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As análises de subgrupos em ensaios clínicos são habitualmente efectuadas para definir a potencial heterogeneidade do efeito do tratamento relacionado com o risco de base ou da fisiopatologia, com a aplicação prática da terapêutica ou ainda da subutilização da terapêutica na prática clínica de rotina devido a incerteza do benefício/risco desta. Quando apropriadamente planeadas, as análises de subgrupos são metodologias válidas para discernir benefícios terapêuticos em subgrupos de doentes, fornecendo desta maneira evidência de boa qualidade de suporte à decisão clínica. No entanto, para a sua realização ser correcta devem ser indicadas a priori no protocolo inicial, devem restringir-se ao outcome primário, devem ser feitos em número limitado, devem ser todas reportadas e, mais importante, devem ser submetidas a testes estatísticos de i...
Crohn’s disease (CD) is a chronic relapsing inflammatory disease of the gastrointestinal tract, which mostly affects young patients. Imaging techniques form a very important part for the evaluation of CD and for monitoring disease progression or response to therapy. Currently, imaging of CD is increasingly being performed by cross-sectional modalities, i.e. multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI), since these techniques allow for simultaneous visualization of luminal, mural and extraintestinal disease extension. MR enterography has the potential to safely and noninvasively accomplish the imaging needs of patients with Crohn disease without exposing them to ionizing radiation. The new imaging paradigm should contemplate patient safety as a very important aspect when assessing the role of an imaging ...
In Portugal, the National Pharmacovigilance System (NPS) was created in 1992, completing during this year 20 years of existence. Having been established in a centralized manner, it soon became aware that its geographic decentralization would bring advantages in terms of proximity of the System to health professionals as well as the involvement of the universities. The NPS currently has four regional pharmacovigilance centres, which cover the entire mainland, which became centers of scientific vocation, carrying out pharmacoepidemiological studies in the area of drug safety. Also, they are the guarantee of proper collection, processing and evaluation of spontaneous reports of adverse drug reactions (ADRs), as well as the continuing disclosure of the System among health professionals and promotion of spontaneous reporting. Over these 20 ...
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