12 results on '"Healthy Volunteer"'
Search Results
2. Volunteering for Infection: Participant Perspectives on a Hepatitis C Virus Controlled Human Infection Model.
- Author
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Eberts JD, Zimmer-Harwood P, Elsey JWB, Fraser-Urquhart A, and Smiley T
- Subjects
- Humans, Research Design, Hepacivirus, Volunteers
- Abstract
Ethical human subjects research requires participants to be treated safely and respectfully, yet much bioethical debate takes place without participants. We aim to address this gap in the context of controlled human infection model (CHIM) research. Based upon our own experience as study participants, and bolstered by a survey of 117 potential hepatitis C virus CHIM participants, we present ideas to inform efficient, ethical, and scientifically useful study design. We advocate for full protocol transparency, higher compensation, commitment to the rapid dissemination of study results, and proactive efforts to detail risk-minimization efforts as early as possible in the recruitment process, among other measures. We encourage researchers to proactively partner with volunteer advocacy organizations that promote collective representation of volunteers to maximize their agency, and guard against ethical issues arising from healthy human subjects research., Competing Interests: Potential conflicts of interest . A. F.-U. reports being a part-time employee and a former full-time employee of 1DaySooner. J. D. E. reports being a full-time employee of 1DaySooner. They also report being the co-chair of the HCV CHIM Advisory Committee. J. W. B. E. reports having conducted paid survey work related to attitudes toward human challenge trials for 1DaySooner. P. Z.-H. reports the provision of transport and accommodation for working on script with co-authors from 1DaySooner, working on a contract to do independent research on behalf of 1DaySooner through Babbage Tech Ltd, and an honorarium payment for conference attendance from 1DaySooner. T. S. reports funding from 1DaySooner for co-authoring “Promoting Ethical Payment in Human Infection Challenge Studies.” All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
- Published
- 2023
- Full Text
- View/download PDF
3. Echocardiographic reference ranges for normal left atrial function parameters: Results from the EACVI NORRE study
- Author
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Sugimoto, T, Robinet, S, Dulgheru, R, Bernard, A, Ilardi, F, Contu, L, Addetia, K, Caballero, L, Kacharava, G, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Rodrigo Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Go, Y, Marchetta, S, Nchimi, A, Rosca, M, Calin, A, Moonen, M, Cimino, S, Magne, J, Cosyns, B, Galli, E, Donal, E, Habib, G, Esposito, R, Galderisi, M, Badano, L, Lang, R, Lancellotti, P, Sugimoto T., Robinet S., Dulgheru R., Bernard A., Ilardi F., Contu L., Addetia K., Caballero L., Kacharava G., Athanassopoulos G. D., Barone D., Baroni M., Cardim N., Hagendorff A., Hristova K., Lopez T., De La Morena G., Popescu B. A., Penicka M., Ozyigit T., Rodrigo Carbonero J. D., Van De Veire N., Von Bardeleben R. S., Vinereanu D., Zamorano J. L., Go Y. Y., Marchetta S., Nchimi A., Rosca M., Calin A., Moonen M., Cimino S., Magne J., Cosyns B., Galli E., Donal E., Habib G., Esposito R., Galderisi M., Badano L., Lang R. M., Lancellotti P., Sugimoto, T, Robinet, S, Dulgheru, R, Bernard, A, Ilardi, F, Contu, L, Addetia, K, Caballero, L, Kacharava, G, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Rodrigo Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Go, Y, Marchetta, S, Nchimi, A, Rosca, M, Calin, A, Moonen, M, Cimino, S, Magne, J, Cosyns, B, Galli, E, Donal, E, Habib, G, Esposito, R, Galderisi, M, Badano, L, Lang, R, Lancellotti, P, Sugimoto T., Robinet S., Dulgheru R., Bernard A., Ilardi F., Contu L., Addetia K., Caballero L., Kacharava G., Athanassopoulos G. D., Barone D., Baroni M., Cardim N., Hagendorff A., Hristova K., Lopez T., De La Morena G., Popescu B. A., Penicka M., Ozyigit T., Rodrigo Carbonero J. D., Van De Veire N., Von Bardeleben R. S., Vinereanu D., Zamorano J. L., Go Y. Y., Marchetta S., Nchimi A., Rosca M., Calin A., Moonen M., Cimino S., Magne J., Cosyns B., Galli E., Donal E., Habib G., Esposito R., Galderisi M., Badano L., Lang R. M., and Lancellotti P.
- Abstract
Aims To obtain the normal ranges for echocardiographic measurements of left atrial (LA) function from a large group of healthy volunteers accounting for age and gender. Methods and results A total of 371 (median age 45 years) healthy subjects were enrolled at 22 collaborating institutions collaborating in the Normal Reference Ranges for Echocardiography (NORRE) study of the European Association of Cardiovascular Imaging (EACVI). Left atrial data sets were analysed with a vendor-independent software (VIS) package allowing homogeneous measurements irrespective of the echocardiographic equipment used to acquire data sets. The lowest expected values of LA function were 26.1%, 48.7%, and 41.4% for left atrial strain (LAS), 2D left atrial emptying fraction (LAEF), and 3D LAEF (reservoir function); 7.7%, 24.2%, and â '0.53/s for LAS-Active, LAEF-Active, and LA strain rate during LA contraction (SRa) (pump function) and 12.0% and 21.6% for LAS-passive and LAEF-passive (conduit function). Left atrial reservoir and conduit function were decreased with age while pump function was increased. All indices of reservoir function and all LA strains had no difference in both gender and vendor. However, inter-vendor differences were observed in LA SRa despite the use of VIS. Conclusion The NORRE study provides contemporary, applicable echocardiographic reference ranges for LA function. Our data highlight the importance of age-specific reference values for LA functions.
- Published
- 2018
4. Echocardiographic reference ranges for normal left ventricular 2D strain: results from the EACVI NORRE study
- Author
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Ralph Stephan von Bardeleben, José Luis Zamorano, Jose David Rodrigo Carbonero, Maurizio Galderisi, Daniele Barone, Monica Baroni, Erwan Donal, Gonzalo de la Morena, Krasimira Hristova, Federica Ilardi, Tolga Ozyigit, Laura Contu, Anne Bernard, Natela Akhaladze, Martin Penicka, Yun Yun Go, Nico Van de Veire, Karima Addetia, Stella Marchetta, Bernard Cosyns, Nuno Cardim, Luis Caballero, Julien Magne, Roberto M. Lang, Dragos Vinereanu, Raluca Elena Dulgheru, Luigi P. Badano, Patrizio Lancellotti, Andreas Hagendorff, Andrea Calin, Tadafumi Sugimoto, Monica Rosca, Gilbert Habib, George Athanassopoulos, Bogdan A. Popescu, Marie Moonen, Teresa López, Cardio-vascular diseases, Clinical sciences, Faculty of Medicine and Pharmacy, Centre Hospitalier Universitaire de Liège (CHU-Liège), Universität Leipzig [Leipzig], Johannes Gutenberg - Universität Mainz (JGU), Universidad de Alcalá - University of Alcalá (UAH), CHU Dupuytren, Academisch Ziekenhuis Vrije Universiteit Brussel, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Universita degli Studi di Padova, University of Chicago, GE Healthcare, Philips Healthcare, Universität Leipzig, Johannes Gutenberg - Universität Mainz = Johannes Gutenberg University (JGU), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Università degli Studi di Padova = University of Padua (Unipd), Sugimoto, T, Dulgheru, R, Bernard, A, Ilardi, F, Contu, L, Addetia, K, Caballero, L, Akhaladze, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Moonen, M, Penicka, M, Ozyigit, T, Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Go, Y, Rosca, M, Calin, A, Magne, J, Cosyns, B, Marchetta, S, Donal, E, Habib, G, Galderisi, M, Badano, L, Lang, R, Lancellotti, P, Sugimoto, Tadafumi, Dulgheru, Raluca, Bernard, Anne, Ilardi, Federica, Contu, Laura, Addetia, Karima, Caballero, Lui, Akhaladze, Natela, Athanassopoulos, George D., Barone, Daniele, Baroni, Monica, Cardim, Nuno, Hagendorff, Andrea, Hristova, Krasimira, Lopez, Teresa, De La Morena, Gonzalo, Popescu, Bogdan A., Moonen, Marie, Penicka, Martin, Ozyigit, Tolga, Carbonero, Jose David Rodrigo, Van De Veire, Nico, Von Bardeleben, Ralph Stephan, Vinereanu, Drago, Zamorano, Jose Lui, Go, Yun Yun, Rosca, Monica, Calin, Andrea, Magne, Julien, Cosyns, Bernard, Marchetta, Stella, Donal, Erwan, Habib, Gilbert, Galderisi, Maurizio, Badano, Luigi P., Lang, Roberto M., and Lancellotti, Patrizio
- Subjects
Male ,Longitudinal strain ,deformation imaging ,[SDV]Life Sciences [q-bio] ,Sex Factor ,030204 cardiovascular system & hematology ,Standard deviation ,Ventricular Function, Left ,Heart Ventricle ,2D echocardiography ,0302 clinical medicine ,Reference Values ,Nuclear Medicine and Imaging ,Image Processing, Computer-Assisted ,Medicine ,Circumferential strain ,Age Factor ,Reference Value ,030212 general & internal medicine ,Multivariate Analysi ,Adult echocardiography ,Deformation imaging ,Reference values ,Radiology, Nuclear Medicine and Imaging ,Cardiology and Cardiovascular Medicine ,Observer Variation ,Strain (chemistry) ,Age Factors ,General Medicine ,Middle Aged ,Healthy Volunteer ,Healthy Volunteers ,Europe ,Homogeneous ,Echocardiography ,Radiology Nuclear Medicine and imaging ,Cardiology ,Linear Model ,Female ,Radiology ,Radial stress ,Human ,Adult ,medicine.medical_specialty ,adult echocardiography ,Heart Ventricles ,03 medical and health sciences ,Sex Factors ,Internal medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,2d strain ,business.industry ,MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,Multivariate Analysis ,Linear Models ,business - Abstract
International audience; Aims - To obtain the normal ranges for 2D echocardiographic (2DE) measurements of left ventricular (LV) strain from a large group of healthy volunteers accounting for age and gender. Methods and results - A total of 549 (mean age: 45.6 ± 13.3 years) healthy subjects were enrolled at 22 collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. 2DE data sets have been analysed with a vendor-independent software package allowing homogeneous measurements irrespective of the echocardiographic equipment used to acquire the data sets. The lowest expected values of LV strains and twist calculated as ± 1.96 standard deviations from the mean were -16.7% in men and -17.8% in women for longitudinal strain, -22.3% and -23.6% for circumferential strain, 20.6% and 21.5% for radial strain, and 2.2 degrees and 1.9 degrees for twist, respectively. In multivariable analysis, longitudinal strain decreased with age whereas the opposite occurred with circumferential and radial strain. Male gender was associated with lower strain for longitudinal, circumferential, and radial strain. Inter-vendor differences were observed for circumferential and radial strain despite the use of vendor-independent software. Importantly, no intervendor differences were noted in longitudinal strain. Conclusion - The NORRE study provides contemporary, applicable 2D echocardiographic reference ranges for LV longitudinal, radial, and circumferential strain. Our data highlight the importance of age- and gender-specific reference values for LV strain.
- Published
- 2017
- Full Text
- View/download PDF
5. Two-dimensional transthoracic echocardiographic normal reference ranges for proximal aorta dimensions: Results from the EACVI NORRE study
- Author
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Teresa López, Nico Van de Veire, Daniele Barone, Ralph Stephan von Bardeleben, Bogdan A. Popescu, Monica Baroni, Erwan Donal, Jose David Rodrigo Carbonero, Dragos Vinereanu, Roberto M. Lang, Ann-Stephan Gori, Luigi P. Badano, Gonzalo de la Morena, Seisyou Kou, Martin Penicka, Tolga Ozyigit, Gilbert Habib, Natalia Gonjilashvili, Karima Addetia, Krasimira Hristova, Patrizio Lancellotti, George Athanassopoulos, Nuno Cardim, José Luis Zamorano, Anne Bernard, Andreas Hagendorff, Bernard Cosyns, Luis Caballero, Raluca Elena Dulgheru, Daniel Saura, Saura, D, Dulgheru, R, Caballero, L, Bernard, A, Kou, S, Gonjilashvili, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Gori, A, Cosyns, B, Donal, E, Habib, G, Addetia, K, Lang, R, Badano, L, Lancellotti, P, Hospital Clínico Universitario Virgen de la Arrixaca = University Hospital Virgen de la Arrixaca [Murcia], Groupe Interdisciplinaire de Génoprotéomique Appliquée (GIGA-Research), Université de Liège, Service de cardiologie, Cardiology, University and Emergency Hospital, CIC-IT Rennes, Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), GE Healthcare and Philips Healthcare, Hospital Virgen de la Arrixaca, Murcia, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Cardio-vascular diseases, Clinical sciences, and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)
- Subjects
Male ,Aorta, Thoracic ,Sex Factor ,030204 cardiovascular system & hematology ,Reproducibility of result ,Cohort Studies ,0302 clinical medicine ,Diastole ,Medicine ,Thoracic aorta ,Age Factor ,Reference Value ,Prospective Studies ,030212 general & internal medicine ,Multivariate Analysi ,Body surface area ,Cardiac cycle ,Age Factors ,General Medicine ,NORRE study ,Middle Aged ,Healthy Volunteer ,Healthy Volunteers ,Europe ,Echocardiography ,echocardiography ,reference values ,reproducibility of results ,sinus of valsalva ,thoracic aorta ,Cardiology ,Linear Model ,[SDV.IB]Life Sciences [q-bio]/Bioengineering ,Female ,Cardiology and Cardiovascular Medicine ,Human ,Adult ,medicine.medical_specialty ,Systole ,Normal values ,Reference values ,03 medical and health sciences ,Young Adult ,Sex Factors ,Internal medicine ,medicine.artery ,Ascending aorta ,Humans ,Radiology, Nuclear Medicine and imaging ,Measurement method ,Aorta ,Analysis of Variance ,business.industry ,Sinus of valsalva ,Reproducibility of Results ,MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,Prospective Studie ,Multivariate Analysis ,Linear Models ,Cohort Studie ,business - Abstract
International audience; AIMS: To report normal reference ranges for echocardiographic dimensions of the proximal aorta obtained in a large group of healthy volunteers recruited using state-of-the-art cardiac ultrasound equipment, considering different measurement conventions, and taking into account gender, age, and body size of individuals. METHODS AND RESULTS: A total of 704 (mean age: 46.0 ± 13.5 years) healthy volunteers (310 men and 394 women) were prospectively recruited from the collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. A comprehensive echocardiographic examination was obtained in all subjects following pre-defined protocols. Aortic dimensions were obtained in systole and diastole, following both the leading-edge to leading-edge and the inner-edge to inner-edge conventions. Diameters were measured at four levels: ventricular-arterial junction, sinuses of Valsalva, sino-tubular junction, and proximal tubular ascending aorta. Measures of aortic root in the short-axis view following the orientation of each of the three sinuses were also performed. Men had significantly larger body sizes when compared with women, and showed larger aortic dimensions independently of the measurement method used. Dimensions indexed by height and body surface area are provided, and stratification by age ranges is also displayed. In multivariable analysis, the independent predictors of aortic dimensions were age, gender, and height or body surface area. CONCLUSION: The NORRE study provides normal values of proximal aorta dimensions as assessed by echocardiography. Reference ranges for different anatomical levels using different (i) measurement conventions and (ii) at different times of the cardiac cycle (i.e. mid-systole and end-diastole) are provided. Age, gender, and body size were significant determinants of aortic dimensions
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- 2017
- Full Text
- View/download PDF
6. Two-dimensional transthoracic echocardiographic normal reference ranges for proximal aorta dimensions: Results from the EACVI NORRE study
- Author
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Saura, D, Dulgheru, R, Caballero, L, Bernard, A, Kou, S, Gonjilashvili, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Gori, A, Cosyns, B, Donal, E, Habib, G, Addetia, K, Lang, R, Badano, L, Lancellotti, P, Saura D., Dulgheru R., Caballero L., Bernard A., Kou S., Gonjilashvili N., Athanassopoulos G. D., Barone D., Baroni M., Cardim N., Hagendorff A., Hristova K., Lopez T., De La Morena G., Popescu B. A., Penicka M., Ozyigit T., Carbonero J. D. R., Van De Veire N., Von Bardeleben R. S., Vinereanu D., Zamorano J. L., Gori A. -S., Cosyns B., Donal E., Habib G., Addetia K., Lang R. M., Badano L., Lancellotti P., Saura, D, Dulgheru, R, Caballero, L, Bernard, A, Kou, S, Gonjilashvili, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Penicka, M, Ozyigit, T, Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Gori, A, Cosyns, B, Donal, E, Habib, G, Addetia, K, Lang, R, Badano, L, Lancellotti, P, Saura D., Dulgheru R., Caballero L., Bernard A., Kou S., Gonjilashvili N., Athanassopoulos G. D., Barone D., Baroni M., Cardim N., Hagendorff A., Hristova K., Lopez T., De La Morena G., Popescu B. A., Penicka M., Ozyigit T., Carbonero J. D. R., Van De Veire N., Von Bardeleben R. S., Vinereanu D., Zamorano J. L., Gori A. -S., Cosyns B., Donal E., Habib G., Addetia K., Lang R. M., Badano L., and Lancellotti P.
- Abstract
Aims To report normal reference ranges for echocardiographic dimensions of the proximal aorta obtained in a large group of healthy volunteers recruited using state-of-the-art cardiac ultrasound equipment, considering different measurement conventions, and taking into account gender, age, and body size of individuals. Methods A total of 704 (mean age: 46.0+13.5 years) healthy volunteers (310 men and 394 women) were prospectively recruited from the collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. A comprehensive echocardiographic examination was obtained in all subjects following pre-defined protocols. Aortic dimensions were obtained in systole and diastole, following both the leading-edge to leading-edge and the inner-edge to inner-edge conventions. Diameters were measured at four levels: ventricular-arterial junction, sinuses of Valsalva, sinotubular junction, and proximal tubular ascending aorta. Measures of aortic root in the short-axis view following the orientation of each of the three sinuses were also performed. Men had significantly larger body sizes when compared with women, and showed larger aortic dimensions independently of the measurement method used. Dimensions indexed by height and body surface area are provided, and stratification by age ranges is also displayed. In multivariable analysis, the independent predictors of aortic dimensions were age, gender, and height or body surface area. Conclusion The NORRE study provides normal values of proximal aorta dimensions as assessed by echocardiography. Reference ranges for different anatomical levels using different (i) measurement conventions and (ii) at different times of the cardiac cycle (i.e. mid-systole and end-diastole) are provided. Age, gender, and body size were significant determinants of aortic dimensions.
- Published
- 2017
7. Echocardiographic reference ranges for normal left ventricular 2D strain: Results from the EACVI NORRE study
- Author
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Sugimoto, T, Dulgheru, R, Bernard, A, Ilardi, F, Contu, L, Addetia, K, Caballero, L, Akhaladze, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Moonen, M, Penicka, M, Ozyigit, T, Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Go, Y, Rosca, M, Calin, A, Magne, J, Cosyns, B, Marchetta, S, Donal, E, Habib, G, Galderisi, M, Badano, L, Lang, R, Lancellotti, P, Sugimoto T., Dulgheru R., Bernard A., Ilardi F., Contu L., Addetia K., Caballero L., Akhaladze N., Athanassopoulos G. D., Barone D., Baroni M., Cardim N., Hagendorff A., Hristova K., Lopez T., De La Morena G., Popescu B. A., Moonen M., Penicka M., Ozyigit T., Carbonero J. D. R., Van De Veire N., Von Bardeleben R. S., Vinereanu D., Zamorano J. L., Go Y. Y., Rosca M., Calin A., Magne J., Cosyns B., Marchetta S., Donal E., Habib G., Galderisi M., Badano L., Lang R. M., Lancellotti P., Sugimoto, T, Dulgheru, R, Bernard, A, Ilardi, F, Contu, L, Addetia, K, Caballero, L, Akhaladze, N, Athanassopoulos, G, Barone, D, Baroni, M, Cardim, N, Hagendorff, A, Hristova, K, Lopez, T, De La Morena, G, Popescu, B, Moonen, M, Penicka, M, Ozyigit, T, Carbonero, J, Van De Veire, N, Von Bardeleben, R, Vinereanu, D, Zamorano, J, Go, Y, Rosca, M, Calin, A, Magne, J, Cosyns, B, Marchetta, S, Donal, E, Habib, G, Galderisi, M, Badano, L, Lang, R, Lancellotti, P, Sugimoto T., Dulgheru R., Bernard A., Ilardi F., Contu L., Addetia K., Caballero L., Akhaladze N., Athanassopoulos G. D., Barone D., Baroni M., Cardim N., Hagendorff A., Hristova K., Lopez T., De La Morena G., Popescu B. A., Moonen M., Penicka M., Ozyigit T., Carbonero J. D. R., Van De Veire N., Von Bardeleben R. S., Vinereanu D., Zamorano J. L., Go Y. Y., Rosca M., Calin A., Magne J., Cosyns B., Marchetta S., Donal E., Habib G., Galderisi M., Badano L., Lang R. M., and Lancellotti P.
- Abstract
Aims To obtain the normal ranges for 2D echocardiographic (2DE) measurements of left ventricular (LV) strain from a large group of healthy volunteers accounting for age and gender Methods and results A total of 549 (mean age: 45.6 ± 13.3 years) healthy subjects were enrolled at 22 collaborating institutions of the Normal Reference Ranges for Echocardiography (NORRE) study. 2DE data sets have been analysed with a vendorindependent software package allowing homogeneous measurements irrespective of the echocardiographic equipment used to acquire the data sets. The lowest expected values of LV strains and twist calculated as ± 1.96 standard deviations from the mean were-16.7% in men and-17.8% in women for longitudinal strain,-22.3% and-23.6% for circumferential strain, 20.6% and 21.5% for radial strain, and 2.2 degrees and 1.9 degrees for twist, respectively. In multivariable analysis, longitudinal strain decreased with age whereas the opposite occurred with circumferential and radial strain. Male gender was associated with lower strain for longitudinal, circumferential, and radial strain. Inter-vendor differences were observed for circumferential and radial strain despite the use of vendor-independent software. Importantly, no intervendor differences were noted in longitudinal strain. Conclusion The NORRE study provides contemporary, applicable 2D echocardiographic reference ranges for LV longitudinal, radial, and circumferential strain. Our data highlight the importance of age-and gender-specific reference values for LV strain.
- Published
- 2017
8. Influenza A Reinfection in Sequential Human Challenge: Implications for Protective Immunity and "Universal" Vaccine Development.
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Memoli MJ, Han A, Walters KA, Czajkowski L, Reed S, Athota R, Angela Rosas L, Cervantes-Medina A, Park JK, Morens DM, Kash JC, and Taubenberger JK
- Subjects
- Antibodies, Viral, Humans, Reinfection, Influenza A Virus, H1N1 Subtype, Influenza Vaccines, Influenza, Human prevention & control, Orthomyxoviridae Infections
- Abstract
Background: Identification of correlates of protection against human influenza A virus infection is important in development of broadly protective ("universal") influenza vaccines. Certain assumptions underlie current vaccine developmental strategies, including that infection with a particular influenza A virus should offer long-term or lifelong protection against that strain, preventing reinfection. In this study we report observations made when 7 volunteers participated in sequential influenza challenge studies where they were challenged intranasally using the identical influenza A(H1N1)pdm09 virus approximately 1 year apart. We evaluate and describe the outcomes of these 7 rechallenge participants and discuss what these results may suggest about correlates of protection and development of more broadly protective influenza vaccines., Methods: Seven participants were enrolled in 2 viral challenge studies at 7.5- to 18.5-month intervals. Both challenge studies used the identical lot of influenza A (H1N1)pdm09 virus administered intranasally. We evaluated pre- and postchallenge hemagglutination inhibition, neuraminidase inhibition, and stalk antibody titers; peripheral blood leukocyte host gene expression response profiles; daily viral detection via nasal wash; and clinical signs and symptoms., Results: At least 3 of 7 participants demonstrated confirmed laboratory evidence of sequential infection, with 5 of 7 demonstrating clinical evidence., Conclusions: The data presented in this report demonstrate that sequential infection with the identical influenza A virus can occur and suggest it may not be rare. These data raise questions about immune memory responses in an acute superficial respiratory mucosal infection and their implications in development of broadly protective influenza vaccines. Further investigation of these observations is warranted., Clinical Trials Registration: NCT01646138; NCT01971255., (Published by Oxford University Press for the Infectious Diseases Society of America 2019.)
- Published
- 2020
- Full Text
- View/download PDF
9. A Dose-finding Study of a Wild-type Influenza A(H3N2) Virus in a Healthy Volunteer Human Challenge Model.
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Han A, Czajkowski LM, Donaldson A, Baus HA, Reed SM, Athota RS, Bristol T, Rosas LA, Cervantes-Medina A, Taubenberger JK, and Memoli MJ
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- Adolescent, Adult, Antibodies, Viral immunology, Female, Healthy Volunteers, Humans, Immunization Schedule, Influenza, Human immunology, Influenza, Human virology, Male, Middle Aged, Virus Shedding, Young Adult, Influenza A Virus, H3N2 Subtype immunology, Influenza Vaccines administration & dosage, Influenza Vaccines immunology, Influenza, Human prevention & control, Vaccination methods
- Abstract
Background: The development of vaccines and therapeutics has relied on healthy volunteer influenza challenge studies. A validated human infection model with wild-type A(H1N1)pdm09 was reported previously. Our objective was to characterize a wild-type influenza A/Bethesda/MM1/H3N2 challenge virus in healthy volunteers., Methods: Participants received a single dose of a cell-based, reverse-genetics, Good Manufacturing Practices-produced wild-type influenza A(H3N2)2011 virus intranasally and were isolated at the National Institutes of Health Clinical Center for ≥9 days. Dose escalation was performed from 104 to 107 TCID50 (50% tissue culture infectious dose). Viral shedding and clinical disease were evaluated daily., Results: Of 37 participants challenged, 16 (43%) had viral shedding and 27 (73%) developed symptoms, with 12 (32%) participants experiencing mild to moderate influenza disease (MMID), defined as shedding and symptoms. Only participants receiving 106 and 107 TCID50 experienced MMID at 44% and 40%, respectively. Symptom severity peaked on day 3, whereas most viral shedding occurred 1-2 days after challenge. Only 10 (29%) participants had a ≥4-fold rise in hemagglutination inhibition antibody titer after challenge., Conclusions: The A/Bethesda/MM1/H3N2 challenge virus safely induced MMID in healthy volunteers, but caused less MMID than the A(H1N1)pdm09 challenge virus even at the highest dose. There was less detection of shedding though the incidence of symptoms was similar to A(H1N1)pdm09. Fewer serum anti-hemagglutinin (HA) antibody responses with less MMID indicate that preexisting immunity factors other than anti-HA antibody may limit shedding in healthy volunteers. This A/Bethesda/MM1/H3N2 challenge virus can be utilized in future studies to further explore pathogenesis and immunity and to evaluate vaccine candidates., Clinical Trials Registration: NCT02594189., (Published by Oxford University Press for the Infectious Diseases Society of America 2019.)
- Published
- 2019
- Full Text
- View/download PDF
10. Ascending aorta diameters measured by echocardiography using both leading edge-to-leading edge and inner edge-to-inner edge conventions in healthy volunteers
- Author
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Muraru, D, Maffessanti, F, Kocabay, G, Peluso, D, Bianco Lucia, D, Piasentini, E, Jose Seena, P, Iliceto, S, Badano, L, Muraru Denisa, Maffessanti Francesco, Kocabay Gonenc, Peluso Diletta, Bianco Lucia Dal, Piasentini Eleonora, Jose Seena Padayattil, Iliceto Sabino, Badano Luigi, Muraru, D, Maffessanti, F, Kocabay, G, Peluso, D, Bianco Lucia, D, Piasentini, E, Jose Seena, P, Iliceto, S, Badano, L, Muraru Denisa, Maffessanti Francesco, Kocabay Gonenc, Peluso Diletta, Bianco Lucia Dal, Piasentini Eleonora, Jose Seena Padayattil, Iliceto Sabino, and Badano Luigi
- Abstract
AIMS: Reference ranges of ascending aorta diameters (AAoD) for two-dimensional echocardiography (2DE) using inner edge (IE) convention are lacking, preventing the comparison of AAoD measurements by 2DE with those obtained by other imaging modalities. METHODS AND RESULTS: We used harmonic imaging 2DE to prospectively study 218 healthy volunteers (56% women, 42 ± 15 years, 18-80 years). Measurements were performed at the level of aortic root (AoR), sinotubular junction (STJ), and proximal tubular portion (TAo, 1 cm from the STJ) using both leading edge (LE) and IE conventions at end-diastole and end-systole. Feasibility of AAoD measurements between end-diastole and end-systole was similar at AoR and STJ levels, but it was significantly different at TAo level (82 vs. 96%, respectively, P < 0.0001). Ascending aorta diameters indexed to height were larger in men than in women (P < 0.0001). After adjusting for the effect of gender, only age and body surface area (BSA) were independent predictors of AAoD at multivariable analysis. Average end-diastolic AoR, STJ, and TAo diameters measured using IE convention were similar between genders (17 ± 2, 15 ± 2, and 15 ± 2 mm/m(2), respectively). Corresponding AAoD measured using the LE convention were 18 ± 2, 16 ± 2, and 17 ± 4 mm/m(2), respectively. On average, the end-systolic AAoD measured using LE were 2 mm larger than those performed using IE or at end-diastole. Mean aortic wall thickness was 2.4 ± 0.8 mm. CONCLUSION: End-diastolic AAoD measured using IE were significantly smaller than those obtained either using LE convention or at end-systole. Gender-specific reference values for AAoD indexed for BSA should be used to identify ascending aorta pathology.
- Published
- 2014
11. Right atrial size and function assessed with three-dimensional and speckle-tracking echocardiography in 200 healthy volunteers
- Author
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Peluso, D, Badano, L, Muraru, D, DAL BIANCO, L, Cucchini, U, Kocabay, G, Kovàcs, A, Casablanca, S, Iliceto, S, PELUSO, DILETTA MARIA, BADANO, LUIGI, MURARU, DENISA, DAL BIANCO, LUCIA, CUCCHINI, UMBERTO, Kocabay, Gonenc, Kovàcs, Attila, Casablanca, Simona, ILICETO, SABINO, Peluso, D, Badano, L, Muraru, D, DAL BIANCO, L, Cucchini, U, Kocabay, G, Kovàcs, A, Casablanca, S, Iliceto, S, PELUSO, DILETTA MARIA, BADANO, LUIGI, MURARU, DENISA, DAL BIANCO, LUCIA, CUCCHINI, UMBERTO, Kocabay, Gonenc, Kovàcs, Attila, Casablanca, Simona, and ILICETO, SABINO
- Abstract
AIMS: Right atrial (RA) size predicts the outcome in some pathological conditions but reference values for RA volumes and myocardial function remain to be defined. Thus, we used two-dimensional speckle-tracking echocardiography (2D-STE) and three-dimensional echocardiography (3DE) to define normative reference values of RA volumes and function. METHODS AND RESULTS: Two hundreds healthy volunteers (43 ± 15 years, range 18-75; 44% men) underwent two-dimensional echocardiography (2DE) to obtain RA volumes and longitudinal strain (LS) of RA wall using 2D-STE, and 3DE to measure maximal (Vmax), minimal, and preA volumes to calculate total, passive, and active emptying volumes (TotEV, PassEV, and ActEV) and emptying fractions (TotEF, PassEF, and ActEF). Three-dimensional echocardiography volumes (Vmax, 52 ± 15 mL vs. 41 ± 14 mL), EVs (TotEV, 33 ± 10 mL vs. 24 ± 9 mL), and EFs (TotEF, 63 ± 9 vs. 58 ± 9%) were larger than 2DE ones (all P < 0.0001). Indexed 3D volumes were significantly larger in men than in women. RA TotEF correlated with total LS (r = 0.24, P = 0.025) and PassEF with positive LS (LSpos; r = 0.34, P < 0.0001). Ageing was associated with a decrease in passive (LSpos, r = -041; PassEV, r = -0.26; PassEF, r = -0.38; all P < 0.0001) and an increase in active RA function (negative LS, r = 0.34; ActEV, r = 0.25; all P < 0.0001; and ActEF, r = 0.15; P = 0.035) in order to maintain TotEV (r = -0.14, P = 0.05). CONCLUSION:Our study provides normative values for RA volumes and function measured by 3DE and 2D-STE in a relatively large cohort of healthy subjects with a wide age range. These data will help clinicians to identify RA remodelling and dysfunction.
- Published
- 2013
12. Validation of the wild-type influenza A human challenge model H1N1pdMIST: an A(H1N1)pdm09 dose-finding investigational new drug study.
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Memoli MJ, Czajkowski L, Reed S, Athota R, Bristol T, Proudfoot K, Fargis S, Stein M, Dunfee RL, Shaw PA, Davey RT, and Taubenberger JK
- Subjects
- Administration, Intranasal, Adolescent, Adult, Animals, Female, Healthy Volunteers, Humans, Male, Middle Aged, Prospective Studies, United States, Virus Shedding, Young Adult, Influenza A Virus, H1N1 Subtype isolation & purification, Influenza, Human pathology, Influenza, Human virology
- Abstract
Background: Healthy volunteer wild-type influenza challenge models offer a unique opportunity to evaluate multiple aspects of this important virus. Such studies have not been performed in the United States in more than a decade, limiting our capability to investigate this virus and develop countermeasures. We have completed the first ever wild-type influenza A challenge study under an Investigational New Drug application (IND). This dose-finding study will lead to further development of this model both for A(H1N1)pdm09 and other strains of influenza., Methods: Volunteers were admitted to an isolation unit at the National Institutes of Health Clinical Center for a minimum of 9 days. A reverse genetics, cell-based, Good Manufacturing Practice (GMP)-produced, wild-type A(H1N1)pdm09 virus was administered intranasally. Escalating doses were given until a dose was reached that produced disease in a minimum of 60% of volunteers., Results: An optimal dose of 10(7) tissue culture infectious dose 50 was reached that caused mild to moderate influenza disease in 69% of individuals with mean viral shedding for 4-5 days and significant rises in convalescent influenza antibody titers. Viral shedding preceded symptoms by 12-24 hours and terminated 2-3 days prior to symptom resolution, indicating that individuals may be infectious before symptom development. As expected, nasal congestion and rhinorrhea were most common, but interestingly, fever was observed in only 10% of individuals., Conclusions: This study represents the first healthy volunteer influenza challenge model using a GMP-produced wild-type virus under an IND. This unique clinical research program will facilitate future studies of influenza pathogenesis, animal model validation, and the rapid, efficient, and cost-effective evaluation of efficacy of novel vaccines and therapeutics. Clinical Trials Registration.NCT01646138., (Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.)
- Published
- 2015
- Full Text
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