Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening.

INTRODUCTION: Squamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA. METHODS AND ANALYSIS: This is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged >25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm. ETHICS AND DISSEMINATION: The study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences. TRIAL REGISTRATION NUMBER: NCT03489707

Evaluating the informatics for integrating biology and the bedside system for clinical research

<p>Abstract</p> <p>Background</p> <p>Selecting patient cohorts is a critical, iterative, and often time-consuming aspect of studies involving human subjects; informatics tools for helping streamline the process have been identified as important infrastructure components for enabling clinical and translational research. We describe the evaluation of a free and open source cohort selection tool from the Informatics for Integrating Biology and the Bedside (i2b2) group: the i2b2 hive.</p> <p>Methods</p> <p>Our evaluation included the usability and functionality of the i2b2 hive using several real world examples of research data requests received electronically at the University of Utah Health Sciences Center between 2006 - 2008. The hive server component and the visual query tool application were evaluated for their suitability as a cohort selection tool on the basis of the types of data elements requested, as well as the effort required to fulfill each research data request using the i2b2 hive alone.</p> <p>Results</p> <p>We found the i2b2 hive to be suitable for obtaining estimates of cohort sizes and generating research cohorts based on simple inclusion/exclusion criteria, which consisted of about 44% of the clinical research data requests sampled at our institution. Data requests that relied on post-coordinated clinical concepts, aggregate values of clinical findings, or temporal conditions in their inclusion/exclusion criteria could not be fulfilled using the i2b2 hive alone, and required one or more intermediate data steps in the form of pre- or post-processing, modifications to the hive metadata, etc.</p> <p>Conclusion</p> <p>The i2b2 hive was found to be a useful cohort-selection tool for fulfilling common types of requests for research data, and especially in the estimation of initial cohort sizes. For another institution that might want to use the i2b2 hive for clinical research, we recommend that the institution would need to have structured, coded clinical data and metadata available that can be transformed to fit the logical data models of the i2b2 hive, strategies for extracting relevant clinical data from source systems, and the ability to perform substantial pre- and post-processing of these data.</p

Emplacement of inflated Pāhoehoe flows in the Naude’s Nek Pass, Lesotho remnant, Karoo continental flood basalt province: use of flow-lobe tumuli in understanding flood basalt emplacement

Physical volcanological features are presented for a 710-m-thick section, of the Naude’s Nek Pass, within the lower part of the Lesotho remnant of the Karoo Large Igneous Province. The section consists of inflated pāhoehoe lava with thin, impersistent sedimentary interbeds towards the base. There are seven discreet packages of compound and hummocky pāhoehoe lobes containing flow-lobe tumuli, making up approximately 50% of the section. Approximately 45% of the sequence consists of 14 sheet lobes, between 10 and 52-m-thick. The majority of the sheet lobes are in two packages indicating prolonged periods of lava supply capable of producing thick sheet lobes. The other sheet lobes are as individual lobes or pairs, within compound flows, suggesting brief increases in lava supply rate. We suggest, contrary to current belief, that there is no evidence that compound flows are proximal to source and sheet lobes (simple flows) are distal to source and we propose that the presence of flow-lobe tumuli in compound flows could be an indicator that a flow is distal to source. We use detailed, previously published, studies of the Thakurvadi Formation (Deccan Traps) as an example. We show that the length of a lobe and therefore the sections that are ‘medial or distal to source’ are specific to each individual lobe and are dependent on the lava supply of each eruptive event, and as such flow lobe tumuli can be used as an indicator of relative distance from source

Patterning in Birthweight in India: Analysis of Maternal Recall and Health Card Data

National data on birthweight from birth certificates or medical records are not available in India. The third Indian National Family Health Survey included data on birthweight of children obtained from health cards and maternal recall. This study aims to describe the population that these data represent and compares the birthweight obtained from health cards with maternal recall data in terms of its socioeconomic patterning and as a risk factor for childhood growth failure.The analytic sample consisted of children aged 0 to 59 months with birthweight data obtained from health cards (n = 3227) and maternal recall (n = 16,787). The difference between the card sample and the maternal recall sample in the distribution across household wealth, parental education, caste, religion, gender, and urban residence was compared using multilevel models. We also assessed the ability of birthweight to predict growth failure in infancy and childhood in the two groups. The survey contains birthweight data from a majority of household wealth categories (>5% in every category for recall), both genders, all age groups, all caste groups, all religion groups, and urban and rural dwellers. However, children from the lowest quintile of household wealth were under-represented (4.73% in card and 8.62% in recall samples). Comparison of data across health cards and maternal recall revealed similar social patterning of low birthweight and ability of birthweight to predict growth failure later in life. Children were less likely to be born with low birthweight if they had mothers with over 12 years of education compared to 1-5 years of education with relative risk (RR) of 0.79 (95% confidence interval [CI]: 0.52, 1.2) in the card sample and 0.70 (95% CI: 0.59, 0.84) in the recall sample. A 100 gram difference in a child's birthweight was associated with a decreased likelihood of underweight in both the card (RR: 0.95; 95% CI: 0.94, 0.96) and recall (RR: 0.96; 95% CI: 0.96, 0.97) samples.Our results suggest that in the absence of other sources, the data on birthweight in the third Indian National Family Health Survey is valuable for epidemiologic research

Acromioclavicular joint dislocation: a comparative biomechanical study of the palmaris-longus tendon graft reconstruction with other augmentative methods in cadaveric models

<p>Abstract</p> <p>Background</p> <p>Acromioclavicular injuries are common in sports medicine. Surgical intervention is generally advocated for chronic instability of Rockwood grade III and more severe injuries. Various methods of coracoclavicular ligament reconstruction and augmentation have been described. The objective of this study is to compare the biomechanical properties of a novel palmaris-longus tendon reconstruction with those of the native AC+CC ligaments, the modified Weaver-Dunn reconstruction, the ACJ capsuloligamentous complex repair, screw and clavicle hook plate augmentation.</p> <p>Hypothesis</p> <p>There is no difference, biomechanically, amongst the various reconstruction and augmentative methods.</p> <p>Study Design</p> <p>Controlled laboratory cadaveric study.</p> <p>Methods</p> <p>54 cadaveric native (acromioclavicular and coracoclavicular) ligaments were tested using the Instron machine. Superior loading was performed in the 6 groups: 1) in the intact states, 2) after modified Weaver-Dunn reconstruction (WD), 3) after modified Weaver-Dunn reconstruction with acromioclavicular joint capsuloligamentous repair (WD.ACJ), 4) after modified Weaver-Dunn reconstruction with clavicular hook plate augmentation (WD.CP) or 5) after modified Weaver-Dunn reconstruction with coracoclavicular screw augmentation (WD.BS) and 6) after modified Weaver-Dunn reconstruction with mersilene tape-palmaris-longus tendon graft reconstruction (WD. PLmt). Posterior-anterior (horizontal) loading was similarly performed in all groups, except groups 4 and 5. The respective failure loads, stiffnesses, displacements at failure and modes of failure were recorded. Data analysis was carried out using a one-way ANOVA, with Student's unpaired t-test for unpaired data (S-PLUS statistical package 2005).</p> <p>Results</p> <p>Native ligaments were the strongest and stiffest when compared to other modes of reconstruction and augmentation except coracoclavicular screw, in both posterior-anterior and superior directions (p < 0.005).</p> <p>WD.ACJ provided additional posterior-anterior (P = 0. 039) but not superior (p = 0.250) stability when compared to WD alone.</p> <p>WD+PLmt, in loads and stiffness at failure superiorly, was similar to WD+CP (p = 0.066). WD+PLmt, in loads and stiffness at failure postero-anteriorly, was similar to WD+ACJ (p = 0.084).</p> <p>Superiorly, WD+CP had similar strength as WD+BS (p = 0.057), but it was less stiff (p < 0.005).</p> <p>Conclusions and Clinical Relevance</p> <p>Modified Weaver-Dunn procedure must always be supplemented with acromioclavicular capsuloligamentous repair to increase posterior-anterior stability. Palmaris-Longus tendon graft provides both additional superior and posterior-anterior stability when used for acromioclavicular capsuloligamentous reconstruction. It is a good alternative to clavicle hook plate in acromioclavicular dislocation.</p

Effects of pretreatments of Napier Grass with deionized water, sulfuric acid and sodium hydroxide on pyrolysis oil characteristics

The depletion of fossil fuel reserves has led to increasing interest in liquid bio-fuel from renewable biomass. Biomass is a complex organic material consisting of different degrees of cellulose, hemicellulose, lignin, extractives and minerals. Some of the mineral elements tend to retard conversions, yield and selectivity during pyrolysis processing. This study is focused on the extraction of mineral retardants from Napier grass using deionized water, dilute sodium hydroxide and sulfuric acid and subsequent pyrolysis in a fixed bed reactor. The raw biomass was characterized before and after each pretreatment following standard procedure. Pyrolysis study was conducted in a fixed bed reactor at 600 o�C, 30 �C/min and 30 mL/min N2 flow. Pyrolysis oil (bio-oil) collected was analyzed using standard analytic techniques. The bio-oil yield and characteristics from each pretreated sample were compared with oil from the non-pretreated sample. Bio-oil yield from the raw sample was 32.06 wt% compared to 38.71, 33.28 and 29.27 wt% oil yield recorded from the sample pretreated with sulfuric acid, deionized water and sodium hydroxide respectively. GC–MS analysis of the oil samples revealed that the oil from all the pretreated biomass had more value added chemicals and less ketones and aldehydes. Pretreatment with neutral solvent generated valuable leachate, showed significant impact on the ash extraction, pyrolysis oil yield, and its composition and therefore can be regarded as more appropriate for thermochemical conversion of Napier grass

Association between tobacco use and body mass index in urban Indian population: implications for public health in India

BACKGROUND: Body mass index [BMI, weight (kg)/height (m(2))], a measure of relative weight, is a good overall indicator of nutritional status and predictor of overall health. As in many developing countries, the high prevalence of very low BMIs in India represents an important public health risk. Tobacco, smoked in the form of cigarettes or bidis (handmade by rolling a dried rectangular piece of temburni leaf with 0.15–0.25 g of tobacco) or chewed, is another important determinant of health. Tobacco use also may exert a strong influence on BMI. METHODS: The relationship between very low BMI (< 18.5 kg/m(2)) and tobacco use was examined using data from a representative cross-sectional survey of 99,598 adults (40,071 men and 59,527 women) carried out in the city of Mumbai (formerly known as Bombay) in western India. Participants were men and women aged ≥ 35 years who were residents of the main city of Mumbai. RESULTS: All forms of tobacco use were associated with low BMI. The prevalence of low BMI was highest in bidi-smokers (32% compared to 13% in non-users). For smokers, the adjusted odds ratio (OR) and 95% confidence interval (CI) were OR = 1.80(1.65 to 1.96) for men and OR = 1.59(1.09 to 2.32) for women, respectively, relative to non-users. For smokeless tobacco and mixed habits (smoking and smokeless tobacco), OR = 1.28(1.19 to 1.38) and OR = 1.83(1.67 to 2.00) for men and OR = 1.50(1.43 to 1.59) and OR = 2.19(1.90 to 3.41) for women, respectively. CONCLUSION: Tobacco use appears to be an independent risk factor for low BMI in this population. We conclude that in such populations tobacco control research and interventions will need to be conducted in concert with nutrition research and interventions in order to improve the overall health status of the population