Navegando por Palavras-chave "Clinical study"

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    Clinical features of childhood granulomatosis with polyangiitis (wegener's granulomatosis)
    (Biomed Central Ltd, 2014-05-26) Bohm, Marek; Fernandez, Maria Isabel Gonzalez; Ozen, Seza; Pistorio, Angela; Dolezalova, Pavla; Brogan, Paul; Barbano, Giancarlo; Sengler, Claudia; Klein-Gitelman, Marisa; Quartier, Pierre; Fasth, Anders; Herlin, Troels; Terreri, Maria Teresa R. A. [UNIFESP]; Nielsen, Susan; van Rossum, Marion A. J.; Avcin, Tadej; Rodolfo Castell, Esteban; Foeldvari, Ivan; Foell, Dirk; Kondi, Anuela; Kone-Paut, Isabelle; Kuester, Rolf-Michael; Michels, Hartmut; Wulffraat, Nico; Ben Amer, Halima; Malattia, Clara; Martini, Alberto; Ruperto, Nicolino; Paediat Rheumatology Int; PRINTO; Charles Univ Prague; Gen Univ Hosp Prague; Hacettepe Univ; Ist Giannina Gaslini; NHS Fdn Trust; Charite; Ann & Robert H Lurie Childrens Hosp Chicago; Univ Paris 05; Univ Gothenburg; Aarhus Univ Hosp; Universidade Federal de São Paulo (UNIFESP); Rigshosp; Emma Children Hosp AMC; Univ Childrens Hosp; Hosp Dr Felipe Glasman; Klinikum Eilbek Hs 6; Univ Hosp Ctr; Univ Paris 11; Asklepios Klin Altona; Kinderklin Garmisch Partenkirchen gGmbH; Wilhelmina Childrens Hosp; Benghazi Children Hosp Benghazi; Univ Genoa
    Background: Granulomatosis with polyangiitis (GPA), formerly known as Wegener's granulomatosis (WG), belongs to the group of ANCA-associated necrotizing vasculitides. This study describes the clinical picture of the disease in a large cohort of GPA paediatric patients.Children with age at diagnosis <= 18 years, fulfilling the EULAR/PRINTO/PRES GPA/WG classification criteria were extracted from the PRINTO vasculitis database. the clinical signs/symptoms and laboratory features were analysed before or at the time of diagnosis and at least 3 months thereafter and compared with other paediatric and adult case series (>50 patients) derived from the literature.Findings: the 56 children with GPA/WG were predominantly females (68%) and Caucasians (82%) with a median age at disease onset of 11.7 years, and a median delay in diagnosis of 4.2 months. the most frequent organ systems involved before/at the time of diagnosis were ears, nose, throat (91%), constitutional (malaise, fever, weight loss) (89%), respiratory (79%), mucosa and skin (64%), musculoskeletal (59%), and eye (35%), 67% were ANCA-PR3 positive, while haematuria/proteinuria was present in > 50% of the children. in adult series, the frequency of female involvement ranged from 29% to 50% with lower frequencies of constitutional (fever, weight loss), ears, nose, throat (oral/nasal ulceration, otitis/aural discharge), respiratory (tracheal/endobronchial stenosis/obstruction), laboratory involvement and higher frequency of conductive hearing loss than in this paediatric series.Conclusions: Paediatric patients compared to adults with GPA/WG have similar pattern of clinical manifestations but different frequencies of organ involvement.
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    An International Clinical Study of Ability and Disability in Autism Spectrum Disorder Using the WHO-ICF Framework
    (Springer/Plenum Publishers, 2018) Mahdi, Soheil; Albertowski, Katja; Almodayfer, Omar; Arsenopoulou, Vaia; Carucci, Sara; Dias, Jose Carlos; Khalil, Mohammad; Knuppel, Ane; Langmann, Anika; Lauritsen, Marlene Briciet; Cunha, Graccielle Rodrigues da [UNIFESP]; Uchiyama, Tokio; Wolff, Nicole; Selb, Melissa; Granlund, Mats; de Vries, Petrus J.; Zwaigenbaum, Lonnie; Bolte, Sven
    This is the fourth international preparatory study designed to develop International Classification of Functioning, Disability and Health (ICF, and Children and Youth version, ICF-CY) Core Sets for Autism Spectrum Disorder (ASD). Examine functioning of individuals diagnosed with ASD as documented by the ICF-CY in a variety of clinical settings. A cross-sectional study was conducted, involving 11 units from 10 countries. Clinical investigators assessed functioning of 122 individuals with ASD using the ICF-CY checklist. In total, 139 ICF-CY categories were identified: 64 activities and participation, 40 body functions and 35 environmental factors. The study results reinforce the heterogeneity of ASD, as evidenced by the many functional and contextual domains impacting on ASD from a clinical perspective.
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    Remoção de cateteres intravenosos periféricos a cada 96 horas ou segundo indicação clínica: estudo clínico, randômico e de não inferioridade
    (Universidade Federal de São Paulo (UNIFESP), 2018-02-22) Vendramim, Patricia [UNIFESP]; Pedreira, Mavilde da Luz Goncalves [UNIFESP]; Avelar, Ariane Ferreira Machado [UNIFESP]; http://lattes.cnpq.br/8919300907658980; http://lattes.cnpq.br/5901248667753975; http://lattes.cnpq.br/8115630097723963; Universidade Federal de São Paulo (UNIFESP)
    Introduction: Peripheral intravenous catheters (PIC) are widely used in clinical practice for intravenous therapy. Although having many advantages when compared to other types of intravascular access, they are not exempt of complications, and in this study, phlebitis is highlighted. In order to prevent phlebitis, it is practiced, to a substantial extent in the national health institutions, the routine replacement of the PIC device at 72 or 96 hours. Aim: To verify if the PIC replacement as clinically indicated is not inferior to the routine replacement every 96 hours regarding phlebitis occurrence; to compare phlebitis severity, PIC dwell time, and other intravenous therapy complications between the study groups. Method: this is a randomized, controlled, noninferiority clinical trial that recruited patients aged eighteen and older, from two São Paulo City hospitals, after approval of ethical merit and clinical study registry, from November 2015 to August 2016. For the sample calculation, 5% of phlebitis prevalence was used, a significance level of 5%, test power of 80% and noninferiority margin of 3%, sample defined number of patients was 1305. The final study sample was composed of 1319 patients, being 672 (50.9%) patients with PIC replacement as per clinical indication and 647 (49.1%) with PIC replacement every 96 hours. Demographics, clinical and intravenous therapy variables were studied. For the statistical analyzes of the categoric variables, the ChiSquare, Fisher's Exact, Fisher's Exact Generalization tests were used; for the numeric variables, MannWhitney or KruskalWallis (p≤0.005) tests were applied. The KaplanMeier curve was used for the survival analysis. Results: For the demographic variables, it was identified a majority of white elderly patients, with almost the same proportion of males and females, and about 55% presented some degree of overweight or obesity, without significant differences between the groups, except for the type of admission that was predominantly clinical (p=0.025). The 1319 patients used 2747 PIC of vialon from different types, and 119 (9.0%) patients developed phlebitis using 134 (4.9%) PIC, with 89.6% of phlebitis grade 1 and 2. There was no significant differences on phlebitis occurrence, (p=0.162) patients and (p=0.324) PIC. The incidence rate of phlebitis/1000 PICday per patient was 14.9 in the clinically indicated replacement group and 23.8 in the routine every 96 hours replacement group (p = 0.006). The survival analyzes has shown no significant differences (p=0.247) between the groups related to the occurrence of the first phlebitis episode. Regarding the number of inserted PIC, it was observed that almost half of number of patients (46.6%) used one PIC and 42.2 % used 2 to 3 PIC with no differences between the groups (p=0.339). The clinically indicated group presented the higher PIC dwell time average (p<0.001), highlighting pain (p=0.004) and infiltration (p=0.002). Conclusion: The study hypothesis was accepted. The PIC replacement according to clinical manifestations was not inferior to the replacement in accordance to time programmed in 96 hours to phlebitis occurrence. Dwell time and the occurrence of other complications, namely, pain and infiltration were more frequent on PIC replacement as per clinical indication.
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    Terapia celular na angina refratária (ReACT) envolvendo células tronco autólogas de medula óssea em pacientes sem disfunção ventricular esquerda: um possível papel dos monócitos
    (Universidade Federal de São Paulo (UNIFESP), 2010-01-27) Hossne Junior, Nelson Americo [UNIFESP]; Buffolo, Enio [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Background Autologous bone marrow mononuclear cell (BMMC) transplantation has emerged as a potential therapeutic option for refractory angina patients. Previous studies have shown conflicting myocardium reperfusion results. The present study evaluated safety and efficacy of CellPraxis Refractory Angina Cell Therapy Protocol (ReACT™), in which a specific BMMC formulation was administered as the sole therapy for these patients. Methods The Phase I/IIa Non-controlled, Open label, Clinical Trial, involved eight patients with refractory angina and viable ischemic myocardium, without left ventricular dysfunction and who were not suitable for conventional myocardial revascularization. ReACT™ is a surgical procedure involving a single series of multiple injections (40-90 injections, 0.2 ml each) into ischemic areas of the left ventricle. Primary endpoints were Canadian Cardiovascular Society Angina Classification (CCSAC) improvement at the 18 month follow-up and myocardium ischemic area reduction (assessed by scintigraphic analysis) at the 12 month followup, in correlation with a specific BMMC formulation. Findings Almost all patients presented progressive improvement in angina classification beginning 3 months (p=0.008) post procedure which was sustained at the eighteenth month follow-up (p=0.004), as well as objective myocardium ischemic area reduction at 12 months (decrease of 84.4%, p<0.004). A positive correlation was found between monocyte concentration and CCSAC improvement (r = -0.759, p < 0.05). Interpretation Improvement in Canadian Cardiovascular Society Angina Classification, followed by correlated reduction in scintigraphic myocardium ischemic area strongly suggests neoangiogenesis as the main stem cell action mechanism. The significant correlation between number of monocytes and improvement strongly supports a cell related effect of ReACT™. ReACT™ appeared safe and effective.