemophilia. This observational cohort study in 12 European haemophilia treatment centres (HTC) incorporated 508 ch

  16. European Union Students Studying in English Higher Education Institutions

    Science.gov (United States)

    Morris, Marian; Rutt, Simon

    2008-01-01

    This study aimed to identify the pathways, intentions and relevant perceptions of (non-UK) European Union (EU) students entering English higher education. It sought to identify why students wished to obtain an English HE qualification, their attitudes towards the uptake and repayment of tuition fee loans and their future career plans. Drawing on…

  17. European Maxillofacial Trauma (EURMAT) project: a multicentre and prospective study

    NARCIS (Netherlands)

    Boffano, P.; Roccia, F.; Zavattero, E.; Dediol, E.; Uglešić, V.; Kovačič, Ž.; Vesnaver, A.; Konstantinović, V.S.; Petrović, M.; Stephens, M.; Kanzaria, A.; Bhatti, N.; Holmes, S.; Pechalova, P.F.; Bakardjiev, A.G.; Malanchuk, V.A.; Kopchak, A.V.; Galteland, P.; Mjøen, E.; Skjelbred, P.; Koudougou, C.; Mouallem, G.; Corre, P.; Løes, S.; Lekven, N.; Laverick, S.; Gordon, P.; Tamme, T.; Akermann, S.; Karagozoglu, K.H.; Kommers, S.C.; Forouzanfar, T.

    2015-01-01

    The purpose of this study was to analyse the demographics, causes and characteristics of maxillofacial fractures managed at several European departments of oral and maxillofacial surgery over one year. The following data were recorded: gender, age, aetiology, site of facial fractures, facial injury

  18. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    Science.gov (United States)

    Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2013-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

  19. Effectiveness and predictors of success of noninvasive ventilation during H1N1 pandemics: a multicenter study.

    Science.gov (United States)

    Nicolini, A; Tonveronachi, E; Navalesi, P; Antonelli, M; Valentini, I; Melotti, R M; Pigna, A; Carrassi, A; Righini, P; Ferrari Bravo, M; Pelosi, P; Nicoli, F; Cosentini, R; Vaschetto, R; Faenza, S; Nava, S

    2012-12-01

    The use of non-invasive ventilation (NIV) in acute hypoxemic respiratory failure (AHRF) due to H1N1 virus infection is controversial. In this multicenter study we aimed to assess the efficacy of NIV in avoiding endotracheal intubation (ETI) and to identify predictors of success or failure. In this prospective multicenter study, 98 patients with new pulmonary infiltrate(s) sustained by H1N1 virus and a PaO(2)/FiO2intubated after 5.8+5.5 hours from enrolment. The remaining 47/60 patients were successfully ventilated with NIV. Hospital mortality was significantly higher in those patients who failed NIV vs. those who succeeded (53.8% vs. 2.1%; OR=0.52, P29 and a PaO(2)/FIO(2)≤127 at admission and PaO2/FIO(2)≤149 after 1 hr of NIV were independently associated with the need for ETI. The early application of NIV, with the aim to avoid invasive ventilation, during the H1N1 pandemics was associated with an overall success rate of 47/98 (48%). Patients presenting at admission with an high SAPS II score and a low PaO(2)/FiO(2) ratio and/or unable to promptly correct gas exchange are at high risk of intubation and mortality.

  20. Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

    Science.gov (United States)

    Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

    2009-11-01

    The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

  1. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study - PRIME study.

    Science.gov (United States)

    Shah, Kshitij; Chaudhari, Omvijay B; Gupta, Palash; Chaudhuri, R Hom; Kamilya, Ranjan; Kulkarni, Shreedhar S; Subbaiah, S; Sorathia, Zubair H; Billa, Gauri

    2017-01-01

    To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician's routine clinical practice. In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18-60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (pevents of moderate intensity. Two patients developed three adverse reactions (burning sensation in urine, giddiness, and urine retention) other than GI events. No serious adverse drug reactions were reported during the study period. Tramadol hydrochloride/diclofenac sodium is an effective and well-tolerated treatment in Indian patients with severe acute pain. Treatment with tramadol hydrochloride/diclofenac sodium provides significant pain relief on day 2 and maintained until day 5 without any serious adverse reactions.

  2. The treatment of angina pectoris with nitroglycerin plasters. A multicenter study involving 6,986 patients.

    Science.gov (United States)

    Agabiti Rosei, E; Muiesan, M L; Pollavini, G; Bichisao, E; Muiesan, G

    1987-10-01

    A multicenter study was carried out in order to evaluate the efficacy and tolerability of 2 doses of a nitroglycerin transdermal system (TTS-NG 5 mg/24 h and TTS-NG 10 mg/24 h) on a large population of patients affected by angina pectoris. Nine hundred and seventy three cardiologists enrolled a total of 6,986 patients, 4,290 males and 2,696 females, mean age 61.7 years (range 26-95), 3,283 with effort-angina, 2,062 with mixed angina and 1,641 with angina at rest. Patients whose angina was not satisfactorily controlled by their previous therapy, were given TTS-NG 5 for 1 week in the morning, while continuing their antianginal treatment, with the exception of nitrates which were gradually withdrawn. At the end of this period, patients who responded to the treatment continued taking the same dose for a further 6 weeks, while poor responders were given a double dose of the study medication over the same period. Six thousand two hundred and sixty patients (90%) completed the study. TTS-NG 5 proved to be effective in 2,091 patients (33%) with a reduction in weekly anginal attacks after only 1 week of treatment (from 5.8 +/- 2.9 to 2.4 +/- 2.3). This reduction improved in the following 2 weeks (from 2.4 +/- 2.3 to 1.2 +/- 1.6) and subsequently remained virtually unchanged. Four thousand one hundred and sixty-nine patients (67%), whose angina was not sufficiently controlled by TTS-NG 5 (from 5.0 +/- 2.4 to 4.3 +/- 2.8), received double the dose at the end of the first week. TTS-NG 10 brought about a reduction in weekly anginal symptoms during the 2nd and the 3rd week (from 4.3 +/- 2.8 to 2.0 +/- 2.2), with a further decrease during the following 2 weeks (from 2.0 +/- 2.2 to 1.1 +/- 1.7). The reduction in anginal attacks was of the same extent both during the day and the night, thus suggesting that the drug is effective throughout 24 hours. A similar pattern was observed in the reduction of the number of anginal attacks weighted by their severity, the severity of attacks

  3. Therapy response evaluation of malignant lymphoma in a multicenter study. Comparison of manual and semiautomatic measurements in CT

    Energy Technology Data Exchange (ETDEWEB)

    Wessling, J.; Schuelke, C. [Muenster Univ. (Germany). Dept. of Clinical Radiology; Koch, R. [Muenster Univ. (Germany). Dept. of Medical Informatics and Biomathematics; and others

    2014-08-15

    Purpose: Comparison of manual one-/bi-dimensional measurements versus semi-automatically derived one-/bi-dimensional and volumetric measurements for therapy response evaluation of malignant lymphoma during CT follow-up examinations in a multicenter setting. Materials and Methods: MSCT data sets of patients with malignant lymphoma were evaluated before (baseline) and after two cycles of chemotherapy (follow-up) at radiological centers of five university hospitals. The long axis diameter (LAD), the short axis diameter (SAD) and the bi-dimensional WHO of 307 target lymph nodes were measured manually and semi-automatically using dedicated software. Lymph node volumetry was performed semi-automatically only. The therapeutic response was evaluated according to lymphoma-adapted RECIST. Results: Based on a single lymph node, semi-automatically derived multidimensional parameters allowed for significantly more accurate therapy response classification than the manual or the semi-automatic unidimensional parameters. Incorrect classifications were reduced by up to 9.6%. Compared to the manual approach, the influence of the study center on correct therapy classification is significantly less relevant when using semi-automatic measurements. Conclusion: Semi-automatic volumetry and bi-dimensional WHO significantly reduce the number of incorrectly classified lymphoma patients by approximately 9.6% in the multicenter setting in comparison to linear parameters. Semi-automatic quantitative software tools may help to significantly reduce wrong classifications that are associated with the manual assessment approach. (orig.)

  4. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

    Science.gov (United States)

    Shah, Kshitij; Chaudhari, Omvijay B; Gupta, Palash; Chaudhuri, R Hom; Kamilya, Ranjan; Kulkarni, Shreedhar S; Subbaiah, S; Sorathia, Zubair H; Billa, Gauri

    2017-01-01

    Objective To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (pTramadol hydrochloride/diclofenac sodium is an effective and well-tolerated treatment in Indian patients with severe acute pain. Treatment with tramadol hydrochloride/diclofenac sodium provides significant pain relief on day 2 and maintained until day 5 without any serious adverse reactions. PMID:28579825

  5. Cardiac preload responsiveness in children with cardiovascular dysfunction or dilated cardiomyopathy: a multicenter observational study.

    Science.gov (United States)

    de la Oliva, Pedro; Menéndez-Suso, Juan J; Iglesias-Bouzas, Mabel; Álvarez-Rojas, Elena; González-Gómez, José M; Roselló, Patricia; Sánchez-Díaz, Juan I; Jaraba, Susana

    2015-01-01

    To characterize cardiac preload responsiveness in pediatric patients with cardiovascular dysfunction and dilated cardiomyopathy using global end-diastolic volume index, stroke volume index, cardiac index, and extravascular lung water index. Prospective multicenter observational study. Medical/surgical PICUs of seven Spanish University Medical Centers. Seventy-five pediatric patients (42 male, 33 female), median age 36 months (range, 1-207 mo), were divided into three groups: normal cardiovascular status, cardiovascular dysfunction, and dilated cardiomyopathy. All patients received hemodynamic monitoring with PiCCO2 (Pulsion Medical System SE, Munich, Germany). We evaluated 598 transpulmonary thermodilution sets of measurements. In 40 patients, stroke volume index, cardiac index, and global end-diastolic volume index were measured before and after 66 fluid challenges and loadings to test fluid responsiveness at different preload levels. Global end-diastolic volume versus predicted body surface area exhibits a power-law relationship: Global end-diastolic volume = 488.8·predicted body surface area (r = 0.93). Four levels of cardiac preload were established from the resulting "normal" global end-diastolic volume index (= 488.8·predicted body surface area). Stroke volume index and cardiac index versus global end-diastolic volume index/normal global end-diastolic volume index built using a linear mixed model analysis emulated Frank-Starling curves: in cardiovascular dysfunction group, stroke volume index (geometric mean [95% CI]) was 27 mL/m (24-31 mL/m) at "≤ 0.67 times normal global end-diastolic volume index," 37 mL/m (35-40 mL/m) at "> 0.67 ≤ 1.33 times normal global end-diastolic volume index" (Δ stroke volume index = 35%; p 1.33 ≤ 1.51 times normal global end-diastolic volume index" (Δ stroke volume index = 21%; p 1.51 times normal global end-diastolic volume index" (Δ stroke volume index = 4%; p = 1; area under the receiver

  6. A multi-center study of hemodynamic characteristics exhibited by children with unexplained syncope

    Institute of Scientific and Technical Information of China (English)

    CHEN Li; TANG Chao-shu; DU Jun-bao; YANG Yuan-yuan; WANG Cheng; WANG Hong-wei; TIAN Hong; ZHANG Qing-you; CHEN Jian-jun; WANG Yu-li; KANG Yi-long

    2006-01-01

    Background Syncope is common in children and adolescents, with 15% estimated to have had at least one syncopal episode by age 18. In recent years, an increasing number of children, especially girls at their school age,have developed unexplained syncope. The mechanism of an unexplained syncope exhibited by children is incompletely studied; the association between different hemodynamic patterns and clinical features is also not clear. The aim of the study was to investigate the hemodynamic patterns of children with unexplained syncope and to examine the clinical relevance.Methods Two hundred and eight children [87 boys, 121 girls, aged 3-19 years, mean (11.66±2.72) years]were selectively recruited from May 2000 to April 2006 when they presented syncope as their main complaint at the Multi-center Network for Childhood Syncope in Beijing, Hunan Province, Hubei Province, and Shanghai of China. All of the patients underwent head-up tilt tests; data were analyzed using SPSS version 10.0 for Windows.Continuous variables were expressed as the mean±standard deviation. Dichotomous variables were compared through a χ2 test. A value of P<0.05 (two sided) was regarded as statistically significant.Results The age distribution of children with syncope was approximately normal. Head-up tilt tests was positive in 155 children, and the incidence of positive response of the baseline head-up tilt test for diagnosing unexplained syncope was 50.48%. The sensitivity value and diagnostic value of sublingual nitroglycerin head-up tilt test were both 74.52%. The hemodynamic pattern was normal in 53 children. The 155 children, who were positive in head-up tilt tests, showed signs of postural orthostatic tachycardia syndrome (60, 28.8%), the vasoinhibitory pattern (72, 34.6%), the cardioinhibitory pattern (5, 2.4%), and the mixed pattern (18, 8.7%). The gender distribution between the two age groups (age < 12 years vs age ≥ 12 years) was not different (P>0.05).The distribution of

  7. Prevalence estimates for primary brain tumors in China: a multi-center cross-sectional study

    Institute of Scientific and Technical Information of China (English)

    JIANG Tao; WU Nai-feng; CHEN Xiao-jun; XING Hou-xun; SU Tong-yong; WANG Zhong-cheng; TANG Gen-fu; LIN Yi; PENG Xiao-xia; ZHANG Xiao; ZHAI Xiu-wei; PENG Xiang; YANG Jin-qing; HUANG Hong-er

    2011-01-01

    Background Although the first leading cause of death in China was malignant neoplasms (mortality,374.1 per 100000 person-years),the full impact of primary brain tumors (PBT) on the healthcare system is not completely described because there are a few well documented reports about the epidemiologic features of brain tumors.This study aimed to report a comprehensive assessment on the prevalence of PBT.Methods A multicenter cross-sectional study on brain tumor (MCSBT) in China was initiated in five regional centers:Daqing (northeast),Puyang (north of China),Shiyan (center of China),Ma'anshan (center of China) and Shanghai (southeast).Prevalence rate was calculated by counting the number of people living with a PBT between October 1,2005 and September 30,2006 and dividing by the total population of the five communities at January 1,2006.Estimates of prevalence were expressed as percentages and grouped according to gender and to age in fifteen-year categories.Within these strata,the rates were estimated with 95% confidence intervals (C/) using the accurate calculation of CI for Poisson distribution.A chi-square test was used to compare the various frequencies with α<0.05.Age-standardized prevalence with the direct method was calculated with the ten-year age-specific prevalence and the age distribution of the Chinese population in 2010,obtained from Worldpopulation prospects:the 2008 revision.Results We estimated that the overall prevalence of PBT was 24.56 per 100 000 (95% CI,14.85 to 34.27),and the overall prevalence of PBT in female population (30.57 per 100 000 and its 95% CI ranged from 19.73 to 41.41 ) was higher than that in male population (18.84 per 100 000 and its 95% CI ranged from 10.33 to 27.35).However,the discrepancy between genders was not statistically significant because the 95% CI overlapped.Of 272 cases of newly diagnosed PBT,the proportion of histological subtypes by age groups,gender was statistically different (χ2=52.6510,P <0.0001).More than

  8. 32nd European Study Group with Industry, Final Report

    DEFF Research Database (Denmark)

    ESGI (European Study Group with Industry) is Europe's leading workshop for interaction between mathematicians and industry. These workshops have taken place in Great Britain for a number of years, going back to 1968 when Prof. Alan Tayler initiated the so-called Oxford Study Group with Industry....... The coordiantion of the study groups is now done by the European Consortium for Mathematics in Industry (ECMI).This is the final report for the first study group in Denmark, (and the first ESGI outside Great Britain). Six Danish companies brought problems to the Study Group, requiring a wide range of mathematical...... a model describing the chlorination of swimming pools.LEGO wanted an algorithm for building an arbitrary model with LEGO bricks in stable manner.SCANtechnology wanted an algorithm to identify features in an image from a 3D laser scanning....

  9. Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B

    Institute of Scientific and Technical Information of China (English)

    Ping Liu; Mo-Bin Wan; Xiong Cai; Zhi-Qing Zhang; Jun Ye; Ren-Xing Zhou; Jia He; Bao-Zhang Tang; Yi-Yang Hu; Cheng Liu; Lie-Ming Xu; Cheng-Hai Liu; Ke-Wei Sun; De-Chang Hu; You-Kuan Yin; Xia-Qiu Zhou

    2005-01-01

    AIM: To study the efficacy and safety of Fuzhenghuayu capsule (FZHY capsule, a capsule for strengthening body resistance to remove blood stasis) against liver fibrosis due to chronic hepatitis B. METHODS: Multicenter, randomized, double blinded and parallel control experiment was conducted in patients (aged from 18 to 65 years) with liver fibrosis due to chronic hepatitis B. Hepatic histologic changes and HBV markers were examined at wk 0 and 24 during treatment. Serologic parameters (HA, LM, P-Ⅲ-P, Ⅳ-C) were determined and B ultrasound examination of the spleen and liver was performed at wk 0, 12 and 24. Liver function (liver function and serologic parameters for liver fibrosis) was observedat wk 0, 6, 12, 18 and 24. Blood and urine routine test, renal function and ECG were examined before and after treatment. RESULTS: There was no significant difference between experimental group (110 cases) and control group (106 cases) in demographic features, vital signs, course of illness, history for drug anaphylaxis and previous therapy, liver function, serologic parameters for liver fibrosis, liver histologic examination (99 cases in experimental group, 96 cases in control group), HBV markers, and renal function. According to the criteria for liver fibrosis staging, meanscore of fibrotic stage(s) in experimental group after treatment (1.80) decreased significantly compared to the previous treatment (2.33, P<0.05), but there was no significant difference in mean score of fibrotic stage(s) (2.11 and 2.14 respectively). There was a significant difference in reverse rate between experimental group (52%) and control group (23.3%) in liver biopsy. With marked effect on decreasing the mean value of inflammatory activity and score of inflammation (P<0.05), Fuzhenghuayu capsule had rather good effects on inhibiting inflammatory activity and was superior to that of Heluoshugan capsule. Compared to that of pretreatment, there was a significant decrease in HA, LM, P-Ⅲ-P and

  10. A 1-year multicenter randomized double-blind comparison of repaglinide and glyburide for the treatment of type 2 diabetes. Dutch and German Repaglinide Study Group

    NARCIS (Netherlands)

    Wolffenbuttel, B H; Landgraf, R

    1999-01-01

    OBJECTIVE: Repaglinide is a newly developed oral blood glucose-lowering agent that exerts its effect by stimulating insulin secretion. This multicenter study was designed to compare the efficacy and safety of this drug with glyburide in a 1-year randomized double-blind study of outpatients with type

  11. Toward Developing a Specific Outcome Instrument for Spine Trauma : An Empirical Cross-sectional Multicenter ICF-Based Study by AOSpine Knowledge Forum Trauma

    NARCIS (Netherlands)

    Oner, F. Cumhur|info:eu-repo/dai/nl/188615326; Sadiqi, Said; Lehr, A. Mechteld; Aarabi, Bizhan; Dunn, Robert N.; Dvorak, Marcel F.; Fehlings, Michael G.; Kandziora, Frank; Post, Marcel W.|info:eu-repo/dai/nl/137146426; Rajasekaran, S.; Vialle, Luiz; Vaccaro, Alexander R.

    2015-01-01

    STUDY DESIGN: Empirical cross-sectional multicenter study. OBJECTIVE: To identify the most commonly experienced problems by patients with traumatic spinal column injuries, excluding patients with complete paralysis. SUMMARY OF BACKGROUND DATA: There is no disease or condition-specific outcome instru

  12. Double-blind randomized multicenter dose-comparison study of interferon-beta-1a (AVONEX) : rationale, design and baseline data

    NARCIS (Netherlands)

    Kristoferitsch, W; Seeldrayers, P; Kyriallis, K; Brochet, B; Confavreux, C; Clanet, M; Cesaro, P; Defer, G; Edan, G; Lyon-Caen, O; Pelletier, J; Rumbach, L; Roullet, E; Vermersch, P; Dengler, R; Zschenderlein, R; Storch-Hagenlocher, B; Sailer, M; Hohlfeld, R; Kunze, KP; Heesen, C; Bamborschke, P; Grunwald, F; Hartung, HP; Rieckmann, P; DeKeyser, J; Montalban, [No Value; Fernandez, U; Arbizu, T; Sandberg, M; Kappos, L; Bates, D; Campbell, MJ; Capildeo, R; Compston, A; McLellan, DL; Wroe, S; Young, C; Clanet, M; Hartung, HP; Hohlfeld, R; Kappos, L; Radue, EW; Rieckmann, P; Sandberg, M; Polman, C; Kesselring, J; Thompson, A; Wekerle, H; Whitehead, J; Bains, H; Butler, E; Kooijmans-Coutinho, M; McAllister, A; Simonian, N; White, K; Anderson, D; Liddiard, S; Keane, R

    2001-01-01

    We describe the rationale and design of a double-blind, randomized multicenter, dose-comparison study of interferon-beta-Ia (IFN-beta -Ia: AVONEX(R) in the treatment of relapsing multiple sclerosis (MS). The study is expected to provide quantitative insights on the dose range for optimal clinical be

  13. A multi-center study of Restylane for treatment of nasolabial folds in China

    Institute of Scientific and Technical Information of China (English)

    YAN Xiao-qing; CHEN Li-yang; HUANG Lü-ping; YOU Lei; MA Yong-guang; L(U) Chang-sheng; LI Wei; XU Jun

    2010-01-01

    Background Restylane, a hyaluronic acid gel, has been widely used as a dermal filler in USA and European countries. This study was designed to study the safety and efficacy of Restylane as a non-permanent dermal filler for facial augmentation therapy in China for the correction of nasolabial folds during a follow-up period of 6 months. Methods The study consisted of a screening visit, a baseline visit during which injection with Restylane was given, and follow-up visits after four weeks, three months and six months. The efficacy was subjectively assessed by comparing the treatment results between pre-treatment and post-treatment. Adverse events were analyzed by severity and duration. Results At six months post-baseline, the subjects and the investigators' independent assessment score of Wrinkle Severity Rating Scale was decreased. Global Aesthetic Improvement Scale was considered to have improved by over 90% in some cases. Adverse events related to product and injection was reported in 21.5% of the injections. A vast majority of the post-treatment reactions were mild. Conclusions The efficacy of Restylane for nasolabial fold in a Chinese population was excellent. Restylane was well tolerated and no systemic reactions or other safety concerns were raised.

  14. In vivo field dependence of proton relaxation times in human brain, liver and skeletal muscle: a multicenter study

    DEFF Research Database (Denmark)

    Henriksen, O; de Certaines, J D; Spisni, A;

    1993-01-01

    T1 and T2 relaxation times are fundamental parameters for signal contrast behaviour in MRI. A number of ex vivo relaxometry studies have dealt with the magnetic field dispersion of T1. By means of multicenter study within the frame of the COMAC BME Concerted Action on Tissue Characterization by MRI...... and MRS, the in vivo field dispersion of T1 and T2 has been measured in order to evaluate whether ex vivo data are representative for the in vivo situation. Brain, skeletal muscle, and liver of healthy human volunteers were studied. Fifteen MR units with a field strength ranging from 0.08 T to 1.5 T took...... part in the trial, which comprised 218 volunteers. All the MR systems were tested for measurement accuracy using the Eurospin TO5 test object. The measured relaxation data were subsequently corrected according to the obtained calibration curves. The results showed a clear field dispersion of T1...

  15. HIV-1 infection: no evidence of cognitive decline during the asymptomatic stages. The Multicenter AIDS Cohort Study.

    Science.gov (United States)

    Selnes, O A; Miller, E; McArthur, J; Gordon, B; Muñoz, A; Sheridan, K; Fox, R; Saah, A J

    1990-02-01

    Cross-sectional studies have not adequately resolved the question of whether subjects infected with HIV-1 may suffer cognitive decline during the early, asymptomatic stages of the infection. We studied longitudinally 238 asymptomatic healthy HIV-1-infected homosexual/bisexual men (CDC groups 2 and 3) and 170 uninfected controls in the Multicenter AIDS Cohort Study with neuropsychological testing at semiannual intervals. A comparison of change in scores between visits 1 and 4 as well as a multivariate autoregressive analysis revealed no evidence of decline in test performance over time in the HIV-1-infected group compared with the seronegative controls. These findings suggest that a gradual cognitive decline does not occur during the early, asymptomatic stages of HIV infection.

  16. A multicenter phase II study of irinotecan in patients with advanced colorectal cancer previously treated with 5-fluorouracil.

    Science.gov (United States)

    Méndez, Miguel; Salut, Antonieta; García-Girón, Carlos; Navalon, Marta; Diz, Pilar; García López, Maria José; España, Pilar; de la Torre, Ascensión; Martínez del Prado, Purificación; Duarte, Isabel; Pujol, Eduardo; Arizcun, Alberto; Cruz, Juan Jesús

    2003-11-01

    This multicenter, open-label, phase II study was performed to assess the efficacy and toxicity of irinotecan 350 mg/m2 intravenously every 3 weeks in patients with advanced colorectal cancer (CRC) previously treated with 5-fluorouracil (5-FU). The study enrolled 115 patients and a total of 558 cycles (median, 6 per patient) were administered. The overall objective response rate on an intent-to-treat basis was 18% (with 1 complete response and 20 partial responses), whereas 42 patients (37%) showed stable disease. Median time to progression was 4.8 months and median survival was 13.6 months. Grade 3/4 toxicities included delayed diarrhea (19.1%), nausea/vomiting (10.4%), and neutropenia (8.7%). There were 2 toxic deaths, 1 from delayed diarrhea and 1 from hemorrhage and grade 4 mucositis. In conclusion, the present study confirms the antitumor efficacy of irinotecan monotherapy in patients with CRC pretreated with 5-FU.

  17. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study.

    Science.gov (United States)

    Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier

    2010-01-01

    Arterial Spin Labeling (ASL) is a method to measure perfusion using magnetically labeled blood water as an endogenous tracer. Being fully non-invasive, this technique is attractive for longitudinal studies of cerebral blood flow in healthy and diseased individuals, or as a surrogate marker of metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measurement of cerebral blood flow (CBF). Here, we evaluated a particular implementation of ASL (called Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing mean displacements of 1.87+/-0.95 mm and rotations of 1.56+/-0.66 degrees . Mean gray matter CBF was 47.4+/-7.5 [ml/100 g/min] with a between-subject standard variation SD(b)=5.5 [ml/100 g/min] and a within-subject standard deviation SD(w)=4.7 [ml/100 g/min]. The corresponding repeatability was 13.0 [ml/100 g/min] and was found to be within the range of previous studies.

  18. Consulting Communities When Patients Cannot Consent: A Multi-Center Study of Community Consultation for Research in Emergency Settings

    Science.gov (United States)

    Dickert, Neal W; Mah, Victoria A; Biros, Michelle H; Harney, Deneil M; Silbergleit, Robert; Sugarman, Jeremy; Veledar, Emir; Weinfurt, Kevin P; Wright, David W; Pentz, Rebecca D

    2013-01-01

    Objective To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent (EFIC) research and understanding of the proposed study. Design A cognitively pre-tested survey instrument was administered to 2,612 community consultation participants at 12 US centers participating in a multi-center trial of treatment for acute traumatic brain injury (TBI). Setting Survey nested within community consultation for a Phase III, randomized controlled trial of treatment for acute TBI conducted within a multi-center trial network and using EFIC. Subjects Adult participants in community consultation events. Interventions Community consultation efforts at participating sites. Measurements and Main Results Acceptance of EFIC in general, attitude toward personal EFIC enrollment, and understanding of the study content were assessed. 54% of participants agreed EFIC was acceptable in the proposed study; 71% were accepting of personal EFIC enrollment. Participants in interactive versus non-interactive community consultation events were more accepting of EFIC in general (63% vs. 49%) and personal EFIC inclusion (77% vs. 67%). Interactive community consultation participants had high-level recall of study content significantly more often than non-interactive consultation participants (77% vs. 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs. 45%) but less likely to recall potential risks (56% vs. 69%). Conclusions Interactive community consultation methods were associated with increased acceptance of EFIC and greater overall recall of study information but lower recall of risks. There was also significant variability in EFIC acceptance among different interactive consultation events. These findings have important implications for IRBs and investigators conducting EFIC research and for community

  19. Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings.

    Science.gov (United States)

    Dickert, Neal W; Mah, Victoria A; Biros, Michelle H; Harney, Deneil M; Silbergleit, Robert; Sugarman, Jeremy; Veledar, Emir; Weinfurt, Kevin P; Wright, David W; Pentz, Rebecca D

    2014-02-01

    To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent research and understanding of the proposed study. A cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers participating in a multicenter trial of treatment for acute traumatic brain injury. Survey nested within community consultation for a phase III randomized controlled trial of treatment for acute traumatic brain injury conducted within a multicenter trial network and using exception from informed consent. Adult participants in community consultation events. Community consultation efforts at participating sites. Acceptance of exception from informed consent in general, attitude toward personal exception from informed consent enrollment, and understanding of the study content were assessed. Fifty-four percent of participants agreed exception from informed consent enrollment was acceptable in general in the proposed study; 71% were accepting of personal exception from informed consent enrollment. Participants in interactive versus noninteractive community consultation events were more accepting of exception from informed consent in general (63% vs 49%) and personal exception from informed consent inclusion (77% vs 67%). Interactive community consultation participants had high-level recall of study content significantly more often than noninteractive consultation participants (77% vs 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs 45%) but less likely to recall potential risks (56% vs 69%). Interactive community consultation methods were associated with increased acceptance of exception from informed consent and greater overall recall of study information but lower recall of risks. There was also significant variability in exception from informed

  20. Structural MRI correlates of cognitive impairment in patients with multiple sclerosis: A Multicenter Study.

    Science.gov (United States)

    Preziosa, Paolo; Rocca, Maria A; Pagani, Elisabetta; Stromillo, Maria Laura; Enzinger, Christian; Gallo, Antonio; Hulst, Hanneke E; Atzori, Matteo; Pareto, Deborah; Riccitelli, Gianna C; Copetti, Massimiliano; De Stefano, Nicola; Fazekas, Franz; Bisecco, Alvino; Barkhof, Frederik; Yousry, Tarek A; Arévalo, Maria J; Filippi, Massimo

    2016-04-01

    In a multicenter setting, we applied voxel-based methods to different structural MR imaging modalities to define the relative contributions of focal lesions, normal-appearing white matter (NAWM), and gray matter (GM) damage and their regional distribution to cognitive deficits as well as impairment of specific cognitive domains in multiple sclerosis (MS) patients. Approval of the institutional review boards was obtained, together with written informed consent from all participants. Standardized neuropsychological assessment and conventional, diffusion tensor and volumetric brain MRI sequences were collected from 61 relapsing-remitting MS patients and 61 healthy controls (HC) from seven centers. Patients with ≥2 abnormal tests were considered cognitively impaired (CI). The distribution of focal lesions, GM and WM atrophy, and microstructural WM damage were assessed using voxel-wise approaches. A random forest analysis identified the best imaging predictors of global cognitive impairment and deficits of specific cognitive domains. Twenty-three (38%) MS patients were CI. Compared with cognitively preserved (CP), CI MS patients had GM atrophy of the left thalamus, right hippocampus and parietal regions. They also showed atrophy of several WM tracts, mainly located in posterior brain regions and widespread WM diffusivity abnormalities. WM diffusivity abnormalities in cognitive-relevant WM tracts followed by atrophy of cognitive-relevant GM regions explained global cognitive impairment. Variable patterns of NAWM and GM damage were associated with deficits in selected cognitive domains. Structural, multiparametric, voxel-wise MRI approaches are feasible in a multicenter setting. The combination of different imaging modalities is needed to assess and monitor cognitive impairment in MS.

  1. MRI, PET/CT and ultrasound in the preoperative staging of endometrial cancer - a multicenter prospective comparative study

    DEFF Research Database (Denmark)

    Antonsen, Sofie Leisby; Jensen, Lisa Neerup; Loft, Annika;

    2013-01-01

    OBJECTIVES: The aim of this prospective multicenter study was to evaluate and compare the diagnostic performance of PET/CT, MRI and transvaginal two-dimensional ultrasound (2DUS) in the preoperative assessment of endometrial cancer (EC). METHODS: 318 consecutive women with EC were included when...... referred to three Danish tertiary gynecological centers for surgical treatment. Preoperatively they were PET/CT-, MRI-, and 2DUS scanned. The imaging results were compared to the final pathological findings. This study was approved by the National Committee on Health Research Ethics. RESULTS......: For predicting myometrial invasion, we found sensitivity, specificity, PPV, NPV, and accuracy for PET/CT to be 93%, 49%, 41%, 95% and 61%, for MRI to be 87%, 57%, 44%, 92%, and 66% and for 2DUS to be 71%, 72%, 51%, 86% and 72%. For predicting cervical invasion, the values were 43%, 94%, 69%, 85% and 83...

  2. A multicenter study of the early detection of synaptic dysfunction in Mild Cognitive Impairment using Magnetoencephalography-derived functional connectivity.

    Science.gov (United States)

    Maestú, Fernando; Peña, Jose-Maria; Garcés, Pilar; González, Santiago; Bajo, Ricardo; Bagic, Anto; Cuesta, Pablo; Funke, Michael; Mäkelä, Jyrki P; Menasalvas, Ernestina; Nakamura, Akinori; Parkkonen, Lauri; López, Maria E; Del Pozo, Francisco; Sudre, Gustavo; Zamrini, Edward; Pekkonen, Eero; Henson, Richard N; Becker, James T

    2015-01-01

    Synaptic disruption is an early pathological sign of the neurodegeneration of Dementia of the Alzheimer's type (DAT). The changes in network synchronization are evident in patients with Mild Cognitive Impairment (MCI) at the group level, but there are very few Magnetoencephalography (MEG) studies regarding discrimination at the individual level. In an international multicenter study, we used MEG and functional connectivity metrics to discriminate MCI from normal aging at the individual person level. A labeled sample of features (links) that distinguished MCI patients from controls in a training dataset was used to classify MCI subjects in two testing datasets from four other MEG centers. We identified a pattern of neuronal hypersynchronization in MCI, in which the features that best discriminated MCI were fronto-parietal and interhemispheric links. The hypersynchronization pattern found in the MCI patients was stable across the five different centers, and may be considered an early sign of synaptic disruption and a possible preclinical biomarker for MCI/DAT.

  3. Topical tretinoin 0.1% for pregnancy-related abdominal striae: an open-label, multicenter, prospective study.

    Science.gov (United States)

    Rangel, O; Arias, I; García, E; Lopez-Padilla, S

    2001-01-01

    In an open-label, multicenter, prospective study, 20 women applied tretinoin (retinoic acid) cream 0.1% daily for 3 months to pregnancy-related stretch marks in the abdominal area. Efficacy was evaluated by analysis of one preselected target lesion, which was rated on a six-point scale (-1 = worse to 4 = cleared). At week 12, significant global improvement was noted from baseline in all stretch marks, and the target lesion decreased in length by 20% (P = .01). Erythema and scaling, the most common adverse events, occurred in 11 patients, decreased in severity after the first month of treatment, and were controlled with continued application of tretinoin and petroleum jelly ointment. In this small study, topical application of tretinoin significantly improved the clinical appearance of pregnancy-related stretch marks.

  4. Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment : a prospective web-based multi-center study in multiple sclerosis patients with a relapse

    NARCIS (Netherlands)

    Jongen, Peter Joseph; Stavrakaki, Ioanna; Voet, Bernard; Hoogervorst, Erwin; van Munster, Erik; Linssen, Wim H.; Sinnige, Ludovicus G.; Verhagen, Wim I.; Visser, Leo H.; van der Kruijk, Ruud; Verheul, Freek; Boringa, Jan; Heerings, Marco; Gladdines, Werner; Lonnqvist, Fredrik; Gaillard, Pieter

    2016-01-01

    In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-repo

  5. No important influence of limited steroid exposure on bone mass during the first year after renal transplantation: a prospective, randomized, multicenter study.

    NARCIS (Netherlands)

    Meulen, C.G. ter; Riemsdijk, I.C. van; Hene, R.J.; Christiaans, M.H.; Borm, G.F.; Corstens, F.H.M.; Gelder, T. van; Hilbrands, L.B.; Weimar, W.; Hoitsma, A.J.

    2004-01-01

    BACKGROUND: Steroid-related bone loss is a recognized complication after renal transplantation. In a prospective, randomized, multicenter study we compared the influence of a steroid-free immunosuppressive regimen with a regimen with limited steroid exposure on the changes in bone mass after renal t

  6. Use of the University of California Los Angeles integrated staging system to predict survival in renal cell carcinoma: an international multicenter study.

    NARCIS (Netherlands)

    Patard, J.J.; Kim, H.L.; Lam, J.; Dorey, F.J.; Pantuck, A.J.; Zisman, A.; Ficarra, V.; Han, K.R.; Cindolo, L.; Taille, A. De La; Tostain, J.; Artibani, W.; Dinney, C.P.; Wood, C.G.; Swanson, D.A.; Abbou, C.C.; Lobel, B.; Mulders, P.F.A.; Chopin, D.K.; Figlin, R.A.; Belldegrun, A.S.

    2004-01-01

    PURPOSE: To evaluate ability of the University of California Los Angeles Integrated Staging System (UISS) to stratify patients with localized and metastatic renal cell carcinoma (RCC) into risk groups in an international multicenter study. PATIENTS AND METHODS: 4,202 patients from eight internationa

  7. Real-World Experience with Echinocandin MICs against Candida Species in a Multicenter Study of Hospitals That Routinely Perform Susceptibility Testing of Bloodstream Isolates

    OpenAIRE

    Eschenauer, Gregory A.; Nguyen, M Hong; Shoham, Shmuel; Jose A. Vazquez; Morris, Arthur J.; Pasculle, William A.; Kubin, Christine J.; Klinker, Kenneth P.; Carver, Peggy L.; Hanson, Kimberly E.; Chen, Sharon; Lam, Simon W.; Potoski, Brian A.; Clarke, Lloyd G.; Ryan K Shields

    2014-01-01

    Reference broth microdilution methods of Candida echinocandin susceptibility testing are limited by interlaboratory variability in caspofungin MICs. Recently revised Clinical and Laboratory Standards Institute (CLSI) breakpoint MICs for echinocandin nonsusceptibility may not be valid for commercial tests employed in hospital laboratories. Indeed, there are limited echinocandin susceptibility testing data from hospital laboratories. We conducted a multicenter retrospective study of 9 U.S., Aus...

  8. Blonanserin Augmentation of Atypical Antipsychotics in Patients with Schizophrenia-Who Benefits from Blonanserin Augmentation?: An Open-Label, Prospective, Multicenter Study

    National Research Council Canada - National Science Library

    Woo, Young Sup; Park, Joo Eon; Kim, Do-Hoon; Sohn, Inki; Hwang, Tae-Yeon; Park, Young-Min; Jon, Duk-In; Jeong, Jong-Hyun; Bahk, Won-Myong

    2016-01-01

    ...) with augmentation by blonanserin in schizophrenic patients. aA total of 100 patients with schizophrenia who were partially or completely unresponsive to treatment with an AAP were recruited in this 12-week, open-label, non-comparative, multicenter study...

  9. Predictors of opioid efficacy in patients with chronic pain: A prospective multicenter observational cohort study

    Science.gov (United States)

    Olesen, Anne E.; Gram, Mikkel; Jonsson, Torsten; Kamp-Jensen, Michael; Andresen, Trine; Nielsen, Christian; Pozlep, Gorazd; Pfeiffer-Jensen, Mogens; Morlion, Bart; Drewes, Asbjørn M.

    2017-01-01

    Opioids are increasingly used for treatment of chronic pain. However, they are only effective in a subset of patients and have multiple side effects. Thus, studies using biomarkers for response are highly warranted. The current study prospectively examined 63 opioid-naïve patients initiating opioid use for diverse types of chronic pain at five European centers. Quantitative sensory testing, electroencephalography (EEG) recordings, and assessment of pain catastrophizing were performed prior to treatment. The co-primary outcomes were change from baseline in ratings of chronic pain and quality of life after 14 days of opioid treatment. Secondary outcomes included patient’s global impression of clinical change and side effects. Logistic regression models adjusted for age and sex were used to identify biomarkers predictive for successful treatment, defined as at least a 30% reduction in average pain intensity or an improvement in quality of life of at least 10 scale points. Fifty-nine patients (94%) completed the study. The mean age was 55 ± 16 years and 69% were females. Pain reduction was predicted by cold pain intensity (OR: 0.69; P = 0.01), pain catastrophizing (OR: 0.82; P = 0.03), relative delta (OR: 0.76; P = 0.03) and beta EEG activity (OR: 1.18; P = 0.04) induced by experimental cold pain. None of the study variables were related to improvement in quality of life. For the first time, individual pain processing characteristics have been linked to opioid response in a mixed chronic pain population. This has the potential to personalize treatment of chronic pain and restrict opioid use to patients with high likelihood for response. PMID:28158269

  10. Pharmacokinetics and pharmacodynamics of medication in asphyxiated newborns during controlled hypothermia. The PharmaCool multicenter study

    Directory of Open Access Journals (Sweden)

    de Haan Timo R

    2012-05-01

    Full Text Available Abstract Background In the Netherlands, perinatal asphyxia (severe perinatal oxygen shortage necessitating newborn resuscitation occurs in at least 200 of the 180–185.000 newly born infants per year. International randomized controlled trials have demonstrated an improved neurological outcome with therapeutic hypothermia. During hypothermia neonates receive sedative, analgesic, anti-epileptic and antibiotic drugs. So far little information is available how the pharmacokinetics (PK and pharmacodynamics (PD of these drugs are influenced by post resuscitation multi organ failure and the metabolic effects of the cooling treatment itself. As a result, evidence based dosing guidelines are lacking. This multicenter observational cohort study was designed to answer the question how hypothermia influences the distribution, metabolism and elimination of commonly used drugs in neonatal intensive care. Methods/Design Multicenter cohort study. All term neonates treated with hypothermia for Hypoxic Ischemic Encephalopathy (HIE resulting from perinatal asphyxia in all ten Dutch Neonatal Intensive Care Units (NICUs will be eligible for this study. During hypothermia and rewarming blood samples will be taken from indwelling catheters to investigate blood concentrations of several antibiotics, analgesics, sedatives and anti-epileptic drugs. For each individual drug the population PK will be characterized using Nonlinear Mixed Effects Modelling (NONMEM. It will be investigated how clearance and volume of distribution are influenced by hypothermia also taking maturation of neonate into account. Similarly, integrated PK-PD models will be developed relating the time course of drug concentration to pharmacodynamic parameters such as successful seizure treatment; pain assessment and infection clearance. Discussion On basis of the derived population PK-PD models dosing guidelines will be developed for the application of drugs during neonatal hypothermia treatment. The

  11. Multicenter trial of motion analysis for injury risk prediction: lessons learned from prospective longitudinal large cohort combined biomechanical - epidemiological studies

    Directory of Open Access Journals (Sweden)

    Timothy E. Hewett

    2015-10-01

    Full Text Available ABSTRACTOur biodynamics laboratory group has conducted large cohort biomechanical-epidemiological studies targeted at identifying the complex interactions among biomechanical, biological, hormonal, and psychosocial factors that lead to increased risk of anterior cruciate ligament (ACL injuries. The findings from our studies have revealed highly sensitive and specific predictors for ACL injury. Despite the high incidence of ACL injuries among young athletes, larger cohorts are needed to reveal the underlying mechanistic causes of increased risk for ACL injury. In the current study, we have outlined key factors that contribute to the overall success of multicenter, biomechanical-epidemiological investigations designed to test a larger number of athletes who otherwise could not be recruited, screened, or tested at a single institution. Twenty-five female volleyball players were recruited from a single high school team and tested at three biodynamics laboratories. All athletes underwent three-dimensional motion capture analysis of a drop vertical jump task. Kinematic and kinetic variables were compared within and among laboratories. Reliability of peak kinematic variables was consistently rated good-to-excellent. Reliability of peak kinetic variables was consistently rated goodto-excellent within sites, but greater variability was observed between sites. Variables measured in the sagittal plane were typically more reliable than variables measured in the coronal and transverse planes. This study documents the reliability of biomechanical variables that are key to identification of ACL injury mechanisms and of athletes at high risk. These findings indicate the feasibility of executing multicenter, biomechanical investigations that can yield more robust, reliable, and generalizable findings across larger cohorts of athletes.

  12. A multicenter evaluation of the Biotest legionella urinary antigen EIA

    DEFF Research Database (Denmark)

    Harrison, Timothy; Uldum, Søren; Alexiou-Daniel, Stella;

    1998-01-01

    OBJECTIVES: To undertake a multicenter study to evaluate the Biotest legionella urinary antigen enzyme immunoassay (EIA) performance against those EIAs already in use in 14 European laboratories. METHODS: Each laboratory examined urine specimens from appropriate patients using both their current...... in the laboratories' current EIAs, and in 94.6% of those specimens which were positive for Legionella pneumophila serogroup 1. CONCLUSION: The Biotest EIA is simple to use and specific and the results obtained in different laboratories show excellent agreement. The assay compares well existing EIAs, at least for L...

  13. China collaborative study on dialysis: a multi-centers cohort study on cardiovascular diseases in patients on maintenance dialysis

    Directory of Open Access Journals (Sweden)

    Hou Fanfan

    2012-08-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the main cause of death in patients on chronic dialysis. The question whether dialysis modality impacts cardiovascular risk remains to be addressed. China Collaborative Study on Dialysis, a multi-centers cohort study, was performed to evaluate cardiovascular morbidity during maintenance hemodialysis (HD and peritoneal dialysis (PD. Method The cohort consisted of chronic dialysis patients from the database of 9 of the largest dialysis facilities around China. The inclusion period was between January 1, 2005, and December 1, 2010. Cardiovascular morbidity was defined as the presence of clinically diagnosed ischemic heart disease, heart failure, peripheral vascular disease, and/or stroke. The patients who had cardiovascular morbidity before initiation of dialysis were excluded. Data collection was based on review of medical record. Result A total of 2,388 adult patients (1,775 on HD and 613 on PD were enrolled. Cardiovascular morbidity affected 57% patients and was comparable between HD and PD patients. However, clinically diagnosed ischemic heart disease and stroke was more prevalent in PD than HD patients. When the patients were stratified by age or dialysis vintage, the cardiovascular morbidity was significantly higher in PD than HD among those aged 50 years or older, or those receiving dialysis over 36 months. Multivariate analysis revealed that the risk factors for cardiovascular morbidity had different pattern in PD and HD patients. Hyperglycemia was the strongest risk factor for cardiovascular morbidity in PD, but not in HD patients. Hypertriglyceridemia and hypoalbuminemia were independently associated with CVD only in PD patients. Conclusions Cardiovascular morbidity during chronic dialysis was more prevalent in PD than HD patients among those with old age and long-term dialysis. Metabolic disturbance-related risk factors were independently associated with CVD only in PD patients

  14. Prevalence of age-related maculopathy in older Europeans: The European Eye Study (EUREYE)

    NARCIS (Netherlands)

    C. Augood (Cristina); J.R. Vingerling (Hans); P.T.V.M. de Jong (Paulus); U. Chakravarthy (Usha); J.H. Seland (Johan ); G. Soubrane; L. Tomazzoli (Laura); F. Topouzis (Fotis); G.C. Bentham (Graham ); M. Rahu; J. Vioque (Jesus); I.S. Young (Ian ); A.E. Fletcher (Astrid E.)

    2006-01-01

    textabstractObjective: To estimate the prevalence of age-related maculopathy in an older population from 7 European countries. Methods: Randomly sampled people 65 years and older were invited to an eye examination in centers across 7 European countries (Norway, Estonia, United Kingdom, France, Italy

  15. Characterization of chronic arthritis in a multicenter study of 852 childhood-onset systemic lupus erythematosus patients.

    Science.gov (United States)

    Sakamoto, Ana Paula; Silva, Clovis Artur; Ferriani, Mariana Paes Leme; Pereira, Rosa Maria Rodrigues; Bonfá, Eloisa; Saad-Magalhães, Claudia; Okuda, Eunice; Appenzeller, Simone; Gomes, Francisco Hugo; Cunha, Ana Luiza Garcia; Salume, Mirna Henriques Tomich; Piotto, Daniela Petry; Terreri, Maria Teresa

    2016-12-01

    Chronic arthritis (CA) is an unusual condition in childhood-onset systemic lupus erythematosus (cSLE) and data in children is very limited. The aim of the study is to assess CA in a large population of cSLE patients, in a multicenter cross-sectional study including 852 cSLE patients followed in ten Pediatric Rheumatology referral services in state of São Paulo, Brazil. CA was observed in 32/852 (3.7 %) cSLE patients mostly in hands and ankles. Chronic monoarthritis was diagnosed in four cSLE patients, oligoarthritis in nine and polyarthritis in 19. In the latter group, six had rhupus syndrome. Two oligoarticular patients had Jaccoud's arthropathy. CA was an isolated manifestation observed at disease onset in 13/32 (41 %) cSLE patients, and juvenile idiopathic arthritis (JIA) was the first diagnosis in 18/32 (56 %). The comparison of last visit of patients with CA and without this manifestation revealed higher frequency of splenomegaly (28 vs. 11 %, p = 0.002). The median of SLICC/ACR-DI score [1(0-9) vs. 0(0-7), p = 0.003] was significantly higher in CA patients compared to patients without this manifestation, likewise the frequency of musculoskeletal damage (31 vs. 9 % p = 0.001). Frequencies of treatment with nonsteroidal anti-inflammatory drugs (75 vs. 26 %, p < 0.0001), hydroxychloroquine sulfate (87 vs. 59 %, p = 0.001) and methotrexate (47 vs. 22 %, p = 0.001) were significantly higher in CA patients. This large multicenter study allowed us to characterize CA as a rare and early manifestation of cSLE, frequently mimicking JIA at disease onset. It is predominantly polyarticular, involving more often hands and ankles and it is associated with significant musculoskeletal accrual damage.

  16. Management of venous thromboembolism in patients with acute leukemia at high bleeding risk: a multi-center study.

    Science.gov (United States)

    Napolitano, Mariasanta; Valore, Luca; Malato, Alessandra; Saccullo, Giorgia; Vetro, Calogero; Mitra, Maria Enza; Fabbiano, Francesco; Mannina, Donato; Casuccio, Alessandra; Lucchesi, Alessandro; Del Principe, Maria Ilaria; Candoni, Anna; Di Raimondo, Francesco; Siragusa, Sergio

    2016-01-01

    In the last decades, evaluation of clinically relevant thrombotic complications in patients with acute leukemia (AL) has been poorly investigated. The authors performed a multi-center study to evaluate the management of symptomatic venous thromboembolism (VTE) in adult patients with AL. The intention was to find as clinically relevant the following: symptomatic Venous Thrombosis (VT) occurred in typical (lower limbs) and atypical (cerebral, upper limbs, abdominal, etc) sites with or without pulmonary embolism (PE). Over a population of 1461 patients with AL, 22 cases of symptomatic VTE were recorded in hospitalized patients with a mean age of 54.6 years. The absolute incidence of VTE was 1.5%. VTE occurred during chemotherapy in 17/22 (77.2%) cases, mainly (14/17, 82.3%) during the induction phase. Treatment of acute VTE was based on Low Molecular Weight Heparin (LMWH) at full dosage for the first month from diagnosis and reduced dosage (75%) for the following months.

  17. Roxatidine versus ranitidine in the treatment of patients with duodenal ulcer: a randomized, double-masked, multicenter study.

    Science.gov (United States)

    Zuberi, S J; Khan, A Q; Irshad-ul-Haque, I; Hussain, A; Hasnain, S S; Shah, S; Sadick, A; Yusuf, M Z; Reuter, M

    1996-01-01

    The comparative efficacy of roxatidine and ranitidine in the treatment of patients with acute duodenal ulcer was assessed at 4 and 6 weeks in this multicenter study. Ninety-four of 192 patients were given roxatidine in a single nightly dose of 150 mg, and 98 patients were given ranitidine in a single nightly dose of 300 mg. All the patients had endoscopically proven duodenal ulcer. Of the 171 assessable patients, ulcers were healed in 88% of the roxatidine group (73 of 83) and in 84% of the ranitidine group (74 of 88). No serious adverse events were reported in either group. We conclude that roxatidine 150 mg once daily is as effective and safe for the treatment of acute duodenal ulcer as ranitidine 300 mg once daily.

  18. [Multicenter study on incidence of total parenteral nutrition complications in the critically-ill patient. ICOMEP study. Part II].

    Science.gov (United States)

    Grau, T; Bonet, A

    2005-01-01

    To assess enteral nutrition complications in a prospective cohort of patients admitted to the ICU. Prospective, multicenter study of patients admitted to the ICU and that received enteral nutrition (EN). Demographical data, main diagnosis, and nutritional and severity indexes were included. Complications were previously defined and were categorized as gastrointestinal or infectious. An independent group managed the databases and performed the statistical analysis. Data were expressed in absolute values or by their median and percentile (25-75). The rate and incidence density of complications and the odds ratio for complications were determined. 544 out of 3409 patients received enteral nutrition. Three hundred and three patients were admitted for medical causes, 149 for surgical causes and 92 for trauma. Ninety nine patients were underfed, and the nutritional risk index was 69.7. The incidence of gastrointestinal complications was 6 episodes per 100 days of nutrition, and in 89 patient they resulted in enteral nutrition withdrawal. Early enteral nutrition did not yield more complications than late EN. Vomiting was more frequent in late EN (OR 0.4; 95%CI: 0.2-0.7). Temporary withdrawal of diet in 140 patients was the most used procedure, which resulted in a lower caloric intake (median of 2 kcal/kg/d) than programmed. Nosocomial infection rates were 7.47% for catheter-induced sepsis and 51% for other nosocomial infections, and 35% developed pneumonia. Gastrointestinal complications with enteral nutrition are frequent, result in insufficient caloric intake and definitive withdrawal of diet in a significant number of cases. Early enteral nutrition is not associated with an increased number of complications. Episodes of increase of the gastric residue do not increase the incidence of pneumonia. Other infectious complications are within the range of what has been published and seem to be little modified by the use of enteral nutrition.

  19. What Is the Impact of Center Variability in a Multicenter International Prospective Observational Study on Developmental Dysplasia of the Hip?

    Science.gov (United States)

    Mulpuri, Kishore; Schaeffer, Emily K; Kelley, Simon P; Castañeda, Pablo; Clarke, Nicholas M P; Herrera-Soto, Jose A; Upasani, Vidyadhar; Narayanan, Unni G; Price, Charles T

    2016-05-01

    Little information exists concerning the variability of presentation and differences in treatment methods for developmental dysplasia of the hip (DDH) in children Hip Dysplasia Institute to establish the need to consider the center as a key variable in multicenter studies. (1) How do patient demographics differ across participating centers at presentation? (2) How do patient diagnoses (severity and laterality) differ across centers? (3) How do initial treatment approaches differ across participating centers? A multicenter prospective hip dysplasia study database was analyzed from 2010 to April 2015. Patients younger than 6 months of age at diagnosis were included if at least one hip was completely dislocated, whereas patients between 6 and 18 months of age at diagnosis were included with any form of DDH. Participating centers (academic, urban, tertiary care hospitals) span five countries across three continents. Baseline data (patient demographics, diagnosis, swaddling history, baseline International Hip Dysplasia Institute classification, and initial treatment) were compared among all nine centers. A total of 496 patients were enrolled with site enrolment ranging from 10 to 117. The proportion of eligible patients who were enrolled and followed at the nine participating centers was 98%. Patient enrollment rates were similar across all sites, and data collection/completeness for relevant variables at initial presentation was comparable. In total, 83% of all patients were female (410 of 496), and the median age at presentation was 2.2 months (range, 0-18 months). Breech presentation occurred more often in younger (Hip Dysplasia Institute classification), which included 58% (51 of 88) of all classified dislocated hips. Splintage was the primary initial treatment of choice at 80% (395 of 496), but was far more likely in younger compared with older patients (94% [309 of 328] versus 18% [17 of 93]; p < 0.001). With the lack of strong prognostic indicators for DDH

  20. Comparison between ultrasonography and computed tomography for detecting the pyramidal lobe of the thyroid gland: A prospective multicenter study

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Dong Wook [Dept. of Radiology, Busan Paik Hospital, Inje University College of Medicine, Busan (Korea, Republic of); Jung, So Lyoung [Dept. of Radiology, Seoul St. Mary' s Hospital, College of Medicine, The Catholic University of Korea, Seoul (Korea, Republic of); Kim, Jin Na [Dept. of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul (Korea, Republic of); Ryu, Ji Hwa [Dept. of Radiology, Haeundae Paik Hospital, Inje University College of Medicine, busan (Korea, Republic of); Sung, Jin Yong [Dept. of Radiology, Thyroid Center, Daerim St. Mary' s Hospital, Seoul (Korea, Republic of); Lim, Hyun Kyung [Dept. of Radiology, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul (Korea, Republic of)

    2015-04-15

    To compare the detection rates of the pyramidal lobe of the thyroid gland (TPL) using ultrasonography (US) and computed tomography (CT) in a prospective multi-center study. We enrolled 582 patients who underwent neck CT at six institutions. Each radiologist prospectively evaluated the presence and features of TPLs on thyroid US. Radiologists were divided into two groups according to their previous experience in detecting TPL on US or CT. The same radiologist also retrospectively assessed CT findings, blinded to the corresponding US findings. The pyramidal lobe of the thyroid glands were detected in 230 cases (39.5%) on US and in 276 cases (47.6%) on CT. The TPL detection rate at the six institutions ranged from 22.0% to 59% for US and from 34.1% to 59% using CT. There were significant differences between US and CT in the detection rate, length, anteroposterior diameter, volume, and superior extent of TPL (p < or = 0.027). The TPL detection rates on both US and CT (p < 0.001) differed significantly according to the experience level of the radiologists. When the CT result was used as a reference standard, the sensitivity, specificity, positive and negative predictive values, as well as the accuracy of US for TPL detection were 72.6%, 91.5%, 89.3%, 77.3%, and 82.1%, respectively. Our prospective multicenter study revealed that US could detect TPL with relatively high diagnostic accuracy compared to CT. Because the detection rate of TPL varied significantly according to the radiologists' level of experience, careful inspection is necessary to avoid imaging pitfalls and ensure appropriate evaluation of TPL on both US and CT.

  1. Quality of Life after Endoscopic Submucosal Dissection for Early Gastric Cancer: A Prospective Multicenter Cohort Study

    Science.gov (United States)

    Kim, Sang Gyun; Ji, Seon Mi; Lee, Na Rae; Park, Seung-Hee; You, Ji Hye; Choi, Il Ju; Lee, Wan Sik; Park, Seun Ja; Lee, Jun Haeng; Seol, Sang-Yong; Kim, Ji Hyun; Lim, Chul-Hyun; Cho, Joo Young; Kim, Gwang Ha; Chun, Hoon Jai; Lee, Yong Chan; Jung, Hwoon-Yong; Kim, Jae J.

    2017-01-01

    Background/Aims Endoscopic submucosal dissection (ESD) has been an established treatment for indicated early gastric cancer (EGC) without deterioration of quality of life (QOL) compared with surgical resection. The aim of this study was to evaluate long-term QOL in patients undergoing ESD for EGC. Methods Patients scheduled to undergo curative ESD for EGC were prospectively enrolled from 12 institutions between May 2010 and December 2011. Assessments of QOL with Korean versions of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire-core (QLQ-C30) and a gastric cancer-specific questionnaire (STO22) were performed at baseline and at 7 days, 3 months, and 6 months after ESD. Results A total of 666 subjects were assessed for QLQ-C30 and QLQ-STO22. The mean QLQ-C30 score was 69.5 at baseline, 68.8 at 7 days, 73.1 at 3 months, and 73.2 at 6 months. The global health status on the EORTC QLQ-C30 was significantly improved after 3 and 6 months (p=0.0003 and p<0.0001, respectively). The QLQ-C30 and STO22 scores were not significantly different, or they only slightly deteriorated between before and immediately after ESD, but they were significantly improved after 3 and 6 months (p<0.05). Conclusions QOL did not deteriorate immediately after ESD, and it improved more significantly at up to 6 months in patients who underwent curative ESD for EGC without significant complications. PMID:27282267

  2. Anisakis hypersensitivity in Italy: prevalence and clinical features: a multicenter study.

    Science.gov (United States)

    2011-12-01

    Anisakis simplex (As), a parasite in fish, is able to sensitize humans via the alimentary tract. The prevalence of hypersensitivity and allergy to As outside the Iberian peninsula has not been investigated so far. We investigated Anisakis hypersensitivity in different areas of Italy. Consecutive subjects seen at 34 Italian allergy centers from October to December 2010 were investigated both by specific interview and by skin prick test (SPT) with As extract. A total of 10 570 subjects were screened, of which 474 (4.5%) scored positive on Anisakis SPT and 66 of these (14% of those sensitized; 0.6% of the studied population) had a history of As allergy. Marinated anchovies were the most frequent cause of allergic reactions. Thirty-four (52%) patients were mono-sensitized to Anisakis. Sensitization rate showed marked geographic differences (range: 0.4-12.7%), being highest along the Adriatic and Tyrrhenian coasts, where homemade marinated anchovies are an age-old tradition. In inland centers in northern Italy, the prevalence was directly related to the number of inhabitants. The analysis of the impact of immigration on the prevalence of Anisakis hypersensitivity showed that about 60% of sensitized subjects in Milano and Torino came from southern Italy or from non-European countries. Anisakis hypersensitivity and allergy are mainly a matter of dietary habits. Areas where marinated anchovies are popular can be considered as 'endemic' for this type of food allergy, whereas immigration and, possibly, new or imported trendy food styles, such as eating raw fish carpaccios or sushi, are a major causative factor in big cities of inland zones. © 2011 John Wiley & Sons A/S.

  3. Heart rate awareness in patients with chronic stable heart failure. A multi-center observational study.

    LENUS (Irish Health Repository)

    Moran, D

    2014-08-23

    We assessed adherence to European Society of Cardiology heart rate guidelines (i.e. heart rates less than 70bpm) in patients with chronic stable heart failure. We also investigated the percent of patients on target doses of rate controlling drugs.

  4. Convergence to the European Energy Policy in European countries: case studies and comparison

    Directory of Open Access Journals (Sweden)

    César Teixeira

    2014-10-01

    Full Text Available Purpose – Our paper aims at analyzing how different European countries cope with the European Energy Policy, which proposes a set of measures (free energy market, smart meters, energy certificates to improve energy utilization and management in Europe.Design/methodology/approach – The paper first reports the general vision, regulations and goals set up by Europe to implement the European Energy Policy. Later on, it performs an analysis of how some European countries are coping with the goals, with financial, legal, economical and regulatory measures. Finally, the paper draws a comparison between the countries to present a view on how Europe is responding to the emerging energy emergency of the modern world.Findings – Our analysis on different use cases (countries showed that European countries are converging to a common energy policy, even though some countries appear to be later than others In particular, Southern European countries were slowed down by the world financial and economical crisis. Still, it appears that contingency plans were put into action, and Europe as a whole is proceeding steadily towards the common vision.Research limitations/implications – European countries are applying yet more cuts to financing green technologies, and it is not possible to predict clearly how each country will evolve its support to the European energy policy.Practical implications – Different countries applied the concepts and measures in different ways. The implementation of the European energy policy has to cope with the resulting plethora of regulations, and a company proposing enhancement regarding energy management still has to possess robust knowledge of the single country, before being able to export experience and know-how between European countries.Originality/Value – Even though a few surveys on energy measures in Europe are already part of the state-of-the-art, organic analysis diagonal to the different topics of the European

  5. Carfilzomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed multiple myeloma: a multicenter, phase 2 study.

    Science.gov (United States)

    Bringhen, Sara; Petrucci, Maria Teresa; Larocca, Alessandra; Conticello, Concetta; Rossi, Davide; Magarotto, Valeria; Musto, Pellegrino; Boccadifuoco, Luana; Offidani, Massimo; Omedé, Paola; Gentilini, Fabiana; Ciccone, Giovannino; Benevolo, Giulia; Genuardi, Mariella; Montefusco, Vittorio; Oliva, Stefania; Caravita, Tommaso; Tacchetti, Paola; Boccadoro, Mario; Sonneveld, Pieter; Palumbo, Antonio

    2014-07-03

    This multicenter, open-label phase 2 trial determined the safety and efficacy of carfilzomib, a novel and irreversible proteasome inhibitor, in combination with cyclophosphamide and dexamethasone (CCyd) in patients with newly diagnosed multiple myeloma (NDMM) ≥65 years of age or who were ineligible for autologous stem cell transplantation. Patients (N = 58) received CCyd for up to 9 28-day cycles, followed by maintenance with carfilzomib until progression or intolerance. After a median of 9 CCyd induction cycles (range 1-9), 95% of patients achieved at least a partial response, 71% achieved at least a very good partial response, 49% achieved at least a near complete response, and 20% achieved stringent complete response. After a median follow-up of 18 months, the 2-year progression-free survival and overall survival rates were 76% and 87%, respectively. The most frequent grade 3 to 5 toxicities were neutropenia (20%), anemia (11%), and cardiopulmonary adverse events (7%). Peripheral neuropathy was limited to grades 1 and 2 (9%). Fourteen percent of patients discontinued treatment because of adverse events, and 21% of patients required carfilzomib dose reductions. In summary, results showed high complete response rates and a good safety profile. This trial was registered at clinicaltrials.gov as #NCT01346787.

  6. Efficacy of glatiramer acetate in neuromyelitis optica spectrum disorder: a multicenter retrospective study.

    Science.gov (United States)

    Ayzenberg, Ilya; Schöllhammer, Joanna; Hoepner, Robert; Hellwig, Kerstin; Ringelstein, Marius; Aktas, Orhan; Kümpfel, Tania; Krumbholz, Markus; Trebst, Corinna; Paul, Friedemann; Pache, Florence; Obermann, Mark; Zeltner, Lena; Schwab, Matthias; Berthele, Achim; Jarius, Sven; Kleiter, Ingo

    2016-03-01

    Glatiramer acetate (GA) is an approved therapy for relapsing-remitting multiple sclerosis, but its efficacy for the prevention of attacks in neuromyelitis optica spectrum disorder (NMOSD) remains unknown. We did a multicenter retrospective analysis of GA-treated patients with NMOSD, identified through a national registry. Annualized relapse rate and expanded disability status scale (EDSS) were the main outcome measures. We identified 23 GA-treated patients (21 female, 16 aquaporin-4 antibody-positive). GA was given for <6 months in seven patients; reasons for stopping were relapses (n = 3), confirmation of NMOSD (n = 2) and side effects (n = 2). Of 16 patients treated ≥ 6 months with GA (15 female, 11 aquaporin-4 antibody-positive), 14 experienced at least one relapse. There was no reduction in the mean annualized relapse rate in the total group (1.9 ± 1.1 before vs. 1.8 ± 1.4 during GA therapy), as well as in those patients who were aquaporin-4 antibody-positive, or had a history of prior immunotherapy or not. The median EDSS increased (2.5 start vs. 3.5 finish of GA, P < 0.05). GA therapy was discontinued in 15/16 patients; reasons were therapeutic inefficacy in 13 and post-injection skin reactions in two patients. We conclude that GA is not beneficial for preventing attacks in most patients with NMOSD, particularly in aquaporin-4 antibody-positive cases.

  7. A multicenter study to map genes for Fuchs endothelial corneal dystrophy: baseline characteristics and heritability.

    Science.gov (United States)

    Louttit, Megan D; Kopplin, Laura J; Igo, Robert P; Fondran, Jeremy R; Tagliaferri, Angela; Bardenstein, David; Aldave, Anthony J; Croasdale, Christopher R; Price, Marianne O; Rosenwasser, George O; Lass, Jonathan H; Iyengar, Sudha K

    2012-01-01

    To describe the methods for family and case-control recruitment for a multicenter genetic and associated heritability analyses of Fuchs endothelial corneal dystrophy (FECD). Twenty-nine enrolling sites with 62 trained investigators and coordinators gathered individual and family information, graded the phenotype, and collected blood and/or saliva for genetic analysis on all individuals with and without FECD. The degree of FECD was assessed in a 0 to 6 semiquantitative scale using standardized clinical methods with pathological verification of FECD on at least 1 member of each family. Central corneal thickness was measured by ultrasonic pachymetry. Three hundred twenty-two families with 330 affected sibling pairs with FECD were enrolled and included a total of 650 sibling pairs of all disease grades. Using the entire 7-step FECD grading scale or a dichotomous definition of severe disease, heritability was assessed in families via sib-sib correlations. Both binary indicators of severe disease and semiquantitative measures of disease severity were significantly heritable, with heritability estimates of 30% for severe disease, 37% to 39% for FECD score, and 47% for central corneal thickness. Genetic risk factors have a strong role in the severity of the FECD phenotype and corneal thickness. Genotyping this cohort with high-density genetic markers followed by appropriate statistical analyses should lead to novel loci for disease susceptibility.

  8. Confirmed adult dengue deaths in Singapore: 5-year multi-center retrospective study

    Directory of Open Access Journals (Sweden)

    Narayanan Rajmohan L

    2011-05-01

    Full Text Available Abstract Background Dengue re-emerges in Singapore despite decades of effective vector control; the infection predominantly afflicts adults. Severe dengue not fulfilling dengue hemorrhagic fever (DHF criteria according to World Health Organization (WHO 1997 guideline was increasingly reported. A new WHO 2009 guideline emphasized warning signs and a wider range of severe dengue manifestations. We aim to evaluate the utility of these two guidelines in confirmed adult dengue fatalities. Methods We conducted a multi-center retrospective chart review of all confirmed adult dengue deaths in Singapore from 1 January 2004 to 31 December 2008. Results Of 28 adult dengue deaths, median age was 59 years. Male gender comprised 67.9% and co-morbidities existed in 75%. From illness onset, patients presented for admission at a median of 4 days and death occurred at a median of 12 days. Intensive care admission was required in 71.4%. Probable dengue was diagnosed in 32.1% by WHO 1997 criteria and 78.6% by WHO 2009. The earliest warning sign was persistent vomiting at a median of 1.5 days. Hematocrit change ≥20% concurrent with platelet count Conclusions In our adult fatal dengue cohort, WHO 2009 criteria had higher sensitivity in diagnosing probable dengue and severe dengue compared with WHO 1997. As warning signs, persistent vomiting occurred early and hematocrit change ≥20% concurrent with platelet count

  9. ProKaSaRe Study Protocol: A Prospective Multicenter Study of Pulmonary Rehabilitation of Patients With Sarcoidosis

    OpenAIRE

    Lingner, H.; Großhennig, Anika; Flunkert, Kathrin; Buhr-Schinner, Heike; Heitmann, Rolf; Tönnesmann, Ulrich; van der Meyden, Jochen; Schultz, Konrad

    2015-01-01

    Background Available data assessing the efficacy of pulmonary rehabilitation for patients with chronic sarcoidosis are scant; for Germany, there are none at all. Objective To gain information about the benefit of in-house pulmonary rehabilitation for patients with chronic sarcoidosis and for the health care system, we intend to collect data in a prospective multicenter “real-life” cohort trial. Methods ProKaSaRe (Prospektive Katamnesestudie Sarkoidose in der pneumologischen Rehabilitation) [P...

  10. Extraskeletal osteosarcoma: A European Musculoskeletal Oncology Society study on 266 patients.

    Science.gov (United States)

    Longhi, A; Bielack, S S; Grimer, R; Whelan, J; Windhager, R; Leithner, A; Gronchi, A; Biau, D; Jutte, P; Krieg, A H; Klenke, F M; Grignani, G; Donati, D M; Capanna, R; Casanova, J; Gerrand, C; Bisogno, G; Hecker-Nolting, S; De Lisa, M; D'Ambrosio, L; Willegger, M; Scoccianti, G; Ferrari, S

    2017-03-01

    Prognosis of extraskeletal osteosarcoma (ESOS) is reported to be poorer than that of skeletal osteosarcoma. This multicenter retrospective study aimed to evaluate factors influencing ESOS prognosis. Members of the European Musculoskeletal Oncology Society (EMSOS) submitted institutional data on patients with ESOS. Data from 274 patients treated from 1981 to 2014 were collected from 16 EMSOS centres; 266 patients were eligible. Fifty (18.7%) had metastases at diagnosis. Of 216 patients with localised disease, 211 (98%) underwent surgery (R0 = 70.6%, R1 = 27%). Five-year overall survival (OS) for all 266 patients was 47% (95% CI 40-54%). Five-year OS for metastatic patients was 27% (95% CI 13-41%). In the analysis restricted to the 211 localised patients who achieved complete remission after surgery 5-year OS was 51.4% (95% CI 44-59%) and 5-year disease-free survival (DFS) was 43% (95% CI 35-51%). One hundred twenty-one patients (57.3%) received adjuvant or neoadjuvant chemotherapy and 80 patients (37.9%) received radiotherapy. A favourable trend was seen for osteosarcoma-type chemotherapy versus soft tissue sarcoma-type (doxorubicin ± ifosfamide) regimens. For the 211 patients in complete remission after surgery, patient age, tumour size, margins and chemotherapy were positive prognostic factors for DFS and OS by univariate analysis. At multivariate analysis, patient age (≤40 years versus >40 years) (P = 0.05), tumour size (P = 0.0001) and receipt of chemotherapy (P = 0.006) were statistically significant prognostic factors for survival. Patient age and tumour size are factors influencing ESOS prognosis. Higher survival was observed in patients who received perioperative chemotherapy with a trend in favour of multiagent osteosarcoma-type regimen which included doxorubicin, ifosfamide and cisplatin. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Sonographic prediction of outcome of vacuum deliveries: a multicenter, prospective cohort study.

    Science.gov (United States)

    Kahrs, Birgitte H; Usman, Sana; Ghi, Tullio; Youssef, Aly; Torkildsen, Erik A; Lindtjørn, Elsa; Østborg, Tilde B; Benediktsdottir, Sigurlaug; Brooks, Lis; Harmsen, Lotte; Romundstad, Pål R; Salvesen, Kjell Å; Lees, Christoph C; Eggebø, Torbjørn M

    2017-07-01

    Safe management of the second stage of labor is of great importance. Unnecessary interventions should be avoided and correct timing of interventions should be focused. Ultrasound assessment of fetal position and station has a potential to improve the precision in diagnosing and managing prolonged or arrested labors. The decision to perform vacuum delivery is traditionally based on subjective assessment by digital vaginal examination and clinical expertise and there is currently no method of objectively quantifying the likelihood of successful delivery. Prolonged attempts at vacuum delivery are associated with neonatal morbidity and maternal trauma, especially so if the procedure is unsuccessful and a cesarean is performed. The aim of the study was to assess if ultrasound measurements of fetal position and station can predict duration of vacuum extractions, mode of delivery, and fetal outcome in nulliparous women with prolonged second stage of labor. We performed a prospective cohort study in nulliparous women at term with prolonged second stage of labor in 7 European maternity units from 2013 through 2016. Fetal head position and station were determined using transabdominal and transperineal ultrasound, respectively. Our preliminary clinical experience assessing head-perineum distance prior to vacuum delivery suggested that we should set 25 mm for the power calculation, a level corresponding roughly to +2 below the ischial spines. The main outcome was duration of vacuum extraction in relation to ultrasound measured head-perineum distance with a predefined cut-off of 25 mm, and 220 women were needed to discriminate between groups using a hazard ratio of 1.5 with 80% power and alpha 5%. Secondary outcomes were delivery mode and umbilical artery cord blood samples after birth. The time interval was evaluated using survival analyses, and the outcomes of delivery were evaluated using receiver operating characteristic curves and descriptive statistics. Results were

  12. Results of prospective multicenter study on heart failure on Campania Internal Medicine wards: the FASHION study

    Directory of Open Access Journals (Sweden)

    Fernando Gallucci

    2017-06-01

    Full Text Available Heart failure (HF is characterized by a high prevalence and hospitalization rate with considerable health and social impact; the knowledge of its epidemiological features remains the mainstay to assess adequacy of the health care needs. The aim of this study was to evaluate the prevalence of HF in Internal Medicine Units of the Campania region (Italy and patients’ characteristics. We recruited all patients with HF admitted between April 1 and June 30, 2014, in 23 Units of Internal Medicine: 975 patients (19.5% of 5000 admissions, 518 women and 457 men, mean age 76.9±9.9 (range 34-100 with 741 (76% older than 70 years. The mean age was higher in women than men; 35.8% of patients had atrial fibrillation, with higher prevalence in women than in men. Coronary artery disease represented the leading etiology while prevalence of non-ischemic heart failure was higher in women. New York Heart Association class was indicated in 926 patients. Left ventricular ejection fraction (LVEF was measured in 503 patients; 18.4% of patients had a severely reduced LVEF<35%, mostly men (P=0.0001 and 67.4% presented a LVEF>40%. At least one hospital admission in the previous 12 months was registered in 39.6% of patients. One, two and more than two relevant comorbidities were present in 8.6%, 24.7% and 64.8% of patients, respectively. Arterial hypertension and coronary artery disease were more frequent in female. In conclusion, advanced age and clinical complexity were the main characteristics of HF patients hospitalized in the Internal Medicine Units in Campania. Gender differences also emerged from the analysis of demographic parameters and etiopathogenetic features. Some diagnostic and therapeutic aspects not in line with that recommended by the most recent HF international guidelines were registered.

  13. A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis.

    Science.gov (United States)

    Kuhle, J; Hardmeier, M; Disanto, G; Gugleta, K; Ecsedi, M; Lienert, C; Amato, M P; Baum, K; Buttmann, M; Bayas, A; Brassat, D; Brochet, B; Confavreux, C; Edan, G; Färkkilä, M; Fredrikson, S; Frontoni, M; D'Hooghe, M; Hutchinson, M; De Keyser, J; Kieseier, B C; Kümpfel, T; Rio, J; Polman, C; Roullet, E; Stolz, C; Vass, K; Wandinger, K P; Kappos, L

    2016-04-01

    To explore long-term effects of treatment and prognostic relevance of variables assessed at baseline and during the European secondary progressive multiple sclerosis (SPMS) trial of interferon beta 1b (IFNB-1b). We assessed 362 patients (60% female; median age 41 years; Expanded Disability Status Scale (EDSS): 5.5; 51% randomized to IFNB-1b) for their EDSS and treatment history after 10 years. Non-parametric analysis of covariance (ANCOVA) and multivariate linear regression models were applied. Median EDSS was 6.0 at the end of the randomized controlled trial (RCT), in the IFNB-1b and placebo groups, and 7.0 in long-term follow-up patients (those receiving IFNB-1b in the RCT were 6.5 and those receiving placebo in the RCT were 7.0; p = 0.086). 24 patients (6.6%) were deceased. The EDSS at baseline and the EDSS change during the RCT were the most important predictors of the EDSS 10 years later (partial R(2): 0.47). The ability to predict changes in EDSS 10 years after the RCT was limited (R(2): 0.12). Magnetic resonance imaging (MRI) measures remained in the predictive models, but explained < 5% of the variability. The results from this analysis did not provide convincing evidence to support a favorable long-term outcome in those patients allocated IFNB-1b during the RCT, in our SPMS cohort. The progressive stage of the disease remains largely unpredictable by clinical and conventional MRI measures, so better prognostic markers are needed. © The Author(s), 2015.

  14. Randomized, multicenter, comparative study of NEURO versus CIMT in poststroke patients with upper limb hemiparesis: the NEURO-VERIFY Study.

    Science.gov (United States)

    Abo, Masahiro; Kakuda, Wataru; Momosaki, Ryo; Harashima, Hiroaki; Kojima, Miki; Watanabe, Shigeto; Sato, Toshihiro; Yokoi, Aki; Umemori, Takuma; Sasanuma, Jinichi

    2014-07-01

    Many poststroke patients suffer functional motor limitation of the affected upper limb, which is associated with diminished health-related quality of life. The aim of this study is to conduct a randomized, multicenter, comparative study of low-frequency repetitive transcranial magnetic stimulation combined with intensive occupational therapy, NEURO (NovEl intervention Using Repetitive TMS and intensive Occupational therapy) versus constraint-induced movement therapy in poststroke patients with upper limb hemiparesis. In this randomized controlled study of NEURO and constraint-induced movement therapy, 66 poststroke patients with upper limb hemiparesis were randomly assigned at 2:1 ratio to low-frequency repetitive transcranial magnetic stimulation plus occupational therapy (NEURO group) or constraint-induced movement therapy (constraint-induced movement therapy group) for 15 days. Fugl-Meyer Assessment and Wolf Motor Function Test and Functional Ability Score of Wolf Motor Function Test were used for assessment. No differences in patients' characteristics were found between the two groups at baseline. The Fugl-Meyer Assessment score was significantly higher in both groups after the 15-day treatment compared with the baseline. Changes in Fugl-Meyer Assessment scores and Functional Ability Score of Wolf Motor Function Test were significantly higher in the NEURO group than in the constraint-induced movement therapy group, whereas the decrease in the Wolf Motor Function Test log performance time was comparable between the two groups (changes in Fugl-Meyer Assessment score, NEURO: 5·39 ± 4·28, constraint-induced movement therapy: 3·09 ± 4·50 points; mean ± standard error of the mean; P < 0·05) (changes in Functional Ability Score of Wolf Motor Function Test, NEURO: 3·98 ± 2·99, constraint-induced movement therapy: 2·09 ± 2·96 points; P < 0·05). The results of the 15-day rehabilitative protocol showed the superiority of NEURO

  15. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial

    NARCIS (Netherlands)

    S.M. Jeurnink; E.W. Steyerberg; J.E. van Hooft; C.H.J. van Eijck; M.P. Schwartz; F.P. Vleggaar; E.J. Kuipers; P.D. Siersema

    2010-01-01

    BACKGROUND: Both gastrojejunostomy (GJJ) and stent placement are commonly used palliative treatments of obstructive symptoms caused by malignant gastric outlet obstruction (GOO). OBJECTIVE: Compare GJJ and stent placement. DESIGN: Multicenter, randomized trial. SETTING: Twenty-one centers in The Net

  16. In-Depth Study Of European Union Fiscal Approximation

    Directory of Open Access Journals (Sweden)

    Andreea Roxana TOMI

    2011-05-01

    Full Text Available The current study presents a viewpoint on the EU fiscal policy contents, advocating the need for an in-depth understanding and acceleration of the 27 national fiscal system components and the creation of the EU Tax System that would enable the Single Market operation and the enforcement of the four fundamental liberties within the European Union. In the author’s opinion, the extant common fiscal policy elements are only marginal, while the actions aimed at an in-depth understanding of a broad fiscal policy are essential to the extent they point at both direct and indirect taxation aspects whose approximation is a priority.

  17. Intravenous ketamine for the treatment of refractory status epilepticus: a retrospective multi-center study

    Science.gov (United States)

    Gaspard, Nicolas; Foreman, Brandon; Judd, Lilith M.; Brenton, James N.; Nathan, Barnett R.; McCoy, Blathnaid M.; Al-Otaibi, Ali; Kilbride, Ronan; Fernández, Ivan Sánchez; Mendoza, Lucy; Samuel, Sophie; Zakaria, Asma; Kalamangalam, Giridhar P.; Legros, Benjamin; Szaflarski, Jerzy P.; Loddenkemper, Tobias; Hahn, Cecil D.; Goodkin, Howard P.; Claassen, Jan; Hirsch, Lawrence J.; LaRoche, Suzette M.

    2013-01-01

    Summary Purpose To examine patterns of use, efficacy and safety of intravenous ketamine for the treatment of refractory status epilepticus (RSE). Methods Multicenter retrospective review of medical records and EEG reports in ten academic medical centers in North America and Europe, including 58 subjects, representing 60 episodes of RSE were identified between 1999 and 2012. Seven episodes occurred after anoxic brain injury. Key findings Permanent control of RSE was achieved in 57% (34/60) of episodes. Ketamine was felt to have contributed to permanent control (“possible” or “likely” responses) in 32% (19/60) including seven (12%) in which ketamine was the last drug added (likely responses). Four of the seven likely responses, but none of the 12 possible ones, occurred in patients with post-anoxic brain injury. No likely responses were observed when infusion rates were lower than 0.9mg/kg/h; when ketamine was introduced at least eight days after SE onset; or after failure of seven or more drugs. Ketamine was discontinued due to possible adverse events in five patients. Complications were mostly attributed to concurrent drugs, especially other anesthetics. Mortality rate was 43% (26/60), but was lower when SE was controlled within 24h of ketamine initiation (16% vs. 56%, p=0.0047). Significance Ketamine appears to be a relatively effective and safe drug for the treatment of RSE. This retrospective series provides preliminary data on effective dose and appropriate time of intervention to aid in the design of a prospective trial to further define the role of ketamine in the treatment of RSE. PMID:23758557

  18. High-Dose and High-Frequency Lanreotide Autogel in Acromegaly: A Randomized, Multicenter Study.

    Science.gov (United States)

    Giustina, Andrea; Mazziotti, Gherardo; Cannavò, Salvatore; Castello, Roberto; Arnaldi, Giorgio; Bugari, Giovanna; Cozzi, Renato; Ferone, Diego; Formenti, Anna Maria; Gatti, Enza; Grottoli, Silvia; Maffei, Pietro; Maffezzoni, Filippo; Montini, Marcella; Terzolo, Massimo; Ghigo, Ezio

    2017-07-01

    Increase in drug frequency or dose is recommended for acromegaly patients with partial response to long-acting somatostatin receptor ligands (SRLs). However, the efficacy and safety data with lanreotide (LAN) Autogel (LAN-ATG) at high dose (HD) or high frequency (HF) are still scanty. To evaluate the biochemical efficacy and safety of HF and HD LAN-ATG in patients with active acromegaly. Twenty-four-week prospective, multicenter, randomized, open-label trial. Thirty patients with active acromegaly, partial responders to SRLs, were randomized to HF (120 mg/21 days; 15 patients) or HD (180 mg/28 days; 15 patients) LAN-ATG. Normalization of serum insulin-like growth factor-I (IGF-I) and reduction in random growth hormone (GH) values < 1.0 µg/L, reduction in serum IGF-I and GH from baseline, differences in biochemical response between HF and HD LAN-ATG, adverse events. IGF-I decreased significantly (P = 0.007) during the 24-week treatment, with greater decrease in HD (P = 0.03) vs HF group (P = 0.08). Normalization in IGF-I values occurred in 27.6% of patients (P = 0.016 vs baseline), without a significant difference between HF and HD groups (P = 0.59). The decrease in serum IGF-I significantly correlated with serum LAN values (P = 0.04), and normalization of IGF-I was predicted by baseline IGF-I values (P = 0.02). Serum GH values did not change significantly (P = 0.22). Overall, 19 patients (63.3%) experienced adverse events, all being mild to moderate and transient, without differences between the two therapeutic arms. HF and HD LAN-ATG regimens are effective in normalizing IGF-I values in about one-third of patients with active acromegaly inadequately controlled by long-term conventional SRLs therapy.

  19. [MIPS: multicenter Italian pneumonia study. Results of an observational, prospective and multicenter study on the clinical approach to community-acquired pneumonia].

    Science.gov (United States)

    Artom, A; Artom, P; Rattenni, S; Castello, C; Lo Pinto, G

    2004-09-01

    In a survey of 25 Divisions of Internal Medicine and Pneumology throughout Italy, our study aimed to ascertain the diagnostic and therapeutic pathway, the gravity in accordance with Fine's score (PSI), the median hospital length of stay and mortality rate among patients consecutively hospitalized for community-acquired pneumonia (CAP), from January 1 to March 31, 2002. Overall 407 patients were evaluated, with a mean age of 69 years; the following Fine's scores: 28% less than 70, 21.4% between 71 and 90, 31.25% between 91 and 130, 19.4% more than130. A single chest radiography was performed in 27.2% of the patients, two chest radiographs in 55.2% of the patients, more than two chest radiographs in 13.2% of the patients. A CT scan of the thorax was performed in 20.1% of the patients; arterial blood gas tensions were measured in 73.4% of the patients. Antibiotics were used as follows: beta-lactams in 46.5% of the patients, fluoroquinolones in 30% of the patients, macrolides in 13.2% of the patients, glycopeptides in 2.2% of the patients, others in 2.9% of the patients. Mean hospital stay was 11 days; the 30-day in-hospital mortality was 9.6%. This study showed that a large number of patients with low-risk CAP were unnecessarily hospitalized.

  20. Effectiveness of a 16-Week Multimodal Exercise Program on Individuals With Dementia: Study Protocol for a Multicenter Randomized Controlled Trial

    Science.gov (United States)

    Scharpf, Andrea; Barisch-Fritz, Bettina; Niermann, Christina; Woll, Alexander

    2017-01-01

    Background The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking. Objective This study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high-quality multicenter trial. Methods A multicenter randomized controlled trial with baseline and postassessments will be performed. It is planned to enroll 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-week ritualized MEP especially developed for IWD. The effectiveness of the MEP on the primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limbs, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, and visual spatial cognition). Results Enrollment for the study started in May 2015. It is planned to complete postassessments by the beginning of 2017. Results are expected to be available in the first half of 2017. Conclusions This study will contribute to enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterized by a dementia-specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant to influence the multiple motor and cognitive impairments of IWD who are often participating in limited physical activity. Trial

  1. Web-based documentation system with exchange of DICOM RT for multicenter clinical studies in particle therapy

    Science.gov (United States)

    Kessel, Kerstin A.; Bougatf, Nina; Bohn, Christian; Engelmann, Uwe; Oetzel, Dieter; Bendl, Rolf; Debus, Jürgen; Combs, Stephanie E.

    2012-02-01

    Conducting clinical studies is rather difficult because of the large variety of voluminous datasets, different documentation styles, and various information systems, especially in radiation oncology. In this paper, we describe our development of a web-based documentation system with first approaches of automatic statistical analyses for transnational and multicenter clinical studies in particle therapy. It is possible to have immediate access to all patient information and exchange, store, process, and visualize text data, all types of DICOM images, especially DICOM RT, and any other multimedia data. Accessing the documentation system and submitting clinical data is possible for internal and external users (e.g. referring physicians from abroad, who are seeking the new technique of particle therapy for their patients). Thereby, security and privacy protection is ensured with the encrypted https protocol, client certificates, and an application gateway. Furthermore, all data can be pseudonymized. Integrated into the existing hospital environment, patient data is imported via various interfaces over HL7-messages and DICOM. Several further features replace manual input wherever possible and ensure data quality and entirety. With a form generator, studies can be individually designed to fit specific needs. By including all treated patients (also non-study patients), we gain the possibility for overall large-scale, retrospective analyses. Having recently begun documentation of our first six clinical studies, it has become apparent that the benefits lie in the simplification of research work, better study analyses quality and ultimately, the improvement of treatment concepts by evaluating the effectiveness of particle therapy.

  2. Long-term application of computer-based pleoptics in home therapy: selected results of a prospective multicenter study.

    Science.gov (United States)

    Kämpf, Uwe; Shamshinova, Angelika; Kaschtschenko, Tamara; Mascolus, Wilfried; Pillunat, Lutz; Haase, Wolfgang

    2008-01-01

    The paper presents selected results of a prospective multicenter study. The reported study was aimed at the evaluation of a software-based stimulation method of computer training applied in addition to occlusion as a complementary treatment for therapy-resistant cases of amblyopia. The stimulus was a drifting sinusoidal grating of a spatial frequency of 0.3 cyc/deg and a temporal frequency of 1 cyc/sec, reciprocally coordinated with each other to a drift of 0.33 deg/sec. This pattern was implemented as a background stimulus into simple computer games to bind attention by sensory-motor coordination tasks. According to an earlier proposed hypothesis, the stimulation aims at the provocation of stimulus-induced phase-coupling in order to contribute to the refreshment of synchronization and coordination processes in the visual transmission channels. To assess the outcome of the therapy, we studied the development of the visual acuity during a period of 6 months. Our cooperating partners of this prospective multicenter study were strabologic departments in ophthalmic clinics and private practices as well. For the issue of therapy control, a partial sample of 55 patients from an overall sample of 198 patients was selected, according to the criterion of strong therapy resistance. The visual acuity was increased about two logarithmic steps by an occlusion combined with computer training in addition to the earlier obtained gain of the same amount by occlusion alone. Recalculated relatively to the duration of the therapy periods, the computer training combined with occlusion was found to be about twice as effective as the preceding occlusion alone. The results of combined computer training and occlusion show an additional increase of the same amount as the preceding occlusion alone, which yielded at its end no further advantage to the development of visual acuity in the selected sample of our 55 therapy-resistant patients. In a concluding theoretical note, a preliminary

  3. Network of European studies of genes in growth (NESTEGG).

    Science.gov (United States)

    Johnston, Linda B; Ester, Wiestske; Caliebe, Janina; Molinas, Catherine; Wollmann, Hartmut; Fryklund, Linda; Clark, Adrian J; Ranke, Michael B; Tauber, Maithe; Hokken Koelega, Anita; Savage, Martin O

    2009-04-01

    The network of European studies of genes in growth (NESTEGG) is an international growth genomics project, focusing on the birth size phenotypes of small for gestational age (SGA) and idiopathic short stature. Seven hundred controls and 1,275 cases with their parents have been recruited. Detailed clinical histories and auxological measurements are recorded in a clinical database. Candidate gene studies are being undertaken with the study DNA samples. These genetic data will be used to explore associations with the clinical phenotypes of short stature and SGA birth size, and, in a subset, response to growth hormone (GH) therapy. This article describes the study methodology and reviews the association of the exon 3-deleted genotype of the GH receptor with GH responsiveness in GH-treated children born SGA. Copyright 2009 S. Karger AG, Basel.

  4. Rapid virological response of telaprevir and boceprevir in a Brazilian cohort of HCV genotype 1 patients: a multicenter longitudinal study

    Directory of Open Access Journals (Sweden)

    Borba HHL

    2017-01-01

    Full Text Available Helena HL Borba,1 Astrid Wiens,1 Laiza M Steimbach,1 Fernanda S Tonin,1 Maria LA Pedroso,2 Cláudia AP Ivantes,3 Fernando Fernandez-Llimos,4 Roberto Pontarolo1 1Pharmaceutical Sciences Postgraduate Research Program, Department of Pharmacy, 2Gastroenterology Service, Hospital de Clínicas, Federal University of Paraná, 3Guidance and Counseling Center, Curitiba City Hall, Curitiba, Paraná, Brazil; 4Department of Social Pharmacy, Faculty of Pharmacy, Research Institute for Medicines, University of Lisboa, Lisbon, Portugal Background: Chronic hepatitis C is a major public health issue, but there is a gap in the literature regarding the effectiveness and safety of direct-acting antiviral agents in the Brazilian population. The main aim of this study was to describe the effectiveness of boceprevir and telaprevir in patients treated at public health care institutions in Brazil.Materials and methods: A prospective longitudinal and multicenter study was conducted in five centers in the State of Paraná between September 2014 and June 2016. Data regarding effectiveness and safety were collected from medical records of patients treated with boceprevir or telaprevir. The effectiveness outcome comprised the rapid virological response (RVR. Multivariate analysis was performed to verify the influence of independent variables (ie, age, gender, baseline viral load on RVR achievement.Results: Data were collected from 117 patients with chronic hepatitis C virus (HCV genotype 1 infection. Fifteen patients received treatment with boceprevir and 102 received telaprevir. The mean age was 51.6 years, 64.1% were male, 44.4% were infected with HCV subtype 1a, 62.4% had a high baseline viral load (≥800,000 IU/mL and 33% were cirrhotic. Furthermore, 79.5% of patients achieved RVR (26.7% in the boceprevir group and 87.3% in the telaprevir group. Multivariate analysis demonstrated that the type of protease inhibitor (boceprevir or telaprevir and the baseline viral load

  5. Extra-coronary calcification (aortic valve calcification, mitral annular calcification, aortic valve ring calcification and thoracic aortic calcification) in HIV seropositive and seronegative men: Multicenter AIDS Cohort Study.

    OpenAIRE

    Rezaeian, P.; Miller, PE; Haberlen, SA; Razipour, A; Bahrami, H; Castillo, R.; Witt, MD; Kingsley, L; Palella, FJ; Nakanishi, R; Matsumoto, S.; Alani, A; Jacobson, LP; Post, WS; Budoff, MJ

    2016-01-01

    Previous studies have demonstrated an association between HIV infection and coronary artery disease (CAD); little is known about potential associations between HIV infection and extra-coronary calcification (ECC).We analyzed 621 HIV infected (HIV+) and 384 HIV uninfected (HIV-) men from the Multicenter AIDS Cohort Study who underwent non-contrast computed tomography (CT) from 2010-2013. Agatston scores were calculated for mitral annular calcification (MAC), aortic valve calcification (AVC), a...

  6. Preoperative Anxiety before Spinal Anesthesia: Does Internet-based Visual Information/Multimedia Research Decrease Anxiety and Information Desire? A Prospective Multicentered Study

    OpenAIRE

    Tulgar, Serkan; Boga, Ibrahim; Piroglu, Mustafa Devrim; Ates, Nagihan Gozde; Bombaci, Elif; Can, Tuba; Selvi, Onur; Tas, Zafer; Kose, Halil Cihan

    2017-01-01

    Background: Preoperative anxiety may lead to peroperative or postoperative problems when not overcome. Aims: The aim of this study was to examine the effect of seeking information and other factors on the anxiety of patients preoperatively. Settings and Design: This study was a prospective, multicentered survey. Materials and Methods: Patients scheduled to undergo surgical procedures under spinal anesthesia, preoperatively evaluated as the American Society of Anesthesia 1?3 and where spinal a...

  7. Natural-cause mortality and long-term exposure to particle components : An Analysis of 19 European cohorts within the multi-center ESCAPE project

    NARCIS (Netherlands)

    Beelen, Rob; Hoek, Gerard; Raaschou-Nielsen, Ole; Stafoggia, Massimo; Andersen, Zorana Jovanovic; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Fischer, Paul H.; Nieuwenhuijsen, Mark J.; Xun, Wei W.; Katsouyanni, Klea; Dimakopoulou, Konstantina; Marcon, Alessandro; Vartiainen, Erkki; Lanki, Timo; Yli-Tuomi, Tarja; Oftedal, Bente; Schwarze, Per E.; Nafstad, Per; de Faire, Ulf; Pedersen, Nancy L.; Östenson, Claes Göran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pershagen, Göran; Eriksen, Kirsten Thorup; Overvad, Kim; Sørensen, Mette; Eeftens, Marloes; Peeters, Petra H.; Meliefste, Kees; Wang, Meng; Bas Bueno-De-Mesquita, H.; Sugiri, Dorothea; Krämer, Ursula; Heinrich, Joachim; De Hoogh, Kees; Key, Timothy; Peters, Annette; Hampel, Regina; Concin, Hans; Nagel, Gabriele; Jaensch, Andrea; Ineichen, Alex; Tsai, Ming Yi; Schaffner, Emmanuel; Probst-Hensch, Nicole M.; Schindler, Christian; Ragettli, Martina S.; Vilier, Alice; Clavel-Chapelon, Françoise; Declercq, Christophe; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Katsoulis, Michail; Trichopoulou, Antonia; Keuken, Menno; Jedynska, Aleksandra; Kooter, Ingeborg M.; Kukkonen, Jaakko; Sokhi, Ranjeet S.; Vineis, Paolo; Brunekreef, Bert

    2015-01-01

    Background: Studies have shown associations between mortality and long-term exposure to particulate matter air pollution. Few cohort studies have estimated the effects of the elemental composition of particulate matter on mortality. oBjectives: Our aim was to study the association between

  8. Natural-cause mortality and long-term exposure to particle components: An Analysis of 19 European cohorts within the multi-center ESCAPE project

    NARCIS (Netherlands)

    Beelen, R.; Hoek, G.; Raaschou-Nielsen, O.; Stafoggia, M.; Andersen, Z.J.; Weinmayr, G.; Hoffmann, B.; Wolf, K.; Samoli, E.; Fischer, P.H.; Nieuwenhuijsen, M.J.; Xun, W.W.; Katsouyanni, K.; Dimakopoulou, K.; Marcon, A.; Vartiainen, E.; Lanki, T.; Yli-Tuomi, T.; Oftedal, B.; Schwarze, P.E.; Nafstad, P.; de Faire, U.; Pedersen, N.L.; Östenson, C.-G.; Fratiglioni, L.; Penell, J.; Korek, M.; Pershagen, G.; Eriksen, K.T.; Overvad, K.; Sørensen, M.; Eeftens, M.; Peeters, P.H.; Meliefste, K.; Wang, M.; Bas Bueno-De-Mesquita, H.; Sugiri, D.; Krämer, U.; Heinrich, J.; De Hoogh, K.; Key, T.; Peters, A.; Hampel, R.; Concin, H.; Nagel, G.; Jaensch, A.; Ineichen, A.; Tsai, M.-Y.; Schaffner, E.; Probst-Hensch, N.M.; Schindler, C.; Ragettli, M.S.; Vilier, A.; Clavel-Chapelon, F.; Declercq, C.; Ricceri, F.; Sacerdote, C.; Galassi, C.; Migliore, E.; Ranzi, A.; Cesaroni, G.; Badaloni, C.; Forastiere, F.; Katsoulis, M.; Trichopoulou, A.; Keuken, M.; Jedynska, A.; Kooter, I.M.; Kukkonen, J.; Sokhi, R.S.; Vineis, P.; Brunekreef, B.

    2015-01-01

    Background: Studies have shown associations between mortality and long-term exposure to particulate matter air pollution. Few cohort studies have estimated the effects of the elemental composition of particulate matter on mortality. oBjectives: Our aim was to study the association between

  9. Natural-cause mortality and long-term exposure to particle components : an analysis of 19 European cohorts within the multi-center ESCAPE project

    NARCIS (Netherlands)

    Beelen, Rob|info:eu-repo/dai/nl/30483100X; Hoek, Gerard|info:eu-repo/dai/nl/069553475; Raaschou-Nielsen, Ole; Stafoggia, Massimo; Andersen, Zorana Jovanovic; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Fischer, Paul H; Nieuwenhuijsen, Mark J; Xun, Wei W; Katsouyanni, Klea; Dimakopoulou, Konstantina; Marcon, Alessandro; Vartiainen, Erkki; Lanki, Timo; Yli-Tuomi, Tarja; Oftedal, Bente; Schwarze, Per E; Nafstad, Per; De Faire, Ulf; Pedersen, Nancy L; Östenson, Claes-Göran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pershagen, Göran; Eriksen, Kirsten Thorup; Overvad, Kim; Sørensen, Mette; Eeftens, Marloes|info:eu-repo/dai/nl/315028300; Peeters, Petra H; Meliefste, Kees; Wang, Meng; Bueno-de-Mesquita, H Bas; Sugiri, Dorothea; Krämer, Ursula; Heinrich, Joachim; de Hoogh, Kees; Key, Timothy; Peters, Annette; Hampel, Regina; Concin, Hans; Nagel, Gabriele; Jaensch, Andrea; Ineichen, Alex; Tsai, Ming-Yi; Schaffner, Emmanuel; Probst-Hensch, Nicole M; Schindler, Christian; Ragettli, Martina S; Vilier, Alice; Clavel-Chapelon, Françoise; Declercq, Christophe; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Katsoulis, Michail; Trichopoulou, Antonia; Keuken, Menno; Jedynska, Aleksandra; Kooter, Ingeborg M; Kukkonen, Jaakko; Sokhi, Ranjeet S; Vineis, Paolo; Brunekreef, Bert|info:eu-repo/dai/nl/067548180

    BACKGROUND: Studies have shown associations between mortality and long-term exposure to particulate matter air pollution. Few cohort studies have estimated the effects of the elemental composition of particulate matter on mortality. OBJECTIVES: Our aim was to study the association between

  10. Natural-cause mortality and long-term exposure to particle components : An Analysis of 19 European cohorts within the multi-center ESCAPE project

    NARCIS (Netherlands)

    Beelen, Rob; Hoek, Gerard; Raaschou-Nielsen, Ole; Stafoggia, Massimo; Andersen, Zorana Jovanovic; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Fischer, Paul H.; Nieuwenhuijsen, Mark J.; Xun, Wei W.; Katsouyanni, Klea; Dimakopoulou, Konstantina; Marcon, Alessandro; Vartiainen, Erkki; Lanki, Timo; Yli-Tuomi, Tarja; Oftedal, Bente; Schwarze, Per E.; Nafstad, Per; de Faire, Ulf; Pedersen, Nancy L.; Östenson, Claes Göran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pershagen, Göran; Eriksen, Kirsten Thorup; Overvad, Kim; Sørensen, Mette; Eeftens, Marloes; Peeters, Petra H.; Meliefste, Kees; Wang, Meng; Bas Bueno-De-Mesquita, H.; Sugiri, Dorothea; Krämer, Ursula; Heinrich, Joachim; De Hoogh, Kees; Key, Timothy; Peters, Annette; Hampel, Regina; Concin, Hans; Nagel, Gabriele; Jaensch, Andrea; Ineichen, Alex; Tsai, Ming Yi; Schaffner, Emmanuel; Probst-Hensch, Nicole M.; Schindler, Christian; Ragettli, Martina S.; Vilier, Alice; Clavel-Chapelon, Françoise; Declercq, Christophe; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Katsoulis, Michail; Trichopoulou, Antonia; Keuken, Menno; Jedynska, Aleksandra; Kooter, Ingeborg M.; Kukkonen, Jaakko; Sokhi, Ranjeet S.; Vineis, Paolo; Brunekreef, Bert

    2015-01-01

    Background: Studies have shown associations between mortality and long-term exposure to particulate matter air pollution. Few cohort studies have estimated the effects of the elemental composition of particulate matter on mortality. oBjectives: Our aim was to study the association between natural-ca

  11. Natural-cause mortality and long-term exposure to particle components : an analysis of 19 European cohorts within the multi-center ESCAPE project

    NARCIS (Netherlands)

    Beelen, Rob; Hoek, Gerard; Raaschou-Nielsen, Ole; Stafoggia, Massimo; Andersen, Zorana Jovanovic; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Fischer, Paul H; Nieuwenhuijsen, Mark J; Xun, Wei W; Katsouyanni, Klea; Dimakopoulou, Konstantina; Marcon, Alessandro; Vartiainen, Erkki; Lanki, Timo; Yli-Tuomi, Tarja; Oftedal, Bente; Schwarze, Per E; Nafstad, Per; De Faire, Ulf; Pedersen, Nancy L; Östenson, Claes-Göran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pershagen, Göran; Eriksen, Kirsten Thorup; Overvad, Kim; Sørensen, Mette; Eeftens, Marloes; Peeters, Petra H; Meliefste, Kees; Wang, Meng; Bueno-de-Mesquita, H Bas; Sugiri, Dorothea; Krämer, Ursula; Heinrich, Joachim; de Hoogh, Kees; Key, Timothy; Peters, Annette; Hampel, Regina; Concin, Hans; Nagel, Gabriele; Jaensch, Andrea; Ineichen, Alex; Tsai, Ming-Yi; Schaffner, Emmanuel; Probst-Hensch, Nicole M; Schindler, Christian; Ragettli, Martina S; Vilier, Alice; Clavel-Chapelon, Françoise; Declercq, Christophe; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Katsoulis, Michail; Trichopoulou, Antonia; Keuken, Menno; Jedynska, Aleksandra; Kooter, Ingeborg M; Kukkonen, Jaakko; Sokhi, Ranjeet S; Vineis, Paolo; Brunekreef, Bert

    2015-01-01

    BACKGROUND: Studies have shown associations between mortality and long-term exposure to particulate matter air pollution. Few cohort studies have estimated the effects of the elemental composition of particulate matter on mortality. OBJECTIVES: Our aim was to study the association between natural-ca

  12. Characterizing restless legs syndrome and leg motor restlessness in patients with Parkinson's disease: A multicenter case-controlled study.

    Science.gov (United States)

    Suzuki, Keisuke; Okuma, Yasuyuki; Uchiyama, Tomoyuki; Miyamoto, Masayuki; Sakakibara, Ryuji; Shimo, Yasushi; Hattori, Nobutaka; Kuwabara, Satoshi; Yamamoto, Toshimasa; Kaji, Yoshiaki; Hirano, Shigeki; Numao, Ayaka; Hirata, Koichi

    2017-08-14

    We investigated the prevalence and impact of restless legs syndrome (RLS) and leg motor restlessness (LMR) in patients with Parkinson's disease (PD) in a multicenter study. A total of 436 PD patients and 401 age- and sex-matched controls were included in this study. RLS was diagnosed based on four essential features. LMR was diagnosed when a participant exhibited the urge to move his or her legs but did not meet the four essential features of RLS. The RLS prevalence did not differ between PD patients and controls (3.4% vs. 2.7%), while LMR prevalence was significantly higher in PD patients than in controls (12.8% vs. 4.5%). PD patients with RLS or LMR had a higher prevalence of excessive daytime sleepiness (EDS) (50.7%, vs. 6.9%), probable REM sleep behavior disorder (38.0% vs. 3.4%) and PD-related sleep problems (49.3% vs. 20.7%) than controls with RLS or LMR. RLS/LMR preceding PD onset was related to an older age of PD onset. Our study revealed an increased prevalence of LMR but not RLS in PD patients. LMR could be an early manifestation of PD; however, whether LMR is within the range of RLS or whether LMR and RLS constitute different entities in PD requires further studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Depression symptoms reduce physical activity in COPD patients: a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    Dueñas-Espín I

    2016-06-01

    Full Text Available Iván Dueñas-Espín,1–5 Heleen Demeyer,6 Elena Gimeno-Santos,1–3 Michael I Polkey,7 Nicholas S Hopkinson,7 Roberto A Rabinovich,8 Fabienne Dobbels,9 Niklas Karlsson,10 Thierry Troosters,6,11 Judith Garcia-Aymerich1–3 On behalf of the PROactive Consortium 1ISGlobal, Centre for Research in Environmental Epidemiology (CREAL, 2Universitat Pompeu Fabra (UPF, 3CIBEREpidemiología y Salud Pública (CIBERESP, Barcelona, Spain; 4Secretaría Nacional de Educación Superior, Ciencia, Tecnología e Innovación del Ecuador (SENESCYT, Quito, Ecuador; 5Institut d’investigacions Biomèdiques August Pi i Sunyer (IDIBAPS, Barcelona, Spain; 6Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium; 7NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, UK; 8ELEGI Colt Laboratory, Centre for Inflammation Research, The Queen’s Medical Research Institute, University of Edinburgh, Edinburgh, UK; 9Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium; 10Health Economics and Outcomes Research, AstraZeneca R&D, Mölndal, Sweden; 11Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium Background: The role of anxiety and depression in the physical activity (PA of patients with COPD is controversial. We prospectively assessed the effect of symptoms of anxiety and depression on PA in COPD patients.Methods: We evaluated anxiety and depression (Hospital Anxiety and Depression Scale [HADS], PA (Dynaport® accelerometer, and other relevant characteristics in 220 COPD patients from five European countries at baseline and at 6 and 12 months of follow-up. HADS score was categorized as: no symptoms (score 0–7, suggested (8–10, and probable (>11 anxiety or depression. We estimated the association between anxiety and depression at t (baseline and 6 months and PA at t+1 (6 and 12 months using

  14. [Multi-center study on the treatment of sudden total deafness].

    Science.gov (United States)

    Zheng, Hong; Dai, Qing-qing; Zhou, Lian; Feng, Ning-yu; Qiu, Jian-hua; Chen, Yang; Wen, Li-ting; Han, Yu; Chen, Jun; Lin, Ying

    2013-05-01

    To assess the results of drug therapy in patients with severe idiopathic sudden sensorineural hearing loss (ISSHL) with total frequency hearing loss. A prospective randomized, single blind, multi-center clinical trial was designed. The untreated patients with ISSHL were included, who had severe hearing loss (pure tone audiometry showed patients had total frequency hearing loss, and their mean auditory threshold of 500, 1000, 2000, 4000 Hz was beyond 81 dB HL), age between 18 to 65 years old, and within 14 days of the onset . The patients were divided into one of the four drug groups [batroxobin, batroxobin + ginkgo biloba leaves extract (EGb), batroxobin + EGb + glucocorticoids, EGb + glucocorticoids] according to the random table, and receive treatment. Totally 276 patients with unilateral severe ISSHL were included from 33 hospitals, from August 2007 to October 2011. Among them, male patients accounted for 135 (48.91%), female 141 (51.09%); the average age was (41.7 ± 13.3)years. Forty cases were recovered (14.49%), 78 cases had marked effective (28.26%), 76 cases were effective (27.54%), 82 cases were in-effective (29.71%), and the total effective rate was 70.29%. Among four drug groups, the separate effective rate were 73.33%, 61.43%, 78.31% and 67.95% respectively, no significant difference was found between groups (χ(2) = 9.97,P = 0.62). Among the four groups, the separate cure rate for hearing loss were 11.11%, 12.86%, 16.87% and 15.38%, the glucocorticoid groups were significantly better than those not used. Among severe sudden deafness patients, 92.39% cases accompanied with tinnitus, 44.93% with dizziness (or vertigo), 50.36% with ear stuffy. There had no significant difference between the four groups with accompanied symptoms (all P > 0.05). It is value to give active treatment to sever sudden deafness patients because of an effective rate of 70%. However, the doctors and patients should be mind of a cure rate of only 14%. Steroids are recommended

  15. Research Design in the study of the European Neighbourhood Policy

    DEFF Research Database (Denmark)

    Exadaktylos, Theofanis; Lynggaard, Kennet

    2017-01-01

    This chapter deals with the pitfalls and pathways of research design aimed at the study of the European Neighbourhood Policy (ENP) and maps out the literature on questions of knowledge ambition, research ontology and epistemology, and choices of approaches to the research object. We include...... a review of traditional research designs in ENP research, through a systematic meta-analysis of a selection of the most-cited articles on the ENP. Inspired by earlier work on awareness of research design in EU studies, ENP research is categorised according to typical choices of research design in the form...... of dichotomous trade-offs. The chapter then discusses how individual contributions to this volume deal with research design challenges of the past and present innovative ways of studying the revised ENP....

  16. Ethics teaching in European veterinary schools: a qualitative case study.

    Science.gov (United States)

    Magalhães-Sant'Ana, M

    2014-12-13

    Veterinary ethics is recognised as a relevant topic in the undergraduate veterinary curriculum. However, there appears to be no widely agreed view on which contents are best suited for veterinary ethics teaching and there is limited information on the teaching approaches adopted by veterinary schools. This paper provides an inside perspective on the diversity of veterinary ethics teaching topics, based on an in-depth analysis of three European veterinary schools: Copenhagen, Lisbon and Nottingham. The case study approach integrated information from the analysis of syllabi contents and interviews with educators (curricular year 2010-2011). These results show that the curriculum of veterinary ethics is multidimensional and can combine a wide range of scientific, regulatory, professional and philosophical subjects, some of which may not be explicitly set out in the course descriptors. A conceptual model for veterinary ethics teaching is proposed comprising prominent topics included within four overarching concepts: animal welfare science, laws/regulations, professionalism, and theories/concepts. It is intended that this work should inform future curriculum development of veterinary ethics in European schools and assist ethical deliberation in veterinary practice.

  17. Multicenter study on hepatitis C virus infection in patients with dilated cardiomyopathy. North Italy Transplant Program (NITP).

    Science.gov (United States)

    Prati, D; Poli, F; Farma, E; Picone, A; Porta, E; De Mattei, C; Zanella, A; Scalamogna, M; Gamba, A; Gronda, E; Faggian, G; Livi, U; Puricelli, C; Viganò, M; Sirchia, G

    1999-06-01

    Preliminary epidemiological and histological studies from Japan suggested that hepatitis C virus (HCV) infection has a role in the development of dilated cardiomyopathy (DCM). This multicenter study was conducted to verify this hypothesis on a large cohort of Italian patients with end-stage heart failure. Antibodies to HCV were determined in the 752 consecutive patients (608 males and 144 females; age, 53 +/- 13 years) who entered the waiting list for cardiac transplantation from 1995 to 1997 at the six cardiac surgery centers participating in the North Italy Transplant program. Three hundred and nine patients (41%) had dilated, 9 (1%) restrictive, and 4 (0.5%) hypertrophic cardiomyopathy; 284 patients (38%) had ischemic, 65 (9%) valvular, and 22 (3%) congenital heart disease; 5 patients (0.5%) had primary pulmonary hypertension; 54 patients (7%) had other or nonspecified heart disease. Overall, 41 of 752 patients (5.4%) resulted anti-HCV-reactive. Serological evidence of HCV infection was found in 12 of 309 patients with DCM (3.9%; 95% CI, 1.7-6.0), and in 29 of 443 without DCM (6.5%; 95% CI, 4.2-8.8), without statistical difference (difference of prevalence rate: 2.6%; 95% CI, -4.9 to 5.8). In conclusion, HCV does not seem to have a primary role in the pathogenesis of DCM. However, since our findings are in disagreement with those obtained in smaller series of patients of other ethnicity, large studies from different countries should be conducted.

  18. A multicenter reproducibility study of single-voxel {sup 1}H-MRS of the medial temporal lobe

    Energy Technology Data Exchange (ETDEWEB)

    Traeber, Frank; Block, Wolfgang; Guer, Okan; Schild, Hans H. [University of Bonn, Department of Radiology, Bonn (Germany); Freymann, Nikolaus; Heun, Reinhard; Jessen, Frank [University of Bonn, Department of Psychiatry, Bonn (Germany); Kucinski, Thomas [University of Hamburg, Department of Neuroradiology, Hamburg (Germany); Hammen, Thilo [University of Erlangen, Department of Psychiatry, Erlangen (Germany); Ende, Gabriele [Central Institute of Mental Health, NMR Research in Psychiatry, Mannheim (Germany); Pilatus, Ulrich [University of Frankfurt, Department of Neuroradiology, Frankfurt (Germany); Hampel, Harald [University of Munich, Department of Psychiatry, Munich (Germany)

    2006-05-15

    Proton magnetic resonance spectroscopy ({sup 1}H-MRS) has provided evidence for a reduction of N-acetyl-aspartate (NAA) in the medial temporal lobe (MTL) in cerebral disorders such as Alzheimer's Disease. Within the {sup 1}H-MRS study of the German Research Network on Dementia, we determined the multicenter reproducibility of single-voxel {sup 1}H-MRS of the MTL. At five sites with 1.5T MR systems, single-voxel {sup 1}H spectra from the MTL of an identical healthy subject were measured. The same subject was also examined at one of the sites five times to assess intracenter stability. The protocol included water-suppressed spectra with TE 272 ms and TE 30 ms and unsuppressed spectra for absolute quantification of metabolite concentrations. The intracenter reproducibility of absolute NAA concentration, expressed as coefficient of variation (CV), was 1.8%. CV for the concentrations of creatine (Cr), choline (Cho), and myoinositol (MI) and for the ratios NAA/Cr, NAA/Cho, and MI/NAA varied by 11-16%. Intercenter CV was 3.9% for NAA and were below 10% for all other metabolites and metabolic ratios. Our study demonstrates that quantitative assessment of NAA with single-voxel MRS can be performed with high intercenter reproducibility. This is the basis for applying {sup 1}H-MRS in large-scale early recognition and treatment studies in MTL affecting disorders. (orig.)

  19. Assessment of the Asian Neurogastroenterology and Motility Association Chronic Constipation Criteria: An Asian Multicenter Cross-sectional Study.

    Science.gov (United States)

    Gwee, Kok-Ann; Bergmans, Paul; Kim, JinYong; Coudsy, Bogdana; Sim, Angelia; Chen, Minhu; Lin, Lin; Hou, Xiaohua; Wang, Huahong; Goh, Khean-Lee; Pangilinan, John A; Kim, Nayoung; Varannes, Stanislas Bruley des

    2017-04-30

    There is a need for a simple and practical tool adapted for the diagnosis of chronic constipation (CC) in the Asian population. This study compared the Asian Neurogastroenterology and Motility Association (ANMA) CC tool and Rome III criteria for the diagnosis of CC in Asian subjects. This multicenter, cross-sectional study included subjects presenting at outpatient gastrointestinal clinics across Asia. Subjects with CC alert symptoms completed a combination Diagnosis Questionnaire to obtain a diagnosis based on 4 different diagnostic methods: self-defined, investigator's judgment, ANMA CC tool, and Rome III criteria. The primary endpoint was the level of agreement/disagreement between the ANMA CC diagnostic tool and Rome III criteria for the diagnosis of CC. The primary analysis comprised of 449 subjects, 414 of whom had a positive diagnosis according to the ANMA CC tool. Rome III positive/ANMA positive and Rome III negative/ANMA negative diagnoses were reported in 76.8% and 7.8% of subjects, respectively, resulting in an overall percentage agreement of 84.6% between the 2 diagnostic methods. The overall percentage disagreement between these 2 diagnostic methods was 15.4%. A higher level of agreement was seen between the ANMA CC tool and self-defined (374 subjects [90.3%]) or investigator's judgment criteria (388 subjects [93.7%]) compared with the Rome III criteria. This study demonstrates that the ANMA CC tool can be a useful for Asian patients with CC.

  20. Prevalence of Neuropathic Pain in Patients with Traumatic Brachial Plexus Injury: A Multicenter Prospective Hospital-Based Study.

    Science.gov (United States)

    Ciaramitaro, Palma; Padua, Luca; Devigili, Grazia; Rota, Eugenia; Tamburin, Stefano; Eleopra, Roberto; Cruccu, Giorgio; Truini, Andrea

    2017-03-03

    Prevalence and clinical characteristics of neuropathic pain due to traumatic brachial plexus injury. Observational epidemiological study. Hospital-based multicenter study. One hundred seven prospectively enrolled patients with brachial plexus injury. All the patients underwent clinical examination and neurophysiological testing for a definitive diagnosis of the brachial plexus lesion. The DN4 questionnaire was used to identify neuropathic pain, and the Neuropathic Pain Symptom Inventory (NPSI) to evaluate the different symptoms of neuropathic pain. The SF36 questionnaire and the Beck Depression Inventory (BDI) were used to assess quality of life and mood disturbances in patients with neuropathic pain. Of the 107 enrolled patients, 74 had pain (69%); neuropathic pain, as assessed by means of the DN4, was identified in 60 (56%) of these patients. According to the NPSI, the most frequent and severe pain type was the spontaneous burning pain. Clinical and neurophysiological findings showed that pain is unrelated to age but is associated with the severity of peripheral nerve damage. The SF36 questionnaire and BDI showed that neuropathic pain impairs quality of life and causes depression. Our study provides information on the prevalence, characteristics, and variables associated with neuropathic pain due to traumatic brachial plexus injuries that might provide a basis for improving the clinical management of this condition.

  1. Preoperative anemia does not predict complications after single-level lumbar fusion: a propensity score-matched multicenter study.

    Science.gov (United States)

    Kim, Bobby D; Edelstein, Adam I; Patel, Alpesh A; Lovecchio, Francis; Kim, John Y S

    2014-11-01

    Multicenter retrospective cohort study. To estimate the impact of preoperative anemia on 30-day complications in patients undergoing single-level lumbar fusion. Anemia has been widely implicated as a risk factor in various surgical procedures including elective spine surgery. No large-scale study has been performed to examine this relationship in single-level lumbar fusion surgery. The American College of Surgeons National Surgical Quality Improvement Program database was retrospectively reviewed to identify all patients who underwent single-level lumbar fusion procedures during 2006 to 2011. A propensity score-matching algorithm was used to match scores of anemic patients with that of nonanemic patients. Multivariate logistic regression analysis of unadjusted and propensity score-matched cohorts was performed to examine the effect of preoperative anemia on 30-day postoperative complication rates and length of hospital stay. A total of 2960 patients met inclusion criteria. The propensity score-matching procedure yielded scores of 491 pairs of well-matched nonanemic and anemic patients. The multivariate analysis of propensity score-matched population found preoperative anemia to carry no significant association with any of the complications analyzed, including overall complications, medical complications, surgical complications, reoperation, mortality, or length of total hospital stay. For patients undergoing single-level lumbar fusion, preoperative anemia is not independently associated with increased risk of 30-day complications or increased length of stay. Further studies are needed to independently validate this relationship in other spine surgical procedures. 3.

  2. Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study

    Directory of Open Access Journals (Sweden)

    Enger Shelley M

    2007-06-01

    Full Text Available Abstract Background The choice between paper data collection methods and electronic data collection (EDC methods has become a key question for clinical researchers. There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study. Methods A computer-based automated menu-driven system with 658 data fields was developed for a cohort study of women aged 65 years or older, diagnosed with invasive histologically confirmed primary breast cancer (N = 1859, at 6 Cancer Research Network sites. Medical record review with direct data entry into the EDC system was implemented. An inter-rater and intra-rater reliability (IRR system was developed using a modified version of the EDC. Results Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process. Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months. In addition, an innovative modified version of the EDC permitted an automated evaluation of inter-rater and intra-rater reliability across six data collection sites. Conclusion Automated EDC is a powerful tool for research efficiency and innovation, especially when multiple data collection sites are involved.

  3. Prevalence, Awareness, and Treatment of Hypertension in Patients with Type 1 Diabetes: A Nationwide Multicenter Study in Brazil

    Directory of Open Access Journals (Sweden)

    Marilia B. Gomes

    2013-01-01

    Full Text Available Objective. This study evaluated the prevalence, awareness, and type of treatment for hypertension in Brazil in patients with type 1 diabetes (T1D. Methods. This was a cross-sectional, multicenter study that was conducted from December 2008 to December 2010 in 28 public clinics located in 20 Brazilian cities. Results. A total of 3,591 patients were studied, 56% female, average age 21.2±11.7 years, with a median duration of diabetes 9.6±8.1 years. Blood pressure levels were available for a total of 3,323 patients and 689 (19.2% patients were hypertensive. Hypertensive patients were older, exhibited longer duration of diabetes, and had higher body mass index (BMI, total cholesterol, triglycerides, and LDL-C values (P<0.001, for all comparisons, but only 370 (53.7% received treatment. Patient awareness of hypertension was documented in 453 (65.5% patients. However, only 76 (22.9% of the treated patients attained the target systolic (sBP and diastolic blood pressures (dBP. Conclusions. Our results demonstrate that a large number of T1D patients with hypertension do not receive appropriate treatment; few of the treated T1D patients achieved the target sBP and dBP values. Greater attention should be paid to blood pressure evaluation, hypertension diagnosis, and treatment of T1D patients in Brazil.

  4. Evaluation of a Teleform-based data collection system: A multi-center obesity research case study

    Science.gov (United States)

    Jenkins, Todd M.; Boyce, Tawny Wilson; Akers, Rachel; Andringa, Jennifer; Liu, Yanhong; Miller, Rosemary; Powers, Carolyn; Buncher, C. Ralph

    2016-01-01

    Utilizing electronic data capture (EDC) systems in data collection and management allows automated validation programs to preemptively identify and correct data errors. For our multi-center, prospective study we chose to use TeleForm, a paper-based data capture software that uses recognition technology to create case report forms (CRFs) with similar functionality to EDC, including custom scripts to identify entry errors. We quantified the accuracy of the optimized system through a data audit of CRFs and the study database, examining selected critical variables for all subjects in the study, as well as an audit of all variables for 25 randomly selected subjects. Overall we found 6.7 errors per 10,000 fields, with similar estimates for critical (6.9/10,000) and non-critical (6.5/10,000) variables – values that fall below the acceptable quality threshold of 50 errors per 10,000 established by the Society for Clinical Data Management. However, error rates were found to widely vary by type of data field, with the highest rate observed with open text fields. PMID:24709056

  5. Barnidipine, a novel calcium antagonist for once-daily treatment of hypertension: a multicenter, double-blind, placebo-controlled, dose-ranging study. Dutch Barnidipine Multicenter Study Group.

    Science.gov (United States)

    Hart, W; Holwerda, N J

    1997-11-01

    The antihypertensive effects and tolerance of once-daily barnidipine, a novel dihydropyridine calcium antagonist, were evaluated. A total of 190 patients with a sitting diastolic blood pressure (DBP) of 95-114 mmHg were investigated in this multicenter, double-blind, placebo-controlled, dose-ranging study. After a 4-week single-blind placebo run-in period, patients were randomized to placebo or barnidipine (10 mg, 20 mg, or 30 mg modified release capsules) once daily for 6 weeks. Nonresponders (sitting DBP > or =90 mmHg and a decrease of barnidipine lowered blood pressure, with a trend toward a dose-response relationship over the dose range 10-30 mg. A dose increment of 10 mg in nonresponders resulted in additional reductions in blood pressure. At the end of the active treatment period, the responder rates were 41% and 57% for 10 mg and 20 mg barnidipine, respectively. Heart rate in both sitting and standing positions was not affected by barnidipine. Treatment with barnidipine was well tolerated, and the incidence of adverse events was dose related and consistent with vasodilatation. In conclusion, barnidipine (10-30 mg) administered once daily is well tolerated and reduces blood pressure in patients with mild to moderate hypertension.

  6. Long-term Exposure to Air Pollution and Cardiovascular Mortality: An Analysis of 22 European Cohorts.

    NARCIS (Netherlands)

    Beelen, Rob; Stafoggia, Massimo; Raaschou-Nielsen, Ole; Andersen, Zorana Jovanovic; Xun, Wei W; Katsouyanni, Klea; Dimakopoulou, Konstantina; Brunekreef, Bert; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Houthuijs, Danny; Nieuwenhuijsen, Mark; Oudin, Anna; Forsberg, Bertil; Olsson, David; Salomaa, Veikko; Lanki, Timo; Yli-Tuomi, Tarja; Oftedal, Bente; Aamodt, Geir; Nafstad, Per; De Faire, Ulf; Pedersen, Nancy L; Ostenson, Claes-Göran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pyko, Andrei; Eriksen, Kirsten Thorup; Tjønneland, Anne; Becker, Thomas; Eeftens, Marloes; Bots, Michiel; Meliefste, Kees; Wang, Meng; Bueno-de-Mesquita, Bas; Sugiri, Dorothea; Krämer, Ursula; Heinrich, Joachim; de Hoogh, Kees; Key, Timothy; Peters, Annette; Cyrys, Josef; Concin, Hans; Nagel, Gabriele; Ineichen, Alex; Schaffner, Emmanuel; Probst-Hensch, Nicole; Dratva, Julia; Ducret-Stich, Regina; Vilier, Alice; Clavel-Chapelon, Françoise; Stempfelet, Morgane; Grioni, Sara; Krogh, Vittorio; Tsai, Ming-Yi; Marcon, Alessandro; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Tamayo, Ibon; Amiano, Pilar; Dorronsoro, Miren; Katsoulis, Michail; Trichopoulou, Antonia; Vineis, Paolo; Hoek, Gerard

    2014-01-01

    BACKGROUND:: Air pollution has been associated with cardiovascular mortality, but it remains unclear as to whether specific pollutants are related to specific cardiovascular causes of death. Within the multicenter European Study of Cohorts for Air Pollution Effects (ESCAPE), we investigated the asso

  7. Familial Aggregation of Pure Tone Hearing Thresholds in an Aging European Population

    NARCIS (Netherlands)

    Hendrickx, J.J.; Huyghe, J.R.; Topsakal, V.; Demeester, K.; Wienker, T.F.; Laer, L.V.; Eyken, E.V.; Fransen, E.; Maki-Torkko, E.; Hannula, S.; Parving, A.; Jensen, M.; Tropitzsch, A.; Bonaconsa, A.; Mazzoli, M.; Espeso, A.; Verbruggen, K.; Huyghe, J.; Huygen, P.L.M.; Kremer, H.; Kunst, S.J.W.; Diaz-Lacava, A.N.; Steffens, M.; Pyykko, I.; Dhooge, I.; Stephens, D.; Orzan, E.; Pfister, M.H.; Bille, M.; Sorri, M.; Cremers, C.W.R.J.; Camp, G.V.; Heyning, P.V. de

    2013-01-01

    OBJECTIVE: To investigate the familial correlations and intraclass correlation of age-related hearing impairment (ARHI) in specific frequencies. In addition, heritability estimates were calculated. STUDY DESIGN: Multicenter survey in 8 European centers. SUBJECTS: One hundred ninety-eight families co

  8. Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography

    Science.gov (United States)

    Khashab, Mouen A.; Van der Merwe, Schalk; Kunda, Rastislav; El Zein, Mohamad H.; Teoh, Anthony Y.; Marson, Fernando P.; Fabbri, Carlo; Tarantino, Ilaria; Varadarajulu, Shyam; Modayil, Rani J.; Stavropoulos, Stavros N.; Peñas, Irene; Ngamruengphong, Saowanee; Kumbhari, Vivek; Romagnuolo, Joseph; Shah, Raj; Kalloo, Anthony N.; Perez-Miranda, Manuel; Artifon, Everson L.

    2016-01-01

    Background and aims: Endoscopic ultrasound-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures after failed endoscopic retrograde cholangiopancreatography (ERCP). However, prospective multicenter data are lacking. The aims of this study were to prospectively assess the short- and long-term efficacy and safety of EUS-BD in patients with malignant distal biliary obstruction. Patients and methods: Consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal biliary obstruction and failed ERCP underwent EUS-BD. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as a reduction in bilirubin by 50 % at 2 weeks or to below 3 mg/dL at 4 weeks. Adverse events were prospectively tracked and graded according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon’s severity grading system. Overall survival and duration of stent patency were calculated using Kaplan–Meier analysis. Results: A total of 96 patients (mean age 66 years, female 45 %, pancreatic cancer 55 %) underwent EUS-BD. Stent placement (technical success) was achieved in 92 (95.8 %) patients (metallic stent 84, plastic stent 8). Mean procedure time was 40 minutes. Clinical success was achieved in 86 (89.5 %) patients. A total of 10 (10.5 %) adverse events occurred: pneumoperitoneum (n = 2), sheared wire (n = 1), bleeding (n = 1), bile leak (n = 3), cholangitis (n = 2), and unintentional perforation (n = 1); 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). A total of 38 (44 %) patients died of disease progression during the study period. The median patient survival was 167 days (95 %CI 112 – 221) days. The 6-month stent patency rate was 95 % (95 %CI 94.94 – 95.06 %) and the 1-year stent patency was 86 % (95 %CI 85.74 – 86

  9. [Designing and implementation of a web-based quality monitoring system for plasma glucose measurement in multicenter population study].

    Science.gov (United States)

    Liu, Yong; Wang, Limin; Pang, Richard; Mo, Nanxun; Hu, Yan; Deng, Qian; Hu, Zhaohui

    2015-05-01

    The aim of this paper is to describe the designing and implementation of a web-based plasma glucose measurement quality monitoring system to assess the analytical quality of plasma glucose measurements in multicenter population study and provide evidence for the future studies. In the chronic non-communicable disease and related factor surveillance in China, a web based quality monitoring system for plasma glucose measurement was established to conduct evaluation on plasma glucose monitoring quality and effectiveness in 302 surveillance centers, including quality control data entry, transmission and feedback. The majority of the surveillance centers met the quality requirements and passed the evaluation of reproducibility and precision of plasma glucose measurement, only a few centers required intensive training and re-assessment. In order to ensure the completeness and reliability of plasma glucose measurement in the surveillance centers, the establishment of web-based plasma glucose measurement quality control system can facilitate the identification of the qualified surveillance centers and evaluation of plasma glucose measurement quality in different regions. Communication and training are important in ensuring plasma glucose measurement quality. It is necessary to further improve this web-based plasma glucose measurement quality monitoring system in the future to reduce the method specific plasma glucose measurement bias.

  10. The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program: rational and design of a multicenter prospective study.

    Science.gov (United States)

    Campo, Gianluca; Pavasini, Rita; Maietti, Elisa; Tonet, Elisabetta; Cimaglia, Paolo; Scillitani, Giulia; Bugani, Giulia; Serenelli, Matteo; Zaraket, Fatima; Balla, Cristina; Trevisan, Filippo; Biscaglia, Simone; Sassone, Biagio; Galvani, Marcello; Ferrari, Roberto; Volpato, Stefano

    2016-10-28

    Frailty has become a high-priority issue in cardiovascular medicine because of the aging of cardiovascular patients. Simple and reproducible tools to assess frailty in elderly patients are clearly on demand. Their application may help physicians in the selection of invasive and medical treatments and in the timing and modality of the follow-up. The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program is designed with the aim to validate the use of the short physical performance battery (SPPB) as prognostic tools in patients admitted to hospital for acute coronary syndrome (ACS). The FRASER program is a multicenter prospective study involving 4 Italian cardiology units. The FRASER program enrolls only patients aged ≥70 years. The core of the FRASER program includes patients admitted to hospital for ACS. The aims are (1) to describe SPPB distribution before hospital discharge and (2) to investigate the prognostic role of SPPB score. The primary outcome is a composite of 1-year all-cause mortality and hospital readmission for any cause. Ancillary analyses will be focused on different study populations (patients hospitalized for arrhythmias or acute heart failure or symptomatic severe aortic stenosis) and on different tools to assess frailty (multidimensional prognostic index, clinical frailty score, grip strength). The FRASER program will fill critical gaps in the knowledge regarding the link between frailty, cardiovascular disease, interventional procedures and outcome and will help physicians in the generation of a more personalized risk assessment and in the identification of potential targets for interventions.

  11. A multicenter observational study on the role of comorbidities in the recurrent episodes of benign paroxysmal positional vertigo.

    Science.gov (United States)

    De Stefano, Alessandro; Dispenza, Francesco; Suarez, Hamlet; Perez-Fernandez, Nicolas; Manrique-Huarte, Raquel; Ban, Jae Ho; Kim, Min-Beom; Kim, Min Beom; Strupp, Michael; Feil, Katharina; Oliveira, Carlos A; Sampaio, Andres L; Araujo, Mercedes F S; Bahmad, Fayez; Ganança, Mauricio M; Ganança, Fernando F; Dorigueto, Ricardo; Lee, Hyung; Kulamarva, Gautham; Mathur, Navneet; Di Giovanni, Pamela; Petrucci, Anna Grazia; Staniscia, Tommaso; Citraro, Leonardo; Croce, Adelchi

    2014-02-01

    Primary objective of this study was to find a statistical link between the most worldwide comorbidities affecting the elderly population (hypertension, diabetes, osteoarthrosis, osteoporosis and depression) and recurrent episodes of BPPV. Secondary objective was defining possible "groups of risk" for people suffering recurrent positional vertigo related to the presence of a well documented comorbidity. This was an observational, cross-sectional, multicenter, spontaneous, non-pharmacological study. The data of 1092 patients suffering BPPV evaluated in 11 different Departments of Otolaryngology, Otoneurology and Neurology, referring Centers for positional vertigo evaluation, were retrospectively collected. Regarding evaluated comorbidities (hypertension, diabetes, osteoarthrosis, osteoporosis and depression), data analysis showed the presence of at least one comorbid disorder in 216 subjects (19.8%) and 2 or more in 408 subjects (37.4%). Moreover there was a statistical significant difference between the number of comorbidities and the number of recurrences, otherwise said as comorbidity disorders increased the number of relapses increased too. The presence of a systemic disease may worsen the status of the posterior labyrinth causing a more frequent otolith detachment. This condition increases the risk for patients suffering BPPV to have recurrent episodes, even if correctly managed by repositioning maneuvers. The combination of two or more of aforementioned comorbidities further increases the risk of relapsing BPPV, worsened by the presence of osteoporosis. On the basis of this results it was possible to define "groups of risk" useful for predicting BPPV recurrence in patients with one or more comorbidity. Copyright © 2013. Published by Elsevier Ireland Ltd.

  12. Restless legs syndrome and multiple sclerosis: a Brazilian multicenter study and meta-analysis of the literature

    Directory of Open Access Journals (Sweden)

    Yára Dadalti Fragoso

    2011-04-01

    Full Text Available OBJECTIVE: The increased prevalence of restless legs syndrome (RLS in multiple sclerosis (MS has recently been the subject of a few papers. The present study investigated the prevalence of RLS symptoms in MS patients and in controls in four Brazilian cities. Additionally, a systematic review and meta-analysis of the literature was carried out on the subject of RLS-MS. METHOD: MS patients and controls were investigated regarding the presence of the four typical symptoms of RLS. A questionnaire assessing RLS severity was also used for patients and controls presenting the four RLS symptoms criteria. The systematic review and meta-analysis on the subject were carried out according to the strict international criteria. RESULTS: In the present report, the RLS-MS association was confirmed as being more than fortuitous in Brazilian MS patients, in a multicenter case-control study. MS patients also presented RLS symptoms of greater severity than did the control population. A systematic review and meta-analysis of the literature showed that MS patients had a fourfold higher chance of presenting RLS than did the controls. CONCLUSION: Although underlying mechanisms to explain the association RLS-MS are still a matter of discussion, there is a clear association of these two neurological conditions.

  13. [Drug resistance in Mycobacterium tuberculosis. A multicenter study of the Barcelona area. Grupo de Trabajo sobre Resistencias en Tuberculosis].

    Science.gov (United States)

    Martin-Casabona, N; Alcaide, F; Coll, P; González, J; Manterola, J M; Salvadó, M; Caylà, J A

    2000-10-21

    The aims of this multicenter study was to establish the level of primary and acquired drug resistance of M. Tuberculosis strains isolated in Barcelona and to identify possible risk groups using clinical data. All tuberculosis patients with isolation and identification of M. tuberculosis strains from October 1995 to September 1997 were included. Susceptibility tests isoniazid, rifampin, ethambutol, streptomycin and pyrazinamide were performed using the Bactec 460 system and the proportions method on solid medium. Logistic progression was used for statistical analysis. The total number of patients included was 1,749 (1,535 non-treated and 214 previously treated). Primary drug resistance was 5.7% (isoniazid 3.8%; rifampin 1.0%, streptomycin 2.1%, ethambutol 0.3% and pyrazinamide 1.0%). Acquired drug resistance was 20.5% (isoniazid 17.3%, rifampin 9.8%, ethambutol 1.9%, streptomycin 4.7% and pyrazinamide 6.5%). Primary drug resistance was associated with people over 60 years old and women. The low level of drug resistance enables antituberculosis treatment of non-treated patients to start with the standardised three-drug regimes except in the case of foreign people from countries with a high level of drug resistance. Susceptibility tests are recommended on all M. tuberculosis strains isolated, together with controlled studies of drug resistance surveillance.

  14. [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

    Science.gov (United States)

    Lu, Quan

    2010-03-01

    To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

  15. LESSER METATARSAL SESAMOIDITIS-POTENTIAL CAUSE OF FORE FOOT PAIN?? : A PROSPECTIVE MULTICENTER EPIDEMIOLOGICAL SCREENING STUDY OF THE ODISHA POPULATION

    Directory of Open Access Journals (Sweden)

    Sunil Kumar

    2014-11-01

    Full Text Available INTRODUCTION: Sesamoiditis as a cause of fore foot pain is less often thought of, patients suffer for extended periods due to misdiagnosis and analgesic abuse resulting in dissatisfaction, depression and anxiety. METHODS: We performed a multicenter prospective epidemiological screening study in Bhubaneswar, Odisha from Nov’ 2013 to July’ 2014 in patients of foot pain for the presence of lesser sesamoids to study the incidences and causes of fore foot pain in Odisha Population. RESULTS: We screened 960 patients (1920 feet in 500 male and 460 female patients. 5th Metatarsal sesamoids were present in 77 (8% patients (M/F: 1.8:1, Bilateral in 67 (86 % patients. (48% patients lesser sesamoids were bipartite and (82% were symptomatic. 52% recovered with conservative measures, 40 % patients required ultrasound guided injections and sesamoidectomy was performed in 8 % patients due to recurrence and/or failure. Other causes of fore foot pain were Rheumatoid Arthritis, Gouty Arthritis, Callosities, Hallux Valgus, Stress Fractures of the Metatarsals, Plantar Fasciitis, Infections, Morton’s Metatarsalgia and Barefoot Walking (mechanical. DISCUSSION: High incidences of lesser sesamoids is attributed to genetics, low socioeconomic status, bare foot walking and high prevalence of Diabetes Mellitus, Smoking and Gout in our country. CT and MRI provide useful information regarding the presence and pathology involving these bones, and should be used in concert with clinical findings to guide successful patient management. An initial trial of conservative measures should follow minimally invasive ultrasound guided injections of anesthetic with steroids and lastly surgical excision.

  16. Home Non-Invasive Ventilation Fails to Improve Quality of Life in the Elderly: Results from a Multicenter Cohort Study.

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    Adrien Tissot

    Full Text Available Home non-invasive ventilation (NIV is a widely used treatment for chronic hypoventilation but little is known on its impact in the elderly. In a multicenter prospective cohort study, we studied tolerance and efficacy of domiciliary NIV in patients aged 75 or more compared to younger ones.264 patients with at least a six-month follow-up were analyzed. Among them, 82 were elderly. In the elderly and the younger, we found an improvement of arterial blood gas, the Epworth sleepiness scale and the Pittsburgh sleep quality index at 6 months. Mean daily use of NIV at 6 months was 7 hours and the rate of non-adherent patients was similar in both group. Health-related quality of life (HRQL assessed by SF-36 questionnaires did not change significantly after NIV initiation in the elderly whereas HRQL improved in the less than 75. On univariate analysis, we found that diabetes was a predictive factor for non-adherence in the elderly (Odds ratio: 3.95% confidence interval: 1.06-8.52.NIV was efficient in the elderly while evaluation at 6 months showed a good adherence but failed to improve HRQL.

  17. Factors associated to temporal artery biopsy result in suspects of giant cell arteritis: a retrospective, multicenter, case-control study.

    Science.gov (United States)

    González-López, Julio J; González-Moraleja, Julio; Burdaspal-Moratilla, Ana; Rebolleda, Gema; Núñez-Gómez-Álvarez, María T; Muñoz-Negrete, Francisco J

    2013-12-01

    To evaluate the positivity rate of temporal artery biopsies (TAB) performed in suspects of giant cell arteritis (GCA) and to study the epidemiological and clinical factors associated to the biopsy result. A retrospective, multicenter, case-control study was performed, including three hundred and thirty-five patients who underwent TAB for a suspicion of GCA from 2001 to 2010. Clinical, epidemiological and pathology data were recovered from the patients' clinical records. Histologic diagnosis of GCA was made when active inflammation or giant cells were found in the arterial wall. Eighty-one biopsies (24.2%) were considered positive for GCA. Clinical factors independently associated to TAB result in a logistic regression analysis were temporal cutaneous hyperalgesia (OR = 10.8; p result and number of days of previous systemic corticosteroid treatment (p = 0.146). However, an association was observed between TAB result and the total accumulated dose of previous systemic corticotherapy (p = 0.043). Exhaustive anamnesis and clinical examination remain of paramount importance in the diagnosis of GCA. To improve the yield of TAB, it should be performed specially in older patients with GCA-compatible clinic. TAB could be avoided in patients with an isolated elevation of acute phase reactants, without GCA-compatible clinic. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

  18. A multicenter, open-label, 52-week study of 2% rebamipide (OPC-12759) ophthalmic suspension in patients with dry eye.

    Science.gov (United States)

    Kinoshita, Shigeru; Awamura, Saki; Nakamichi, Norihiro; Suzuki, Hiroyuki; Oshiden, Kazuhide; Yokoi, Norihiko

    2014-03-01

    To investigate the efficacy and safety of 2% rebamipide ophthalmic suspension administered 4 times daily for 52 weeks in patients with dry eye. Multicenter (17 sites), open-label, single-arm study. A total of 154 patients with dry eye were enrolled in this study. After a 2-week screening period, patients received 2% rebamipide, instilled as 1 drop in each eye, 4 times daily for 52 weeks. The signs and symptoms measures were assessed at baseline, at weeks 2 and 4, and at every 4 weeks thereafter. The objective signs were fluorescein corneal staining score, lissamine green conjunctival staining score, and tear film break-up time, while subjective symptoms were dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision). The safety variable was the occurrence of adverse events. For all objective signs and subjective symptoms, the scores significantly improved at week 2 compared with baseline (P rebamipide is effective in improving both the objective signs and subjective symptoms of dry eye patients for at least 52 weeks. In addition, 2% rebamipide treatment was generally well tolerated. Copyright © 2014. Published by Elsevier Inc.

  19. Efficacy and safety of adalimumab in Behçet's disease-related uveitis: a multicenter retrospective observational study.

    Science.gov (United States)

    Fabiani, Claudia; Vitale, Antonio; Emmi, Giacomo; Vannozzi, Lorenzo; Lopalco, Giuseppe; Guerriero, Silvana; Orlando, Ida; Franceschini, Rossella; Bacherini, Daniela; Cimino, Luca; Soriano, Alessandra; Frediani, Bruno; Galeazzi, Mauro; Iannone, Florenzo; Tosi, Gian Marco; Salvarani, Carlo; Cantarini, Luca

    2017-01-01

    The study aim was to evaluate the efficacy of adalimumab (ADA) in a large series of Behçet's disease (BD)-related uveitis. We performed a multicenter retrospective observational study including 40 selected patients (66 eyes) receiving ADA. Clinical data were retrospectively analyzed at baseline, at 3 and 12 months of treatment. Primary end point was reduction of ocular inflammatory flares. Secondary end points were improvement of best corrected visual acuity (BCVA), reduction of macular thickness measured by optical coherence tomography (OCT), reduction in the occurrence of vasculitis assessed by fluorescein angiography (FA), and evaluation of statistically significant differences between patients treated with ADA monotherapy and those undergoing ADA plus DMARDs and in patients firstly treated with ADA compared to patients previously administered with other biologics; ADA steroid sparing effect was also evaluated. During the first 12 months of ADA therapy, the number of flares significantly decreased from 200 flares/100 patients/year to 8.5 flares/100 patients/year (p cases at baseline (55%), 8 (20%) cases after 3 months, and in only one (2.5%) case at 12-month follow-up. FA improvement was highly significant at 3- and 12-month follow-up if compared to baseline (p < 0.0001 and p = 0.006, respectively). ADA is highly effective and safe for the treatment of BD-related uveitis, providing a long-term control of ocular inflammation.

  20. Factors influencing the choice of a nursing or a non-nursing degree: a multicenter, cross-sectional study.

    Science.gov (United States)

    Dante, Angelo; Graceffa, Giuseppina; Del Bello, Matteo; Rizzi, Lorena; Ianderca, Barbara; Battistella, Nadia; Bulfone, Teresa; Grando, Roberta; Zuliani, Stefania; Casetta, Anica; Palese, Alvisa

    2014-12-01

    Current literature has paid increasing attention to the factors influencing career decisions; nevertheless, few studies have compared candidates that have chosen a nursing versus a non-nursing degree. A multicenter, cross-sectional study design was performed to explore whether or not certain individual variables and having inaccurate data about nursing as a profession influenced the choice of a non-nursing degree. Six non-nursing and three nursing degree programs offered by two public Italian universities were involved. A total of 507 students who had just enrolled in non-nursing degree programs and 202 in nursing degree programs were invited to complete a questionnaire comprising 12 closed items. Overall, from 40.0% to 57.1% of the variation in choosing a degree other than nursing was explained by variables such as age, and having inaccurate data on the nursing profession. For each year over 19 years of age, the likelihood that the student would decide to enroll in a nursing degree program increases. For each wrong answer reported on the questionnaire evaluating knowledge on nursing profession, there was a reduction of approximately six times in the likelihood that the student would enroll in a nursing degree program. Information regarding the nursing profession should be offered in early stages of life; in addition, offering accurate data on the profession is a key factor in evaluating the congruence of the career with the individual's personal motivations, aspirations, and talents.

  1. Evaluation of prenatal corticosteroid use in spontaneous preterm labor in the Brazilian Multicenter Study on Preterm Birth (EMIP).

    Science.gov (United States)

    Dias, Tabata Z; Passini, Renato; Tedesco, Ricardo P; Lajos, Giuliane J; Rehder, Patricia M; Nomura, Marcelo L; Costa, Maria L; Oliveira, Paulo F; Sousa, Maria H; Cecatti, Jose G

    2017-11-01

    To evaluate prenatal corticosteroid use in women experiencing spontaneous preterm labor and preterm delivery. The present cross-sectional multicenter study analyzed interview data from patients attending 20 hospitals in Brazil owing to preterm delivery between April 1, 2011 and July 30, 2012. Patients were stratified based on preterm delivery occurring before 34 weeks or at 34-36(+6)  weeks of pregnancy, and the frequency of prenatal corticosteroid use at admission was compared. Prenatal corticosteroid use, sociodemographic data, obstetric characteristics, and neonatal outcomes were examined. There were 1455 preterm deliveries included in the present study; 527 (36.2%) occurred before 34 weeks of pregnancy and prenatal corticosteroids were used in 285 (54.1%) of these pregnancies. Among neonates delivered at 32-33(+6)  weeks, prenatal corticosteroid use was associated with lower pneumonia (P=0.026) and mortality (P=0.029) rates. Among neonates delivered at 34-36(+6)  weeks, prenatal corticosteroid use was associated with longer neonatal hospital admission (PPreterm labor and late preterm delivery were associated with worse neonatal outcomes following prenatal corticosteroids. This could reflect a sub-optimal interval between administration and delivery. © 2017 International Federation of Gynecology and Obstetrics.

  2. Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma

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    Hernandez Jackie

    2010-09-01

    Full Text Available Abstract Background Several single center studies have provided evidence of immune activation and antitumor activity of therapeutic vaccination with dendritic cells (DC in patients with metastatic melanoma. The efficacy of this approach in patients with favorable prognosis metastatic melanoma limited to the skin, subcutaneous tissues and lung (stages IIIc, M1a, M1b was tested in a multicenter two stage phase 2 study with centralized DC manufacturing. Methods The vaccine (IDD-3 consisted 8 doses of autologous monocyte-derived matured DC generated in serum-free medium with granulocyte macrophage colony stimulating factor (GM-CSF and interleukin-13 (IL-13, pulsed with lysates of three allogeneic melanoma cell lines, and matured with interferon gamma. The primary endpoint was antitumor activity. Results Among 33 patients who received IDD-3 there was one complete response (CR, two partial responses (PR, and six patients had stable disease (SD lasting more than eight weeks. The overall prospectively defined tumor growth control rate was 27% (90% confidence interval of 13-46%. IDD-3 administration had minimal toxicity and it resulted in a high frequency of immune activation to immunizing melanoma antigens as assessed by in vitro immune monitoring assays. Conclusions The administration of matured DC loaded with tumor lysates has significant immunogenicity and antitumor activity in patients with limited metastatic melanoma. Clinical trial registration NCT00107159.

  3. A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine.

    Science.gov (United States)

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D; Zava, Dario; Pinessi, Lorenzo

    2011-04-01

    The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1-3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment periods lasting rizatriptan (3.2±1.1). The rates of pain-free (33% frovatriptan vs. 39% rizatriptan) and pain relief (55 vs. 62%) episodes at 2 h were not significantly different between the two treatments. The rate of recurrent episodes was significantly (prizatriptan). No significant differences were observed in sustained pain-free episodes (26% frovatriptan vs. 22% rizatriptan). The number of patients with adverse events was not significantly different between rizatriptan (34) and frovatriptan (25, p=NS). The results suggest that frovatriptan has a similar efficacy to rizatriptan, but a more prolonged duration of action.

  4. Varus thrust during walking and the risk of incident and worsening medial tibiofemoral MRI lesions: the Multicenter Osteoarthritis Study.

    Science.gov (United States)

    Wink, A E; Gross, K D; Brown, C A; Guermazi, A; Roemer, F; Niu, J; Torner, J; Lewis, C E; Nevitt, M C; Tolstykh, I; Sharma, L; Felson, D T

    2017-06-01

    To determine the association of varus thrust during walking to incident and worsening medial tibiofemoral cartilage damage and bone marrow lesions (BMLs) over 2 years in older adults with or at risk for osteoarthritis (OA). Subjects from the Multicenter Osteoarthritis Study (MOST) were studied. Varus thrust was visually assessed from high-speed videos of forward walking trials. Baseline and two-year MRIs were acquired from one knee per subject and read for cartilage loss and BMLs. Logistic regression with generalized estimating equations was used to estimate the odds of incident and worsening cartilage loss and BMLs, adjusting for age, sex, race, body mass index (BMI), and clinic site. The analysis was repeated stratified by varus, neutral, and valgus alignment. 1007 participants contributed one knee each. Varus thrust was observed in 29.9% of knees. Knees with thrust had 2.17 [95% CI: 1.51, 3.11] times the odds of incident medial BML, 2.51 [1.85, 3.40] times the odds of worsening medial BML, and 1.85 [1.35, 2.55] times the odds of worsening medial cartilage loss. When stratified by alignment, varus knees also had significantly increased odds of these outcomes. Varus thrust observed during walking is associated with increased odds of incident and worsening medial BMLs and worsening medial cartilage loss. Increased odds of these outcomes persist in varus-aligned knees. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  5. Microorganisms Associated With Pneumonia in Children Emerging Countries: The GABRIEL Pneumonia Multicenter, Prospective, Case-Control Study.

    Science.gov (United States)

    Bénet, Thomas; Sánchez Picot, Valentina; Messaoudi, Mélina; Chou, Monidarin; Eap, Tekchheng; Wang, Jianwei; Shen, Kunling; Pape, Jean-William; Rouzier, Vanessa; Awasthi, Shally; Pandey, Nitin; Bavdekar, Ashish; Sanghavi, Sonali; Robinson, Annick; Rakoto-Andrianarivelo, Mala; Sylla, Maryam; Diallo, Souleymane; Nymadawa, Pagbajabyn; Naranbat, Nymadawaagiin; Russomando, Graciela; Basualdo, Wilma; Komurian-Pradel, Florence; Endtz, Hubert; Vanhems, Philippe; Paranhos-Baccalà, Gláucia

    2017-06-12

    Pneumonia, the leading infectious cause of child mortality globally, mainly afflicts developing countries. This prospective observational study aimed to assess the microorganisms associated with pneumonia in children aged emerging countries. A multicenter, case-control study by the GABRIEL (Global Approach to Biological Research, Infectious diseases and Epidemics in Low-income countries) network was conducted between 2010 and 2014 in Cambodia, China, Haiti, India (2 sites), Madagascar, Mali, Mongolia, and Paraguay. Cases were hospitalized children with radiologically confirmed pneumonia; controls were children from the same setting without any features suggestive of pneumonia. Nasopharyngeal swabs were collected from all subjects; 19 viruses and 5 bacteria were identified by reverse-transcription polymerase chain reaction. Associations between microorganisms and pneumonia were quantified by calculating the adjusted population attributable fraction (aPAF) after multivariate logistic regression analysis adjusted for sex, age, time period, other pathogens, and site. Overall, 888 cases and 870 controls were analyzed; ≥1 microorganism was detected in respiratory samples in 93.0% of cases and 74.4% of controls (P emerging countries. Increasing S. pneumoniae vaccination coverage may substantially reduce the burden of pneumonia among children in developing countries.

  6. A multicenter study of the early detection of synaptic dysfunction in Mild Cognitive Impairment using Magnetoencephalography-derived functional connectivity

    Directory of Open Access Journals (Sweden)

    Fernando Maestú, PhD

    2015-01-01

    Full Text Available Synaptic disruption is an early pathological sign of the neurodegeneration of Dementia of the Alzheimer's type (DAT. The changes in network synchronization are evident in patients with Mild Cognitive Impairment (MCI at the group level, but there are very few Magnetoencephalography (MEG studies regarding discrimination at the individual level. In an international multicenter study, we used MEG and functional connectivity metrics to discriminate MCI from normal aging at the individual person level. A labeled sample of features (links that distinguished MCI patients from controls in a training dataset was used to classify MCI subjects in two testing datasets from four other MEG centers. We identified a pattern of neuronal hypersynchronization in MCI, in which the features that best discriminated MCI were fronto-parietal and interhemispheric links. The hypersynchronization pattern found in the MCI patients was stable across the five different centers, and may be considered an early sign of synaptic disruption and a possible preclinical biomarker for MCI/DAT.

  7. Association of ADH4 genetic variants with alcohol dependence risk and related phenotypes: results from a larger multicenter association study.

    Science.gov (United States)

    Preuss, Ulrich W; Ridinger, Monika; Rujescu, Dan; Samochowiec, Jerzy; Fehr, Christoph; Wurst, Friedrich M; Koller, Gabriele; Bondy, Brigitta; Wodarz, Norbert; Debniak, Tadeusz; Grzywacz, Anna; Soyka, Michael; Zill, Peter

    2011-04-01

    Genetic variants of the alcohol-metabolizing enzyme ADH4, located on chromosome 4q22-4q23, have been related to alcohol dependence (AD) risk in previous research. The aim of this association study in a large multicenter sample of alcohol-dependent individuals and controls is to confirm ADH4 single nucleotide polymorphism (SNP) and haplotype association with AD and relevant related phenotypes. One thousand, six hundred and twenty-two (1622) inpatient subjects and 1469 control subjects with DSM-IV. AD from four addiction treatment centres were included. Characteristics of AD and related phenotypes including alcohol withdrawal, Cloninger's type I and II and first ages of drinking, regular drinking and AD onset were obtained using standardized structured interviews. After subjects were genotyped for 2 ADH4 polymorphisms, single SNP case-control and haplotype analyses were conducted. Both variants--rs1800759 and rs1042364--and the A-A and C-G haplotypes were significantly related to AD across samples. Furthermore, associations with AD-related phenotypes and subtypes revealed a potential protective influence of this haplotype. This study confirms the significant relationship of ADH4 variants with AD and related phenotypes. While the rs1800759 and rs1042364 A-A haplotype had a potential protective influence on the risk for several AD-related phenotypes, this effect is rather small compared to functional variants of other alcohol or acetaldehyde-metabolizing enzymes like ALDH2*2 or ADH1B*2.

  8. Prospective Multicenter Study of the Epidemiology, Molecular Identification, and Antifungal Susceptibility of Candida parapsilosis, Candida orthopsilosis, and Candida metapsilosis Isolated from Patients with Candidemia ▿

    OpenAIRE

    Cantón, Emilia; Pemán, Javier; Quindós, Guillermo; Eraso, Elena; Miranda-Zapico, Ilargi; Álvarez, María; Merino, Paloma; Campos-Herrero, Isolina; Marco, Francesc; de la Pedrosa, Elia Gomez G.; Yagüe, Genoveva; Guna, Remedios; Rubio, Carmen; Miranda, Consuelo; Pazos, Carmen

    2011-01-01

    A 13-month prospective multicenter study including 44 hospitals was carried out to evaluate the epidemiology of Candida parapsilosis complex candidemia in Spain. Susceptibility to amphotericin B, flucytosine, fluconazole, itraconazole, voriconazole, posaconazole, anidulafungin, caspofungin, and micafungin was tested by the microdilution colorimetric method. A total of 364 C. parapsilosis complex isolates were identified by molecular methods: C. parapsilosis (90.7%), Candida orthopsilosis (8.2...

  9. A prospective, multicenter phase I/II study of induction chemotherapy with docetaxel, cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma

    OpenAIRE

    Satake, Hironaga; Tahara, Makoto; Mochizuki, Satoshi; KATO, Ken; Hara, Hiroki; Yokota, Tomoya; Kiyota, Naomi; Kii, Takayuki; Chin, Keisho; Zenda, Sadamoto; Kojima, Takashi; Bando, Hideaki; YAMAZAKI, Tomoko; Iwasa, Satoru; Honma, Yoshitaka

    2016-01-01

    Purpose Standard care for unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is concurrent chemoradiotherapy, but survival remains limited. Neoadjuvant chemotherapy with docetaxel, cisplatin and fluorouracil (DCF) has demonstrated promising activity, with a pathological complete response (CR) of 17 % for resectable stage II/III ESCC. Here, we conducted a multicenter study to assess the efficacy and safety of induction chemotherapy with DCF followed by CRT in patients with...

  10. Isolated limb perfusion with tumor necrosis factor and melphalan for limb salvage in 186 patients with locally advanced soft tissue extremity sarcomas. The cumulative multicenter European experience

    NARCIS (Netherlands)

    A.M.M. Eggermont (Alexander); P.M. Schlag; D. Lienard; A.N. van Geel (Albert); F.J. Lejeune; H.J. Hoekstra; I. Meller; J.C. Pector; O.E. Nieweg (Omgo); G. Ben-Ari; C. Kettelhack; H. Schraffordt Koops; J.M. Klausner; B.B. Kroon

    1996-01-01

    textabstractOBJECTIVE: The objective of the study was to achieve limb salvage in patients with locally advanced soft tissue sarcomas that can only be treated by amputation or functionally mutilating surgery by performing an isolated limb perfusion (ILP) with tumor necro

  11. Use of artificial intelligence as an innovative donor-recipient matching model for liver transplantation: results from a multicenter Spanish study.

    Science.gov (United States)

    Briceño, Javier; Cruz-Ramírez, Manuel; Prieto, Martín; Navasa, Miguel; Ortiz de Urbina, Jorge; Orti, Rafael; Gómez-Bravo, Miguel-Ángel; Otero, Alejandra; Varo, Evaristo; Tomé, Santiago; Clemente, Gerardo; Bañares, Rafael; Bárcena, Rafael; Cuervas-Mons, Valentín; Solórzano, Guillermo; Vinaixa, Carmen; Rubín, Angel; Colmenero, Jordi; Valdivieso, Andrés; Ciria, Rubén; Hervás-Martínez, César; de la Mata, Manuel

    2014-11-01

    There is an increasing discrepancy between the number of potential liver graft recipients and the number of organs available. Organ allocation should follow the concept of benefit of survival, avoiding human-innate subjectivity. The aim of this study is to use artificial-neural-networks (ANNs) for donor-recipient (D-R) matching in liver transplantation (LT) and to compare its accuracy with validated scores (MELD, D-MELD, DRI, P-SOFT, SOFT, and BAR) of graft survival. 64 donor and recipient variables from a set of 1003 LTs from a multicenter study including 11 Spanish centres were included. For each D-R pair, common statistics (simple and multiple regression models) and ANN formulae for two non-complementary probability-models of 3-month graft-survival and -loss were calculated: a positive-survival (NN-CCR) and a negative-loss (NN-MS) model. The NN models were obtained by using the Neural Net Evolutionary Programming (NNEP) algorithm. Additionally, receiver-operating-curves (ROC) were performed to validate ANNs against other scores. Optimal results for NN-CCR and NN-MS models were obtained, with the best performance in predicting the probability of graft-survival (90.79%) and -loss (71.42%) for each D-R pair, significantly improving results from multiple regressions. ROC curves for 3-months graft-survival and -loss predictions were significantly more accurate for ANN than for other scores in both NN-CCR (AUROC-ANN=0.80 vs. -MELD=0.50; -D-MELD=0.54; -P-SOFT=0.54; -SOFT=0.55; -BAR=0.67 and -DRI=0.42) and NN-MS (AUROC-ANN=0.82 vs. -MELD=0.41; -D-MELD=0.47; -P-SOFT=0.43; -SOFT=0.57, -BAR=0.61 and -DRI=0.48). ANNs may be considered a powerful decision-making technology for this dataset, optimizing the principles of justice, efficiency and equity. This may be a useful tool for predicting the 3-month outcome and a potential research area for future D-R matching models. Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights

  12. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

    Institute of Scientific and Technical Information of China (English)

    Elena Ricart; Maria Esteve; Montserrat Andreu; Francesc Casellas; David Monfort; Miquel Sans; Natalia Oudovenko; Raúl Lafuente; Julián Panés

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis.METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and L1 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases.Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported.CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.

  13. Aneuploidy screening by array comparative genomic hybridization improves success rates of in vitro fertilization: A multicenter Indian study

    Directory of Open Access Journals (Sweden)

    Aditi Kotdawala

    2016-01-01

    Full Text Available Objective: To evaluate the usefulness of preimplantation genetic screening (PGS using array comparative genomic hybridization (aCGH in the Indian population. Materials and Methods: This is a retrospective, multicenter study including 235 PGS cycles following intracytoplasmic sperm injection performed at six different infertility centers from September 2013 to June 2015. Patients were divided as per maternal age in several groups (40 years and as per indication for undergoing PGS. Indications for performing PGS were recurrent miscarriage, repetitive implantation failure, severe male factor, previous trisomic pregnancy, and advanced maternal age (≥35. Day 3 embryo biopsy was performed and analyzed by aCGH followed by day 5 embryo transfer in the same cycle or the following cycle. Outcomes such as pregnancy rates (PRs/transfer, implantation rates, miscarriage rates, percentage of abnormal embryos, and number of embryos with more than one aneuploidy and chaotic patterns were recorded for all the treated subjects based on different age and indication groups. Results: aCGH helped in identifying aneuploid embryos, thus leading to consistent implantation (range: 33.3%-42.9% and PRs per transfer (range: 31.8%-54.9% that were obtained for all the indications in all the age groups, after performing PGS. Conclusion: Aneuploidy is one of the major factors which affect embryo implantation. aCGH can be successfully employed for screening of aneuploid embryos. When euploid embryos are transferred, an increase in PRs can be achieved irrespective of the age or the indication.

  14. A Multicenter Comparative Clinical Study of Sino-Levonorgestrel-Releasing Implants-No.Ⅰ and No.Ⅱ with Norplant

    Institute of Scientific and Technical Information of China (English)

    Hui-min FAN; Zhao-jin TONG; Song-ling WU; Rong-fen WANG; Xiao-qing GONG; Zeng-di Zhou; Li-fang QI; Li-hui HAN; Jing-wei JIANG; Ming-hui WU; Bao-ying CHEN; Fan MENG; Ming-kun DU; Feng-xian NI; Gui-ying ZHANG

    2004-01-01

    Objective To compare the efficacy, side effects and acceptability of two Sino-implants with NorplantMethods A randomized, prospective multicenter comparative clinical study was conducted in 10 clinical centers in China.Results Totally 1 001, 1 000 and 998 cases were recruited for Sino-implant No. Ⅰ, No.Ⅱ and Norplant, respectively, in 1993. The follow-up rate was 99.8% totally in 5 years.Three and five pregnancies occurred respectively in Sino-implant No. I and No. Ⅱgroup, while no pregnancy occurred in the Norplant group. The cumulative pregnancy rate was 0.4, 0.7 and 0 per 100 women respectively in implant No.Ⅰ, No. Ⅱ and Norplant group for five years, meaning that there was no statistical difference. There was no ectopic pregnancy in the three groups. The cumulative discontinuation rates at the end of five years were not significantly different among the three groups, either. Menstrual problems were the main reason for termination. The menstrual blood loss decreased significantly and no serious health problems arose from implants use.Conclusion The two Sino-implants provided similar high efficacy and safety to Norplant, therefore, they can be used by women at reproductive age who are from different areas, different of races, educational background and occupation.

  15. Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States

    Science.gov (United States)

    Jiang, Alice; O'Donnell, Meghan; Cohen, Seth

    2016-01-01

    The prevalence rates of Mycoplasma genitalium infections and coinfections with other sexually transmitted organisms and the frequency of a macrolide antibiotic resistance phenotype were determined in urogenital specimens collected from female and male subjects enrolled in a multicenter clinical study in the United States. Specimens from 946 subjects seeking care from seven geographically diverse clinical sites were tested for M. genitalium and for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Sequencing was used to assess macrolide antibiotic resistance among M. genitalium-positive subjects. M. genitalium prevalence rates were 16.1% for females and 17.2% for males. Significant risk factors for M. genitalium infections were black race, younger age, non-Hispanic ethnicity, and female symptomatic status. Female M. genitalium infections were significantly more prevalent than C. trachomatis and N. gonorrhoeae infections, while the M. genitalium infection rate in males was significantly higher than the N. gonorrhoeae and T. vaginalis infection rates. The macrolide-resistant phenotype was found in 50.8% of females and 42% of males. These results show a high prevalence of M. genitalium single infections, a lower prevalence of coinfections with other sexually transmitted organisms, and high rates of macrolide antibiotic resistance in a diverse sample of subjects seeking care across a wide geographic area of the United States. PMID:27307460

  16. [Role of the Web on behaviors and health choices in six Italian cities: results of a multicenter study].

    Science.gov (United States)

    Lovato, E; Bert, F; Bruno, S; Ceruti, M; De Vito, E; La Torre, G; Liguori, G; Manzoli, L; Messina, G; Minniti, D; Siliquini, R

    2011-01-01

    A cross-sectional, multicenter study was carried out in 6 Italian cities (Cassino, Chieti, Naples, Rome, Siena, Turin) in order to highlight differences in Web use to find out health information and its related consequences on behavioral choices and to describe the distribution of the phenomenon in Italy. Data were collected from October 2009 to September 2010 on a sample of volunteers recruited from laboratory analysis, with face-to-face interview, including information about socio-demographic, health, and Web use to health. Data analysis shows that e-health use is greater in Northern Italy, in women aged 30-41 years, in chronic patients and those who have been caught up medical malpractice. Behavioral changes are associated with the Region; in particular Rome and Cassino show to choose/change professionals and facilities, engaging in alternative therapies and buy drugs online more frequently. Living in Southern Italy, a lower educational level and the infrequent drugs use are associated with a greater probability of incurring in negative behaviors. Positive results on the behavior are instead low and not significant. Given the regional differences, the potentiality and the risks of e-health use, it will be important to identify strategies for risks containment and implementation of the web in prevention.

  17. Incidence and Risk Factors for Delirium among Mechanically Ventilated Patients in an African Intensive Care Setting: An Observational Multicenter Study

    Directory of Open Access Journals (Sweden)

    Arthur Kwizera

    2015-01-01

    Full Text Available Aim. Delirium is common among mechanically ventilated patients in the intensive care unit (ICU. There are little data regarding delirium among mechanically ventilated patients in Africa. We sought to determine the burden of delirium and associated factors in Uganda. Methods. We conducted a multicenter prospective study among mechanically ventilated patients in Uganda. Eligible patients were screened daily for delirium using the confusional assessment method (CAM-ICU. Comparisons were made using t-test, chi-squares, and Fisher’s exact test. Predictors were assessed using logistic regression. The level of statistical significance was set at P<0.05. Results. Of 160 patients, 81 (51% had delirium. Median time to onset of delirium was 3.7 days. At bivariate analysis, history of mental illness, sedation, multiorgan dysfunction, neurosurgery, tachypnea, low mean arterial pressure, oliguria, fevers, metabolic acidosis, respiratory acidosis, anaemia, physical restraints, marital status, and endotracheal tube use were significant predictors. At multivariable analysis, having a history of mental illness, sedation, respiratory acidosis, higher PEEP, endotracheal tubes, and anaemia predicted delirium. Conclusion. The prevalence of delirium in a young African population is lower than expected considering the high mortality. A history of mental illness, anaemia, sedation, endotracheal tube use, and respiratory acidosis were factors associated with delirium.

  18. The Key Role of Psychosocial Risk on Therapeutic Outcome in Obese Children and Adolescents. Results from a Longitudinal Multicenter Study

    Directory of Open Access Journals (Sweden)

    Markus Röbl

    2013-06-01

    Full Text Available Objective: Childhood obesity is high on the global public health agenda. Although risk factors are well known, the influence of social risk on the therapeutic outcome of lifestyle intervention is poorly examined. This study aims to investigate the influence of migration background, low education, and parental unemployment. Methods: 62,147 patients participated in multidimensional lifestyle intervention programs in 179 pediatric obesity centers. Data were collected using standardized software for longitudinal multicenter documentation. 12,305 (19.8% attended care for 6-24 months, undergoing an intensive therapy period and subsequent follow-ups for up to 3 years. A cumulative social risk score was calculated based on different risk indicators. Results: Migration background, low education, and parental employment significantly influenced the outcome of lifestyle intervention. The observed BMI-SDS reduction was significantly higher in the subgroup with low social risks factors (Δ BMI-SDS -0.19 compared to those presenting moderate (Δ BMI-SDS -0.14 and high social risk (Δ BMI-SDS -0.11. Conclusion: Our data underline the effect of children's social setting on the outcome of multidimensional lifestyle intervention. The presence of a high social risk burden is a negative predictor for successful weight loss. Specific therapeutic programs need to be developed for disadvantaged children and adolescents.

  19. Prevalence, awareness, and treatment of anemia in Chinese patients with nondialysis chronic kidney disease: First multicenter, cross-sectional study.

    Science.gov (United States)

    Li, Ya; Shi, Hao; Wang, Wei-Ming; Peng, Ai; Jiang, Geng-Ru; Zhang, Jin-Yuan; Ni, Zhao-Hui; He, Li-Qun; Niu, Jian-Ying; Wang, Nian-Song; Mei, Chang-Lin; Xu, Xu-Dong; Guo, Zhi-Yong; Yuan, Wei-Jie; Yan, Hai-Dong; Deng, Yue-Yi; Yu, Chen; Cen, Jun; Zhang, Yun; Chen, Nan

    2016-06-01

    This was the first multicenter, cross-sectional survey to assess the prevalence of anemia, patient awareness, and treatment status in China. Data of patients with chronic kidney disease (CKD; age, 18-75 years; both out- and inpatients) from 25 hospitals in Shanghai, seeking medical treatment at the nephrology department, were collected between July 1, 2012 and August 31, 2012. The prevalence, awareness, and treatment of anemia in patients with nondialysis CKD (ND-CKD) were assessed. Anemia was defined as serum hemoglobin (Hb) levels ≤12 g/dL in women and ≤13 g/dL in men. A total of 2420 patients with ND-CKD were included. Anemia was established in 1246 (51.5%) patients: 639 (51.3%) men and 607 (48.7%) women. The prevalence of anemia increased with advancing CKD stage (χtrend = 675.14, P Anemia was more prevalent in patients with diabetic nephropathy (68.0%) than in patients with hypertensive renal damage (56.6%) or chronic glomerulonephritis (46.1%, both P anemia patients, only 7.5% received more effective and recommended intravenous supplementation. Anemia is highly prevalent in patients with ND-CKD in China, with a low target-achieving rate and poor treatment patterns. The study highlights the need to improve multiple aspects of CKD management to delay the progression of renal failure.

  20. The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

    Science.gov (United States)

    Legro, Richard S; Brzyski, Robert G; Diamond, Michael P; Coutifaris, Christos; Schlaff, William D; Alvero, Ruben; Casson, Peter; Christman, Gregory M; Huang, Hao; Yan, Qingshang; Haisenleder, Daniel J; Barnhart, Kurt T; Bates, G Wright; Usadi, Rebecca; Lucidi, Richard; Baker, Valerie; Trussell, J C; Krawetz, Stephen A; Snyder, Peter; Ohl, Dana; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping

    2014-01-01

    To summarize baseline characteristics from a large multicenter infertility clinical trial. Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene). Academic Health Centers throughout the United States. Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. None. Historic, biometric, biochemical, and questionnaire parameters. Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters. The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. NCT00719186. Copyright © 2014 American Society for Reproductive Medicine. All rights reserved.

  1. "They're younger… it's harder." Primary providers' perspectives on hypertension management in young adults: a multicenter qualitative study.

    Science.gov (United States)

    Johnson, Heather M; Warner, Ryan C; Bartels, Christie M; LaMantia, Jamie N

    2017-01-03

    Young adults (18-39 year-olds) have the lowest hypertension control rates among adults with hypertension in the United States. Unique barriers to hypertension management in young adults with primary care access compared to older adults have not been evaluated. Understanding these differences will inform the development of hypertension interventions tailored to young adults. The goals of this multicenter study were to explore primary care providers' perspectives on barriers to diagnosing, treating, and controlling hypertension among young adults with regular primary care. Primary care providers (physicians and advanced practice providers) actively managing young adults with uncontrolled hypertension were recruited by the Wisconsin Research & Education Network (WREN), a statewide practice-based research network. Semi-structured qualitative interviews were conducted in three diverse Midwestern clinical practices (academic, rural, and urban clinics) using a semi-structured interview guide, and content analysis was performed. Primary care providers identified unique barriers across standard hypertension healthcare delivery practices for young adults. Altered self-identity, greater blood pressure variability, and unintended consequences of medication initiation were critical hypertension control barriers among young adults. Gender differences among young adults were also noted as barriers to hypertension follow-up and antihypertensive medication initiation. Tailored interventions addressing the unique barriers of young adults are needed to improve population hypertension control. Augmenting traditional clinic structure to support the "health identity" of young adults and self-management skills are promising next steps to improve hypertension healthcare delivery.

  2. Medical and non-medical expenditure for breast cancer diagnosis and treatment in China: a multicenter cross-sectional study.

    Science.gov (United States)

    Liao, Xian-Zhen; Shi, Ju-Fang; Liu, Jing-Shi; Huang, Hui-Yao; Guo, Lan-Wei; Zhu, Xin-Yu; Xiao, Hai-Fan; Wang, Le; Bai, Ya-Na; Liu, Guo-Xiang; Mao, A-Yan; Ren, Jian-Song; Sun, Xiao-Jie; Mai, Ling; Liu, Yu-Qin; Song, Bing-Bing; Gong, Ji-Yong; Zhou, Jin-Yi; Du, Ling-Bing; Zhou, Qi; Cao, Rong; Zhu, Lin; Ren, Ying; Lou, Pei-An; Lan, Li; Sun, Xiao-Hua; Qi, Xiao; Wang, Yuan-Zheng; Zhang, Kai; He, Jie; Dai, Min

    2017-07-03

    We aimed to assess economic burden of breast cancer (BC) diagnosis and treatment in China through a multicenter cross-sectional study, and to obtain theoretical evidence for policy-making. This survey was conducted in 37 hospital centers across 13 provinces in China from September 2012 to December 2014. We collected information on the subject characteristics. We then assessed the medical and non-medical expenditure for BC diagnosis and treatment, factors influencing the average case expense, variations between medical and non-medical expenditure at different clinical stages, economic impact of overall expenditure in newly diagnosed course after reimbursement to the patient's family, composition of non-medical expenditure and time loss for the patient and family. Among 2746 women with BC (72.6% were admitted to specialized hospitals), the overall average expenditure was US $8450 (medical expenditure: $7527; non-medical expenditure: $922). Significant differences were found among the overall expenditure in the four clinical stages (P < 0.0001); the expenditure was higher in stages III and IV than that in stages I and II, whereas the stage IV was the highest (P < 0.0001). Moreover, a higher self-reported predicted reimbursement ratio was associated with a less economic impact on the patient's family, and the average time lost was estimated as $1529. Early detection and treatment of breast cancer might be effective for decreasing the economic burden, because costs escalate as the degree of malignancy increases. © 2017 John Wiley & Sons Australia, Ltd.

  3. Randomized Multi-center Study of Baofuxin for Treatment of Bleeding Side-effect Induced by IUD

    Institute of Scientific and Technical Information of China (English)

    吴尚纯; 王翠萍; 程渭玉; 韩学军; 王素贞; 戚娟芳; 刘莹; 付伟

    2000-01-01

    Objective To observe the efficacy of Baofuxin for treatment of bleeding side effect induced by IUD.Method The study is a multi-center trial. The subjects were randomly allocated into two groups, Baofuxin group ( 90 cases) and Indomethacin group ( 90 cases). In the Baofuxin group, the subjects took the medicine on the first day of menses, once a bag,twice a day for 10 days. In the Indomethacin group, only one capsule was taken once a time, twice a day for 7 days. The treatment was given for three menstrual cycles.The subjects were asked to record their bleeding~spotting by using menstrual diary card not only during the treatment cycles but also during the three months previous and after the treatment cycles. The menstrual profile was analyzed by using MDSv2. 3 program that was provided by WHO.Results Within each 90-day reference period of treatment and post-treatment cycles,the number of bleeding/spotting days decreased obviously and bleeding/spotting free days were greatly increased. Both medicines have little effect on number of episode of bleeding/spotting. The subjects who thought the treatment were highly effective were 81. 1% in the Baofuxin group and 56. 2% in the Indomethacin group respectively (P< 0.01).Conclusion Both Baofuxin and indomethacin are highly effective on treatment of bleeding side effect induced by IUD, but Baofuxin had longer effects and was more acceptable.

  4. Factors that impact health-related quality of life in adults with celiac disease: A multicenter study

    Institute of Scientific and Technical Information of China (English)

    F Casellas; M Papo; J Gelabert; JR Malagelada; L Rodrigo; J López Vivancos; S Riestra; C Pantiga; JS Baudet; F Junquera; V Puig Diví; C Abadia

    2008-01-01

    AIM:To evaluate the factors involved in the impairment of health-related quality of life (HRQOL) in patients with celiac disease.METHODS: A multicenter, cross-sectional prospective study was performed in patients with celiac disease who completed two HRQOL questionnaires: the gastrointestinal quality of life index (GIQLI) and the EuroQol-SD (EQ).RESULTS: Three hundred and forty patients (163 controlled with a gluten-free diet, and 177 newly diagnosed with a normal diet) were included. The GIQLI score was significantly better in patients on a gluten- free diet (GFD) than in non-treated patients on their usual diet, both in terms of the overall score (3.3 vs 2.7,respectively; P<0.001), as well as on the individual questionnaire dimensions. Both the preference value of the EQ as the visual analogue scale were significantly better in treated than in non-treated patients (0.93 vs 0.72 P<0.001 and 80 vs 70 P<0.001, respectively). Variables significantly associated with a worse HRQOL score were female gender, failure to adhere to a GFD,and symptomatic status.CONCLUSION: In untreated celiac disease, the most important factors that influence patient perception of health are the presence of symptoms and a normal diet.HRQOL improves to levels similar to those described in the general population in celiac disease patients well controlled with a GFD.

  5. Multicenter study to evaluate efficacy and irritation potential of benzoyl peroxide 4% cream in hydrophase base (Brevoxyl in acne vulgaris

    Directory of Open Access Journals (Sweden)

    Sawleshwarkar S

    2003-01-01

    Full Text Available In this multicenter, open, non-comparative study, the efficacy and irritation potential of 4% benzoyl peroxide cream in hydrophase base (Brevoxyl was evaluated for the treatment of acne vulgaris. All evaluable patients (n=567 received treatment with 4% benzoyl peroxide cream in hydrophase base for six weeks. The investigators evaluated the patients at baseline and at 1,2,4 & 6 weeks. Patients also rated their improvement and adverse effects. Doctor′s assessment showed that at the end of 6′h week 85.6% had good to very good effect of the treatment. The profile of side effects observed by doctors revealed that 53.8% of total patients did not have any irritation whereas only 11.6% had moderate to severe irritation. 53.8% of patients did not report any irritation: 41.4% had some irritation whereas only 4.8% patients reported troublesome irritation. A satisfactory response was reported as ear;y as two weeks and most of the patients had a very satisfactory response after six weeks and were willing to continue the treatment. This supports the theory that the hydrophase formulation in ′Brevoxyl helped to enhance efficacy and decrease the irritation associated with use of benzoyl peroxide.

  6. The Study of a European Neutrino Factory Complex

    CERN Document Server

    Gruber, P; Amand, J F; Autin, Bruno; Baldy, J L; Benedikt, Michael; Benett, R; Bernardon, A; Blondel, A; Bongardt, K; Cappi, R; Castellano, M G; Chiaveri, Enrico; Delahaye, J P; Densham, C J; Drumm, P V; Edgecocka, R; Fabich, A; Franchetti, Giuliano; Gareyte, Jacques; Garoby, R; Gastaldi, Ugo; Gerigk, F; Gilardoni, S S; Giovannozzi, Massimo; Hancock, S; Hanke, K; Haseroth, H; Hill, C; Hoffman, I; Holzer, B; Hübner, K; Jansson, A; Johnson, C D; Johnston, C; Küchler, D; Lettry, Jacques; Lindroos, M; Lombardi, A M; Martini, M; Migliorati, M; Méot, F; Métral, Elias; Möhl, D; Müller, A S; Neuffer, David V; Palumbo, L; Pasternak, J; Perrin, A; Pirkl, Werner; Poehler, M; Prior, C R; Ravn, H L; Rees, G; Riche, A; Russenschuck, Stephan; Ryne, Robert D; Schindl, Karlheinz; Schriber, Stanley O; Schönauer, Horst Otto; Scrivens, R; Senichev, Yu V; Sievers, P; Silari, Marco; Tazzioli, F; Ullrich, H M; Vassilopoulos, N; Verdier, A; Vretenar, Maurizio; Wenander, F; Wilson, Edmund J N; Wyss, C; Zimmermann, M F; Zisman, M S; Zucchelli, P

    2004-01-01

    The Neutrino Factory is a new concept for an accelerator that produces a high-intensity, high-energy beam of electron and muon neutrinos - the ultimate tool for neutrino oscillation studies and the only machine conceived up today that could help detect CP violation of leptons. The basic concept of the Neutrino Factory is the production of neutrinos from the decay of high-energy muons. Due to their short lifetime, these muons have to be accelerated very fast. Several new accelerator techniques, like a high-intenstiy proton linac, high-power targets, ionization cooling or recirculating muon linacs are required. This paper presents a snapshot of the accelerator design at CERN. Although some aspects of this European Neutrino Factory Scheme have been optimised for the CERN site, the basic principle is site-independent.

  7. A comparative study of European nuclear energy programs

    Energy Technology Data Exchange (ETDEWEB)

    Presas i Puig, Albert (ed.)

    2011-07-01

    The report includes the following contributions: Comparative study of European Nuclear Energy Programs. From international cooperation to the failure of a national program: the Austrian case. The ''go-and-stop'' of the Italian civil nuclear programs, among improvisations, ambitions and conspiracy. Nuclear energy in Spain - a research agenda for economic historians. The Portuguese nuclear program: a peripheral experience under dictatorship (1945-1973). The nuclear energy programs in Switzerland. The rise and decline of an independent nuclear power industry in Sweden, 1945-1970. The German fast breeder program, a historical review. Fast reactors as future visions - the case of Sweden. Transnational flows of nuclear knowledge between the U.S. and the U.K. and continental Europe in the 1950/60s. The Carter administration and its non-proliferation policies: the road to INFCE.

  8. Variability of fish consumption within the 10 European countries participating in the European Investigation into Cancer and Nutrition (EPIC) study

    DEFF Research Database (Denmark)

    Welch, A.A.; Lund, E.; Amiano, P.;

    2002-01-01

    OBJECTIVE: To describe and compare the consumption of total fish (marine foods) and the fish sub-groups - white fish, fatty fish, very fatty fish, fish products and crustacea, in participants from the European Investigation into Cancer and Nutrition (EPIC) study. DESIGN: Cross-sectional analysis ...

  9. Protocol for Evaluating the Cardio-Ankle Vascular Index to Predict Cardiovascular Events in Japan: A Prospective Multicenter Cohort Study

    Science.gov (United States)

    Miyoshi, Toru; Ito, Hiroshi; Horinaka, Shigeo; Shirai, Kohji; Higaki, Jitsuo; Orimio, Hajime

    2017-01-01

    Introduction The cardio-ankle vascular index (CAVI) was developed in Japan and is a blood pressure-independent index of arterial stiffness from the origin of the aorta to the ankle. In recent years, it has been studied by many researchers worldwide, and it is strongly anticipated that it will play a role as a predictive factor for arteriosclerotic diseases. The objective of this study was to examine the benefits of using CAVI as a predictor of cardiovascular events in high-risk patients. Methods and Design This prospective multicenter study to evaluate the usefulness of the CAVI to predict cardiovascular events in Japan (CAVI-J) is a cohort study with central registration. Participants (n = 3,000) will be scheduled to enroll and data will be collected for up to 5 years from entry of participants into the study. To be eligible to participate in the CAVI-J study, individuals have to be aged between 40 and 74 years and have at least one of the following risk factors for arteriosclerosis: (1) type 2 diabetes mellitus; (2) high-risk hypertension; (3) metabolic syndrome; (4) chronic kidney disease (stage 3), or (5) history of coronary artery disease or noncardiogenic cerebral infarction. The primary endpoints of this study are cardiovascular death, nonfatal myocardial infarction, and stroke. The secondary endpoints are composite cardiovascular events including all cause death, angina pectoris with revascularization, new incidence of peripheral artery disease, abdominal aortic aneurysm, aortic dissection, heart failure requiring hospitalization, and deterioration in renal function. The cutoff for CAVI against the incidence of cardiovascular events will be determined. PMID:28275590

  10. Coordination of international multicenter studies: governance and administrative structure Coordinación de estudios multicéntricos internacionales: estructura administrativa y reglamentación

    Directory of Open Access Journals (Sweden)

    Shrikant I. Bangdiwala

    2003-01-01

    Full Text Available A well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. The organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented. The elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration. The experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (WorldSAFE, illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators.La ejecución de estudios multicéntricos requiere el establecimiento de procedimientos uniformes, control de calidad, asegurar estandarización, y la colaboración entre las instituciones participantes. Este trabajo describe la estructura y la dinámica de los estudios multicéntricos internacionales, enfocando los aspectos de administración y reglamentación. Se describe la estructura organizativa de un estudio multicéntrico, así como los roles de los integrantes de un sistema de supervisión y coordinación. Se presentan los elementos de un documento de reglamentación y se describen algunas guías y políticas para una colaboración eficaz. La experiencia del estudio internacional colaborativo World Studies of Abuse in the Family Environment (WorldSAFE se utiliza como ejemplo de la aplicación de estas normas. Un centro de coordinación estadística, así como un documento de auto-reglamentación son

  11. EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA): a protocol of a European multicentre observational study

    Science.gov (United States)

    Gutiérrez-Gutiérrez, Belén; Sojo-Dorado, Jesús; Bravo-Ferrer, José; Cuperus, Nienke; de Kraker, Marlieke; Kostyanev, Tomislav; Raka, Lul; Daikos, George; Feifel, Jan; Folgori, Laura; Pascual, Alvaro; Goossens, Herman; O'Brien, Seamus; Bonten, Marc J M; Rodríguez-Baño, Jesús

    2017-01-01

    Introduction The rapid worldwide spread of carbapenem-resistant Enterobacteriaceae (CRE) constitutes a major challenge. The aim of the EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA), which is part of the Innovative Medicines Initiative Joint Undertaking (IMI JU) funded COMBACTE-CARE project, is to investigate risk factors for and outcome determinants of CRE infections to inform randomised clinical trial designs and to provide a historical cohort that could eventually be used for future comparisons with new drugs targeting CRE. Methods A multicentre (50 sites), multinational (11 European countries), analytical observational project was designed, comprising 3 studies. The aims of study 1 (a prospective cohort study) include characterising the features, clinical management and outcomes of hospitalised patients with intra-abdominal infection, pneumonia, complicated urinary tract infections and bloodstream infections caused by CRE (202 patients in each group). The main outcomes will be 30-day all-cause mortality and clinical response. Study 2 (a nested case–control study) will identify the risk factors for target infections caused by CRE; 248 selected patients from study 1 will be matched with patients with carbapenem-susceptible Enterobacteriaceae (1:1) and with hospitalised patients (1:3) and will provide a historical cohort of patients with CRE infections. Study 3 (a matched cohort study) will follow patients in study 2 in order to assess mortality, length of stay and hospital costs associated with CRE. All patients will be followed for 30 days. Different, up-to-date statistical methods will be applied to come to unbiased estimates for all 3 studies. Ethics and dissemination Before-study sites will be initiated, approval will be sought from appropriate regulatory agencies and local Ethics Committees of Research or Institutional Review Boards (IRBs) to conduct the study in accordance with regulatory requirements

  12. ICT-based system to predict and prevent falls (iStoppFalls): study protocol for an international multicenter randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Falls are very common, especially in adults aged 65 years and older. Within the current international European Commission’s Seventh Framework Program (FP7) project ‘iStoppFalls’ an Information and Communication Technology (ICT) based system has been developed to regularly assess a person’s risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention. The primary aims of iStoppFalls are to assess the feasibility and acceptability of the intervention program, and its effectiveness to improve balance, muscle strength and quality of life in older people. Methods/Design This international, multicenter study is designed as a single-blinded, two-group randomized controlled trial. A total of 160 community-dwelling older people aged 65 years and older will be recruited in Germany (n = 60), Spain (n = 40), and Australia (n = 60) between November 2013 and May 2014. Participants in the intervention group will conduct a 16-week exercise program using the iStoppFalls system through their television set at home. Participants are encouraged to exercise for a total duration of 180 minutes per week. The training program consists of a variety of balance and strength exercises in the form of video games using exergame technology. Educational material about a healthy lifestyle will be provided to each participant. Final reassessments will be conducted after 16 weeks. The assessments include physical and cognitive tests as well as questionnaires assessing health, fear of falling, quality of life and psychosocial determinants. Falls will be followed up for six months by monthly falls calendars. Discussion We hypothesize that the regular use of this newly developed ICT-based system for fall prevention at home is feasible for older people. By using the iStoppFalls sensor-based exercise program, older people are expected to improve in balance and strength outcomes. In addition, the exercise

  13. Impact of surveillance of hepatitis b and hepatitis c in patients with inflammatory bowel disease under anti-TNF therapies: multicenter prospective observational study (REPENTINA 3).

    Science.gov (United States)

    Loras, C; Gisbert, J P; Saro, M C; Piqueras, M; Sánchez-Montes, C; Barrio, J; Ordás, I; Montserrat, A; Ferreiro, R; Zabana, Y; Chaparro, M; Fernández-Bañares, F; Esteve, M

    2014-11-01

    Assess IBD patients starting anti-TNF for the im