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Article: Partisan polarization, historical heritage, and public health: Exploring COVID-19 outcomes.

Curtis, Craig / Stillman, John / Remmel, Megan / Pierce, John C / Lovrich, Nicholas P / Adams-Curtis, Leah E

World medical & health policy

2022

Abstract: When the COVID-19 virus first arrived in the United States in early 2020, many epidemiologists and public health officers counseled for shutdowns and advised policymakers to prepare for a major pandemic. In 2020, though, US society was rife with major ... ...

Abstract	When the COVID-19 virus first arrived in the United States in early 2020, many epidemiologists and public health officers counseled for shutdowns and advised policymakers to prepare for a major pandemic. In 2020, though, US society was rife with major political and cultural divides. Some elected leaders promoted policies at odds with the experts, and many people refused to heed the public health-based communications about the coming pandemic. Additionally, the capacity to respond to a pandemic was distributed in the country in a highly unequal fashion. This paper analyzes the noteworthy geopolitical patterns of COVID-19 illnesses, subsequent demands on hospitals, and resulting deaths. This description is based on a snapshot of archival data gathered in the midst of the pandemic during late January and early February of 2021. Demographic data, indicators of political party support, indicators of citizen attitudes, and public health compliance behaviors are combined in a multivariate analysis to explain COVID-19 outcomes at the local government (county) level. The analysis suggests strongly that regional political culture and local demographics played a substantial role in determining the severity of the public health impact of the COVID-19 pandemic.
Language	English
Publishing date	2022-08-24
Publishing country	United States
Document type	Journal Article
ISSN	2153-2028
ISSN	2153-2028
DOI	10.1002/wmh3.543
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Article ; Online: A relationship between temperature and aggression in NFL football penalties

Curtis Craig / Randy W. Overbeek / Miles V. Condon / Shannon B. Rinaldo

Journal of Sport and Health Science, Vol 5, Iss 2, Pp 205-

2016 Volume 210

Abstract: Background: Increased ambient temperature has been implicated in increased physical aggression, which has important practical consequences. The present study investigates this established relationship between aggressive behavior and ambient temperature ... ...

Abstract	Background: Increased ambient temperature has been implicated in increased physical aggression, which has important practical consequences. The present study investigates this established relationship between aggressive behavior and ambient temperature in the highly aggressive context of professional football in the National Football League (NFL). Methods: Using a publicly available dataset, authors conducted multiple hierarchical regression analyses on game-level data (2326 games). Results: The analysis revealed that temperature positively predicted aggressive penalties in football, and that this relationship was significant for teams playing at home but not for visiting teams. Conclusion: These results indicate that even in the aggressive context of football, warmer weather contributes to increased violence. Further, the presence of the heat-aggression relationship for the home team suggests that the characteristics of interacting groups may influence whether heat would have an adverse effect on the outcome of those interactions.
Keywords	Aggression ; American football ; Intergroup ; Sports ; Temperature ; GV557-1198.995 ; Sports medicine ; RC1200-1245
Subject code	796
Language	English
Publishing date	2016-06-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
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Article ; Online: Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials.

Lu, Ming / Pontecorvo, Michael J / Devous, Michael D / Arora, Anupa K / Galante, Nicholas / McGeehan, Anne / Devadanam, Catherine / Salloway, Stephen P / Doraiswamy, P Murali / Curtis, Craig / Truocchio, Stephen P / Flitter, Matthew / Locascio, Tricia / Devine, Marybeth / Zimmer, Jennifer A / Fleisher, Adam S / Mintun, Mark A

JAMA neurology

2021 Volume 78, Issue 4, Page(s) 445–453

Abstract: Importance: Flortaucipir positron emission tomography (PET) scans, rated with a novel, US Food and Drug Administration-approved, clinically applicable visual interpretation method, provide valuable information regarding near-term clinical progression of ...

Abstract	Importance: Flortaucipir positron emission tomography (PET) scans, rated with a novel, US Food and Drug Administration-approved, clinically applicable visual interpretation method, provide valuable information regarding near-term clinical progression of patients with Alzheimer disease (AD) or mild cognitive impairment (MCI). Objective: To evaluate the association between flortaucipir PET visual interpretation and patients' near-term clinical progression. Design/setting/participants: Two prospective, open-label, longitudinal studies were conducted from December 2014 to September 2019. Study 1 screened 298 patients and enrolled 160 participants who had a flortaucipir scan at baseline visit. Study 2 selected 205 participants from the AMARANTH trial, which was terminated after futility analysis. Out of the 2218 AMARANTH participants, 424 had a flortaucipir scan around randomization, but 219 did not complete 18-month clinical dementia rating (CDR) assessments and thus were excluded. In both studies, all participants were diagnosed as clinically impaired, and they were longitudinally followed up for approximately 18 months after baseline. Main outcomes and measures: Flortaucipir scans were rated as either advanced or nonadvanced AD pattern using a predetermined visual interpretation method. The CDR sum of box (CDR-SB) score was used as primary clinical end point measurement in both studies. Results: Of the 364 study participants who had readable scans, 48% were female (n = 174 of 364), and the mean (SD) age was 71.8 (8.7) years. Two hundred forty participants were rated as having an advanced AD pattern. At 18 months follow-up, 70% of those with an advanced AD pattern (n = 147 of 210) had 1 point or more increase in CDR-SB, an event predefined as clinically meaningful deterioration. In contrast, only 46% of those with a nonadvanced AD pattern scan (n = 48 of 105) experienced the same event (risk ratio [RR], 1.40; 95% CI, 1.11-1.76; P = .005). The adjusted mean CDR-SB changes were 2.28 and 0.98 for advanced and nonadvanced AD pattern groups, respectively (P < .001). Analyses with other clinical end point assessments, as well as analyses with each individual study's data, consistently indicated a higher risk of clinical deterioration associated with an advanced AD scan pattern. Conclusions and relevance: These results suggest that flortaucipir PET scans, when interpreted with an US Food and Drug Administration-approved, clinically applicable visual interpretation method, may provide valuable information regarding the risk of clinical deterioration over 18 months among patients with AD and MCI. Trial registration: ClinicalTrials.gov Identifier: NCT02016560 and NCT03901105.
MeSH term(s)	Aged ; Aged, 80 and over ; Alzheimer Disease/diagnostic imaging ; Alzheimer Disease/metabolism ; Carbolines/metabolism ; Cognitive Dysfunction/diagnostic imaging ; Cognitive Dysfunction/metabolism ; Contrast Media/metabolism ; Disease Progression ; Female ; Humans ; Longitudinal Studies ; Male ; Middle Aged ; Positron-Emission Tomography/methods ; Prospective Studies ; Protein Aggregates/physiology ; Risk Factors ; tau Proteins/metabolism
Chemical Substances	Carbolines ; Contrast Media ; MAPT protein, human ; Protein Aggregates ; tau Proteins ; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole (J09QS3Z3WB)
Language	English
Publishing date	2021-01-20
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2702023-X
ISSN	2168-6157 ; 2168-6149
ISSN (online)	2168-6157
ISSN	2168-6149
DOI	10.1001/jamaneurol.2020.5505
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Article ; Online: Pharmacokinetics and Safety of Velpatasvir and Sofosbuvir/Velpatasvir in Subjects with Hepatic Impairment.

Mogalian, Erik / Brainard, Diana M / Osinusi, Anu / Moorehead, Lisa / Murray, Bernard / Ling, Kah Hiing John / Perry, Robert / Curtis, Craig / Lawitz, Eric / Lasseter, Kenneth / Marbury, Thomas / Mathias, Anita

Clinical pharmacokinetics

2018 Volume 57, Issue 11, Page(s) 1449–1457

Abstract: Background: The pharmacokinetics and safety of velpatasvir, a potent pangenotypic hepatitis C virus NS5A inhibitor, were evaluated in two hepatic impairment studies: a phase I study in hepatitis C virus-uninfected subjects and a phase III study (ASTRAL- ... ...

Abstract	Background: The pharmacokinetics and safety of velpatasvir, a potent pangenotypic hepatitis C virus NS5A inhibitor, were evaluated in two hepatic impairment studies: a phase I study in hepatitis C virus-uninfected subjects and a phase III study (ASTRAL-4) in hepatitis C virus-infected patients. Methods: In the phase I study, subjects with moderate or severe hepatic impairment (Child-Pugh-Turcotte Class B or C), and demographically matched subjects with normal hepatic function received a single dose of velpatasvir 100 mg. Pharmacokinetics and safety assessments were performed, and pharmacokinetic parameters were calculated using non-compartmental methods and summarized using descriptive statistics and compared statistically by geometric least-squares mean ratios and 90% confidence intervals. In ASTRAL-4, subjects with decompensated cirrhosis (Child-Pugh-Turcotte Class B) were randomized to receive treatment with either sofosbuvir/velpatasvir ± ribavirin for 12 weeks or sofosbuvir/velpatasvir for 24 weeks. Pharmacokinetic and safety assessments were performed and pharmacokinetic parameters were calculated using a non-compartmental analysis and summarized using descriptive statistics and were compared to pharmacokinetics from ASTRAL-1 [subjects without cirrhosis or with compensated (Child-Pugh-Turcotte Class A) cirrhosis]. Results: In the phase I study, plasma exposures (area under the concentration-time curve) were similar in subjects with Child-Pugh-Turcotte Class B (n = 10) or Child-Pugh-Turcotte Class C hepatic impairment (n = 10) compared with normal hepatic function (n = 13). Percent free velpatasvir was similar in subjects without or with any degree of hepatic impairment. In the phase III study, velpatasvir overall exposure (area under the concentration-time curve over the 24-h dosing interval; AUC Conclusions: No sofosbuvir/velpatasvir dose modification is warranted for patients with any degree of hepatic impairment.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antiviral Agents/adverse effects ; Antiviral Agents/blood ; Antiviral Agents/pharmacokinetics ; Antiviral Agents/therapeutic use ; Carbamates/adverse effects ; Carbamates/blood ; Carbamates/pharmacokinetics ; Drug Combinations ; Drug Therapy, Combination/statistics & numerical data ; Female ; Hepatic Insufficiency/blood ; Hepatic Insufficiency/drug therapy ; Hepatitis C/blood ; Hepatitis C/complications ; Hepatitis C/drug therapy ; Heterocyclic Compounds, 4 or More Rings/adverse effects ; Heterocyclic Compounds, 4 or More Rings/blood ; Heterocyclic Compounds, 4 or More Rings/pharmacokinetics ; Humans ; Liver Cirrhosis/blood ; Liver Cirrhosis/complications ; Male ; Middle Aged ; Ribavirin/therapeutic use ; Sofosbuvir/adverse effects ; Sofosbuvir/pharmacokinetics ; Uridine/analogs & derivatives ; Uridine/blood ; Uridine/pharmacokinetics ; Young Adult
Chemical Substances	Antiviral Agents ; Carbamates ; Drug Combinations ; GS331007 ; Heterocyclic Compounds, 4 or More Rings ; sofosbuvir-velpatasvir drug combination ; Ribavirin (49717AWG6K) ; velpatasvir (KCU0C7RS7Z) ; Uridine (WHI7HQ7H85) ; Sofosbuvir (WJ6CA3ZU8B)
Language	English
Publishing date	2018-03-05
Publishing country	Switzerland
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	197627-8
ISSN	1179-1926 ; 0312-5963
ISSN (online)	1179-1926
ISSN	0312-5963
DOI	10.1007/s40262-018-0645-6
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Article: Community pharmacist targeted screening for chronic kidney disease.

Al Hamarneh, Yazid N / Hemmelgarn, Brenda / Curtis, Craig / Balint, Carlee / Jones, Charlotte A / Tsuyuki, Ross T

Canadian pharmacists journal : CPJ = Revue des pharmaciens du Canada : RPC

2015 Volume 149, Issue 1, Page(s) 13–17

Language	English
Publishing date	2015-12-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	2200008-2
ISSN	1913-701X ; 1715-1635
ISSN (online)	1913-701X
ISSN	1715-1635
DOI	10.1177/1715163515618421
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Article: Online clinical pathway for managing adults with chronic kidney disease.

Curtis, Craig / Balint, Carlee / Al Hamarneh, Yazid N / Donald, Maoliosa / Tsuyuki, Ross T / McBrien, Kerry / Jackson, Wes / Hemmelgarn, Brenda

Canadian pharmacists journal : CPJ = Revue des pharmaciens du Canada : RPC

2015 Volume 148, Issue 5, Page(s) 257–262

Language	English
Publishing date	2015-10-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	2200008-2
ISSN	1913-701X ; 1715-1635
ISSN (online)	1913-701X
ISSN	1715-1635
DOI	10.1177/1715163515597243
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Article ; Online: Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses.

Falloon, Judith / Talbot, H Keipp / Curtis, Craig / Ervin, John / Krieger, Diane / Dubovsky, Filip / Takas, Therese / Yu, Jing / Yu, Li / Lambert, Stacie L / Villafana, Tonya / Esser, Mark T

Clinical and vaccine immunology : CVI

2017 Volume 24, Issue 9

Abstract: This is the second phase 1 study of a respiratory syncytial virus (RSV) vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A (GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double-blind study, 261 ... ...

Abstract	This is the second phase 1 study of a respiratory syncytial virus (RSV) vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A (GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double-blind study, 261 subjects aged ≥60 years received inactivated influenza vaccine (IIV), a vaccine containing 120 μg sF with escalating doses of GLA (1, 2.5, or 5 μg) in SE, or a vaccine containing 80 μg sF with 2.5 μg GLA in SE. Subjects receiving 120 μg sF with 2.5 or 5 μg GLA were also randomized to receive IIV or placebo. Immunity to RSV was assessed by detection of microneutralizing, anti-F immunoglobulin G, and palivizumab-competitive antibodies and F-specific gamma interferon enzyme-linked immunosorbent spot assay T-cell responses. Higher adjuvant doses increased injection site discomfort, but at the highest dose, the reactogenicity was similar to that of IIV. Significant humoral and cellular immune responses were observed. The 120 μg sF plus 5.0 μg GLA formulation resulted in the highest responses in all subjects and in older subjects. These results confirm previous observations of vaccine tolerability, safety, and immunogenicity and were used to select the 120 μg sF plus 5.0 μg GLA formulation for phase 2 evaluation. (This study has been registered at ClinicalTrials.gov under registration no. NCT02289820.).
Language	English
Publishing date	2017-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	2221082-9
ISSN	1556-679X ; 1556-6811
ISSN (online)	1556-679X
ISSN	1556-6811
DOI	10.1128/CVI.00157-17
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Article ; Online: ABBY: A phase 2 randomized trial of crenezumab in mild to moderate Alzheimer disease.

Cummings, Jeffrey L / Cohen, Sharon / van Dyck, Christopher H / Brody, Mark / Curtis, Craig / Cho, William / Ward, Michael / Friesenhahn, Michel / Rabe, Christina / Brunstein, Flavia / Quartino, Angelica / Honigberg, Lee A / Fuji, Reina N / Clayton, David / Mortensen, Deborah / Ho, Carole / Paul, Robert

Neurology

2018 Volume 90, Issue 21, Page(s) e1889–e1897

Abstract: Objective: To evaluate the safety and efficacy of crenezumab in patients with mild to moderate Alzheimer disease (AD).: Methods: In this phase 2 trial, 431 patients with mild to moderate AD 50 to 80 years of age were randomized 2:1 (crenezumab: ... ...

Abstract	Objective: To evaluate the safety and efficacy of crenezumab in patients with mild to moderate Alzheimer disease (AD). Methods: In this phase 2 trial, 431 patients with mild to moderate AD 50 to 80 years of age were randomized 2:1 (crenezumab:placebo). Patients received low-dose subcutaneous crenezumab 300 mg or placebo every 2 weeks (n = 184) or high-dose intravenous crenezumab 15 mg/kg or placebo every 4 weeks (n = 247) for 68 weeks. Primary outcome measures were change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) and Clinical Dementia Rating-Sum of Boxes scores from baseline to week 73. Results: The primary and secondary endpoints were not met. In an exploratory post hoc analysis, a reduction in decline on the ADAS-Cog12 was observed in the high-dose group. Separation from the placebo group on the ADAS-Cog12 was greatest in the milder subsets of AD patients and reached statistical significance in the group with Mini-Mental State Examination scores of 22 to 26. In both groups, there was a significant increase in CSF β-amyloid Conclusions: Although prespecified criteria for testing treatment effects were not met, these data suggest a potential treatment effect in patients with mild AD treated with high-dose crenezumab. Together with the safety profile for crenezumab, these data support the exploration of crenezumab treatment at even higher doses in patients with early AD. Clinicaltrialsgov identifier: NCT 01343966. Classification of evidence: This study provides Class II evidence that, for people with AD, crenezumab does not significantly improve cognition or function at 18 months. The study is rated Class II because <80% of enrolled patients completed the study.
MeSH term(s)	Aged ; Aged, 80 and over ; Alzheimer Disease/drug therapy ; Alzheimer Disease/psychology ; Antibodies, Monoclonal/therapeutic use ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Neuropsychological Tests ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal ; crenezumab (O8AS5277H0)
Language	English
Publishing date	2018-04-25
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	207147-2
ISSN	1526-632X ; 0028-3878
ISSN (online)	1526-632X
ISSN	0028-3878
DOI	10.1212/WNL.0000000000005550
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Article ; Online: A phase 1a, first-in-human, randomized study of a respiratory syncytial virus F protein vaccine with and without a toll-like receptor-4 agonist and stable emulsion adjuvant.

Falloon, Judith / Ji, Fei / Curtis, Craig / Bart, Stephan / Sheldon, Eric / Krieger, Diane / Dubovsky, Filip / Lambert, Stacie / Takas, Therese / Villafana, Tonya / Esser, Mark T

Vaccine

2016 Volume 34, Issue 25, Page(s) 2847–2854

Abstract: Background: Respiratory syncytial virus (RSV) causes significant illness in older adults resulting in substantial health and economic impact. A successful vaccine would reduce morbidity in this growing segment of the population.: Methods: In this ... ...

Abstract	Background: Respiratory syncytial virus (RSV) causes significant illness in older adults resulting in substantial health and economic impact. A successful vaccine would reduce morbidity in this growing segment of the population. Methods: In this double-blind phase 1 study, subjects 60 years of age and older were enrolled by cohort and randomized to receive vaccines containing escalating doses (20, 50, or 80μg) of soluble RSV fusion protein (sF) alone or adjuvanted with 2.5μg of glucopyranosyl lipid A, a toll-like receptor-4 agonist, in 2% stable emulsion (GLA-SE). Each cohort included 20 vaccine and 4 placebo recipients. Immune responses were evaluated using assays for RSV microneutralizing, anti-F IgG, and palivizumab competitive antibodies and for F-specific interferon (IFN)-γ enzyme-linked immunospot (ELISPOT) responses. Results: The inclusion of adjuvant increased local reactogenicity, with the majority of subjects who received sF and adjuvant reporting low-grade injection site pain or tenderness. At all doses, the safety profile was acceptable for further development. Immune responses were antigen dose-dependent, and the inclusion of adjuvant increased both humoral and cellular immune responses, with responses statistically higher than for placebo recipients in all 4 assays. At the highest dosage level with adjuvant, half of the subjects had a ≥3-fold rise from day 0 in RSV neutralizing antibody titers, and all had a ≥3-fold rise in antibody levels by anti-F IgG and palivizumab competitive antibody assays on day 29. For the day 8 IFNγ ELISPOT assay, 74% of subjects in the highest dosing cohort had a ≥3-fold rise from baseline. Conclusions: The safety and immunogenicity results from this study support inclusion of the GLA-SE adjuvant in this RSV vaccine for older adults and also support assessment of the efficacy of the vaccine in a larger clinical trial. Clinicaltrials.gov NCT02115815.
MeSH term(s)	Adjuvants, Immunologic/administration & dosage ; Aged ; Aged, 80 and over ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; Double-Blind Method ; Emulsions ; Female ; Glucosides/administration & dosage ; Humans ; Immunity, Cellular ; Immunity, Humoral ; Immunoglobulin G/blood ; Lipid A/administration & dosage ; Male ; Middle Aged ; Respiratory Syncytial Virus Infections/prevention & control ; Respiratory Syncytial Virus Vaccines/therapeutic use ; Respiratory Syncytial Virus, Human ; Toll-Like Receptor 4/agonists ; Viral Fusion Proteins/immunology
Chemical Substances	Adjuvants, Immunologic ; Antibodies, Neutralizing ; Antibodies, Viral ; Emulsions ; F protein, human respiratory syncytial virus ; Glucosides ; Immunoglobulin G ; Lipid A ; Respiratory Syncytial Virus Vaccines ; TLR4 protein, human ; Toll-Like Receptor 4 ; Viral Fusion Proteins ; glucopyranosyl lipid-A
Language	English
Publishing date	2016-05-27
Publishing country	Netherlands
Document type	Clinical Trial, Phase I ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2016.04.002
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Article ; Online: Positron Emission Tomography Imaging With [18F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes.

Fleisher, Adam S / Pontecorvo, Michael J / Devous, Michael D / Lu, Ming / Arora, Anupa K / Truocchio, Stephen P / Aldea, Patricia / Flitter, Matthew / Locascio, Tricia / Devine, Marybeth / Siderowf, Andrew / Beach, Thomas G / Montine, Thomas J / Serrano, Geidy E / Curtis, Craig / Perrin, Allison / Salloway, Stephen / Daniel, Misty / Wellman, Charles /

Joshi, Abhinay D / Irwin, David J / Lowe, Val J / Seeley, William W / Ikonomovic, Milos D / Masdeu, Joseph C / Kennedy, Ian / Harris, Thomas / Navitsky, Michael / Southekal, Sudeepti / Mintun, Mark A

JAMA neurology

2020 Volume 77, Issue 7, Page(s) 829–839

Abstract: Importance: Positron emission tomography (PET) may increase the diagnostic accuracy and confirm the underlying neuropathologic changes of Alzheimer disease (AD).: Objective: To determine the accuracy of antemortem [18F]flortaucipir PET images for ... ...

Abstract	Importance: Positron emission tomography (PET) may increase the diagnostic accuracy and confirm the underlying neuropathologic changes of Alzheimer disease (AD). Objective: To determine the accuracy of antemortem [18F]flortaucipir PET images for predicting the presence of AD-type tau pathology at autopsy. Design, setting, and participants: This diagnostic study (A16 primary cohort) was conducted from October 2015 to June 2018 at 28 study sites (27 in US sites and 1 in Australia). Individuals with a terminal illness who were older than 50 years and had a projected life expectancy of less than 6 months were enrolled. All participants underwent [18F]flortaucipir PET imaging, and scans were interpreted by 5 independent nuclear medicine physicians or radiologists. Supplemental autopsy [18F]flortaucipir images and pathological samples were also collected from 16 historically collected cases. A second study (FR01 validation study) was conducted from March 26 to April 26, 2019, in which 5 new readers assessed the original PET images for comparison to autopsy. Main outcomes and measures: [18F]flortaucipir PET images were visually assessed and compared with immunohistochemical tau pathology. An AD tau pattern of flortaucipir retention was assessed for correspondence with a postmortem B3-level (Braak stage V or VI) pathological pattern of tau accumulation and to the presence of amyloid-β plaques sufficient to meet the criteria for high levels of AD neuropathological change. Success was defined as having at least 3 of the 5 readers above the lower bounds of the 95% CI for both sensitivity and specificity of 50% or greater. Results: A total of 156 patients were enrolled in the A16 study and underwent [18F]flortaucipir PET imaging. Of these, 73 died during the study, and valid autopsies were performed for 67 of these patients. Three autopsies were evaluated as test cases and removed from the primary cohort (n = 64). Of the 64 primary cohort patients, 34 (53%) were women and 62 (97%) were white; mean (SD) age was 82.5 (9.6) years; and 49 (77%) had dementia, 1 (2%) had mild cognitive impairment, and 14 (22%) had normal cognition. Prespecified success criteria were met for the A16 primary cohort. The flortaucipir PET scans predicted a B3 level of tau pathology, with sensitivity ranging from 92.3% (95% CI, 79.7%-97.3%) to 100.0% (95% CI, 91.0%-100.0%) and specificity ranging from 52.0% (95% CI, 33.5%-70.0%) to 92.0% (95% CI, 75.0%-97.8%). A high level of AD neuropathological change was predicted with sensitivity of 94.7% (95% CI, 82.7%-98.5%) to 100.0% (95% CI, 90.8%-100.0%) and specificity of 50.0% (95% CI, 32.1%-67.9%) to 92.3% (95% CI, 75.9%-97.9%). The FR01 validation study also met prespecified success criteria. Addition of the supplemental autopsy data set and 3 test cases, which comprised a total of 82 patients and autopsies for both the A16 and FR01 studies, resulted in improved specificity and comparable overall accuracy. Among the 156 enrolled participants, 14 (9%) experienced at least 1 treatment-emergent adverse event. Conclusions and relevance: This study's findings suggest that PET imaging with [18F]flortaucipir could be used to identify the density and distribution of AD-type tau pathology and the presence of high levels of AD neuropathological change, supporting a neuropathological diagnosis of AD.
MeSH term(s)	Aged ; Aged, 80 and over ; Alzheimer Disease/diagnostic imaging ; Alzheimer Disease/pathology ; Amyloid beta-Peptides/metabolism ; Autopsy ; Brain/diagnostic imaging ; Brain/pathology ; Carbolines ; Contrast Media ; Female ; Humans ; Male ; Neurofibrillary Tangles/pathology ; Neuroimaging/methods ; Plaque, Amyloid/diagnostic imaging ; Plaque, Amyloid/pathology ; Positron-Emission Tomography/methods ; Radiopharmaceuticals ; Sensitivity and Specificity ; tau Proteins/metabolism
Chemical Substances	Amyloid beta-Peptides ; Carbolines ; Contrast Media ; MAPT protein, human ; Radiopharmaceuticals ; tau Proteins ; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole (J09QS3Z3WB)
Language	English
Publishing date	2020-04-27
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2702023-X
ISSN	2168-6157 ; 2168-6149
ISSN (online)	2168-6157
ISSN	2168-6149
DOI	10.1001/jamaneurol.2020.0528
Database	MEDical Literature Analysis and Retrieval System OnLINE

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