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1.
Arch Dis Child Fetal Neonatal Ed ; 105(1): 4-7, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31666312

RESUMO

OBJECTIVE: There is a paucity of data about normal blood metabolite concentrations in healthy babies, in part because of a reluctance to undertake non-therapeutic invasive testing in newborns. The Glucose in Well Babies study (GLOW) sought to describe blood glucose, lactate and beta-hydroxybutyrate concentrations in healthy term babies over the first 5 postnatal days. We also sought to understand both parents' experience of participation in this invasive non-therapeutic study. DESIGN, SETTING, PATIENTS AND INTERVENTIONS: Eligible babies were healthy, term, appropriately grown singletons born in a birthing centre, hospital or home within the greater Hamilton area and then discharged home. Babies had subcutaneous continuous glucose monitoring placed soon after birth, up to 14 heel-prick blood samples, twice-daily home visits and parents were asked to record all feeds. At study completion, both parents were asked to independently complete a questionnaire about their experience. RESULTS: All eligible babies completed the study and every parent completed the questionnaire (65 fathers, 66 mothers). Parents reported they liked contributing to improving healthcare (126/131, 96%) and support from the GLOW team (119/131, 91%). Nearly all (127/131, 97%) would participate in GLOW again if they had another eligible baby, and all would recommend GLOW to family and friends. Two-thirds of parents (87/131, 66%) reported that participation had made them more likely to contribute to clinical research in the future. CONCLUSIONS: Non-therapeutic studies involving invasive procedures in healthy term babies are feasible, and parents were positive about their experience.


Assuntos
Ácido 3-Hidroxibutírico/sangue , Atitude Frente a Saúde , Glicemia/análise , Ácido Láctico/sangue , Experimentação Humana não Terapêutica , Pais , Adulto , Coleta de Amostras Sanguíneas , Feminino , Enfermagem Domiciliar , Humanos , Recém-Nascido , Masculino , Monitorização Fisiológica , Nova Zelândia , Estudos Prospectivos , Valores de Referência , Inquéritos e Questionários
2.
Sensors (Basel) ; 19(14)2019 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-31336759

RESUMO

We present a text entry technique called HiFinger, which is an eyes-free, one-handed wearable text entry technique for immersive virtual environments by thumb-to-fingers touch. This technique enables users to input text quickly, accurately, and comfortably with the sense of touch and a two-step input mode. It is especially suitable for mobile scenarios where users need to move (such as walking) in virtual environments. Various input signals can be triggered by moving the thumb towards ultra-thin pressure sensors placed on other fingers. After acquiring the comfort range of the touch between the thumb and other fingers, six placement modes for text entry are designed and tested, resulting in an optimal placement mode that leverages six pressure sensors for the text entry and two for the control function. A three-day study is conducted to evaluate the proposed technique, and experimental results show that novices can achieve an average text entry efficiency of 9.82 words per minute (WPM) in virtual environments based on head-mounted displays after a training period of 25 min.


Assuntos
Dedos , Tato , Interface Usuário-Computador , Dispositivos Eletrônicos Vestíveis , Adulto , Desenho de Equipamento , Feminino , Mãos , Humanos , Modelos Lineares , Masculino , Experimentação Humana não Terapêutica , Realidade Virtual , Caminhada
3.
Sensors (Basel) ; 19(14)2019 Jul 12.
Artigo em Inglês | MEDLINE | ID: mdl-31336945

RESUMO

Non-contact wireless sensing approaches have emerged in recent years, in order to enable novel enhanced developments in the framework of healthcare and biomedical scenarios. One of these technologically advanced solutions is given by software-defined radar platforms, a low-cost radar implementation, where all operations are implemented and easily changed via software. In the present paper, a software-defined radar implementation with Doppler elaboration features is presented, to be applied for the non-contact monitoring of human respiration signals. A quadrature receiver I/Q (In-phase/Quadrature) architecture is adopted in order to overcome the critical issues related to the occurrences of null detection points, while the phase-locked loop components included in the software defined radio transceiver are successfully exploited to guarantee the phase correlation between I/Q signal components. The proposed approach leads to a compact, low-cost, and flexible radar solution, whose application abilities may be simply changed via software, with no need for hardware modifications. Experimental results on a human target are discussed so as to demonstrate the feasibility of the proposed approach for vital signs detection.


Assuntos
Monitorização Fisiológica/métodos , Respiração , Software , Desenho de Equipamento , Humanos , Monitorização Fisiológica/instrumentação , Experimentação Humana não Terapêutica , Radar , Reprodutibilidade dos Testes , Taxa Respiratória , Processamento de Sinais Assistido por Computador
4.
Med Biol Eng Comput ; 57(9): 2069-2079, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31352660

RESUMO

Divided attention is defined as focusing on different tasks at once, and this is described as one of the biggest problems of today's society. Default examinations for understanding attention are questionnaires or physiological signals, like evoked potentials and electroencephalography. Physiological records were obtained using visual, auditory, and auditory-visual stimuli combinations with 48 participants-18-25-year-old university students-to find differences between sustained and divided attention. A Fourier-based filter was used to get a 0.01-30-Hz frequency band. Fractal dimensions, entropy values, power spectral densities, and Hjorth parameters from electroencephalography and P300 components from evoked potentials were calculated as features. To decrease the size of the feature set, some features, which yield less detail level for data, were eliminated. The visual and auditory stimuli in selective attention were compared with the divided attention state, and the best accuracy was found to be 88.89% on a support vector machine with linear kernel. As a result, it was seen that divided attention could be more difficult to determine from selective attention, but successful classification could be obtained with appropriate methods. Contrary to literature, the study deals with the infrastructure of attention types by working on a completely healthy and attention-high group. Graphical abstract.


Assuntos
Atenção/fisiologia , Eletroencefalografia/métodos , Potenciais Evocados/fisiologia , Processamento de Sinais Assistido por Computador , Estimulação Acústica , Adolescente , Adulto , Entropia , Potencial Evocado P300/fisiologia , Feminino , Fractais , Humanos , Masculino , Experimentação Humana não Terapêutica , Estimulação Luminosa , Reprodutibilidade dos Testes , Adulto Jovem
5.
Kennedy Inst Ethics J ; 29(1): 33-49, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31080176

RESUMO

This article describes oversight mechanisms for clinical research that have developed substantially over the last few decades, including institutional review boards and data safety and monitoring boards. LeRoy Walters and others in the 1970s in the US thoughtfully described the importance of fundamental ethical principles and the application of bioethics to clinical research. Dr. Walters's important essay and work with the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research helped identify and explain ethical principles that guide research. These principles, subsequently enunciated by the Commission in the Belmont Report, remain central to our understanding of the ethics of clinical research and are the foundation of our regulations. In this article, I review some history, successes, and challenges of IRBs and DSMBs to exemplify the significance of understanding and applying ethical principles to the design and conduct of clinical research, and to honor Dr. Walters's contributions.


Assuntos
Bioética , Pesquisa Biomédica/ética , Comitês de Monitoramento de Dados de Ensaios Clínicos/história , Comitês de Monitoramento de Dados de Ensaios Clínicos/normas , Comitês de Ética em Pesquisa/história , Comitês de Ética em Pesquisa/normas , Ética em Pesquisa , Pesquisa Biomédica/legislação & jurisprudência , Comitês de Monitoramento de Dados de Ensaios Clínicos/legislação & jurisprudência , Barreiras de Comunicação , Conflito de Interesses , Comitês de Ética em Pesquisa/legislação & jurisprudência , Regulamentação Governamental/história , Política de Saúde/legislação & jurisprudência , História do Século XX , Experimentação Humana/ética , Experimentação Humana/história , Experimentação Humana/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/ética , Legislação como Assunto , Experimentação Humana não Terapêutica/ética , Guias de Prática Clínica como Assunto , Política Pública/legislação & jurisprudência , Medição de Risco , Estados Unidos
6.
Med Biol Eng Comput ; 57(8): 1709-1725, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31127535

RESUMO

This work presents a classification performance comparison between different frameworks for functional connectivity evaluation and complex network feature extraction aiming to distinguish motor imagery classes in electroencephalography (EEG)-based brain-computer interfaces (BCIs). The analysis was performed in two online datasets: (1) a classical benchmark-the BCI competition IV dataset 2a-allowing a comparison with a representative set of strategies previously employed in this BCI paradigm and (2) a statistically representative dataset for signal processing technique comparisons over 52 subjects. Besides exploring three classical similarity measures-Pearson correlation, Spearman correlation, and mean phase coherence-this work also proposes a recurrence-based alternative for estimating EEG brain functional connectivity, which takes into account the recurrence density between pairwise electrodes over a time window. These strategies were followed by graph feature evaluation considering clustering coefficient, degree, betweenness centrality, and eigenvector centrality. The features were selected by Fisher's discriminating ratio and classification was performed by a least squares classifier in agreement with classical and online BCI processing strategies. The results revealed that the recurrence-based approach for functional connectivity evaluation was significantly better than the other frameworks, which is probably associated with the use of higher order statistics underlying the electrode joint probability estimation and a higher capability of capturing nonlinear inter-relations. There were no significant differences in performance among the evaluated graph features, but the eigenvector centrality was the best feature regarding processing time. Finally, the best ranked graph-based attributes were found in classical EEG motor cortex positions for the subjects with best performances, relating functional organization and motor activity. Graphical Abstract Evaluating functional connectivity based on Space-Time Recurrence Counting for motor imagery classification in brain-computer interfaces. Recurrences are evaluated between electrodes over a time window, and, after a density threshold, the electrodes adjacency matrix is stablish, leading to a graph. Graph-based topological measures are used for motor imagery classification.


Assuntos
Interfaces Cérebro-Computador , Eletroencefalografia/métodos , Imaginação/fisiologia , Encéfalo/fisiologia , Sincronização Cortical , Bases de Dados Factuais , Eletrodos , Eletroencefalografia/instrumentação , , Mãos , Humanos , Atividade Motora/fisiologia , Experimentação Humana não Terapêutica , Processamento de Sinais Assistido por Computador , Língua
9.
Ethics Hum Res ; 41(2): 29-34, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30895754

RESUMO

The U.S. Public Health Service's sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments were tested, exposed to STDs, and exploited as the source of biological specimens-all without informed consent and often with active deceit. It also explores and evaluates governmental and professional responses that followed the public revelation of these experiments, including by academic institutions, professional organizations, and the U.S. federal government, pushing us to reconsider both how we prevent such lapses in the future and how we respond when they are first revealed.


Assuntos
Ética em Pesquisa/história , Experimentação Humana não Terapêutica/ética , Experimentação Humana não Terapêutica/história , Sujeitos da Pesquisa , Doenças Sexualmente Transmissíveis/induzido quimicamente , Doenças Sexualmente Transmissíveis/história , United States Public Health Service/ética , Adulto , Criança , Coerção , Decepção , Feminino , Guatemala , História do Século XX , Humanos , Consentimento Livre e Esclarecido/ética , Masculino , Manejo de Espécimes/ética , Manejo de Espécimes/história , Estados Unidos , Populações Vulneráveis/etnologia
10.
JAMA Oncol ; 5(3): 406-410, 2019 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-30703213

RESUMO

Newly revised regulations for human research affecting translational oncology will become effective in January 2019. A substantial component of the debate leading to this revision was how to regulate biospecimen research; specifically, whether all biospecimens should be considered inherently "identifiable," thereby necessitating informed consent for use in research. The famous cases seminal to this discussion involve cancer cell lines, but the unique features of this kind of biospecimen research were largely missing from the regulatory deliberation. However, special aspects of cell line research-at the stages of procurement, generation, evolution, and sharing-alter how society should balance participant interests against the goals of research. Recommendations are offered to cancer researchers and policymakers going forward to enable ethically appropriate regulation of biospecimen research across its diverse spectrum.


Assuntos
Bancos de Espécimes Biológicos/legislação & jurisprudência , Técnicas de Cultura de Células , Consentimento Livre e Esclarecido/legislação & jurisprudência , Oncologia/legislação & jurisprudência , Experimentação Humana não Terapêutica/legislação & jurisprudência , Manejo de Espécimes , Pesquisa Médica Translacional/legislação & jurisprudência , Bancos de Espécimes Biológicos/ética , Linhagem Celular , Humanos , Consentimento Livre e Esclarecido/ética , Oncologia/ética , Experimentação Humana não Terapêutica/ética , Formulação de Políticas , Manejo de Espécimes/ética , Pesquisa Médica Translacional/ética
11.
Biochimie ; 159: 99-106, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29936295

RESUMO

Systemic inflammation plays a pivotal role in a multitude of conditions, including sepsis, trauma, major surgery and burns. However, comprehensive analysis of the pathophysiology underlying this systemic inflammatory response is greatly complicated by variations in the immune response observed in critically ill patients, which is a result of inter-individual differences in comorbidity, comedication, source of infection, causative pathogen, and onset of the inflammatory response. During experimental human endotoxemia, human subjects are challenged with purified endotoxin (lipopolysaccharide) intravenously which induces a short-lived, well-tolerated and controlled systemic inflammatory response, similar to that observed during sepsis. The human endotoxemia model can be conducted in a highly standardized and reproducible manner, using a carefully selected homogenous study population. As such, the experimental human endotoxemia model does not share the aforementioned clinical limitations and enables us to investigate both the mechanisms of systemic inflammation, as well as to evaluate novel (pharmacological) interventions in humans in vivo. The present review provides a detailed overview of the various designs, organ-specific changes, and strengths and limitations of the experimental human endotoxemia model, with the main focus on its use as a translational model for sepsis research.


Assuntos
Endotoxemia , Lipopolissacarídeos/toxicidade , Modelos Biológicos , Endotoxemia/induzido quimicamente , Endotoxemia/metabolismo , Endotoxemia/patologia , Humanos , Lipopolissacarídeos/química , Experimentação Humana não Terapêutica
12.
Sci Rep ; 8(1): 17141, 2018 11 20.
Artigo em Inglês | MEDLINE | ID: mdl-30459409

RESUMO

Self-esteem refers to the extent to which we feel positive or negative about ourselves, and reflects an individual's subjective evaluation of personal worth and attitudes about the self. As one kind of positive psychosocial resources, high self-esteem has been found to buffer the effects of stress on physical health. However, little is known about the possible neural basis underlying the association between physical health and self-esteem. In the present study, we investigated whether the hippocampus served as a neuroanatomical basis for the association between self-esteem and physical health in a large population of healthy young adults. We examined self-esteem and self-reported physical health with the Rosenberg Self Esteem Scale (RSES) and the Chinese Constitution Questionnaire (CCQ) respectively, and gray matter volume of the hippocampus was measured using magnetic resonance imaging. As expected, we found that individuals with higher levels of self-esteem had better self-reported physical health. Importantly, the mediation analysis showed that the gray matter volume of the hippocampus mediated the link between self-esteem and physical health, suggesting its critical role in the neural circuitry through which self-esteem is related to physical health.


Assuntos
Hipocampo/fisiologia , Autoimagem , Feminino , Hipocampo/diagnóstico por imagem , Humanos , Imagem por Ressonância Magnética , Masculino , Experimentação Humana não Terapêutica , Autorrelato , Adulto Jovem
14.
Nat Commun ; 9(1): 4294, 2018 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-30327462

RESUMO

Fear extinction does not prevent post-traumatic stress or have long-term therapeutic benefits in fear-related disorders unless extinction memories are easily retrieved at later encounters with the once-threatening stimulus. Previous research in rodents has pointed towards a role for spontaneous prefrontal activity occurring after extinction learning in stabilizing and consolidating extinction memories. In other memory domains spontaneous post-learning activity has been linked to dopamine. Here, we show that a neural activation pattern - evoked in the ventromedial prefrontal cortex (vmPFC) by the unexpected omission of the feared outcome during extinction learning - spontaneously reappears during postextinction rest. The number of spontaneous vmPFC pattern reactivations predicts extinction memory retrieval and vmPFC activation at test 24 h later. Critically, pharmacologically enhancing dopaminergic activity during extinction consolidation amplifies spontaneous vmPFC reactivations and correspondingly improves extinction memory retrieval at test. Hence, a spontaneous dopamine-dependent memory consolidation-based mechanism may underlie the long-term behavioral effects of fear extinction.


Assuntos
Dopamina/metabolismo , Medo/fisiologia , Córtex Pré-Frontal/fisiologia , Administração Oral , Adulto , Dopamina/administração & dosagem , Dopamina/farmacologia , Extinção Psicológica/fisiologia , Humanos , Imagem por Ressonância Magnética , Masculino , Consolidação da Memória , Experimentação Humana não Terapêutica , Córtex Pré-Frontal/efeitos dos fármacos
15.
Nat Commun ; 9(1): 4162, 2018 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-30327469

RESUMO

It was recently proposed that olfaction evolved to aid navigation. Consistent with this hypothesis, olfactory identification and spatial memory are linked to overlapping brain areas which include the orbitofrontal cortex and hippocampus. However, the relationship between these two processes has never been specifically investigated. Here, we show that olfactory identification covaries with spatial memory in humans. We also found that the cortical thickness of the left medial orbitofrontal cortex, and the volume of the right hippocampus, predict both olfactory identification and spatial memory. Finally, we demonstrate deficits in both olfactory identification and spatial memory in patients with lesions of the medial orbitofrontal cortex. Our findings reveal an intrinsic relationship between olfaction and spatial memory that is supported by a shared reliance on the hippocampus and medial orbitofrontal cortex. This relationship may find its roots in the parallel evolution of the olfactory and hippocampal systems.


Assuntos
Hipocampo/fisiologia , Córtex Pré-Frontal/fisiologia , Olfato/fisiologia , Memória Espacial/fisiologia , Adulto , Idoso , Estudos de Casos e Controles , Córtex Cerebral/diagnóstico por imagem , Córtex Cerebral/fisiologia , Feminino , Hipocampo/diagnóstico por imagem , Humanos , Imagem por Ressonância Magnética , Masculino , Aprendizagem em Labirinto , Pessoa de Meia-Idade , Testes Neuropsicológicos , Experimentação Humana não Terapêutica , Córtex Pré-Frontal/diagnóstico por imagem , Córtex Pré-Frontal/patologia
16.
Nat Commun ; 9(1): 4288, 2018 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-30327503

RESUMO

When we produce actions we predict their likely consequences. Dominant models of action control suggest that these predictions are used to 'cancel' perceptual processing of expected outcomes. However, normative Bayesian models of sensory cognition developed outside of action propose that rather than being cancelled, expected sensory signals are represented with greater fidelity (sharpened). Here, we distinguished between these models in an fMRI experiment where participants executed hand actions (index vs little finger movement) while observing movements of an avatar hand. Consistent with the sharpening account, visual representations of hand movements (index vs little finger) could be read out more accurately when they were congruent with action and these decoding enhancements were accompanied by suppressed activity in voxels tuned away from, not towards, the expected stimulus. Therefore, inconsistent with dominant action control models, these data show that sensorimotor prediction sharpens expected sensory representations, facilitating veridical perception of action outcomes.


Assuntos
Modelos Neurológicos , Percepção/fisiologia , Adulto , Encéfalo/diagnóstico por imagem , Feminino , Dedos/fisiologia , Humanos , Imagem por Ressonância Magnética , Masculino , Movimento , Experimentação Humana não Terapêutica , Estimulação Luminosa/métodos , Máquina de Vetores de Suporte
18.
Sci Rep ; 8(1): 9980, 2018 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-29967356

RESUMO

Both reasoning ability and social learning play a crucial role in human adaptation. Cognitive abilities like enhanced reasoning skills have combined with cumulative cultural adaptation to allow our species to dominate the world like no other. Thus, understanding how social learning interacts with individual reasoning ability is crucial for unravelling our evolutionary history. Here we describe a laboratory experiment designed to investigate the effect of social learning on individuals' ability to infer a general rule about unfamiliar problems. In this experiment, social information had both positive and negative effects on individuals' likelihood of inferring the rule. Social learners required more evidence to infer the rule than did individual learners, suggesting that social learning inhibits cognitive effort but social learning provided individuals with information that individual learners were unlikely to gather on their own, especially as the task became more difficult. When individuals are unlikely to discover useful information by themselves, social learning can potentiate understanding even though it reduces individual cognitive effort.


Assuntos
Resolução de Problemas , Aprendizado Social , Adolescente , Adulto , Compreensão , Feminino , Humanos , Masculino , Experimentação Humana não Terapêutica , Comunicação não Verbal , Distribuição Aleatória
19.
Ann Oncol ; 29(8): 1727-1740, 2018 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-29945232

RESUMO

The classical development of drugs has progressively faded away, and we are currently in an era of seamless drug-development, where first-in-human trials include unusually big expansion cohorts in the search for early signs of activity and rapid regulatory approval. The fierce competition between different pharmaceutical companies and the hype for immune combinations obliges us to question the current way in which we are evaluating these drugs. In this review, we discuss critical issues and caveats in immunotherapy development. A particular emphasis is put on the limitations of pre-clinical toxicology studies, where both murine models and cynomolgus monkeys have underpredicted toxicity in humans. Moreover, relevant issues surrounding dose determination during phase I trials, such as dose-escalation methods or flat versus body-weight dosing, are discussed. A proposal of how to face these different challenges is offered, in order to achieve maximum efficacy with minimum toxicity for our patients.


Assuntos
Antineoplásicos Imunológicos/efeitos adversos , Desenvolvimento de Medicamentos/métodos , Ensaios de Seleção de Medicamentos Antitumorais/métodos , Neoplasias/tratamento farmacológico , Animais , Antineoplásicos Imunológicos/administração & dosagem , Ensaios Clínicos Fase I como Assunto , Relação Dose-Resposta a Droga , Humanos , Camundongos , Camundongos Transgênicos , Modelos Animais , Neoplasias/imunologia , Experimentação Humana não Terapêutica , Especificidade da Espécie , Testes de Toxicidade/métodos
20.
J Neurosci Methods ; 304: 1-10, 2018 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-29653130

RESUMO

BACKGROUND: Mixed frequency and phase coding (FPC) can achieve the significant increase of the number of commands in steady-state visual evoked potential-based brain-computer interface (SSVEP-BCI). However, the inconsistent phases of the SSVEP over channels in a trial and the existence of non-contributing channels due to noise effects can decrease accurate detection of stimulus frequency. NEW METHOD: We propose a novel command detection method based on a complex sparse spatial filter (CSSF) by solving ℓ1- and ℓ2,1-regularization problems for a mixed-coded SSVEP-BCI. In particular, ℓ2,1-regularization (aka group sparsification) can lead to the rejection of electrodes that are not contributing to the SSVEP detection. RESULTS: A calibration data based canonical correlation analysis (CCA) and CSSF with ℓ1- and ℓ2,1-regularization cases were demonstrated for a 16-target stimuli with eleven subjects. The results of statistical test suggest that the proposed method with ℓ1- and ℓ2,1-regularization significantly achieved the highest ITR. COMPARISON WITH EXISTING METHODS: The proposed approaches do not need any reference signals, automatically select prominent channels, and reduce the computational cost compared to the other mixed frequency-phase coding (FPC)-based BCIs. CONCLUSIONS: The experimental results suggested that the proposed method can be usable implementing BCI effectively with reduce visual fatigue.


Assuntos
Eletroencefalografia , Potenciais Evocados Visuais/fisiologia , Percepção Visual/fisiologia , Adulto , Algoritmos , Mapeamento Encefálico , Interfaces Cérebro-Computador , Simulação por Computador , Feminino , Voluntários Saudáveis , Humanos , Masculino , Experimentação Humana não Terapêutica , Reconhecimento Automatizado de Padrão , Estimulação Luminosa , Psicofísica , Adulto Jovem
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