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Blache, Régis, and Éric Férard. "Newton stratification for polynomials: The open stratum." Journal of Number Theory 123, no. 2 (2007): 456–72. http://dx.doi.org/10.1016/j.jnt.2006.06.009.
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Hasanah, Niswatin. "Analisis Finansial Pendapatan Peternak Plasma Broiler Open House System PT X di Kabupaten Kediri." Jurnal Ilmu Peternakan Terapan 1, no. 2 (2018): 70–76. http://dx.doi.org/10.25047/jipt.v1i2.894.
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The study aimed to determine the production costs, revenue, earning, farming efisiency in terms of financial aspects. The farm efficiency can be obtained although R/C ratio, and BEP price during 6 production period of 30 plasma according to 3 scale enterprises. Birds stratum divided into stratum I (3.000–12.000 birds, n= 16), stratum II (12.001-21.000, n= 11), stratum III (21.001-30.000 birds, n= 3). The results indicated that the highest profit was strata III period 2 (Rp2,217.00/kg of live weight), the production cost was Rp14,700.00/kg of live weight (influenced by feed factor 75.7% and DOC 22.3%) and the revenue was Rp17,580.00 (consisted of affected by 98.8% broiler sales and bonus 0,57%) to produce 1 kilogram of live weight of broiler. In strata III period 2 the most efficient based on BEP price reached Rp15,252.00/kg broiler live weight and aspect R/C ratio was 1.17.
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Graham, C., I. Gatherar, I. Haslam, M. Glanville, and N. L. Simmons. "Expression and localization of monocarboxylate transporters and sodium/proton exchangers in bovine rumen epithelium." American Journal of Physiology-Regulatory, Integrative and Comparative Physiology 292, no. 2 (2007): R997—R1007. http://dx.doi.org/10.1152/ajpregu.00343.2006.
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Monocarboxylate-H+ cotransporters, such as monocarboxylate transporter (MCT) SLC16A, have been suggested to mediate transruminal fluxes of short-chain fatty acids, ketone bodies, and lactate. Using an RT-PCR approach, we demonstrate expression of MCT1 (SLC16A1) and MCT2 (SLC16A7) mRNA in isolated bovine rumen epithelium. cDNA sequence from these PCR products combined with overlapping expressed sequence tag data allowed compilation of the complete open reading frames for MCT1 and MCT2. Immunohistochemical localization of MCT1 shows plasma membrane staining in cells of the stratum basale, with intense staining of the basal aspects of the cells. Immunostaining decreased in the cell layers toward the rumen lumen, with weak staining in the stratum spinsoum. Immunostaining in the stratum granulosum and stratum corneum was essentially negative. Since monocarboxylate transport will load the cytosol with acid, expression and location of Na+/H+ exchanger (NHE) family members within the rumen epithelium were determined. RT-PCR demonstrates expression of multiple NHE family members, including NHE1, NHE2, NHE3, and NHE8. In contrast to MCT1, immunostaining showed that NHE1 was predominantly localized to the stratum granulosum, with a progressive decrease toward the stratum basale. NHE2 immunostaining was observed mainly at an intracellular location in the stratum basale, stratum spinosum, and stratum granulosum. Given the anatomic localization of MCT1, NHE1, and NHE2, the mechanism of transruminal short-chain fatty acid, ketone body, and lactate transfer is discussed in relation to a functional model of the rumen epithelium comprising an apical permeability barrier at the stratum granulosum, with a cell syncitium linking the stratum granulosum to the blood-facing stratum basale.
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Dorris, Kathleen, Melissa Widener, Vladimir Amani, et al. "EPCT-18. PHASE 0/I STUDY OF GM-CSF AND INTRATHECAL TRASTUZUMAB IN CHILDREN WITH RECURRENT POSTERIOR FOSSA EPENDYMOMA." Neuro-Oncology 22, Supplement_3 (2020): iii307. http://dx.doi.org/10.1093/neuonc/noaa222.140.
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Abstract BACKGROUND Posterior fossa ependymoma (PF EPN) is a pediatric central nervous system malignancy that has a poor outcome to standard therapeutic approaches. The majority of PF EPN tumors have increased HER2 expression. Trastuzumab is a monoclonal antibody that targets HER2, and sargramostim (GM-CSF) stimulates hematopoietic progenitor cell proliferation. The combination of trastuzumab and GM-CSF has been shown to trigger antibody-dependent cell cytotoxicity in vitro in PF EPN cell lines. METHODS Children aged 1–21 years with relapsed PF EPN and no ventriculoperitoneal shunt or CSF obstruction are eligible for the Phase 0/I institutional trial at Children’s Hospital Colorado. Stratum 1 involves IT trastuzumab and subcutaneous (subQ) GM-CSF prior to standard-of-care surgical resection. Stratum 2 involves a 3 + 3 phase I design with serial IT trastuzumab doses, each preceded by three days of GM-CSF, to establish the MTD for IT trastuzumab. RESULTS Trastuzumab was detected in a sufficient number of tumors after presurgical IT delivery in Stratum 1 to open Stratum 2. Four patients (75% female) have been enrolled in Stratum 2 at trastuzumab Dose Level 1. Median age at enrollment is 9.8 years (range, 3.5–20.2 years). Preliminary CSF pharmacokinetic analysis demonstrated detectable trastuzumab up to 14 days after IT doses. No dose-limiting toxicities have occurred. Two patients progressed on therapy (median, 4 cycles). One patient is progression-free at 18 months off therapy. One patient remains on study therapy. CONCLUSIONS IT trastuzumab penetrates PF EPN tumor tissue. Stratum 2 remains open to accrual at Dose Level 2.
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Riverin, Stéphane, and Réjean Gagnon. "Dynamique de la régénération d'une pessière à lichen dans la zone de la pessière noire à mousses, nord du Saguenay–Lac-Saint-Jean (Québec)." Canadian Journal of Forest Research 26, no. 8 (1996): 1504–9. http://dx.doi.org/10.1139/x26-168.
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Regeneration dynamics have been studied in three open lichen–spruce woodlands located in the black spruce feather-moss forest zone. Black spruces (Piceamariana (Mill.) BSP) belonging to the adult stratum originated from a fire that occurred in 1877. Population history and ecology has been studied on the basis of the establishment period of individuals. The age of black spruces belonging to the regeneration stratum was calculated by using the cross-dating method. The establishment period of the seedlings was determined by the age structure. The black spruces of these open forests belong to two different populations. The adult population originated from the 1877 fire whereas the regeneration population seems to have established itself following another fire that occurred in 1922–1923. Black spruce seedlings of the regeneration stratum are very old (60 years-old on average) in spite of a low height (mean height of 96 cm). Although these open forests are under favourable climatic conditions, they have dynamics similar to lichen–spruce woodlands of the taiga zone. In the last 45 years, no seedlings have settled in these sparse forests.
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Sakuragi, Mina, Emika Maeda, and Katsuki Kusakabe. "Penetration Process of a Hydrated Deep Eutectic Solvent Through the Stratum Corneum and its Application as a Protein Penetration Enhancer." ChemistryOpen 9, no. 9 (2020): 953–58. http://dx.doi.org/10.1002/open.202000114.
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Sharma, Vanita, and Satish Kumar. "Analysis of size dependency on Love-type wave propagation in a functionally graded piezoelectric smart material." Mathematics and Mechanics of Solids 25, no. 8 (2020): 1517–33. http://dx.doi.org/10.1177/1081286520909522.
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This study investigates Love-type wave propagation in a layered structure consisting of a functionally graded piezoelectric material (FGPEM) stratum followed by a semi-infinite couple-stress substrate exhibiting microstructural properties. Dispersion relations are obtained for electrically open and short conditions. Possible particular cases are discussed. The dispersion relation is reduced to the classical Love wave equation to validate the results. The influence of microstructural parameters, electromechanical coupling factor, thickness, functional gradedness and material parameters of the FGPEM stratum on the phase velocity of the Love-type wave has been scrutinized and illustrated graphically for electrically open and short conditions. The findings have meaningful practical application in the enhancement of efficiency and performance of sensors and transducers.
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Tolaney, Sara M., Kevin Kalinsky, Virginia G. Kaklamani, et al. "A phase Ib/II study of eribulin (ERI) plus pembrolizumab (PEMBRO) in metastatic triple-negative breast cancer (mTNBC) (ENHANCE 1)." Journal of Clinical Oncology 38, no. 15_suppl (2020): 1015. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.1015.
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1015 Background: As monotherapies, both ERI (a chemotherapeutic microtubule inhibitor) and PEMBRO (a programmed death [PD]-1 blocking immunotherapy) have shown promising antitumor activity in mTNBC. Emerging data suggest that the addition of immunotherapy to traditional chemotherapy holds promise for mTNBC. This open-label, single-arm, phase 1b/2 study evaluated the safety and efficacy of ERI + PEMBRO in mTNBC. Methods: Patients (pts) with mTNBC and ≤2 prior systemic anticancer therapies for metastatic disease were enrolled and stratified by prior number of therapy (Stratum 1, 0; Stratum 2, 1–2). Pts received IV ERI 1.4 mg/m2 on day (d)1 and d8 and IV PEMBRO 200 mg on d1 of a 21-d cycle. The primary objectives were safety and objective response rate (ORR per RECIST 1.1 by independent imaging review). Assessments also included efficacy outcomes by PD ligand-1 (PD-L1) expression status; PD-L1+ was defined as a combined positive score ≥1 using the PD-L1 IHC 22C3 pharmDx. Results: As of data cutoff (July 31, 2019), 167 pts (Stratum 1, n=66; Stratum 2, n=101) were enrolled and treated. No dose-limiting toxicities were observed. The most common treatment-emergent adverse events were fatigue (66%), nausea (57%), peripheral sensory neuropathy (41%), alopecia (40%), and constipation (37%). No deaths were considered treatment related. The overall ORR was 23.4% (95% CI: 17.2–30.5). Efficacy outcomes by PD-L1 status (PD-L1+, n=74; PD-L1-, n=75) and stratum are presented (table). Conclusions: ERI + PEMBRO has activity in pts with mTNBC. There was a trend toward more robust activity for the combination among patients with PD-L1+ tumors compared to PD-L1- tumors in the first-line setting (Stratum 1); whereas, in the later-line setting (Stratum 2) similar survival outcomes were observed among the PD-L1+ and PD-L1- pts. ERI + PEMBRO shows promise for mTNBC with efficacy that appears greater than historical reports of either agent alone. Clinical trial information: NCT02513472 . [Table: see text]
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Gisslinger, Heinz, Mary Frances McMullin, Nadja Jaekel, et al. "A phase Ib, open-label, dose-finding study of ruxolitinib in patients (pts) with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF), or post-essential thrombocythemia-myelofibrosis (PET-MF) and baseline platelets (PLTs) 50 to <100 x 109/l." Journal of Clinical Oncology 30, no. 15_suppl (2012): TPS6642. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.tps6642.
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TPS6642^ Background: Ruxolitinib, a potent and selective oral JAK1/2 inhibitor, has demonstrated rapid and durable reductions in splenomegaly and improved MF-related symptoms and quality of life in 2 phase 3 studies in pts with PMF, PPV-MF, or PET-MF. There is considerable experience in pts who develop thrombocytopenia on study, and ruxolitinib is well-tolerated with dose adjustment. However, there is limited experience in pts with baseline thrombocytopenia as those with low PLTs (< 100 x 109/L) were excluded from the phase 3 protocols. EXPAND (Evaluating RuXolitinib in Patients with Low Baseline PlAtelet CouNts Diagnosed With Myelofibrosis) will evaluate the safety of ruxolitinib and establish the maximum safe starting dose (MSSD) in thrombocytopenic pts with MF. Methods: This is a phase 1b, open-label, dose-finding study (NCT01317875) in pts with PMF, PPV-MF, or PET-MF and baseline PLT 50-100 x 109/L. A Bayesian logistic regression model with escalation with overdose control will be used to guide dose-escalation decisions. The study consists of 2 phases: dose-escalation and safety-expansion. The starting dose is ruxolitinib 5 mg twice daily (BID) with a maximum of 15 mg BID. In the dose-escalation phase, cohorts will be: 5 mg BID, 5 mg am/10 mg pm, 10 mg BID, 10 mg am/15 mg pm, and 15 mg BID; only pts with PLT 75-100 x 109/L (1st stratum) will initially be enrolled. Once safety is established at the first 2 dose levels (5 mg BID; 5 mg am/10 mg pm), pts with PLT 50-75 x 109/L will be included (2nd stratum). Each dose level in the 2nd stratum will be open only if both that dose and the following one are deemed safe in the 1st stratum. In the safety-expansion phase, 20 pts (10 from each stratum) additional to those treated at the MSSD during dose escalation will be treated at the respective MSSD for their stratum. In cohort 1 (n = 4), 3 pts were evaluable as they completed > 28 days of treatment; 1/4 pts discontinued after 6 doses due to disease progression. No dose-limiting toxicities were observed. The second cohort (5 mg am/10 mg pm) has completed enrollment (n = 3) and is ongoing.
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Harrison, Claire N., Heinz Gisslinger, Carole B. Miller, et al. "Expand: a Phase 1b, Open-Label, Dose-Finding Study of Ruxolitinib in Patients with Myelofibrosis and Baseline Platelet Counts Between 50 × 109/L and 99 × 109/L." Blood 120, no. 21 (2012): 177. http://dx.doi.org/10.1182/blood.v120.21.177.177.
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Abstract Abstract 177 Background: Ruxolitinib (rux) is a potent oral JAK1 and JAK2 inhibitor that has demonstrated superiority over traditional therapies for the treatment of myelofibrosis (MF). In the two phase 3 COMFORT studies, rux demonstrated rapid and durable reductions in splenomegaly and improved MF-related symptoms and quality of life. Although there has been considerable experience in patients (pts) who developed thrombocytopenia in the COMFORT studies, there has been limited experience in pts with baseline thrombocytopenia as those with platelet counts (PLTs) < 100 × 109/L were excluded. The aims of EXPAND are to evaluate the safety of rux and to establish the maximum safe starting dose (MSSD) in thrombocytopenic MF pts. Methods: Phase 1b, open-label, dose-finding study (NCT01317875) in pts with PMF, PPV-MF, or PET-MF and baseline PLTs 50–99 × 109/L. A Bayesian logistic regression model will be used to guide dose-escalation decisions; intra-pt dose modification is allowed during the study. The study consists of 2 phases: dose escalation and safety expansion. Starting dose of rux is 5 mg bid with a maximum of 15 mg bid. In the dose-escalation phase, cohorts will be: 5 mg bid, 5 mg AM/10 mg PM, 10 mg bid, 10 mg AM/15 mg PM, and 15 mg bid. Pts are assigned to 1 of 2 strata based on their baseline PLTs: stratum 1, 75–99 × 109/L; stratum 2, 50–74 × 109/L. Each dose level in the second stratum will be open only if both that dose and the following one are deemed safe in the first stratum. In the safety-expansion phase, 20 additional pts (10 in each stratum) will be treated at the respective MSSD for their stratum. Results: 14 pts (PMF, n = 10; PPV-MF, n = 3; PET-MF, n = 1) have been enrolled in 4 cohorts: 4 pts in stratum 1/cohort 1 (5 mg bid), 3 in stratum 1/cohort 2 (5 mg AM/10 mg PM), 4 in stratum 1/cohort 3 (10 mg bid), and 3 in stratum 2/cohort 1 (5 mg bid). At baseline, all pts had an ECOG performance status of 0–2, and spleen length ranged from 5–30 cm below the costal margin. 12 pts have completed > 28 days of treatment and are evaluable. 2 pts were nonevaluable: 1 pt discontinued at day 6 due to granulocytic sarcoma, and 1 pt took an incorrect dosage from day 1 to 7 but treatment is ongoing. Reported adverse events (AEs) were similar to those previously seen with rux. 7 pts experienced grade 3/4 AEs (only 2 anemia events were study-drug related), and 4 pts experienced serious AEs (Table). The majority of hemoglobin and absolute neutrophil count (ANC) abnormalities were grade 1 or 2. No pt had a grade 4 decrease in PLTs or ANC; 2 pts experienced a grade 4 decrease in hemoglobin. No pt discontinued due to anemia, neutropenia, or thrombocytopenia. No hemorrhagic events were observed. The lowest PLTs across all pts ranged from 29–96 × 109/L. No dose-limiting toxicities (DLTs) were observed. Reductions in spleen length were reported for all 12 evaluable pts and 1 ongoing nonevaluable pt. Splenomegaly completely resolved in 3 pts. Spleen length reductions were rapid and occurred within the first few weeks of therapy. Conclusions: In this study, no DLT has occurred with the first 3 dose levels in pts with PLTs 75–99 × 109/L or with the first dose level in pts with PLTs 50–74 × 109/L. Rux was generally well tolerated, similar to results reported in previous studies, and no pt has discontinued because of thrombocytopenia. The study is ongoing, and additional pts are being recruited for both strata. Pts are receiving dose levels approaching those approved for nonthrombocytopenic MF pts. Disclosures: Harrison: Novartis: Honoraria, Research Funding, Speakers Bureau; YM Bioscience: Consultancy, Honoraria; Sanofi Aventis: Honoraria; Shire: Honoraria, Research Funding. Gisslinger:Novartis: Consultancy, Research Funding, Speakers Bureau; Celgene: Consultancy, Research Funding, Speakers Bureau; AOP Orphan Pharmaceuticals AG: Consultancy, Speakers Bureau. Miller:Novartis: Consultancy, Research Funding, Speakers Bureau, development of educational presentations Other; Incyte: development of educational presentations, development of educational presentations Other. Kiladjian:Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Shire: Membership on an entity's Board of Directors or advisory committees; Incyte: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding. Atienza:Novartis Pharmaceuticals Corporation: Employment. Stalbovskaya:Novartis Pharma AG: Employment, Equity Ownership. Sirulnik:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Al-Ali:Sanofi Aventis: Consultancy, Honoraria; Celgene: Honoraria, Research Funding; Novartis: Consultancy, Honoraria. McMullin:Novartis: Honoraria; Bristol-Myers Squibb: Honoraria; Shire: Honoraria. Verstovsek:Incyte Corporation: Research Funding. Vannucchi:Novartis: Membership on an entity's Board of Directors or advisory committees.
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Morschhauser, F., D. Huglo, G. Martinelli, et al. "Yttrium-90 Ibritumomab Tiuxetan (Zevalin) for Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Not Appropriate for Autologous Stem Cell Transplantation: Results of an Open-Label Phase II Trial." Blood 104, no. 11 (2004): 130. http://dx.doi.org/10.1182/blood.v104.11.130.130.
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Abstract Presently, there is no standard second-line regimen for patients (pts) with diffuse large B-cell lymphoma (DLBCL) who cannot undergo stem cell transplantation. Since yttrium-90 (90Y) ibritumomab tiuxetan (Zevalin) is highly active in pts with follicular lymphoma, we wished to establish whether it is also effective in pts with relapsed DLBCL. We therefore conducted a prospective, single-arm, open-label, non-randomized, multicenter phase II trial to evaluate the efficacy and safety of 90Y ibritumomab tiuxetan in elderly pts with histologically confirmed first relapsed or primary refractory DLBCL not appropriate for autologous stem cell transplantation. Pts were divided into 2 groups: those previously treated with chemotherapy alone [Group A, n=76], and those previously treated with chemotherapy and rituximab [Group B, n=28]. Pts in Group A were further divided into 3 strata: pts with primary refractory disease (stratum 1, n= 33), pts relapsing within a year from presentation (stratum 2, n=10), and those relapsing more than 1 year from presentation (stratum 3, n=33). All pts were to receive a single dose of 90Y ibritumomab tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). The primary endpoint was overall response (ORR) assessed by using IWNHL criteria at Weeks 6, 12, and 24. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). 104 pts were included. Three pts progressed after the first rituximab dose and in 1 patient the 111In labeling procedure failed; 103 pts were evaluable for efficacy and 104 for safety. An ORR of 44% was observed in the entire study population. In Group A, the ORR was 52% in stratum 1, 40% in stratum 2, 58% in stratum 3. In Group B, where 37% of pts were refractory to CHOP-rituximab, the ORR was 19%. The median PFS was 5.9, 2.3, and 6.2 months in strata 1, 2, 3 of Group A, respectively; the median PFS for Group B was 1.6 months. Median OS in Group A was 22.4 months in stratum 3 and has not yet been reached at a maximum follow-up time of 32 months in strata 1&2. Median OS was 4.5 months for Group B. Adverse events (AEs) with the exception of hematologic AEs were generally mild or moderate (CTC grade 1 and 2). There were 4 deaths due to SAEs. Three pts died of suspected cerebral hemorrhage, preceded by CTC grade 4 thrombocytopenias; another died of bleeding from a duodenal ulcer 280 days after the start of study medication, but this AE was determined not to be related to the study drug. The incidence of severe infection is low with 7% of pts hospitalized for infection during the study. In conclusion, 90Y ibritumomab tiuxetan has useful activity in the treatment of relapsed/refractory DLBCL, with no unexpected toxicities observed. The results of this study support a further evaluation of 90Y ibritumomab tiuxetan in combination with chemotherapy or immuno-chemotherapy earlier in the time course of DLBCL.
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张, 乾辉. "Study on Excavation Scheme of Multi Chamber Open Caisson in Uneven Silt Stratum." Hans Journal of Civil Engineering 09, no. 10 (2020): 1014–23. http://dx.doi.org/10.12677/hjce.2020.910106.
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Valtonen, Kathleen. "Bread and Tea: A Study of the Integration of Low-Income Immigrants from Other Caribbean Territories into Trinidad." International Migration Review 30, no. 4 (1996): 995–1019. http://dx.doi.org/10.1177/019791839603000406.
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This study examines immigrant integration in the low socioeconomic stratum in Trinidad. Integration is operationalized as participation in overlapping societal spheres. The study also focuses on corollary aspects of access and goals. While several factors facilitated participation in the social sphere, labor market participation was inhibited by conditions of open unemployment and underemployment. These exigencies had elicited strategies of subsistence from first generation immigrants whose work-related attitudes, ethics, and wage expectation levels functioned to their advantage and led to their competitiveness in a difficult labor market. Some of the second generation were disengaging themselves from their parents’ level of labor market activity but relocating farther from the mainstream labor market into a marginalized peer stratum.
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Thakur, Neha, Prabhat Jain, and Vivek Jain. "FORMULATION DEVELOPMENT AND EVALUATION OF TRANSFEROSOMAL GEL." Journal of Drug Delivery and Therapeutics 8, no. 5 (2018): 168–77. http://dx.doi.org/10.22270/jddt.v8i5.1826.
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Transfersomes are particularly optimized, ultradeformable (ultraflexible) lipid supramolecular aggregates, which are able to penetrate the mammalian skin intact. Transfersome is a type of carrier system which is capable of transdermal delivery of low as well as high molecular weight drugs. Transfersomes penetrate through the pores of stratum corneum which are smaller than its size and get into the underlying viable skin in intact form. Acne vulgaris is a disease of the pilosebaceous follicle characterized by non-inflammatory (open and closed comedones) and inflammatory lesions (papules, pustules, and nodules). In such situation transdermal drug delivery remains the most preferential mode of administration. But, stratum corneum forms the most formidable barrier for the penetration of drug through skin. To overcome the stratum corneum barrier, the use of lipid vesicles like transfersomes in delivery systems has involved increasing attention in recent years. The aim of the present study was to statistically optimize the vesicular formulations (Transfersomes) for enhanced skin delivery of a model drug Clindamycin Phosphate.
 Keywords: Transfersomes, Acne vulgaris, Clindamycin Phosphate
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Mueller, Daniel Wilhelm, Thorsten Oliver Goetze, Akin Atmaca, et al. "The "INSIGHT" Trial: Two new strata of an explorative, open-labeled phase I study evaluating the feasibility and safety of subcutaneous IMP321 injections (LAG-3Ig fusion protein, eftilagimod alpha) combined with either standard-of-care drug therapy or PD-L1 inhibition (avelumab) in advanced-stage solid tumor entities." Journal of Clinical Oncology 37, no. 15_suppl (2019): TPS2651. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps2651.
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TPS2651 Background: The two new strata of the INSIGHT trial evaluate feasibility and safety of s.c. injections of IMP321 (eftilagimod alpha) in combination with either SOC first/second-line drug therapy (Stratum C) or in combination with an PD-L1 inhibitor (avelumab; Stratum D) in advanced stage solid tumors as well as to generate first efficacy data. This proof-of-concept data could build the basis for further clinical studies exploring the therapeutic potential of combinations of active immunotherapy using IMP321 with SOC drug therapies or immunotherapies targeting the PD-1/PD-L1 axis in various solid tumor entities. IMP321 is a MHC class II agonist that activates antigen-presenting cells (primary target cells) and then CD8 T cells (secondary target cells). Activation of the dendritic cell network and subsequent T cell recruitment at the tumor site with IMP321 may lead to enhanced anti-tumor CD8 T cell responses. Thus, especially combinations with PD-1/PD-L1 inhibitors might display interesting effects by activating immune cells and disabling immune inhibitory mechanisms at the same time. Methods: This is a prospective investigator initiated phase I trial consisting of four strata. New stratum C: Patients with solid tumors treated with SOC chemo- or targeted therapy in first or second line receive concomitant s.c. IMP321 injections. This combination is aimed to enhance the immune response against tumor cells compared to chemo-/targeted SOC therapy alone. New stratum D: Patients will receive avelumab i.v. q2w along with s.c. IMP321 injections. This combination is aimed to enhance efficacy by combining IMP321’s activating effects on immune cells with the release of immune inhibitory effects caused by interruption of the PD-1/PD-L1 axis. It is planned to enroll 20 patients in Stratum C and 12 patients in stratum D. Main efficacy endpoint is the overall response rate (RECIST 1.1). Overall recruitment has started; currently (Feb 2019) 14 patients have been enrolled. EudraCT: 2016-002309-20. Clinical trial information: NCT03252938.
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Zheng, Yangxing, George N. Kiladis, Toshiaki Shinoda, et al. "Upper-Ocean Processes under the Stratus Cloud Deck in the Southeast Pacific Ocean." Journal of Physical Oceanography 40, no. 1 (2010): 103–20. http://dx.doi.org/10.1175/2009jpo4213.1.
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Abstract The annual mean heat budget of the upper ocean beneath the stratocumulus/stratus cloud deck in the southeast Pacific is estimated using Simple Ocean Data Assimilation (SODA) and an eddy-resolving Hybrid Coordinate Ocean Model (HYCOM). Both are compared with estimates based on Woods Hole Oceanographic Institution (WHOI) Improved Meteorological (IMET) buoy observations at 20°S, 85°W. Net surface heat fluxes are positive (warming) over most of the area under the stratus cloud deck. Upper-ocean processes responsible for balancing the surface heat flux are examined by estimating each term in the heat equation. In contrast to surface heat fluxes, geostrophic transport in the upper 50 m causes net cooling in most of the stratus cloud deck region. Ekman transport provides net warming north of the IMET site and net cooling south of the IMET site. Although the eddy heat flux divergence term can be comparable to other terms at a particular location, such as the IMET mooring site, it is negligible for the entire stratus region when area averaged because it is not spatially coherent in the open ocean. Although cold-core eddies are often generated near the coast in the eddy-resolving model, they do not significantly impact the heat budget in the open ocean in the southeast Pacific.
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Forrest, Suzanne J., Joanna Yi, Cassie Kline, et al. "Phase II study of nivolumab and ipilimumab in children and young adults with INI1-negative cancers." Journal of Clinical Oncology 39, no. 15_suppl (2021): TPS10055. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.tps10055.
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TPS10055 Background: Several aggressive pediatric and young adult cancers are characterized by SMARCB1 inactivation resulting in loss of INI1 expression, including rhabdoid tumors, epithelioid sarcoma and undifferentiated chordoma. These malignancies are associated with a poor prognosis and few effective treatment options for relapsed or refractory disease. Prior studies and emerging data suggest INI1-negative cancers may be uniquely susceptible to treatment with immune checkpoint inhibitors: Many INI1-negative pediatric tumors express PD-L1 and are infiltrated by immune cells, and there are reports of patients with advanced INI1-negative cancers with clinical responses to immune checkpoint blockade (Forrest et al. Clinical Cancer Research, 2020). We hypothesize that INI1 loss predicts tumor response to immune checkpoint inhibition (ICI). Methods: This is an ongoing multicenter, phase II, open-label clinical trial to evaluate the activity of nivolumab and ipilimumab in patients aged 6 months to 30 years with relapsed or refractory INI1-negative cancers (NCT04416568). The study enrolls patients in 2 strata: extracranial solid tumors in Stratum 1 and intracranial solid tumors in Stratum 2. Patients treated with prior ICI are excluded. Patients are treated with intravenous (IV) nivolumab 3mg/kg plus ipilimumab 1mg/kg IV every 3 weeks for 4 cycles followed by nivolumab 3mg/kg (max dose 240mg) IV every 2 weeks for up to 1-year. The primary objective is to evaluate the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) for Stratum 1 and by Response Assessment in Neuro-Oncology (RANO) criteria for Stratum 2. The trial has a 2-stage design targeting a 25% or greater response rate, with each stratum assessed independently. The analysis for Stage 1 in a given Stratum will be performed after 10 patients are enrolled. If a sufficient number of responders are observed, an additional 10 patients will be enrolled at Stage 2. Secondary endpoints include progression-free survival, overall survival, and disease control rate at 12 months. Correlative aims include assessing tissue and blood biomarkers associated with treatment response. Enrollment began 14 Aug 2020 and is ongoing. Clinical trial information: NCT04416568.
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Etherington, Rohan, and Alison Shapcott. "Do habitat fragmentation and fire influence variation of plant species composition, structure and diversity within three regional ecosystems on the Sunshine Coast, Queensland, Australia?" Australian Journal of Botany 62, no. 1 (2014): 36. http://dx.doi.org/10.1071/bt13232.
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Habitat fragmentation is considered to be one of the greatest threats to biodiversity. Species richness is predicted to decrease with decreasing patch size and increasing isolation, and this has been shown in some ecosystems. However, few studies have specifically investigated the effects of fragmentation on specific vegetation types, or compared different vegetation types within the same region. In this study, we assessed the influence of habitat fragmentation and time since fire on the floristic composition, structure and diversity of three ecosystems with varying fire proneness within the Sunshine Coast region. This study found that the tall-open forest ecosystem (RE 12.9-10.14) had higher overall species richness within fixed sample areas used for this study than did either open forest (RE 12.5.3) or gallery rainforest (RE 12.3.1), because it was composed of species typical of each of these ecosystem types. Open forest species richness was found mostly in the lower stratum, whereas gallery rainforest diversity was found in the upper stratum. Species richness decreased with increasing isolation in the open forest ecosystem where seeds are mostly abiotically dispersed. However, this study did not find strong evidence for reduced species richness within smaller patches in any ecosystem type studied; instead, finding species richness decreased with increasing patch size in the open forest ecosystem. Overall, across ecosystems, time since fire affected vegetation structure, but in fire-prone ecosystems, time since fire was not a determinant of species richness within the sites studied.
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Kitchigina, Valentina F. "Theta Oscillations and Reactivity of Hippocampal Stratum Oriens Neurons." Scientific World JOURNAL 10 (2010): 930–43. http://dx.doi.org/10.1100/tsw.2010.90.
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The supposition was advanced that the neuronal theta rhythmicity is the key mode of signal selection at the hippocampal level. To address this hypothesis, the experimental data on the responses of putative hippocampal interneurons of the stratum oriens CA1-CA3 to stimulation during enhanced theta rhythm and after its blockade are reviewed. Both a strong increase and a decrease of the natural theta rhythm disturbed the reactions of hippocampal neurons; during theta augmentation, the responses were masked or disappeared, and after theta blockade, they lost the ability to habituate. In both cases, two important events were broken: the resetting of the background activity and the phase-locking of theta cycles to stimulus. These data allow one to suppose that only important stimuli are normally capable to evoke these events and these stimuli are selected for recording. When the response to a significant stimulus occurs, the following theta prevents the responses to other stimuli. This probably protects the hippocampal activity from interference from irrelevant signals. Presumably, the absence of the theta deprives the hippocampus of this protection. During enhanced and persistent theta oscillations, the reset disappeared and theta bursts were generated without stimulus locking. In this state, the system is probably closed and the information cannot be recorded. During the theta blockade, the reset was too long and did not habituate. In this case, the system is open for any signals and the hippocampus loses the ability to select signal. This analysis suggests that information selection in the hippocampus may be performed with the participation of nonpyramidal neurons.
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Liu, Jianjun, Linzhi Zhang, and Jinzhou Zhao. "Numerical Simulation on Open Wellbore Shrinkage and Casing Equivalent Stress in Bedded Salt Rock Stratum." Scientific World Journal 2013 (2013): 1–5. http://dx.doi.org/10.1155/2013/718196.
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Most salt rock has interbed of mudstone in China. Owing to the enormous difference of mechanical properties between the mudstone interbed and salt rock, the stress-strain and creep behaviors of salt rock are significantly influenced by neighboring mudstone interbed. In order to identify the rules of wellbore shrinkage and casings equivalent stress in bedded salt rock stratum, three-dimensional finite difference models were established. The effects of thickness and elasticity modulus of mudstone interbed on the open wellbore shrinkage and equivalent stress of casing after cementing operation were studied, respectively. The results indicate that the shrinkage of open wellbore and equivalent stress of casings decreases with the increase of mudstone interbed thickness. The increasing of elasticity modulus will reduce the shrinkage of open wellbore and casing equivalent stress. Research results can provide the scientific basis for the design of mud density and casing strength.
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Son, Moorak. "Earth pressure on the support system in jointed rock mass." Canadian Geotechnical Journal 50, no. 5 (2013): 493–502. http://dx.doi.org/10.1139/cgj-2012-0147.
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This paper investigates the magnitude and distribution of earth pressure on a support system in open cuts in jointed rock mass for the safer and more economical design and construction of earth-retaining structures installed in a rock stratum. The paper first investigates the limitations of previous research on earth pressure and then addresses them to provide a numerical parametric study based on the discrete element method, which can consider the joint characteristics of a rock stratum. The controlled parameters include rock type, joint conditions (shear strength and angle of joints), and wall type. The magnitude and distribution of earth pressure are investigated based on interactions between the ground and the retaining structure. In addition, earth pressure in the rock stratum is compared with Peck's earth pressure for soil ground. The results indicate that the magnitude and distribution of earth pressure in jointed rock mass are strongly influenced by rock type, joint conditions, and wall type, and that this pressure can be very different from that in soil ground. Furthermore, the results of numerical tests are compared with field measurements, and the comparison shows a reasonable agreement. This paper provides useful data for the assessment of earth pressure in designing support systems for jointed rock mass.
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Yao, James C., Catherine Lombard-Bohas, Eric Baudin, et al. "Daily Oral Everolimus Activity in Patients With Metastatic Pancreatic Neuroendocrine Tumors After Failure of Cytotoxic Chemotherapy: A Phase II Trial." Journal of Clinical Oncology 28, no. 1 (2010): 69–76. http://dx.doi.org/10.1200/jco.2009.24.2669.
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PurposeNo established treatment exists for pancreatic neuroendocrine tumor (NET) progression after failure of chemotherapy. Everolimus (RAD001), an oral inhibitor of mammalian target of rapamycin, in combination with octreotide has demonstrated encouraging antitumor activity in patients with NETs.Patients and MethodsThis open-label, phase II study assessed the clinical activity of everolimus in patients with metastatic pancreatic NETs who experienced progression on or after chemotherapy. Patients were stratified by prior octreotide therapy (stratum 1: everolimus 10 mg/d, n = 115; stratum 2: everolimus 10 mg/d plus octreotide long-acting release [LAR], n = 45). Tumor assessments (using Response Evaluation Criteria in Solid Tumors) were performed every 3 months. Chromogranin A (CgA) and neuron-specific enolase (NSE) were assessed monthly if elevated at baseline. Trough concentrations of everolimus and octreotide were assessed.ResultsBy central radiology review, in stratum 1, there were 11 partial responses (9.6%), 78 patients (67.8%) with stable disease (SD), and 16 patients (13.9%) with progressive disease; median progression-free survival (PFS) was 9.7 months. In stratum 2, there were two partial responses (4.4%), 36 patients (80%) with SD, and no patients with progressive disease; median PFS was 16.7 months. Patients with an early CgA or NSE response had a longer PFS compared with patients without an early response. Coadministration of octreotide LAR and everolimus did not impact exposure to either drug. Most adverse events were mild to moderate and were consistent with those previously seen with everolimus.ConclusionDaily everolimus, with or without concomitant octreotide LAR, demonstrates antitumor activity as measured by objective response rate and PFS and is well tolerated in patients with advanced pancreatic NETs after failure of prior systemic chemotherapy.
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Chung, Jae Keun. "Comparison between time-domain and spectral-domain OCT in the detection of retinal nerve fiber layer defects in glaucoma patients." International Eye Research 1, no. 2 (2020): 89–94. http://dx.doi.org/10.18240/ier.2020.02.05.
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AIM: To compare, using the instruments’ built-in normative databases, the sensitivities of time-domain optical coherence tomography (Stratus OCT) and spectral-domain OCT (Spectralis OCT) in the detection of retinal nerve fiber layer (RNFL) defects in patients with glaucoma. METHODS: Fifty-two eyes of 35 patients with open angle glaucoma were included. A total of 69 hemiretinas with photographically identified RFNL defects were analyzed using the fast RNFL scan of Stratus OCT and the circle scan in Spectralis OCT. The OCT parameters were evaluated at 5% and 1% abnormality levels using the instruments’ built-in normative databases. The diagnostic sensitivity of each parameter was compared between the two devices. RESULTS: The Spectralis OCT detected RNFL defects within each quadrant more frequently than the Stratus OCT at both the 5% (79.7% vs 63.8%, P=0.01) and 1% (56.5% vs 40.6%, P=0.01) abnormality levels. At the 1% abnormality level, the sensitivity was significantly higher in the standard sector of Spectralis OCT than in the clock-hour sector of the Stratus OCT (68.1% vs 39.1%, P<0.01).
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RAFAEL, JOSÉ A., DAYSE W. A. MARQUES, and FRANCISCO LIMEIRA-DE-OLIVEIRA. "Atriadops macula (Wiedemann) inhabiting the canopy: the first record of Nemestrinidae (Diptera) in the Amazon Basin." Zootaxa 4722, no. 5 (2020): 486–90. http://dx.doi.org/10.11646/zootaxa.4722.5.7.
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This is the first record of the family Nemestrinidae in the Amazon Basin, based on three females identified as Atriadops macula (Wiedemann, 1824). The specimens were collected in the canopy using flight interception traps. This species was previously known to inhabit understory open areas. The canopy, the new habitat record, is an open area stratum with higher insolation, higher temperature and less humidity. As the adults of A. macula have the mouthparts greatly reduced, they probably do not feed and their occurrence in the canopy probably is more likely related to the distribution of their hosts as well as the environmental factors.
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Zhang, Fei, Jing Cao, and Hai Ming Liu. "Research on the Failure Mechanism of Bedding High Rock Slope at an Open-Pit Mine." Advanced Materials Research 671-674 (March 2013): 266–73. http://dx.doi.org/10.4028/www.scientific.net/amr.671-674.266.
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The bedding high rock slope is most likely to failure in the rock slopes. It is the sliding and bending deformation model (buckling failure) according to deformation characteristic of the north wing slope at the open-pit mine. Considering the influence of rocky self-weight, seismic force and groundwater, the failure mechanism of bedding high rock slope by energy method is researched on the basis of stability theory for elastic plane. And the critical length is obtained. Finally, the influences of model geometry on the critical length, such as the rock stratum dip angle, thickness and width length ratio, is analyzed.
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Fedoriak, Mariia, Oleksandr Kulmanov, Alina Zhuk, et al. "Stakeholders’ views on sustaining honey bee health and beekeeping: the roles of ecological and social system drivers." Landscape Ecology 36, no. 3 (2021): 763–83. http://dx.doi.org/10.1007/s10980-020-01169-4.
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Abstract Context Honey bees provide multiple ecosystem services. Comparisons of coupled social-ecological systems (SES) can improve the understanding of the factors affecting honey bees and beekeeping. Objectives Stressing the need for SES analyses, we explore beekeepers’ perceived factors affecting bees and beekeeping, test the hypothesis that honey bee colony losses are associated to agricultural land use intensity, and discuss the role of beekeeping for rural development. Methods We used as a case study the steep gradient in SES in Ukraine’s Chernivtsi region with three strata: (i) traditional villages, (ii) intermediate and (iii) intensive agriculture. In each stratum, we analysed the social system using five open-ended focus groups. Regarding the ecological system, we analysed data about winter loss rate of honey bee colonies, number of colonies per beekeeper, the average amount of supplemental feeding, and proportion of beekeepers treating against Varroa mite. Results Thirty-three themes were extracted, of which 73% concerned the social system at multiple levels of governance. The number of themes increased from the traditional stratum with higher winter colony losses to the intensive agriculture stratum with lower losses. This does not support the hypothesis that the intensive agriculture per se affect honey bees negatively. Conclusions Social system factors dominate over ecological factors, and interact across scales. This requires systems analyses of honey bees and beekeeping. We see beekeeping as a social innovation enhancing stakeholders’ navigation in social systems, thus supporting rural development in countries in transition like Ukraine.
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Tan, Wenhui, P. H. S. W. Kulatilake, and Hongbao Sun. "Influence of an Inclined Rock Stratum on In-Situ Stress State in an Open-Pit Mine." Geotechnical and Geological Engineering 32, no. 1 (2013): 31–42. http://dx.doi.org/10.1007/s10706-013-9689-4.
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Awada, Ahmad, Javier Cortes, Miguel Martin, et al. "A phase II trial of trabectedin (T) in patients with hormone receptor-positive, HER2-negative advanced breast cancer, according to xeroderma pigmentosum gene (XPG) expression." Journal of Clinical Oncology 30, no. 15_suppl (2012): TPS652. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.tps652.
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TPS652 Background: Hormone receptor-positive, HER2-negative breast cancer (BC) is currently associated with 3-4 years overall survival in the metastatic setting and, after ≥2 relapses, therapeutic approaches are reduced. XPG expression is frequently modified in BC. T is a cytotoxic agent that forms a complex with the XPG, inducing cell apoptosis. As a single agent, T has shown anti-tumor activity in patients with poor prognosis BC, and a better response to T in BC patients with XPG RNA overexpression has been observed. Methods: This is an open-label, phase II study of T (1.3 mg/m2 in 3-hour intravenous infusion every 3 weeks) in patients with hormone receptor-positive, HER2-negative advanced BC, according to their primary tumor’s XPG expression. Primary endpoint: to evaluate the efficacy of T in terms of progression free survival rate at 4 months (PFS4) according to the patient’s XPG expression. Secondary endpoints: Comparison of PFS, overall response rate, duration of response, overall survival and safety profile in XPG-high and XPG-low patients. Assignment: BC patients who have previously received anthracyclins and/or taxanes and who progressed after 2-5 chemotherapy lines will be assigned according to their XPG expression from paraffin embedded tumor samples to stratum A (XPG-high [>3]) or to stratum B (XPG-low [≤3]) (threshold was selected from median XPG expression values observed in a previous trial). Statistical methods: A two-stage design was chosen: at a first stage 20 patients will be enrolled in each stratum. A futility analysis (O’Brien Fleming boundary) based on the primary endpoint (PFS4) will be conducted once 40 evaluable patients have been recruited. If ≥ 7 out of 20 patients achieve PFS4, recruitment will continue to a maximum sample size of 50 evaluable patients per stratum. If ≥ 22 out of 50 patients achieve PFS4, T will be considered active in this group (alpha error: 0.025, power: 80%). To date, 35 patients (16 XPG-high and 15 XPG-low) have been enrolled from three countries and five centers. Recruitment is ongoing.
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Bendix, Jörg, Boris Thies, Jan Cermak, and Thomas Nauß. "Ground Fog Detection from Space Based on MODIS Daytime Data—A Feasibility Study." Weather and Forecasting 20, no. 6 (2005): 989–1005. http://dx.doi.org/10.1175/waf886.1.
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Abstract The distinction made by satellite data between ground fog and low stratus is still an open problem. A proper detection scheme would need to make a determination between low stratus thickness and top height. Based on this information, stratus base height can be computed and compared with terrain height at a specific picture element. In the current paper, a procedure for making the distinction between ground fog and low-level stratus is proposed based on Moderate Resolution Imaging Spectroradiometer (MODIS, flying on board the NASA Terra and Aqua satellites) daytime data for Germany. Stratus thickness is alternatively derived from either empirical relationships or a newly developed retrieval scheme (lookup table approach), which relies on multiband albedo and radiative transfer calculations. A trispectral visible–near-infrared (VIS–NIR) approach has been proven to give the best results for the calculation of geometrical thickness. The comparison of horizontal visibility data from synoptic observing (SYNOP) stations of the German Weather Service and the results of the ground fog detection schemes reveals that the lookup table approach shows the best performance for both a valley fog situation and an extended layer of low stratus with complex local visibility structures. Even if the results are very encouraging [probability of detection (POD) = 0.76], relatively high percentage errors and false alarm ratios still occur. Uncertainties in the retrieval scheme are mostly due to possible collocation errors and known problems caused by comparing point and pixel data (time lag between satellite overpass and ground observation, etc.). A careful inspection of the pixels that mainly contribute to the false alarm ratio reveals problems with thin cirrus layers and the fog-edge position of the SYNOP stations. Validation results can be improved by removing these suspicious pixels (e.g., percentage error decreases from 28% to 22%).
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Zhao, Zhong Guo, Pei Ling Zhao, Xiao Long Wu, and Chun Lei Xu. "The Study of Failure Status and Treatment Methods of Open-Mining Rock Slope in Chongqing." Applied Mechanics and Materials 353-356 (August 2013): 1297–302. http://dx.doi.org/10.4028/www.scientific.net/amm.353-356.1297.
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Open-mining forms high steep rock slope, slope stability is affected by geological environment, structure, stratum, lithology, hydro-geology, rock structure, structural plane appearance, slope azimuth with spatial combination relations. After mining the bared slope with weathering, due to heavy rainfall, earthquake and other factors causes secondary disasters and serious impact on people's life and property safety. This paper is based on a comprehensive investigation, statistic and classification of the status quo and failure patterns of the rock slope and treatment method is simulated and analyzed, pros and cons of various treatment methods were compared, to provide the decision-making reference for similar mines management, and basis of theory and practice , to build green mines and sustainable environment.
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Kay, J. E., K. Raeder, A. Gettelman, and J. Anderson. "The Boundary Layer Response to Recent Arctic Sea Ice Loss and Implications for High-Latitude Climate Feedbacks." Journal of Climate 24, no. 2 (2011): 428–47. http://dx.doi.org/10.1175/2010jcli3651.1.
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Abstract This study documents and evaluates the boundary layer and energy budget response to record low 2007 sea ice extents in the Community Atmosphere Model version 4 (CAM4) using 1-day observationally constrained forecasts and 10-yr runs with a freely evolving atmosphere. While near-surface temperature and humidity are minimally affected by sea ice loss in July 2007 forecasts, near-surface stability decreases and atmospheric humidity increases aloft over newly open water in September 2007 forecasts. Ubiquitous low cloud increases over the newly ice-free Arctic Ocean are found in both the July 2007 and the September 2007 forecasts. In response to the 2007 sea ice loss, net surface [top of the atmosphere (TOA)] energy budgets change by +19.4 W m−2 (+21.0 W m−2) and −17.9 W m−2 (+1.4 W m−2) in the July 2007 and September 2007 forecasts, respectively. While many aspects of the forecasted response to sea ice loss are consistent with physical expectations and available observations, CAM4’s ubiquitous July 2007 cloud increases over newly open water are not. The unrealistic cloud response results from the global application of parameterization designed to diagnose stratus clouds based on lower-tropospheric stability (CLDST). In the Arctic, the well-mixed boundary layer assumption implicit in CLDST is violated. Requiring a well-mixed boundary layer to diagnose stratus clouds improves the CAM4 cloud response to sea ice loss and increases July 2007 surface (TOA) energy budgets over newly open water by +11 W m−2 (+14.9 W m−2). Of importance to high-latitude climate feedbacks, unrealistic stratus cloud compensation for sea ice loss occurs only when stable and dry atmospheric conditions exist. Therefore, coupled climate projections that use CAM4 will underpredict Arctic sea ice loss only when dry and stable summer conditions occur.
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Specht, Ray L., and Alison Specht. "The ratio of foliar nitrogen to foliar phosphorus: a determinant of leaf attributes and height in life-forms of subtropical and tropical plant communities." Australian Journal of Botany 58, no. 7 (2010): 527. http://dx.doi.org/10.1071/bt07110.
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In the species-rich overstorey of tropical and subtropical closed-forests (rainforests), a series of life-forms (emergent trees, canopy trees, subcanopy trees, mid-stratum trees and shrubs, interlaced with lianes) of increasing basal area, height and foliage attributes (leaf area, leaf specific weight and internode length) develop in equilibrium with aerodynamic fluxes (frictional, thermal, evaporative ± atmospheric salinity) in the atmosphere as it flows turbulently over and through a plant community. In both closed-forest and open-forest communities in eastern Australia, the translocation of high-energy nitrogen and phosphorus compounds into developing leaves – during the driest season of the year – increases as soil water becomes more available in the climatic gradient from the subhumid to the per-humid zone. Foliage attributes (leaf area and leaf specific weight) of vertical shoots are determined by the rate of input of high-energy compounds into developing shoot apices. Increasing nutrient input in the transpiration stream results in a greater number of leaves (with similar leaf specific weights) on vertical foliage shoots. The leaf area index of the tree is thus enhanced and leads to increased biomass, basal area and height at maturity. In each life-form within a closed-forest, the size of the root system is allometrically related to aboveground attributes. The ability of the root system to explore available nitrogen and phosphorus stored in the surface soil thus determines the attributes of developing foliage shoots in each of these life-forms. Both leaf areas and leaf specific weights decrease from maxima in canopy trees to leaves of subcanopy and mid-stratum trees in the milder climate under the dense structure of per-humid rainforests. In contrast, in the open-structured, subhumid rainforests, although leaf areas decrease in the gradient from canopy to mid-stratum trees – all exposed to direct solar radiation – leaf specific weights increase as temperatures in the boundary layer around growth-apices increase. The production of nitrate ions in soil, exposed to solar radiation in gaps, increases the uptake of nitrogen into leaves of pioneer trees. Larger and thinner leaves, with higher foliar N : P ratios and nitrate reductase activity, result in and enable rapid regeneration of the rainforest.
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Romanukha, Oleksandr M. "ГРАФІЧНИЙ ІНТЕРФЕЙС ЯК ДИДАКТИЧНИЙ КОМПОНЕНТ ЕЛЕКТРОННОГО ПІДРУЧНИКА". Information Technologies and Learning Tools 67, № 5 (2018): 1. http://dx.doi.org/10.33407/itlt.v67i5.2221.
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This article deals with the issue of updating the principles of creation of e-textbooks via graphical interface. The close attention has to be paid to the transformation of the modern society where the new generation of people uses computers, smartphones and tablets not only as working tools but as the means of discovering the world as well. Therefore the graphical interface is considered the code of understanding the information environment. It is emphasised that the spread of information technologies and information transmission and processing methods have become an integral element of human thinking and perception of the world. Getting most of their information through the Internet modern people perceive process and memorize it according to the principles of the interface and programming languages. In this regard graphical interface is seen as the fundamental of the e-textbook visualization. The article presents the model description of the e-textbook “History of Ukraine” visualized as the cube. Each tier in this cube describes the cultural stratum of the epoch and shows the general dynamics of historical development. Each plane in this cube analyses the content of each problem. Studying every part, students open consistently the horizontal cube stratums and see the topics of the epoch represented by the graphical interface device. Every topic contains visualized scheme with hyperactive dates and surnames with zero traditional text with hyperlinks. The advantage of such e-textbook structure is to rise student cognitive activity due to the new principles of the educational material visualization. The e-textbook interface is intuitive; it can be updated and used to get the insight into selected topics and questions. It has means to activate the resources of human higher nervous system taking into account the individual features of students and topics they are studying. Attention is drawn to the fact that scientific progress has been made possible largely thanks to the improvement of semiotics, that is, the development of our language, especially those of its branches, as the language of symbolic logic, rather than by improving brain function.
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Cai, Ji Hua, Xiao Ming Wu, and Sui Gu. "Anti-Collapse Drilling Fluids for the Cretaceous Scientific Drilling in Songliao Basin, China: A Case Study." Applied Mechanics and Materials 170-173 (May 2012): 1196–201. http://dx.doi.org/10.4028/www.scientific.net/amm.170-173.1196.
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CCSD-SK1 well was the first Cretaceous scientific drilling well in the world, locating in Songliao basin, Northeast China. It included main well (also called north well) and south well. This paper introduced the anti-collapse drilling fluid technology in main well where the desired continuous coring section was from 164.77 m to 1792.00 m. Continuous technical barriers challenged the intelligence of drilling engineers of this project. First, preserving the wellbore stability was the most critical aspect of continuous core drilling. From top to bottom, the unconsolidated sandstone in the Quaternary super stratum, the water sensitive shale in the Sifangtai group and upper stratum of the Nenjiang group, and the brittle shale of under stratum of the Nenjiang group increased the difficulty of anti-collapse drilling fluid technology. Water invasion into the shale formation often weakens the wellbore and causes problems such as wellbore collapse, shale destabilization and stuck pipe. Fluids should be designed to mitigate these shale problems. Secondly, the openhole strategy imposed the difficulty of maintaining wellbore stability in the second open process (from 245.00 m to the bottom). Finally, the total expense of the well was only one fifth of south well, which was drilled by an oilfield drilling contractor. To overcome these technical challenges, not only different drilling fluid systems such as PAM drilling fluid, DFD-LG-CMC drilling fluid and DFD-NH4HPAN-SAKH drilling fluid were adopted separately, but also technology of feasible viscosity and managed pressure drilling were used. A total of 395 trips had been run in this Cretaceous scientific drilling well and no accidents even dangerous cases occurred. The experience of CCSD-SK1 (main well) explored a successful way of employing economic drilling fluid to preceding similar scientific drilling projects in similar shale formations.
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Ziabreva, Irina, Reinhild Schnabel, and Katharina Braun. "Parental Deprivation Induces N-Methyl-D-Aspartate-Receptor Upregulation in Limbic Brain Areas ofOctodon degus: Protective Role of the Maternal Call." Neural Plasticity 7, no. 4 (2000): 233–44. http://dx.doi.org/10.1155/np.2000.233.
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An optimal coordination between parents and their offspring involves a sequence of reciprocal behaviors to ensure the adequate care of the young, which is critical for a healthy physical, emotional, and social development. Parental deprivation, particularly an impaired child-mother attachment, induces lasting changes in emotional as well as in cognitive capacities in later life. We assessed in the South American precocial species,Octodon degus, whether alterations of glutamatergic function of the limbic system induced by parental deprivation may be a neural correlate for such behavioral changes. Further, we analyzed whether the mother's voice can protect from separation-induced changes of brain function. Changes of N-methyl-D-aspartate (NMDA) receptor expression were examined in the following three groups of 2-week-oldOctodon deguspups: (I) control animals who remained undisturbed with the family; (II) animals who were repeatedly separated from the family and individually placed in an unfamiliar environment for behavioral analysis (open field); and (III) animals who were treated like the group described under (lI) but were presented with maternal vocalizations during separation. Relative to those in the control group I, the animals in group II showed an upregulation of NMDA receptor density in the (a)anterior cingulate, prelimbic, infralimbic, and anterior insular cortices; (b)CA1/stratum radiatum; (c)CA1/stratum lacunosum moleculare and CA3/stratum radiatum; and (d)in the basomedial amygdaloid nucleus. Presentation of the maternal call during the separation period (group III) suppressed the separation-induced NMDA receptor upregulation in all regions. The results demonstrate that early life events can influence the expression of transmitter receptors and that maternal behavior, acting to control the pup's socio-emotional environment, is a key factor for regulating such developmental events.
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Brandão, Leonardo R., Manuela Albisetti, Jacqueline Halton, et al. "Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children." Blood 135, no. 7 (2020): 491–504. http://dx.doi.org/10.1182/blood.2019000998.
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Abstract This open-label, single-arm, prospective cohort trial is the first phase 3 safety study to describe outcomes in children treated with dabigatran etexilate for secondary venous thromboembolism (VTE) prevention. Eligible children aged 12 to &lt;18 years (age stratum 1), 2 to &lt;12 years (stratum 2), and &gt;3 months to &lt;2 years (stratum 3) had an objectively confirmed diagnosis of VTE treated with standard of care (SOC) for ≥3 months, or had completed dabigatran or SOC treatment in the DIVERSITY trial (NCT01895777) and had an unresolved clinical thrombosis risk factor requiring further anticoagulation. Children received dabigatran for up to 12 months, or less if the identified VTE clinical risk factor resolved. Primary end points included VTE recurrence, bleeding events, and mortality at 6 and 12 months. Overall, 203 children received dabigatran, with median exposure being 36.3 weeks (range, 0-57 weeks); 171 of 203 (84.2%) and 32 of 203 (15.8%) took capsules and pellets, respectively. Overall, 2 of 203 children (1.0%) experienced on-treatment VTE recurrence, and 3 of 203 (1.5%) experienced major bleeding events, with 2 (1.0%) reporting clinically relevant nonmajor bleeding events, and 37 (18.2%) minor bleeding events. There were no on-treatment deaths. On-treatment postthrombotic syndrome was reported for 2 of 162 children (1.2%) who had deep vein thrombosis or central-line thrombosis as their most recent VTE. Pharmacokinetic/pharmacodynamic relationships of dabigatran were similar to those in adult VTE patients. In summary, dabigatran showed a favorable safety profile for secondary VTE prevention in children aged from &gt;3 months to &lt;18 years with persistent VTE risk factor(s). This trial was registered at www.clinicaltrials.gov as #NCT02197416.
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Wang, Gui Lei, Hai Tao Xue, Shuang Fang Lu, and Wei Ming Wang. "Chemical Kinetics Application of Hydrocarbon Generation of Shuang Yang Stratum in well Chang 27." Advanced Materials Research 807-809 (September 2013): 2133–38. http://dx.doi.org/10.4028/www.scientific.net/amr.807-809.2133.
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To determine the hydrocarbon - generating characteristics of Shuangyang Formation in Well Chang 27.We selected dark mudstone in Shuangyang Formation to launch Rock-Eval (open system) thermal simulation. Through thermal simulation data to demarcate a kinetic model,the Shuangyang Stratum mudstone samples reveal the gas intensity is mainly distributed in (210~230) kJ/mol),the average activation energy is 223kJ/mol. The hydrocarbon - generating characteristics of Shuangyang Formation in Well Chang 27 whose hydrocarbon generation stage mainly in the period (37~24) Ma, corresponding the late period of the Yongji Formation deposition to the late period of the Qijia Formation deposition. In Chang 27 Well area,the average generating strength of gas in Shuangyang Formation is (21~37×108) m3·km2. The hydrocarbon generation stage of Shuangyang Formation in Chang 27 Well area is mainly in (37~24) Ma, corresponding to the late deposition period of the Yongji Formation and Qijia Formation. Both the shorter periods of hydrocarbon generation and late hydrocarbon generation period made great contributions to accumulation, in which Shuang_1 formation played a bigger role.
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Liu, Shuaigang, Jianbiao Bai, Xiangyu Wang, et al. "Study on Dynamic Evolution of Roof Crack and Support Timing of Secondary Tunneling for Large Section Open-Off Cut in Deep Mines." Advances in Civil Engineering 2021 (April 20, 2021): 1–16. http://dx.doi.org/10.1155/2021/9918470.
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The stability of large section open-off cut in deep mines (LODM) is the key factor affecting the normal equipment installation and safe mining in fully mechanized top-coal caving face. The mechanical model shows that the deflection of the roof of the LODM is proportional to the cubic of span. In this paper, UDEC Trigon model is established, and the parameters of different coal measures strata are modified in detail. The evolution law, failure mode, and damage degree of roof cracks in secondary tunneling are studied, and the roof support effect is analyzed. The numerical simulation results show that the process of roof crack evolution after the primary excavation section and the second excavation section can be divided into three stages according to microseismic activities, and the reasonable supporting time can control the propagation of roof microcracks and reduce the development height of macrocracks. The rock bridge existing in the roof rock stratum after the combined support of long and short anchor cables can effectively limit the formation of macrocracks and their interaction; especially the key support in the interface area can reduce the development height of roof cracks in secondary tunneling and weaken the damage degree of roof rock stratum in the LODM. The field test shows that the moved volume of rib-to-rib and roof-to-floor of the LODM is stable at about 350 mm and 550 mm, respectively. The numerical simulation in this paper is helpful to understand the failure mode of roof in LODM with large mining height and provides a method for the design of its control technologies.
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Albisetti, Manuela, Ivan Manastirski, Martina Brueckmann, et al. "Rationale and Design of a Phase IIb/III Open-Label, Multicenter Study of Dabigatran Etexilate for Venous Thromboembolism in Children: The Diversity Study." Blood 128, no. 22 (2016): 5025. http://dx.doi.org/10.1182/blood.v128.22.5025.5025.
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Abstract Background Venous thromboembolism (VTE) is increasing in children. The current standard of care comprises unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) for at least 5 days followed by UFH, LMWH or Vitamin K antagonists (VKA) for approximately 3 months in general. All of the current options have limitations: UFH and LMWH require parenteral administration; VKA requires frequent international normalized ratio (INR) monitoring and is associated with multiple food and drug interactions. The direct thrombin inhibitor, dabigatran, which is orally administered as the prodrug, dabigatran etexilate (DE) is effective for the treatment of VTE in adults and may overcome some of the limitations associated with standard of care. Objective To describe the design of a study evaluating the appropriateness of a proposed DE dosing algorithm and assessing the safety and efficacy of DE versus standard of care in pediatric patients with VTE. Methods This open-label, randomized, parallel-group, active-controlled, multi-center, non-inferiority study (NCT01895777) will be conducted in approximately 100 sites in approximately 30 countries. Patients aged 0 to < 18 years with an imaging-confirmed diagnosis of VTE initially receiving parenteral treatment with UFH or LMWH for 5-7 days (but no more than 21 days) who are expected to require anticoagulation therapy for at least 3 months will be eligible for inclusion. Main exclusion criteria include conditions associated with an increased risk of bleeding, renal dysfunction, active infective endocarditis, mechanical or biological heart valve prosthesis, hepatic disease and anemia or thrombocytopenia. Patients will be stratified into three age groups: stratum 1 (12 to < 18 years), stratum 2 (2 to < 12 years) and stratum 3 (birth to < 2 years). Recruitment will begin in stratum 1, being subsequently escalated to strata 2 and 3, respectively based on recommendations from the Data Monitoring Committee. Patients will be randomized (2:1) to receive DE versus standard of care (LMWH or VKA). DE will be administered twice daily as capsules, pellets or an oral liquid formulation depending on patient age and the patient's ability to swallow pellets or capsules. Upon completion of a 3-month treatment period (including the initial parenteral treatment phase) patients will be followed off-study drug for any adverse events. DE will be dosed to achieve steady-state measured trough circulating plasma concentrations (≥50 and < 250 ng/mL); the initial dose required will be calculated using a nomogram, which adjusts dosing according to the age and weight of the child. Dabigatran plasma concentrations will be evaluated at all study visits (7 scheduled during treatment period); DE will be up- or down-titrated as required. Results In terms of efficacy, the study will evaluate the proportion of patients with complete thrombus resolution, freedom from recurrent VTE (including symptomatic and asymptomatic, contiguous progression or non-contiguous new thrombus, deep vein thrombosis, pulmonary and paradoxical embolism, and thrombus progression) and freedom from VTE-related mortality. With regards to safety, the key endpoint will be freedom from major bleeding events, as per International Society on thrombosis and Haemostasis (ISTH) pediatric-specific criteria. All components of the primary efficacy and key safety endpoints will be adjudicated by an independent blinded committee. Conclusion This study, one of the largest controlled pediatric studies for VTE, will provide data on the safety and efficacy of DE compared with standard of care for the treatment of VTE in children aged 0 to < 18 years. Disclosures Albisetti: Boehringer Ingelheim: Other: Pediatric Expert Working Group. Manastirski:Boehringer Ingelheim: Employment. Brueckmann:Boehringer Ingelheim: Employment. Gropper:Boehringer Ingelheim: Employment. Wang:Boehringer Ingelheim: Employment. Tartakovsky:Boehringer Ingelheim: Employment. Biss:Boehringer Ingelheim: Employment. Huang:Boehringer Ingelheim: Employment. Mitchell:Boehringer Ingelheim: Consultancy; Pfizer: Consultancy; Bristol Myers Squibb: Consultancy. Halton:Boehringer Ingelheim: Other: Pediatric Expert Working Group for Boehringer Ingelheim.
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Pires, Liliana R., KB Vinayakumar, Maria Turos, Verónica Miguel, and João Gaspar. "A Perspective on Microneedle-Based Drug Delivery and Diagnostics in Paediatrics." Journal of Personalized Medicine 9, no. 4 (2019): 49. http://dx.doi.org/10.3390/jpm9040049.
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Microneedles (MNs) have been extensively explored in the literature as a means to deliver drugs in the skin, surpassing the stratum corneum permeability barrier. MNs are potentially easy to produce and may allow the self-administration of drugs without causing pain or bleeding. More recently, MNs have been investigated to collect/assess the interstitial fluid in order to monitor or detect specific biomarkers. The integration of these two concepts in closed-loop devices holds the promise of automated and minimally invasive disease detection/monitoring and therapy. These assure low invasiveness and, importantly, open a window of opportunity for the application of population-specific and personalised therapies.
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Silaya, Thomas, and Juglans H. Pietersz. "Upaya Pengembangan Pola Agroforestri Tradisional “Dusung” Sebagai Sumber Pangan Masyarakat." MAKILA 13, no. 1 (2019): 1–13. http://dx.doi.org/10.30598/makila.v13i1.2316.
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This study aims to determine the structure and composition of vegetation types in the development of dusung, factors that affect economic aspects, environment, and management in the development of dusung and the optimal benefits of economic, ecological and management aspects to support food security. The research method used in this research is descriptive method with quantitative (positivism) and qualitative (phenomenological) approaches. Determination of the location of the study was done by purposive sampling, and data collection was carried out using open and in-depth interviews. The results showed that the structure and composition of dusung vegetation in Hative village consisted of the tree, pole, weaning and seedling levels, with stratification consisting of stratum A to stratum E. Factors influencing economic, environmental and management aspects in Dusung management were social factors- culture in the form of community wisdom such as sasi and Kewang, Dusung Inheritance / Ownership system, cropping patterns and types of soil in Dusung as well as changes in community lifestyle. The development of the dusung has strengths in the form of various kinds of vegetation such as Eugenia aromatica, Durio zibethinus, Lansium domesticum, Bouea macrophylla, Gmelina molucanna, and Myristica fragrans, possessing fertile soil and accessibility of locations easily accessible; and dusung development opportunities namely marketing aspects that have a positive impact on increasing income for the community.
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Witczak, Izabela. "Profit and loss account as the source of open pension funds efficiency." Zeszyty Naukowe Uniwersytetu Szczecińskiego Finanse, Rynki Finansowe, Ubezpieczenia 2015 (June 30, 2015): 505–14. http://dx.doi.org/10.18276/frfu.2015.75-41.
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Laslavíková, Jana. "Between province and metropolis. The opera repertoire of the Pressburger Stadttheater in the late nineteenth century." Studia Musicologica 58, no. 3-4 (2017): 363–77. http://dx.doi.org/10.1556/6.2017.58.3-4.5.
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The establishment and development of the Municipal Theater in Pressburg in the period 1886–1920 was closely linked with the cultural and social development of the city in the period following the Austrian-Hungarian Compromise in 1867. The theater was built by the rising stratum of Pressburg townsmen, based on a requirement of the Hungarian government. The theater was in the possession of the town that rented it to theater directors and their German and Hungarian companies. The theater had a primacy among provincial theaters in Hungary. This was mainly due to the vicinity of Vienna and the efforts to resemble the metropolis, notably by the local patriotism of Pressburg inhabitants who wanted their locality to be regarded as a leading Hungarian town. The opera performances and their reception in the newspapers demonstrate the history of culture of the town, mentalities and collective identifications of its citizens, and last but not least the history of culture of Central Europe.
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Tang, Yan Chun, and Jing Nian Fang. "Analysis on Stability of Land Parcel of Fushun Mining Group Headquarters by Exploitation of West Open-Pit Mine." Applied Mechanics and Materials 368-370 (August 2013): 1610–13. http://dx.doi.org/10.4028/www.scientific.net/amm.368-370.1610.
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Through calculation on the variation of deformation of land parcel of Fushun mining group headquarters on different exploitation conditions of west open-pit mine, the stability of land parcel of Fushun mining group headquarters has been analyzed. The analyzed results show that when the slope has been excavated to line D and the exploitation is on N1200, the influence for the stability of land parcel is smaller, but when the exploitation is on N1600, because of the concentrated distribution of displacement and obviously enlargement of the scope of plastic zone on the area between the fault F1 and F1A, the stability of land parcel has been changed obviously. At the aim of the security of land parcel of Fushun mining group headquarters, the excavation of slope should not be more than line D and the exploitation of coal stratum should not be more than N1200. The achieved results can provide a research foundation for a reasonable and orderly exploitation for Fushun west open-pit mine.
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Zheng, Yangxing, Toshiaki Shinoda, Jia-Lin Lin, and George N. Kiladis. "Sea Surface Temperature Biases under the Stratus Cloud Deck in the Southeast Pacific Ocean in 19 IPCC AR4 Coupled General Circulation Models." Journal of Climate 24, no. 15 (2011): 4139–64. http://dx.doi.org/10.1175/2011jcli4172.1.
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Abstract This study examines systematic biases in sea surface temperature (SST) under the stratus cloud deck in the southeast Pacific Ocean and upper-ocean processes relevant to the SST biases in 19 coupled general circulation models (CGCMs) participating in the Intergovernmental Panel on Climate Change (IPCC) Fourth Assessment Report (AR4). The 20 years of simulations from each model are analyzed. Pronounced warm SST biases in a large portion of the southeast Pacific stratus region are found in all models. Processes that could contribute to the SST biases are examined in detail based on the computation of major terms in the upper-ocean heat budget. Negative biases in net surface heat fluxes are evident in most of the models, suggesting that the cause of the warm SST biases in models is not explained by errors in net surface heat fluxes. Biases in heat transport by Ekman currents largely contribute to the warm SST biases both near the coast and the open ocean. In the coastal area, southwestward Ekman currents and upwelling in most models are much weaker than observed owing to weaker alongshore winds, resulting in insufficient advection of cold water from the coast. In the open ocean, warm advection due to Ekman currents is overestimated in models because of the larger meridional temperature gradient, the smaller zonal temperature gradient, and overly weaker Ekman currents.
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Grün, R. "Revised open system U-series/ESR age calculations for teeth from Stratum C at the Hoxnian Interglacial type locality, England." Quaternary Science Reviews 19, no. 12 (2000): 1151–54. http://dx.doi.org/10.1016/s0277-3791(00)00085-8.
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Yuan, Hua, Zhi Liang Zhao, and Yun Hua Li. "Selection of Groundwater Control Scheme for Deep Excavation in Alluvial Soil along the Yellow River." Applied Mechanics and Materials 212-213 (October 2012): 323–26. http://dx.doi.org/10.4028/www.scientific.net/amm.212-213.323.
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Kaifeng locates on a flat and open alluvial plain of the middle and lower reaches of the Yellow River. Owing to its complex history and long-term deposition, a silty stratum with multi-miscellaneous fill and alluvial soil interphase is gradually formed. Combing with the soil actual characteristics of Kaifeng area, which is mainly composed of “high water content”, “high water head”, “strong permeability”, “low strength”, “adequate water supply”, a optimal groundwater control scheme for deep excavation under above complicated geological conditions is proposed. Moreover, the most appropriate waterproof curtain form is recommended for the foundation pit engineering whose excavation depth is less than 10m. The findings of this investigation may offer some suggestions for the choice of groundwater control scheme for construction purpose in similar strata.
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Akshintala, Srivandana, Brigitte C. Widemann, Donald A. Barkauskas, et al. "Phase 2 trial of cabozantinib in children and young adults with refractory sarcomas, Wilms tumor, and rare tumors: Children's Oncology Group Study (ADVL1622)." Journal of Clinical Oncology 39, no. 15_suppl (2021): 10010. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.10010.
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10010 Background: Cabozantinib is an inhibitor of multiple receptor tyrosine kinases (RTKs) including MET, VEGFR2, RET, and AXL. Preclinical and clinical data support these RTKs as potential therapeutic targets; Safety, tolerability, and responses were demonstrated in a COG phase 1 trial. We conducted a multi-center open label phase 2 trial to determine the activity of cabozantinib in select pediatric solid tumors (NCT02867592). Methods: Patients age 2-30 years old with selected relapsed or refractory cancer that was measurable (RECISTv.1.1) were eligible. Using a Simon minimax design, patients were enrolled to six strata: Osteosarcoma (OS), Ewing sarcoma (EWS), rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), Wilms tumor (WT), and rare tumor (a non-statistical stratum including tumors of specific histologies or molecular features). Cabozantinib (40 mg/m2/day) was administered on a continuous schedule (1 cycle = 28 days). For the OS stratum, activity was determined based on objective response rate (ORR, complete response (CR) + Partial response (PR)) or disease control success defined as at least stable disease (SD) for ≥ 4 months. For all other strata, the primary endpoint was ORR. Pharmacokinetics were performed in patients < 19 years. Results: Between May 2017- Oct 2020, 109 patients enrolled (105 eligible, 104 evaluable for response and toxicity). Median age was 15.8 (range 5.6-27.1) years; 55 were male. In the OS stratum, 10/29 (34%) patients had central review confirmed disease control ≥ 4 months (2 PR, 8 SD), exceeding the protocol-defined criteria for activity of cabozantinib in OS. Median duration of therapy was 3 cycles (range 1-28+). In EWS, RMS, NRSTS, and WT strata (n = 13 evaluable patients each) no PR or CR were observed. In the rare tumor stratum (n = 23), 1/4 patients with renal cell carcinoma, 1/1 patients with RET fusion positive papillary thyroid cancer had a PR, and 1 patient with medullary thyroid cancer had a delayed PR. SD ≥ 6 cycles was seen in patients with EWS (n = 2), NRSTS (n = 5), WT (n = 3), and hepatocellular carcinoma (n = 1). At data cutoff (12/31/2020), 430 treatment cycles were administered; two patients remain on therapy. Cycle 1 and later cycle dose limiting toxicities (DLT) were seen in 20 (19%) and 39 (38%) patients, respectively. Common DLT were elevated liver enzymes, bilirubin, and lipase, hyponatremia, weight loss, anorexia, nausea, vomiting, wound dehiscence, palmar-plantar erythrodysesthesia, and pneumothorax. Day 1 pharmacokinetics (mean ± SD, n = 16) demonstrated a maximum plasma concentration of 556 ± 376 ng/ml, half-life 106 ± 102 hours, and area under the curve (AUC0-24h) 8093 ± 4368 ng•h/mL. Conclusions: Cabozantinib is active in patients with relapsed refractory OS and deserves further study in this disease. PRs were also seen in select carcinomas. Activity is limited in other sarcomas and WT. Clinical trial information: NCT02867592.
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Das, A., A. Spira, N. Iannotti, et al. "A phase II study of a novel anti-tubulin, E7389, in patients with advanced non-small cell lung cancer (NSCLC)." Journal of Clinical Oncology 24, no. 18_suppl (2006): 7106. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.7106.
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7106 Background: E7389, a synthetic analog of halichondrin B that was isolated from a marine sponge, has broad anti-proliferative activity at nanomolar levels and a unique profile of tubulin interactions. Methods: This is an open-label, single-arm, stratified phase II study of E7389 in patients with measurable, recurrent and/or metastatic NSCLC who progressed during or after platinum-based doublet chemotherapy. E7389 (1.4 mg/m2) was administered as a bolus IV on days 1, 8, and 15 of a 28-day cycle to 72 patients (cohort 1) in stratum I (55 taxane pretreated patients) and stratum II (17 taxane-naive patients) and on Days 1 and 8 of a 21-day cycle (cohort 2), providing an additional 22 patients in stratum I. The primary efficacy endpoint was objective response rate to E7389 monotherapy. Results: As of 9 December 2005, 94 evaluable patients received E7389. Nineteen tumors were classified as squamous cell carcinomas, 39 as adenocarcinomas, and 36 were large cell carcinomas or unclassified. The median number of cycles completed was 3. Fifteen patients completed 6 or more cycles and 75 patients underwent tumor assessments after cycle 2. Major toxicities related to study drug included myelosuppression, nausea, fatigue, dehydration, arthralgias, dyspnea, and peripheral neuropathy. Based on RECIST criteria, 6 partial responses (PR) were observed among 94 evaluable patients (PR rate = 6.4%, 95% CI: 2.8%, 12.8%). For 33 patients the best response was stable disease (SD rate = 35.1%, 95% CI: 25.5%, 45.1%). Disease control rate (PR + SD) was 41.5% (95% CI: 31.4%, 51.7%). For cohort 1, the 12-week progression free survival rate was 57.2%. As of 9 December 2005, median PFS time was 108 days (95% CI = 55, min-max = 1–239+). Cohort 2 is being followed to estimate their 12-week PFS. The correlation of beta tubulin isotype, stathmin, microtubule-associated protein 4 (MAP4) and tau protein mRNA expression with tumor responses is on-going. Conclusions: Based on this data, E7389 has been shown to be safe and effective in the treatment of NSCLC patients. Updated information and results of molecular correlations of responses will be presented. [Table: see text]
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Goetze, Thorsten Oliver, Daniel Wilhelm Mueller, Mohammad-Reza Rafiyan, et al. "Open-label, phase I study evaluating feasibility and safety of subcutaneous IMP321 (LAG-3Ig fusion protein, eftilagimod alpha) combined with avelumab in advanced stage solid tumor entities: Results from stratum D of the INSIGHT platform trial." Journal of Clinical Oncology 38, no. 15_suppl (2020): 3099. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.3099.
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3099 Background: Stratum D of the INSIGHT study investigates the feasibility and safety of s.c. application of IMP321 (eftilagimod alpha) combined with the PD-L1 inhibitor avelumab in advanced stage solid tumors. The MHC class II agonist IMP321 activates antigen-presenting cells followed by CD8 T-cell activation. The addition of avelumab aims at enhancing activity by combining IMP321’s activating effects on immune cells with the release of immune inhibitory effects caused by interruption of the PD-1/PD-L1 axis. Methods: This investigator-initiated phase I trial consists of four strata: intratumoral (A) or intraperitoneal IMP321 (B); s.c. IMP321 with SOC (C) or with PD-L1 inhibition (D). This abstract focuses on Stratum D. Patients (pts) receive 800mg avelumab i.v. q2w along with s.c. IMP321 injections (6mg IMP321 in cohort 1 and 30mg IMP321 in cohort 2). 12 pts are planned in stratum D : 6 pts in cohort 1 and 6 pts in cohort 2. Primary endpoint is safety. Results: So far, 8 pts have been enrolled (6 in cohort 1 and 2 in cohort 2). In 6 pts (cohort 1) treated for different tumor indications (gastric, gallbladder, colon cancer, pleural mesothelioma), no dose limiting toxicities occurred. 3 serious adverse events (SAEs) (1 acute kidney injury grade 5 in 1 pt, 2 preileus grade 3 in 1 pt) were reported, none of them was related to any of the study drugs. In total, 34 adverse events (AEs; grade 1-2, 21; grade 3, 12; no grade 4; grade 5, 1) have been documented in 5 pts. Most common grade 1-2 AEs were pain, nausea, and injection site reaction in 50%, 33%, and 17% of the pts. Most common grade 3 AEs were nausea/vomiting, preileus/ileus, and ascites in 33%, 33%, and 17% of the pts. One AE grade 5 (acute kidney injury) was reported. 4 AEs grade 1-2 were possibly or definitely related to IMP321 (injection site reaction 2x; fever; lipohypertrophy), 6 AEs grade 1-2 were possibly or definitely related to avelumab (nausea 2x; chills; fever; dyspnea; lipohypertrophy). All AEs grade 3-5 were unrelated to any of the study drugs. Of the 8 pts enrolled so far, 4 had disease progression (acc. to RECIST 1.1), 1 partial response, 1 stable disease with some extent of tumor shrinkage, and 2 have not had tumor assessment yet. Conclusions: Combination treatment with avelumab 800mg and IMP321 6mg is safe and well tolerated. Cohort 2 will be presented at the meeting. Clinical trial information: NCT03252938 .