1,721,219 research outputs found
The daily diary and the questionnaire are not equivalent for the evaluation of bowel habits
COLLABORATOR ITALIAN CONSTIPATION STUDY GROUP:
Bellini M, Biagi S, Costa F, De Bortoli N, Gambaccini D, Mammini C, Mumolo MG, Ricchiuti A, Marchi S, Bove A, Balzano A, Sormani MP, Bruzzi P, Battaglia E, Niola P, Verna C, Grassini M, Bocchini R, Cimatti M, Fornasari L, Montaletti I, Pazzi P, Alduini P, Berni I, Ceccarelli G, Bassotti G, Corazzi N, Morozzi B, Viegas LB, Pucciani F, Giani I, Ringressi N
Multiple sclerosis: clinical trial design 2019
PURPOSE OF REVIEW: Recent years have seen the approval of more than 15 disease-modifying drugs for multiple sclerosis (MS), mainly for its relapsing-remitting form (RRMS). The focus of the MS clinical trials is moving toward clinical trials aimed at progressive patients or based on putatively neuroprotective compounds. Here we reviewed the challenges of this paradigm shift. RECENT FINDINGS: Progressive MS and neuroprotective drugs trials will both need a change in patients' enrollment criteria, outcome selection, and clinical trials design. Published ocrelizumab Primary Progressive MS data, as well as translational neuroimaging and clinical research suggest that MRI markers of inflammation could be used to enrich progressive MS trials population, albeit with the risk of overestimating the relevance of antiinflammatory therapeutic effects in this population and that conventional MRI-based metrics need to be complemented with volumetric and multiparametric approaches to disease severity quantification. Lastly, regarding statistical design, Bayesian approaches are at last making their way from oncology to neurology improving our ability to evaluate multiple treatments in the same trials' population. SUMMARY: Adequate clinical trials design was one of the key factors in the RRMS treatment success story. Multidisciplinary collaborations are needed to adequately plan the progressive MS and restorative therapies trials that lay ahead in the near future
A composite score to predict short-term disease activity in patients with relapsing-remitting MS
Short-term evolution of individual enhancing MS lesions studied with magnetization transfer imaging
A reassessment of the plateauing relationship between T2 lesion load and disability in MS
The influence of slice orientation on brain MRI lesion load measurement in multiple sclerosis
MRI metrics as surrogate markers for clinical relapse rate in relapsing-remitting MS patients
Quantification of brain gray matter damage in different MS phenotypes by use of diffusion tensor MR imaging
The distribution of the magnetic resonance imaging response to glatiramer acetate in multiple sclerosis
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