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3. A First-in-Human Clinical Trial of Pulmonary Macrophage Transplantation Therapy of Hereditary Pulmonary Alveolar Proteinosis Caused by Biallelic CSF2RA Mutations

Author

Trapnell, B.C., primary, Arumugam, P., additional, Carey, B., additional, Trump-Durbin, L., additional, Wessendarp, M., additional, Suzuki, T., additional, Ma, Y., additional, Shima, K., additional, Stock, J., additional, Chalk, C., additional, Wikenheiser-Brokamp, K.A., additional, and Lutzko, C.M., additional

Published
2024
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19. Complementation of CSF2RA Mutations Restores GM-CSF Signaling to Macrophages from Patients with Hereditary Pulmonary Alveolar Proteinosis

Author

Arumugam, P.I., primary, Wessendarp, M., additional, Carey, B.C., additional, Trump-Durbin, L., additional, Shima, K., additional, Ma, Y., additional, Stock, J., additional, Chalk, C., additional, Lachmann, N., additional, Moritz, T., additional, Suzuki, T., additional, Lutzko, C.M., additional, and Trapnell, B.C., additional

Published
2021
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23. Minimal manifestation status and prednisone withdrawal in the MGTX trial

Author

Lee, I., Kuo, H. -C., Aban, I. B., Cutter, G. R., McPherson, T., Kaminski, H. J., Sussman, J., Strobel, P., Oger, J., Cea, G., Heckmann, J. M., Evoli, A., Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias-Tosta, E., Yoshikawa, H., Waddington-Cruz, M., Pulley, M. T., Rivner, M. H., Kostera-Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Verschuuren, J. J. G., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Minisman, G., Sonett, J. R., Wolfe, G. I., Evoli A. (ORCID:0000-0003-0282-8787), Lee, I., Kuo, H. -C., Aban, I. B., Cutter, G. R., McPherson, T., Kaminski, H. J., Sussman, J., Strobel, P., Oger, J., Cea, G., Heckmann, J. M., Evoli, A., Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias-Tosta, E., Yoshikawa, H., Waddington-Cruz, M., Pulley, M. T., Rivner, M. H., Kostera-Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Verschuuren, J. J. G., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Minisman, G., Sonett, J. R., Wolfe, G. I., and Evoli A. (ORCID:0000-0003-0282-8787)

Abstract

OBJECTIVE: To examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG). METHODS: This study is a post hoc analysis of data from a randomized trial of thymectomy in MG (Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy [MGTX]). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody-positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone vs prednisone alone. Participants were age 18-65 years at enrollment with disease duration less than 5 years. All patients received oral prednisone titrated up to 100 mg on alternate days until they achieved MMS, which prompted a standardized prednisone taper as long as MMS was maintained. The achievement rate of sustained MMS (no symptoms of MG for 6 months) with complete withdrawal of prednisone was compared between the thymectomy plus prednisone and prednisone alone groups. RESULTS: Patients with MG in the thymectomy plus prednisone group achieved sustained MMS with complete withdrawal of prednisone more frequently (64% vs 38%) and quickly compared to the prednisone alone group (median time 30 months vs no median time achieved, p < 0.001) over the 5-year study period. Prednisone-associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone. CONCLUSIONS: Thymectomy benefits patients with MG by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone. CLINICALTRIALSGOV IDENTIFIER: NCT00294658. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with generalized MG with AChR antibody, those receiving thymectomy plus prednisone are more likely to attain sustained MMS and complete prednisone wi

Published
2020

27. A Formal Toxicology Study of the Safety, Tolerability, and Efficacy of Gene-Pulmonary Macrophage Transplantation (PMT) Therapy of Hereditary Pulmonary Alveolar Proteinosis (HPAP)

Author

Arumugam, P.I., primary, Shima, K., additional, Wessendarp, M., additional, Ma, Y., additional, Carey, B.C., additional, Yombo, D.J.K., additional, Collins, M., additional, Imbrogno, M., additional, Black, D., additional, Chalk, C., additional, Lachmann, N., additional, Moritz, T., additional, Suzuki, T., additional, and Trapnell, B.C., additional

Published
2020
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36. Flight Evaluation of an Aircraft with Side and Center Stick Controllers and Rate-Limited Ailerons

Author

Deppe, P. R, Chalk, C. R, and Shafer, M. F

Subjects
Aircraft Stability And Control
Abstract

As part of an ongoing government and industry effort to study the flying qualities of aircraft with rate-limited control surface actuators, two studies were previously flown to examine an algorithm developed to reduce the tendency for pilot-induced oscillation when rate limiting occurs. This algorithm, when working properly, greatly improved the performance of the aircraft in the first study. In the second study, however, the algorithm did not initially offer as much improvement. The differences between the two studies caused concern. The study detailed in this paper was performed to determine whether the performance of the algorithm was affected by the characteristics of the cockpit controllers. Time delay and flight control system noise were also briefly evaluated. An in-flight simulator, the Calspan Learjet 25, was programmed with a low roll actuator rate limit, and the algorithm was programmed into the flight control system. Side- and center-stick controllers, force and position command signals, a rate-limited feel system, a low-frequency feel system, and a feel system damper were evaluated. The flight program consisted of four flights and 38 evaluations of test configurations. Performance of the algorithm was determined to be unaffected by using side- or center-stick controllers or force or position command signals. The rate-limited feel system performed as well as the rate-limiting algorithm but was disliked by the pilots. The low-frequency feel system and the feel system damper were ineffective. Time delay and noise were determined to degrade the performance of the algorithm.

Published
1996

37. A study of pulsed thermography for life assessment of thin EB-PVD TBCs undergoing oxidation ageing

Author

Tinsley, L., Chalk, C., Nicholls, J., Mehnen, J., and Roy, R.

Subjects
Thermal diffusivity, T1, TA, Oxidation ageing, Thermal Barrier Coating, TJ, sense organs, Pulse thermography
Abstract

This paper presents an assessment of ageing for thin Thermal Barrier Coatings (TBC) using active thermography. As TBCs undergo ageing during their service life, sintering changes the porosity, elements migrate from the substrate, and micro-cracks build up in the structure of the material, exhibiting a change in thermal conductivity and diffusion properties. As the material ages and these properties change over time, it is possible to exploit trends in this change for characterisation of coating ageing, which would provide a diagnostics tool to estimate remaining useful life. In this study, through-depth diffusivity measurement has been applied to thin EB-PVD coatings which are artificially aged via oxidation furnace cycles. In order to address the difficulties of capturing a fast thermal event in a thin coating, a novel parametric study approach has been carried out to optimise data capture and analysis, maximising available frames for the model fitting step. Through-depth diffusivities have been measured during ageing for six samples, yielding a repeatable trend in thermal diffusivity measurements, with three features, which can be exploited for ageing characterisation of thin EB-PVD TBCs, and used as an alarm of imminent failure.

Published
2017

40. Randomized Trial of Thymectomy in Myasthenia Gravis

Author

Wolfe, Gi, Kaminski, Hj, Aban, Ib, Minisman, G, Kuo, Hc, Marx, A, Ströbel, P, Mazia, C, Oger, J, Cea, Jg, Heckmann, Jm, Evoli, A, Nix, W, Ciafaloni, E, Antonini, G, Witoonpanich, R, King, Jo, Beydoun, Sr, Chalk, Ch, Barboi, Ac, Amato, Aa, Shaibani, Ai, Katirji, B, Lecky, Br, Buckley, C, Vincent, A, Dias Tosta, E, Yoshikawa, H, Waddington Cruz, M, Pulley, Mt, Rivner, Mh, Kostera Pruszczyk, A, Pascuzzi, Rm, Jackson, Ce, Garcia Ramos GS, Verschuuren, Jj, Massey, Jm, Kissel, Jt, Werneck, Lc, Benatar, M, Barohn, Rj, Tandan, R, Mozaffar, T, Conwit, R, Odenkirchen, J, Sonett, Jr, 3rd, Jaretzki A., Newsom Davis, J, Cutter, Gr, MGTX study group including Cutter GR, Feese, M, Saluto, V, Rosenberg, M, Alvarez, V, Rey, L, King, J, Butzkueven, H, Goldblatt, J, Carey, J, Pollard, J, Reddel, S, Handel, N, Mccaughan, B, Pallot, L, Novis, R, Boasquevisque, C, Morato Fernandez, R, Ximenes, M, Werneck, L, Scola, R, Soltoski, P, Chalk, C, Moore, F, Mulder, D, Wadup, L, Mezei, M, Evans, K, Jiwa, T, Schaffar, A, White, C, Toth, C, Gelfand, G, Wood, S, Pringle, E, Zwicker, J, Maziak, D, Shamji, F, Sundaresan, S, Seely, A, Cea, G, Verdugo, R, Aguayo, A, Jander, S, Zickler, P, Klein, M, Weis, Ca, Melms, A, Bischof, F, Aebert, H, Ziemer, G, Thümler, B, Wilhem Schwenkmezger, T, Mayer, E, Schalke, B, Pöschel, P, Hieber, G, Wiebe, K, Clemenzi, A, Ceschin, V, Rendina, E, Venuta, F, Morino, S, Bucci, E, Durelli, Luca, Tavella, A, Clerico, Marinella, Contessa, G, Borasio, P, Servidei, S, Granone, P, Mantegazza, R, Berta, E, Novellino, L, Spinelli, L, Motomura, M, Matsuo, H, Nagayasu, T, Takamori, M, Oda, M, Matsumoto, I, Furukawa, Y, Noto, D, Motozaki, Y, Iwasa, K, Yanase, D, Ramos, Gg, Cacho, B, de la Garza, L, Lipowska, M, Kwiecinski, H, Potulska Chromik, A, Orlowski, T, Silva, A, Feijo, M, Freitas, A, Heckmann, J, Frost, A, Pan, El, Tucker, L, Rossouw, J, Drummond, F, Illa, I, Diaz, J, Leon, C, Yeh, Jh, Chiu, Hc, Hsieh, Ys, Tunlayadechanont, S, Attanavanich, S, Verschuuren, J, Straathof, C, Titulaer, M, Versteegh, M, Pels, A, Krum, Y, Leite, M, Hilton Jones, D, Ratnatunga, C, Farrugia, Me, Petty, R, Overell, J, Kirk, A, Gibson, A, Mcdermott, C, Hopkinson, D, Lecky, B, Watling, D, Marshall, D, Saminaden, S, Davies, D, Dougan, C, Sathasivam, S, Page, R, Sussman, J, Ealing, J, Krysiak, P, Amato, A, Salajegheh, M, Jaklitsch, M, Roe, K, Ashizawa, T, Smith, Rg, Zwischenberg, J, Stanton, P, Barboi, A, Jaradeh, S, Tisol, W, Gasparri, M, Haasler, G, Yellick, M, Dennis, C, Barohn, R, Pasnoor, M, Dimachkie, M, Mcvey, A, Gronseth, G, Dick, A, Kramer, J, Currence, M, Herbelin, L, Belsh, J, Li, G, Langenfeld, J, Mertz, Ma, Harrison, T, Force, S, Usher, S, Beydoun, S, Lin, F, Demeester, S, Akhter, S, Malekniazi, A, Avenido, G, Crum, B, Milone, M, Cassivi, S, Fisher, J, Heatwole, C, Watson, T, Hilbert, J, Smirnow, A, Distad, B, Weiss, M, Wood, D, Haug, J, Ernstoff, R, Cao, J, Chmielewski, G, Welsh, R, Duris, R, Gutmann, L, Pawar, G, Graeber, Gm, Altemus, P, Nance, C, Jackson, C, Grogan, P, Calhoon, J, Kittrell, P, Myers, D, Kaminski, H, Hayat, G, Naunheim, K, Eller, S, Holzemer, E, Alshekhlee, A, Robke, J, Karlinchak, B, Katz, J, Miller, R, Roan, R, Forshew, D, Kissel, J, Elsheikh, B, Ross, P, Chelnick, S, Lewis, R, Acsadi, A, Baciewicz, F, Masse, S, Massey, J, Juel, V, Onaitis, M, Lowe, J, Lipscomb, B, Thai, G, Milliken, J, Martin, V, Karayan, R, Muley, S, Parry, G, Shumway, S, Oh, S, Claussen, G, Lu, L, Cerfolio, R, Young, A, Morgan, M, Pascuzzi, R, Kincaid, J, Kesler, K, Guingrich, S, Michaels, A, Phillips, L, Burns, T, Jones, D, Fischer, C, Pulley, M, Berger, A, D'Agostino, H, Smith, L, Rivner, M, Pruitt, J, Landolfo, K, Hillman, D, Shaibani, A, Sermas, A, Ruel, R, Ismail, F, Sivak, M, Goldstein, M, Camunas, J, Bratton, J, Panitch, H, Leavitt, B, Jones, M, Wolfe, G, Muppidi, S, Vernino, S, Nations, S, Meyer, D, and Gorham, N.

Subjects
Male, medicine, medicine.medical_treatment, 030204 cardiovascular system & hematology, Medical and Health Sciences, Severity of Illness Index, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Prednisone, Adolescent, Adult, Aged, Combined Modality Therapy, Female, Glucocorticoids, Hospitalization, Humans, Middle Aged, Myasthenia Gravis, Single-Blind Method, Treatment Outcome, Young Adult, Thymectomy, Medicine (all), Young adult, MGTX Study Group, General Medicine, Settore MED/26 - NEUROLOGIA, 6.1 Pharmaceuticals, medicine.drug, medicine.medical_specialty, Clinical Trials and Supportive Activities, Autoimmune Disease, 03 medical and health sciences, Rare Diseases, Clinical Research, General & Internal Medicine, Internal medicine, Severity of illness, business.industry, Neurosciences, Evaluation of treatments and therapeutic interventions, Retrospective cohort study, medicine.disease, Myasthenia gravis, Surgery, Clinical research, adolescent, adult, aged, combined modality therapy, female, glucocorticoids, hospitalization, humans, male, middle aged, myasthenia gravis, prednisone, severity of Illness index, single-blind method, treatment outcome, young adult, thymectomy, business, 030217 neurology & neurosurgery
Abstract

BackgroundThymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone.MethodsWe compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period.ResultsA total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, P

Published
2016
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41. Script concordance testing: a review of published validity evidence

Author

Lubarsky, S., Charlin, B., Cook, D.A., Chalk, C., Vleuten, C.P.M. van der, Onderwijsontw & Onderwijsresearch, and RS: SHE School of Health Professions Education

Subjects
education, Effective primary care and public health [NCEBP 7]
Abstract

Item does not contain fulltext CONTEXT: Script concordance test (SCT) scores are intended to reflect respondents' competence in interpreting clinical data under conditions of uncertainty. The validity of inferences based on SCT scores has not been rigorously established. OBJECTIVES: This study was conducted in order to develop a structured validity argument for the interpretation of test scores derived through use of the script concordance method. METHODS: We searched the PubMed, EMBASE and PsycINFO databases for articles pertaining to script concordance testing. We then reviewed these articles to evaluate the construct validity of the script concordance method, following an established approach for analysing validity data from five categories: content; response process; internal structure; relations to other variables, and consequences. RESULTS: Content evidence derives from clear guidelines for the creation of authentic, ill-defined scenarios. High internal consistency reliability supports the internal structure of SCT scores. As might be expected, SCT scores correlate poorly with assessments of pure factual knowledge, in which correlations for more advanced learners are lower. The validity of SCT scores is weakly supported by evidence pertaining to examinee response processes and educational consequences. CONCLUSIONS: Published research generally supports the use of SCT to assess the interpretation of clinical data under conditions of uncertainty, although specifics of the validity argument vary and require verification in different contexts and for particular SCTs. Our review identifies potential areas of further validity inquiry in all five categories of evidence. In particular, future SCT research might explore the impact of the script concordance method on teaching and learning, and examine how SCTs integrate with other assessment methods within comprehensive assessment programmes. 01 april 2011

Published
2011
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42. Randomized trial of thymectomy in myasthenia gravis

Author

Wolfe, G. I., Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. -C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Evoli Stampanoni-B, Amelia, Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias-Tosta, E., Yoshikawa, H., Waddington-Cruz, M., Pulley, M. T., Rivner, M. H., Kostera-Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Garcia Ramos, G. S., Verschuuren, J. J. G. M., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Odenkirchen, J., Sonett, J. R., Jaretzki, A., Newsom-Davis, J., Cutter, G. R., Evoli, A. (ORCID:0000-0003-0282-8787), Wolfe, G. I., Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. -C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Evoli Stampanoni-B, Amelia, Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias-Tosta, E., Yoshikawa, H., Waddington-Cruz, M., Pulley, M. T., Rivner, M. H., Kostera-Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Garcia Ramos, G. S., Verschuuren, J. J. G. M., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Odenkirchen, J., Sonett, J. R., Jaretzki, A., Newsom-Davis, J., Cutter, G. R., and Evoli, A. (ORCID:0000-0003-0282-8787)

Abstract

BACKGROUND: Thymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone. METHODS: We compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period. RESULTS: A total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, P<0.001); patients in the thymectomy group also had a lower average requirement for alternate-day prednisone (44 mg vs. 60 mg, P<0.001). Fewer patients in the thymectomy group than in the prednisone-only group required immunosuppression with azathioprine (17% vs. 48%, P<0.001) or were hospitalized for exacerbations (9% vs. 37%, P<0.001). The number of patients with treatment-associated complications did not differ significantly between groups (P=0.73), but patients in the thymectomy group had fewer treatment-associated symptoms related to immunosuppressive medications (P<0.001) and lower distress levels related to symptoms (P=0.003). CONCLUSIONS: Thymectomy improved cl

Published
2016

43. Randomized trial of thymectomy in myasthenia gravis

Author

Wolfe, G. I, Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Evoli Stampanoni-B, Amelia, Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias Tosta, E., Yoshikawa, H., Waddington Cruz, M., Pulley, M. T., Rivner, M. H., Kostera Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Garcia Ramos, G. S., Verschuuren, J. J. G. M., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Odenkirchen, J., Sonett, J. R., Jaretzki, A., Newsom Davis, J., Cutter, G. R., Evoli, Amelia (ORCID:0000-0003-0282-8787), Wolfe, G. I, Kaminski, H. J., Aban, I. B., Minisman, G., Kuo, H. C., Marx, A., Ströbel, P., Mazia, C., Oger, J., Cea, J. G., Heckmann, J. M., Evoli Stampanoni-B, Amelia, Nix, W., Ciafaloni, E., Antonini, G., Witoonpanich, R., King, J. O., Beydoun, S. R., Chalk, C. H., Barboi, A. C., Amato, A. A., Shaibani, A. I., Katirji, B., Lecky, B. R. F., Buckley, C., Vincent, A., Dias Tosta, E., Yoshikawa, H., Waddington Cruz, M., Pulley, M. T., Rivner, M. H., Kostera Pruszczyk, A., Pascuzzi, R. M., Jackson, C. E., Garcia Ramos, G. S., Verschuuren, J. J. G. M., Massey, J. M., Kissel, J. T., Werneck, L. C., Benatar, M., Barohn, R. J., Tandan, R., Mozaffar, T., Conwit, R., Odenkirchen, J., Sonett, J. R., Jaretzki, A., Newsom Davis, J., Cutter, G. R., and Evoli, Amelia (ORCID:0000-0003-0282-8787)

Abstract

BACKGROUND: Thymectomy has been a mainstay in the treatment of myasthenia gravis, but there is no conclusive evidence of its benefit. We conducted a multicenter, randomized trial comparing thymectomy plus prednisone with prednisone alone. METHODS: We compared extended transsternal thymectomy plus alternate-day prednisone with alternate-day prednisone alone. Patients 18 to 65 years of age who had generalized nonthymomatous myasthenia gravis with a disease duration of less than 5 years were included if they had Myasthenia Gravis Foundation of America clinical class II to IV disease (on a scale from I to V, with higher classes indicating more severe disease) and elevated circulating concentrations of acetylcholine-receptor antibody. The primary outcomes were the time-weighted average Quantitative Myasthenia Gravis score (on a scale from 0 to 39, with higher scores indicating more severe disease) over a 3-year period, as assessed by means of blinded rating, and the time-weighted average required dose of prednisone over a 3-year period. RESULTS: A total of 126 patients underwent randomization between 2006 and 2012 at 36 sites. Patients who underwent thymectomy had a lower time-weighted average Quantitative Myasthenia Gravis score over a 3-year period than those who received prednisone alone (6.15 vs. 8.99, P<0.001); patients in the thymectomy group also had a lower average requirement for alternate-day prednisone (44 mg vs. 60 mg, P<0.001). Fewer patients in the thymectomy group than in the prednisone-only group required immunosuppression with azathioprine (17% vs. 48%, P<0.001) or were hospitalized for exacerbations (9% vs. 37%, P<0.001). The number of patients with treatment-associated complications did not differ significantly between groups (P=0.73), but patients in the thymectomy group had fewer treatment-associated symptoms related to immunosuppressive medications (P<0.001) and lower distress levels related to symptoms (P=0.003). CONCLUSIONS: Thymectomy improved cl

Published
2016

44. Role of early enteral feeding and acute starvation on postburn bacterial translocation and host defense: prospective, randomized trials

Author

Gianotti, L, Alexander, J, Nelson, J, Fukushima, R, Pyles, T, Chalk, C, GIANOTTI, LUCA VITTORIO, Chalk, C., Gianotti, L, Alexander, J, Nelson, J, Fukushima, R, Pyles, T, Chalk, C, GIANOTTI, LUCA VITTORIO, and Chalk, C.

Abstract

To investigate the effect of: a) starvation during the preburn period and b) immediate postburn enteral nutrition on the permeability of the gut to microorganisms and the ability of the host to kill translocated bacteria.

Published
1994

45. Post injury hypermetabolic response and magnitude of translocation: prevention by early enteral nutrition

Author

GIANOTTI, LUCA VITTORIO, Nelson, J, Alexander, J, Chalk, C, Pyles, T., Gianotti, L, Nelson, J, Alexander, J, Chalk, C, and Pyles, T

Subjects
Vanilmandelic Acid, Enteral Nutrition, Hydrocortisone, Animal, Escherichia coli, MED/18 - CHIRURGIA GENERALE, Burn, Female, Basal Metabolism, Intestinal Mucosa, Energy Metabolism, Regression Analysi, Guinea Pig
Abstract

The relationship between hypermetabolism and bacterial translocation was investigated in guinea pigs receiving a 40% burn. Animals were infused intragastrically with a complete enteral diet or Ringer's solution for 48 h, given 10(10) 14C-labeled Escherichia coli intragastrically, and killed 4 h later. Resting metabolic expenditure (RME), translocation (dpm of the 14C-labeled E. coli) to the portal blood and ileal mucosa, plasma cortisol, and urinary vanillylmandelic acid (VMA) were determined. Enterally fed animals had significantly lower RME, cortisol, VMA, and dpm, but higher mucosal and body weight than the Ringer's group. Disintegrations per minute (dpm) in the blood were positively correlated with RME (r = 0.856), cortisol (r = 0.872), VMA (r = 0.759), and dpm mucosa (r = 0.836) and inversely correlated with mucosal weight (r = -0.883). We conclude that bacterial translocation is reduced by early feeding and is an important cause of hypermetabolism and stress hormone production after burn injury.

Published
1994

46. Influence of dietary fiber on microbial growth in vitro and bacterial translocation after burn injury in mice

Author

Nelson, J, Alexander, J, Chalk, C, Pyles, T., GIANOTTI, LUCA VITTORIO, Nelson, J, Alexander, J, Gianotti, L, Chalk, C, and Pyles, T

Subjects
Dietary Fiber, Mice, Inbred BALB C, Chitosan, Animal, Burn, Chitin, Enterobacteriaceae Infection, Lignin, Mice, Enterobacteriaceae, Escherichia coli, MED/18 - CHIRURGIA GENERALE, Female, Digestive System
Abstract

Translocation of enteric bacteria from the gut to the mesenteric lymph nodes and beyond can cause life-threatening infection and multiple-organ failure in immunocompromised and traumatized patients. One of the conditions that promotes bacterial translocation is disruption of the normal gut flora, which results in bacterial overgrowth. In vitro methods were used to determine whether the fibers pectin, cellulose, chitosan, kaolin, lignin, or soy had bactericidal properties. Our results indicated that only chitosan and lignin significantly reduce microbial growth in vitro. A burned mouse model (20% total-body surface area) was used to study the effects of dietary lignin, cellulose, pectin, and chitosan on burn-induced bacterial translocation. Animals were fed a standard mouse diet containing no fiber, pectin, cellulose, lignin, or chitosan (10% of diet) for 14 days ad libitum. On day 14, all animals were burned. Four hours later the animals were killed and the mesenteric lymph nodes, spleen, liver, and cecum were aseptically harvested for determination of quantitative aerobic microbial growth. The animals which received chitosan, and lignin to a lesser extent, added to their diet had significantly lower levels of bacteria in the cecum, mesenteric lymph nodes, and liver. We suggest that addition of chitosan and possibly lignin to the diet may reduce the amount of bacterial translocation after burn injury, presumably by reducing the bacterial population of the cecum.

Published
1994

48. Subcortical white matter lesions in osmotic demyelination syndrome

Author

Bourgouin, P M, Chalk, C, Richardson, J, Duang, H, and Vezina, J L

Subjects
Adult, Cerebral Cortex, Saline Solution, Hypertonic, Brain Diseases, Water-Electrolyte Imbalance, Case Reports, Magnetic Resonance Imaging, Alcoholism, Fatal Outcome, Pons, Thalamic Nuclei, Humans, Female, Myelin Sheath, Demyelinating Diseases, Hyponatremia
Abstract

We describe a case of histologically proved osmotic demyelination syndrome. In addition to abnormal T2 signal within the pons and thalami, MR showed linear enhancing lesions at the cortical medullary junction.

Published
1995

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