Efficacy of mast cell directed therapies in irritable bowel syndrome: a systematic review.

Background And Study Aim: Lately, mast cells (MCs) are increasingly implicated in the pathophysiology of irritable bowel syndrome (IBS). The aim of this systematic review was to assess the efficacy of mast cell directed therapies in reducing the main symptoms of IBS: abdominal pain and changes in stool frequency or consistency.

Patients And Methods: Pubmed, Web of Science and Scopus were searched until December 19, 2022.

Temporomandibular Joint Herniation into the External Auditory Canal.

Always ask a patient to open and close their mouth when you see a mass protruding into the external auditory canal, as to not miss this rare anomaly.

Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries.

To study regulatory approaches for the implementation and utilization of the Hospital Exemption (HE) in nine EU countries. Using public regulatory documentation and interviews with authorities we characterized the national implementation process of the HE, including national implementation characteristics and two outcomes: national licensing provisions and the amount of license holders. National licensing provisions vary substantially among selected countries as a result of different regulatory considerations that relate to unmet medical needs, benefit/risk balance, and innovation.

Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries.

Background Aims: As part of the advanced therapy medicinal product (ATMP) regulation, the hospital exemption (HE) was enacted to accommodate manufacturing of custom-made ATMPs for treatment purposes in the European Union (EU). However, how the HE pathway has been used in practice is largely unknown.

Methods: Using a survey and interviews, we provide the product characteristics, scale and motivation for ATMP manufacturing under HE and other, non-ATMP-specific exemption pathways in seven European countries.

Publication rates and reported results in a cohort of gene- and cell-based therapy trials.

We investigated publication rates and reported results for gene- and cell-based therapy trials. In a cohort of Institutional Review Board (IRB)-authorized trials during 2007-2017 in the Netherlands (n = 105), we examine publication rates and reported results in scientific papers and conference abstracts as well as associations with the occurrence of trial characteristics. The publication rate for scientific papers was 27% and 17% for conference abstracts (median survival time: 1050 days).