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A recently developed preparation of C1 inhibitor concentrate was evaluated in patients with hereditary angioedema in two trials. In the acute-attack treatment trial, the time to relief of an acute attack of angioedema was significantly shorter with the C1 inhibitor than with placebo. In the prophylaxis trial, the attack rate over a 12-week period was significantly lower with the C1 inhibitor than with placebo. Hereditary angioedema due to C1 inhibitor deficiency is an autosomal dominant disorder characterized by recurrent episodes of angioedema that typically involve the extremities, abdomen, external genitalia, face, or oropharynx. 1 Abdominal attacks of angioedema, which are caused by local mucosal swelling, are often associated with severe abdominal pain, nausea, and vomiting. Such attacks frequently lead to hospitalization and occasionally to unnecessary exploratory surgery. 2 Laryngeal attacks are associated with a substantial risk of death. 2 Two forms of hereditary angioedema have been defined: type I (accounting for 85% of cases) is characterized by low antigenic and functional levels of C1 inhibitor, whereas type . . .

Context .—Aperio Technologies, Inc (Vista, California) provides a new immunohistochemistry (IHC) HER2 Image Analysis (IA) system that allows tuning of the intensity thresholds of the HER2/ neu scoring scheme to adapt to the staining characteristics of different reagents. Objective .—To compare the trainable IHC HER2 IA system for different reagents to conventional manual microscopy (MM) in a multisite study. Design .—Two hundred sixty formalin-fixed, paraffin-embedded breast cancer specimens from 3 clinical sites were assayed: 180 specimens stained with Dako's HercepTest (Carpinteria, California), and 80 specimens stained with Ventana's PATHWAY HER-2/ neu (Tucson, California). At each site, 3 pathologists performed a blinded reading of the glass slides with the use of a light microscope. The glass slides were then scanned and after a wash-out period and randomization, the same pathologists outlined a representative set of tumor regions to be analyzed by IHC HER2 IA. Each of the methods, MM and IA, was evaluated separately and comparatively by using κ statistics of negative HER2/ neu scores (0, 1+) versus equivocal HER2/ neu scores (2+) versus positive HER2/ neu scores (3+) among the different pathologists. Results .— κ Values for IA and MM were obtained across all sites. MM: 0.565–0.864; IA: 0.895–0.947; MM versus IA: 0.683–0.892 for site 1; MM: 0.771–0.837; IA: 0.726–0.917; MM versus IA: 0.687–0.877 for site 2; MM: 0.463–0.674; IA: 0.864–0.918; MM versus IA: 0.497–0.626 for site 3. Conclusion .—Aperio's trainable IHC HER2 IA system shows substantial equivalence to MM for Dako's HercepTest and Ventana's PATHWAY HER-2/ neu at 3 clinical sites. Image analysis improved interpathologist agreement in the different clinical sites.

A multisite study was conducted to assess the performance of the Aperio digital pathology system (Aperio Technologies, Vista, CA) for reading estrogen receptor (ER) and progesterone receptor (PR) slides on a computer monitor. A total of 520 formalin-fixed breast tissue specimens were assayed at 3 clinical sites for ER and PR (260 each). Percentage and average staining intensity of positive nuclei were assessed. At each site, 3 pathologists performed a blinded reading of the glass slides using their microscopes initially and later using digital images on a computer monitor. Comparable percentages of agreements were obtained for manual microscopy (MM) and manual digital slide reading (MDR) (ER, percentage of positive nuclei with cutoffs: MM, 91.3%-99.0%/MDR, 91.3%-100.0%; PR, percentage of positive nuclei with cutoffs: MM, 83.8%-99.0%/MDR, 76.3%-100.0%). Reading ER and PR slides on a computer monitor using the Aperio digital pathology system is equivalent to reading the slides with a conventional light microscope.

Background and objective: The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb® is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (±5%). The device uses a technique of parting the user’s hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb® laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA). Methods: This double-blind, sham device-controlled, multicentre, 26-week trial randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax LaserComb® or the sham device (2: 1). The sham device used in the study was identical to the active device except that the laser light was replaced by a non-active incandescent light source. Results: Of the 110 patients who completed the study, subjects in the HairMax LaserComb® treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the sham device group (p <0.0001). Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients’ subjective assessment (p < 0.015) at 26 weeks over baseline. The HairMax LaserComb® was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups. Conclusions: The results of this study suggest that the HairMax LaserComb® is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.

Aperio Technologies, Inc (Vista, California) provides a new immunohistochemistry (IHC) HER2 Image Analysis (IA) system that allows tuning of the intensity thresholds of the HER2/ neu scoring scheme to adapt to the staining characteristics of different reagents. To compare the trainable IHC HER2 IA system for different reagents to conventional manual microscopy (MM) in a multisite study. Two hundred sixty formalin-fixed, paraffin-embedded breast cancer specimens from 3 clinical sites were assayed: 180 specimens stained with Dako's HercepTest (Carpinteria, California), and 80 specimens stained with Ventana's PATHWAY HER-2/neu (Tucson, California). At each site, 3 pathologists performed a blinded reading of the glass slides with the use of a light microscope. The glass slides were then scanned and after a wash-out period and randomization, the same pathologists outlined a representative set of tumor regions to be analyzed by IHC HER2 IA. Each of the methods, MM and IA, was evaluated separately and comparatively by using κ statistics of negative HER2/neu scores (0, 1+) versus equivocal HER2/neu scores (2+) versus positive HER2/neu scores (3+) among the different pathologists. κ Values for IA and MM were obtained across all sites. MM: 0.565-0.864; IA: 0.895-0.947; MM versus IA: 0.683-0.892 for site 1; MM: 0.771-0.837; IA: 0.726-0.917; MM versus IA: 0.687-0.877 for site 2; MM: 0.463-0.674; IA: 0.864-0.918; MM versus IA: 0.497-0.626 for site 3. Aperio's trainable IHC HER2 IA system shows substantial equivalence to MM for Dako's HercepTest and Ventana's PATHWAY HER-2/neu at 3 clinical sites. Image analysis improved interpathologist agreement in the different clinical sites.

This paper reviews and discusses alternative methods for assessing average partial association in three-way contingency tables. Primary attention is directed at the relationship between two of the variables, while controlling for the effects of a set of covariables. One approach is a class of multivariate extensions of the Cochran-Mantel-Haenszel test to sets of (s × r) tables. These statistics are based on expected values and covariances from the multiple hypergeometric distribution for each table. As such they make no underlying assumption regarding second-order interaction, although the absence of such interaction is incorporated within the hypothesis being tested. Alternatively, a log-linear model can be used to investigate average partial association conditional on the assumption of no second-order interaction. If the fit of such a model is supported by the data, then likelihood ratio methods or functional asymptotic regression methods (FARM) can be used to test the significance of correspondingly appropriate parameters. These procedures are all illustrated with a data set relating atomic bomb radiation to the incidence of leukemia adjusted for age at exposure. /// Cet article passe en revue et discute un choix de méthodes en vue d'établir la présence d'association partielle moyenne dans les tableaux de contingence à trois dimensions. L'attention se porte avant tout sur la relation existant entre deux des variables, alors qu'on contrôle les effets d'un ensemble de covariables. Une approche consiste à étendre à plus de deux variables le test de Cochran-Mantel-Haenszel pour des ensembles de tableaux (r × s). Ces statistiques reposent sur des espérances mathématiques et des covariances de la distribution hypergéométrique généralisée concernant chaque tableau. Par là même, elles ne comportent aucune hypothèse sous-jacente sur les interactions du second ordre, bien que l'absence de telles interactions soit incluse dans l'hypothèse à tester. On peut encore passer par un modèle log-linéaire pour explorer l'association partielle moyenne conditionnée par l'hypothèse de non-interaction du second ordre. Si les données se plient à un tel modèle, on peut alors employer soit les méthodes du ratio des vraisemblances, soit les méthodes de régression asymptotique fonctionnelle (FARM) pour tester si les paramètres correspondants sont ou non significatifs. Toutes ces façons de procéder sont illustrées au moyen d'un ensemble de données concernant les radiations de la bombe atomique et leur incidence sur la leucémie, corrélativement à l'âge lors de l'exposition aux radiations.

Coronavirus disease 2019 (COVID-19) is associated with increased rates of deep vein thrombosis (DVT) and pulmonary embolism (PE). Pulmonary Embolism Response Teams (PERT) have previously been associated with improved outcomes. We aimed to investigate whether PERT utilization, recommendations, and outcomes for patients diagnosed with acute PE changed during the COVID-19 pandemic. This is a retrospective cohort study of all adult patients with acute PE who received care at an academic hospital system in New York City between March 1st and April 30th, 2020. These patients were compared against historic controls between March 1st and April 30th, 2019. PE severity, PERT utilization, initial management, PERT recommendations, and outcomes were compared. There were more cases of PE during the pandemic (82 vs. 59), but less PERT activations (26.8% vs. 64.4%, p < 0.001) despite similar markers of PE severity. PERT recommendations were similar before and during the pandemic; anticoagulation was most recommended (89.5% vs. 86.4%, p = 0.70). During the pandemic, those with PERT activations were more likely to be female (63.6% vs. 31.7%, p = 0.01), have a history of DVT/PE (22.7% vs. 1.7%, p = 0.01), and to be SARS-CoV-2 PCR negative (68.2% vs. 38.3% p = 0.02). PERT activation during the pandemic is associated with decreased length of stay (7.7 ± 7.7 vs. 13.2 ± 12.7 days, p = 0.02). PERT utilization decreased during the COVID-19 pandemic and its activation was associated with different biases. PERT recommendations and outcomes were similar before and during the pandemic, and led to decreased length of stay during the pandemic.