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1.
Bernoche, Claudia; Timerman, Sergio; Polastri, Thatiane Facholi; Giannetti, Natali Schiavo; Siqueira, Adailson Wagner da Silva; Piscopo, Agnaldo; Soeiro, Alexandre de Matos; Reis, Amélia Gorete Afonso da Costa; Tanaka, Ana Cristina Sayuri; Thomaz, Ana Maria; Quilici, Ana Paula; Catarino, Andrei Hilário; Ribeiro, Anna Christina de Lima; Barreto, Antonio Carlos Pereira; Azevedo, Antonio Fernando Barros de Filho; Pazin, Antonio Filho; Timerman, Ari; Scarpa, Bruna Romanelli; Timerman, Bruno; Tavares, Caio de Assis Moura; Martins, Cantidio Soares Lemos; Serrano, Carlos Vicente Junior; Malaque, Ceila Maria Sant'Ana; Pisani, Cristiano Faria; Batista, Daniel Valente; Leandro, Daniela Luana Fernandes; Szpilman, David; Gonçalves, Diego Manoel; Paiva, Edison Ferreira de; Osawa, Eduardo Atsushi; Lima, Eduardo Gomes; Adam, Eduardo Leal; Peixoto, Elaine; Evaristo, Eli Faria; Azeka, Estela; Silva, Fabio Bruno da; Wen, Fan Hui; Ferreira, Fatima Gil; Lima, Felipe Gallego; Fernandes, Felipe Lourenço; Ganem, Fernando; Galas, Filomena Regina Barbosa Gomes; Tarasoutchi, Flavio; Souza, Germano Emilio Conceição; Feitosa, Gilson Soares Filho; Foronda, Gustavo; Guimarães, Helio Penna; Abud, Isabela Cristina Kirnew; Leite, Ivanhoé Stuart Lima; Linhares, Jaime Paula Pessoa Filho; Moraes, Junior João Batista de Moura Xavier; Falcão, João Luiz Alencar de Araripe; Ramires, Jose Antônio Franchini; Cavalini, José Fernando; Saraiva, José Francisco Kerr; Abrão, Karen Cristine; Pinto, Lecio Figueira; Bianchi, Leonardo Luís Torres; Lopes, Leonardo Nícolau Geisler Daud; Piegas, Leopoldo Soares; Kopel, Liliane; Godoy, Lucas Colombo; Tobase, Lucia; Hajjar, Ludhmila Abrahão; Dallan, Luís Augusto Palma; Caneo, Luiz Fernando; Cardoso, Luiz Francisco; Canesin, Manoel Fernandes; Park, Marcelo; Rabelo, Marcia Maria Noya; Malachias, Marcus Vinícius Bolívar; Gonçalves, Maria Aparecida Batistão; Almeida, Maria Fernanda Branco de; Souza, Maria Francilene Silva; Favarato, Maria Helena Sampaio; Carrion, Maria Julia Machline; Gonzalez, Maria Margarita; Bortolotto, Maria Rita de Figueiredo Lemos; Macatrão-Costa, Milena Frota; Shimoda, Mônica Satsuki; Oliveira-Junior, Mucio Tavares de; Ikari, Nana Miura; Dutra, Oscar Pereira; Berwanger, Otávio; Pinheiro, Patricia Ana Paiva Corrêa; Reis, Patrícia Feitosa Frota dos; Cellia, Pedro Henrique Moraes; Santos Filho, Raul Dias dos; Gianotto-Oliveira, Renan; Kalil Filho, Roberto; Guinsburg, Ruth; Managini, Sandrigo; Lage, Silvia Helena Gelas; Yeu, So Pei; Franchi, Sonia Meiken; Shimoda-Sakano, Tania; Accorsi, Tarso Duenhas; Leal, Tatiana de Carvalho Andreucci; Guimarães, Vanessa; Sallai, Vanessa Santos; Ávila, Walkiria Samuel; Sako, Yara Kimiko.
Arq. bras. cardiol ; 113(3): 449-663, Sept. 2019. tab, graf
Artigo em Português | LILACS-Express | LILACS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1038561
2.
Am Heart J ; 168(2): 213-9.e1, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25066561

RESUMO

BACKGROUND: Early termination of clinical trials due to low recruitment represents an understudied challenge for clinical research. We aimed to describe characteristics of cardiovascular trials terminated because of low recruitment and identify the major predictors of such early termination. METHODS: We reviewed all cardiovascular clinical trials (7,042 studies) registered in ClinicalTrials.gov from February 29, 2000, to January 17, 2013, and assessed information about trials that were completed and those that were terminated early. Logistic regression models were developed to identify independent predictors of early termination due to low recruitment. RESULTS: Our search strategy identified 6,279 cardiovascular clinical trials, of which 684 (10.9%) were terminated prematurely. Of these halted trials, the main reason for termination was lower than expected recruitment (278 trials; 53.6%). When comparing trials that terminated early because of low recruitment with those that were completed, we found that studies funded by the National Institutes of Health or other US federal agencies (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.14-0.89), studies of behavior/diet intervention (OR 0.35, 95% CI 0.19-0.65), and single-arm design studies (OR 0.57, 95% CI 0.42-0.78) were associated with a lower risk of early termination. University/hospital-funded (OR 1.52, 95% CI 1.10-2.10) and mixed-source-funded studies (OR 2.14, 95% CI 1.52-3.01) were associated with a higher likelihood of early termination due to lower than expected recruitment rates. CONCLUSIONS: Low recruitment represents the main cause of early termination of cardiovascular clinical trials. Funding source, type of intervention, and study design are factors associated with early termination due to low recruitment and might be good targets for improving enrollment into cardiovascular clinical trials.


Assuntos
Doenças Cardiovasculares , Ensaios Clínicos como Assunto , Término Precoce de Ensaios Clínicos/estatística & dados numéricos , Seleção de Pacientes , Adulto , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , National Library of Medicine (U.S.) , Prevalência , Sistema de Registros/estatística & dados numéricos , Viés de Seleção , Estados Unidos
3.
Epilepsy Behav ; 17(1): 120-3, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20004148

RESUMO

The aim of the study was to evaluate excessive daytime sleepiness and subjective sleep quality in patients who undergo epilepsy surgery for treatment of refractory partial seizures. Forty-eight patients were enrolled in this research study. All of them were evaluated 2 days before and 3 months after the surgery. Two questionnaires were used to assess daytime sleepiness (Epworth Sleepiness Scale [ESS]) and sleep quality (Pittsburgh Sleep Quality Index [PSQI]). Global PSQI was high (mean=5.65 SD=3.71) before the surgical procedure (P<0.001). PSQI evaluation revealed higher and statistically significant scores in three components as well as in the global score, when analyzed by predominance of daytime or nocturnal seizures. ESS and PSQI scores were also analyzed by gender, antiepileptic drug class, age, and seizure frequency, with no significant differences. We concluded that patients with partial recurrent seizures of temporal origin have poor subjective sleep quality that improves significantly after epilepsy surgery.


Assuntos
Procedimentos Neurocirúrgicos/métodos , Convulsões/complicações , Transtornos do Sono-Vigília , Adulto , Eletroencefalografia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Tempo de Reação/fisiologia , Estudos Retrospectivos , Convulsões/cirurgia , Índice de Gravidade de Doença , Transtornos do Sono-Vigília/diagnóstico , Transtornos do Sono-Vigília/etiologia , Transtornos do Sono-Vigília/cirurgia , Estatísticas não Paramétricas , Inquéritos e Questionários , Resultado do Tratamento , Adulto Jovem
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