531 research outputs found

    Pharming Out Data: A Proposal for Promoting Innovation and Public Health through a Hybrid Clinical Data Protection Scheme

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    The pharmaceutical industry, one of the largest industries in the world, is rapidly becoming globalized. Clinical trials, which are required for drugs to be approved for human use, are increasingly performed outside of the pharmaceutical company\u27s home country in an attempt to save money. This is mainly due to drug development\u27s steep costs, and the high risks involved in an industry where only 12 percent of products that begin development ever make it to market. In order to help offset these risks and encourage innovation, many countries offer clinical trial data certain protections through patents, market exclusivity, or trade secret protection. However, regulations and clinical data protection often do not align between the originator country and the location of the clinical trial. This leads to confusion and undermines the goals of providing clinical data protection. Additionally, providing too much protection to test data can negatively affect consumers, who will not be able to access cheaper generic versions of drugs. While it is commonly accepted that clinical data protection must be standardized on a global level, it is less clear what level and type of protection is appropriate. This Note proposes a hybrid system of clinical data protection that offers one year of data exclusivity, followed by a four-year period of cost sharing, during which generic competitors must pay a fee to rely on the originator company\u27s data. Such a scheme would properly balance the need to encourage pharmaceutical companies to undertake the risky business of innovating with the need to provide easy access to affordable medications

    Operator Counting for N=2 Chern-Simons Gauge Theories with Chiral-like Matter Fields

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    The localization formula of Chern-Simons quiver gauge theory on S3S^3 nicely reproduces the geometric data such as volume of Sasaki-Einstein manifolds in the large-NN limit, at least for vector-like models. The validity of chiral-like models is not established yet, due to technical problems in both analytic and numerical approaches. Recently Gulotta, Herzog and Pufu suggested that the counting of chiral operators can be used to find the eigenvalue distribution of quiver matrix models. In this paper we apply this method to some vector-like or chiral-like quiver theories, including the triangular quivers with generic Chern-Simons levels which are dual to in-homogeneous Sasaki-Einstein manifolds Yp,k(CP2)Y^{p,k}(\mathbb{CP}^2). The result is consistent with AdS/CFT and the volume formula. We discuss the implication of our analysis.Comment: 23 pages; v2. revised version; v3. corrected typos and clarified argument

    Mixed Neural-Conventional Processing to Differentiate Airway Diseases by Means of Functional Noninvasive Tests

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    This paper describes a processing technique that can be used to combine information from different medical analyze to discriminate between different pathologies that have similar symptoms. The paper is focused on the differentiation between asthma, bronchitis, and emphysema, using only functional noninvasives tests, but the proposed technique can be easily applied to other similar situations where different tests have to be used to identify a pathology. The technique is based on mixed neural-and-conventional processing that not only suggests the pathology, but also estimates the reliability of this suggestion

    Technical characteristics can make the difference in a surgical linear stapler. or not?

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    Background Anastomotic leak (AL) after gastrointestinal surgery is a severe complication associated with relevant short- and long-term sequelae. Most of the anastomosis are currently performed with a surgical stapler that is required to have appropriate characteristics to guarantee good performances. The aim of our study was to evaluate, in the laboratory, pressure resistance and tensile strength of anastomosis performed with different surgical linear staplers, available in the market. Materials and methods We have been studying three linear staplers, with diverse cartridges and staple heights, of three different companies, used for gastrointestinal anastomosis and gastric or intestinal closure. We performed 50 anastomosis for each device, with the pertinent different cartridges, on fresh pig intestine, for a total of 350 anastomosis, then injected saline solution and recorded the pressure that provokes a leak on the staple line. There were no statistically significant differences between the mean pressure necessary to induce an AL in the various instruments (P > 0.05). For studying the tensile strength, we performed a total of 350 anastomosis with the different linear staplers on a special strong paper (Tyvek), then recorded the maximal tensile force that could open the anastomosis. Results There were no statistically significant differences between the different staplers about the strength necessary to open the staple line (P > 0.05). Conclusions we demonstrated that different linear staplers of three companies available in the market give comparable anastomotic pressure resistance and tensile strength. This might suggest that small dissimilarities between different devices are not involved, at least as major parameters, in AL etiology

    Numerical studies of the ABJM theory for arbitrary N at arbitrary coupling constant

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    We show that the ABJM theory, which is an N=6 superconformal U(N)*U(N) Chern-Simons gauge theory, can be studied for arbitrary N at arbitrary coupling constant by applying a simple Monte Carlo method to the matrix model that can be derived from the theory by using the localization technique. This opens up the possibility of probing the quantum aspects of M-theory and testing the AdS_4/CFT_3 duality at the quantum level. Here we calculate the free energy, and confirm the N^{3/2} scaling in the M-theory limit predicted from the gravity side. We also find that our results nicely interpolate the analytical formulae proposed previously in the M-theory and type IIA regimes. Furthermore, we show that some results obtained by the Fermi gas approach can be clearly understood from the constant map contribution obtained by the genus expansion. The method can be easily generalized to the calculations of BPS operators and to other theories that reduce to matrix models.Comment: 35 pages, 20 figures; reference added. The simulation code is available upon request to [email protected]

    Interacting fermions and N=2 Chern-Simons-matter theories

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    The partition function on the three-sphere of N=3 Chern-Simons-matter theories can be formulated in terms of an ideal Fermi gas. In this paper we show that, in theories with N=2 supersymmetry, the partition function corresponds to a gas of interacting fermions in one dimension. The large N limit is the thermodynamic limit of the gas and it can be analyzed with the Hartree and Thomas-Fermi approximations, which lead to the known large N solutions of these models. We use this interacting fermion picture to analyze in detail N=2 theories with one single node. In the case of theories with no long-range forces we incorporate exchange effects and argue that the partition function is given by an Airy function, as in N=3 theories. For the theory with g adjoint superfields and long-range forces, the Thomas-Fermi approximation leads to an integral equation which determines the large N, strongly coupled R-charge.Comment: 29 pages, 4 figure

    Revision Total Shoulder Arthroplasty is Associated with Increased Thirty-Day Postoperative Complications and Wound Infections Relative to Primary Total Shoulder Arthroplasty

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    © 2017, Hospital for Special Surgery. Background: With an increasing volume of primary total shoulder arthroplasties (TSA), the number of revision TSA cases is expected to increase as well. However, the postoperative medical morbidity of revision TSA has not been clearly described. Questions/Purposes: The purpose of this study was to determine the rate of postoperative complications following revision TSA, relative to primary TSA. In addition, we sought to identify independent predictors of complications, as well as to compare operative time and postoperative length of stay between primary and revision TSA. Methods: Patients who underwent primary/revision TSA between 2005 and 2015 were identified in the American College of Surgeons National Surgical Quality Improvement Program. Differences in complications, readmission rates, operative time, length of stay, and predictors of complications were evaluated using bivariate and multivariate analyses. Results: A total of 10,371 primary TSA (95.4%) and 496 revision TSA cases (4.6%) were identified. The overall complication rate was 6.5% in primary and 10.7% in revision TSA patients (p \u3c 0.001). Multivariate analysis identified an increased risk of any complication (odds ratio 1.73, p \u3c 0.001), major complication (2.08, p = 0.001), and wound infection (3.45, p = 0.001) in revision TSA patients, relative to primary cases. Operative time was increased in revision cases (mean ± standard deviation, 125 ± 62.5), relative to primary (115 ± 47.7, p \u3c 0.001). Age \u3e 75, female sex, history of diabetes or chronic obstructive pulmonary disease, and American Society of Anesthesiologists classification ≥ 3 were associated with increased risk of any complication. Smoking history was the only significant predictor of wound infection. Conclusion: Revision TSA, in comparison to primary, poses an increased risk of postoperative complications, particularly wound infections. A history of smoking was an independent predictor of wound infections

    A method of reconstruction after pancreaticoduodenectomy for pancreatic malignancies in very young children: Two cases reports

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    Pancreatic tumors are very rare diseases in very young children. Most information about those diseases in children was published in cases reports. Due to the rare nature of pancreatic tumors in children, there remains the absence of diagnostic algorithms, clear radiographic and morphological assessments as well as evidence based best treatment options. Because of the young age of patients and the rare occurrence of pancreatic neoplasms, tumor detection remains poor. For malignancies affecting the head of the pancreas the only possibility for achieving clear surgical margins is performing a pancreaticoduodenectomy (PD). We describe two cases of diagnostic and treatment of pancreatic tumor of very young children what was done in our institute

    Analysis of the Thymidylate Synthase Gene Structure in Colorectal Cancer Patients and Its Possible Relation with the 5-Fluorouracil Drug Response

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    Thymidylate synthase (TS) catalyzes methylation of dUMP to dTMP and it is the target for the 5-Fluorouracil (5-FU) activity. Barbour et al. showed that variant structural forms of TS in tumour cell lines confer resistance to fluoropyrimidines. We planned to perform the whole TS gene structure by means of sequencing techniques in human colorectal cancer (CRC) samples to try to identify the presence of any possible TS variant form that could be responsible of fluoropyrimidines drug resistance and of the worse prognosis. We performed the TS-DNA gene sequence in 68 CRC from patients of A, B, and C Dukes' stages and different histological grade, but we did not find any mutation in the TS-DNA structure. In the future we intend to widen the TS structure analysis to the metastatic CRCs, because due to their higher genomic instability, they could present a TS variant form responsible of the fluoropyrimidines drug resistance and the worse prognosis
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