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Article ; Online: The International Collaboration on Cancer Reporting (ICCR): 10 Years Progress in the Development of Cancer Pathology Datasets.

Helliwell, Timothy R / Judge, Meagan J / Birdsong, George G / Ellis, David W / Srigley, John R

International journal of gynecological pathology : official journal of the International Society of Gynecological Pathologists

2022 Volume 41, Issue Suppl 1, Page(s) S3–S7

MeSH term(s)	Humans ; Pathology, Clinical ; Neoplasms
Language	English
Publishing date	2022-08-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	604859-6
ISSN	1538-7151 ; 0277-1691
ISSN (online)	1538-7151
ISSN	0277-1691
DOI	10.1097/PGP.0000000000000899
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Article ; Online: TIME Trial: Effect of Timing of Stem Cell Delivery Following ST-Elevation Myocardial Infarction on the Recovery of Global and Regional Left Ventricular Function: Final 2-Year Analysis.

Circulation research

2017 Volume 122, Issue 3, Page(s) 479–488

Abstract: Rationale: The TIME trial (Timing in Myocardial Infarction Evaluation) was the first cell therapy trial sufficiently powered to determine if timing of cell delivery after ST-segment-elevation myocardial infarction affects recovery of left ventricular ( ... ...

Abstract	Rationale: The TIME trial (Timing in Myocardial Infarction Evaluation) was the first cell therapy trial sufficiently powered to determine if timing of cell delivery after ST-segment-elevation myocardial infarction affects recovery of left ventricular (LV) function. Objective: To report the 2-year clinical and cardiac magnetic resonance imaging results and their modification by microvascular obstruction. Methods and results: TIME was a randomized, double-blind, placebo-controlled trial comparing 150 million bone marrow mononuclear cells versus placebo in 120 patients with anterior ST-segment-elevation myocardial infarctions resulting in LV dysfunction. Primary end points included changes in global (LV ejection fraction) and regional (infarct and border zone) function. Secondary end points included changes in LV volumes, infarct size, and major adverse cardiac events. Here, we analyzed the continued trajectory of these measures out to 2 years and the influence of microvascular obstruction present at baseline on these long-term outcomes. At 2 years (n=85), LV ejection fraction was similar in the bone marrow mononuclear cells (48.7%) and placebo groups (51.6%) with no difference in regional LV function. Infarct size and LV mass decreased ≥30% in each group at 6 months and declined gradually to 2 years. LV volumes increased ≈10% at 6 months and remained stable to 2 years. Microvascular obstruction was present in 48 patients at baseline and was associated with significantly larger infarct size (56.5 versus 36.2 g), greater adverse LV remodeling, and marked reduction in LV ejection fraction recovery (0.2% versus 6.2%). Conclusions: In one of the longest serial cardiac magnetic resonance imaging analyses of patients with large anterior ST-segment-elevation myocardial infarctions, bone marrow mononuclear cells administration did not improve recovery of LV function over 2 years. Microvascular obstruction was associated with reduced recovery of LV function, greater adverse LV remodeling, and more device implantations. The use of cardiac magnetic resonance imaging leads to greater dropout of patients over time because of device implantation in patients with more severe LV dysfunction resulting in overestimation of clinical stability of the cohort. Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00684021.
MeSH term(s)	Adult ; Aged ; Bone Marrow Transplantation/methods ; Double-Blind Method ; Female ; Follow-Up Studies ; Heart Ventricles/pathology ; Humans ; Magnetic Resonance Imaging ; Male ; Microcirculation ; Middle Aged ; Organ Size ; ST Elevation Myocardial Infarction/complications ; ST Elevation Myocardial Infarction/pathology ; ST Elevation Myocardial Infarction/therapy ; Stroke Volume ; Time Factors ; Ventricular Dysfunction, Left/etiology ; Ventricular Dysfunction, Left/therapy
Language	English
Publishing date	2017-12-05
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	80100-8
ISSN	1524-4571 ; 0009-7330 ; 0931-6876
ISSN (online)	1524-4571
ISSN	0009-7330 ; 0931-6876
DOI	10.1161/CIRCRESAHA.117.311466
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Ui IV Zs.60: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)

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Article ; Online: Excess of proximal microsatellite-stable colorectal cancer in African Americans from a multiethnic study.

Xicola, Rosa M / Gagnon, Molly / Clark, Julia R / Carroll, Timothy / Gao, Weihua / Fernandez, Christian / Mijic, Dragana / Rawson, James B / Janoski, Ashley / Pusatcioglu, Cenk K / Rajaram, Priyanka / Gluskin, Adam B / Regan, Maureen / Chaudhry, Vivek / Abcarian, Herand / Blumetti, Jennifer / Cintron, Jose / Melson, Joshua / Xie, Hui /

Guzman, Grace / Emmadi, Rajyasree / Alagiozian-Angelova, Victoria / Kupfer, Sonia S / Braunschweig, Carol / Ellis, Nathan A / Llor, Xavier

Clinical cancer research : an official journal of the American Association for Cancer Research

2014 Volume 20, Issue 18, Page(s) 4962–4970

Abstract: Purpose: African Americans (AA) have the highest incidence of colorectal cancer compared with other U.S. populations and more proximal colorectal cancers. The objective is to elucidate the basis of these cancer disparities.: Experimental design: Of ... ...

Abstract	Purpose: African Americans (AA) have the highest incidence of colorectal cancer compared with other U.S. populations and more proximal colorectal cancers. The objective is to elucidate the basis of these cancer disparities. Experimental design: Of note, 566 AA and 328 non-Hispanic White (NHW) colorectal cancers were ascertained in five Chicago hospitals. Clinical and exposure data were collected. Microsatellite instability (MSI) and BRAF (V600E) and KRAS mutations were tested. Statistical significance of categorical variables was tested by the Fisher exact test or logistic regression and age by the Mann-Whitney U test. Results: Over a 10-year period, the median age at diagnosis significantly decreased for both AAs (68-61; P < 0.01) and NHWs (64.5- 62; P = 0.04); more AA patients were diagnosed before age 50 than NHWs (22% vs. 15%; P = 0.01). AAs had more proximal colorectal cancer than NHWs (49.5% vs. 33.7%; P < 0.01), but overall frequencies of MSI, BRAF and KRAS mutations were not different nor were they different by location in the colon. Proximal colorectal cancers often presented with lymphocytic infiltrate (P < 0.01) and were diagnosed at older ages (P = 0.02). Smoking, drinking, and obesity were less common in this group, but results were not statistically significant. Conclusions: Patients with colorectal cancer have gotten progressively younger. The excess of colorectal cancer in AAs predominantly consists of more proximal, microsatellite stable tumors, commonly presenting lymphocytic infiltrate and less often associated with toxic exposures or a higher BMI. Younger AAs had more distal colorectal cancers than older ones. These data suggest two different mechanisms driving younger age and proximal location of colorectal cancers in AAs.
MeSH term(s)	African Americans/genetics ; Age Distribution ; Age of Onset ; Aged ; Colorectal Neoplasms/epidemiology ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/pathology ; Humans ; Microsatellite Instability ; Middle Aged ; Mutation ; Proto-Oncogene Proteins/genetics ; Proto-Oncogene Proteins B-raf/genetics ; Proto-Oncogene Proteins p21(ras) ; ras Proteins/genetics
Chemical Substances	KRAS protein, human ; Proto-Oncogene Proteins ; BRAF protein, human (EC 2.7.11.1) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1) ; Proto-Oncogene Proteins p21(ras) (EC 3.6.5.2) ; ras Proteins (EC 3.6.5.2)
Language	English
Publishing date	2014-07-10
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-14-0353
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Zs.A 4223: Show issues

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Article: The novel gamma secretase inhibitor N-[cis-4-[(4-chlorophenyl)sulfonyl]-4-(2,5-difluorophenyl)cyclohexyl]-1,1,1-trifluoromethanesulfonamide (MRK-560) reduces amyloid plaque deposition without evidence of notch-related pathology in the Tg2576 mouse.

Best, Jonathan D / Smith, David W / Reilly, Michael A / O'Donnell, Ruth / Lewis, Huw D / Ellis, Semantha / Wilkie, Neil / Rosahl, Thomas W / Laroque, Philippe A / Boussiquet-Leroux, Christine / Churcher, Ian / Atack, John R / Harrison, Timothy / Shearman, Mark S

The Journal of pharmacology and experimental therapeutics

2007 Volume 320, Issue 2, Page(s) 552–558

Abstract: There is a substantial body of evidence indicating that beta-amyloid peptides (Abeta) are critical factors in the onset and development of Alzheimer's disease (AD). One strategy for combating AD is to reduce or eliminate the production of Abeta through ... ...

Abstract	There is a substantial body of evidence indicating that beta-amyloid peptides (Abeta) are critical factors in the onset and development of Alzheimer's disease (AD). One strategy for combating AD is to reduce or eliminate the production of Abeta through inhibition of the gamma-secretase enzyme, which cleaves Abeta from the amyloid precursor protein (APP). We demonstrate here that chronic treatment for 3 months with 3 mg/kg of the potent, orally bioavailable and brain-penetrant gamma-secretase inhibitor N-[cis-4-[(4-chlorophenyl)-sulfonyl]-4-(2,5-difluorophenyl)cyclohexyl]-1,1,1-trifluoromethanesulfonamide (MRK-560) attenuates the appearance of amyloid plaques in the Tg2576 mouse. These reductions in plaques were also accompanied by a decrease in the level of reactive gliosis. The morphometric and histological measures agreed with biochemical analysis of Abeta(40) and Abeta(42) in the cortex. Interestingly, the volume of the plaques across treatment groups did not change, indicating that reducing Abeta levels does not significantly alter deposit growth once initiated. Furthermore, we demonstrate that these beneficial effects can be achieved without causing histopathological changes in the ileum, spleen, or thymus as a consequence of blockade of the processing of alternative substrates, such as the Notch family of receptors. This indicates that in vivo a therapeutic window between these substrates seems possible--a key concern in the development of this approach to AD. An understanding of the mechanisms whereby MRK-560 shows differentiation between the APP and Notch proteolytic pathway of gamma-secretase should provide the basis for the next generation of gamma-secretase inhibitors.
MeSH term(s)	Alzheimer Disease/drug therapy ; Alzheimer Disease/metabolism ; Alzheimer Disease/pathology ; Amyloid Precursor Protein Secretases/antagonists & inhibitors ; Amyloid beta-Peptides/metabolism ; Amyloid beta-Protein Precursor/antagonists & inhibitors ; Amyloid beta-Protein Precursor/metabolism ; Animals ; Brain/drug effects ; Brain/pathology ; Female ; Male ; Mice ; Protease Inhibitors/pharmacology ; Receptors, Notch/antagonists & inhibitors ; Receptors, Notch/metabolism ; Sulfonamides/pharmacology ; Sulfones/pharmacology
Chemical Substances	Amyloid beta-Peptides ; Amyloid beta-Protein Precursor ; MRK 560 ; Protease Inhibitors ; Receptors, Notch ; Sulfonamides ; Sulfones ; Amyloid Precursor Protein Secretases (EC 3.4.-)
Language	English
Publishing date	2007-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	3106-9
ISSN	1521-0103 ; 0022-3565
ISSN (online)	1521-0103
ISSN	0022-3565
DOI	10.1124/jpet.106.114330
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Article ; Online: CropPol: A dynamic, open and global database on crop pollination.

Allen-Perkins, Alfonso / Magrach, Ainhoa / Dainese, Matteo / Garibaldi, Lucas A / Kleijn, David / Rader, Romina / Reilly, James R / Winfree, Rachael / Lundin, Ola / McGrady, Carley M / Brittain, Claire / Biddinger, David J / Artz, Derek R / Elle, Elizabeth / Hoffman, George / Ellis, James D / Daniels, Jaret / Gibbs, Jason / Campbell, Joshua W /

Brokaw, Julia / Wilson, Julianna K / Mason, Keith / Ward, Kimiora L / Gundersen, Knute B / Bobiwash, Kyle / Gut, Larry / Rowe, Logan M / Boyle, Natalie K / Williams, Neal M / Joshi, Neelendra K / Rothwell, Nikki / Gillespie, Robert L / Isaacs, Rufus / Fleischer, Shelby J / Peterson, Stephen S / Rao, Sujaya / Pitts-Singer, Theresa L / Fijen, Thijs / Boreux, Virginie / Rundlöf, Maj / Viana, Blandina Felipe / Klein, Alexandra-Maria / Smith, Henrik G / Bommarco, Riccardo / Carvalheiro, Luísa G / Ricketts, Taylor H / Ghazoul, Jaboury / Krishnan, Smitha / Benjamin, Faye E / Loureiro, João / Castro, Sílvia / Raine, Nigel E / de Groot, Gerard Arjen / Horgan, Finbarr G / Hipólito, Juliana / Smagghe, Guy / Meeus, Ivan / Eeraerts, Maxime / Potts, Simon G / Kremen, Claire / García, Daniel / Miñarro, Marcos / Crowder, David W / Pisanty, Gideon / Mandelik, Yael / Vereecken, Nicolas J / Leclercq, Nicolas / Weekers, Timothy / Lindstrom, Sandra A M / Stanley, Dara A / Zaragoza-Trello, Carlos / Nicholson, Charlie C / Scheper, Jeroen / Rad, Carlos / Marks, Evan A N / Mota, Lucie / Danforth, Bryan / Park, Mia / Bezerra, Antônio Diego M / Freitas, Breno M / Mallinger, Rachel E / Oliveira da Silva, Fabiana / Willcox, Bryony / Ramos, Davi L / D da Silva E Silva, Felipe / Lázaro, Amparo / Alomar, David / González-Estévez, Miguel A / Taki, Hisatomo / Cariveau, Daniel P / Garratt, Michael P D / Nabaes Jodar, Diego N / Stewart, Rebecca I A / Ariza, Daniel / Pisman, Matti / Lichtenberg, Elinor M / Schüepp, Christof / Herzog, Felix / Entling, Martin H / Dupont, Yoko L / Michener, Charles D / Daily, Gretchen C / Ehrlich, Paul R / Burns, Katherine L W / Vilà, Montserrat / Robson, Andrew / Howlett, Brad / Blechschmidt, Leah / Jauker, Frank / Schwarzbach, Franziska / Nesper, Maike / Diekötter, Tim / Wolters, Volkmar / Castro, Helena / Gaspar, Hugo / Nault, Brian A / Badenhausser, Isabelle / Petersen, Jessica D / Tscharntke, Teja / Bretagnolle, Vincent / Willis Chan, D Susan / Chacoff, Natacha / Andersson, Georg K S / Jha, Shalene / Colville, Jonathan F / Veldtman, Ruan / Coutinho, Jeferson / Bianchi, Felix J J A / Sutter, Louis / Albrecht, Matthias / Jeanneret, Philippe / Zou, Yi / Averill, Anne L / Saez, Agustin / Sciligo, Amber R / Vergara, Carlos H / Bloom, Elias H / Oeller, Elisabeth / Badano, Ernesto I / Loeb, Gregory M / Grab, Heather / Ekroos, Johan / Gagic, Vesna / Cunningham, Saul A / Åström, Jens / Cavigliasso, Pablo / Trillo, Alejandro / Classen, Alice / Mauchline, Alice L / Montero-Castaño, Ana / Wilby, Andrew / Woodcock, Ben A / Sidhu, C Sheena / Steffan-Dewenter, Ingolf / Vogiatzakis, Ioannis N / Herrera, José M / Otieno, Mark / Gikungu, Mary W / Cusser, Sarah J / Nauss, Thomas / Nilsson, Lovisa / Knapp, Jessica / Ortega-Marcos, Jorge J / González, José A / Osborne, Juliet L / Blanche, Rosalind / Shaw, Rosalind F / Hevia, Violeta / Stout, Jane / Arthur, Anthony D / Blochtein, Betina / Szentgyorgyi, Hajnalka / Li, Jin / Mayfield, Margaret M / Woyciechowski, Michał / Nunes-Silva, Patrícia / Halinski de Oliveira, Rosana / Henry, Steve / Simmons, Benno I / Dalsgaard, Bo / Hansen, Katrine / Sritongchuay, Tuanjit / O'Reilly, Alison D / Chamorro García, Fermín José / Nates Parra, Guiomar / Magalhães Pigozo, Camila / Bartomeus, Ignasi

Ecology

2022 Volume 103, Issue 3, Page(s) e3614

Abstract: Seventy five percent of the world's food crops benefit from insect pollination. Hence, there has been increased interest in how global change drivers impact this critical ecosystem service. Because standardized data on crop pollination are rarely ... ...

Abstract	Seventy five percent of the world's food crops benefit from insect pollination. Hence, there has been increased interest in how global change drivers impact this critical ecosystem service. Because standardized data on crop pollination are rarely available, we are limited in our capacity to understand the variation in pollination benefits to crop yield, as well as to anticipate changes in this service, develop predictions, and inform management actions. Here, we present CropPol, a dynamic, open, and global database on crop pollination. It contains measurements recorded from 202 crop studies, covering 3,394 field observations, 2,552 yield measurements (i.e., berry mass, number of fruits, and fruit density [kg/ha], among others), and 47,752 insect records from 48 commercial crops distributed around the globe. CropPol comprises 32 of the 87 leading global crops and commodities that are pollinator dependent. Malus domestica is the most represented crop (32 studies), followed by Brassica napus (22 studies), Vaccinium corymbosum (13 studies), and Citrullus lanatus (12 studies). The most abundant pollinator guilds recorded are honey bees (34.22% counts), bumblebees (19.19%), flies other than Syrphidae and Bombyliidae (13.18%), other wild bees (13.13%), beetles (10.97%), Syrphidae (4.87%), and Bombyliidae (0.05%). Locations comprise 34 countries distributed among Europe (76 studies), North America (60), Latin America and the Caribbean (29), Asia (20), Oceania (10), and Africa (7). Sampling spans three decades and is concentrated on 2001-2005 (21 studies), 2006-2010 (40), 2011-2015 (88), and 2016-2020 (50). This is the most comprehensive open global data set on measurements of crop flower visitors, crop pollinators and pollination to date, and we encourage researchers to add more datasets to this database in the future. This data set is released for non-commercial use only. Credits should be given to this paper (i.e., proper citation), and the products generated with this database should be shared under the same license terms (CC BY-NC-SA).
MeSH term(s)	Animals ; Bees ; Crops, Agricultural ; Ecosystem ; Flowers ; Insecta ; Pollination
Language	English
Publishing date	2022-02-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2010140-5
ISSN	1939-9170 ; 0012-9658
ISSN (online)	1939-9170
ISSN	0012-9658
DOI	10.1002/ecy.3614
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Article ; Online: LateTIME: a phase-II, randomized, double-blinded, placebo-controlled, pilot trial evaluating the safety and effect of administration of bone marrow mononuclear cells 2 to 3 weeks after acute myocardial infarction.

Traverse, Jay H / Henry, Timothy D / Vaughan, Douglas E / Ellis, Stephen G / Pepine, Carl J / Willerson, James T / Zhao, David X M / Simpson, Lara M / Penn, Marc S / Byrne, Barry J / Perin, Emerson C / Gee, Adrian P / Hatzopoulos, Antonis K / McKenna, David H / Forder, John R / Taylor, Doris A / Cogle, Christopher R / Baraniuk, Sarah / Olson, Rachel E /

Jorgenson, Beth C / Sayre, Shelly L / Vojvodic, Rachel W / Gordon, David J / Skarlatos, Sonia I / Moyè, Lemuel A / Simari, Robert D

Texas Heart Institute journal

2010 Volume 37, Issue 4, Page(s) 412–420

Abstract: A realistic goal for cardiac cell therapy may be to attenuate left ventricular remodeling following acute myocardial infarction to prevent the development of congestive heart failure. Initial clinical trials of cell therapy have delivered cells 1 to 7 ... ...

Abstract	A realistic goal for cardiac cell therapy may be to attenuate left ventricular remodeling following acute myocardial infarction to prevent the development of congestive heart failure. Initial clinical trials of cell therapy have delivered cells 1 to 7 days after acute myocardial infarction. However, many patients at risk of developing congestive heart failure may not be ready for cell delivery at that time-point because of clinical instability or hospitalization at facilities without access to cell therapy. Experience with cell delivery 2 to 3 weeks after acute myocardial infarction has not to date been explored in a clinical trial. The objective of the LateTIME study is to evaluate by cardiac magnetic resonance the effect on global and regional left ventricular function, between baseline and 6 months, of a single intracoronary infusion of 150 × 106 autologous bone marrow mononuclear cells (compared with placebo) when that infusion is administered 2 to 3 weeks after moderate-to-large acute myocardial infarction. The 5 clinical sites of the Cardiovascular Cell Therapy Research Network (CCTRN) will enroll a total of 87 eligible patients in a 2:1 bone marrow mononuclear cells-to-placebo patient ratio; these 87 will have undergone successful percutaneous coronary intervention of a major coronary artery and have left ventricular ejection fractions ≤0.45 by echocardiography. When the results become available, this study should provide insight into the clinical feasibility and appropriate timing of autologous cell therapy in high-risk patients after acute myocardial infarction and percutaneous coronary intervention.
MeSH term(s)	Angioplasty, Balloon, Coronary ; Bone Marrow Transplantation/adverse effects ; Double-Blind Method ; Echocardiography ; Heart Failure/diagnosis ; Heart Failure/etiology ; Heart Failure/physiopathology ; Heart Failure/prevention & control ; Humans ; Magnetic Resonance Imaging ; Myocardial Infarction/complications ; Myocardial Infarction/diagnosis ; Myocardial Infarction/physiopathology ; Myocardial Infarction/therapy ; Myocardium/pathology ; Pilot Projects ; Placebo Effect ; Research Design ; Time Factors ; Transplantation, Autologous ; Treatment Outcome ; United States ; Ventricular Function, Left ; Ventricular Remodeling
Language	English
Publishing date	2010-09-14
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	604761-0
ISSN	1526-6702 ; 0730-2347
ISSN (online)	1526-6702
ISSN	0730-2347
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Zs.A 1452: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Intramyocardial injection of autologous bone marrow mononuclear cells for patients with chronic ischemic heart disease and left ventricular dysfunction (First Mononuclear Cells injected in the US [FOCUS]): Rationale and design.

Willerson, James T / Perin, Emerson C / Ellis, Stephen G / Pepine, Carl J / Henry, Timothy D / Zhao, David X M / Lai, Dejian / Penn, Marc S / Byrne, Barry J / Silva, Guilherme / Gee, Adrian / Traverse, Jay H / Hatzopoulos, Antonis K / Forder, John R / Martin, Daniel / Kronenberg, Marvin / Taylor, Doris A / Cogle, Christopher R / Baraniuk, Sarah /

Westbrook, Lynette / Sayre, Shelly L / Vojvodic, Rachel W / Gordon, David J / Skarlatos, Sonia I / Moyé, Lemuel A / Simari, Robert D

American heart journal

2010 Volume 160, Issue 2, Page(s) 215–223

Abstract: Background: The increasing worldwide prevalence of coronary artery disease (CAD) continues to challenge the medical community. Management options include medical and revascularization therapy. Despite advances in these methods, CAD is a leading cause of ...

Abstract	Background: The increasing worldwide prevalence of coronary artery disease (CAD) continues to challenge the medical community. Management options include medical and revascularization therapy. Despite advances in these methods, CAD is a leading cause of recurrent ischemia and heart failure, posing significant morbidity and mortality risks along with increasing health costs in a large patient population worldwide. Trial design: The Cardiovascular Cell Therapy Research Network (CCTRN) was established by the National Institutes of Health to investigate the role of cell therapy in the treatment of chronic cardiovascular disease. FOCUS is a CCTRN-designed randomized, phase II, placebo-controlled clinical trial that will assess the effect of autologous bone marrow mononuclear cells delivered transendocardially to patients with left ventricular (LV) dysfunction and symptomatic heart failure or angina. All patients need to have limiting ischemia by reversible ischemia on single-photon emission computed tomography assessment. Results: After thoughtful consideration of both statistical and clinical principles, we will recruit 87 patients (58 cell treated and 29 placebo) to receive either bone marrow-derived stem cells or placebo. Myocardial perfusion, LV contractile performance, and maximal oxygen consumption are the primary outcome measures. Conclusions: The designed clinical trial will provide a sound assessment of the effect of autologous bone marrow mononuclear cells in improving blood flow and contractile function of the heart. The target population is patients with CAD and LV dysfunction with limiting angina or symptomatic heat failure. Patient safety is a central concern of the CCTRN, and patients will be followed for at least 5 years.
MeSH term(s)	Bone Marrow Transplantation ; Chronic Disease ; Humans ; Injections, Intralesional ; Leukocytes, Mononuclear/transplantation ; Linear Models ; Myocardial Ischemia/therapy ; Outcome Assessment, Health Care ; Research Design ; Tomography, Emission-Computed, Single-Photon ; Transplantation, Autologous ; Ventricular Dysfunction, Left/therapy
Language	English
Publishing date	2010-08-05
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2010.03.029
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Article ; Online: Endocrine-therapy-resistant ESR1 variants revealed by genomic characterization of breast-cancer-derived xenografts.

Li, Shunqiang / Shen, Dong / Shao, Jieya / Crowder, Robert / Liu, Wenbin / Prat, Aleix / He, Xiaping / Liu, Shuying / Hoog, Jeremy / Lu, Charles / Ding, Li / Griffith, Obi L / Miller, Christopher / Larson, Dave / Fulton, Robert S / Harrison, Michelle / Mooney, Tom / McMichael, Joshua F / Luo, Jingqin /

Tao, Yu / Goncalves, Rodrigo / Schlosberg, Christopher / Hiken, Jeffrey F / Saied, Laila / Sanchez, Cesar / Giuntoli, Therese / Bumb, Caroline / Cooper, Crystal / Kitchens, Robert T / Lin, Austin / Phommaly, Chanpheng / Davies, Sherri R / Zhang, Jin / Kavuri, Megha Shyam / McEachern, Donna / Dong, Yi Yu / Ma, Cynthia / Pluard, Timothy / Naughton, Michael / Bose, Ron / Suresh, Rama / McDowell, Reida / Michel, Loren / Aft, Rebecca / Gillanders, William / DeSchryver, Katherine / Wilson, Richard K / Wang, Shaomeng / Mills, Gordon B / Gonzalez-Angulo, Ana / Edwards, John R / Maher, Christopher / Perou, Charles M / Mardis, Elaine R / Ellis, Matthew J

Cell reports

2013 Volume 4, Issue 6, Page(s) 1116–1130

Abstract: To characterize patient-derived xenografts (PDXs) for functional studies, we made whole-genome comparisons with originating breast cancers representative of the major intrinsic subtypes. Structural and copy number aberrations were found to be retained ... ...

Abstract	To characterize patient-derived xenografts (PDXs) for functional studies, we made whole-genome comparisons with originating breast cancers representative of the major intrinsic subtypes. Structural and copy number aberrations were found to be retained with high fidelity. However, at the single-nucleotide level, variable numbers of PDX-specific somatic events were documented, although they were only rarely functionally significant. Variant allele frequencies were often preserved in the PDXs, demonstrating that clonal representation can be transplantable. Estrogen-receptor-positive PDXs were associated with ESR1 ligand-binding-domain mutations, gene amplification, or an ESR1/YAP1 translocation. These events produced different endocrine-therapy-response phenotypes in human, cell line, and PDX endocrine-response studies. Hence, deeply sequenced PDX models are an important resource for the search for genome-forward treatment options and capture endocrine-drug-resistance etiologies that are not observed in standard cell lines. The originating tumor genome provides a benchmark for assessing genetic drift and clonal representation after transplantation.
MeSH term(s)	Adaptor Proteins, Signal Transducing/genetics ; Alleles ; Animals ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Breast Neoplasms/metabolism ; Breast Neoplasms/pathology ; Drug Resistance, Neoplasm ; Estradiol/pharmacology ; Estrogen Receptor alpha/genetics ; Female ; Gene Amplification ; Genomic Instability ; Heterografts ; Humans ; Mice ; Neoplasm Proteins/biosynthesis ; Neoplasm Proteins/genetics ; Neoplasm Staging ; Phosphoproteins/genetics ; Point Mutation ; RNA, Neoplasm/biosynthesis ; RNA, Neoplasm/genetics ; Transcription Factors ; Translocation, Genetic
Chemical Substances	Adaptor Proteins, Signal Transducing ; ESR1 protein, human ; Estrogen Receptor alpha ; Neoplasm Proteins ; Phosphoproteins ; RNA, Neoplasm ; Transcription Factors ; YAP1 protein, human ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2013-09-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2649101-1
ISSN	2211-1247 ; 2211-1247
ISSN (online)	2211-1247
ISSN	2211-1247
DOI	10.1016/j.celrep.2013.08.022
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Article ; Online: Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction.

Traverse, Jay H / Henry, Timothy D / Vaughan, Douglas E / Vaughn, Douglas E / Ellis, Stephen G / Pepine, Carl J / Willerson, James T / Zhao, David X M / Piller, Linda B / Penn, Marc S / Byrne, Barry J / Perin, Emerson C / Gee, Adrian P / Hatzopoulos, Antonis K / McKenna, David H / Forder, John R / Taylor, Doris A / Cogle, Christopher R / Olson, Rachel E /

Jorgenson, Beth C / Sayre, Shelly L / Vojvodic, Rachel W / Gordon, David J / Skarlatos, Sonia I / Moye', Lemuel A / Simari, Robert D

American heart journal

2009 Volume 158, Issue 3, Page(s) 356–363

Abstract: Several previous studies have demonstrated that administration of autologous bone marrow-derived mononuclear cells (BMMNCs) improves cardiac function in patients after acute myocardial infarction (AMI). However, optimum timing of administration has not ... ...

Abstract	Several previous studies have demonstrated that administration of autologous bone marrow-derived mononuclear cells (BMMNCs) improves cardiac function in patients after acute myocardial infarction (AMI). However, optimum timing of administration has not been investigated in a clinical trial. The Cardiovascular Cell Therapy Research Network was developed and funded by the National Heart, Lung, and Blood Institute to address important questions such as timing of cell delivery and to accelerate research in the use of cell-based therapies. The TIME trial is a randomized, phase II, double-blind, placebo-controlled clinical trial. The 5 member clinical sites of the Cardiovascular Cell Therapy Research Network will enroll 120 eligible patients with moderate-to-large anterior AMIs who have undergone successful percutaneous coronary intervention of the left anterior descending coronary artery and have a left ventricular (LV) ejection fraction </=45% by echocardiography. Participants will have bone marrow aspirations and intracoronary infusions of 150 x 10(6) BMMNCs or placebo on day 3 or day 7 post-AMI. Objectives of this study are (1) to evaluate effects of BMMNCs on regional and global LV function compared to placebo therapy in patients with acute AMI as assessed by cardiac magnetic resonance imaging at 6 months and (2) to assess whether effects of BMMNC infusion on global and regional LV function and safety are influenced by the time of administration. This study will provide further insight into the clinical feasibility and appropriate timing of autologous BMMNC therapy in high-risk patients after AMI and percutaneous coronary intervention.<br />
MeSH term(s)	Adult ; Angioplasty, Balloon, Coronary ; Bone Marrow Transplantation ; Double-Blind Method ; Feasibility Studies ; Humans ; Leukocytes, Mononuclear/transplantation ; Myocardial Infarction/therapy ; Pilot Projects ; Research Design ; Time Factors ; Treatment Outcome
Language	English
Publishing date	2009-07-23
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2009.06.009
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Article ; Online: Effect of the use and timing of bone marrow mononuclear cell delivery on left ventricular function after acute myocardial infarction: the TIME randomized trial.

Traverse, Jay H / Henry, Timothy D / Pepine, Carl J / Willerson, James T / Zhao, David X M / Ellis, Stephen G / Forder, John R / Anderson, R David / Hatzopoulos, Antonis K / Penn, Marc S / Perin, Emerson C / Chambers, Jeffrey / Baran, Kenneth W / Raveendran, Ganesh / Lambert, Charles / Lerman, Amir / Simon, Daniel I / Vaughan, Douglas E / Lai, Dejian /

Gee, Adrian P / Taylor, Doris A / Cogle, Christopher R / Thomas, James D / Olson, Rachel E / Bowman, Sherry / Francescon, Judy / Geither, Carrie / Handberg, Eileen / Kappenman, Casey / Westbrook, Lynette / Piller, Linda B / Simpson, Lara M / Baraniuk, Sarah / Loghin, Catalin / Aguilar, David / Richman, Sara / Zierold, Claudia / Spoon, Daniel B / Bettencourt, Judy / Sayre, Shelly L / Vojvodic, Rachel W / Skarlatos, Sonia I / Gordon, David J / Ebert, Ray F / Kwak, Minjung / Moyé, Lemuel A / Simari, Robert D

JAMA

2012 Volume 308, Issue 22, Page(s) 2380–2389

Abstract: Context: While the delivery of cell therapy after ST-segment elevation myocardial infarction (STEMI) has been evaluated in previous clinical trials, the influence of the timing of cell delivery on the effect on left ventricular function has not been ... ...

Abstract	Context: While the delivery of cell therapy after ST-segment elevation myocardial infarction (STEMI) has been evaluated in previous clinical trials, the influence of the timing of cell delivery on the effect on left ventricular function has not been analyzed. Objectives: To determine the effect of intracoronary autologous bone marrow mononuclear cell (BMC) delivery after STEMI on recovery of global and regional left ventricular function and whether timing of BMC delivery (3 days vs 7 days after reperfusion) influences this effect. Design, setting, and patients: A randomized, 2 × 2 factorial, double-blind, placebo-controlled trial, Timing In Myocardial infarction Evaluation (TIME) enrolled 120 patients with left ventricular dysfunction (left ventricular ejection fraction [LVEF] ≤ 45%) after successful primary percutaneous coronary intervention (PCI) of anterior STEMI between July 17, 2008, and November 15, 2011, as part of the Cardiovascular Cell Therapy Research Network sponsored by the National Heart, Lung, and Blood Institute. Interventions: Intracoronary infusion of 150 × 106 BMCs or placebo (randomized 2:1) within 12 hours of aspiration and cell processing administered at day 3 or day 7 (randomized 1:1) after treatment with PCI. Main outcome measures: The primary end points were change in global (LVEF) and regional (wall motion) left ventricular function in infarct and border zones at 6 months measured by cardiac magnetic resonance imaging and change in left ventricular function as affected by timing of treatment on day 3 vs day 7. The secondary end points included major adverse cardiovascular events as well as changes in left ventricular volumes and infarct size. Results: The mean (SD) patient age was 56.9 (10.9) years and 87.5% of participants were male. At 6 months, there was no significant increase in LVEF for the BMC group (45.2% [95% CI, 42.8% to 47.6%] to 48.3% [95% CI, 45.3% to 51.3%) vs the placebo group (44.5% [95% CI, 41.0% to 48.0%] to 47.8% [95% CI, 43.4% to 52.2%]) (P = .96). There was no significant treatment effect on regional left ventricular function observed in either infarct or border zones. There were no significant differences in change in global left ventricular function for patients treated at day 3 (−0.9% [95% CI, −6.6% to 4.9%], P = .76) or day 7 (1.1% [95% CI, −4.7% to 6.9%], P = .70). The timing of treatment had no significant effect on regional left ventricular function recovery. Major adverse events were rare among all treatment groups. Conclusion: Among patients with STEMI treated with primary PCI, the administration of intracoronary BMCs at either 3 days or 7 days after the event had no significant effect on recovery of global or regional left ventricular function compared with placebo. Trial registration: clinicaltrials.gov Identifier: NCT00684021.
MeSH term(s)	Aged ; Bone Marrow Transplantation/methods ; Double-Blind Method ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Myocardial Infarction/complications ; Myocardial Infarction/therapy ; Time Factors ; Treatment Outcome ; Ventricular Dysfunction, Left/complications ; Ventricular Dysfunction, Left/therapy
Language	English
Publishing date	2012-11-06
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Intramural
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2012.28726
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