Academic literature on the topic 'IRB 14000'

Collaborative industrial robots meet the modern approach to robotization. They enable cooperation with a human being in the robot’s work area. As part of the article, it was decided to design and build a robotic station enabling the implementation of human–machine cooperation. CAD models of the station were created using the Autodesk Inventor software. The station design was made in the RobotStudio environment with the use of the IRB 14000 YuMi robot. The software is based on smart components and Rapid language code. A graphical user interface was created, interactive with a human in virtual reality. The software was verified with the participation of the operator in virtual reality.

AbstractThe UBVRI photometric follow-up of SN 2011fu has been initiated a few days after the explosion, shows a rise followed by steep decay in all bands and shares properties very similar to that seen in case of SN 1993J, with a possible detection of the adiabatic cooling phase at very early epochs. The spectral modeling performed with SYNOW suggests that the early-phase line velocities for H and Fe ii features were ~ 16000 km s−1 and ~ 14000 km s−1, respectively. Studies of rare class of type IIb SNe are important to understand the evolution of the possible progenitors of core-collapse SNe in more details.

14001 Background: Acneiform rash is the main toxicity of erlotinib, an epidermal growth factor receptor (EGFR) inhibitor. The length of the CA dinucleotide repeat in EGFR intron 1 has been suggested to predict the biological effects of tyrosin kinase inhibitors. Thus, we compared this polymorphism with the rash severity in non-small cell lung cancer (NSCLC) patients treated with erlotinib. Methods: Toxicity was evaluated in 18 metastatic or locally advanced unresectable NSCLC patients treated orally with 150 mg/d of erlotinib: 7 retrospectively and 11 prospectively. Rash was graded according to a modified scale based on the Common Toxicity Criteria v.3.0, which subclassified grade II rash into IIA (topic intervention indicated) and IIB (oral intervention indicated). Genomic DNA was isolated from each patient; the length of the EGFR intron 1 CA dinucleotide repeat was measured by PCR amplification and analyzed on a capillary sequencer. Results: The most common EGFR genotypes were: 16, 20, 17 and 18 CA repeats (with 50, 25, 8 and 8% frequency, respectively). 33% of the subjects with a total amount of CA repeats <34 had grade IIB-III rash vs 11% of the subjects with =34 CA repeats. In addition, all patients with 0 grade toxicity belonged to the =34 CA group. When the only patient with a previous dermatological disease (psoriasis) was excluded from the analysis, the difference between both groups increased, reaching statistical significance (p=0.047). Conclusions: This data suggests that NSCLC patients with long EGFR intron 1 CA alleles present lower grades of skin toxicity when treated with erlotinib than patients with short CA alleles. Further studies are required to confirm this data. [Table: see text] No significant financial relationships to disclose.

6557 Background: Clinico-genomic data sharing is consistently identified by the global oncology community as a critical requirement to accelerate the discovery and development of new targeted therapies. However, lack of effective collaborative models, fragmented and lengthy legal contracting processes, paucity of funding, and inadequate technological platforms have historically been obstacles for effective data sharing. Methods: In 2015, 10 US academic medical centers (AMC) and Foundation Medicine Inc. (FMI) formed PMEC. Feasibility assessments included creation of a master agreement across sites and willingness to use a central IRB. Oversight and research steering committees were created within the consortium. Through a centralized, secure web-based platform, FoundationInsight, we combined and shared de-identified, harmonized comprehensive FoundationOne genomic profiling data. Research proposals mining this data warehouse are invited quarterly from participant AMCs and peer-reviewed; approved studies are executed at all sites. Results: All 10 AMCs collaborated to execute a master registry participation agreement, followed by a master IRB protocol (New England IRB # 120180008), subsequently approved by individual site IRBs. Since its launch, the PMEC database has grown, on average, 60% per year, to now house over 14,000 cases. The shared dataset covers all tumor types (most commonly lung [17.2%], gastrointestinal [13.8%] and breast [9.2%]), encompasses genomic alterations in >300 genes, and reports relevant supplementary data such as tumor mutation burden and microsatellite instability status. To date, 15 studies have been proposed and evaluated using this platform, with 2 projects currently approved and in progress. Conclusions: We demonstrated the feasibility of creating a collaborative academic consortium that facilitates data sharing and potential discovery efforts in oncology. Technology solutions can accelerate the ability of AMCs, in partnership with central labs, to share and harmonize data to advance precision medicine. This approach lays the groundwork for conducting prospective, biomarker-enriched clinical trials among participating AMCs.

551 Background: Randomized trials demonstrated a modest (3-5%) absolute benefit from EET in patients (pts) with early stage HR+ breast cancer (BC), but also a risk of toxicities. BCI is a validated gene expression-based assay that provides 2 results: BCI Prognostic, based on the algorithmic combination of HoxB13/IL17BR (H/I ratio) and a set of proliferation-based genes, reports individualized risk of late distant recurrence (DR); BCI Predictive, based on H/I alone, reports a prediction of high vs low likelihood of benefit from EET. The objective of this study was to assess clinical and pathologic patient characteristics, prognostic and predictive assay results, and physician testing patterns in >14,000 clinical cases. Methods: The BCI Clinical Database for Correlative Studies is a de-identified database developed under an IRB approved protocol that contains >50 clinicopathologic and molecular variables from cases submitted for BCI in clinical practice. Clinicopathologic variables were abstracted from pathology reports, and were available for a subset of cases. Results: Across all pts (N=14,463), median age was 58.2y (range: 23-92y; 73.9% ≥50y). The majority were Stage I (47.3% IA, 3.5% IB, 29.1% IIA, 14.1% IIB, 6% III). Cases were 29%, 51%, and 20% Grade 1, 2, and 3, respectively. Most pts were ER+/PR+ (87.7%) or ER+/PR- (11.3%); 11.3% were HER2+. The majority of cases (55.7%) were ordered 4-6y postdiagnosis, with 23.1% >6y, 14.4% between 1-4y, and 6.8% <1y postdiagnosis. In LN- pts (n=3395), BCI Prognostic identified 50.6% as low risk for late DR vs 49.4% as high risk, while BCI Predictive (H/I) classified 41.0% as high vs 59.0% as low likelihood of benefit. In LN+ pts tested with the BCIN+ Prognostic algorithm (BCI + size/grade, n=818), 77.3% were classified as high risk vs 22.7% as low risk, while BCI Predictive (H/I) classified 44.6% and 55.4% as high vs low likelihood of benefit. Conclusions: Findings from this large cohort characterize utilization of BCI in clinical practice for pts with early-stage, HR+ BC. BCI stratification of pts with high risk and high likelihood of benefit from EET may facilitate selection of pts for prolonged regimens.

14002 Background: Gemcitabine, the standard chemotherapy for advanced pancreatic cancer (APC), produces low response rates and short time to progression. Preclinical studies suggest that zoledronic acid inhibits pancreatic cell lines by interfering with the p21ras/raf-1/MEK1/ERKL signaling pathway. We conducted this trial to evaluate the efficacy and toxicity of gemcitabine and zoledronic acid in subjects with APC. Methods: Eligible subjects had histological or cytological diagnosis of metastatic pancreatic adenocarcinoma (Stage IV) not amenable to resection with curative intent. Gemcitabine 1000 mg/m2 IV was given on Days 1, 8, 15, and 22 in Cycle 1 and Days 1, 8, and 15 in subsequent cycles. Zoledronic acid 4 mg IV was given on Day 1 every 4 weeks. Toxicity was assessed at each visit. Results: Between December 2004 and July 2005, 35 subjects were enrolled. Baseline characteristics: 20 males (57%), median age 66.7 years (range, 40–83.5), and KPS of 70/80/90/100 = 8%/29%/34%/29%, respectively. Four patients had locally advanced disease (3 stage IIB and 1 stage III), 86% of subjects had Stage IV disease at diagnosis; 91% of subjects had adenocarcinoma. Prior therapy included surgery (n=15, 43%), chemotherapy (n=3, 9%), and radiotherapy (n=2, 6%). To date, there has been 1 PR and 9 SD; the clinical benefit rate (PR+SD≥6 months) was 14%. Grade 3 and 4 treatment-related toxicities included: neutropenia (22%); thrombocytopenia and fatigue, (12.5% each); and anemia, nausea/vomiting, dehydration, and diarrhea (6% each). Seven treatment-related SAEs have been reported; 28 subjects are off study. Patients discontinued treatment due to: progressive disease (PD) (n=15), toxicity (n=4, 1 each DVT, infection, back pain, and generalized weakness), withdrew consent (n=3), MD decision (n=2), patient request (n=2), and death (n=2), To date, 21 subjects have died; deaths were attributed to PD (n=16), CVA (n=1), and unknown (n=4). Conclusions: Pancreatic cancer, typically advanced at diagnosis, remains a major treatment challenge. Zoledronic acid in combination with gemcitabine was well-tolerated in this study. Future genomic testing is proposed for responders. Updated toxicity, response, and survival data will be presented. Supported by Novartis Pharmaceuticals Corp., East Hanover, NJ. No significant financial relationships to disclose.

The authors report on a consecutive series of 253 cases of seminoma of the testis followed with periodic chest X-ray examinations from a minimum of three to a maximum of 27 years. The detection rate of asymptomatic intrathoracic metastases (ITM) was considered together with the costs of the follow-up procedure. Chest X-ray follow-up is not advisable beyond one year from primary treatment, since most (14 of 18) ITM occur in the first year, the detection rate of ITM beyond this date is too low (0.11% patients/year), and the related costs are too high (over $ 130,000 per ITM detected). Chest X-ray follow-up is questionable even in the first year after primary treatment for Stage I cases because of the low detection rate (1.38% patients/year) and the high costs (over $ 14,000 per ITM detected), whereas it appears to be opportune in Stages IIA and IIB.

Introduction: Hydroxyurea (HU) is the most used cytoreductive therapy (tx) for patients (pts) with polycythemia vera (PV). However, many pts may have suboptimal responses (SubOR) and/or toxicity (TOX) to HU. After HU, Ruxolitinib (RUX) may achieve hematocrit (HCT) and spleen reductions, but other tx are also available, mainly busulfan (BUS) and interferons (IFN). Aims: In a large cohort of PV pts, we investigated if: 1) type of SubOR to HU influenced subsequent tx strategy; 2) differential tx had an impact on overall survival (OS). Methods: After IRB approval, clinical/laboratory data of 2016 WHO-defined PV pts from 21 European Hematology Centers were retrospectively collected. SubOR included ≥1 of the following criteria after ≥3 mos of HU: WBC/PLT count &gt;10/400 x109/l, need for phlebotomies (PHL); splenomegaly and/or symptoms persistence/occurrence (Barosi G et al, Blood 2009). Only pts with stable SubOR were included in this analysis. Since a complete response was never achieved, the index date (ID) was set at 3 mos from HU start in all pts (Barosi G et al, BJH 2009). OS was calculated from the ID by Cox analysis with age&gt;80, adjusted with left truncation from PV diagnosis. Results: At data cut-off date (June 2020), 808 PV pts were collected; 688 received HU. Among the 452 (65.7%) pts who presented a stable SubOR to HU, 41 did not receive any tx for PV due to early death or progression to BP/MF and were excluded from this analysis. Baseline characteristics of the 411 evaluable pts were: median age: 65 yrs (21- 87); males: 54%; median (range) WBC/PLT count, x109/l: 10 (1.1-38)/465 (139-1209); median Hb (g/dl)/HCT (%): 18.6/56 (males); 17.6/54 (females); palpable splenomegaly: 38%; symptoms: 80.5%; pruritus: 42%. A previous thrombosis occurred in 104 (25.3%) pts. At least one cardiovascular risk factor (CVRF: smoke, diabetes, hypertension, dyslipidemia and overweight) was present in 325 pts (79.1%). After a median follow-up of 4.8 yrs (0.5-27.6) from HU start, 104 (25.3%) switched to RUX (HU-RUX), 18 (4.4%) switched to another agent (HU-other, including IFN, BUS, PHL only), and 289 (70.3%) continued HU (HU-alone). Pts with baseline palpable spleen (p&lt;0.001) and pruritus (p=0.01) more frequently switched to RUX. Conversely, pts ≥80y more frequently received HU-alone/other (p=0.03). Notably, Charlson Comorbidity Index and CVRF had no impact on tx strategy. Median HU daily dose was 0.65 g (≥2 g/d: 8.7% of pts) and was higher in HU-RUX pts (1 vs 0.6 g/d in HU-alone/other pts, p=0.004). While 331 (80.5%) pts had a stable SubOR without TOX, 80 (19.5%) had also TOX. Notably, pts with only SubOR more frequently continued HU (p&lt;0.001). Conversely, the co-occurrence of TOX was significantly associated to RUX switch (p&lt;0.001) (Fig. 1a). In 45.5% of pts, the SubOR was related only to uncontrolled WBC/PLT/HCT, while 16.1% of pts had an optimal hematological control but presented spleen/symptoms; the remaining 38.4% of pts had both uncontrolled myeloproliferation and spleen/symptoms. The presence of both uncontrolled myeloproliferation and spleen/symptoms significantly predicted RUX switch (p&lt;0.001). Investigating the SubOR criteria individually among the HU-alone/other and the HU-RUX groups, we found that uncontrolled leukocytosis and/or thrombocytosis (p&lt;0.001), rather than PHL need (p=0.13), was significantly associated with RUX switch. Moreover, the persistence/occurrence of symptoms (p=0.001) or splenomegaly (p=0.005) were significantly associated with RUX use (Fig. 1b). After the ID, 31 pts died. HU-RUX pts presented increased OS compared to HU-alone/other pts (p=0.03). Conclusions. This study revealed a high rate of SubOR to HU, possibly also affected by low HU doses, and a lack of urgency to change the tx in these pts, with &gt;70% of pts continuing HU despite the stable SubOR. Particularly, good tolerance to HU, absence of splenomegaly and pruritus, and older age were the main factors against a tx change. Notably, despite HCT&gt;45% is associated with worse outcome (Marchioli R, NEJM 2013), PHL need did not significantly trigger tx change. The better OS in the HU-RUX group is presumably multifactorial and requires further confirmation. Overall, this analysis points out the need to improve HU management and response evaluations, weighing appropriate tx strategies in case of SubOR. Disclosures Palandri: Novartis: Consultancy, Honoraria. Benevolo:Amgen: Honoraria; Celgene: Honoraria; Novartis: Honoraria. Breccia:Bristol-Myers Squibb/Celgene: Consultancy, Honoraria; Abbvie: Consultancy; Incyte: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Cavazzini:Pfize: Honoraria; Novartis: Honoraria; Incyte: Honoraria. Heidel:Celgene: Consultancy; CTI: Consultancy; Novartis: Consultancy, Research Funding. Crugnola:BMS: Honoraria; Janssen: Honoraria; Celgene: Honoraria; Novartis: Honoraria. Pane:Daiichi Sankyo: Consultancy, Other: Travel Expenses; Janssen: Other: Travel Expenses; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Jazz Pharmaceuticals: Consultancy, Other: travel expenses, Speakers Bureau; Novartis pharma SAS: Consultancy, Other: Travel Expenses, Research Funding, Speakers Bureau; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Consultancy, Other: Travel Expenses, Speakers Bureau; AbbVie: Consultancy, Other: Travel Expenses, Speakers Bureau. Cuneo:Gilead: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Astra Zeneca: Honoraria; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Krampera:Janssen: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Semenzato:Takeda: Honoraria; Roche: Honoraria; Abbvie: Honoraria. Lemoli:Jazz: Consultancy, Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Servier: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; BerGenBio ASA: Research Funding; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees. Cavo:Jannsen, BMS, Celgene, Sanofi, GlaxoSmithKline, Takeda, Amgen, Oncopeptides, AbbVie, Karyopharm, Adaptive: Consultancy, Honoraria. Palumbo:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Nowadays many organizations worldwide have/are implemented/ implementing an environmental management system (EMS) according to ISO 14001, considering the context, the need to minimize negative environmental impacts, and long-term benefits. It has been observed for decades that for successful implementation of EMS are required different changes in the organizational structure, chances that lead to a successful integration and operation of this management system. Studying the literature it was observed the inexistence of relevant investigations conducted at Romanian organizations level, investigations which include different methodologies with models adapted to the particularities of the Romanian context, and relevant results for the current situation (PA). This paper intends to resolve the problem covered through the following general steps: I. identifying the problem (MP); II. goal setting: conceiving a model to analyze the effects produced at organizational structure level as a result of implementing an EMS; III. collecting data / information / knowledge from the literature (focusing on previous studies conducted starting from Mintzberg and others (authors as C. Hunt, E. Auster, M.C. Lopez-Fernandez, A. Zutshi, A. Sohal and so on) and from discussions with various managers of the environment department of several organizations located in the NE Romania; IV. the construction of the model; V. validate the constructs from the proposed model. The proposed research analysis model approaches three general dimensions that should characterize finally the effects resulted from the implementation of environmental management system at organization level; dimensions: I. aspects of organizational structure: I.a. Specialization (S1.horizontal; S2.vertical), I.b. Decentralization (D1.horizontal; D2.vertical), I.c. Formalization, I.d. Environmental trainings (per profile), I.e. Professional competence, I.f. Processes/ systems orientation, I.g. Systems/ process planning and control, I.h. Coordination/ cooperation in environmental issue; II. The effects of EMS implementation/ integration on organizational structure; and III. The quality of the organization's EMS integration

The aim of the master thesis is to design a laboratory station and a control program operated by a collaborative robot IRB 14000 YuMi using an integrated effector camera to identify laboratory objects and control the progress of the task. In the introductory part, collaborative robots are briefly introduced, the IRB 14000 on which the task is implemented and the RobotStudio development environment together with the IntegratedVision extension are described in more detail. The following chapters describe the laboratory task itself, its solution and testing of the designed program.

Numa sociedade e num mercado em convulsão, a insolvência de empresas é um tema na ordem do dia, pelas implicações sociais e económicas que acarreta. E em tempo de crise, como atualmente, há cada vez mais empresas em situação de insolvência. O fenómeno da insolvência empresarial tem sido objeto de estudo nas mais diversas áreas, e a controvérsia tem acompanhado, desde sempre, a sua abordagem. O tema é complexo, e torna-se ainda mais polémico quando abraça outro como a tributação das sociedades insolventes, também ele complexo. Este estudo pretende, assim, identificar e analisar os principais problemas suscitados pelo regime fiscal da tributação do produto da liquidação das sociedades insolventes. Para o efeito elaborámos um estudo empírico que avalia e confronta as opiniões de Administradores da Insolvência (AI), da Autoridade Tributária e Aduaneira (AT) e de Magistrados Judiciais (MJ), com o objetivo de contribuir para uma melhor solução na tributação de empresas neste regime.

Diesel particulate filters (DPF) have seen widespread use in on- and off-road applications as an effective means for meeting increasingly stringent particle emissions regulations. Over time, incombustible material or ash, primarily derived from metallic additives in the engine lubricant, accumulates in the DPF. Ash accumulation leads to increased flow restriction and an associated increase in pressure drop across the particulate filter, negatively impacting engine performance and fuel economy, and eventually requiring periodic filter service or replacement. While the adverse effects of ash accumulation on DPF performance are well known, the underlying mechanisms controlling these effects are not. The results of this work show ash accumulation and distribution in the DPF as a dynamic process with each stage of ash accumulation altering the filter’s pressure drop response. Through a combined approach employing targeted experiments and comparison with the existing knowledge base, this work further demonstrates the significant effect ash deposits have on DPF pressure drop sensitivity to soot accumulation. Ash deposits reduce the available filtration area, resulting in locally elevated soot loads and higher exhaust gas velocities through the filter, altering the conditions under which the soot is deposited and ultimately control the filter’s pressure drop characteristics. In this study, a novel accelerated ash loading system was employed to generate the ash and load the DPFs under carefully-controlled exhaust conditions. The ash loading system was coupled to the exhaust of a Cummins ISB diesel engine, allowing for accelerated ash loading and DPF performance evaluation with realistic exhaust conditions. Following DPF performance evaluation, the filters were subjected to a detailed post-mortem analysis in which key ash properties were measured and quantified. The experimental results, coupled with the ash property measurements, provide additional insight into the underlying physical mechanisms controlling ash properties, ash/soot interactions, and their effects on DPF performance.

Single angle members have been rarely used as supporting structures in nuclear power plant because they are open sections which have significantly reduced capacities when considered in comparison to closed sections, and have weakness for twisting load such as local torsion caused by loading eccentricity of geometric center and shear center. However, in APR1400 (Advanced Power Reactor 1400 MW-class in Korea), the extended application of single angle members for supporting structures of small bore piping systems is considered to enhance the constructability and economics of plant. Furthermore, although it is general guideline for support design in APR1400 that supporting structures for equipment should be directly welded to embedded plates or steel structures in buildings as far as possible, in the case of small bore piping system, for the low level priority of construction in site, supporting steel structures for small bore piping could not be evitable to be welded onto the CEA (Concrete Expansion Anchor) plate. Per the ACI 318, ACI 349 and ACI 355.2, most CEA plate designs and anchor bolt load determinations are now based on finite element models that many applications have been individually made for CEA plates. If single angle members are attached onto these plates, integrated finite element models should be developed and analyzed in detail accroding to NRC IEB 79-02. Such a detailed analysis may appear to be excessive to small bore pipe supports which have diverse design materials and frequently subjected to field changes requiring rapid revision. Consideration should be given to reviewing current practices and reducing the level of effort being used for the integrated analysis of support and CEA plate by developing consensus standard regarding reasonable support and CEA plate designs. In this paper, allowable piping loads for single angle members such as L2×2×1/4, L2-1/2×2-1/2×1/4, L3×3×3/8, and L4×4×1/2 welded on the 4-bolt CEA assembly are derived and reviewed for general use for small bore pipe support design, and L2-1/2×2-1/2×1/4 and L3×3×3/8 welded onto 4-bolt (3/8″Φ sleeve type) CEA plate (1/2″×9″×9″) are recommended as standard small bore pipe supports with post-installed anchor system in APR1400.