A core outcome domain set for clinical research on capillary malformations (the COSCAM project): an e-Delphi process and consensus meeting.

Background: There is limited evidence on the best available treatment options for capillary malformations (CMs), mainly due to the absence of uniform outcome measures in trials on therapies. A core outcome set (COS) enables standard reporting of trial outcomes, which facilitates comparison of treatment results.

Objectives: To develop a core outcome domain set (CDS), as part of a core outcome set (COS), for clinical research on CMs.

Development of a core outcome domain set for clinical research on capillary malformations (the COSCAM project).

Background: Due to a large variety in treatment outcomes reported in therapeutic trials and lacking patient-relevant outcomes, it is hard to adequately compare and improve current therapies for patients with capillary malformations (CMs). The Core Outcome Set for Capillary Malformations (COSCAM) project aims to develop a core outcome set (COS) for use in future CM trials, in which we will first develop a core outcome (sub)domain set (CDS). Here, we describe the methods for the development of a CDS and present the results of the first development stage.

In Vivo Assessment of Thermosensitive Liposomes for the Treatment of Port Wine Stains by Antifibrinolytic Site-Specific Pharmaco-Laser Therapy.

Antifibrinolytic site-specific pharmaco-laser therapy (SSPLT) is an experimental treatment modality for refractory port wine stains (PWS). Conceptually, antifibrinolytic drugs encapsulated in thermosensitive liposomes are delivered to thrombi that form in semi-photocoagulated PWS blood vessels after conventional laser treatment. Local release of antifibrinolytics is induced by mild hyperthermia, resulting in hyperthrombosis and complete occlusion of the target blood vessel (clinical endpoint).

Site-specific pharmaco-laser therapy: A novel treatment modality for refractory port wine stains.

Unlabelled: Despite extensive efforts to optimize laser therapy, i.e., the current gold standard treatment, a majority of port wine stain (PWS) patients responds suboptimally to laser therapy.

Port wine stain treatment outcomes have not improved over the past three decades.

Background: Since the early '80s, the pulsed dye laser has been the standard treatment tool for non-invasive port wine stain (PWS) removal. In the last three decades, a considerable amount of research has been conducted to improve clinical outcomes, given that a fraction of PWS patients proved recalcitrant to laser treatment. Whether this research actually led to increased therapeutic efficacy has not been systematically investigated.

Prospective analysis of the port-wine stain patient population in the Netherlands in light of novel treatment modalities.

Background: Pulsed dye laser is the gold standard for port-wine stain (PWS) treatment. However, pulsed dye lasers achieve suboptimal clinical results in a majority of patients. Patient demand for novel therapies and willingness to participate in clinical studies is currently unknown, yet, imperative for steering R&D activity.

Diagnostic features of malignancy-associated pseudoachalasia.

Background: Pseudoachalasia is a condition in which clinical and manometric signs of achalasia are mimicked by another abnormality, most often a malignancy.

Aim: To identify risk factors that suggest presence of malignancy-associated pseudoachalasia.

Methods: In this retrospective cohort study, achalasia patients newly diagnosed by manometry were included.

Tranexamic Acid-Encapsulating Thermosensitive Liposomes for Site-Specific Pharmaco-Laser Therapy of Port Wine Stains.

Site-specific pharmaco-laser therapy (SSPLT) is a developmental stage treatment modality designed to non-invasively remove superficial vascular pathologies such as port wine stains (PWS) by combining conventional laser therapy with the prior administration of a prothrombotic and/or antifibrinolytic pharmaceutical-containing drug delivery system. For the antifibrinolytic SSPLT component, six different PEGylated thermosensitive liposomal formulations encapsulating tranexamic acid (TA), a potent antifibrinolytic lysine analogue, were characterized for drug:lipid ratio, encapsulation efficiency, size, endovesicular TA concentration (C TA), phase transition temperature (T m), and assayed for heat-induced TA release. Assays were developed for the quantification of liposomal TA and heat-induced TA release from two candidate formulations.

The influence of life history characteristics on flea (Siphonaptera) species distribution models.

Background: Ectoparasites exhibit pronounced variation in life history characteristics such as time spent on the host and host range. Since contemporary species distribution (SD) modelling does not account for differences in life history, the accuracy of predictions of current and future species' ranges could differ significantly between life history groups.

Results: SD model performance was compared between 21 flea species that differ in microhabitat preferences and level of host specificity.

Embryos of an early Jurassic prosauropod dinosaur and their evolutionary significance.

Articulated embryos from the Lower Jurassic Elliot Formation of South Africa are referable to the prosauropod Massospondylus carinatus and, together with other material, provide substantial insights into the ontogenetic development in this early dinosaur. The large forelimbs and head and the horizontally held neck indicate that the hatchlings were obligate quadrupeds. In contrast, adult Massospondylus were at least facultatively bipedal.