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Items: 1 to 50 of 127

1.

A meta-analysis of clinical studies conducted during the West Africa Ebola virus disease outbreak confirms the need for randomized control groups.

Dodd LE, Follmann D, Proschan M, Wang J, Malvy D, van Griensven J, Ciglenecki I, Horby PW, Ansumana R, Jiang JF, Davey RT, Lane HC, Gouel-Cheron A.

Sci Transl Med. 2019 Nov 27;11(520). pii: eaaw1049. doi: 10.1126/scitranslmed.aaw1049.

PMID:
31776287
2.

A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.

Mulangu S, Dodd LE, Davey RT Jr, Tshiani Mbaya O, Proschan M, Mukadi D, Lusakibanza Manzo M, Nzolo D, Tshomba Oloma A, Ibanda A, Ali R, Coulibaly S, Levine AC, Grais R, Diaz J, Lane HC, Muyembe-Tamfum JJ; PALM Writing Group; PALM Consortium Study Team, Sivahera B, Camara M, Kojan R, Walker R, Dighero-Kemp B, Cao H, Mukumbayi P, Mbala-Kingebeni P, Ahuka S, Albert S, Bonnett T, Crozier I, Duvenhage M, Proffitt C, Teitelbaum M, Moench T, Aboulhab J, Barrett K, Cahill K, Cone K, Eckes R, Hensley L, Herpin B, Higgs E, Ledgerwood J, Pierson J, Smolskis M, Sow Y, Tierney J, Sivapalasingam S, Holman W, Gettinger N, Vallée D, Nordwall J.

N Engl J Med. 2019 Nov 27. doi: 10.1056/NEJMoa1910993. [Epub ahead of print]

PMID:
31774950
3.

Evaluation of an antibody to α4β7 in the control of SIVmac239-nef-stop infection.

Di Mascio M, Lifson JD, Srinivasula S, Kim I, DeGrange P, Keele BF, Belli AJ, Reimann KA, Wang Y, Proschan M, Lane HC, Fauci AS.

Science. 2019 Sep 6;365(6457):1025-1029. doi: 10.1126/science.aav6695.

PMID:
31488688
4.

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
5.

8-Day Inpatient Directly Observed Therapy for ART Failure: A Tool For Preventing Unnecessary ART Changes and Optimizing Adherence Support.

Winchester NE, Maldarelli F, Mejia Y, Dee N, Dewar R, Laidlaw E, Kuriakose SS, Stoll P, Proschan M, Lane HC, Pau AK.

Clin Infect Dis. 2019 Jul 11. pii: ciz590. doi: 10.1093/cid/ciz590. [Epub ahead of print]

PMID:
31298273
6.

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
7.

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.

8.

The Past Need Not Be Prologue: Recommendations for Testing and Positioning the Most-Promising Medical Countermeasures for the Next Outbreak of Ebola Virus Infection.

Davey RT Jr, Dodd L, Proschan M, Jahrling P, Hensley L, Higgs E, Lane HC.

J Infect Dis. 2018 Nov 22;218(suppl_5):S690-S697. doi: 10.1093/infdis/jiy334.

9.

Transmission of Mycobacterium tuberculosis From Patients Who Are Nucleic Acid Amplification Test Negative.

Xie YL, Cronin WA, Proschan M, Oatis R, Cohn S, Curry SR, Golub JE, Barry CE 3rd, Dorman SE.

Clin Infect Dis. 2018 Nov 13;67(11):1653-1659. doi: 10.1093/cid/ciy365.

10.

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
11.

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
12.

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.

13.

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
14.

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.

15.

Validity and power considerations on hypothesis testing under minimization.

Xu Z, Proschan M, Lee S.

Stat Med. 2016 Dec 20;35(29):5527-5528. doi: 10.1002/sim.7037. No abstract available.

PMID:
27870128
16.

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.

17.

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
18.

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
19.

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.

20.

Validity and power considerations on hypothesis testing under minimization.

Xu Z, Proschan M, Lee S.

Stat Med. 2016 Jun 30;35(14):2315-27. doi: 10.1002/sim.6874. Epub 2016 Jan 19.

PMID:
26787557
21.

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.

22.

High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study.

Petersen T, Townsend K, Gordon LA, Sidharthan S, Silk R, Nelson A, Gross C, Calderón M, Proschan M, Osinusi A, Polis MA, Masur H, Kottilil S, Kohli A.

Hepatol Int. 2016 Mar;10(2):310-9. doi: 10.1007/s12072-015-9680-7. Epub 2015 Nov 26.

23.

Four-Week Direct-Acting Antiviral Regimens in Noncirrhotic Patients With Hepatitis C Virus Genotype 1 Infection: An Open-Label, Nonrandomized Trial.

Kohli A, Kattakuzhy S, Sidharthan S, Nelson A, McLaughlin M, Seamon C, Wilson E, Meissner EG, Sims Z, Silk R, Gross C, Akoth E, Tang L, Price A, Jolley TA, Emmanuel B, Proschan M, Teferi G, Chavez J, Abbott S, Osinusi A, Mo H, Polis MA, Masur H, Kottilil S.

Ann Intern Med. 2015 Dec 15;163(12):899-907. doi: 10.7326/M15-0642. Epub 2015 Nov 24.

PMID:
26595450
24.

Transient elastography for the detection of hepatic fibrosis in HIV-monoinfected adults with elevated aminotransferases on antiretroviral therapy.

Morse CG, McLaughlin M, Proschan M, Koh C, Kleiner DE, Heller T, Kovacs JA.

AIDS. 2015 Nov;29(17):2297-302. doi: 10.1097/QAD.0000000000000841.

25.

Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection.

Osinusi A, Townsend K, Kohli A, Nelson A, Seamon C, Meissner EG, Bon D, Silk R, Gross C, Price A, Sajadi M, Sidharthan S, Sims Z, Herrmann E, Hogan J, Teferi G, Talwani R, Proschan M, Jenkins V, Kleiner DE, Wood BJ, Subramanian GM, Pang PS, McHutchison JG, Polis MA, Fauci AS, Masur H, Kottilil S.

JAMA. 2015 Mar 24-31;313(12):1232-9. doi: 10.1001/jama.2015.1373.

PMID:
25706232
26.

Nonalcoholic Steatohepatitis and Hepatic Fibrosis in HIV-1-Monoinfected Adults With Elevated Aminotransferase Levels on Antiretroviral Therapy.

Morse CG, McLaughlin M, Matthews L, Proschan M, Thomas F, Gharib AM, Abu-Asab M, Orenstein A, Engle RE, Hu X, Lempicki R, Hadigan C, Kleiner DE, Heller T, Kovacs JA.

Clin Infect Dis. 2015 May 15;60(10):1569-78. doi: 10.1093/cid/civ101. Epub 2015 Feb 13.

27.

Two-part test of vaccine effect.

Hu Z, Proschan M.

Stat Med. 2015 May 20;34(11):1904-11. doi: 10.1002/sim.6412. Epub 2015 Jan 29.

28.

Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study.

Kohli A, Osinusi A, Sims Z, Nelson A, Meissner EG, Barrett LL, Bon D, Marti MM, Silk R, Kotb C, Gross C, Jolley TA, Sidharthan S, Petersen T, Townsend K, Egerson D, Kapoor R, Spurlin E, Sneller M, Proschan M, Herrmann E, Kwan R, Teferi G, Talwani R, Diaz G, Kleiner DE, Wood BJ, Chavez J, Abbott S, Symonds WT, Subramanian GM, Pang PS, McHutchison J, Polis MA, Fauci AS, Masur H, Kottilil S.

Lancet. 2015 Mar 21;385(9973):1107-13. doi: 10.1016/S0140-6736(14)61228-9. Epub 2015 Jan 13.

29.

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.

30.

Enzyme immunoassay versus latex agglutination cryptococcal antigen assays in adults with non-HIV-related cryptococcosis.

Panackal AA, Dekker JP, Proschan M, Beri A, Williamson PR.

J Clin Microbiol. 2014 Dec;52(12):4356-8. doi: 10.1128/JCM.02017-14. Epub 2014 Sep 24.

31.

Salvage combination antifungal therapy for acute invasive aspergillosis may improve outcomes: a systematic review and meta-analysis.

Panackal AA, Parisini E, Proschan M.

Int J Infect Dis. 2014 Nov;28:80-94. doi: 10.1016/j.ijid.2014.07.007. Epub 2014 Sep 18. Review.

32.

Connections between permutation and t-tests: relevance to adaptive methods.

Proschan M, Glimm E, Posch M.

Stat Med. 2014 Nov 30;33(27):4734-42. doi: 10.1002/sim.6288. Epub 2014 Aug 25.

33.

On the design and analysis of clinical trials with correlated outcomes.

Follmann D, Proschan M.

Contemp Clin Trials. 2014 Sep;39(1):86-94. doi: 10.1016/j.cct.2014.08.001. Epub 2014 Aug 8.

34.

Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life.

Bhandari N, Rongsen-Chandola T, Bavdekar A, John J, Antony K, Taneja S, Goyal N, Kawade A, Kang G, Rathore SS, Juvekar S, Muliyil J, Arya A, Shaikh H, Abraham V, Vrati S, Proschan M, Kohberger R, Thiry G, Glass R, Greenberg HB, Curlin G, Mohan K, Harshavardhan GV, Prasad S, Rao TS, Boslego J, Bhan MK; India Rotavirus Vaccine Group.

Vaccine. 2014 Aug 11;32 Suppl 1:A110-6. doi: 10.1016/j.vaccine.2014.04.079.

35.

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.

36.

Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial.

Bhandari N, Rongsen-Chandola T, Bavdekar A, John J, Antony K, Taneja S, Goyal N, Kawade A, Kang G, Rathore SS, Juvekar S, Muliyil J, Arya A, Shaikh H, Abraham V, Vrati S, Proschan M, Kohberger R, Thiry G, Glass R, Greenberg HB, Curlin G, Mohan K, Harshavardhan GV, Prasad S, Rao TS, Boslego J, Bhan MK; India Rotavirus Vaccine Group.

Lancet. 2014 Jun 21;383(9935):2136-43. doi: 10.1016/S0140-6736(13)62630-6. Epub 2014 Mar 12.

37.

Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.

Osinusi A, Meissner EG, Lee YJ, Bon D, Heytens L, Nelson A, Sneller M, Kohli A, Barrett L, Proschan M, Herrmann E, Shivakumar B, Gu W, Kwan R, Teferi G, Talwani R, Silk R, Kotb C, Wroblewski S, Fishbein D, Dewar R, Highbarger H, Zhang X, Kleiner D, Wood BJ, Chavez J, Symonds WT, Subramanian M, McHutchison J, Polis MA, Fauci AS, Masur H, Kottilil S.

JAMA. 2013 Aug 28;310(8):804-11. doi: 10.1001/jama.2013.109309. Erratum in: JAMA. 2013 Nov 13;310(18):1987. Dosage error in article text.

38.

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.

39.

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.

40.

Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis.

Salmon DA, Proschan M, Forshee R, Gargiullo P, Bleser W, Burwen DR, Cunningham F, Garman P, Greene SK, Lee GM, Vellozzi C, Yih WK, Gellin B, Lurie N; H1N1 GBS Meta-Analysis Working Group.

Lancet. 2013 Apr 27;381(9876):1461-8. doi: 10.1016/S0140-6736(12)62189-8. Epub 2013 Mar 13.

PMID:
23498095
41.

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.

42.

How much effect of different antihypertensive medications on cardiovascular outcomes is attributable to their effects on blood pressure?

Proschan M, Ford CE, Cutler JA, Graumlich JF, Pavlik V, Cushman WC, Davis BR, Alderman MH, Gordon D, Furberg CD, Franklin SS, Blumenthal SS, Castaldo RS, Preston RA; LHAT Collaborative Research Group.

Stat Med. 2013 Feb 28;32(5):884-97. doi: 10.1002/sim.5580. Epub 2012 Sep 7.

PMID:
22961832
43.

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
44.

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.

45.

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.

46.

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.

47.

A test of location for exchangeable multivariate normal data with unknown correlation.

Follmann D, Proschan M.

J Multivar Anal. 2012 Feb;104(1):115-125.

48.

Asymptotics of Bonferroni for Dependent Normal Test Statistics.

Proschan MA, Shaw PA.

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

49.

Lactic acidosis and symptomatic hyperlactataemia in a randomized trial of first-line therapy in HIV-infected adults in South Africa.

Dlamini J, Ledwaba L, Mokwena N, Mokhathi T, Orsega S, Tsoku M, Kowo H, Proschan M, Khabo P, Maja P, Hadigan C.

Antivir Ther. 2011;16(4):605-9. doi: 10.3851/IMP1790.

PMID:
21685549
50.

Minimize the use of minimization with unequal allocation.

Proschan M, Brittain E, Kammerman L.

Biometrics. 2011 Sep;67(3):1135-41. doi: 10.1111/j.1541-0420.2010.01545.x. Epub 2011 Jan 31.

PMID:
21281276

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