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Items: 1 to 50 of 71

1.

An open-label phase 1 clinical trial of the anti-α4β7 monoclonal antibody vedolizumab in HIV-infected individuals.

Sneller MC, Clarridge KE, Seamon C, Shi V, Zorawski MD, Justement JS, Blazkova J, Huiting ED, Proschan MA, Mora JR, Shetzline M, Moir S, Lane HC, Chun TW, Fauci AS.

Sci Transl Med. 2019 Sep 11;11(509). pii: eaax3447. doi: 10.1126/scitranslmed.aax3447. Epub 2019 Sep 5.

PMID:
31488581
2.

Re-randomization tests in clinical trials.

Proschan MA, Dodd LE.

Stat Med. 2019 May 30;38(12):2292-2302. doi: 10.1002/sim.8093. Epub 2019 Jan 22.

PMID:
30672002
3.

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design.

Dimairo M, Coates E, Pallmann P, Todd S, Julious SA, Jaki T, Wason J, Mander AP, Weir CJ, Koenig F, Walton MK, Biggs K, Nicholl J, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG.

BMC Med. 2018 Nov 16;16(1):210. doi: 10.1186/s12916-018-1196-2.

4.

A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection.

Sneller MC, Justement JS, Gittens KR, Petrone ME, Clarridge KE, Proschan MA, Kwan R, Shi V, Blazkova J, Refsland EW, Morris DE, Cohen KW, McElrath MJ, Xu R, Egan MA, Eldridge JH, Benko E, Kovacs C, Moir S, Chun TW, Fauci AS.

Sci Transl Med. 2017 Dec 6;9(419). pii: eaan8848. doi: 10.1126/scitranslmed.aan8848.

PMID:
29212716
5.

Re-randomization tests for unplanned changes in clinical trials.

Proschan MA.

Clin Trials. 2017 Oct;14(5):425-431. doi: 10.1177/1740774517710657. Epub 2017 Jun 16. Review.

PMID:
28622753
6.

Controlling the family-wise error rate in multi-arm, multi-stage trials.

Crouch LA, Dodd LE, Proschan MA.

Clin Trials. 2017 Jun;14(3):237-245. doi: 10.1177/1740774517694130. Epub 2017 Mar 19.

7.

Trial of ZMapp for Ebola Virus Infection.

Davey RT Jr, Nordwall J, Proschan MA; Prevail II Study Team.

N Engl J Med. 2017 Feb 16;376(7):700-701. doi: 10.1056/NEJMc1614625. No abstract available.

PMID:
28199801
8.

Effect of HIV Antibody VRC01 on Viral Rebound after Treatment Interruption.

Bar KJ, Sneller MC, Harrison LJ, Justement JS, Overton ET, Petrone ME, Salantes DB, Seamon CA, Scheinfeld B, Kwan RW, Learn GH, Proschan MA, Kreider EF, Blazkova J, Bardsley M, Refsland EW, Messer M, Clarridge KE, Tustin NB, Madden PJ, Oden K, O'Dell SJ, Jarocki B, Shiakolas AR, Tressler RL, Doria-Rose NA, Bailer RT, Ledgerwood JE, Capparelli EV, Lynch RM, Graham BS, Moir S, Koup RA, Mascola JR, Hoxie JA, Fauci AS, Tebas P, Chun TW.

N Engl J Med. 2016 Nov 24;375(21):2037-2050. Epub 2016 Nov 9.

9.

A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection.

PREVAIL II Writing Group; Multi-National PREVAIL II Study Team, Davey RT Jr, Dodd L, Proschan MA, Neaton J, Neuhaus Nordwall J, Koopmeiners JS, Beigel J, Tierney J, Lane HC, Fauci AS, Massaquoi MBF, Sahr F, Malvy D.

N Engl J Med. 2016 Oct 13;375(15):1448-1456.

10.

Comments on Berry et al.'s response-adaptive randomization platform trial for Ebola.

Brittain EH, Proschan MA.

Clin Trials. 2016 Oct;13(5):566-7. doi: 10.1177/1740774516654440. Epub 2016 Jun 30. No abstract available.

PMID:
27365017
11.

Response.

Proschan MA, Dodd LE.

Clin Trials. 2016 Aug;13(4):454-5. doi: 10.1177/1740774516644906. Epub 2016 May 2. No abstract available.

PMID:
27136948
12.

Design of a Randomized Controlled Trial for Ebola Virus Disease Medical Countermeasures: PREVAIL II, the Ebola MCM Study.

Dodd LE, Proschan MA, Neuhaus J, Koopmeiners JS, Neaton J, Beigel JD, Barrett K, Lane HC, Davey RT Jr.

J Infect Dis. 2016 Jun 15;213(12):1906-13. doi: 10.1093/infdis/jiw061. Epub 2016 Feb 11.

13.

Statistical considerations for a trial of Ebola virus disease therapeutics.

Proschan MA, Dodd LE, Price D.

Clin Trials. 2016 Feb;13(1):39-48. doi: 10.1177/1740774515620145. Epub 2016 Jan 14.

14.

Combining one-sample confidence procedures for inference in the two-sample case.

Fay MP, Proschan MA, Brittain E.

Biometrics. 2015 Mar;71(1):146-156. doi: 10.1111/biom.12231. Epub 2014 Oct 1.

15.

A modest proposal for dropping poor arms in clinical trials.

Proschan MA, Dodd LE.

Stat Med. 2014 Aug 30;33(19):3241-52. doi: 10.1002/sim.6169. Epub 2014 Apr 22.

16.

Baseline CD4+ T-cell counts predict HBV viral kinetics to adefovir treatment in lamivudine-resistant HBV-infected patients with or without HIV infection.

Cortez KJ, Proschan MA, Barrett L, Brust DG, Weatherley B, Formentini E, Davey RT, Masur H, Polis MA, Neumann And AU, Kottilil S.

HIV Clin Trials. 2013 Jul-Aug;14(4):149-59. doi: 10.1310/hct1404-149.

17.

Pointwise confidence intervals for a survival distribution with small samples or heavy censoring.

Fay MP, Brittain EH, Proschan MA.

Biostatistics. 2013 Sep;14(4):723-36. doi: 10.1093/biostatistics/kxt016. Epub 2013 Apr 30.

18.

Innovative trial designs to improving tuberculosis drug development.

Dodd LE, Proschan MA.

J Infect Dis. 2013 Feb 1;207(3):544. doi: 10.1093/infdis/jis704. Epub 2012 Nov 21. No abstract available.

19.

Spending functions and continuous-monitoring boundaries.

Proschan MA, Lan KK.

Stat Med. 2012 Nov 10;31(25):3024-30. doi: 10.1002/sim.5481. Epub 2012 Jul 16.

PMID:
22807204
20.

Null but not void: considerations for hypothesis testing.

Shaw PA, Proschan MA.

Stat Med. 2013 Jan 30;32(2):196-205. doi: 10.1002/sim.5497. Epub 2012 Jul 16.

21.

Unplanned adaptations before breaking the blind.

Posch M, Proschan MA.

Stat Med. 2012 Dec 30;31(30):4146-53. doi: 10.1002/sim.5361. Epub 2012 Jun 27.

22.

Treatment with IL-7 prevents the decline of circulating CD4+ T cells during the acute phase of SIV infection in rhesus macaques.

Vassena L, Miao H, Cimbro R, Malnati MS, Cassina G, Proschan MA, Hirsch VM, Lafont BA, Morre M, Fauci AS, Lusso P.

PLoS Pathog. 2012;8(4):e1002636. doi: 10.1371/journal.ppat.1002636. Epub 2012 Apr 12.

23.

Asymptotics of Bonferroni for Dependent Normal Test Statistics.

Proschan MA, Shaw PA.

Stat Probab Lett. 2011 Jul 1;81(7):739-748.

24.

B cells in early and chronic HIV infection: evidence for preservation of immune function associated with early initiation of antiretroviral therapy.

Moir S, Buckner CM, Ho J, Wang W, Chen J, Waldner AJ, Posada JG, Kardava L, O'Shea MA, Kottilil S, Chun TW, Proschan MA, Fauci AS.

Blood. 2010 Dec 16;116(25):5571-9. doi: 10.1182/blood-2010-05-285528. Epub 2010 Sep 13.

26.

Does treatment effect depend on control event rate? Revisiting a meta-analysis of suicidality and antidepressant use in children.

Proschan MA, Brittain EH, Fay MP.

Clin Trials. 2010 Apr;7(2):109-17; discussion 118-120. doi: 10.1177/1740774510363310. Epub 2010 Mar 25.

PMID:
20338902
27.

Cycling of gut mucosal CD4+ T cells decreases after prolonged anti-retroviral therapy and is associated with plasma LPS levels.

Ciccone EJ, Read SW, Mannon PJ, Yao MD, Hodge JN, Dewar R, Chairez CL, Proschan MA, Kovacs JA, Sereti I.

Mucosal Immunol. 2010 Mar;3(2):172-81. doi: 10.1038/mi.2009.129. Epub 2009 Dec 2.

28.

Treatment intensification does not reduce residual HIV-1 viremia in patients on highly active antiretroviral therapy.

Dinoso JB, Kim SY, Wiegand AM, Palmer SE, Gange SJ, Cranmer L, O'Shea A, Callender M, Spivak A, Brennan T, Kearney MF, Proschan MA, Mican JM, Rehm CA, Coffin JM, Mellors JW, Siliciano RF, Maldarelli F.

Proc Natl Acad Sci U S A. 2009 Jun 9;106(23):9403-8. doi: 10.1073/pnas.0903107106. Epub 2009 May 22.

29.

IL-7 administration drives T cell-cycle entry and expansion in HIV-1 infection.

Sereti I, Dunham RM, Spritzler J, Aga E, Proschan MA, Medvik K, Battaglia CA, Landay AL, Pahwa S, Fischl MA, Asmuth DM, Tenorio AR, Altman JD, Fox L, Moir S, Malaspina A, Morre M, Buffet R, Silvestri G, Lederman MM; ACTG 5214 Study Team.

Blood. 2009 Jun 18;113(25):6304-14. doi: 10.1182/blood-2008-10-186601. Epub 2009 Apr 20.

30.

Sample size re-estimation in clinical trials.

Proschan MA.

Biom J. 2009 Apr;51(2):348-57. doi: 10.1002/bimj.200800266. Review.

PMID:
19358221
31.

Evidence for HIV-associated B cell exhaustion in a dysfunctional memory B cell compartment in HIV-infected viremic individuals.

Moir S, Ho J, Malaspina A, Wang W, DiPoto AC, O'Shea MA, Roby G, Kottilil S, Arthos J, Proschan MA, Chun TW, Fauci AS.

J Exp Med. 2008 Aug 4;205(8):1797-805. doi: 10.1084/jem.20072683. Epub 2008 Jul 14.

32.

Conditioning in 2 x 2 tables.

Proschan MA, Nason M.

Biometrics. 2009 Mar;65(1):316-22. doi: 10.1111/j.1541-0420.2008.01053.x. Epub 2008 May 23.

PMID:
18505423
33.

Normalization of B cell counts and subpopulations after antiretroviral therapy in chronic HIV disease.

Moir S, Malaspina A, Ho J, Wang W, Dipoto AC, O'Shea MA, Roby G, Mican JM, Kottilil S, Chun TW, Proschan MA, Fauci AS.

J Infect Dis. 2008 Feb 15;197(4):572-9. doi: 10.1086/526789.

PMID:
18240953
34.

Combining treatment selection and definitive testing.

Proschan MA, Hunsberger SA.

Biom J. 2006 Aug;48(4):690-2; discussion 693-6.

PMID:
16972721
35.

Clinical events in high-risk hypertensive patients randomly assigned to calcium channel blocker versus angiotensin-converting enzyme inhibitor in the antihypertensive and lipid-lowering treatment to prevent heart attack trial.

Leenen FH, Nwachuku CE, Black HR, Cushman WC, Davis BR, Simpson LM, Alderman MH, Atlas SA, Basile JN, Cuyjet AB, Dart R, Felicetta JV, Grimm RH, Haywood LJ, Jafri SZ, Proschan MA, Thadani U, Whelton PK, Wright JT; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group.

Hypertension. 2006 Sep;48(3):374-84. Epub 2006 Jul 24.

PMID:
16864749
36.

Clinical trial results applied to management of the individual cancer patient.

Jatoi I, Proschan MA.

World J Surg. 2006 Jul;30(7):1184-9.

PMID:
16794903
37.

Comparison of two or more measurement techniques to a standard.

Proschan MA, Leifer ES.

Contemp Clin Trials. 2006 Oct;27(5):472-82. Epub 2006 Apr 7.

PMID:
16750939
38.

Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial.

Elmer PJ, Obarzanek E, Vollmer WM, Simons-Morton D, Stevens VJ, Young DR, Lin PH, Champagne C, Harsha DW, Svetkey LP, Ard J, Brantley PJ, Proschan MA, Erlinger TP, Appel LJ; PREMIER Collaborative Research Group.

Ann Intern Med. 2006 Apr 4;144(7):485-95.

PMID:
16585662
39.

Adaptive regression.

Proschan MA, Leifer E, Liu Q.

J Biopharm Stat. 2005;15(4):593-603.

PMID:
16022165
40.

Two-stage sample size re-estimation based on a nuisance parameter: a review.

Proschan MA.

J Biopharm Stat. 2005;15(4):559-74.

PMID:
16022163
41.
42.

Effect of the dietary approaches to stop hypertension diet and reduced sodium intake on blood pressure control.

Svetkey LP, Simons-Morton DG, Proschan MA, Sacks FM, Conlin PR, Harsha D, Moore TJ.

J Clin Hypertens (Greenwich). 2004 Jul;6(7):373-81.

43.

Individual blood pressure responses to changes in salt intake: results from the DASH-Sodium trial.

Obarzanek E, Proschan MA, Vollmer WM, Moore TJ, Sacks FM, Appel LJ, Svetkey LP, Most-Windhauser MM, Cutler JA.

Hypertension. 2003 Oct;42(4):459-67. Epub 2003 Sep 2.

PMID:
12953018
44.

Premier: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristics.

Svetkey LP, Harsha DW, Vollmer WM, Stevens VJ, Obarzanek E, Elmer PJ, Lin PH, Champagne C, Simons-Morton DG, Aickin M, Proschan MA, Appel LJ.

Ann Epidemiol. 2003 Jul;13(6):462-71.

PMID:
12875806
45.

Estimation of energy requirements in a controlled feeding trial.

Lin PH, Proschan MA, Bray GA, Fernandez CP, Hoben K, Most-Windhauser M, Karanja N, Obarzanek E; DASH Collaborative Research Group.

Am J Clin Nutr. 2003 Mar;77(3):639-45.

PMID:
12600854
46.

Practical midcourse sample size modification in clinical trials.

Proschan MA, Liu Q, Hunsberger S.

Control Clin Trials. 2003 Feb;24(1):4-15.

PMID:
12559638
47.

Effects on blood lipids of a blood pressure-lowering diet: the Dietary Approaches to Stop Hypertension (DASH) Trial.

Obarzanek E, Sacks FM, Vollmer WM, Bray GA, Miller ER 3rd, Lin PH, Karanja NM, Most-Windhauser MM, Moore TJ, Swain JF, Bales CW, Proschan MA; DASH Research Group.

Am J Clin Nutr. 2001 Jul;74(1):80-9.

PMID:
11451721
48.

A multivariate test of interaction for use in clinical trials.

Follmann DA, Proschan MA.

Biometrics. 1999 Dec;55(4):1151-5.

PMID:
11315061
49.
50.

Valid inference in random effects meta-analysis.

Follmann DA, Proschan MA.

Biometrics. 1999 Sep;55(3):732-7.

PMID:
11315000

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