Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction - BAMPI TRIAL: an open-label, randomized controlled trial protocol

Background It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction. Methods/design This is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate). Discussion The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction

Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry

Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase

Effects of freezing temperatures on early life stages of native trees of different elevational origin: Implications for tree recruitment in seasonally dry mountain forests

In mountain forests, tree regeneration is limited by increasingly frequent frosts with increasing elevation. We investigated the effects of exposure to freezing temperature on early life stages of two native trees of different elevational origin in a seasonally dry mountain forest. We hypothesized that the negative effects of freezing exposure on performance of early life stages increases as freezing temperature decreases, and that frost resistance increases in plants of high elevational origin. We collected seeds of two tree species (Kageneckia lanceolata and Lithraea molleoides) from populations located at different elevations and grew seedlings and saplings in a greenhouse. Dry seeds, imbibed seeds and 1-month-old seedlings were exposed to seven temperature treatments ranging from 4 °C to −20 °C, while 12-month-old saplings were exposed to four temperature treatments from −8 °C to −20 °C. After freezing exposure in a climate chamber, we monitored seed germination and seedling and sapling survival. Germination of K. lanceolata decreased with decreasing temperature only for imbibed seeds from mid- and high elevations, whereas germination of L. molleoides slightly increased with decreasing temperature only for imbibed seeds from high elevations. For both species, seedling survival decreased with decreasing temperature. For K. lanceolata, the negative effects of freezing temperatures were weaker as elevational origin of seeds increased, whereas L. molleoides showed the opposite pattern. For both species, saplings only survived at the mildest applied freezing temperature (−8 °C). We conclude that effects of climatic variation associated with elevation depend on the study species and life stage. The observed patterns could be caused by maternal effects, which are absent at the sapling stage. Moreover, temperatures below −8 °C can limit recruitment since partial mortality of seedlings and saplings occurred at such values.Fil: Torres, Romina Cecilia. Universidad Nacional de Córdoba; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Investigaciones Biológicas y Tecnológicas. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas, Físicas y Naturales. Instituto de Investigaciones Biológicas y Tecnológicas; ArgentinaFil: Valfré Giorello, Tatiana Alejandra. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Investigaciones Biológicas y Tecnológicas. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas, Físicas y Naturales. Instituto de Investigaciones Biológicas y Tecnológicas; Argentina. Universidad Nacional de Córdoba; ArgentinaFil: Cingolani, Ana María. Universidad Nacional de Córdoba; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto Multidisciplinario de Biología Vegetal. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas Físicas y Naturales. Instituto Multidisciplinario de Biología Vegetal; ArgentinaFil: Cáceres, Yolanda. Martin-luther-universität Halle-wittenberg; Alemania. German Centre For Integrative Biodiversity Research (idiv) Halle-jena-leipzig; AlemaniaFil: Barberá, Iván. Universidad Nacional del Comahue; Argentina. Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet - Patagonia Norte. Instituto de Investigaciones En Biodiversidad y Medioambiente. Subsede San Martín de Los Andes-inibioma | Universidad Nacional del Comahue. Centro Regional Universitario Bariloche. Instituto de Investigaciones En Biodiversidad y Medioambiente. Subsede San Martín de Los Andes-inibioma.; ArgentinaFil: Hensen, Isabell. German Centre For Integrative Biodiversity Research (idiv) Halle-jena-leipzig; Alemania. Martin-luther-universität Halle-wittenberg; AlemaniaFil: Renison, Daniel. Universidad Nacional de Córdoba; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Instituto de Investigaciones Biológicas y Tecnológicas. Universidad Nacional de Córdoba. Facultad de Ciencias Exactas, Físicas y Naturales. Instituto de Investigaciones Biológicas y Tecnológicas; Argentin

A Global eDelphi Exercise to Identify Core Domains and Domain Items for the Development of a Global Registry of Alopecia Areata Disease Severity and Treatment Safety (GRASS)

Importance: A recent expert consensus exercise emphasized the importance of developing a global network of patient registries for alopecia areata to redress the paucity of comparable, real-world data regarding the effectiveness and safety of existing and emerging therapies for alopecia areata. Objective: To generate core domains and domain items for a global network of alopecia areata patient registries. Evidence Review: Sixty-six participants, representing physicians, patient organizations, scientists, the pharmaceutical industry, and pharmacoeconomic experts, participated in a 3-round eDelphi process, culminating in a face-to-face meeting at the World Congress of Dermatology, Milan, Italy, June 14, 2019. Findings: Ninety-two core data items, across 25 domains, achieved consensus agreement. Twenty further noncore items were retained to facilitate data harmonization in centers that wish to record them. Broad representation across multiple stakeholder groups was sought; however, the opinion of physicians was overrepresented. Conclusions and Relevance: This study identifies the domains and domain items required to develop a global network of alopecia areata registries. These domains will facilitate a standardized approach that will enable the recording of a comprehensive, comparable data set required to oversee the introduction of new therapies and harness real-world evidence from existing therapies at a time when the alopecia areata treatment paradigm is being radically and positively disrupted. Reuse of similar, existing frameworks in atopic dermatitis, produced by the Treatment of Atopic Eczema (TREAT) Registry Taskforce, increases the potential to reuse existing resources, creates opportunities for comparison of data across dermatology subspecialty disease areas, and supports the concept of data harmonization..</p

Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry

International audienc