BACKGROUND: Chlamydia trachomatis infection is highly prevalent among young women in the United States. Prevention of long-term sequelae of infection, including tubal factor infertility, is a primary goal of chlamydia screening and treatment activities. However, the population-attributable fraction of tubal factor infertility associated with chlamydia is unclear, and optimal measures for assessing tubal factor infertility and prior chlamydia in epidemiological studies have not been established. Black women have increased rates of chlamydia and tubal factor infertility compared with White women but have been underrepresented in prior studies of the association of chlamydia and tubal factor infertility. OBJECTIVES: The objectives of the study were to estimate the population-attributable fraction of tubal factor infertility associated with Chlamydia trachomatis infection by race (Black, non-Black) and assess how different definitions of Chlamydia trachomatis seropositivity and tubal factor infertility affect population-attributable fraction estimates. STUDY DESIGN: We conducted a case-control study, enrolling infertile women attending infertility practices in Birmingham, AL, and Pittsburgh, PA, during October 2012 through June 2015. Tubal factor infertility case status was primarily defined by unilateral or bilateral fallopian tube occlusion (cases) or bilateral fallopian tube patency (controls) on hysterosalpingogram. Alternate tubal factor infertility definitions incorporated history suggestive of tubal damage or were based on laparoscopic evidence of tubal damage. We aimed to enroll all eligible women, with an expected ratio of 1 and 3 controls per case for Black and non-Black women, respectively. We assessed Chlamydia trachomatis seropositivity with a commercial assay and a more sensitive research assay; our primary measure of seropositivity was defined as positivity on either assay. We estimated Chlamydia trachomatis seropositivity and calculated Chlamydia trachomatisetubal factor infertility odds ratios and population-attributable fraction, stratified by race. RESULTS: We enrolled 107 Black women (47 cases, 60 controls) and 620 non-Black women (140 cases, 480 controls). Chlamydia trachomatis seropositivity by either assay was 81% (95% confidence interval, 73-89%) among Black and 31% (95% confidence interval, 28-35%) among non-Black participants (P <.001). Using the primary Chlamydia trachomatis seropositivity and tubal factor infertility definitions, no significant association was detected between chlamydia and tubal factor infertility among Blacks (odds ratio, 1.22, 95% confidence interval, 0.45-3.28) or non-Blacks (odds ratio, 1.41, 95% confidence interval, 0.95-2.09), and the estimated population-attributable fraction was 15% (95% confidence interval, -97% to 68%) among Blacks and 11% (95% confidence interval, -3% to 23%) among non-Blacks. Use of alternate serological measures and tubal factor infertility definitions had an impact on the magnitude of the chlamydiaetubal factor infertility association and resulted in a significant association among non-Blacks. CONCLUSION: Low population-attributable fraction estimates suggest factors in addition to chlamydia contribute to tubal factor infertility in the study population. However, high background Chlamydia trachomatis seropositivity among controls, most striking among Black participants, could have obscured an association with tubal factor infertility and resulted in a population-attributable fraction that underestimates the true etiological role of chlamydia. Choice of chlamydia and tubal factor infertility definitions also has an impact on the odds ratio and population-attributable fraction estimates.
Process analytical technology (PAT) and quality by design have gained importance in all areas of pharmaceutical development and manufacturing. One important method for monitoring of critical product attributes and process optimization in laboratory scale freeze-drying is manometric temperature measurement (MTM). A drawback of this innovative technology is that problems are encountered when processing high-concentrated amorphous materials, particularly protein formulations. In this study, a model solution of bovine serum albumin and sucrose was lyophilized at both conservative and aggressive primary drying conditions. Different temperature sensors were employed to monitor product temperatures. The residual moisture content at primary drying endpoints as indicated by temperature sensors and batch PAT methods was quantified from extracted sample vials. The data from temperature probes were then used to recalculate critical product parameters, and the results were compared with MTM data. The drying endpoints indicated by the temperature sensors were not suitable for endpoint indication, in contrast to the batch methods endpoints. The accuracy of MTM Pice data was found to be influenced by water reabsorption. Recalculation of Rp and Pice values based on data from temperature sensors and weighed vials was possible. Overall, extensive information about critical product parameters could be obtained using data from complementary PAT tools.
Background: Prevalence estimates from population-based surveys do not suffer from the same biases as case-report and clinic positivity data and may be better to monitor sexually transmitted disease morbidity over time.Methods: We estimated the prevalence of Neisseria gonorrhoeae in a nationally representative sample of persons aged 14 to 39 years participating in the National Health and Nutrition Examination Survey.Results: From 1999 to 2008, the overall prevalence of gonorrhea was 0.27% (95% confidence interval, 0.13%-0.47%). In the 2005 to 2006 and 2007 to 2008 cycles, prevalence approached 0% and was based on too few positive sample persons to obtain reliable estimates. In 2004, most infections were found in 1 survey location.Discussion: Given the low prevalence and geographic clustering of disease, gonorrhea estimates from national probability surveys are often imprecise and unstable. In 2008, gonorrhea testing in National Health and Nutrition Examination Survey was discontinued. Continued surveillance of gonorrhea should include case reporting and prevalence estimates from local surveys and sentinel surveillance systems.
Background: We report the first population-based assessment of national trends in chlamydia prevalence in the United States. Methods: We investigated trends in chlamydia prevalence in representative samples of the US population aged 14 to 39 years using data from five 2-year survey cycles of the National Health and Nutrition Examination Survey from 1999 to 2008. Prevalence estimates and 95% confidence intervals (CI) are reported stratified by age, gender, and race/ethnicity. Percent change in prevalence over this time period was estimated from regression models. Results: In the 2007–2008 cycle, chlamydia prevalence among participants aged 14 to 39 years was 1.6% (95% CI: 1.1%–2.4%). Prevalence was higher among females (2.2%, 95% CI: 1.4%–3.4%) than males (1.1%, 95% CI: 0.7%–1.7%). Prevalence among non-Hispanic black persons was 6.7% (95% CI: 4.6%–9.9%) and was 2.5% (95% CI: 1.6%–3.8%) among adolescents aged 14 to 19 years. Over the five 2-year cycles, there was an estimated 40% reduction (95% CI: 8%–61%) in prevalence among participants aged 14 to 39 years. Decreases in prevalence were notable in men (53% reduction, 95% CI: 19%–72%), adolescents aged 14 to 19 years (48% reduction, 95% CI: 11%–70%), and adolescent non-Hispanic black persons (45%, reduction, 95% CI: 4%–70%). There was no change in prevalence among females aged 14 to 25 years, the population targeted for routine annual screening. Conclusions: On the basis of population estimates of chlamydia prevalence, the overall chlamydia burden in the United States decreased from 1999 to 2008. However, there remains a need to reduce prevalence in populations most at risk and to reduce racial disparities.
The freeze-drying behavior and cake morphology of a model protein in an amorphous formulation were studied at varying protein concentrations using conservative (-25 degrees C) and aggressive (+25 degrees C) shelf temperatures at constant chamber pressure during primary drying. The two cycles were characterized by manometric temperature measurements (MTM) in a SMART freeze dryer that estimates the sublimation rate (dm/dt), product temperature at the freeze-drying front (T(p-MTM)) and product resistance (R(p)) during a run. The calculated sublimation rates (dm/dt) were 3-4 times faster in the aggressive cycle compared to the conservative cycle. For conservatively dried cakes R(p) increased with both dry layer thickness and protein concentration. For aggressively dried cakes (where freeze-drying occurs at the edge of microcollapse), R(p) also increased with protein concentration but was independent of the dry layer thickness. The sublimation rate was influenced by R(p), dry layer thickness and T(p-MTM) in the conservative cycle, but was governed mainly by T(p-MTM) in the aggressive cycle, where R(p) is independent of the dry layer thickness. The aggressively dried cakes had a more open and porous structure compared to their conservatively dried counterparts.
This work investigated the impact of primary drying conditions on the microstructure and protein stability of bovine serum albumin (BSA) containing lyophilized cakes. Two primary drying conditions were employed (termed ‘conservative’, slower drying rate and ‘aggressive’, higher drying rate) at two protein loadings (5 and 50mg mL−1). The cake attributes were characterized using micro-X-ray computed tomography (micro-CT), scanning electron microscopy, manometric temperature measurements, Fourier transform infrared spectroscopy (FTIR) and size exclusion chromatography (SEC). The combination of analytical techniques revealed that although the aggressive drying conditions produced intact cakes which retained their macrostructure, they had undergone various degrees of microcollapse. The study demonstrates the applicability of micro-CT for resolving microstructural attributes of the freeze-dried cakes such as residual porosity, pore size distribution and connectivity. Micro-CT data showed significant differences in residual porosity and matrix connectivity between aggressively and conservatively dried cakes. The FTIR data show that at each protein loading, there is no observable difference in the secondary structure of the protein and the SEC data show comparable stability in the cakes produced under different primary drying conditions. Good content uniformity was observed with respect to BSA and sucrose distribution in the cakes.
Addressing the recent commentaries of Michael Confino and Elise Kimerling Wirtschafter on soslovie and class in Imperial Russia, the author suggests that both have overstated the difficulties associated with these concepts. Admittedly, problems of imprecision and inconsistency are associated with both terms, yet both refer to tangible divisions in Russian society - divisions that affected identities, perceptions and behavior. Although ideas of class and soslovie do not conclusively define the divisions in Russian society, they do illuminate those divisions and direct researchers' attention toward significant empirical questions.
Chlamydia trachomatis is an obligate intracellular Gram negative bacterium, which infects mucosal epithelial cells (Schachter and Stephens 2008). Chlamydia display a unique two-stage life cycle consisting of an infectious stage and a replicative stage. During the infectious stage the organism assumes a metabolically inactive form, the elementary bodyElementary body , which can survive in the host extracellular environment. Upon entry into a host cell the elementary body transforms within a host cell vacuole into a metabolically active, replicating form, the reticulateReticulate body. Over a period of approximately 36–72 hours of growth and replication, the reticulate bodies transform into infectious elementary bodies, which are extruded from the cell and repeat the cycle by infecting additional cells of the same or a second host.
Background. Some screening and treatment programs implemented to control Chlamydia trachomatis genital infections and their complications have shown initial reductions in infection prevalence, followed by increases to preprogram levels or higher. One hypothesis is that treatment shortens duration of infection, attenuates development of protective immunity, and thereby, increases risk of reinfection. Methods. A literature review was undertaken to assess evidence supporting the concept of protective immunity,its characteristics, and its laboratory correlates in human chlamydial infection. The discussion is organized around key questions formulated in preparation for the Chlamydia Immunology and Control Expert Advisory Meeting held by the Centers for Disease Control and Prevention in April 2008. Results. Definitive human studies are not available, but cross-sectional studies show that chlamydia prevalence,organism load, and concordance rates in couples decrease with age, and organism load is lower in those with repeat infections, supporting the concept of protective immunity. The protection appears partial and can be overcome after reexposure, similar to what has been found in rodent models of genital infection. No data are available to define the duration of infection required to confer a degree of immunity or the time course of immunity after resolution of untreated infection. In longitudinal studies involving African sex workers, a group presumed to have frequent and ongoing exposure to chlamydial infection, interferon-g production by peripheral blood mononuclear cells in response to chlamydial heat-shock protein 60 was associated with low risk of incident infection.In cross-sectional studies, relevant T helper 1-type responses were found in infected persons, paralleling the studies in animal models. Conclusions. The data support the concept that some degree of protective immunity against reinfection develops after human genital infection, although it appears, at best, to be partial. It is likely that factors besides population levels of immunity contribute to trends in prevalence observed in screening and treatment programs.Future studies of protective immunity in humans will require longitudinal follow-up of individuals and populations,frequent biological and behavioral sampling, and special cohorts to help control for exposure.
The freeze–drying behavior of three model proteins, namely, lysozyme, BSA, and IgG, has been studied using a variety of techniques under two different primary drying conditions (shelf temperatures of −25°C and +25°C, respectively) in an amorphous formulation. Manometric temperature measurements were used to characterize product temperature (Tpr), sublimation rates, and product resistance (Rp) during primary drying. Biophysical techniques such as circular dichroism, fluorescence, and Fourier transform infrared spectroscopy were used to study protein conformation. Size exclusion chromatography was used to monitor the formation of high-molecular-weight species (HMWS) over time on storage, and cake morphology was studied using scanning electron microscopy. The differences in the freeze–drying behavior of the three proteins were more evident at higher protein concentrations, where the protein significantly influences the behavior of the formulation matrix. However, these differences were minimized in the aggressive mode and were insignificant at lower protein concentrations where excipients dominated the freeze–drying behavior. Differences in cake morphology were observed between the two drying conditions employed as well as between the three proteins studied. The stability and the protein structure, however, were equivalent for the protein cakes generated using the two different primary drying conditions.
ABSTRACT It is uncertain which methods for the diagnosis of rectal gonococcal and chlamydial infection are optimal. This study evaluated the performance of culture and nucleic acid amplification tests (NAATs) for rectal chlamydial and gonococcal diagnosis. From July 2003 until February 2007, 441 rectal test sets were collected from individuals attending a sexually transmitted disease clinic and three HIV clinics who gave a history of anal intercourse or were women at high risk for Neisseria gonorrhoeae or Chlamydia trachomatis infections. Rectal swab specimens were tested using culture and commercial NAATs employing transcription-mediated amplification (TMA), strand displacement amplification (SDA), and PCR amplification. Test performance was evaluated using a rotating standard by which patients were classified as infected if either two or three comparator tests were positive. Test sensitivities for the detection of N. gonorrhoeae ranged from 66.7% to 71.9% for culture to 100% for TMA. Specificities were 99.7% to 100% for culture and greater than 95.5% for all three NAATs. Test sensitivities for C. trachomatis ranged from 36.1% to 45.7% for culture and among NAATS from 91.4% to 95.8% for PCR to 100% for TMA. Specificities of the NAATs ranged from 95.6% to 98.5% (two-of-three standard) and from 88.8% to 91.8% (three-of-three standard). Over 60% and 80% of gonococcal and chlamydial infections, respectively, among men who have sex with men and over 20% of chlamydial infections in women would have been missed if the rectal site had not been tested. Currently available NAATs are more sensitive for the detection of chlamydial and gonococcal infection at the rectal site than is culture.
March, 1949 the Army's Medical Nutrition Laboratory Robert E. Johnson Robert E. Johnson Medical Nutrition Laboratory Department of the Army Search for other works by this author on: Oxford Academic PubMed Google Scholar Nutrition Reviews, Volume 7, Issue 3, March 1949, Pages 65–66, https://doi.org/10.1111/j.1753-4887.1949.tb02168.x Published: 01 March 1949
After the conference session or reading the abstract, the participant will be able to state each of the “5 A's” and define the leading factors that influenced participants' choices for weight loss counseling type.
OBJECTIVES:To evaluate factors associated with recurrent chlamydial infection and failure to return for retesting in socioeconomically disadvantaged women (aged 16-24 years) entering the National Job Training Program, 1998--2005.GOAL:To evaluate sociodemographic characteristics of young women associated with recurrent chlamydial infection.STUDY DESIGN:We computed chlamydia prevalence at initial visit and recurrent infection (defined as a positive chlamydia test 1-2 months after completing treatment) and percent of infected women who were retested by sociodemographic variables.RESULTS:At entrance, women had a high prevalence of chlamydia infection (10.7%). Chlamydia prevalence varied by age, race/ethnicity, and place of residence (South, Midwest, Northeast, and West), year of test, and type of test. Among women infected at initial visit, younger aged women (16-17 years), blacks and Hispanics, those who resided in the South and Midwest, and those tested in 1998--2000 were less likely to be retested. Of the 13,550 infected women, 5,892 (43.5%) were retested. Of those retested, 332 (5.6%) had recurrent infection 1-2 months after completing treatment. Although chlamydia prevalence at retesting did not differ significantly by sociodemographic characteristics, the pattern of the prevalence was similar to the pattern at the initial test. Multivariate logistic regression analyses showed similar findings.CONCLUSIONS:The high prevalence of recurrent infection in these women may be due to reinfection and/or treatment failure. The findings of this analysis underscore the need for retesting infected women regardless of their demographic characteristics.
In 2002, 2 million American women of reproductive age were infertile. Infertility is also common among men. The Centers for Disease Control and Prevention (CDC) conducts surveillance and research on the causes of infertility, monitors the safety and efficacy of infertility treatment, and sponsors national prevention programs. A CDC-wide working group found that, despite this effort, considerable gaps and opportunities exist in surveillance, research, communication, and program and policy development. We intend to consult with other federal agencies, professional and consumer organizations, the scientific community, the health care community, industry, and other stakeholders, and participate in the development of a national public health plan for the prevention, detection, and management of infertility.
Background: Nationally representative surveys of chlamydia and gonorrhea are an important measure of disease burden and progress of screening programs.Objective: To measure chlamydia and gonorrhea prevalence in the United States.Design: Analysis of sexual history information and urine specimens collected in the National Health and Nutrition Examination Survey (NHANES), 1999-2002.Setting: U.S. civilian noninstitutionalized population as sampled by NHANES, 1999-2002.Participants: 6632 NHANES respondents.Measurements: Urine specimens were tested for chlamydia and gonorrhea. Results were weighted to represent the U.S. civilian, non institutionalized population between 14 and 39 years of age.Results: Prevalence of gonorrheal infection was 0.24% (95% Cl, 0.16% to 0.38%). Prevalence of gonorrheal infection was higher among non-Hispanic black persons (1.2% [Cl, 0.7% to 1.9%]) than among non-Hispanic white persons (0.07% [Cl, 0.02% to 0.24%]). Among those with gonorrheal infection, 46% also had chlamydial infection. Prevalence of chlamyclial infection was 2.2% (Cl, 1.8% to 2.8%) and was similar between males (2.0% [Cl, 1.6% to 2.5%]) and females (2.5% [Cl, 1.8% to 3.4%]). Among females, the highest prevalence was in those age 14 to 19 years, whereas among males, it was highest in those age 14 to 29 years. Prevalence was higher among non-Hispanic black persons (6.4% [Cl, 5.4% to 7.5%]) than non-Hispanic white persons (1.5% [Cl, 1.0% to 2.4%]). Among females with a history of gonorrhea or chlamydia in the previous 12 months, chlamydia prevalence was 16.7% (Cl, 5.5% to 50.7%).Limitations: The specificity of urine-based assays for chlamydia and gonorrhea is limited, and the possible misclassification of sexual experience status may have affected the accuracy of some estimates.Conclusions: The findings support current recommendations to screen sexually active females age 25 years or younger for chlamydia, to retest infected females for chlamyclial infection, and to co-treat individuals with gonorrhea for chlamydia.