11,828 research outputs found
PT-VWD posing diagnostic and therapeutic challenges-small case series.
No full textDespite the increased worldwide awareness, over the last decade, of the platelet-type von Willebrand Disease (PT-VWD), many uncertainties remain around this rare platelet bleeding disorder. This report aims to correctly identify and study the phenotype of new patients and highlights the diagnostic and therapeutic challenges this disease remains to pose. We describe four PT-VWD cases confirmed by genetic analysis in which either the diagnosis and/or the treatment posed challenge. We provide the details of the clinical presentation, laboratory analysis, and the treatment and the responses in each case. We show that in addition to type 2B VWD, PT-VWD can be misdiagnosed as idiopathic thrombocytopenic purpura, neonatal alloimmune thrombocytopenia, and unexplained gestational thrombocytopenia. The disease can be diagnosed as early as 1 year of age and with phenotypically normal parents. Bleeding in some patients can be managed successfully using Humate P and DDAVP combined with tranexamic acid with no significant thrombocytopenia. We provide for the first time an evidence of an efficient response to rFVIIa in PT-VWD. Anaphylactic reaction to VWF preparations may be related to PT-VWD and the development of HLA antibodies is not uncommon. Progressive thrombocytopenia with normal VWF levels can be seen with PT-VWD and the platelet count was normalized at 2.5 weeks postpartum in one case. We conclude that these studies represent a record of clinical observations/interventions that help improve diagnoses/management of PT-VWD, highlight the variations in age and clinical presentations, laboratory diagnostic approaches, the importance of genetic testing for accurate diagnosis and consideration of therapeutic alternatives.Fil: Sánchez Luceros, Analía Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Medicina Experimental. Academia Nacional de Medicina de Buenos Aires. Instituto de Medicina Experimental; Argentina. Academia Nacional de Medicina de Buenos Aires. Instituto de Investigaciones Hematológicas ; ArgentinaFil: Woods, Adriana Inés. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Medicina Experimental. Academia Nacional de Medicina de Buenos Aires. Instituto de Medicina Experimental; ArgentinaFil: Bermejo, Emilse. Academia Nacional de Medicina de Buenos Aires. Instituto de Investigaciones Hematológicas ; ArgentinaFil: Shukla, Shilpa. Academia Nacional de Medicina de Buenos Aires; ArgentinaFil: Acharya, Suchitra. Cohen's Children Medical Center of New York; Estados UnidosFil: Lavin, Michelle. St. James Hospital; IrlandaFil: Rydz, Natalia. University of Calgary; CanadáFil: Othman, Maha. Queens University; Canad
Implementasi Protokol Keamanan Dan Segmentasi Jaringan Dalam Project Pembangunan WLAN Untuk PT Pan Pacific Insurance
No full textSecurity of data and network devices is essential in the development of a computer network, either in the creation of new computer networks or in the development of existing computer networks. PT. Pan Pacific Insurance as a company that holds large amounts of data along with its supporting computer network's infrastructure, focuses on security aspects in addition to performance aspects in its computer network. To get the flexibility of its computer network, the company developed a wireless local area network (WLAN) in line with the relocation of its head office. The Existing company's network needs to be improved with a WLAN network, so it does not only improve employee performance and provides the best security for company data. For those purposes, the authors applied the use of Cisco Wireless LAN Controller (WLC), Cisco Access Point and applied the WPA+WPA2 PSK security protocol for the SSID used by employees. Using this protocol when employees want to connect to the network wireless, they will be forced to type the password that has been set. In addition to implementing the security protocol, the author also applies the Web Policy Authentication security protocol for the SSID used by guests. So that guests who want to connect to a wireless network will be directed to a web browser to be asked to enter a username and password first. A series of security protocols, also added with network segmentation on each SSID to use a different network address. Thus, the essence of network security and performance is expected to increase. From the results of the tests carried out, obtained security guarantees on the PT. Pan Pacific Insurance successfully directs every user connected to the network as part of the security protocol implemented. Furthermore, with network segmentation, user traffic is more controlled because guests get their network segmentation, so they don't interfere with network traffic for users or company staff in company operations
Abstract P4-02-08: Opto-acoustic imaging of the breast: Downclassification and upclassification of suspicious breast masses
No full textAbstract
Background
Imagio® is an opto-acoustic (OA) breast imaging system designed to concomitantly collect OA images together with diagnostic ultrasound (CDU). The device is intended to improve distinction between benign and malignant masses. In this interim analysis of the post-market surveillance MAESTRO study we report the results of 75 patients who had breast masses classified as BI-RADS 4a and 4b by CDU.
Aim
We assessed OA's sensitivity, specificity, and its ability to downgrade benign masses and upgrade malignant masses based on the probability of malignancy (POM) and BI-RADS category.
Methods
Seventy-five patients with 78 breast masses were evaluated with OA prior to biopsy. For each mass, the radiologist scored 5 OA features, assigned a POM and BI-RADS category. OA sensitivity, specificity, and BI-RADS downgrade and upgrade percentages were assessed with and without contribution from a previously derived nomogram.
Results
The mean POM difference between malignant and benign masses was higher for OA (37%) than for CDU (27%). OA specificity was 43% without the nomogram and 68% with the nomogram. OA sensitivity was 97% with and without the nomogram. With OA 43% of benign masses could be downgraded and 47% of malignant masses could be upgraded in BIRADS category.
Conclusion
These results appear to confirm the previously reported ability of OA to improve the differentiation between benign and malignant masses compared to CDU alone, to potentially decrease negative biopsies, and to upgrade BI-RADS category in malignant masses. The MAESTRO study (n=200) may further confirm these results.
Citation Format: Menezes GLG, Pijnappel RM, Meeuwis C, Bisschops B, Veltman J, Lavin PT, Mann RM. Opto-acoustic imaging of the breast: Downclassification and upclassification of suspicious breast masses [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-02-08.</jats:p
Titanium oxide adhesion layer for high temperature annealed Si/Si3N4/TiOx/Pt/LiCoO2 battery structures
No full textThis work describes the influence of a high annealing temperature of about
700C on the Si(substrate)/Si3N4/TiOx/Pt/LiCoO2 multilayer system for the
fabrication of all-solid-state lithium ion thin film microbatteries. Such microbatteries
typically utilize lithium cobalt oxide (LiCoO2) as cathode material
with a platinum (Pt) current collector. Silicon nitride (Si3N4) is used to act as a
barrier against Li diffusion into the substrate. For a good adherence between
Si3N4 and Pt, commonly titanium (Ti) is used as intermediate layer. However,
to achieve crystalline LiCoO2 the multilayer system has to be annealed at high
temperature. This post-treatment initiates Ti diffusion into the Pt-collector
and an oxidation to TiOx, leading to volume expansion and adhesion failures.
To solve this adhesion problem, we introduce titanium oxide (TiOx) as an
adhesion layer, avoiding the diffusion during the annealing process. LiCoO2,
Pt and Si3N4 layers were deposited by magnetron sputtering and the TiOx
layer by thermal oxidation of Ti layers deposited by e-beam technique. Asdeposited
and annealed multilayer systems using various TiOx layer thicknesses
were studied by scanning electron microscopy (SEM) and time-of-flight
secondary ion mass spectrometry (ToF-SIMS) and x-ray photoelectron spectroscopy
(XPS). The results revealed that an annealing process at temperature
of 700C leads to different interactions of Ti atoms between the layers, for
various TiOx layer thicknesses (25–45 nm).This work was financially supported by FEDER/ COMPETE and FCT funds with the Projects PTDC/ EEA-ELC/114713/2009, PEst-C/QUI/UI0686/2013 and UID/EEA/04436/2013, first author scholarship SFRH/BPD/95905/2013 and second author scholarship SFRH/BD/78217/2011. This work was carried out with the support of the Karlsruhe Nano Micro Facility (KNMF, www.kit.edu/knmf), a Helmholtz Research Infrastructure at Karlsruhe Institute of Technology (KIT, www.kit.edu)
A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis
No full textGheorghe Doros,1 Philip T Lavin,2 Michael Daley,3 Larry E Miller4 1School of Public Health, Boston University, Boston, 2Lavin Consulting LLC, Framingham, MA, 3OrthogenRx Inc., Doylestown, PA, 4Miller Scientific Consulting, Inc., Asheville, NC, USA Abstract: Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US. In September 2015, GenVisc 850® (sodium hyaluronate), a hyaluronic acid approved for the treatment of knee osteoarthritis, was approved by the US Food and Drug Administration (FDA) based upon indistinguishable characteristics in comparison to an approved branded hyaluronic acid (Supartz®/Supartz FX™). The purpose of this paper is to review the methodology and report the main outcomes used to demonstrate clinical comparability of GenVisc 850 with Supartz/Supartz FX. The FDA approval was collectively attained using prospectively defined methods for preclinical, physical, and chemical testing, as well as noninferiority in clinical performance comparisons. Evidence from five randomized controlled studies of Supartz/Supartz FX vs saline control injections (used for Supartz approval), two randomized controlled trials of GenVisc 850 vs saline control injections, and one randomized controlled study of GenVisc 850 vs Supartz/Supartz FX provided evidence of safety for GenVisc 850. Efficacy was further assessed based on assessment of the same Supartz studies and three prospectively identified GenVisc 850 studies. A Bayesian network meta-analysis was used to demonstrate that the clinical efficacy of GenVisc 850 was noninferior to Supartz/Supartz FX and superior to saline control. Overall, safety of GenVisc 850 was similar to that of Supartz/Supartz FX and saline control injections, while efficacy of GenVisc 850 was noninferior to that of Supartz/Supartz FX and superior to saline control injections. Keywords: Food and Drug Administration, generic, substantially equivalent, biosimilar, indistinguishable, hyaluronic acid, knee, class III, medical device, osteoarthriti
Abstract P4-02-03: Breast biopsy histology relationships with opto-acoustic imaging of breast masses
No full textAbstract
Purpose: The Imagio® breast imaging system, a diagnostic opto-acoustic (OA) imaging device bearing the CE Mark, is in the U.S. FDA Premarket Approval process. OA provides both functional (relative oxygenation/de-oxygenation) and anatomic (angiogenesis) information that is co-registered and temporally interleaved in real time with gray-scale ultrasound that may improve distinction between benign and malignant masses. OA imaging pathology correlation was performed to elucidate the histologic features of OA features of breast cancers.
Methods and Materials: A multicenter postmarket surveillance and clinical follow-up study was conducted in five Dutch sites in which 209 women with breast masses underwent OA prior to biopsy. Histopathology examination of the biopsies revealed 146 benign masses (mostly fibroadenomas) and 76 malignant masses (mostly invasive ductal carcinomas). For invasive ductal carcinomas, histologic grade and the features used to assess histologic grade (nuclear pleomorphism, tubule formation, and mitotic count) were assessed. For each mass, 5 pre-determined OA features, 3 internal features, and 2 external features were evaluated. The 3 internal scores (vessels, blush, and hemoglobin) and 2 external features (capsular boundary zone and peripheral boundary zone) were separately and collectively summed for testing relationships with traditional histopathology measures using a two-sided Jonckheere-Terpstra test of ordered outcomes. Distribution differences between benign and malignant masses were performed using a Wilcoxon Rank Sum test for each internal, external, and summed total internal, external, and total score.
Results: The mean differences were significantly higher for malignant vs. benign for internal vessels (p=0.0009), internal blush (p=0.0085), external boundary zone (p&lt;0.0001), and external peripheral zone (p&lt;0.0001), but not internal hemoglobin. Mean Total Internal Score, Total External Score, and Total Internal and External Score were all significantly higher (all p&lt;0.01) for malignant vs. benign. Among invasive carcinomas, Total Internal Score and Total Internal and External Score were significantly higher for higher histologic tumor grade (p=0.04, 0.02), significantly higher Total External Score and Total Internal and External Score for higher tubule score (p=0.06, 0.03), slightly higher Total Internal Score and Total Internal and External Score for higher nuclear pleomorphism score (p=0.04, 0.05), and slightly higher Total Internal Score for higher mitotic score (p=0.03).
Conclusion: OA feature summary scores appear to differentiate between benign vs. malignant and correspond to histologic grade and scoring components of histologic grade. The U.S. investigational PIONEER pivotal study (n=2,095) may further confirm these results.
Citation Format: van de Vijver M, Lavin PT, Stavros AT. Breast biopsy histology relationships with opto-acoustic imaging of breast masses [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-02-03.</jats:p
PROSEDUR PENGAJUAN DOKUMEN PROYEK PADA PT FIBERHOME TECHNOLOGIES INDONESIA SURABAYA
No full textThe purpose of this study was to determine the submission procedure of project's documents in PT FiberHome Technologies Indonesia. The method used in this study is a direct approach, the author does not just reading and taking references from the books of the project but as a project secretary, authors also took a part in the project's document submission process. The results showed that the procedures for submission of project's documents in PT FiberHome Technologies Indonesia has been running welL. Procedures for the submission project's document in PT FiberHome Technologies Indonesia are as follows: Permitting, Preparation of drawings and material needs, Implementation, Ready for Service, Project controlling,
Acceptance Test
STRATEGI BISNIS PT. POS INDONESIA
No full textPT. Pos Indonesia is a company focusing on the delivery of packages and documents worldwide. Now we know that many courier companies and forwarding serve delivery services. So that PT. Pos Indonesia can survive amid competition, the author will formulate a strategy. But earlier, the authors need to analyze internal and external factors. The author will use a SWOT analysis to complete this study. This method is quite flexible in various state companies. The results of this study PT. Pos Indonesia are advised to use its strength to deal with the threats and opportunities. The strategies implemented by utilizing the factors of internal forces that exist to grab opportunities PT. Pos Indonesia in order to increase business. Based on the author analysis, an IFE score of 2.35 and EFE score of 2.24 and be in quadrant V, stability
Effect of Pt bottom electrode texture selection on the tetragonality and physical properties of Ba 0.8Sr 0.2TiO 3 thin films produced by pulsed laser deposition
No full textThe effect of platinum (Pt) bottom electrode texture on the tetragonality, dielectric, ferroelectric, and polarization switching response of pulsed laser deposited Ba 0.8Sr 0.2TiO 3 (BST) thin films has been studied. The x-ray diffraction and Raman analysis revealed the higher tetragonality of BST films when they were grown on higher (111) textured Pt layer. The properties like dielectric permittivity, polarization, switching time, and leakage currents were found to be correlated to tetragonality and orientation of the BST films. The polarization current was observed to be higher in BST films on Pt epitaxial layer and it exhibits exponential dependence on the electric field. The voltage-current measurements displayed Ohmic behavior of leakage current irrespective of Pt texture for low voltages (up to 1 V), whereas at higher voltages the conduction mechanism was found to be dependent on texture selection of bottom Pt electrode. © 2012 American Institute of Physics.The author J.P.B.S. thanks FCT for the financial support (Grant SFRH/BD/44861/2008). K.C.S. thanks FCT for Postdoc Grant (SFRH/BPD/68489/2010). J.M.S. thanks FCT for the financial support (Grant SFRH/BPD/64850/2009).Peer Reviewe
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