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Filtenborg Crabtree posted an update 6 months, 1 week ago
It was also observed that in 41% of the cases a successful outcome was contingent upon willingness of the applicant to restrict the indication.
A majority of oncology procedures that had an OE resulted in a positive outcome suggesting that such agency interaction is an important opportunity for the applicant to have a last chance to resolve any outstanding issues at the final stage of the procedure.
A majority of oncology procedures that had an OE resulted in a positive outcome suggesting that such agency interaction is an important opportunity for the applicant to have a last chance to resolve any outstanding issues at the final stage of the procedure.
Additional antibiotic options are needed to treat bone and joint infections caused by penicillin-resistant Gram-positive pathogens.
This subanalysis of the Telavancin Observational Use Registry (TOUR™) aimed to record real-world telavancin usage patterns in patients with bone and joint infections treated with telavancin.
TOUR was a multicenter observational-use registry study conducted at 45 US sites between January 2015 and March 2017. Patient characteristics, infection type, infecting pathogen(s), previous treatment, telavancin dosing and duration, clinical response, and adverse event data were collected by retrospective medical chart reviews. TGF-beta inhibitor As such, inclusion/exclusion criteria were limited, and any patient receiving at least one dose of telavancin at the discretion of the treating physician was eligible. Patients were assessed as either positive clinical response, failed treatment, or indeterminate outcome.
Of the 1063 patients enrolled in TOUR, 27.4% (291/1063) were patients with bone and jointered with ClinicalTrials.gov (NCT02288234) on 11 November, 2014.
This trial was registered with ClinicalTrials.gov (NCT02288234) on 11 November, 2014.The purpose of this study was to examine relationships among caregiver social support, caregiver depressive symptoms, medication adherence, and asthma control in a sample of low-income, urban, Black children aged 3-12 years with uncontrolled asthma and their caregivers. Using longitudinal data from a randomized controlled trial (RCT) assessing the efficacy of an environmental control educational intervention, we used generalized estimating equations and ordered logistic regression models to evaluate the relationship between caregiver social support (Medical Outcomes Study Social Support Survey), depressive symptoms (Center for Epidemiologic Studies Depression scale), and two child asthma outcomes (a) medication adherence (Asthma Medication Ratio) and (b) asthma control. At baseline, 45.7% of the 208 children had very poorly controlled asthma. Nearly a third of caregivers (97% female) had clinically significant depressive symptoms at each data collection point. Social support was not associated with either asthma outcome nor did it moderate the relationship between depressive symptoms and child asthma outcomes. Higher caregiver depressive symptoms predicted decreased medication adherence (b=-0.003, SE 0.002). Moderate asthma at baseline (OR 0.305, SE 0.251), severe asthma at baseline (OR 0.142, SE 0.299), household income less then $20,000 per year (OR 0.505, SE 0.333), and fall season (OR 0.643, SE 0.215) were associated with poorer asthma control. Attending to the social context of low-income, urban, Black children with asthma is critical to reduce asthma morbidity. Maternal depressive symptoms are modifiable and should be targeted in interventions to improve child asthma outcomes in this vulnerable population. The RCT was registered with ClinicalTrials.gov (NCT01981564) in October 2013.Racial-ethnic minority youth between the ages of 13 and 24 in the USA are disproportionately impacted by HIV. Low HIV knowledge and psychological antecedents such as low perception of risk and low sexual negotiation skills have all been associated with HIV risk behaviors; however, the role of ethnic identity on these factors is unclear in the literature. Ethnic identity, which is a critical part of identity development among racial-ethnic minority youth, has been found to be a protective factor in risk-taking behaviors. However, limited research is available on the role of ethnic identity in HIV prevention research among youth. For this study, data were collected as part of a larger HIV prevention education program using a sample of 564 students of color (Meanage = 16.30, standard deviation = 1.26; 67.4% Hispanic, 29.5% Black) from an underserved northeastern US urban community. We examined whether ethnic identity moderated the relationship between psychological antecedents (e.g., perception of risk and sexual negotiation skills), gender, and viral hepatitis knowledge on HIV knowledge. Findings revealed that ethnic identity significantly moderated the relationship between psychological antecedent variables and HIV knowledge by strengthening these associations as ethnic identity increased. Female adolescents were also more likely to have higher levels of HIV knowledge than males. Findings provide support for cultural and gender-specific prevention programs for racial-ethnic minority youth that seek to reduce HIV risk behaviors by increasing ethnic identity, particularly in under-resourced communities.
Upadacitinib is a Janus kinase inhibitor with demonstrated efficacy in patients with rheumatoid arthritis (RA).
The aim of this study was to assess the long-term safety of upadacitinib in patients with active RA from Japan compared with global clinical trial populations.
Pooled data in patients enrolled from Japan (the ‘Japanese population’; SELECT-SUNRISE, SELECT-EARLY, and SELECT-MONOTHERAPY) were compared with that from global (Japan and ex-Japan) upadacitinib clinical trial populations and summarized descriptively.
The Japanese population (mean age 57.0 years; mean RA duration 6.1 years) received upadacitinib 7.5 mg (n=121), 15mg (n=126), and 30 mg (n=124) once daily, while the global population (mean age 54.8 years; mean RA duration 9.1 years) received upadacitinib 6 mg twice daily/15 mg once daily (n=2883) and 12 mg twice daily/30 mg once daily (n=1375). Most patients were female (79.3%). The exposure-adjusted incidence rates (EAIRs) of serious adverse events in the Japanese population were 11.5, 12.