The Church, State, and Literature of Carolingian France

This thesis examines the eighth century rise in power of the Carolingian Church and the Carolingian dynasty through an early promise of religious revival, monarchial revival, and increased Papal power. Such aims gained the Carolingians a powerful in the Church. Aided by Boniface (672-754 AD) and the Church, the Carolingians replaced the Merovingians in Francia. In conjunction with this revival, Church scholars dictated a reformation of kingship in treatises called the Speculum Principum. A king’s position became tremulous when they strayed from these rules, as it betrayed their alliance. Ultimately, Louis the Pious (778-840 AD) faced deposition after they disagreed on his appointments and adherence to the ideologies of the Speculum Principum

Imagery and Objectification: A Study of Early Modern Queenship

Queen Anne Boleyn (~1507-1536) failed to meet social norms during her time as Queen Consort to Henry VIII (1491-1548). By tracing concepts of queenship through the works of Chrétien de Troyes, Andreas Capellanus, Thomas Malory, and Juan Luis Vives this thesis demonstrates how Anne united the office of queen and mistress to bring her downfall and introduce a new construct of queenship

On the analysis of tuberculosis studies with intermittent missing sputum data

In randomized studies evaluating treatments for tuberculosis (TB), individuals are scheduled to be routinely evaluated for the presence of TB using sputum cultures. One important endpoint in such studies is the time of culture conversion, the first visit at which a patient’s sputum culture is negative and remains negative. This article addresses how to draw inference about treatment effects when sputum cultures are intermittently missing on some patients. We discuss inference under a novel benchmark assumption and under a class of assumptions indexed by a treatment-specific sensitivity parameter that quantify departures from the benchmark assumption. We motivate and illustrate our approach using data from a randomized trial comparing the effectiveness of two treatments for adult TB patients in Brazil.Fil: Scharfstein, Daniel. University Johns Hopkins; Estados UnidosFil: Rotnitzky, Andrea Gloria. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Torcuato Di Tella. Departamento de Economía; ArgentinaFil: Abraham, Maria. Statistics Collaborative; Estados UnidosFil: McDermott, Aidan. University Johns Hopkins; Estados UnidosFil: Chaisson, Richard. University Johns Hopkins; Estados UnidosFil: Geiter, Lawrence. Otsuka Novel Products; Estados Unido

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The Sol-gel process for nano-technologies : new nanocomposites with interesting optical and mechanical properties

Various nanocomposite systems have been synthesized by sol-gel routes. For this reason, prefabricated nanoparticles (SiO2 sols or boehmite powder) have been dispersed after surface modification in sol-gel-derived organically modified or polymeric ligand matrices. In all cases, a significant effect on dispersibility by surface modification could be observed. After curing, the mechanical or optical properties depend strongly on the dispersion and surface modification. Using these results, composites to be used in chip coupling and as hard coatings on polycarbonate and CR 39 have been developed

Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial

Objective To compare the incidence of tuberculosis over two years in infants vaccinated at birth with intradermal BCG or with percutaneous BCG

TB incidence in an adolescent cohort in South Africa

BACKGROUND: Tuberculosis (TB) is a major public health problem globally. Little is known about TB incidence in adolescents who are a proposed target group for new TB vaccines. We conducted a study to determine the TB incidence rates and risk factors for TB disease in a cohort of school-going adolescents in a high TB burden area in South Africa. METHODS: We recruited adolescents aged 12 to 18 years from high schools in Worcester, South Africa. Demographic and clinical information was collected, a tuberculin skin test (TST) performed and blood drawn for a QuantiFERON TB Gold assay at baseline. Screening for TB cases occurred at follow up visits and by surveillance of registers at public sector TB clinics over a period of up to 3.8 years after enrolment. RESULTS: A total of 6,363 adolescents were enrolled (58% of the school population targeted). During follow up, 67 cases of bacteriologically confirmed TB were detected giving an overall incidence rate of 0.45 per 100 person years (95% confidence interval 0.29-0.72). Black or mixed race, maternal education of primary school or less or unknown, a positive baseline QuantiFERON assay and a positive baseline TST were significant predictors of TB disease on adjusted analysis. CONCLUSION: The adolescent TB incidence found in a high burden setting will help TB vaccine developers plan clinical trials in this population. Latent TB infection and low socio-economic status were predictors of TB disease

A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis

BACKGROUND: Linezolid is an effective, but toxic anti-tuberculosis drug that is currently recommended for the treatment of drug-resistant tuberculosis. Improved oxazolidinones should have a better safety profile, while preserving efficacy. Delpazolid is a novel oxazolidinone developed by LegoChem Biosciences Inc. that has been evaluated up to phase 2a clinical trials. Since oxazolidinone toxicity can occur late in treatment, LegoChem Biosciences Inc. and the PanACEA Consortium designed DECODE to be an innovative dose-ranging study with long-term follow-up for determining the exposure-response and exposure-toxicity relationship of delpazolid to support dose selection for later studies. Delpazolid is administered in combination with bedaquiline, delamanid and moxifloxacin. METHODS: Seventy-five participants with drug-sensitive, pulmonary tuberculosis will receive bedaquiline, delamanid and moxifloxacin, and will be randomized to delpazolid dosages of 0 mg, 400 mg, 800 mg, 1200 mg once daily, or 800 mg twice daily, for 16 weeks. The primary efficacy endpoint will be the rate of decline of bacterial load on treatment, measured by MGIT liquid culture time to detection from weekly sputum cultures. The primary safety endpoint will be the proportion of oxazolidinone class toxicities; neuropathy, myelosuppression, or tyramine pressor response. Participants who convert to negative liquid media culture by week 8 will stop treatment after the end of their 16-week course and will be observed for relapse until week 52. Participants who do not convert to negative culture will receive continuation phase treatment with rifampicin and isoniazid to complete a six-month treatment course. DISCUSSION: DECODE is an innovative dose-finding trial, designed to support exposure-response modelling for safe and effective dose selection. The trial design allows assessment of occurrence of late toxicities as observed with linezolid, which is necessary in clinical evaluation of novel oxazolidinones. The primary efficacy endpoint is the change in bacterial load, an endpoint conventionally used in shorter dose-finding trials. Long-term follow-up after shortened treatment is possible through a safety rule excluding slow-and non-responders from potentially poorly performing dosages. TRIAL REGISTRATION: DECODE was registered in ClinicalTrials.gov before recruitment start on 22 October 2021 (NCT04550832)

How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India

<p>Abstract</p> <p>Background</p> <p>A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed.</p> <p>Aims</p> <p>The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation.</p> <p>Methods</p> <p>In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process.</p> <p>Results</p> <p>In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location.</p> <p>Conclusions</p> <p>The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.</p