Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 trials.

BackgroundSentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [(99m)Tc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance.MethodsA total of 13 centers contributed 148 patients with breast cancer. Each patient received [(99m)Tc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [(99m)Tc]tilmanocept.ResultsA total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [(99m)Tc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [(99m)Tc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [(99m)Tc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [(99m)Tc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 (p = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [(99m)Tc]tilmanocept.Conclusion[(99m)Tc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [(99m)Tc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD

Complexidade e escala na investigação da eficácia do ensino: reflexões do estudo MET

Researchers and policymakers in the US and beyond increasingly seek to identify teaching qualities that are associated with academic achievement gains for K-12 students through effectiveness studies. Yet teaching quality varies with academic content and social contexts, involves multiple participants, and requires a range of skills, knowledge, and dispositions. In this essay, we address the inescapable tension between complexity and scale in research on teaching effectiveness. We provide five recommendations to study designers and analysts to manage this tension to enhance effectiveness research, drawing on our recent experiences as the first external analysts of the Measures of Effective Teaching (MET) study. Our recommendations address conceptual framing, the measurement of teaching (e.g., observation protocols, student surveys), sampling, classroom videoing, and the use and interpretation of value-added models.Investigadores y legisladores en los Estados Unidos y en otros países buscan identificar las cualidades de la enseñanza que se asocian con incrementos de desempeño académico para alumnos de primaria y secundaria a través de estudios de eficacia. Sin embargo, la calidad de la enseñanza varía según el contenido académico y los contextos sociales, involucra a múltiples participantes y requiere una variedad de habilidades, conocimientos y disposiciones. En este ensayo, abordamos la ineludible tensión entre la complejidad y la escala en la investigación sobre la eficacia de la enseñanza. Proveemos cinco recomendaciones a los diseñadores de estudios y analistas para manejar esta tensión y mejorar la investigación de eficacia, aprovechando nuestras experiencias recientes como los primeros analistas externos del estudio Measures of Effective Teaching (MET). Nuestras recomendaciones abordan el marco conceptual, la medición de la enseñanza (por ej., protocolos de observación, encuestas de estudiantes), el muestreo, el video en el aula y el uso e interpretación de modelos de valor agregado.Pesquisadores e legisladores nos Estados Unidos e em outros países buscam identificar as qualidades de ensino associadas ao aumento do desempenho acadêmico de alunos do ensino fundamental e médio por meio de estudos de eficácia. No entanto, a qualidade do ensino varia de acordo com o conteúdo acadêmico e os contextos sociais, envolve múltiplos participantes e requer uma variedade de habilidades, conhecimentos e disposições. Neste ensaio, abordamos a tensão inescapável entre complexidade e escala na pesquisa sobre a eficácia do ensino. Fornecemos cinco recomendações para projetistas e analistas de estudo para gerenciar essa tensão e melhorar a pesquisa sobre eficácia, alavancando nossas experiências recentes como os primeiros analistas externos do estudo Measures of Effective Teaching (MET). Nossas recomendações abordam a estrutura conceitual, a medição do ensino (por exemplo, protocolos de observação, pesquisas com estudantes), amostragem, vídeo em sala de aula e o uso e interpretação de modelos de valor agregado

Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials.

BackgroundInhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF.MethodsTwo pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of ≥15 and <25 on two arterial blood gases and had not previously received INO, were randomly assigned to receive two doses of IPGE1 (300 and 150 ng/kg/min) or placebo. The primary outcome was the enrollment of 50 infants in six to nine months at 10 sites. The first pilot was halted after four months for failure to enroll a single infant. The most common cause for non-enrollment was prior initiation of INO. In a re-designed second pilot, co-administration of IPGE1 and INO was permitted. Infants with suboptimal response to INO received either aerosolized saline or IPGE1 at a low (150 ng/kg/min) or high dose (300 ng/kg/min) for a maximum duration of 72 hours. The primary outcome was the recruitment of an adequate number of patients (n = 50) in a nine-month-period, with fewer than 20% protocol violations.ResultsNo infants were enrolled in the first pilot. Seven patients were enrolled in the second pilot; three in the control, two in the low-dose IPGE1, and two in the high-dose IPGE1 groups. The study was halted for recruitment futility after approximately six months as enrollment targets were not met. No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported.ConclusionsThese two pilot RCTs failed to recruit adequate eligible newborns with NHRF. Complex management RCTs of novel therapies for persistent pulmonary hypertension of the newborn (PPHN) may require novel study designs and a longer period of time from study approval to commencement of enrollment.Trial registrationCLINICALTRIALS.GOV: Pilot one: NCT number: 00598429 registered on 10 January 2008. Last updated: 3 February 2011. Pilot two: NCT number: 01467076 17 October 2011. Last updated: 13 February 2013

The Grizzly, October 7, 1988

Berman Art Center Breaks Ground • Pledging Undergoes Changes • Welcome Home Alumni! • Letter: Honor Code Discussion Revived • Giving Garbage the Dump • Jazz: Basie Style • Ursinus Presents: A Voice of My Own • On the Forum Front • Mistake Free Bears Get First Win • Field Hockey Making Gains • Soccer Gains Respect • Annual Run Offers Health and Fun • 1988 Homecoming Queen Candidates • Sherman Strutting Stuff • Intramural Results Announced • U.C. Welcomes Gilbert\u27s Enthusiasm • Cycling Club Returns • Campbell: Not Your Typical Bowl of Soup • Econ: Economopolis • Professor LoBue Introduces New Chemistry in Pfahler • Discover Discover! • U.C. Students Study Better Late Than Neverhttps://digitalcommons.ursinus.edu/grizzlynews/1219/thumbnail.jp

Early pregnancy loss in Belagavi, Karnataka, India 2014–2017: a prospective population-based observational study in a low-resource setting

Background The prevalence of early pregnancy loss through miscarriage and medically terminated pregnancy (MTP) is largely unknown due to lack of early registration of pregnancies in most regions, and especially in low- and middle-income countries. Understanding the rates of early pregnancy loss as well as the characteristics of pregnant women who experience miscarriage or MTP can assist in better planning of reproductive health needs of women. Methods A prospective, population-based study was conducted in Belagavi District, south India. Using an active surveillance system of women of childbearing age, all women were enrolled as soon as possible during pregnancy. We evaluated rates and risk factors of miscarriage and MTP between 6 and 20 weeks gestation as well as rates of stillbirth and neonatal death. A hypothetical cohort of 1000 women pregnant at 6 weeks was created to demonstrate the impact of miscarriage and MTP on pregnancy outcome. Results A total of 30,166 women enrolled from 2014 to 2017 were included in this analysis. The rate of miscarriage per 1000 ongoing pregnancies between 6 and 8 weeks was 115.3, between 8 and 12 weeks the miscarriage rate was 101.9 per 1000 ongoing pregnancies and between 12 and 20 weeks the miscarriage rate was 60.3 per 1000 ongoing pregnancies. For those periods, the MTP rate was 40.2, 45.4, and 48.3 per 1000 ongoing pregnancies respectively. The stillbirth rate was 26/1000 and the neonatal mortality rate was 24/1000. The majority of miscarriages (96.6%) were unattended and occurred at home. The majority of MTPs occurred in a hospital and with a physician in attendance (69.6%), while 20.7% of MTPs occurred outside a health facility. Women who experienced a miscarriage were older and had a higher level of education but were less likely to be anemic than those with an ongoing pregnancy at 20 weeks. Women with MTP were older, had a higher level of education, higher parity, and higher BMI, compared to those with an ongoing pregnancy, but these results were not consistent across gestational age periods. Conclusions Of women with an ongoing pregnancy at 6 weeks, about 60% will have a living infant at 28 days of age. Two thirds of the losses will be spontaneous miscarriages and one third will be secondary to a MTP. High maternal age and education were the risk factors associated with miscarriage and MTP. Trial registration The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475

The Vehicle, Fall 1980

Vol. 22, No. 1 Table of Contents UntitledSusan Mehlpage 4 MitchJohn Stockmanpage 5 HallwayAndy Leszczynskipage 6 At The MoviesElise Hempelpage 8 HaikuAngie Patrickpage 8 On MagnoliasThersa Kennypage 9 NeighborJohn Stockmanpage 10 WetCathy Georgepage 10 HaikuThersa Kennypage 10 The Speed QueenCarolyn Perrypage 11 A ThoughtThersa Kennypage 14 The Stone Belongs to the LakeRobert Schumacherpage 15 Driving South of WinnipegJerry McAnultypage 16 Travels with the ExecutionerPeter Lindemanpage 17 NightwingLaura Muellerpage 18 Thoughts of an Uninterested StudentDru Seftonpage 19 Rainbird\u27s ManMary McDanielpage 20 EffortlessKevin Stottpage 25 Where the Waves SoundTheresa Whitesidepage 26 \u2745Ray Wallacepage 28 Epigram #1P. James Kruegerpage 28 UntitledSusan Mehlpage 29 RerunsAngie Patrickpage 30 SunsetGloria Rhoadspage 34 Return of the NativeRay Wallacepage 35 The GuitarJoanne Dunnepage 35 In Grandmother\u27s BedroomElise Hempelpage 36 Cindy Poem No. 3John Stockmanpage 36 Dust in the DarkLaura Muellerpage 37 Suspension BridgeLaura Henrypage 39 WavesLeslie Garnerpage 39 Oyama: a Setting and a GirlJerry McAnultypage 40 the middle of the nightKevin Stottpage 41 Old State RoadLaura Henrypage 43 Dairy QueenJohn Stockmanpage 43 Art CoverDennis Wunsch Pen and ink drawingRose Huberpage 3 PhotographIrene Brownpage 7 PhotographIrene Brownpage 27 PhotographIrene Brownpage 42 Pen and ink drawingRose Huberpage 44https://thekeep.eiu.edu/vehicle/1036/thumbnail.jp

Inference of Antibiotic Resistance and Virulence among Diverse Group A Streptococcus Strains Using emm Sequencing and Multilocus Genotyping Methods

typing (direct sequencing of the genomic segment coding for the antigenic portion of the M protein) or by multilocus genotyping methods. Phenotype analysis, including critical AbR typing, is generally achieved by much slower and more laborious direct culture-based methods. type and the associated AbR and virulence phenotypes. types

A BAC-Based Transgenic Mouse Specifically Expresses an Inducible Cre in the Urothelium

Cre-loxp mediated conditional knockout strategy has played critical roles for revealing functions of many genes essential for development, as well as the causal relationships between gene mutations and diseases in the postnatal adult mice. One key factor of this strategy is the availability of mice with tissue- or cell type-specific Cre expression. However, the success of the traditional molecular cloning approach to generate mice with tissue specific Cre expression often depends on luck. Here we provide a better alternative by using bacterial artificial chromosome (BAC)-based recombineering to insert iCreERT2 cDNA at the ATG start of the Upk2 gene. The BAC-based transgenic mice express the inducible Cre specifically in the urothelium as demonstrated by mRNA expression and staining for LacZ expression after crossing with a Rosa26 reporter mouse. Taking into consideration the size of the gene of interest and neighboring genes included in a BAC, this method should be widely applicable for generation of mice with tissue specific gene expression or deletions in a more specific manner than previously reported

Protocol for the ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults

<p>Abstract</p> <p>Background</p> <p>Proximal humeral fractures, which occur mainly in older adults, account for approximately 4 to 5% of all fractures. Approximately 40% of these fractures are displaced fractures involving the surgical neck. Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory. In particular it is not clear whether surgery gives better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform this decision.</p> <p>Methods/Design</p> <p>We aim to undertake a pragmatic UK-based multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck. The choice of surgical intervention is left to the surgeon, who must use techniques that they are fully experienced with. This will avoid 'learning curve' problems. We will promote good standards of non-surgical care, similarly insisting on care-provider competence, and emphasize the need for comparable provision of rehabilitation for both groups of patients.</p> <p>We aim to recruit 250 patients from a minimum of 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome is the Oxford Shoulder Score, which will be collected via questionnaires completed by the trial participants at 6, 12 and 24 months. This is a 12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment. We will also collect data for other outcomes, including general health measures and complications, and for an economic evaluation. Additionally, we plan a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial, and their baseline characteristics, treatment preferences and intended treatment.</p> <p>Discussion</p> <p>This article presents the protocol for a multi-centre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN50850043</p