19 research outputs found
A tale of two cognitions: The Evolution of Social Constructivism in International Relations
Abstract Constructivism in International Relations (IR) is popular, but constructivists seem disappointed. Allegedly something has been lost. Such criticisms are misplaced. There was never a uniform Constructivism. Since constructivism is socially constructed, to argue that constructivism has evolved “wrongly” is odd. This paper explains the dissatisfaction with constructivism followed by a second reading of its evolution as a tale of two cognitions. These two cognitions distinguish genera in the constructivist “family”. A criticism against one genus based on the cognition of the other is unfair. A focus on cognitions and the use of genera helps in perceiving constructivism’s future evolution
A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome
Study Objective: To evaluate the efficacy and tolerability of gabapentin enacarbil (GEn) 1200 mg or 600 mg compared with placebo in subjects with moderate-to-severe primary restless legs syndrome (RLS). Methods: This 12-week, multicenter, double-blind, placebo-controlled study randomized subjects (1:1:1) to GEn 1200 mg, 600 mg, or placebo. Co-primary endpoints: mean change from baseline in International Restless Legs Scale (IRLS) total score and proportion of responders (rated as very much or much improved) on the investigator-rated Clinical Global Impression-Improvement scale (CGI-I) at Week 12 LOCF for GEn 1200 mg compared with placebo. Secondary endpoints included GEn 600 mg compared with placebo on the IRLS and CGI-I at Week 12 LOCF and subjective measures for sleep. Safety and tolerability assessments included adverse events. Results: 325 subjects were randomized (GEn 1200 mg = 113; 600 mg = 115; placebo = 97). GEn 1200 mg significantly improved mean [SD] IRLS total score at Week 12 LOCF (baseline: 23.2 [5.32]; Week 12: 10.2 [8.03]) compared with placebo (baseline: 23.8 [4.58]; Week 12: 14.0 [7.87]; adjusted mean treatment difference [AMTD]: -3.5; p = 0.0015), and significantly more GEn 1200 mg-treated (77.5%) than placebo-treated (44.8%) subjects were CGI-I responders (p \u3c 0.0001). Similar significant results were observed with GEn 600 mg for IRLS (AMTD: -4.3; p \u3c 0.0001) and CGI-I (72.8% compared with 44.8%; p \u3c 0.0001). GEn also significantly improved sleep outcomes (Post-Sleep Questionnaire, Pittsburgh Sleep Diary and Medical Outcomes Sleep Scale) compared with placebo. The most commonly reported adverse events were somnolence (GEn 1200 mg = 18.0%; 600 mg = 21.7%; placebo = 2.1%) and dizziness (GEn 1200 mg = 24.3%; 600 mg = 10.4%; placebo = 5.2%). Dizziness increased with increased dose and led to discontinuation in 2 subjects (GEn 1200 mg, n = 1; GEn 600 mg, n = 1). Somnolence led to discontinuation in 3 subjects (GEn 600 mg). Conclusions: GEn 1200 mg and 600 mg significantly improve RLS symptoms and sleep disturbance compared with placebo and are generally well tolerated
Increased all-cause and cancer mortality in HTLV-II infection.
BackgroundHuman T-lymphotropic virus (HTLV)-I and HTLV-II cause chronic human retroviral infections, but few studies have examined the impact of either virus on survival among otherwise healthy individuals. The authors analyzed all-cause and cancer mortality in a prospective cohort of 155 HTLV-I, 387 HTLV-II, and 799 seronegative subjects.MethodsVital status was ascertained using death certificates, the US Social Security Death Index or family report, and causes of death were grouped into 9 categories. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazards models.ResultsAfter a median follow-up of 15.9 years, there were 105 deaths: 22 HTLV-I, 41 HTLV-II, and 42 HTLV-seronegative. Cancer was the predominant cause of death, resulting in 8 HTLV-I, 17 HTLV-II, and 15 HTLV-seronegative deaths. After adjustment for confounding, HTLV-I status was not significantly associated with increased all-cause mortality, though there was a positive trend (HR: 1.6, 95% CI: 0.8 to 3.1). HTLV-II status was strongly associated with increased all-cause (HR: 2.4, 95% CI: 1.4 to 4.4) and cancer mortality (HR: 3.8, 95% CI: 1.6 to 9.2).ConclusionsThe observed associations of HTLV-II with all-cause and cancer mortality could reflect biological effects of HTLV-II infection, residual confounding by socioeconomic status or other factors, or differential access to health care and cancer screening
Of false promises and good bets: a plea for a pragmatic approach to theory building (the Tartu lecture)
In this lecture I review some of the issues that meta-theorizing was supposed to address in international relations and show how this project of securing knowledge through hierarchization and finding absolute foundations failed. Basically I argue that since neither the 'order of being' nor the categories of the mind provide an unproblematic and trans-historically valid Archimedean point that allows for an incontestable 'view from nowhere', the traditional epistemological project cannot make good on its promise. I'm trying to refute the twin fallacies that seem to fuel much of the hypertrophic concern with epistemology: First, that in the absence of secure universally valid and trans-historically established criteria everything becomes 'relative' and that, therefore, the adherents of a more critical or pragmatic orientation towards knowledge have to be either nihilists or charlatans since they deny 'truth'. Second, since the foundationalist claims of traditional epistemology can be shown to be faulty, indeed 'anything goes' and we need not worry about criteria that warrant our knowledge claims. Here relatively mindless research activism or some form of pragmatism at basement prices is supposed to take care of the problems. I argue for a pragmatic turn in theorizing not in the hope of having now found a new foundation after the failure of the epistemological project, but with the understanding that such a turn represents a good bet in pursuing our research while remaining attentive to the importance of meta-theoretical issues that arise in its course
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How do I implement an outpatient program for the administration of convalescent plasma for COVID-19?
Convalescent plasma, collected from donors who have recovered from a pathogen of interest, has been used to treat infectious diseases, particularly in times of outbreak, when alternative therapies were unavailable. The COVID-19 pandemic revived interest in the use of convalescent plasma. Large observational studies and clinical trials that were executed during the pandemic provided insight into how to use convalescent plasma, whereby high levels of antibodies against the pathogen of interest and administration early within the time course of the disease are critical for optimal therapeutic effect. Several studies have shown outpatient administration of COVID-19 convalescent plasma (CCP) to be both safe and effective, preventing clinical progression in patients when administered within the first week of COVID-19. The United States Food and Drug Administration expanded its emergency use authorization (EUA) to allow for the administration of CCP in an outpatient setting in December 2021, at least for immunocompromised patients or those on immunosuppressive therapy. Outpatient transfusion of CCP and infusion of monoclonal antibody therapies for a highly transmissible infectious disease introduces nuanced challenges related to infection prevention. Drawing on our experiences with the clinical and research use of CCP, we describe the logistical considerations and workflow spanning procurement of qualified products, infrastructure, staffing, transfusion, and associated management of adverse events. The purpose of this description is to facilitate the efforts of others intent on establishing outpatient transfusion programs for CCP and other antibody-based therapies