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Study design considerations for evaluating the efficacy and safety of pancreatic enzyme replacement therapy in patients with cystic fibrosis.

Clinical investigation

Konstan MW, Borowitz D, Mayer-Hamblett N, Milla C, Hendeles L, Murray S, Kronmal RA, Casey S, Rose LM, Morgan WJ, Ramsey BW.
PMID: 25132954
Clin Investig (Lond). 2013 Aug;3(8):731-741. doi: 10.4155/cli.13.63.

In 2006, the US FDA issued a 'Guidance for Industry' regarding submission of New Drug Applications for pancreatic enzyme replacement therapy (PERT) products. Five oral delayed-release PERT products have been approved by the FDA, and several others are under...

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Konstan MW, Borowitz D, Mayer-Hamblett N, et al. Study design considerations for evaluating the efficacy and safety of pancreatic enzyme replacement therapy in patients with cystic fibrosis. Clin Investig (Lond). 2013;3(8):731-741doi: 10.4155/cli.13.63.
Konstan, M. W., Borowitz, D., Mayer-Hamblett, N., Milla, C., Hendeles, L., Murray, S., Kronmal, R. A., Casey, S., Rose, L. M., Morgan, W. J., & Ramsey, B. W. (2013). Study design considerations for evaluating the efficacy and safety of pancreatic enzyme replacement therapy in patients with cystic fibrosis. Clinical investigation, 3(8), 731-741. https://doi.org/10.4155/cli.13.63
Konstan, Michael W, et al. "Study design considerations for evaluating the efficacy and safety of pancreatic enzyme replacement therapy in patients with cystic fibrosis." Clinical investigation vol. 3,8 (2013): 731-741. doi: https://doi.org/10.4155/cli.13.63
Konstan MW, Borowitz D, Mayer-Hamblett N, Milla C, Hendeles L, Murray S, Kronmal RA, Casey S, Rose LM, Morgan WJ, Ramsey BW. Study design considerations for evaluating the efficacy and safety of pancreatic enzyme replacement therapy in patients with cystic fibrosis. Clin Investig (Lond). 2013 Aug;3(8):731-741. doi: 10.4155/cli.13.63. PMID: 25132954; PMCID: PMC4131768.
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Ventricular remodeling and the renin angiotensin aldosterone system.

Congestive heart failure (Greenwich, Conn.)

Patten RD, Konstam MA.
PMID: 12147951
Congest Heart Fail. 2000 Jul-Aug;6(4):187-192. doi: 10.1111/j.1527-5299.2000.80159.x.

Ventricular remodeling in patients with left ventricular systolic dysfunction is an indolent process that is associated with a poor prognosis. Clinical and experimental data support the central role played by the renin-angiotensin-aldosterone system in the pathophysiology of remodeling. ACE...

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Patten RD, Konstam MA. Ventricular remodeling and the renin angiotensin aldosterone system. Congest Heart Fail. 2000;6(4):187-192doi: 10.1111/j.1527-5299.2000.80159.x.
Patten, R. D., & Konstam, M. A. (2000). Ventricular remodeling and the renin angiotensin aldosterone system. Congestive heart failure (Greenwich, Conn.), 6(4), 187-192. https://doi.org/10.1111/j.1527-5299.2000.80159.x
Patten, R D, and Konstam, M A. "Ventricular remodeling and the renin angiotensin aldosterone system." Congestive heart failure (Greenwich, Conn.) vol. 6,4 (2000): 187-192. doi: https://doi.org/10.1111/j.1527-5299.2000.80159.x
Patten RD, Konstam MA. Ventricular remodeling and the renin angiotensin aldosterone system. Congest Heart Fail. 2000 Jul-Aug;6(4):187-192. doi: 10.1111/j.1527-5299.2000.80159.x. PMID: 12147951.
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Administration of captopril following MI reduced the incidence of ischemia-related events.

Evidence-based cardiovascular medicine

Konstam MA.
PMID: 16379785
Evid Based Cardiovasc Med. 1998 Mar;2(1):21. doi: 10.1016/s1361-2611(98)80018-3.

No abstract available.

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Konstam MA. Administration of captopril following MI reduced the incidence of ischemia-related events. Evid Based Cardiovasc Med. 1998;2(1):21doi: 10.1016/s1361-2611(98)80018-3.
Konstam, M. A. (1998). Administration of captopril following MI reduced the incidence of ischemia-related events. Evidence-based cardiovascular medicine, 2(1), 21. https://doi.org/10.1016/s1361-2611(98)80018-3
Konstam, M A. "Administration of captopril following MI reduced the incidence of ischemia-related events." Evidence-based cardiovascular medicine vol. 2,1 (1998): 21. doi: https://doi.org/10.1016/s1361-2611(98)80018-3
Konstam MA. Administration of captopril following MI reduced the incidence of ischemia-related events. Evid Based Cardiovasc Med. 1998 Mar;2(1):21. doi: 10.1016/s1361-2611(98)80018-3. PMID: 16379785.
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The Challenges of Ensuring Participant Consent in Internet-based Sex Studies: A Case Study of the Men's INTernet Sex (MINTS-I and II) Studies.

Journal of computer-mediated communication : JCMC

Rosser BR, Gurak L, Horvath KJ, Oakes JM, Konstan J, Danilenko GP.
PMID: 24204104
J Comput Mediat Commun. 2009 Apr;14(3). doi: 10.1111/j.1083-6101.2009.01455.x.

This study documents our experience in designing, testing, and refining human subjects' consent protocol in 3 of the first NIH-funded online studies of HIV/STI sexual risk behavior in the USA. We considered 4 challenges primary: a) designing recruitment and...

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Rosser BR, Gurak L, Horvath KJ, et al. The Challenges of Ensuring Participant Consent in Internet-based Sex Studies: A Case Study of the Men's INTernet Sex (MINTS-I and II) Studies. J Comput Mediat Commun. 2009;14(3)doi: 10.1111/j.1083-6101.2009.01455.x.
Rosser, B. R., Gurak, L., Horvath, K. J., Oakes, J. M., Konstan, J., & Danilenko, G. P. (2009). The Challenges of Ensuring Participant Consent in Internet-based Sex Studies: A Case Study of the Men's INTernet Sex (MINTS-I and II) Studies. Journal of computer-mediated communication : JCMC, 14(3), . https://doi.org/10.1111/j.1083-6101.2009.01455.x
Rosser, B R Simon, et al. "The Challenges of Ensuring Participant Consent in Internet-based Sex Studies: A Case Study of the Men's INTernet Sex (MINTS-I and II) Studies." Journal of computer-mediated communication : JCMC vol. 14,3 (2009). doi: https://doi.org/10.1111/j.1083-6101.2009.01455.x
Rosser BR, Gurak L, Horvath KJ, Oakes JM, Konstan J, Danilenko GP. The Challenges of Ensuring Participant Consent in Internet-based Sex Studies: A Case Study of the Men's INTernet Sex (MINTS-I and II) Studies. J Comput Mediat Commun. 2009 Apr;14(3). doi: 10.1111/j.1083-6101.2009.01455.x. PMID: 24204104; PMCID: PMC3817747.
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Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis.

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

Elborn JS, Konstan MW, Taylor-Cousar JL, Fajac I, Horsley A, Sutharsan S, Aaron SD, Daines CL, Uluer A, Downey DG, Lucidi VV, Ahuja S, Springman E, Mershon J, Grosswald R, Rowe SM.
PMID: 34538755
J Cyst Fibros. 2021 Nov;20(6):1026-1034. doi: 10.1016/j.jcf.2021.08.007. Epub 2021 Sep 17.

BACKGROUND: Cystic fibrosis (CF) is characterized by neutrophilic inflammation in the airways. Leukotriene B4 (LTBMETHODS: Subjects were randomized (1:1:1) to once-daily acebilustat 50 mg, 100 mg or placebo for 48 weeks, concomitantly with their current therapeutic regimen. Subjects were...

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Elborn JS, Konstan MW, Taylor-Cousar JL, et al. Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis. J Cyst Fibros. 2021;20(6):1026-1034doi: 10.1016/j.jcf.2021.08.007.
Elborn, J. S., Konstan, M. W., Taylor-Cousar, J. L., Fajac, I., Horsley, A., Sutharsan, S., Aaron, S. D., Daines, C. L., Uluer, A., Downey, D. G., Lucidi, V. V., Ahuja, S., Springman, E., Mershon, J., Grosswald, R., Rowe, S. M. (2021). Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 20(6), 1026-1034. https://doi.org/10.1016/j.jcf.2021.08.007
Elborn, J Stuart, et al. "Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis." Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society vol. 20,6 (2021): 1026-1034. doi: https://doi.org/10.1016/j.jcf.2021.08.007
Elborn JS, Konstan MW, Taylor-Cousar JL, Fajac I, Horsley A, Sutharsan S, Aaron SD, Daines CL, Uluer A, Downey DG, Lucidi VV, Ahuja S, Springman E, Mershon J, Grosswald R, Rowe SM. Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis. J Cyst Fibros. 2021 Nov;20(6):1026-1034. doi: 10.1016/j.jcf.2021.08.007. Epub 2021 Sep 17. PMID: 34538755; PMCID: PMC8649042.
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Annotations.

The Hospital

Konstam MA, Grinfeld L.
PMID: 29815632
Hospital (Lond 1886). 1909 May 22;46(1188):199.

No abstract available.

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Konstam MA, Grinfeld L. Annotations. Hospital (Lond 1886). 1909;46(1188):199
Konstam, M. A., & Grinfeld, L. (1909). Annotations. The Hospital, 46(1188), 199.
Konstam, and Grinfeld. "Annotations." The Hospital vol. 46,1188 (1909): 199.
Konstam MA, Grinfeld L. Annotations. Hospital (Lond 1886). 1909 May 22;46(1188):199. PMID: 29815632; PMCID: PMC5200275.
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Symposium summary remarks.

The American journal of cardiology

Konstam MA, Pearson TA, Roberts WC, Smith SC.
PMID: 9373007
Am J Cardiol. 1997 Oct 30;80(8):89H-90H. doi: 10.1016/s0002-9149(97)00829-1.

No abstract available.

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Konstam MA, Pearson TA, Roberts WC, et al. Symposium summary remarks. Am J Cardiol. 1997;80(8):89H-90Hdoi: 10.1016/s0002-9149(97)00829-1.
Konstam, M. A., Pearson, T. A., Roberts, W. C., & Smith, S. C. (1997). Symposium summary remarks. The American journal of cardiology, 80(8), 89H-90H. https://doi.org/10.1016/s0002-9149(97)00829-1
Konstam, M A, et al. "Symposium summary remarks." The American journal of cardiology vol. 80,8 (1997): 89H-90H. doi: https://doi.org/10.1016/s0002-9149(97)00829-1
Konstam MA, Pearson TA, Roberts WC, Smith SC. Symposium summary remarks. Am J Cardiol. 1997 Oct 30;80(8):89H-90H. doi: 10.1016/s0002-9149(97)00829-1. PMID: 9373007.
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Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection.

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

Bilton D, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Jumadilova Z, Ciesielska M, Konstan MW.
PMID: 34144923
J Cyst Fibros. 2021 Nov;20(6):1010-1017. doi: 10.1016/j.jcf.2021.05.013. Epub 2021 Jun 16.

BACKGROUND: . In CLEAR-108-a phase 3, randomised, open-label study-once-daily amikacin liposome inhalation suspension (ALIS) was noninferior to twice-daily tobramycin inhalation solution (TIS) in improving lung function in patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection after 3...

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Bilton D, Fajac I, Pressler T, et al. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021;20(6):1010-1017doi: 10.1016/j.jcf.2021.05.013.
Bilton, D., Fajac, I., Pressler, T., Clancy, J. P., Sands, D., Minic, P., Cipolli, M., Galeva, I., Solé, A., Quittner, A. L., Jumadilova, Z., Ciesielska, M., Konstan, M. W. (2021). Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 20(6), 1010-1017. https://doi.org/10.1016/j.jcf.2021.05.013
Bilton, Diana, et al. "Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection." Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society vol. 20,6 (2021): 1010-1017. doi: https://doi.org/10.1016/j.jcf.2021.05.013
Bilton D, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Jumadilova Z, Ciesielska M, Konstan MW. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021 Nov;20(6):1010-1017. doi: 10.1016/j.jcf.2021.05.013. Epub 2021 Jun 16. PMID: 34144923.
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The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients.

European journal of internal medicine

Lampropoulos CE, Konsta M, Roumpou A, Dradaki V, Papaioannou I.
PMID: 34763980
Eur J Intern Med. 2021 Dec;94:115-118. doi: 10.1016/j.ejim.2021.10.034. Epub 2021 Nov 08.

No abstract available.

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Lampropoulos CE, Konsta M, Roumpou A, et al. The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients. Eur J Intern Med. 2021;94:115-118doi: 10.1016/j.ejim.2021.10.034.
Lampropoulos, C. E., Konsta, M., Roumpou, A., Dradaki, V., & Papaioannou, I. (2021). The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients. European journal of internal medicine, 94115-118. https://doi.org/10.1016/j.ejim.2021.10.034
Lampropoulos, Christos E, et al. "The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients." European journal of internal medicine vol. 94 (2021): 115-118. doi: https://doi.org/10.1016/j.ejim.2021.10.034
Lampropoulos CE, Konsta M, Roumpou A, Dradaki V, Papaioannou I. The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients. Eur J Intern Med. 2021 Dec;94:115-118. doi: 10.1016/j.ejim.2021.10.034. Epub 2021 Nov 08. PMID: 34763980.
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The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients.

European journal of internal medicine

Lampropoulos CE, Konsta M, Roumpou A, Dradaki V, Papaioannou I.
PMID: 34763980
Eur J Intern Med. 2021 Dec;94:115-118. doi: 10.1016/j.ejim.2021.10.034. Epub 2021 Nov 08.

No abstract available.

Cite
Lampropoulos CE, Konsta M, Roumpou A, et al. The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients. Eur J Intern Med. 2021;94:115-118doi: 10.1016/j.ejim.2021.10.034.
Lampropoulos, C. E., Konsta, M., Roumpou, A., Dradaki, V., & Papaioannou, I. (2021). The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients. European journal of internal medicine, 94115-118. https://doi.org/10.1016/j.ejim.2021.10.034
Lampropoulos, Christos E, et al. "The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients." European journal of internal medicine vol. 94 (2021): 115-118. doi: https://doi.org/10.1016/j.ejim.2021.10.034
Lampropoulos CE, Konsta M, Roumpou A, Dradaki V, Papaioannou I. The prognostic value of malnutrition on duration of admission, financial cost and mortality in elderly, hospitalized patients. Eur J Intern Med. 2021 Dec;94:115-118. doi: 10.1016/j.ejim.2021.10.034. Epub 2021 Nov 08. PMID: 34763980.
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Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis.

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

Elborn JS, Konstan MW, Taylor-Cousar JL, Fajac I, Horsley A, Sutharsan S, Aaron SD, Daines CL, Uluer A, Downey DG, Lucidi VV, Ahuja S, Springman E, Mershon J, Grosswald R, Rowe SM.
PMID: 34538755
J Cyst Fibros. 2021 Nov;20(6):1026-1034. doi: 10.1016/j.jcf.2021.08.007. Epub 2021 Sep 17.

BACKGROUND: Cystic fibrosis (CF) is characterized by neutrophilic inflammation in the airways. Leukotriene B4 (LTBMETHODS: Subjects were randomized (1:1:1) to once-daily acebilustat 50 mg, 100 mg or placebo for 48 weeks, concomitantly with their current therapeutic regimen. Subjects were...

Cite
Elborn JS, Konstan MW, Taylor-Cousar JL, et al. Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis. J Cyst Fibros. 2021;20(6):1026-1034doi: 10.1016/j.jcf.2021.08.007.
Elborn, J. S., Konstan, M. W., Taylor-Cousar, J. L., Fajac, I., Horsley, A., Sutharsan, S., Aaron, S. D., Daines, C. L., Uluer, A., Downey, D. G., Lucidi, V. V., Ahuja, S., Springman, E., Mershon, J., Grosswald, R., Rowe, S. M. (2021). Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 20(6), 1026-1034. https://doi.org/10.1016/j.jcf.2021.08.007
Elborn, J Stuart, et al. "Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis." Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society vol. 20,6 (2021): 1026-1034. doi: https://doi.org/10.1016/j.jcf.2021.08.007
Elborn JS, Konstan MW, Taylor-Cousar JL, Fajac I, Horsley A, Sutharsan S, Aaron SD, Daines CL, Uluer A, Downey DG, Lucidi VV, Ahuja S, Springman E, Mershon J, Grosswald R, Rowe SM. Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis. J Cyst Fibros. 2021 Nov;20(6):1026-1034. doi: 10.1016/j.jcf.2021.08.007. Epub 2021 Sep 17. PMID: 34538755; PMCID: PMC8649042.
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Disease burden in people with cystic fibrosis heterozygous for F508del and a minimal function mutation.

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

Sawicki GS, Van Brunt K, Booth J, Bailey E, Millar SJ, Konstan MW, Flume PA.
PMID: 34289939
J Cyst Fibros. 2021 Jul 19; doi: 10.1016/j.jcf.2021.07.003. Epub 2021 Jul 19.

BACKGROUND: People with cystic fibrosis (CF) heterozygous for F508del-CFTR and a minimal function CFTR mutation (F/MF) that results in no CFTR protein or results in CFTR protein that is not responsive to tezacaftor, ivacaftor, and tezacaftor/ivacaftor in vitro comprise...

Cite
Sawicki GS, Van Brunt K, Booth J, et al. Disease burden in people with cystic fibrosis heterozygous for F508del and a minimal function mutation. J Cyst Fibros. 2021;doi: 10.1016/j.jcf.2021.07.003.
Sawicki, G. S., Van Brunt, K., Booth, J., Bailey, E., Millar, S. J., Konstan, M. W., & Flume, P. A. (2021). Disease burden in people with cystic fibrosis heterozygous for F508del and a minimal function mutation. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, . https://doi.org/10.1016/j.jcf.2021.07.003
Sawicki, Gregory S, et al. "Disease burden in people with cystic fibrosis heterozygous for F508del and a minimal function mutation." Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society vol. (2021). doi: https://doi.org/10.1016/j.jcf.2021.07.003
Sawicki GS, Van Brunt K, Booth J, Bailey E, Millar SJ, Konstan MW, Flume PA. Disease burden in people with cystic fibrosis heterozygous for F508del and a minimal function mutation. J Cyst Fibros. 2021 Jul 19; doi: 10.1016/j.jcf.2021.07.003. Epub 2021 Jul 19. PMID: 34289939.
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Showing 13 to 24 of 41 entries