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Items: 1 to 20 of 47


An FDA analysis of clinical hold deficiencies affecting investigational new drug applications for oncology products.

Manning ML, Thompson MD, Saber H, Maher VE, Crich JZ, Leighton JK.

Regul Toxicol Pharmacol. 2020 Feb;110:104511. doi: 10.1016/j.yrtph.2019.104511. Epub 2019 Oct 31.


Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) Recommendations: An Important First Step-But There Is Much Work to Be Done.

Gregory AJ, Grant MC, Manning MW, Cheung AT, Ender J, Sander M, Zarbock A, Stoppe C, Meineri M, Grocott HP, Ghadimi K, Gutsche JT, Patel PA, Denault A, Shaw A, Fletcher N, Levy JH.

J Cardiothorac Vasc Anesth. 2020 Jan;34(1):39-47. doi: 10.1053/j.jvca.2019.09.002. Epub 2019 Sep 7. No abstract available.


Subcutaneous C1 inhibitor for prevention of attacks of hereditary angioedema: additional outcomes and subgroup analysis of a placebo-controlled randomized study.

Li HH, Zuraw B, Longhurst HJ, Cicardi M, Bork K, Baker J, Lumry W, Bernstein J, Manning M, Levy D, Riedl MA, Feuersenger H, Prusty S, Pragst I, Machnig T, Craig T; COMPACT Investigators.

Allergy Asthma Clin Immunol. 2019 Aug 28;15:49. doi: 10.1186/s13223-019-0362-1. eCollection 2019.


FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults.

Li RJ, Jin R, Liu C, Cao X, Manning ML, Di XM, Przepiorka D, Namuswe F, Deisseroth A, Goldberg KB, Blumenthal GM, Pazdur R.

Clin Cancer Res. 2020 Jan 15;26(2):328-331. doi: 10.1158/1078-0432.CCR-19-1255. Epub 2019 Aug 23.


Impact of an enhanced recovery pathway on length of stay and complications in elective radical cystectomy: a before and after cohort study.

Dunkman WJ, Manning MW, Whittle J, Hunting J, Rampersaud EN, Inman BA, Thacker JK, Miller TE.

Perioper Med (Lond). 2019 Aug 22;8:9. doi: 10.1186/s13741-019-0120-4. eCollection 2019.


Post-Reperfusion Syndrome in Liver Transplantation-An Overview.

Manning MW, Kumar PA, Maheshwari K, Arora H.

J Cardiothorac Vasc Anesth. 2020 Feb;34(2):501-511. doi: 10.1053/j.jvca.2019.02.050. Epub 2019 Mar 7. Review. No abstract available.


Indirect comparison of intravenous vs. subcutaneous C1-inhibitor placebo-controlled trials for routine prevention of hereditary angioedema attacks.

Bernstein JA, Li HH, Craig TJ, Manning ME, Lawo JP, Machnig T, Krishnarajah G, Fridman M.

Allergy Asthma Clin Immunol. 2019 Mar 7;15:13. doi: 10.1186/s13223-019-0328-3. eCollection 2019.


Perioperative Anesthetic and Transfusion Management of Veno-Venous Extracorporeal Membrane Oxygenation Patients Undergoing Noncardiac Surgery: A Case Series of 21 Procedures.

Fierro MA, Dunne B, Ranney DN, Daneshmand MA, Haney JC, Klapper JA, Hartwig MG, Bonadonna D, Manning MW, Bartz RR.

J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1855-1862. doi: 10.1053/j.jvca.2019.01.055. Epub 2019 Jan 24.


Long-Term Outcomes with Subcutaneous C1-Inhibitor Replacement Therapy for Prevention of Hereditary Angioedema Attacks.

Craig T, Zuraw B, Longhurst H, Cicardi M, Bork K, Grattan C, Katelaris C, Sussman G, Keith PK, Yang W, Hébert J, Hanzlikova J, Staubach-Renz P, Martinez-Saguer I, Magerl M, Aygören-Pürsün E, Farkas H, Reshef A, Kivity S, Neri S, Crisan I, Caballero T, Baeza ML, Hernandez MD, Li H, Lumry W, Bernstein JA, Hussain I, Anderson J, Schwartz LB, Jacobs J, Manning M, Levy D, Riedl M, Christiansen S, Feuersenger H, Pragst I, Mycroft S, Pawaskar D, Jacobs I; COMPACT Investigators.

J Allergy Clin Immunol Pract. 2019 Jul - Aug;7(6):1793-1802.e2. doi: 10.1016/j.jaip.2019.01.054. Epub 2019 Feb 15.


Complex Role for E-Prostanoid 4 Receptors in Hypertension.

Herrera M, Yang T, Sparks MA, Manning MW, Koller BH, Coffman TM.

J Am Heart Assoc. 2019 Feb 19;8(4):e010745. doi: 10.1161/JAHA.118.010745.


Treatment effect of switching from intravenous to subcutaneous C1-inhibitor for prevention of hereditary angioedema attacks: COMPACT subgroup findings.

Craig T, Lumry W, Cicardi M, Zuraw B, Bernstein JA, Anderson J, Jacobs J, Riedl MA, Manning ME, Banerji A, Gower RG, Caballero T, Farkas H, Feuersenger H, Jacobs I, Machnig T, Longhurst H; COMPACT Investigators.

J Allergy Clin Immunol Pract. 2019 Jul - Aug;7(6):2035-2038. doi: 10.1016/j.jaip.2019.01.007. Epub 2019 Jan 17. No abstract available.


FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.

Krauss AC, Gao X, Li L, Manning ML, Patel P, Fu W, Janoria KG, Gieser G, Bateman DA, Przepiorka D, Shen YL, Shord SS, Sheth CM, Banerjee A, Liu J, Goldberg KB, Farrell AT, Blumenthal GM, Pazdur R.

Clin Cancer Res. 2019 May 1;25(9):2685-2690. doi: 10.1158/1078-0432.CCR-18-2990. Epub 2018 Dec 12.


Patterns and trends in OSHA occupational noise exposure measurements from 1979 to 2013.

Sayler SK, Roberts BJ, Manning MA, Sun K, Neitzel RL.

Occup Environ Med. 2019 Feb;76(2):118-124. doi: 10.1136/oemed-2018-105041. Epub 2018 Nov 27.


Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks: A Randomized Clinical Trial.

Banerji A, Riedl MA, Bernstein JA, Cicardi M, Longhurst HJ, Zuraw BL, Busse PJ, Anderson J, Magerl M, Martinez-Saguer I, Davis-Lorton M, Zanichelli A, Li HH, Craig T, Jacobs J, Johnston DT, Shapiro R, Yang WH, Lumry WR, Manning ME, Schwartz LB, Shennak M, Soteres D, Zaragoza-Urdaz RH, Gierer S, Smith AM, Tachdjian R, Wedner HJ, Hebert J, Rehman SM, Staubach P, Schranz J, Baptista J, Nothaft W, Maurer M; HELP Investigators.

JAMA. 2018 Nov 27;320(20):2108-2121. doi: 10.1001/jama.2018.16773. Erratum in: JAMA. 2019 Apr 23;321(16):1636.


Outcomes of Laparoscopic Cholecystectomy in Patients Supported with a Left Ventricular Assist Device.

Suresh V, Bishawi M, Bryner B, Manning M, Patel C, Milano C, Schroder J, Sommer C.

J Laparoendosc Adv Surg Tech A. 2019 Apr;29(4):441-444. doi: 10.1089/lap.2018.0431. Epub 2018 Nov 16.


Enhanced Recovery After Surgery and Multimodal Strategies for Analgesia.

Dunkman WJ, Manning MW.

Surg Clin North Am. 2018 Dec;98(6):1171-1184. doi: 10.1016/j.suc.2018.07.005. Epub 2018 Aug 22. Review.


Treatment patterns and healthcare resource utilization among patients with hereditary angioedema in the United States.

Riedl MA, Banerji A, Manning ME, Burrell E, Joshi N, Patel D, Machnig T, Tai MH, Watson DJ.

Orphanet J Rare Dis. 2018 Oct 12;13(1):180. doi: 10.1186/s13023-018-0922-3.


The rising tide of opioid use and abuse: the role of the anesthesiologist.

Koepke EJ, Manning EL, Miller TE, Ganesh A, Williams DGA, Manning MW.

Perioper Med (Lond). 2018 Jul 3;7:16. doi: 10.1186/s13741-018-0097-4. eCollection 2018. Review.


What Does a Red Meat Allergy Have to Do With Anesthesia? Perioperative Management of Alpha-Gal Syndrome.

Dunkman WJ, Rycek W, Manning MW.

Anesth Analg. 2019 Nov;129(5):1242-1248. doi: 10.1213/ANE.0000000000003460.


Effect of A1C and Glucose on Postoperative Mortality in Noncardiac and Cardiac Surgeries.

van den Boom W, Schroeder RA, Manning MW, Setji TL, Fiestan GO, Dunson DB.

Diabetes Care. 2018 Apr;41(4):782-788. doi: 10.2337/dc17-2232. Epub 2018 Feb 13.


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