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Frigaard, Niels-Ulrik, Julia A. Maresca, Colleen E. Yunker, A. Daniel Jones, and Donald A. Bryant. "Genetic Manipulation of Carotenoid Biosynthesis in the Green Sulfur Bacterium Chlorobium tepidum." Journal of Bacteriology 186, no. 16 (August 15, 2004): 5210–20. http://dx.doi.org/10.1128/jb.186.16.5210-5220.2004.
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ABSTRACT The green sulfur bacterium Chlorobium tepidum is a strict anaerobe and an obligate photoautotroph. On the basis of sequence similarity with known enzymes or sequence motifs, nine open reading frames encoding putative enzymes of carotenoid biosynthesis were identified in the genome sequence of C. tepidum, and all nine genes were inactivated. Analysis of the carotenoid composition in the resulting mutants allowed the genes encoding the following six enzymes to be identified: phytoene synthase (crtB/CT1386), phytoene desaturase (crtP/CT0807), ζ-carotene desaturase (crtQ/CT1414), γ-carotene desaturase (crtU/CT0323), carotenoid 1′,2′-hydratase (crtC/CT0301), and carotenoid cis-trans isomerase (crtH/CT0649). Three mutants (CT0180, CT1357, and CT1416 mutants) did not exhibit a discernible phenotype. The carotenoid biosynthetic pathway in C. tepidum is similar to that in cyanobacteria and plants by converting phytoene into lycopene using two plant-like desaturases (CrtP and CrtQ) and a plant-like cis-trans isomerase (CrtH) and thus differs from the pathway known in all other bacteria. In contrast to the situation in cyanobacteria and plants, the construction of a crtB mutant completely lacking carotenoids demonstrates that carotenoids are not essential for photosynthetic growth of green sulfur bacteria. However, the bacteriochlorophyll a contents of mutants lacking colored carotenoids (crtB, crtP, and crtQ mutants) were decreased from that of the wild type, and these mutants exhibited a significant growth rate defect under all light intensities tested. Therefore, colored carotenoids may have both structural and photoprotection roles in green sulfur bacteria. The ability to manipulate the carotenoid composition so dramatically in C. tepidum offers excellent possibilities for studying the roles of carotenoids in the light-harvesting chlorosome antenna and iron-sulfur-type (photosystem I-like) reaction center. The phylogeny of carotenogenic enzymes in green sulfur bacteria and green filamentous bacteria is also discussed.
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Gómez, Melissa, Sebastián Campusano, María Soledad Gutiérrez, Dionisia Sepúlveda, Salvador Barahona, Marcelo Baeza, Víctor Cifuentes, and Jennifer Alcaíno. "Sterol regulatory element-binding protein Sre1 regulates carotenogenesis in the red yeast Xanthophyllomyces dendrorhous." Journal of Lipid Research 61, no. 12 (September 15, 2020): 1658–74. http://dx.doi.org/10.1194/jlr.ra120000975.
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Xanthophyllomyces dendrorhous is a basidiomycete yeast that produces carotenoids, mainly astaxanthin. Astaxanthin is an organic pigment of commercial interest due to its antioxidant and coloring properties. X. dendrorhous has a functional SREBP pathway, and the Sre1 protein is the SREBP homolog in this yeast. However, how sterol regulatory element (Sre)1 promotes the biosynthesis of sterols and carotenoids in X. dendrorhous is unknown. In this work, comparative RNA-sequencing analysis between modified X. dendrorhous strains that have an active Sre1 protein and the WT was performed to identify Sre1-dependent genes. In addition, Sre1 direct target genes were identified through ChIP combined with lambda exonuclease digestion (ChIP-exo) assays. SRE motifs were detected in the promoter regions of several Sre1 direct target genes and were consistent with the SREs described in other yeast species. Sre1 directly regulates genes related to ergosterol biosynthesis as well as genes related to the mevalonate (MVA) pathway, which synthesizes the building blocks of isoprenoids, including carotenoids. Two carotenogenic genes, crtE and crtR, were also identified as Sre1 direct target genes. Thus, carotenogenesis in X. dendrorhous is regulated by Sre1 through the regulation of the MVA pathway and the regulation of the crtE and crtR genes. As the crtR gene encodes a cytochrome P450 reductase, Sre1 regulates pathways that include cytochrome P450 enzymes, such as the biosynthesis of carotenoids and sterols. These results demonstrate that Sre1 is a sterol master regulator that is conserved in X. dendrorhous.
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To, Sarah, Stephen J. Rodda, Peter D. Rathjen, and Rebecca A. Keough. "Modulation of CP2 Family Transcriptional Activity by CRTR-1 and Sumoylation." PLoS ONE 5, no. 7 (July 22, 2010): e11702. http://dx.doi.org/10.1371/journal.pone.0011702.
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Zainal Abidin, Aisamuddin Ardi, Chotika Yokthongwattana, and Zetty Norhana Balia. "Carotenogenesis in Nannochloropsis oculata under Oxidative and Salinity Stress." Sains Malaysiana 50, no. 2 (February 28, 2021): 327–37. http://dx.doi.org/10.17576/jsm-2021-5002-05.
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Nannochloropsis oculata is a unicellular microalgae which is vastly found throughout the environment and have been widely studied due to its high productivity of secondary metabolites and oil content. It is majorly cultured in the aquaculture sector as fish feed and for industries for its polyunsaturated fatty acids. This work aims to study the impact of salinity and oxidative stress on the expression of carotenoid biosynthesis genes and the accumulation of their products in N. oculata via qPCR and HPLC analyses. Three genes responsible for production of high value carotenoids namely lycopene beta-cyclase (CrTL-B/LCYB), beta-carotene oxygenase (CrTO)and beta-carotene hydroxylase (CrTR) under different stresses and time points were identified and quantified, and the amount of their products namely β-carotene, zeaxanthin, canthaxanthin, and astaxanthin was measured. N. oculata was treated with different concentrations of Cu2+ ion (1, 2, and 5 ppm) and NaCl (50, 150, 250 mM) which resembles conditions of oxidative and salinity stress, respectively. RNA and carotenoids extraction, RT-PCR, qPCR and HPLC was carried out in order to identify the correlation of carotenogenesis genes expression with carotenoids production. Under exposure of both treatments, the carotenoids biosynthesis genes were upregulated up to 6-fold compared to control and targeted carotenoids were overexpressed up to 7-fold. Results from this study gave insights which are beneficial in understanding microalgae’s responses towards abiotic stress via the synthesis of carotenoids.
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Rodda, Stephen, Shiwani Sharma, Michaela Scherer, Gavin Chapman, and Peter Rathjen. "CRTR-1, a Developmentally Regulated Transcriptional Repressor Related to the CP2 Family of Transcription Factors." Journal of Biological Chemistry 276, no. 5 (November 9, 2000): 3324–32. http://dx.doi.org/10.1074/jbc.m008167200.
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Giorio, G., A. L. Stigliani, and C. D'Ambrosio. "OVER-EXPRESSION OF CAROTENE β-HYDROXYLASE 1 (CRTR-B1) AND LYCOPENE β-CYCLASE (LCY-B) IN TRANSGENIC TOMATO FRUITS." Acta Horticulturae, no. 789 (May 2008): 277–84. http://dx.doi.org/10.17660/actahortic.2008.789.37.
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Zhang, Ying, Ramar Thangam, Sung-Hwan You, Rukhsora D. Sultonova, Akhil Venu, Jung-Joon Min, and Yeongjin Hong. "Engineering Calreticulin-Targeting Monobodies to Detect Immunogenic Cell Death in Cancer Chemotherapy." Cancers 13, no. 11 (June 4, 2021): 2801. http://dx.doi.org/10.3390/cancers13112801.
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Surface-exposed calreticulin (ecto-CRT) plays a crucial role in the phagocytic removal of apoptotic cells during immunotherapy. Ecto-CRT is an immunogenic signal induced in response to treatment with chemotherapeutic agents such as doxorubicin (DOX) and mitoxantrone (MTX), and two peptides (KLGFFKR (Integrin-α) and GQPMYGQPMY (CRT binding peptide 1, Hep-I)) are known to specifically bind CRT. To engineer CRT-specific monobodies as agents to detect immunogenic cell death (ICD), we fused these peptide sequences at the binding loops (BC and FG) of human fibronectin domain III (FN3). CRT-specific monobodies were purified from E. coli by affinity chromatography. Using these monobodies, ecto-CRT was evaluated in vitro, in cultured cancer cell lines (CT-26, MC-38, HeLa, and MDA-MB-231), or in mice after anticancer drug treatment. Monobodies with both peptide sequences (CRT3 and CRT4) showed higher binding to ecto-CRT than those with a single peptide sequence. The binding affinity of the Rluc8 fusion protein–engineered monobodies (CRT3-Rluc8 and CRT4-Rluc8) to CRT was about 8 nM, and the half-life in serum and tumor tissue was about 12 h. By flow cytometry and confocal immunofluorescence of cancer cell lines, and by in vivo optical bioluminescence imaging of tumor-bearing mice, CRT3-Rluc8 and CRT4-Rluc8 bound specifically to ecto-CRT and effectively detected pre-apoptotic cells after treatment with ICD-inducing agents (DOX and MTX) but not a non-ICD-inducing agent (gemcitabine). Using CRT-specific monobodies, it is possible to detect ecto-CRT induction in cancer cells in response to drug exposure. This technique may be used to predict the therapeutic efficiency of chemo- and immuno-therapeutics early during anticancer treatment.
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Tonegawa-Kuji, Reina, Yuko Y. Inoue, Michikazu Nakai, Koshiro Kanaoka, Yoko Sumita, Yuichiro Miyazaki, Akinori Wakamiya, et al. "Differences in patient characteristics, clinical practice and outcomes of cardiac implantable electric device therapy between Japan and the USA: a cross-sectional study using data from nationally representative administrative databases." BMJ Open 13, no. 1 (January 2023): e068124. http://dx.doi.org/10.1136/bmjopen-2022-068124.
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ObjectivesTo identify differences in patient characteristics, clinical practice and outcomes of cardiac implantable electronic device (CIED) therapy between Japan and the USA.DesignA cross-sectional study.SettingNationally representative administrative databases from Japan and the USA containing hospitalisations with first-time implantations of pacemakers, implantable cardioverter-defibrillators (ICD) and cardiac-resynchronisation therapy with or without defibrillators (CRTP/CRTD).ParticipantsPatients hospitalised with first-time implantations of CIEDs.Outcome measuresIn-hospital mortality, in-hospital complication and 30-day readmission rates.ResultsOverall, 107 339 (median age 78 (71–84), 48 415 women) and 295 584 (age 76 (67–83), 127 349 women) records with CIED implantations were included from Japan and the USA, respectively. Proportion of women in defibrillator recipients was lower in Japan than in the USA (ICD, 21% vs 28%, p<0.001; CRTD, 24% vs 29%, p<0.001). Length of stay after CIED implantation was longer in Japan than in the USA for all device types (conventional pacemaker, 8(7–11) vs 1 (1–3) days, p<0.001; leadless pacemaker, 5 (3–9) vs 2 (1–5) days, p<0.001; ICD, 8 (7–11) vs 1 (1–3) days, p<0.001, CRTP, 9 (7–13) vs 2 (1–4) days, p<0.001; CRTD, 9 (8–14) vs 2 (1–4) days, p<0.001). In-hospital mortality after CIED implantation was similar between Japan and the USA ((OR) (95% CI), conventional pacemaker 0.58 (0.83 to 1.004); ICD 0.77 (0.57 to 1.03); CRTP 0.85 (0.51 to 1.44); CRTD 1.11 (0.81 to 1.51)), except that after leadless pacemaker implantation in Japan was lower than that in the USA (0.32 (0.23 to 0.43)). 30-day readmission rates were lower in Japan than in the USA for all device types (conventional pacemaker 0.55 (0.53 to 0.57); leadless pacemaker 0.50 (0.43 to 0.58); ICD 0.54 (0.49 to 0.58); CRTP 0.51 (0.42 to 0.62); CRTD 0.57 (0.51 to 0.64)).ConclusionsInternational variations in patient characteristics, practice and outcomes were observed. In-hospital mortality after CIED implantation was similar between Japan and the USA, except in cases of leadless pacemaker recipients.
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Lloyd-Evans, Brynmor, Marina Christoforou, David Osborn, Gareth Ambler, Louise Marston, Danielle Lamb, Oliver Mason, et al. "Crisis resolution teams for people experiencing mental health crises: the CORE mixed-methods research programme including two RCTs." Programme Grants for Applied Research 7, no. 1 (April 2019): 1–102. http://dx.doi.org/10.3310/pgfar07010.
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Background Crisis resolution teams (CRTs) seek to avert hospital admissions by providing intensive home treatment for people experiencing a mental health crisis. The CRT model has not been highly specified. CRT care is often experienced as ending abruptly and relapse rates following CRT discharge are high. Aims The aims of CORE (Crisis resolution team Optimisation and RElapse prevention) workstream 1 were to specify a model of best practice for CRTs, develop a measure to assess adherence to this model and evaluate service improvement resources to help CRTs implement the model with high fidelity. The aim of CORE workstream 2 was to evaluate a peer-provided self-management programme aimed at reducing relapse following CRT support. Methods Workstream 1 was based on a systematic review, national CRT manager survey and stakeholder qualitative interviews to develop a CRT fidelity scale through a concept mapping process with stakeholders (n = 68). This was piloted in CRTs nationwide (n = 75). A CRT service improvement programme (SIP) was then developed and evaluated in a cluster randomised trial: 15 CRTs received the SIP over 1 year; 10 teams acted as controls. The primary outcome was service user satisfaction. Secondary outcomes included CRT model fidelity, catchment area inpatient admission rates and staff well-being. Workstream 2 was a peer-provided self-management programme that was developed through an iterative process of systematic literature reviewing, stakeholder consultation and preliminary testing. This intervention was evaluated in a randomised controlled trial: 221 participants recruited from CRTs received the intervention and 220 did not. The primary outcome was re-admission to acute care at 1 year of follow-up. Secondary outcomes included time to re-admission and number of days in acute care over 1 year of follow-up and symptoms and personal recovery measured at 4 and 18 months’ follow-up. Results Workstream 1 – a 39-item CRT fidelity scale demonstrated acceptability, face validity and promising inter-rater reliability. CRT implementation in England was highly variable. The SIP trial did not produce a positive result for patient satisfaction [median Client Satisfaction Questionnaire score of 28 in both groups at follow-up; coefficient 0.97, 95% confidence interval (CI) –1.02 to 2.97]. The programme achieved modest increases in model fidelity. Intervention teams achieved lower inpatient admission rates and less inpatient bed use. Qualitative evaluation suggested that the programme was generally well received. Workstream 2 – the trial yielded a statistically significant result for the primary outcome, in which rates of re-admission to acute care over 1 year of follow-up were lower in the intervention group than in the control group (odds ratio 0.66, 95% CI 0.43 to 0.99; p = 0.044). Time to re-admission was lower and satisfaction with care was greater in the intervention group at 4 months’ follow-up. There were no other significant differences between groups in the secondary outcomes. Limitations Limitations in workstream 1 included uncertainty regarding the representativeness of the sample for the primary outcome and lack of blinding for assessment. In workstream 2, the limitations included the complexity of the intervention, preventing clarity about which were effective elements. Conclusions The CRT SIP did not achieve all its aims but showed potential promise as a means to increase CRT model fidelity and reduce inpatient service use. The peer-provided self-management intervention is an effective means to reduce relapse rates for people leaving CRT care. Study registration The randomised controlled trials were registered as Current Controlled Trials ISRCTN47185233 and ISRCTN01027104. The systematic reviews were registered as PROSPERO CRD42013006415 and CRD42017043048. Funding The National Institute for Health Research Programme Grants for Applied Research programme.
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Lloyd-Evans, Brynmor, David Osborn, Louise Marston, Danielle Lamb, Gareth Ambler, Rachael Hunter, Oliver Mason, et al. "The CORE service improvement programme for mental health crisis resolution teams: results from a cluster-randomised trial." British Journal of Psychiatry 216, no. 6 (February 14, 2019): 314–22. http://dx.doi.org/10.1192/bjp.2019.21.
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BackgroundCrisis resolution teams (CRTs) offer brief, intensive home treatment for people experiencing mental health crisis. CRT implementation is highly variable; positive trial outcomes have not been reproduced in scaled-up CRT care.AimsTo evaluate a 1-year programme to improve CRTs’ model fidelity in a non-masked, cluster-randomised trial (part of the Crisis team Optimisation and RElapse prevention (CORE) research programme, trial registration number: ISRCTN47185233).MethodFifteen CRTs in England received an intervention, informed by the US Implementing Evidence-Based Practice project, involving support from a CRT facilitator, online implementation resources and regular team fidelity reviews. Ten control CRTs received no additional support. The primary outcome was patient satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-8), completed by 15 patients per team at CRT discharge (n = 375). Secondary outcomes: CRT model fidelity, continuity of care, staff well-being, in-patient admissions and bed use and CRT readmissions were also evaluated.ResultsAll CRTs were retained in the trial. Median follow-up CSQ-8 score was 28 in each group: the adjusted average in the intervention group was higher than in the control group by 0.97 (95% CI −1.02 to 2.97) but this was not significant (P = 0.34). There were fewer in-patient admissions, lower in-patient bed use and better staff psychological health in intervention teams. Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up. There were no significant effects for other outcomes.ConclusionsThe CRT service improvement programme did not achieve its primary aim of improving patient satisfaction. It showed some promise in improving CRT model fidelity and reducing acute in-patient admissions.
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Pelton, T. A., S. Sharma, T. C. Schulz, J. Rathjen, and P. D. Rathjen. "Transient pluripotent cell populations during primitive ectoderm formation: correlation of in vivo and in vitro pluripotent cell development." Journal of Cell Science 115, no. 2 (January 15, 2002): 329–39. http://dx.doi.org/10.1242/jcs.115.2.329.
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Formation and differentiation of a pluripotent cell population is central to mammalian development, and the isolation, identification and manipulation of human pluripotent cells is predicted to be of therapeutic use. Within the early mammalian embryo, two distinct populations of pluripotent cells have been described: the inner cell mass (ICM), which differentiates to form a second pluripotent cell populations, the primitive ectoderm. Indirect evidence suggests the existence of temporally distinct intermediate pluripotent cell populations as primitive ectoderm is formed. We coupled an in vitro model of primitive ectoderm formation (the transition of embryonic stem cells to early primitive ectoderm-like (EPL) cells) with ddPCR-based techniques to identify three novel genes, Psc1, CRTR-1 and PRCE, that were expressed differently during pluripotent cell progression. Detailed mapping of these genes with Oct4, Rex1 and Fgf5 on pregastrulation embryos provided the first molecular evidence for the existence of successive, temporally distinct pluripotent cell populations in the embryo between the ICM and primitive ectoderm. No evidence was found for spatial heterogeneity within the Oct4+ pool. The transition between populations correlated with morphological or developmental alterations in pluripotent cells in vivo. Genes that are temporally expressed during pluripotent cell progression may provide an opportunity for molecular discrimination of pluripotent cells at different stages of maturation in vivo and an understanding of the cellular origins and properties of pluripotent cell lines isolated from diverse sources. Furthermore, the strong correlation of gene expression demonstrated between EPL cell formation in vitro and primitive ectoderm formation in vivo validates EPL cells as a model for primitive ectoderm, thereby providing a model system for the investigation of pluripotent differentiation and an opportunity for directed differentiation of pluripotent cells to therapeutically useful cell populations.
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Nix, Hayden P., Charles Weijer, Jamie C. Brehaut, David Forster, Cory E. Goldstein, and Monica Taljaard. "Informed consent in cluster randomised trials: a guide for the perplexed." BMJ Open 11, no. 9 (September 2021): e054213. http://dx.doi.org/10.1136/bmjopen-2021-054213.
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In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention—not the unit of randomisation—that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.
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Lee, Agnes Y., Carolyn Webb, Qing Guo, Lorrie Costantini, Greg Butler, and Mark N. Levine. "Prospective Cohort Study of the Incidence, Risk Factors and Long-Term Sequelae of Symptomatic Catheter-Related Thrombosis in Adults with Cancer." Blood 104, no. 11 (November 16, 2004): 2200. http://dx.doi.org/10.1182/blood.v104.11.2200.2200.
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Abstract Long-term indwelling central venous catheters (CVCs) are used for delivering chemotherapy, parenteral nutrition, antibiotics, and blood products, as well as for facilitating blood drawing, in many patients with malignancy. Although the important supportive role of CVCs is unquestioned, there is uncertainty regarding the prevention and treatment of catheter-related thrombosis (CRT) because there is a lack of prospective and contemporary data on the natural history of this complication. As a first step towards improving CRT management, we conducted a prospective cohort study to examine the incidence, clinical risk factors, and the long-term sequelae of symptomatic CRT in adults with cancer. Consecutive patients undergoing insertion of a CVC at a tertiary care center were enrolled and followed for the duration of their catheter-dwell time plus 4 weeks or a maximum of 52 weeks, whichever comes first. Scheduled assessments were done at weeks 1, 2, 4, 8, 12, 24, 36 and 52 weeks after insertion. Patients with symptomatic CRT were treated with anticoagulants and were followed for an additional 52 weeks from the date of CRT diagnosis. Baseline information and follow-up data regarding catheter patency, thromboprophylaxis, clinical symptoms, and thrombotic events was collected. Standardized regional guidelines for catheter care were followed and symptomatic CRT was diagnosed based on objective testing and satisfaction of prespecified criteria. Between March 2002 and July 2003, 444 patients underwent 500 catheter insertions. The mean patient age was 56 y (range 18–91 y) and 55% of patients were female. Catheters inserted included PICCs (65%), ports (18%), pheresis (11%), and Hickman catheters (6%). As of July 22, 2004, 442 patients had completed follow-up. The total catheter-dwell time was 59,959 d (median 88 d), while the total follow-up was 73,654 pt-d (median 151 d). Colorectal was the most common tumor type in 18% of patients and 41% of all patients at enrolment had metastatic solid tumor. Overall, there were 19 episodes of symptomatic CRT, representing an incidence of 4.3% (95% CI 2.6–6.6%) of patients or 0.3 CRTs per 1000 catheter-dwell days (95% CI 0.2–0.5 per 1000 d). The mean time to CRT was 53 d (range 6–162 d). Development of CRT was not associated with age, ECOG performance status, cancer treatment, catheter type, side of insertion, thromboprophylaxis, infection, or previous history of thrombosis. The only significant risk factor was ovarian cancer (P=0.02). In patients with symptomatic CRT, 89% (17/19) of CRTs were treated with anticoagulant therapy alone, 5.3% (1/19) had the catheter removed, and 5.3% (1/19) were treated with both; none had symptomatic pulmonary embolism or post-thrombotic syndrome during follow-up. In summary, the incidence of symptomatic CRT in adults with cancer is low and treatment with anticoagulant therapy alone was not associated with any serious long-term sequelae. Due to the small number of CRTs observed, larger studies are required to further evaluate risk factors and identify the optimal therapeutic approach for CRTs.
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Cong, X., X. Zang, M. Dong, Z. Wang, B. He, L. Hou, X. Wei, et al. "Accumulation of phytoene and astaxanthin and related genes expression in Haematococcus pluvialis under sodium acetate stress." Aquatic Biology 29 (November 19, 2020): 155–64. http://dx.doi.org/10.3354/ab00733.
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Phytoene and astaxanthin are 2 important carotenoids in the green alga Haematococcus pluvialis. Under environmental stress, the synthesis of phytoene in H. pluvialis increases significantly, and phytoene is converted to astaxanthin through enzymatic catalysis. This paper analyzes the relationship between astaxanthin and phytoene accumulation in carotenoid synthesis pathways under different concentrations of sodium acetate (NaAc) by high-performance liquid chromatography. The highest concentrations of phytoene and astaxanthin were observed at the NaAc concentration of 6 g l-1 on the 12th day of induction. The highest astaxanthin concentration achieved was 2.26 ± 0.28%. Therefore, we concluded that 6 g l-1 NaAc and induction for 12 d provided the optimal inducing conditions for astaxanthin accumulation in H. pluvialis. psy, pds, lcyB, β-carotene ketolase crtw, and crtz, which are genes related to phytoene and astaxanthin synthesis, were cloned and studied at the transcriptional level. crtw and crtz were continuously up-regulated since the first day of induction, while psy, pds, and lcyB were continuously up-regulated starting on the 3rd day of induction. These findings are important for enhancing our understanding of the mechanism of accumulation of phytoene and astaxanthin in H. pluvialis and provide a foundation for identifying the induction conditions necessary for optimizing astaxanthin production and increasing astaxanthin yields.
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Efird, Jimmy T., Ethan J. Anderson, Charulata Jindal, Thomas S. Redding, Andrew D. Thompson, Ashlyn M. Press, Julie Upchurch, Christina D. Williams, Yuk Ming Choi, and Ayako Suzuki. "The Interaction of Vitamin D and Corticosteroids: A Mortality Analysis of 26,508 Veterans Who Tested Positive for SARS-CoV-2." International Journal of Environmental Research and Public Health 19, no. 1 (December 31, 2021): 447. http://dx.doi.org/10.3390/ijerph19010447.
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This data-based cohort consisted of 26,508 (7%) United States veterans out of the 399,290 who tested positive for SARS-CoV-2 from 1 March to 10 September 2020. We aimed to assess the interaction of post-index vitamin D (Vit D) and corticosteroid (CRT) use on 30-day mortality among hospitalized and non-hospitalized patients with coronavirus disease 2019 (COVID-19). Combination Vit D and CRT drug use was assessed according to four multinomial pairs (−|+, −|−, +|+, +|−). Respective categorical effects were computed on a log-binomial scale as adjusted relative risk (aRR). Approximately 6% of veterans who tested positive for SARS-CoV-2 died within 30 days of their index date. Among hospitalized patients, a significantly decreased aRR was observed for the use of Vit D in the absence of CRTs relative to patients who received CRTs but not Vit D (aRR = 0.30; multiplicity corrected, p = 0.0004). Among patients receiving systemically administered CRTs (e.g., dexamethasone), the use of Vit D was associated with fewer deaths in hospitalized patients (aRR = 0.51) compared with non-hospitalized patients (aRR = 2.5) (P-for-Interaction = 0.0071). Evaluating the effect of modification of these compounds in the context of hospitalization may aid in the management of COVID-19 and provide a better understanding of the pathophysiological mechanisms underlying this and future infectious disease outbreaks.
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Lee, Jong Bin, Hyun Yeon Kim, Yun Young Kim, and Geun Woo Lee. "Predictors of Dexamethasone Response of Residual Edema by Branch Retinal Vein Occlusion after Bevacizumab Injection." Journal of the Korean Ophthalmological Society 63, no. 4 (April 15, 2022): 370–79. http://dx.doi.org/10.3341/jkos.2022.63.4.370.
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Purpose: To predict the response to intravitreal dexamethasone (IVD) implant injection in cases where macular edema (ME) caused by branch retinal vein occlusion persists despite intravitreal bevacizumab injection.Methods: Three consecutive (monthly) bevacizumab injections were given to treat ME caused by branched retinal vein occlusion (BRVO) 63 eyes that received additional dexamethasone or bevacizumab injection 1 month later to treat residual ME were retrospectively studied. Each injection group was divided into two subgroups according to ME disappearance status by 6 months after diagnosis. Initial central retinal thickness (CRT), subfoveal choroidal thickness (SFCT), and hyperreflective focus status were compared among the subgroups, as were the changes in these values.Results: At the decision point, the dexamethasone good response subgroups exhibited thicker CRTs and smaller CRT changes than the dexamethasone partial response subgroups (all p < 0.05). The good dexamethasone response subgroup showed smaller SFCT changes, a thicker CRT, and smaller CRT changes than the bevacizumab good response subgroup (all p < 0.05) at the decision point. The cutoff values of the Youden index were 409 μm for the CRT and 62.5 μm for the CRT change (p = 0.002 and p = 0.011, respectively).Conclusions: If ME persists after three bevacizumab injections, IVD more effectively reduces edema if the CRT is thick or if the CRT change is small.
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Aydiner, A., and G. Can. "Third-generation drugs in the chemoradiation of stage III non-small cell lung cancer (NSCLC): A meta-analysis of efficacy and toxicity parameters." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 7536. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.7536.
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7536 Background: The role of third generation drugs (paclitaxel, docetaxel, gemcitabine and vinorelbine) in the chemoradiotherapy to maximize survival and decrease toxicity in NSCLC is unclear. We performed a meta-analysis of published randomized controlled trials (RCT) comparing third generation drugs. Methods: We searched MEDLINE, EMBASE, CENTRAL, proceedings of ASCO and other Cancer Congresses to December 08 for RCTs comparing chemoradiation treatment (CRT) including any type of third generation drugs in stage III NSCLC patients who had not been treated surgically. Standard meta-analysis techniques, using random effects model, were used to compare study arms with regards to treatment response, survival and toxicity data. For treatment response odds ratio (OR), to reach complete response and overall response were calculated. For survival data, hazard ratios (HR) and confidence intervals (CI) of individual studies were calculated based on survival curves-published in the manuscript (Parmar MKB, 1998). Basically two types of comparisons were performed: (1) subgroups defined by the type of CRTs, (2) subgroups defined by the type of drugs administered. Results: We found 18 RCTs including 2725 patients. Concurrent CRT was superior to the pool of other types of CRT (overall survival [OAS] HR 0.76, 95%CI 0.6–0.96, p=0.021) and sequential CRT (OAS HR 0.59, 95%CI 0.39–0.88, p=0.01). CRT with paclitaxel was superior to CRT without paclitaxel or with another type of third generation drug with regard to complete response (OR 1.93, 95%CI 1.02–3.67, p=0.044), with no significant difference in OAS (HR 0.94, 95%CI 0.56–1.57, p=0.799). CRT with paclitaxel was less toxic to CRTs without paclitaxel or with another type of third generation drug with regard to the incidence of grade III and IV anemia (OR 0.1, 95%CI 0.03–0.36, p<0.001) and febrile neutropenia (OR 0.22, 95%CI 0.1–0.49, p<0.001). Conclusions: Paclitaxel has less haematologic toxicity when compared with the other drugs without any significant survival difference. No significant financial relationships to disclose.
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Wrighton, Katharine H. "Staying alive without CRTC-1." Nature Reviews Molecular Cell Biology 12, no. 4 (March 9, 2011): 206–7. http://dx.doi.org/10.1038/nrm3081.
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Li, Zhuolun, Youhong Gao, and Lang Han. "Holocene vegetation signals in the Alashan Desert of northwest China revealed by lipid molecular proxies from calcareous root tubes." Quaternary Research 88, no. 1 (June 29, 2017): 60–70. http://dx.doi.org/10.1017/qua.2017.33.
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AbstractIn the hinterland of deserts, it is difficult to reconstruct paleovegetation using fossil pollen because of the low pollen concentration. Therefore, an efficient method is needed to reconstruct the paleovegetation of desert regions. In this study, 34 Holocene calcareous root tube (CRT) samples were collected from the Alashan Desert in northwest China, and lipid molecular proxies from CRTs were selected to address this deficiency. The results show that n-alkanes mainly maximized at C27, C29, and C16, and that the carbon preference index is close to 1. Thus, the sources of n-alkanes from CRTs were the roots of higher plants and microorganisms, and thus changes in n-alkanes from CRTs could reveal variations in vegetation cover. The n-alkane Cmax of long-chain n-alkanes (C>25) in CRTs, maximizing at C27, indicated that vegetation in the Alashan Desert was characterized by shrub vegetation during the Holocene. Changes in the ratio of (C27+C29)/(C31+C33) indicated that the biomass of shrub vegetation increased during the period 7–2 cal ka BP. Moreover, the relative concentration of short-chain to long-chain n-alkanes decreased from 7 to 2 cal ka BP, suggesting that the effective moisture decreased during that period.
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Lairaksa, Nirut, and Tony Moon. "Use of CRT Funnel Glass as a Fine Aggregate in Self-Compacting Mortar: The Effect of Limestone on Pb Immobilization." Applied Mechanics and Materials 193-194 (August 2012): 513–16. http://dx.doi.org/10.4028/www.scientific.net/amm.193-194.513.
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End-of-life CRTs are classified as hazardous waste since the funnel glass component has a high Pb content. Alternative management of the glass is required due to the cessation of closed-loop recycling of CRT glass. This study aims to compare the feasibility of using CRT funnel glass as fine aggregates in a self-compacting mortar by addition of limestone to enhance the Pb immobilization. Sample mixtures of self-compacting mortar were prepared from Ordinary Portland cement Type 1 (OPC) with water/cementitious (W/C) ratio of 0.38 by weight, which contained 0, 20 and 40 wt% of Samsung CRT funnel glass ground to sizes smaller than 595 µm as a sand replacement. The sample with glass mixtures contained additions of 5, 10 and 15 wt% of limestone, ground to sizes smaller than 297 µm as a viscosity modifying agent (VMA). The samples’ flow ability was tested by V-funnel and Marsh cone. Pb-fixation in the samples was analysed by TCLP at 7 days and 14 days. The addition of limestone as a viscosity modifying agent improved flow ability in mixtures with CRT funnel glass, with the addition of 10 wt% limestone showing the highest flow improvement in V-funnel tests for both glass mixtures. CRT funnel glass utilized as sand replacement at 20 and 40 wt% showed Pb leaching results within the US EPA allowable limits. However, the addition of limestone reduced the Pb immobilization ability in mortars. A silica based VMA such as fly ash and rice husk ash should be used for these applications.
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Samaila, Aliyu, and Maxwell O. Adibe. "Symptoms’ resolution, adverse events profile and 1-year survival rate associated with different cervical cancer therapies among patients receiving care in two Nigerian tertiary hospitals." Journal of Pharmaceutical Health Services Research 13, no. 1 (December 18, 2021): 25–30. http://dx.doi.org/10.1093/jphsr/rmab066.
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Abstract Objectives To evaluate the symptoms’ resolution, adverse events (AEs) profile and 1-year survival rate associated with different cervical cancer (CC) therapies among patients receiving care in two Nigerian tertiary hospitals. Methods This study employed a prospective longitudinal design with a 12-month patient follow-up. It was conducted at Usmanu Danfodiyo University Teaching Hospital (UDUTH), Sokoto in Sokoto state and Ahmadu Bello University Teaching Hospital (ABUTH), Zaria in Kaduna state, North-Western Nigeria. Data of all the 157 eligible CC patients who came to the Radiotherapy and Clinical Oncology clinics of the hospitals were collected at baseline and after the first, third and last treatment courses/radiation fractions. Data analysis was done with appropriate descriptive and inferential statistics using SPSS V. 20 for windows. P < 0.05 was considered statistically significant. Key findings Patients who received chemoradiation therapy (CRT), 29 (100.0%), adjuvant chemoradiation therapy (CRTS), 9 (100.0%), adjuvant chemotherapy (CTS), 6 (100.0%) and chemotherapy (CT), 27 (28.1%) (P < 0.001) reported per vaginal bleeding (PVB) to have been completely stopped after therapy. Patients who received CT 4 (9.8%) experienced grade 3 anaemia, leucopaenia was experienced by patients who received CT 27 (54.0%) and CRT 20 (52.6%), P = 0.004. Grade 2 creatinine increase was observed in patients who received CRT 3 (8.1%) and CT 2 (3.1%), P = 0.013. There was no significant association between the therapy option received and 1-year survival rate of the patients within the clinical stage at P < 0.05. However, age (OR = 0.257, P = 0.042), number of comorbidities (OR = 0.123, P = 0.039) and number of complications (OR = 0.013, P < 0.001) were found to be the independent predictors of survival. Conclusions Chemoradiation and adjuvant therapies were found to be associated with the best resolution of symptoms. CT and CRT had high frequencies and severities of AEs. Therapy options received by the patients were not associated with their 1-year survival rates within clinical stages.
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AHMADIAN, F., and R. ZARE. "Electronic structure and band alignments of ${\mbox{ZnTe} \mathord{\left/ {\vphantom {\mbox{ZnTe} {\mbox{CrTe(0 0 1)}}}} \right. \kern-\nulldelimiterspace} {\mbox{CrTe}}}(0 0 1)$ , ${\mbox{CdSe} \mathord{\left/ {\vphantom {\mbox{CdSe} {\mbox{CrTe(0 0 1)}}}} \right. \kern-\nulldelimiterspace} {\mbox{CrTe}}}(0 0 1)$ and ${\mbox{CdTe} \mathord{\left/ {\vphantom {\mbox{CdTe} {\mbox{CrTe(0 0 1)}}}} \right. \kern-\nulldelimiterspace} {\mbox{CrTe}}}(0 0 1)$ interfaces." Pramana 77, no. 2 (August 2011): 383–94. http://dx.doi.org/10.1007/s12043-011-0133-0.
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Sardu, Celestino, Gaetano Santulli, Gianluigi Savarese, Maria Consiglia Trotta, Cosimo Sacra, Matteo Santamaria, Mario Volpicelli, et al. "Endothelial Dysfunction Drives CRTd Outcome at 1-Year Follow-Up: A Novel Role as Biomarker for miR-130a-5p." International Journal of Molecular Sciences 24, no. 2 (January 12, 2023): 1510. http://dx.doi.org/10.3390/ijms24021510.
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Endothelial dysfunction (ED) causes worse prognoses in heart failure (HF) patients treated with cardiac resynchronization therapy (CRTd). ED triggers the downregulation of microRNA-130 (miR-130a-5p), which targets endothelin-1 (ET-1). Thus, we evaluated ED and the response to CRTd by assessing miR-130a-5p and ET-1 serum levels. We designed a prospective multi-center study with a 1-year follow-up to evaluate ED, ET-1, and miR-130a-5p in CRTd patients with ED (ED-CRTd) vs. patients without ED (NED-CRTd). Clinical outcomes were CRTd response, HF hospitalization, cardiac death, and all-cause death. At 1-year follow-up, NED-CRTd (n = 541) vs. ED-CRTd (n = 326) patients showed better clinical statuses, lower serum values of B type natriuretic peptide (BNP: 266.25 ± 10.8 vs. 297.43 ± 16.22 pg/mL; p < 0.05) and ET-1 (4.57 ± 0.17 vs. 5.41 ± 0.24 pmol/L; p < 0.05), and higher values of miR-130a-5p (0.51 ± 0.029 vs. 0.41 ± 0.034 A.U; p < 0.05). Compared with NED-CRTd patients, ED-CRTd patients were less likely to be CRTd responders (189 (58%) vs. 380 (70.2%); p < 0.05) and had higher rates of HF hospitalization (115 (35.3%) vs. 154 (28.5%); p < 0.05) and cardiac deaths (30 (9.2%) vs. 21 (3.9%); p < 0.05). Higher miR-130a-5p levels (HR 1.490, CI 95% [1.014–2.188]) significantly predicted CRTd response; the presence of hypertension (HR 0.818, CI 95% [0.669–0.999]), and displaying higher levels of ET-1 (HR 0.859, CI 98% [0.839–0.979]), lymphocytes (HR 0.820, CI 95% [0.758–0.987]), LVEF (HR 0.876, CI 95% [0.760–0.992]), and ED (HR 0.751, CI 95% [0.624–0.905]) predicted CRTd non-response. Higher serum miR-130a-5p levels (HR 0.332, CI 95% [0.347–0.804]) and use of ARNI (HR 0.319, CI 95% [0.310–0.572]) predicted lower risk of HF hospitalization, whereas hypertension (HR 1.818, CI 95% [1.720–2.907]), higher BNP levels (HR 1.210, CI 95% [1.000–1.401]), and presence of ED (HR 1.905, CI 95% [1.238–2.241]) predicted a higher risk of HF hospitalization. Hence, serum miR-130a-5p could identify different stages of ED and independently predict CRTd response, therefore representing a novel prognostic HF biomarker.
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Culakova, Eva, Supriya Gupta Mohile, Mostafa Refaat Mohamed, Erika E. Ramsdale, Rachael Tylock, Megan Wells, Zhihong Zhang, et al. "Impact of adverse events on independence in daily functioning of older adults with advanced cancer treated with systemic therapy." Journal of Clinical Oncology 40, no. 28_suppl (October 1, 2022): 269. http://dx.doi.org/10.1200/jco.2022.40.28_suppl.269.
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269 Background: Older adults with advanced cancer are at increased risk of treatment-related toxicities, which can compromise physical performance and independence in daily functioning. However, studies evaluating the relationship of toxicities with functional capacity in this population are scarce. The aim of this analysis is to assess the effect of clinician-reported toxicities (CRTs) and patient-reported symptomatic toxicities (PRSTs) on physical performance and independence in daily functioning. Methods: This is a secondary analysis of GAP 70+ (NCT02054741, n = 718), a cluster randomized trial of older patients (70+ years) with advanced cancer initiating a new systemic therapy regimen. Impairments in physical performance [measured by Short Physical Performance Battery (SPPB)], and functional independence [measured by activities of daily living (ADL), and instrumental ADL (IADL)] were classified by established cut points. CRTs were collected by Common Terminology Criteria for Adverse Events (CTCAE) and PRSTs by Patient-Reported Outcome version of CTCAE (PRO-CTCAE). PRST grade was determined by severity of the items (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). To count as a PRST event, symptom severity had to increase from pre-treatment level (baseline adjusted method). Patients without baseline impairment in SPPB, IADL, and ADL (n = 104, 308, 461, respectively), who provided data after baseline were included in the analysis. To assess the association of experiencing toxicity within 3 months and developing functional impairment within 6 months, generalized estimating equation (GEE) modeling was used. Models were adjusted for practice sites (random effect) and the study arm. Results: Patients were 70-96 years old (mean 77), 56% were male, and majority (87%) were white. Gastrointestinal (34%) and lung (25%) were the most common cancer types. During treatment, impairments in SPPB developed in 57.7% (60/104), in IADL 47.4% (146/308), and in ADL 31.0% (143/461). There was no association of CRT grade with developing impairment in SPPB (p = 0.92). A greater proportion of patients who experienced grade ≥ 3 CRT, compared to those with grade 2 and grade ≤ 1 CRT, developed impairment in IADL (54.4 vs 38.3 vs 25.2%, p = 0.01) and also in ADL (34.8 vs 23.9 vs 22.7%, p = 0.02). Patients who experienced grade ≥ 3 PRST, compared to those with grade 2 and grade ≤ 1 PRST, were more likely to developed impaired SPPB (73.6 vs 50.4 vs 27.8%, p = 0.01), IADL (50.8 vs 45.4 vs 31.5%, p = 0.20), and ADL (38.1 vs 18.5 vs 19.7%, p < 0.01). Conclusions: Assessing both patient- and clinician-reported toxicity provides insight into loss of independent functioning. Information patients provide about symptoms can help with early detection of decline in physical performance in older adults. These findings may help to guide interventions to mitigate functional decline. Clinical trial information: NCT02054741.
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Forté, Stéphanie, Nafanta Fadiga, Olivia Pestrin, John Chinawaeze Aneke, Shivani Bhat, Richard Ward, and Kevin H. M. Kuo. "Is There a Role for Thromboprophylaxis in Sickle Cell Patients with Central Venous Access Devices?" Blood 132, Supplement 1 (November 29, 2018): 3518. http://dx.doi.org/10.1182/blood-2018-99-119716.
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Abstract Introduction: Chronic transfusion is a therapeutic modality in the prevention and treatment of end-organ damage in sickle cell disease (SCD) patients. Central venous access devices (CVAD) are commonly used in many SCD patients due to poor venous access. However, CVAD is a known risk factor for venous thromboembolism (VTE) (Evans et al, 2010), with right atrial thrombi prevalence estimated between 5.4 and 12.5% (Shah et al., 2004; Gilon et al., 1998). Although SCD is a prothrombotic state (Wun et al, 2013), it is not known whether this risk factor interacts with CVADs in a synergistic manner to increase the overall risk of VTE. No study has specifically addressed the role of thromboprophylaxis for CVAD-related VTEs in SCD, and as such the practice of prophylactic anticoagulation and/or antiplatelet therapy for CVAD is heterogeneous. We therefore conducted a quality improvement study to investigate whether thromboprophylaxis is a protective factor for new catheter-related thrombi (CRT). Methods: By cross-referencing imaging, thrombosis clinic, and sickle cell clinic databases, we identified adult SCD patients (≥ 18) of all genotypes followed within the Toronto General Hospital SCD center between January 1, 2009 and December 31, 2017 who had a CVAD intended for long-term use (≥3 months). CRT was defined as a VTE that developed while the CVAD was in place. Patients with no VTE during CVAD placement were assigned to the comparator group. Patients who were on anticoagulation for any alternative reason prior to CVAD insertion were excluded. The presence, type, and intensity of pharmacological thromboprophylaxis at the time of CRT or line insertion were recorded. Patient, catheter, and treatment-related risk factors of VTE were extracted from electronic patient records. Fisher-exact and chi-square tests were conducted to explore possible associations between categorical co-variates, and thromboprophylaxis use. Linear regression was performed for continuous variables; while binary logistic regression was conducted to examine the potential association between thromboprophylaxis use and CRT, while adjusting for sex, genotype, hydroxyurea use, and concomitant thrombosis risk factors. Results: We identified 52 unique patients from 3 databases. After applying the inclusion and exclusion criteria, 25 patients were retained as stated in Figure 1-CONSORT Flow Diagram. Patient characteristics are summarized in Table 1-Patient Demographics and Characteristics. Events were distributed as follows: 3 deep venous thrombi, 1 superficial venous thrombus, 1 pulmonary emboli, 2 right atrial thrombi, and 2 thrombi from other sites. Patients with CRT incurred significant sequelae, including open heart surgery to remove the clot in the two patients with right atrial thrombi. Univariate analysis illustrated association between the development of a CRT and the use of thromboprophylaxis, type of thromboprophylaxis, and dose intensity (p=0.011, p=0.011 and p=0.017, respectively). HU use showed a trend towards lower risk for CRT (OR 0.129, p=0.061). However, CRT was not associated with gender, genotype, type, site of insertion, year of insertion, duration of insertion, indication for CVAD, BMI, or ferritin. Association between CVAD thromboprophylaxis and CRT remained significant despite adjusting for sex, genotype, HU and concomitant thrombosis risk factors in binary logistic regression (p=0.032). Patients who received pharmacologic thromboprophylaxis for CVAD were 30.9 times less likely to have a CRT. Due to the limited sample size, not all variables could be included in the logistic regression. Conclusion: The presence of a CVAD is a significant risk factor for VTE in SCD patients. The retrospective study demonstrated that CRTs are associated with the absence of pharmacological thromboprophylaxis for CVADs. In addition, the potential role of HU in reducing thromboembolic risk in SCD patients with CVADs, requires further exploration. Finally, in the event that a CVAD is unavoidable we recommend consideration of pharmacologic thromboprophylaxis, in order to reduce patient morbidity and health-care associated costs. Disclosures Forté: Novartis: Honoraria.
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Sayyed, M. I., Nouf Almousa, and Mohamed Elsafi. "Green Conversion of the Hazardous Cathode Ray Tube and Red Mud into Radiation Shielding Concrete." Materials 15, no. 15 (August 2, 2022): 5316. http://dx.doi.org/10.3390/ma15155316.
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The present investigation was aimed at the utilization of alternate materials, emphasizing hazardous industrial products (red mud and cathode ray tubes), as constituents of radiation shielding concrete. The usage of these hazardous industrial products improves the sustainability and performance of the radiation shielding concrete. Five concrete blocks were cast and their density, compressive strength, gamma shielding factors, radiation absorption ratio, and transmission factor were explored. For this purpose, gamma-ray shielding measurements were done with the help of an HPGe detector. Mix-1, with zero contents of red mud and CRTs, had the lowest LAC. The LAC results demonstrated that the shielding performance of the current concretes would be better with the increase in red mud and cathode ray tube glass. The Transmission factor (TF) for the prepared concretes with a thickness of 2 cm varied between 11.9–26.1% at 0.06 MeV, while it varied between 4–13% for a thickness of 3 cm. The TF results showed that the composites with a thickness of 2, 3, or 5 cm are good shields against lower energy radiation. The radiation absorption ratio (RAR) for the prepared concretes is high at low energy, suggesting that these new composites can absorb most of the low-energy photons. The RAR results emphasize that the increase in CRTs in the new composites enhanced the radiation shielding features, and when the CRT glass is at a maximum, more attenuation was achieved.
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Bello, Hassan, and Kazeem Gbolagade. "An Efficient CRT Based Reverse Converter for {22n+1-1, 2n-1, 22n-1} Moduli Set." Journal of Advances in Mathematics and Computer Science 25, no. 6 (December 20, 2017): 1–9. http://dx.doi.org/10.9734/jamcs/2017/38517.
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Birgegard, Gunnar, Carlos Besses, Martin Griesshammer, Luigi Gugliotta, Claire N. Harrison, Mohamed Hamdani, Heinrich Achenbach, and Jean-Jacques Kiladjian. "Treatment of Essential Thrombocythemia in Europe: An Observational Study of 3649 High-Risk Patients in Exels." Blood 124, no. 21 (December 6, 2014): 1846. http://dx.doi.org/10.1182/blood.v124.21.1846.1846.
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Abstract BACKGROUND: The Evaluation of Xagrid Efficacy and Long-term Safety (EXELS) study (NCT00567502) is the largest prospective observational cohort of high-risk patients (pts) with essential thrombocythemia (ET) reported to date. OBJECTIVES: The primary objective was safety and pregnancy outcomes of anagrelide (ANA) compared with other cytoreductive therapies (CRT). Secondary objectives included efficacy, measured by the incidence of thrombohemorrhagic events and platelet reduction. METHODS: High-risk pts (≥1 of age >60 yrs, previous thrombotic event, platelet count >1000 x 109/L) with ET were enrolled across 13 countries in Europe between 2005 and 2009. Pts were required to be receiving CRT. Data, including events predefined in the protocol (PDEs), were collected every 6 mo for 5 yrs for all patients. Event rates are presented as number of pts per 100 patient-years exposure and by treatment at time of event. Event rates are provided rather than p values due to the observational nature of the study. Preliminary final data are presented and final data, including platelet response and pregnancy results, will be available at ASH. Recently, results have remained stable and conclusions are not expected to change. RESULTS: 3649 pts were categorized according to treatment at registration as follows: ANA (n=804), ANA + other CRT (n=141), other CRT (n=2666) and no CRT (n=38). Over 80% of pts received either hydroxycarbamide (HC) or ANA, and 69.8% of pts received anti-aggregatory therapy. At registration, median age was lower in the ANA (55.5 yrs, range 18‒89) and ANA + other CRT (59.0 yrs, range 22–88) groups vs the other CRT group (70.0 yrs, range 17‒95). The arterial thrombotic event rate was similar in ANA (1.63) and other CRT (1.62) groups, whereas venous thrombotic event rates differed (0.35 vs 0.57). The major hemorrhagic event rate was highest in the ANA group, especially in pts also treated with anti-aggregatory therapy (1.24). 105 pts transformed to myelofibrosis (MF) and 62 to acute leukemia (AL). Transformation to MF rates were similar in the ANA (1.31), ANA + other CRT (1.27) groups, and lower in the other CRT (0.32) group. Rate of transformation to AL was 0.17, 0.46, and 0.33, respectively. In pts who had only ever received either ANA or HC, rate of transformation to MF was higher in the ANA vs HC group (0.78 vs 0.17) whereas transformation to AL was higher in the HC vs ANA group (0.22 vs 0). All pts who ever received ANA and transformed to AL had also received prior HC. PDEs of greatest interest are displayed in Table 1. Non-hematological malignancy was the most frequent PDE in the other CRT group. 57.4% of deaths were attributed to a PDE; transformation (event rate, 1.9), most frequently to AL (1.3), and non-hematological malignancies (1.6) were the most frequent causes of PDE-related death. No unexpected side effects were noted. The proportion of pts with a white blood cell (WBC) count >15 x 109/L at any time was higher in pts who died (12.5%) vs alive pts (6.1%) and in pts who had transformed (15.7%) vs those who did not transform (5.7%). CONCLUSION: Pts receiving ANA were younger than those receiving other CRT. Thrombotic event rates were low; arterial events were similar between ANA and other CRT groups, and venous events were lower in the ANA vs other CRT group. Hemorrhage was most frequent in the ANA + anti-aggregatory therapy group, whereas non-hematological malignancy was most frequent in the other CRT group. Transformation to MF and AL were most frequent in the ANA and HC groups, respectively. The incidence of death and transformation was higher in pts with a WBC count >15 x 109/L. Abstract 1846. Table 1 Treatment at time of event ANA N=1127 ANA + other CRTN=451 Other CRT N=2909 No CRT N=645 PDE Pts(events)n Event rate Pts(events)n Event rate Pts(events)n Event rate Pts(events)n Event rate Total thrombohemorrhagic events 92 (113) 2.75 24 (29) 2.86 270 (326) 2.60 30 (33) 4.91 Arterial thrombotic events 55 (65) 1.63 19 (21) 2.25 171 (200) 1.62 17 (19) 2.74 Venous thrombotic events 12 (13) 0.35 1 (1) 0.11 61 (67) 0.57 7 (7) 1.13 Major hemorrhagic events 30 (35) 0.87 6 (7) 0.69 53 (59) 0.49 7 (7) 1.12 Transformation to: Myelofibrosis 45 (45) 1.31 11 (11) 1.27 35 (35) 0.32 14 (14) 2.31 Acute leukemia 6 (6) 0.17 4 (4) 0.46 36 (36) 0.33 16 (17) 2.57 Non-hematological malignancy 17 (18) 0.49 4 (5) 0.46 143 (161) 1.35 12 (13) 1.95 Non-PDE death 22 (22) 0.64 7 (7) 0.8 128 (128) 1.18 30 (30) 4.80 ANA, anagrelide; CRT, cytoreductive therapy; PDE, predefined event; Pts, patients Disclosures Birgegard: Shire Pharmaceuticals: Consultancy, Honoraria, Research Funding. Besses:Shire Pharmaceuticals: honoraria for educational lectures Other. Griesshammer:Amgen: Honoraria; Sanofi: Honoraria; Shire: Honoraria; Novartis: Honoraria; Roche: Honoraria. Gugliotta:Shire Pharmaceuticals: Honoraria, Research Funding. Harrison:Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; S Bio: Honoraria; YMBioscience: Honoraria; CTI: Honoraria; Gilead: Honoraria; Sanofi: Honoraria, Speakers Bureau; Shire Pharmaceuticals: Honoraria, Speakers Bureau. Hamdani:Shire Pharmaceuticals: Employment. Achenbach:Shire Pharmaceuticals: Employee Other. Kiladjian:Shire Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees.
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Lin, Jiunn-Lee. "S32-1 ICD/CRT-D Therapy in Asia." CVD Prevention and Control 4 (May 2009): S43. http://dx.doi.org/10.1016/s1875-4570(09)60161-3.
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Hwang, Deok Won, Su Jin Lee, Jeeyun Lee, Se Hoon Park, Joonoh Park, YoungSuk Park, Hoyeong Lim, and WonKi Kang. "Adjuvant chemoradiation therapy with 5-FU/LV (INT-0116) versus S-1 chemotherapy in completely resected gastric cancer: Practice pattern and feasibility at a single institution." Journal of Clinical Oncology 30, no. 4_suppl (February 1, 2012): 57. http://dx.doi.org/10.1200/jco.2012.30.4_suppl.57.
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57 Background: Considering the high incidence of gastric cancer worldwide, large-scaled phase III adjuvant trials have been relatively scarcely reported. Until 2010, there have been two large-scaled adjuvant trials in gastric cancer that showed survival benefit from adjuvant chemotherapy +/- radiotherapy: S-1 monotherapy and chemoradiation therapy (CRT) with 5-FU/LV. There has been no direct comparison between S-1 monotherapy and CRT. We analyzed the practice pattern of adjuvant treatment at single institution in Korea in terms of patient’s preference, compliance rate, adverse events between CRT and S-1. Methods: From January 2008 to July 2009, 405 gastric cancer patients who had received adjuvant therapy after curative resection were included for the study. The CRT regimen was INT 0116 protocol. The S-1 monotherapy was to administer 40-60 mg bid, for 28 days, every 6 weeks (8 cycles). Results: Of the total 405 patients, 244 (60.3%) patients had CRT and 161 (39.7%) patients had S-1 monotherapy. The median age was 54 years (range, 24-80) and most of the patients were ECOG PS 0-1. S-1 group was more common than CRT group in Stage II (52.2% for S-1 vs. 47.8% for CCRT) and CRT group was more common in stage III-IV (72.4% for CCRT vs. 27.6% for S-1, p<0.001). The patients’ compliance for the planned treatment was significantly higher in CRT group (95.1% vs. 72.8%, p<0.001). Most common reason for cessation of S-1 therapy was patients’ refusal. For severe adverse events, grade 3-4 neutropenia was substantially more frequent in CRT group (40.2% vs. 8.7%, p<0.001) and GI toxicities of nausea and mucositis were frequent in CRT group when compared with S-1 group (CRT vs S-1; nausea, 5.7% vs <1%; p=0.002; mucositis, 7.4% vs 2.5%; p=0.034). Conclusions: Patients with advanced stage (III–IV) preferred CRT to S-1. The compliance was significantly higher for the CRT group despite of higher incidence of adverse events.
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Shirasawa, Masayuki, Tatsuya Yoshida, Noriko Motoi, Yuji Matsumoto, Yuki Shinno, Yusuke Okuma, Yasushi Goto, et al. "Impact of chemoradiotherapy (CRT) on immune-related tumor microenvironment and the efficacy of anti-PD-1 therapy after the recurrence of CRT in unresectable locally advanced NSCLC patients." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e21719-e21719. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e21719.
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e21719 Background: Chemoradiotherapy (CRT) followed by durvalumab as maintenance therapy prolonged progression-free survival (PFS) and overall survival (OS) in unresectable locally advanced NSCLC (LA-NSCLC). Additionally, the history of radiotherapy and CRT has been reported to increase the efficacy of PD-1 blockade in advanced NSCLC patients. We evaluated the efficacy of anti-PD-(L)1 antibody therapy after CRT failure, and how CRT changes the status of PD-L1 expression on tumors and tumor infiltrated lymphocytes (TILs) in tumor microenvironment (TME) in unresectable LA-NSCLC patients. Methods: We retrospectively reviewed unresectable LA-NSCLC patients treated with CRT between December 2007 and December 2018, and evaluated the efficacy of PD-1 blockade after CRT failure. We also analyzed PD-L1 (clone: 22C3) expression on tumor cells, and CD8 positive TILs using the paired specimens that had been obtained pre-CRT and post-CRT failure. Results: We identified 422 patients who received CRT. Median follow-up was 36.1 months (range 2.7–138.1 months). Among these patients, sixty-five patients who had progressed post-CRT received anti-PD- (L)1 therapy (PD-1 therapy: 61 patients, PD-L1 therapy: 4 patients). Response rate (RR) and PFS of anti-PD-(L)1 therapy were 48% (95% CI, 35–60) and 8.7 (95% CI, 4.5–13.0) months. The RR and PFS did not differ according to PD-L1 expression levels (Table). Of the 18 patients, 9, 7, and 2 showed upregulation in PD-L1 expression or down- or no change, respectively, post-CRT. In contrast, the density of CD8 positive TILs in TME increased by CRT treatment ([pre-CRT]: median, 110 ± 239 /mm2 vs. [post-CRT]: median, 470 ± 533 /mm2, p = 0.025). Conclusions: The clinical outcome of anti-PD-(L)1 therapy after CRT failure in LA-NSCLC patients could be better than advanced NSCLC patients, but did not differ according to PD-L1 expression levels. The efficacy of PD-(L)1 therapy enhanced by CRT treatment could be due to the infiltration of CD8 T-cells into TME. [Table: see text]
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Ni, Xiang-Rong, Yi-Ying Zhao, Hai-Ping Cai, Zhi-Hui Yu, Jing Wang, Fu-Rong Chen, Yan-Jiao Yu, Guo-Kai Feng, and Zhong-ping chen. "NIMG-25. TRANSFERRIN RECEPTOR 1 TARGETED PET/CT AND NIFR PROBES FOR IMAGING GLIOBLASTOMA MOUSE MODELS." Neuro-Oncology 22, Supplement_2 (November 2020): ii152. http://dx.doi.org/10.1093/neuonc/noaa215.638.
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Abstract OBJECTIVE A new imaging technology that indiscriminately detects intracranial glioblastoma (GBM) can help neurosurgeons remove tumor mass completely. Transferrin receptors (TfR 1) have been widely investigated as a diagnostic and therapeutic target in GBM. A TfR 1-targeted peptide, CRTIGPSVC (CRT) can accumulate at high levels in GBM tissues. In our study, taking the advantage of CRT, we synthesized two molecular imaging probes for imaging GBM precisely. One is a PET/CT probe 18F-NOTA-CRT, and the other is a near-infrared fluorescent (NIFR) probe Cy5-CRT. METHODS We initially confirmed the overexpression of TfR 1 in most of GBM and the tumor-specific homing ability of 18F-NOTA-CRT and Cy5-CRT in orthotopic U87 GBM (TfR 1 overexpression) mouse models. We then examined the feasibility of Cy5-CRT for specially identifying the GBM tissue margin in the intracranial U87 xenografts in vivo and ex vivo. Next, we compared Cy5-CRT with the clinically used fluorescein sodium in identifying tumor margins. Finally, we used Cy5-CRT to carry out a fluorescence-guided operation on a orthotopic U87 mouse model. RESULTS Both 18F-NOTA-CRT and Cy5-CRT probes specifically accumulated in U87 GBM xenografts with TfR 1 overexpression, but not in U373 GBM xenografts with very low TfR 1 expression. Cy5-CRT detected the intracranial tumor burden with exceptional contrast, enabling fluorescence-guided GBM resection under NIFR live imaging conditions. Importantly, Cy5-CRT recognized the GBM tissue margin more clearly than fluorescein sodium. CONCLUSIONS Our probes were capable of thoroughly detecting GBM tissue in vivo imaging. For translational applications, we may screen patients before surgery by PET/CT imaging with 18F-NOTA-CRT to identify gliomas with TfR 1 overexpression. As for fluorescence-guided surgery, the TfR 1-targeted optical probe Cy5-CRT specifically differentiates tumor tissues from normal brain with high sensitivity, indicating its potential application for the precise surgical removal of GBM. Keywords: Transferrin receptor 1; PET/CT; near-infrared fluorescence imaging; glioblastoma, fluorescence-guided surgery
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Tolaney, Sara M., Nabihah Tayob, Chau Dang, Denise A. Yardley, Steven J. Isakoff, Vicente Valero, Meredith Faggen, et al. "Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial." Journal of Clinical Oncology 39, no. 21 (July 20, 2021): 2375–85. http://dx.doi.org/10.1200/jco.20.03398.
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PURPOSE The ATEMPT trial was designed to determine if treatment with trastuzumab emtansine (T-DM1) caused less toxicity than paclitaxel plus trastuzumab (TH) and yielded clinically acceptable invasive disease-free survival (iDFS) among patients with stage I human epidermal growth factor receptor 2–positive (HER2+) breast cancer (BC). METHODS Patients with stage I centrally confirmed HER2+ BC were randomly assigned 3:1 to T-DM1 or TH and received T-DM1 3.6 mg/kg IV every 3 weeks for 17 cycles or T 80 mg/m2 IV with H once every week × 12 weeks (4 mg/kg load →2 mg/kg), followed by H × 39 weeks (6 mg/kg once every 3 weeks). The co-primary objectives were to compare the incidence of clinically relevant toxicities (CRTs) in patients treated with T-DM1 versus TH and to evaluate iDFS in patients receiving T-DM1. RESULTS The analysis population includes all 497 patients who initiated protocol therapy (383 T-DM1 and 114 TH). CRTs were experienced by 46% of patients on T-DM1 and 47% of patients on TH ( P = .83). The 3-year iDFS for T-DM1 was 97.8% (95% CI, 96.3 to 99.3), which rejected the null hypothesis ( P < .0001). Serially collected patient-reported outcomes indicated that patients treated with T-DM1 had less neuropathy and alopecia and better work productivity compared with patients on TH. CONCLUSION Among patients with stage I HER2+ BC, one year of adjuvant T-DM1 was associated with excellent 3-year iDFS, but was not associated with fewer CRT compared with TH.
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Park, Byung-Jae, Duk-Gyu Lee, Jae-Ran Yu, Sun-ki Jung, Kyuyeong Choi, Jungsoo Lee, Jiyeon Lee, et al. "Calreticulin, a Calcium-binding Molecular Chaperone, Is Required for Stress Response and Fertility in Caenorhabditis elegans." Molecular Biology of the Cell 12, no. 9 (September 2001): 2835–45. http://dx.doi.org/10.1091/mbc.12.9.2835.
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Calreticulin (CRT), a Ca2+-binding protein known to have many cellular functions, including regulation of Ca2+ homoeostasis and chaperone activity, is essential for heart and brain development during embryogenesis in mice. Here, we report the functional characterization of Caenorhabditis elegans calreticulin (crt-1). Acrt-1 null mutant does not result in embryonic lethality but shows temperature-dependent reproduction defects. In C. elegans CRT-1 is expressed in the intestine, pharynx, body-wall muscles, head neurons, coelomocytes, and in sperm. crt-1males exhibit reduced mating efficiency and defects late in sperm development in addition to defects in oocyte development and/or somatic gonad function in hermaphrodites. Furthermore, crt-1 anditr-1 (inositol triphosphate receptor) together are required for normal behavioral rhythms. crt-1transcript level is elevated under stress conditions, suggesting that CRT-1 may be important for stress-induced chaperoning function inC. elegans.
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Boehm, Ernest, Sharon Chan, Mina Monfared, Theo Wallimann, Kieran Clarke, and Stefan Neubauer. "Creatine transporter activity and content in the rat heart supplemented by and depleted of creatine." American Journal of Physiology-Endocrinology and Metabolism 284, no. 2 (February 1, 2003): E399—E406. http://dx.doi.org/10.1152/ajpendo.00259.2002.
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The intracellular creatine concentration is an important bioenergetic parameter in cardiac muscle. Although creatine uptake is known to be via a NaCl-dependent creatine transporter (CrT), its localization and regulation are poorly understood. We investigated CrT kinetics in isolated perfused hearts and, by using cardiomyocytes, measured CrT content at the plasma membrane or in total lysates. Rats were fed control diet or diet supplemented with creatine or the creatine analog β-guanidinopropionic acid (β-GPA). Creatine transport in control hearts followed saturation kinetics with a K m of 70 ± 13 mM and a V max of 3.7 ± 0.07 nmol · min−1 · g wet wt−1. Creatine supplementation significantly decreased the V max of the CrT (2.7 ± 0.17 nmol · min−1 · g wet wt−1). This was matched by an ∼35% decrease in the plasma membrane CrT; the total CrT pool was unchanged. Rats fed β-GPA exhibited a >80% decrease in tissue creatine and increase in β-GPAtotal. The V max of the CrT was increased (6.0 ± 0.25 nmol · min−1 · g wet wt−1) and the K m decreased (39.8 ± 3.0 mM). The plasma membrane CrT increased about fivefold, whereas the total CrT pool remained unchanged. We conclude that, in heart, creatine transport is determined by the content of a plasma membrane isoform of the CrT but not by the total cellular CrT pool.
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Wang, Tian, Ezra Wiater, Xinmin Zhang, John B. Thomas, and Marc Montminy. "Crtc modulates fasting programs associated with 1-C metabolism and inhibition of insulin signaling." Proceedings of the National Academy of Sciences 118, no. 12 (March 15, 2021): e2024865118. http://dx.doi.org/10.1073/pnas.2024865118.
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Fasting in mammals promotes increases in circulating glucagon and decreases in circulating insulin that stimulate catabolic programs and facilitate a transition from glucose to lipid burning. The second messenger cAMP mediates effects of glucagon on fasting metabolism, in part by promoting the phosphorylation of CREB and the dephosphorylation of the cAMP-regulated transcriptional coactivators (CRTCs) in hepatocytes. In Drosophila, fasting also triggers activation of the single Crtc homolog in neurons, via the PKA-mediated phosphorylation and inhibition of salt-inducible kinases. Crtc mutant flies are more sensitive to starvation and oxidative stress, although the underlying mechanism remains unclear. Here we use RNA sequencing to identify Crtc target genes that are up-regulated in response to starvation. We found that Crtc stimulates a subset of fasting-inducible genes that have conserved CREB binding sites. In keeping with its role in the starvation response, Crtc was found to induce the expression of genes that inhibit insulin secretion (Lst) and insulin signaling (Impl2). In parallel, Crtc also promoted the expression of genes involved in one-carbon (1-C) metabolism. Within the 1-C pathway, Crtc stimulated the expression of enzymes that encode modulators of S-adenosyl-methionine metabolism (Gnmt and Sardh) and purine synthesis (ade2 and AdSl). Collectively, our results point to an important role for the CREB/CRTC pathway in promoting energy balance in the context of nutrient stress.
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Miyatani, Tomohiko, Toru Utsunomiya, Nobuhiro Kurita, Takashi Iwata, Hirohiko Sato, Masanori Nishioka, Shinya Morimoto, et al. "Randomized clinical trial of preoperative chemoradiotherapy by S-1 versus UFT to rectal cancer for personalized therapy." Journal of Clinical Oncology 30, no. 4_suppl (February 1, 2012): 432. http://dx.doi.org/10.1200/jco.2012.30.4_suppl.432.
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432 Background: Preoperative chemoradiotherapy (CRT) in rectal cancer reduces the local recurrence rate after operation and preserves the anus, but it is difficult to predict the effects of CRT. Our purpose of this study was to determine the effects and adverse events of CRT (S-1 or UFT) and to predict the response to CRT in rectal cancer by using both miRNA and DNA expression patterns. Methods: Rectal cancer patients (n=60) who underwent preoperative CRT were randomly divided into two groups (40Gy radiotherapy combined with S-1: 31 patients or UFT: 29 patients). The effects and adverse events of CRT were compared between S-1 group and UFT group. Additionally, RNA and DNA isolated from biopsy specimens of rectal cancer before preoperative CRT were hybridized to miRNA and DNA microarrays. Response to CRT was determined by histopathologic examination of surgically resected specimens. Results: Response to CRT determined by histopathologic examination of surgically resected specimens and RECIST were as follows: responders (grade 2 or 3) were 60%(S-1) and 52%(UFT) (p=0.52). Adverse events of CRT did not differ significantly between the 2 groups, and there was no adverse event of grade 3 or 4. As candidate predictive genes, 184 genes (S-1 group) and 193 genes (UFT group) were identified by DNA microarray, while 6 miRNA (S-1 group) and 16 miRNA (UFT group) were isolated by miRNA microarray as candidate predictive miRNA. Conclusions: Preoperative CRT using S-1 or UFT to rectal cancer is effective and the adverse events were acceptable. Expression profiling of both gene and miRNA may predict the effects of preoperative CRT, implicating the possible personalized therapy for patients with rectal cancer.
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Kim, Kyung Hwan, Hongryull Pyo, Dongryul Oh, Jae Myoung Noh, Yong Chan Ahn, Hong In Yoon, Jiyun Lee, et al. "Abstract 5198: Dynamics of circulating immune cells during chemoradiotherapy in patients with locally advanced non-small cell lung cancer support earlier administration of anti-PD-1/PD-L1 therapy." Cancer Research 82, no. 12_Supplement (June 15, 2022): 5198. http://dx.doi.org/10.1158/1538-7445.am2022-5198.
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Abstract Background: Chemoradiotherapy (CRT) followed by consolidation immune checkpoint inhibitors (ICIs) significantly improves survival in unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, the optimal sequence for CRT and ICIs has not yet been established. We investigated the dynamics of peripheral blood immune cells during CRT to determine the best sequence for treatment. Methods: Peripheral blood samples were prospectively collected pre-treatment, weekly during CRT for 6 weeks, and 1 month post-treatment in 24 patients with LA-NSCLC who received definitive CRT. Immune cell analysis was performed by flow cytometry. Ex vivo PD-1 blockade assays were performed by IFN-γ intracellular cytokine staining. Results: Lymphopenia was prominently observed during CRT and mostly recovered 1 month post-CRT. Robust proliferation of CD8+ T cells was induced, peaking in the last week during CRT and decreasing post-CRT. The robust proliferation of CD8+ T cells led to an increase in the frequency of CD28-CD57+ replicative senescent and terminally differentiated cells post-CRT. Tumor-reactive CD8+ T cells increased during CRT and peaked in the last week. One month post-CRT, the frequency of tumor-reactive CD8+ T cells decreased and TOXhiTCF1lo terminally exhausted CD8+ T cells significantly increased. Anti-PD-1-induced functional restoration of PD-1+CD8+ T cells was maximized in the last week of CRT and significantly decreased post-CRT. Conclusions: The findings suggest that earlier administration of PD-1 blockade may be associated with superior efficacy compared to delayed administration after completion of CRT. These findings provide an immunological rationale for optimal timing of combining ICIs with CRT in clinical trials. Citation Format: Kyung Hwan Kim, Hongryull Pyo, Dongryul Oh, Jae Myoung Noh, Yong Chan Ahn, Hong In Yoon, Jiyun Lee, Sehhoon Park, Hyun-Ae Jung, Jong-Mu Sun, Se-Hoon Lee, Jin Seok Ahn, Keunchil Park, Bo Mi Ku, Myung-Ju Ahn, Eui-Cheol Shin. Dynamics of circulating immune cells during chemoradiotherapy in patients with locally advanced non-small cell lung cancer support earlier administration of anti-PD-1/PD-L1 therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5198.
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Valueva, Maria, Georgii Valuev, Nataliya Semyonova, Pavel Lyakhov, Nikolay Chervyakov, Dmitry Kaplun, and Danil Bogaevskiy. "Construction of Residue Number System Using Hardware Efficient Diagonal Function." Electronics 8, no. 6 (June 20, 2019): 694. http://dx.doi.org/10.3390/electronics8060694.
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The residue number system (RNS) is a non-positional number system that allows one to perform addition and multiplication operations fast and in parallel. However, because the RNS is a non-positional number system, magnitude comparison of numbers in RNS form is impossible, so a division operation and an operation of reverse conversion into a positional form containing magnitude comparison operations are impossible too. Therefore, RNS has disadvantages in that some operations in RNS, such as reverse conversion into positional form, magnitude comparison, and division of numbers are problematic. One of the approaches to solve this problem is using the diagonal function (DF). In this paper, we propose a method of RNS construction with a convenient form of DF, which leads to the calculations modulo 2 n , 2 n − 1 or 2 n + 1 and allows us to design efficient hardware implementations. We constructed a hardware simulation of magnitude comparison and reverse conversion into a positional form using RNS with different moduli sets constructed by our proposed method, and used different approaches to perform magnitude comparison and reverse conversion: DF, Chinese remainder theorem (CRT) and CRT with fractional values (CRTf). Hardware modeling was performed on Xilinx Artix 7 xc7a200tfbg484-2 in Vivado 2016.3 and the strategy of synthesis was highly area optimized. The hardware simulation of magnitude comparison shows that, for three moduli, the proposed method allows us to reduce hardware resources by 5.98–49.72% in comparison with known methods. For the four moduli, the proposed method reduces delay by 4.92–21.95% and hardware costs by twice as much by comparison to known methods. A comparison of simulation results from the proposed moduli sets and balanced moduli sets shows that the use of these proposed moduli sets allows up to twice the reduction in circuit delay, although, in several cases, it requires more hardware resources than balanced moduli sets.
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Piette, Caroline, Stefan Suciu, Yves Bertrand, Anne Uyttebroeck, Els Vandecruys, Geneviève Plat, Patrick Lutz, et al. "Prophylactic CNS Therapy (with or without Radiation Therapy) in Medium-High Risk Acute Lymphoblastic Leukemia (ALL) Children: Long-Term Outcome Evaluation of the Randomized BFM-Oriented Trial 58832 (period 1983-1989) of the EORTC Children Leukemia Group." Blood 128, no. 22 (December 2, 2016): 2775. http://dx.doi.org/10.1182/blood.v128.22.2775.2775.
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Abstract Background Cranial radiotherapy (CRT) is associated with early and late side effects. Intrathecal (IT) and systemic chemotherapy could successfully replace CRT in most protocols for standard risk ALL. However, in medium and high risk ALL patients (pts) its omission is still debatable. Aim We investigated the long-term outcome, the occurrence of second malignant neoplasms (SMN) and the incidence of late toxicities in pts randomized for receiving or not CRT in the EORTC 58832 study. Methods From 1983 to 1989, ALL children under 18 years (yrs) were included in EORTC Children Leukemia Group BFM-oriented studies, either 58831, for standard risk pts (Riehm-Langerman Risk Factor (RF) < 1.2), or 58832, for medium risk (RF 1.2-1.69) and high risk pts (RF ≥1.7). Pts with central nervous system (CNS) involvement at diagnosis were ineligible. The present report focusses on pts included in the 58832 trial (randomized for receiving or not prophylactic CRT). Prophylactic CNS therapy consisted of 4 high-dose methotrexate (HD-MTX) injections (2500 mg/m2) during consolidation and 7 IT MTX injections scheduled during the treatment period. Pts still in complete remission (CR) after the end of late intensification were randomized for receiving prophylactic CRT (standard arm) or not (experimental arm) before the start of continuation therapy. Dose of CRT was age dependent: 24 Gy (> 2 yrs), 20 Gy (1-2 yrs) and 16 Gy (< 1 yr). Endpoints were: disease-free survival (DFS) (event: relapse, death in CR), incidence of SMN, event-free survival (EFS) (event: relapse, death in CR, SMN), incidence of late toxicities, and overall survival (OS) from randomization. Results 788 pts were included in the 58831/58832 study. Among them, 189 were randomized in the 58832 study to receive CRT (n=93) or No CRT (n=96). A total of 6 pts did not meet eligibility criteria, 2 had an early relapse, 3 had an early protocol violation and 2 refused allocated treatment. Finally, 176 randomized pts were included in the analyses: 84 in the CRT group and 92 in the No CRT group. The median follow-up was 20 yrs (range 4-32 yrs). Omission of CRT did not increase the 25-yr incidence of isolated CNS relapse, any CNS relapse or non-CNS relapse (4.8 vs 6.5; 11.9 vs 8.7 and 16.7 vs 21.8 in the CRT vs No CRT arms, respectively). No relapses occurred after 10 yrs. The 25-yr DFS rates were similar in both arms: 70.2% with CRT and 67.4% without CRT; No CRT vs CRT hazard ratio (HR)=1.08, 95% CI (0.63, 1.83). CRT was associated with an increase of the 25-yr SMN incidence: 13.2% with CRT and 3.9% without CRT. In the CRT arm, 9 pts (10.7%) developed SMN: 2 acute myeloid leukemias (AML), 1 non-Hodgkin lymphoma, 1 thyroid carcinoma, 4 meningiomas and 1 malignant histiocytosis. One SMN (meningioma) occurred after a CNS combined relapse. Three pts developed second SMN (meningiomas): 1 after an AML and 2 after a first meningioma. In the No CRT arm, 3 pts (3.3%) had SMN: 1 pleomorphic xanthoastrocytoma, 1 melanoma and 1 adenocarcinoma of the ileum. One SMN occurred after a bone marrow (BM) relapse. The 25-yr EFS rates were similar in both arms: 60.3% with CRT and 63.2% without CRT, HR=0.90, 95% CI (0.55, 1.46). CRT was also associated with an increase of late CNS and endocrine toxicities. Five pts (19.2% of the pts with available data) developed leukoencephalopathy in the CRT arm, versus 2 pts (8.7%) in the No CRT arm. Noteworthy, 1 of those 2 pts received CRT for a BM relapse, while the other received total body irradiation for a CNS relapse. Stroke was observed in 2 pts (7.7%) who received CRT. In contrast, there was no clear increase of the incidence of cognitive disturbance after CRT: 33.3% in the CRT arm vs 25.0% in the No CRT arm. Regarding endocrine toxicities, GH deficiency, hypothyroidism and precocious puberty were more frequent in the CRT arm: 53.1% vs 29.6%, 27.8% vs 0% and 29.4% vs 0%, respectively. Finally, the 25-yr OS rates were similar in both arms: 78.5% with CRT and 78.1% without CRT, HR=1.00, 95% CI (0.53, 1.88). Conclusion In medium and high risk pts without CNS involvement at diagnosis and treated with HD-MTX in the EORTC trial 58832 (1983-1989), omission of CRT did not increase the risk of CNS or non-CNS relapse. On long-term evaluation, CRT was associated with a higher incidence of SMN, late CNS and endocrine toxicities. These long-term results indicate that prophylactic CRT can be safely omitted in childhood medium and high risk ALL pts receiving IT and systemic chemotherapy (including HD-MTX) as CNS prophylaxis. Table Table. Disclosures No relevant conflicts of interest to declare.
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Inadomi, Kyoko, Masayuki Watanabe, Yohei Nagai, Koichi Nonaka, Koichi Sakurai, Satoshi Ida, Shiro Iwagami, et al. "Clinical availability of endoscopic submucosal dissection for patients with local failure after chemoradiotherapy for esophageal squamous cell carcinoma." Journal of Clinical Oncology 30, no. 4_suppl (February 1, 2012): 118. http://dx.doi.org/10.1200/jco.2012.30.4_suppl.118.
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118 Background: Local failure after chemoradiotherapy (CRT) remains a major problem for patients with esophageal squamous cell carcinoma (ESCC), and there are few curative treatment options available in such cases except salvage esophagectomy. The aim of this study is to demonstrate the clinical efficacy and safety of endoscopic submucosal dissection as a salvage therapy (salvage ESD) for local failure after CRT. Methods: Between 2007 and 2011, 66 patients underwent ESD for superficial ESCC in our hospital. Five of these patients underwent salvage ESD for local failure after CRT, and were reviewed retrospectively. They were treated with CRT, consisting of 60 Gy irradiation and concurrent chemotherapy. The indications for salvage ESD were as follows: 1) absence of lymph-node or distant metastasis after CRT; 2) superficial and endoscopically resectable lesion after CRT; 3) refusal by patient to undergo salvage esophagectomy; 4) written informed consent. Salvage ESD was performed using a flush knife or hook knife with a hyaluronic acid injection into the submucosal layer. Results: The baseline stage before CRT was as follows: T1b/T2/T3 in 3/1/1, N0/1 in 4/1, and M0/1 in 4/1 patients, respectively. These 5 patients had histologically proven local failure, and the stage after CRT was as follows: T1a/T1b in 1/4, N0/1 in 5/0, and M0/1 in 5/0 patients, respectively. Salvage ESD was performed in all patients who had en bloc resection with no complications and pathologically R0 resection. In 5 patients, 2 had a pT1a lesion, and 3 had a pT1b lesion. 1 lesion recurred in other site 3 months after salvage ESD, which was resected successfully by a second ESD procedure. Conclusions: Salvage ESD is an available option for patients with local failure after CRT for ESCC.
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Fanari, Zaher, Hadi Mahmaljy, Mohammad Al-Akchar, Jennifer Nichelson, Kurtis A. Heil, John B. Gill, Shailesh Nandish, Gregory Mishkel, Nilesh J. Goswami, and Jeffrey A. Goldstein. "CRT-700.07 Predictors of 1-Year Mortality After TAVR." JACC: Cardiovascular Interventions 11, no. 4 (February 2018): S48. http://dx.doi.org/10.1016/j.jcin.2018.01.160.
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Bui, Van Cuong, The Tam Le, Tuyen Hong Nguyen, Nam Thi Pham, Hoang Dinh Vu, Xuan Canh Nguyen, Quang De Tran, Thai Hoang, Quang Le Dang, and Tran Dai Lam. "Curcumin-removed turmeric oleoresin nano-emulsion as a novel botanical fungicide to control anthracnose (Colletotrichum gloeosporioides) in litchi." Green Processing and Synthesis 10, no. 1 (January 1, 2021): 729–41. http://dx.doi.org/10.1515/gps-2021-0071.
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Abstract During curcumin production in Vietnam, curcumin-removed turmeric oleoresin (CRTO) has been considered as a by-product. It costs to treat the by-product to prevent environmental pollution. In this study, the by-product was utilized as an active ingredient for preparing a botanical fungicide-based nano-emulsion and evaluated for its in vitro and in vivo control efficacy against Colletotrichum gloeosporioides, a causal agent of anthracnose of litchi, in the laboratory as well as a field trial. The nano-emulsion is colloidally stable and uniform with particle sizes of 95–250 nm. CRTO nano-emulsion significantly affected various Colletotrichum species. Notably, this nano-emulsion showed potent inhibition for the mycelial growth of C. gloeosporioides and solidly suppressed the development of anthracnose on litchi fruits. In the in vitro inhibition test, the equivalent half-maximal inhibitory concentration of CRTO in nano-formulation was 0.11 mg·mL−1, which was 3.0× and 6.1× lower than IC50 values of CRTO alone (0.33 mg·mL−1) and a mixture of curcuminoids (0.48 mg·mL−1), respectively. In the field trial, the litchi anthracnose infection was effectively controlled by nano-formulation. These results suggest that CRTO nano-emulsion could be used as an alternative to harmful synthetic fungicides to control anthracnose on litchi fruits.
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Saito, Gota, Sotaro Sadahiro, Hiroshi Miyakita, Kazutake Okada, Akira Tanaka, and Toshiyuki Suzuki. "Relations of changes in serum carcinoembryonic antigen (CEA) levels before and after chemoradiotherapy (CRT) and after surgery to histological response and outcomes in patients with locally advanced rectal cancer (LARC)." Journal of Clinical Oncology 35, no. 4_suppl (February 1, 2017): 804. http://dx.doi.org/10.1200/jco.2017.35.4_suppl.804.
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804 Background: Multidisciplinary treatment had been a standard of care for locally advanced rectal cancer. Serum CEA had been reported as one of the predictive factors to CRT, however, serum CEA levels may change after CRT and surgery. We examined the relations of serum CEA before CRT, after CRT, and after surgery to histological response and outcomes. Methods: The subjects were 149 patients with cStage II or III adenocarcinoma of the rectum who underwent surgery after CRT from 2005 through 2013. A total dose of 40 to 45 Gy with concurrent oral UFT or S-1 was delivered. Surgery was performed 6 to 8 weeks after CRT. A serum CEA > 5 ng/mL was defined as positive. Patients with negative serum CEA before CRT were designated as group 1. Patients with positive serum CEA before CRT that became negative after CRT were designated as group 2. Patients with positive serum CEA after CRT that became negative after surgery were designated as group 3, and patients with positive serum CEA after CRT as well as after surgery were designated as group 4. The median follow-up period of the survivors was 60.4 months. Results: The numbers of patients in Groups 1, 2, 3, and 4 were 55 (37%), 41 (28%), 37 (25%), and 16 (11%), respectively. The incidences of pCR, T downstaging, and N downstaging did not differ significantly among the groups (p = 0.094, 0.060, and 0.346). Rates of marked regression (TRG Grade 1 or 2) were 55% in Group 1, 42% in Group 2, 16% in Group 3, 25% in group 4. The rates were significantly higher in groups 1 and 2 (p = 0.001).5y DFS was 76% in group 1, 75% in group 2, 77% in group 3, and 48% in group 4 and was significantly lower in group 4 (p = 0.024). 5y OS was 88% in group 1, 91% in group 2, 85% in group 3, and 68% in group 4 and was significantly lower in group 4 than that in groups 1 and 2 (p = 0.03, 0.019). Conclusions: In patients with rectal cancer who received CRT, changes in serum CEA levels before and after CRT and after surgery were intimately related to the histological response of the primary lesion. Patients who continued to have positive serum CEA levels after surgery had poor outcomes, strongly suggesting the presence of occult distant metastasis.
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Hitt, R., J. J. Grau, A. Lopez-Pousa, A. Berrocal, C. Garcia Giron, A. Irigoyen, J. Sastre, J. Martinez, H. Cortes-Funes, and J. Cruz-Hernandez. "Final results of a randomized phase III trial comparing induction chemotherapy with cisplatin/5-FU or docetaxel/cisplatin/5-FU follow by chemoradiotherapy (CRT) versus CRT alone as first-line treatment of unresectable locally advanced head and neck cancer (LAHNC)." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 6009. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6009.
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6009 Background: Induction chemotherapy (IC) with TPF isa standard regimen for patients (pts) with locally advanced head and neck squamous cell carcinoma (N Engl J Med. 2007;357:1705–1715). However, CRT alone is standard treatment for unresectable LAHNC. We designed a trial to compare two different regimens of IC followed by CRT versus CRT alone in pts with unresectable LAHNC. Methods: Pts with unresectable, measurable LAHNC, adequate organ function, and ECOG 0–1 were enrolled and stratified according to primary tumor site. (IC) regimens (3 cycles): PF (cisplatin 100 mg/m2 day [d] 1, then 5-FU 1,000 mg/m2 continuous infusion [CI], d1–5, q21d); TPF (docetaxel 75 mg/m2 d1, cisplatin 75 mg/m2 d1, 5-FU 750 mg/m2 CI, d1–5, q21d plus G-CSF and ciprofloxacin). All pts were to receive CRT, consisting of conventional radiotherapy up to 70 Gy plus cisplatin 100 mg/m2 d 1, 22, 43. The primary end point was time to treatment failure (TTF) for (IC) vs. no (IC); secondary endpoints included locoregional control (LRC) rate and safety; 438 pts were needed to demonstrate a 15% difference in treatment failure (death, progression, surgery, other treatments) with α = 0.05, β = 0.2. Results: From December 2002 to June 2007, 439 pts were enrolled: IC 311 pts (TPF 155, PF 156) and CRT 128 pts. The majority of pts were: ECOG 1 (70%); oropharynx and oral cavity (63%); T4 (75%); N2-N3 (61%). In evaluable pts (at least 1 cycle), the median TTF was 12.5 months with IC/CRT vs. 4.9 months with CRT alone (p < 0.001; HR 0.57; 95%CI 0.44–0.74); LRC rate was 60.9% IC/CRT vs. 44.5% CRT (p = 0.003; OR = 0.52; 95%CI 0.3–0.81). Grade 3–4 adverse events (IC/CRT vs. CRT) occurred in 83% vs. 69% of pts and included febrile neutropenia (10% vs 1%), and stomatitis (43.7% vs 37%). Conclusions: This is the first phase III trial to demonstrate that (IC) followed by CRT significantly increases TTF and LRC compared with CRT alone in pts with unresectable LAHNC. IC/CRT should now be considered standard treatment for these pts. No significant financial relationships to disclose.
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Grasso, Lewis, Daniel T. Lindsey, Yoo-Jeong Noh, Christopher O’Dell, Ting-Chi Wu, and Fanyou Kong. "Improvements to Cloud-Top Brightness Temperatures Computed from the CRTM at 3.9 μm." Monthly Weather Review 146, no. 11 (November 1, 2018): 3927–44. http://dx.doi.org/10.1175/mwr-d-17-0342.1.
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ABSTRACT In preparation for all-sky satellite radiance assimilation, the Community Radiative Transfer Model (CRTM), version 2.1.3, was used to produce Geostationary Operational Environmental Satellite-12/13 (GOES-12/13) imagery near 3.9 μm. For the current study, model output simulated from different models, microphysics, and weather events was used by the CRTM to generate imagery over and near the United States. A direct comparison of observed and CRTM GOES-12/13 imagery near 3.9 μm revealed that CRTM brightness temperatures of solid-water cold cloud tops were approximately 30 K less than observed values. Two CRTM errors were identified and resolved: 1) a coding error that was found by the CRTM team and 2) incorrect optical properties of ice, resulting in improved values of brightness temperatures. Further, changes in microphysics also contributed to improvements, save for one case. The coding error solution appeared in the publicly released CRTM, version 2.3.0, on 27 November 2017, while the inclusion of the optical property solution is undetermined. Since the CRTM is the radiative transfer model within the operational data assimilation system at the National Centers for Environmental Prediction (NCEP), improvements to both the CRTM and model microphysics will be beneficial for future all-sky radiance assimilation activities.
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Steiger, Sabine, Shinichi Takaichi, and Gerhard Sandmann. "Heterologous production of two unusual acyclic carotenoids, 1,1′-dihydroxy-3,4-didehydrolycopene and 1-hydroxy-3,4,3′,4′-tetradehydrolycopene by combination of the crtC and crtD genes from Rhodobacter and Rubrivivax." Journal of Biotechnology 97, no. 1 (July 2002): 51–58. http://dx.doi.org/10.1016/s0168-1656(02)00055-x.
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Nishioka, M., M. Shimada, N. Kurita, T. Iwata, S. Morimoto, K. Yoshikawa, J. Higashijima, T. Miyatani, H. Kashihara, and C. Mikami. "A randomized phase II trial of chemoradiotherapy with oral fluoropyrimidine inhibitory for dihydropyrimidine dehydrogenase for low rectal cancer: An interim report." Journal of Clinical Oncology 29, no. 4_suppl (February 1, 2011): 524. http://dx.doi.org/10.1200/jco.2011.29.4_suppl.524.
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524 Background: Preoperative chemoradiotherapy (CRT) has been widely used to improve local control of disease and to preserve anal sphincter in the treatment of rectal cancer. However, the response to CRT differs among individual tumors. In ASCO 2008 Gastrointestinal Cancers Symposium, we reported that the patients with up-regulation of 17 genes were suggested to be good responder of CRT. Our purpose of this study was to evaluate the toxicity and efficacy of CRT using UFT versus S-1 and explore biomarkers for response in patients with locally advanced rectal cancer. Methods: Fifty patients who received preoperative CRT (40Gy radiotherapy) were randomly assigned to either UFT or S-1. UFT and S-1 were administered during the radiotherapy course. S-1 was a novel oral fluoropyrimidine inhibitory for dihydropyrimidine dehydrogenase and had potent radiosensitizing property. Biopsy specimens were obtained from rectal cancer before preoperative CRT and were analyzed by focused DNA microarray (132 genes). To pick up the predictive factors, the 132 genes were selected in the view of sensitivity of 5FU. Response to CRT was determined by RECIST and histopathologic examination of surgically resected specimens and classified as responders (CR, PR and grade 2, 3) or nonresponders (SD, PD and grade 0, 1). Results: UFT group (n=25) and S-1 group (n=25) were enrolled. Response rate (grade 2 or 3) to CRT determined by histopathologic examination of surgically resected specimens was 58% in the UFT group and was 75% in the S-1 group. Response rate evaluated by RECIST criteria was 62% in the UFT group and was 77% in the S-1 group. National Cancer Institute Common Toxicity Criteria grade 2 or 3 toxicity was observed in 8% of the patients in the UFT group and 23% of patients in the S-1 group. Grade 2 or 3 toxicity in the UFT group was neutropenia and was diarrhea, neutropenia and dermatitis in the S-1 group. In ASCO 2010, we will report each candidate biomarker genes for response to CRT in the UFT and S-1 group. Conclusions: The results have suggested that CRT using UFT or S-1 is feasible and effective for patients with locally advanced rectal cancer. [Table: see text]
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Paradis, Catherine, Jinhui Zhao, and Tim Stockwell. "What popular bars post on social media platforms: a case for improved alcohol advertising regulation." Health Promotion and Chronic Disease Prevention in Canada 40, no. 5/6 (June 2020): 160–70. http://dx.doi.org/10.24095/hpcdp.40.5/6.03.
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Introduction The aim of this study was to document the scope of violations of the Canadian Radio-television and Telecommunications Commission (CRTC) "Code for Broadcast Advertising of Alcoholic Beverages" (CRTC Code) by drinking venues posting alcohol-related content on social media platforms, and to assess whether CRTC Code violations by drinking venues relate to their popularity among university students and to students' drinking behaviours. Methods In phase 1 of the study, a probability sample of 477 students from four Canadian university responded to a questionnaire about their drinking and preferred drinking venues. In phase 2, a probability sample of 78 students assessed the compliance of drinking venues' social media posts with the 17 CRTC Code guidelines. We pooled both datasets and linked them by drinking venues. Results Popular drinking venues were overwhelming posting alcohol-related content that contravenes the CRTC Code. Adjusted effect estimates show that a decrease in the mean level of compliance with the CRTC Code was significantly associated with a 1% increase in popularity score of drinking venues (t-test, p < .001). With regard to drinking behaviours, a 1% increase in the overall mean level of compliance with the CRTC Code was associated with 0.458 fewer drinking days per week during a semester (t-test, p = .01), 0.294 fewer drinks per occasion (t-test, p = .048) and a lesser likelihood of consuming alcohol when attending a drinking venue (t-test, p = .001). Conclusion The results of this study serve as a reminder to territorial and provincial regulatory agencies to review their practices to ensure that alcohol advertising guidelines are applied and enforced consistently. More importantly, these results call for the adoption of federal legislation with a public health mandate that would apply to all media, including print, television and radio, digital and social.
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Chan, Claire L., Clémence Leyrat, and Sandra M. Eldridge. "Quality of reporting of pilot and feasibility cluster randomised trials: a systematic review." BMJ Open 7, no. 11 (November 2017): e016970. http://dx.doi.org/10.1136/bmjopen-2017-016970.
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ObjectivesTo systematically review the quality of reporting of pilot and feasibility of cluster randomised trials (CRTs). In particular, to assess (1) the number of pilot CRTs conducted between 1 January 2011 and 31 December 2014, (2) whether objectives and methods are appropriate and (3) reporting quality.MethodsWe searched PubMed (2011–2014) for CRTs with ‘pilot’ or ‘feasibility’ in the title or abstract; that were assessing some element of feasibility and showing evidence the study was in preparation for a main effectiveness/efficacy trial. Quality assessment criteria were based on the Consolidated Standards of Reporting Trials (CONSORT) extensions for pilot trials and CRTs.ResultsEighteen pilot CRTs were identified. Forty-four per cent did not have feasibility as their primary objective, and many (50%) performed formal hypothesis testing for effectiveness/efficacy despite being underpowered. Most (83%) included ‘pilot’ or ‘feasibility’ in the title, and discussed implications for progression from the pilot to the future definitive trial (89%), but fewer reported reasons for the randomised pilot trial (39%), sample size rationale (44%) or progression criteria (17%). Most defined the cluster (100%), and number of clusters randomised (94%), but few reported how the cluster design affected sample size (17%), whether consent was sought from clusters (11%), or who enrolled clusters (17%).ConclusionsThat only 18 pilot CRTs were identified necessitates increased awareness of the importance of conducting and publishing pilot CRTs and improved reporting. Pilot CRTs should primarily be assessing feasibility, avoiding formal hypothesis testing for effectiveness/efficacy and reporting reasons for the pilot, sample size rationale and progression criteria, as well as enrolment of clusters, and how the cluster design affects design aspects. We recommend adherence to the CONSORT extensions for pilot trials and CRTs.