Safety and efficacy of C1-inhibitor in traumatic brain injury (CIAO@TBI): study protocol for a randomized, placebo-controlled, multi-center trial

Background: Traumatic brain injury (TBI) is a major cause of death and disability across all ages. After the primary impact, the pathophysiologic process of secondary brain injury consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system could therefore be a therapeutic target in TBI.Objective: To study the safety and efficacy of C1-inhibitor (C1-INH) compared to placebo in patients with TBI. By temporarily blocking the complement system, we hypothesize a decrease in the posttraumatic neuroinflammatory response resulting in a less unfavorable clinical outcome for TBI patients.Methods: CIAO@TBI is a multicenter, randomized, blinded, phase II placebo-controlled trial. Adult TBI patients with GCS < 13 requiring intracranial pressure (ICP) monitoring will be randomized, using block randomization, within 12 h after trauma to one dose 6000 IU C1-INH or placebo. A total of 106 patients will be included, and follow-up will occur up to 12 months. The primary endpoints are (1) Therapy Intensity Level (TIL) Scale, (2) Glasgow Outcome Scale-Extended (GOSE) at 6 months, and (3) complication rate during hospitalization. Outcomes will be determined by a trial nurse blinded for the treatment allocation. Analyses will be conducted in an intention-to-treat analysis.Discussion: We expect that C1-INH administration will be safe and potentially effective to improve clinical outcomes by reducing neuroinflammation in TBI patients.Development and application of statistical models for medical scientific researc

The potential of the skin as a readout system to test artificial turf systems: clinical and immunohistological effects of a sliding on natural grass and artificial turf

Contains fulltext : 119207.pdf (publisher's version ) (Closed access)The purpose of this study was to investigate the interaction of skin with natural grass and artificial turf at clinical, histological and immunohistochemical level. Therefore, 14 male volunteers performed slidings on dry natural grass, wet natural grass and artificial turf. Directly and 24 h after the slidings, a clinical picture and a 3-mm punch biopsy of the lesion were taken. Paraffin sections (6 microm) were hematoxylin-eosin stained. Immunohistochemistry was performed for CD3, hBD-2, K16, K10, Ki67 and HSP70. Clinically, a sliding performed on artificial turf caused less erythema but more abrasion compared to natural grass. At histological level, artificial turf or dry natural grass damaged the stratum corneum the most. Directly after the sliding, CD3, hBD-2, K16, K10, Ki67 and HSP70 expression was normal. 24 h after a sliding on artificial turf or dry natural grass, an increase of K16, hBD-2 and HSP70 expression was observed. In this pilot study it was not possible to clearly distinguish between skin damage induced by a sliding on artificial turf and natural grass. However, small differences at clinical and histological level seem to exist. This demonstrates the potential of the skin as readout system to evaluate artificial turf systems and mechanical skin damage

Rapports au bénévolat dans l'espace sportif.

BACKGROUND: Evaluation of (immuno)histological and cell biological changes in damaged skin requires often an invasive skin biopsy, making in vivo models inappropriate to study skin damage. Reflectance confocal microscopy (RCM) might overcome this limitation. Therefore, we evaluated the use of a tape-stripping model in combination with RCM to provide morphological data on skin damage and recovery. METHODS: In 25 volunteers, a tape-stripping stimulus was applied. The skin was imaged with RCM during 1 week and 3 mm punch biopsies were obtained. RESULTS: Strong correlations between epidermal thickness determined by RCM and conventional histological measurements were found. RCM thickness measurements correlated well with epidermal proliferation. The 10x or 15x repeated tape-stripping resulted in skin damage similar to acute stripping. Mild repeated tape-stripping showed no skin damage. CONCLUSION: Overall, we demonstrated that non-invasive RCM in combination with tape-stripping could be used as model to obtain morphological and cell biological data on skin-material interactions

An investigation into the structure and position of organic bases in ZSM-5-type zeolites by high-resolution solid-state carbon-13 NMR spectroscopy

Cross-polarization magic-angle-spinning 13C NMR was used to study the structure and position of Pr4N+ X- (X = Br, Cl, OH) occluded in ZSM-5-type zeolites. Pr4N+ is occluded, chem. intact, into the zeolites, and splitting of the 13C signal of the Me C atom shows the presence of >=2 dissimilar sites within the zeolite

The elusiveness of white-collar and corporate crime in a globalized economy

We live in a time that is dominated by business firms operating across the globe. While globalization has created opportunities for many, it has also: increased opportunities for white?collar and corporate crime, led to the transference of social, environmental, and economic harms to jurisdictions vulnerable to this, and created serious problems for the regulation and enforcement of business behavior. This chapter discusses and illustrates these issues using three examples: the (mis)use of corporate vehicles for financial gain, transnational corporate bribery, and environmental crime in the waste industry. The chapter concludes with some of the key challenges for the future study of white?collar and corporate crime