40 research outputs found

    Results of a phase 1, randomized, placebocontrolled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel

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    HIV pre-exposure prophylaxis (PrEP) is dominated by clinical therapeutic antiretroviral (ARV) drugs. Griffithsin (GRFT) is a non-ARV lectin with potent anti-HIV activity. GRFT’s preclinical safety, lack of systemic absorption after vaginal administration in animal studies, and lack of cross-resistance with existing ARV drugs prompted its development for topical HIV PrEP. We investigated safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of PC-6500 (0.1% GRFT in a carrageenan (CG) gel) in healthy women after vaginal administration. This randomized, placebo-controlled, parallel group, double-blind first-in-human phase 1 study enrolled healthy, HIV-negative, non-pregnant women aged 24–45 years. In the open label period, all participants (n = 7) received single dose of PC- 6500. In the randomized period, participants (n = 13) were instructed to self-administer 14 doses of PC-6500 or its matching CG placebo (PC-535) once daily for 14 days. The primary outcomes were safety and PK after single dose, and then after 14 days of dosing. Exploratory outcomes were GRFT concentrations in cervicovaginal fluids, PD, inflammatory mediators and gene expression in ectocervical biopsies. This trial is registered with ClinicalTrials. gov, number NCT02875119. No significant adverse events were recorded in clinical or laboratory results or histopathological evaluations in cervicovaginal mucosa, and no anti-drug (GRFT) antibodies were detected in serum. No cervicovaginal proinflammatory responses and no changes in the ectocervical transcriptome were evident. Decreased levels of proinflammatory chemokines (CXCL8, CCL5 and CCL20) were observed. GRFT was not detected in plasma. GRFT and GRFT/CG in cervicovaginal lavage samples inhibited HIV and HPV, respectively, in vitro in a dose-dependent fashion. These data suggest GRFT formulated in a CG gel is a safe and promising on-demand multipurpose prevention technology product that warrants further investigation

    The effect of neuroticism in the process of goal pursuit

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    This study examines the link between Neuroticism and work motivation under work conditions that provide clear behavioral expectations. Within a two-phase correlational laboratory setup, participants (N = 158) worked on a simple task with specific, high goals that were linked to monetary rewards. Structural equation modeling analysis largely supported the postulated model. Focusing on antecedents and consequences of goal commitment, we found that Neuroticism was indirectly related to the attainment of assigned goals via motivational variables in the process of goal pursuit. Independent of cognitive ability, positive and negative effects of Neuroticism were evident in the motivational process, which forms an explanation for the close-to-zero relationships to performance outcomes. Two facets (Anxiety, Selfconsciousness) seem to offer explanations for the contradicting effects of Neuroticism in the process of goal pursuit

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    Die Partizipative Innovationsgruppe im Praxistest

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    In dem vorliegenden Beitrag werden die Grundzüge der Partizipativen Innovationsgruppe sowie die ersten Umsetzungserfahrungen mit diesem Konzept vorgestellt. Mit der Einführung und Etablierung dieser Arbeitsgruppen werden im praktischen Arbeitsalltag gezielt Freiräume und Motivierungspotenziale für Innovationen geschaffen. In unserem Praxisbeispiel beschäftigte sich die Gruppe mit der Problemidentifikation, Ideengenerierung sowie der Umsetzung einer Prozessinnovation an der Schnittstelle zwischen (internen) Kunden und technischen Dienstleistern. Erste Ergebnisse sprechen für einen positiven Effekt der Arbeit dieser Pilotgruppe bezüglich einer innovationsförderlichen Unternehmenskultur im Arbeitsalltag

    Goal setting via videoconference

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    In two experiments (N = 126, N = 120) telework in an advertising company was simulated. Participants communicated either face-to-face or via a PC-videoconference with a supervisor who motivated employees to solve brainstorming tasks using several goal setting strategies. In addition, communication with the supervisor prior to goal setting was manipulated to examine the impact of a personal meeting with the supervisor and to investigate the effect of having some prior experience with this technology. In both experiments, stimulating challenging goals improved performance compared to "do your best" instructions when goal setting was conducted via a videoconference. Moreover, it was found that participative goal setting was more effective than directive goal setting. However, a prior personal meeting with a supervisor or an additional interaction via videoconference prior to goal setting had no impact on performance or the effectiveness of goal setting. In sum, these findings indicate that goal setting effects are robust and can be found even if communication is based on a videoconference. When difficult goals have to be set within a videoconference, participative goal setting strategies are most effective

    Work Motivation in The Context of a Globalizing Economy

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