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Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office.

Pharmaceuticals (Basel, Switzerland)

Dri DA, Praticò G, Gaucci E, Marianecci C, Gramaglia D.
PMID: 34959722
Pharmaceuticals (Basel). 2021 Dec 17;14(12). doi: 10.3390/ph14121321.

One year after the spread of the pandemic, we analyzed the assessment results of the quality documentation submitted to the Clinical Trials Office of the Italian Medicines Agency as part of the request for authorization of clinical trials with...

Cite
Dri DA, Praticò G, Gaucci E, et al. Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office. Pharmaceuticals (Basel). 2021;14(12)doi: 10.3390/ph14121321.
Dri, D. A., Praticò, G., Gaucci, E., Marianecci, C., & Gramaglia, D. (2021). Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office. Pharmaceuticals (Basel, Switzerland), 14(12), . https://doi.org/10.3390/ph14121321
Dri, Diego Alejandro, et al. "Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office." Pharmaceuticals (Basel, Switzerland) vol. 14,12 (2021). doi: https://doi.org/10.3390/ph14121321
Dri DA, Praticò G, Gaucci E, Marianecci C, Gramaglia D. Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office. Pharmaceuticals (Basel). 2021 Dec 17;14(12). doi: 10.3390/ph14121321. PMID: 34959722.
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VPS35 regulates tau phosphorylation and neuropathology in tauopathy.

Molecular psychiatry

Vagnozzi AN, Li JG, Chiu J, Razmpour R, Warfield R, Ramirez SH, Praticò D.
PMID: 31289348
Mol Psychiatry. 2021 Nov;26(11):6992-7005. doi: 10.1038/s41380-019-0453-x. Epub 2019 Jul 09.

The vacuolar protein sorting 35 (VPS35) is a major component of the retromer recognition core complex which regulates intracellular protein sorting and trafficking. Deficiency in VPS35 by altering APP/Aβ metabolism has been linked to late-onset Alzheimer's disease. Here we...

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Vagnozzi AN, Li JG, Chiu J, et al. VPS35 regulates tau phosphorylation and neuropathology in tauopathy. Mol Psychiatry. 2019;26(11):6992-7005doi: 10.1038/s41380-019-0453-x.
Vagnozzi, A. N., Li, J. G., Chiu, J., Razmpour, R., Warfield, R., Ramirez, S. H., & Praticò, D. (2021). VPS35 regulates tau phosphorylation and neuropathology in tauopathy. Molecular psychiatry, 26(11), 6992-7005. https://doi.org/10.1038/s41380-019-0453-x
Vagnozzi, Alana N, et al. "VPS35 regulates tau phosphorylation and neuropathology in tauopathy." Molecular psychiatry vol. 26,11 (2021): 6992-7005. doi: https://doi.org/10.1038/s41380-019-0453-x
Vagnozzi AN, Li JG, Chiu J, Razmpour R, Warfield R, Ramirez SH, Praticò D. VPS35 regulates tau phosphorylation and neuropathology in tauopathy. Mol Psychiatry. 2021 Nov;26(11):6992-7005. doi: 10.1038/s41380-019-0453-x. Epub 2019 Jul 09. PMID: 31289348; PMCID: PMC6949432.
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A rigorous evaluation of optimal peptide targets for MS-based clinical diagnostics of Coronavirus Disease 2019 (COVID-19).

medRxiv : the preprint server for health sciences

Rajczewski AT, Mehta S, Nguyen DDA, Grüning BA, Johnson JE, McGowan T, Griffin TJ, Jagtap PD.
PMID: 33688669
medRxiv. 2021 Mar 01; doi: 10.1101/2021.02.09.21251427.

The Coronavirus Disease 2019 (COVID-19) global pandemic has had a profound, lasting impact on the world's population. A key aspect to providing care for those with COVID-19 and checking its further spread is early and accurate diagnosis of infection,...

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Rajczewski AT, Mehta S, Nguyen DDA, et al. A rigorous evaluation of optimal peptide targets for MS-based clinical diagnostics of Coronavirus Disease 2019 (COVID-19). medRxiv. 2021;doi: 10.1101/2021.02.09.21251427.
Rajczewski, A. T., Mehta, S., Nguyen, D. D. A., Grüning, B. A., Johnson, J. E., McGowan, T., Griffin, T. J., & Jagtap, P. D. (2021). A rigorous evaluation of optimal peptide targets for MS-based clinical diagnostics of Coronavirus Disease 2019 (COVID-19). medRxiv : the preprint server for health sciences, . https://doi.org/10.1101/2021.02.09.21251427
Rajczewski, Andrew T, et al. "A rigorous evaluation of optimal peptide targets for MS-based clinical diagnostics of Coronavirus Disease 2019 (COVID-19)." medRxiv : the preprint server for health sciences vol. (2021). doi: https://doi.org/10.1101/2021.02.09.21251427
Rajczewski AT, Mehta S, Nguyen DDA, Grüning BA, Johnson JE, McGowan T, Griffin TJ, Jagtap PD. A rigorous evaluation of optimal peptide targets for MS-based clinical diagnostics of Coronavirus Disease 2019 (COVID-19). medRxiv. 2021 Mar 01; doi: 10.1101/2021.02.09.21251427. PMID: 33688669; PMCID: PMC7941646.
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Gestational high fat diet protects 3xTg offspring from memory impairments, synaptic dysfunction, and brain pathology.

Molecular psychiatry

Di Meco A, Jelinek J, Lauretti E, Curtis ME, Issa JJ, Praticò D.
PMID: 31451749
Mol Psychiatry. 2021 Nov;26(11):7006-7019. doi: 10.1038/s41380-019-0489-y. Epub 2019 Aug 27.

Maternal history for sporadic Alzheimer's disease (AD) predisposes the offspring to the disease later in life. However, the mechanisms behind this phenomenon are still unknown. Lifestyle and nutrition can directly modulate susceptibility to AD. Herein we investigated whether gestational...

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Di Meco A, Jelinek J, Lauretti E, et al. Gestational high fat diet protects 3xTg offspring from memory impairments, synaptic dysfunction, and brain pathology. Mol Psychiatry. 2019;26(11):7006-7019doi: 10.1038/s41380-019-0489-y.
Di Meco, A., Jelinek, J., Lauretti, E., Curtis, M. E., Issa, J. J., & Praticò, D. (2021). Gestational high fat diet protects 3xTg offspring from memory impairments, synaptic dysfunction, and brain pathology. Molecular psychiatry, 26(11), 7006-7019. https://doi.org/10.1038/s41380-019-0489-y
Di Meco, Antonio, et al. "Gestational high fat diet protects 3xTg offspring from memory impairments, synaptic dysfunction, and brain pathology." Molecular psychiatry vol. 26,11 (2021): 7006-7019. doi: https://doi.org/10.1038/s41380-019-0489-y
Di Meco A, Jelinek J, Lauretti E, Curtis ME, Issa JJ, Praticò D. Gestational high fat diet protects 3xTg offspring from memory impairments, synaptic dysfunction, and brain pathology. Mol Psychiatry. 2021 Nov;26(11):7006-7019. doi: 10.1038/s41380-019-0489-y. Epub 2019 Aug 27. PMID: 31451749; PMCID: PMC7044032.
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Correction to: A pharmacological chaperone improves memory by reducing Aβ and tau neuropathology in a mouse model with plaques and tangles.

Molecular neurodegeneration

Li JG, Chiu J, Ramanjulu M, Blass BE, Praticò D.
PMID: 34183043
Mol Neurodegener. 2021 Jun 28;16(1):42. doi: 10.1186/s13024-021-00461-4.

No abstract available.

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Li JG, Chiu J, Ramanjulu M, et al. Correction to: A pharmacological chaperone improves memory by reducing Aβ and tau neuropathology in a mouse model with plaques and tangles. Mol Neurodegener. 2021;16(1):42doi: 10.1186/s13024-021-00461-4.
Li, J. G., Chiu, J., Ramanjulu, M., Blass, B. E., & Praticò, D. (2021). Correction to: A pharmacological chaperone improves memory by reducing Aβ and tau neuropathology in a mouse model with plaques and tangles. Molecular neurodegeneration, 16(1), 42. https://doi.org/10.1186/s13024-021-00461-4
Li, Jian-Guo, et al. "Correction to: A pharmacological chaperone improves memory by reducing Aβ and tau neuropathology in a mouse model with plaques and tangles." Molecular neurodegeneration vol. 16,1 (2021): 42. doi: https://doi.org/10.1186/s13024-021-00461-4
Li JG, Chiu J, Ramanjulu M, Blass BE, Praticò D. Correction to: A pharmacological chaperone improves memory by reducing Aβ and tau neuropathology in a mouse model with plaques and tangles. Mol Neurodegener. 2021 Jun 28;16(1):42. doi: 10.1186/s13024-021-00461-4. PMID: 34183043; PMCID: PMC8240188.
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Diagnosis and Management of Autoimmune Hemolytic Anemia in Patients with Liver and Bowel Disorders.

Journal of clinical medicine

Bianco C, Coluccio E, Prati D, Valenti L.
PMID: 33499290
J Clin Med. 2021 Jan 22;10(3). doi: 10.3390/jcm10030423.

Anemia is a common feature of liver and bowel diseases. Although the main causes of anemia in these conditions are represented by gastrointestinal bleeding and iron deficiency, autoimmune hemolytic anemia should be considered in the differential diagnosis. Due to...

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Bianco C, Coluccio E, Prati D, et al. Diagnosis and Management of Autoimmune Hemolytic Anemia in Patients with Liver and Bowel Disorders. J Clin Med. 2021;10(3)doi: 10.3390/jcm10030423.
Bianco, C., Coluccio, E., Prati, D., & Valenti, L. (2021). Diagnosis and Management of Autoimmune Hemolytic Anemia in Patients with Liver and Bowel Disorders. Journal of clinical medicine, 10(3), . https://doi.org/10.3390/jcm10030423
Bianco, Cristiana, et al. "Diagnosis and Management of Autoimmune Hemolytic Anemia in Patients with Liver and Bowel Disorders." Journal of clinical medicine vol. 10,3 (2021). doi: https://doi.org/10.3390/jcm10030423
Bianco C, Coluccio E, Prati D, Valenti L. Diagnosis and Management of Autoimmune Hemolytic Anemia in Patients with Liver and Bowel Disorders. J Clin Med. 2021 Jan 22;10(3). doi: 10.3390/jcm10030423. PMID: 33499290; PMCID: PMC7865399.
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Age-dependent impact of the major common genetic risk factor for COVID-19 on severity and mortality.

The Journal of clinical investigation

Nakanishi T, Pigazzini S, Degenhardt F, Cordioli M, Butler-Laporte G, Maya-Miles D, Bujanda L, Bouysran Y, Niemi ME, Palom A, Ellinghaus D, Khan A, Martínez-Bueno M, Rolker S, Amitrano S, Roade Tato L, Fava F, Spinner CD, Prati D, Bernardo D, Garcia F, Darcis G, Fernández-Cadenas I, Holter JC, Banales JM, Frithiof R, Kiryluk K, Duga S, Asselta R, Pereira AC, Romero-Gómez M, Nafría-Jiménez B, Hov JR, Migeotte I, Renieri A, Planas AM, Ludwig KU, Buti M, Rahmouni S, Alarcón-Riquelme ME, Schulte EC, Franke A, Karlsen TH, Valenti L, Zeberg H, Richards JB, Ganna A.
PMID: 34597274
J Clin Invest. 2021 Dec 01;131(23). doi: 10.1172/JCI152386.

BackgroundThere is considerable variability in COVID-19 outcomes among younger adults, and some of this variation may be due to genetic predisposition.MethodsWe combined individual level data from 13,888 COVID-19 patients (n = 7185 hospitalized) from 17 cohorts in 9 countries...

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Nakanishi T, Pigazzini S, Degenhardt F, et al. Age-dependent impact of the major common genetic risk factor for COVID-19 on severity and mortality. J Clin Invest. 2021;131(23)doi: 10.1172/JCI152386.
Nakanishi, T., Pigazzini, S., Degenhardt, F., Cordioli, M., Butler-Laporte, G., Maya-Miles, D., Bujanda, L., Bouysran, Y., Niemi, M. E., Palom, A., Ellinghaus, D., Khan, A., Martínez-Bueno, M., Rolker, S., Amitrano, S., Roade Tato, L., Fava, F., Spinner, C. D., Prati, D., Bernardo, D., Garcia, F., Darcis, G., Fernández-Cadenas, I., Holter, J. C., Banales, J. M., Frithiof, R., Kiryluk, K., Duga, S., Asselta, R., Pereira, A. C., Romero-Gómez, M., Nafría-Jiménez, B., Hov, J. R., Migeotte, I., Renieri, A., Planas, A. M., Ludwig, K. U., Buti, M., Rahmouni, S., Alarcón-Riquelme, M. E., Schulte, E. C., Franke, A., Karlsen, T. H., Valenti, L., Zeberg, H., Richards, J. B., & Ganna, A. (2021). Age-dependent impact of the major common genetic risk factor for COVID-19 on severity and mortality. The Journal of clinical investigation, 131(23), . https://doi.org/10.1172/JCI152386
Nakanishi, Tomoko, et al. "Age-dependent impact of the major common genetic risk factor for COVID-19 on severity and mortality." The Journal of clinical investigation vol. 131,23 (2021). doi: https://doi.org/10.1172/JCI152386
Nakanishi T, Pigazzini S, Degenhardt F, Cordioli M, Butler-Laporte G, Maya-Miles D, Bujanda L, Bouysran Y, Niemi ME, Palom A, Ellinghaus D, Khan A, Martínez-Bueno M, Rolker S, Amitrano S, Roade Tato L, Fava F, Spinner CD, Prati D, Bernardo D, Garcia F, Darcis G, Fernández-Cadenas I, Holter JC, Banales JM, Frithiof R, Kiryluk K, Duga S, Asselta R, Pereira AC, Romero-Gómez M, Nafría-Jiménez B, Hov JR, Migeotte I, Renieri A, Planas AM, Ludwig KU, Buti M, Rahmouni S, Alarcón-Riquelme ME, Schulte EC, Franke A, Karlsen TH, Valenti L, Zeberg H, Richards JB, Ganna A. Age-dependent impact of the major common genetic risk factor for COVID-19 on severity and mortality. J Clin Invest. 2021 Dec 01;131(23). doi: 10.1172/JCI152386. PMID: 34597274; PMCID: PMC8631592.
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Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office.

Pharmaceuticals (Basel, Switzerland)

Dri DA, Praticò G, Gaucci E, Marianecci C, Gramaglia D.
PMID: 34959722
Pharmaceuticals (Basel). 2021 Dec 17;14(12). doi: 10.3390/ph14121321.

One year after the spread of the pandemic, we analyzed the assessment results of the quality documentation submitted to the Clinical Trials Office of the Italian Medicines Agency as part of the request for authorization of clinical trials with...

Cite
Dri DA, Praticò G, Gaucci E, et al. Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office. Pharmaceuticals (Basel). 2021;14(12)doi: 10.3390/ph14121321.
Dri, D. A., Praticò, G., Gaucci, E., Marianecci, C., & Gramaglia, D. (2021). Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office. Pharmaceuticals (Basel, Switzerland), 14(12), . https://doi.org/10.3390/ph14121321
Dri, Diego Alejandro, et al. "Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office." Pharmaceuticals (Basel, Switzerland) vol. 14,12 (2021). doi: https://doi.org/10.3390/ph14121321
Dri DA, Praticò G, Gaucci E, Marianecci C, Gramaglia D. Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office. Pharmaceuticals (Basel). 2021 Dec 17;14(12). doi: 10.3390/ph14121321. PMID: 34959722; PMCID: PMC8709226.
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Platelet activation and modulation in thrombosis with thrombocytopenia syndrome associated with ChAdO×1 nCov-19 vaccine.

Haematologica

Scavone M, Clerici B, Birocchi S, Mencarini T, Calogiuri M, Ghali C, Prati D, Bozzi S, Villa P, Cattaneo M, Podda GM.
PMID: 34474550
Haematologica. 2021 Dec 01;106(12):3228-3231. doi: 10.3324/haematol.2021.279345.

No abstract available.

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Scavone M, Clerici B, Birocchi S, et al. Platelet activation and modulation in thrombosis with thrombocytopenia syndrome associated with ChAdO×1 nCov-19 vaccine. Haematologica. 2021;106(12):3228-3231doi: 10.3324/haematol.2021.279345.
Scavone, M., Clerici, B., Birocchi, S., Mencarini, T., Calogiuri, M., Ghali, C., Prati, D., Bozzi, S., Villa, P., Cattaneo, M., & Podda, G. M. (2021). Platelet activation and modulation in thrombosis with thrombocytopenia syndrome associated with ChAdO×1 nCov-19 vaccine. Haematologica, 106(12), 3228-3231. https://doi.org/10.3324/haematol.2021.279345
Scavone, Mariangela, et al. "Platelet activation and modulation in thrombosis with thrombocytopenia syndrome associated with ChAdO×1 nCov-19 vaccine." Haematologica vol. 106,12 (2021): 3228-3231. doi: https://doi.org/10.3324/haematol.2021.279345
Scavone M, Clerici B, Birocchi S, Mencarini T, Calogiuri M, Ghali C, Prati D, Bozzi S, Villa P, Cattaneo M, Podda GM. Platelet activation and modulation in thrombosis with thrombocytopenia syndrome associated with ChAdO×1 nCov-19 vaccine. Haematologica. 2021 Dec 01;106(12):3228-3231. doi: 10.3324/haematol.2021.279345. PMID: 34474550.
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Previously Unreported .

Molecular syndromology

Venti V, Scalia B, Sauna A, Nasca MR, Smilari P, Praticò AD, Fiumara A, Pappalardo XG, Pavone P.
PMID: 32021608
Mol Syndromol. 2020 Jan;10(6):332-338. doi: 10.1159/000504210. Epub 2019 Nov 16.

Epidermolysis bullosa (EB) encompasses a group of inheritable skin disorders characterized by various degrees of epithelial fragility that lead to cutaneous and mucosal blistering following negligible mechanical traumas. These disorders are clinically and genetically heterogeneous, ranging from mild skin...

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Venti V, Scalia B, Sauna A, et al. Previously Unreported . Mol Syndromol. 2019;10(6):332-338doi: 10.1159/000504210.
Venti, V., Scalia, B., Sauna, A., Nasca, M. R., Smilari, P., Praticò, A. D., Fiumara, A., Pappalardo, X. G., & Pavone, P. (2020). Previously Unreported . Molecular syndromology, 10(6), 332-338. https://doi.org/10.1159/000504210
Venti, Valeria, et al. "Previously Unreported ." Molecular syndromology vol. 10,6 (2020): 332-338. doi: https://doi.org/10.1159/000504210
Venti V, Scalia B, Sauna A, Nasca MR, Smilari P, Praticò AD, Fiumara A, Pappalardo XG, Pavone P. Previously Unreported . Mol Syndromol. 2020 Jan;10(6):332-338. doi: 10.1159/000504210. Epub 2019 Nov 16. PMID: 32021608; PMCID: PMC6995948.
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Improve your Galaxy text life: The Query Tabular Tool.

F1000Research

Johnson JE, Kumar P, Easterly C, Esler M, Mehta S, Eschenlauer AC, Hegeman AD, Jagtap PD, Griffin TJ.
PMID: 30519459
F1000Res. 2018 Oct 05;7:1604. doi: 10.12688/f1000research.16450.2. eCollection 2018.

Galaxy provides an accessible platform where multi-step data analysis workflows integrating disparate software can be run, even by researchers with limited programming expertise. Applications of such sophisticated workflows are many, including those which integrate software from different 'omic domains...

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Johnson JE, Kumar P, Easterly C, et al. Improve your Galaxy text life: The Query Tabular Tool. F1000Res. 2018;7:1604doi: 10.12688/f1000research.16450.2.
Johnson, J. E., Kumar, P., Easterly, C., Esler, M., Mehta, S., Eschenlauer, A. C., Hegeman, A. D., Jagtap, P. D., & Griffin, T. J. (2018). Improve your Galaxy text life: The Query Tabular Tool. F1000Research, 71604. https://doi.org/10.12688/f1000research.16450.2
Johnson, James E, et al. "Improve your Galaxy text life: The Query Tabular Tool." F1000Research vol. 7 (2018): 1604. doi: https://doi.org/10.12688/f1000research.16450.2
Johnson JE, Kumar P, Easterly C, Esler M, Mehta S, Eschenlauer AC, Hegeman AD, Jagtap PD, Griffin TJ. Improve your Galaxy text life: The Query Tabular Tool. F1000Res. 2018 Oct 05;7:1604. doi: 10.12688/f1000research.16450.2. eCollection 2018. PMID: 30519459; PMCID: PMC6248266.
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Stochastic Dispersal Rather Than Deterministic Selection Explains the Spatio-Temporal Distribution of Soil Bacteria in a Temperate Grassland.

Frontiers in microbiology

Richter-Heitmann T, Hofner B, Krah FS, Sikorski J, Wüst PK, Bunk B, Huang S, Regan KM, Berner D, Boeddinghaus RS, Marhan S, Prati D, Kandeler E, Overmann J, Friedrich MW.
PMID: 32695081
Front Microbiol. 2020 Jun 30;11:1391. doi: 10.3389/fmicb.2020.01391. eCollection 2020.

Spatial and temporal processes shaping microbial communities are inseparably linked but rarely studied together. By Illumina 16S rRNA sequencing, we monitored soil bacteria in 360 stations on a 100 square meter plot distributed across six intra-annual samplings in a...

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Richter-Heitmann T, Hofner B, Krah FS, et al. Stochastic Dispersal Rather Than Deterministic Selection Explains the Spatio-Temporal Distribution of Soil Bacteria in a Temperate Grassland. Front Microbiol. 2020;11:1391doi: 10.3389/fmicb.2020.01391.
Richter-Heitmann, T., Hofner, B., Krah, F. S., Sikorski, J., Wüst, P. K., Bunk, B., Huang, S., Regan, K. M., Berner, D., Boeddinghaus, R. S., Marhan, S., Prati, D., Kandeler, E., Overmann, J., & Friedrich, M. W. (2020). Stochastic Dispersal Rather Than Deterministic Selection Explains the Spatio-Temporal Distribution of Soil Bacteria in a Temperate Grassland. Frontiers in microbiology, 111391. https://doi.org/10.3389/fmicb.2020.01391
Richter-Heitmann, Tim, et al. "Stochastic Dispersal Rather Than Deterministic Selection Explains the Spatio-Temporal Distribution of Soil Bacteria in a Temperate Grassland." Frontiers in microbiology vol. 11 (2020): 1391. doi: https://doi.org/10.3389/fmicb.2020.01391
Richter-Heitmann T, Hofner B, Krah FS, Sikorski J, Wüst PK, Bunk B, Huang S, Regan KM, Berner D, Boeddinghaus RS, Marhan S, Prati D, Kandeler E, Overmann J, Friedrich MW. Stochastic Dispersal Rather Than Deterministic Selection Explains the Spatio-Temporal Distribution of Soil Bacteria in a Temperate Grassland. Front Microbiol. 2020 Jun 30;11:1391. doi: 10.3389/fmicb.2020.01391. eCollection 2020. PMID: 32695081; PMCID: PMC7338559.
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