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Drug Regulation in the Era of Individualized Therapies.

Woodcock J, Marks P.

N Engl J Med. 2019 Oct 9. doi: 10.1056/NEJMe1911295. [Epub ahead of print] No abstract available.


Moving towards hepatitis C micro-elimination among people living with HIV in Australia: the CEASE study.

Martinello M, Yee J, Bartlett SR, Read P, Baker D, Post JJ, Finlayson R, Bloch M, Doyle J, Shaw D, Hellard M, Petoumenos K, Lin L, Marks P, Applegate T, Dore GJ, Matthews GV; CEASE study team.

Clin Infect Dis. 2019 Oct 4. pii: ciz985. doi: 10.1093/cid/ciz985. [Epub ahead of print]


Knee dislocation and associated injuries: an analysis of the American College of Surgeons National Trauma Data Bank.

Chowdhry M, Burchette D, Whelan D, Nathens A, Marks P, Wasserstein D.

Knee Surg Sports Traumatol Arthrosc. 2019 Sep 26. doi: 10.1007/s00167-019-05712-y. [Epub ahead of print]


Evaluation of a hepatitis C virus core antigen assay from venepuncture and dried blood spot collected samples: A cohort study.

Catlett B, Lamoury FMJ, Bajis S, Hajarizadeh B, Martinez D, Mowat Y, Cunningham PH, Jacka BP, Cloherty GA, Marks P, Dore GJ, Grebely J, Applegate TL.

J Viral Hepat. 2019 Aug 26. doi: 10.1111/jvh.13196. [Epub ahead of print]


Distal Double Cuff Vs Transcorporal Cuff as Salvage Options-A Prospective Analysis of Different Artificial Urinary Sphincter (AMS 800) Implantation Sites.

Maurer V, Dahlem R, Rosenbaum CM, Gild P, Vetterlein MW, Schüttfort V, Meyer CP, Riechardt S, Fisch M, Marks P, Ludwig TA.

Urology. 2019 Jul 25. pii: S0090-4295(19)30653-3. doi: 10.1016/j.urology.2019.07.018. [Epub ahead of print]


Functional outcomes of artificial urinary sphincter implantation with distal bulbar double cuff in men with and without a history of external beam radiotherapy: an analysis of a prospective database.

Maurer V, Marks P, Dahlem R, Rosenbaum CM, Meyer CP, Riechardt S, Fisch M, Ludwig T.

BJU Int. 2019 Jul 27. doi: 10.1111/bju.14882. [Epub ahead of print]


The FDA's Regulatory Framework for Chimeric Antigen Receptor-T Cell Therapies.

Marks P.

Clin Transl Sci. 2019 Sep;12(5):428-430. doi: 10.1111/cts.12666. Epub 2019 Jul 22. No abstract available.


Patterns of drug, alcohol use and injection equipment sharing among people with recent injecting drug use or receiving opioid agonist treatment during and following hepatitis C virus treatment with direct-acting antiviral therapies: An international study.

Artenie AA, Cunningham EB, Dore GJ, Conway B, Dalgard O, Powis J, Bruggmann P, Hellard M, Cooper C, Read P, Feld JJ, Hajarizadeh B, Amin J, Lacombe K, Stedman C, Litwin AH, Marks P, Matthews GV, Quiene S, Erratt A, Bruneau J, Grebely J.

Clin Infect Dis. 2019 Jul 11. pii: ciz633. doi: 10.1093/cid/ciz633. [Epub ahead of print]


Toward universal pathogen reduction of the blood supply (Conference Report, p. 3002).

Marks P, Verdun N.

Transfusion. 2019 Sep;59(9):3026-3028. doi: 10.1111/trf.15410. Epub 2019 Jun 19. No abstract available.


Multi-platform discovery of haplotype-resolved structural variation in human genomes.

Chaisson MJP, Sanders AD, Zhao X, Malhotra A, Porubsky D, Rausch T, Gardner EJ, Rodriguez OL, Guo L, Collins RL, Fan X, Wen J, Handsaker RE, Fairley S, Kronenberg ZN, Kong X, Hormozdiari F, Lee D, Wenger AM, Hastie AR, Antaki D, Anantharaman T, Audano PA, Brand H, Cantsilieris S, Cao H, Cerveira E, Chen C, Chen X, Chin CS, Chong Z, Chuang NT, Lambert CC, Church DM, Clarke L, Farrell A, Flores J, Galeev T, Gorkin DU, Gujral M, Guryev V, Heaton WH, Korlach J, Kumar S, Kwon JY, Lam ET, Lee JE, Lee J, Lee WP, Lee SP, Li S, Marks P, Viaud-Martinez K, Meiers S, Munson KM, Navarro FCP, Nelson BJ, Nodzak C, Noor A, Kyriazopoulou-Panagiotopoulou S, Pang AWC, Qiu Y, Rosanio G, Ryan M, Stütz A, Spierings DCJ, Ward A, Welch AE, Xiao M, Xu W, Zhang C, Zhu Q, Zheng-Bradley X, Lowy E, Yakneen S, McCarroll S, Jun G, Ding L, Koh CL, Ren B, Flicek P, Chen K, Gerstein MB, Kwok PY, Lansdorp PM, Marth GT, Sebat J, Shi X, Bashir A, Ye K, Devine SE, Talkowski ME, Mills RE, Marschall T, Korbel JO, Eichler EE, Lee C.

Nat Commun. 2019 Apr 16;10(1):1784. doi: 10.1038/s41467-018-08148-z.


Guidance on prevention of unintended and accidental radiation exposures in nuclear medicine.

Martin CJ, Marengo M, Vassileva J, Giammarile F, Poli GL, Marks P.

J Radiol Prot. 2019 Sep;39(3):665-695. doi: 10.1088/1361-6498/ab19d8. Epub 2019 Apr 16.


How to use fitness landscape models for the analysis of collective decision-making: a case of theory-transfer and its limitations.

Marks P, Gerrits L, Marx J.

Biol Philos. 2019;34(1):7. doi: 10.1007/s10539-018-9669-4. Epub 2019 Jan 12.


Etiology, Risk Factors and Outcome of 1003 Cases of Infective Endocarditis from a 33-year National Survey in the Slovak Republic: An increasing proportion of elderly patients.

Krčméry V, Hricak V, Fischer V, Mrazova M, Brnova J, Hulman M, Outrata R, Bauer F, Kalavsky E, Babela R, Mikolasova G, Spanik S, Karvaj M, Marks P.

Neuro Endocrinol Lett. 2019 Mar;39(8):544-549.


Resolving the full spectrum of human genome variation using Linked-Reads.

Marks P, Garcia S, Barrio AM, Belhocine K, Bernate J, Bharadwaj R, Bjornson K, Catalanotti C, Delaney J, Fehr A, Fiddes IT, Galvin B, Heaton H, Herschleb J, Hindson C, Holt E, Jabara CB, Jett S, Keivanfar N, Kyriazopoulou-Panagiotopoulou S, Lek M, Lin B, Lowe A, Mahamdallie S, Maheshwari S, Makarewicz T, Marshall J, Meschi F, O'Keefe CJ, Ordonez H, Patel P, Price A, Royall A, Ruark E, Seal S, Schnall-Levin M, Shah P, Stafford D, Williams S, Wu I, Xu AW, Rahman N, MacArthur D, Church DM.

Genome Res. 2019 Apr;29(4):635-645. doi: 10.1101/gr.234443.118. Epub 2019 Mar 20.


The impact of variant histological differentiation on extranodal extension and survival in node positive bladder cancer treated with radical cystectomy.

Marks P, Gild P, Soave A, Janisch F, Minner S, Engel O, Vetterlein MW, Shariat SF, Sauter G, Dahlem R, Fisch M, Rink M.

Surg Oncol. 2019 Mar;28:208-213. doi: 10.1016/j.suronc.2019.01.008. Epub 2019 Jan 30.


Prospective analysis of artificial urinary sphincter AMS 800 implantation after buccal mucosa graft urethroplasty.

Maurer V, Marks P, Dahlem R, Rosenbaum C, Meyer CP, Riechardt S, Fisch M, Ludwig T.

World J Urol. 2019 Apr;37(4):647-653. doi: 10.1007/s00345-019-02631-y. Epub 2019 Jan 17.


Urothelial Carcinoma in Bladder Diverticula: A Multicenter Analysis of Characteristics and Clinical Outcomes.

Voskuilen CS, Seiler R, Rink M, Poyet C, Noon AP, Roghmann F, Necchi A, Aziz A, Lavollé A, Young MJ, Marks P, Saba K, van Rhijn BWG, Fransen van de Putte EE, Ablat J, Black PC, Sosnowski R, Dobruch J, Kumar P, Jallad S, Catto JWF, Xylinas E, Hendricksen K; Young Academic Urologists’ Working Group on Urothelial Carcinoma of the European Association of Urology.

Eur Urol Focus. 2018 Dec 14. pii: S2405-4569(18)30382-1. doi: 10.1016/j.euf.2018.12.002. [Epub ahead of print]


Paritaprevir, ritonavir, ombitasvir, and dasabuvir with and without ribavirin in people with HCV genotype 1 and recent injecting drug use or receiving opioid substitution therapy.

Grebely J, Conway B, Cunningham EB, Fraser C, Moriggia A, Gane E, Stedman C, Cooper C, Castro E, Schmid P, Petoumenos K, Hajarizadeh B, Marks P, Erratt A, Dalgard O, Lacombe K, Feld JJ, Bruneau J, Daulouede JP, Powis J, Bruggmann P, Matthews GV, Kronborg I, Shaw D, Dunlop A, Hellard M, Applegate TL, Crawford S, Dore GJ; D3FEAT Study Group.

Int J Drug Policy. 2018 Dec;62:94-103. doi: 10.1016/j.drugpo.2018.10.004. Epub 2018 Oct 29.


Adherence to sofosbuvir and velpatasvir among people with chronic HCV infection and recent injection drug use: The SIMPLIFY study.

Cunningham EB, Amin J, Feld JJ, Bruneau J, Dalgard O, Powis J, Hellard M, Cooper C, Read P, Conway B, Dunlop AJ, Norton B, Litwin AH, Hajarizadeh B, Thurnheer MC, Dillon JF, Weltman M, Shaw D, Bruggmann P, Gane E, Fraser C, Marks P, Applegate TL, Quiene S, Siriragavan S, Matthews GV, Dore GJ, Grebely J; SIMPLIFY study group.

Int J Drug Policy. 2018 Dec;62:14-23. doi: 10.1016/j.drugpo.2018.08.013. Epub 2018 Oct 22.


Evaluating Guideline Adherence for T1 Bladder Cancer Treatment and Surveillance: A Retrospective German Multicenter Observation.

Vetterlein MW, Gild P, Marks P, Roschinski J, Doh O, Höppner W, Wagner W, Isbarn H, Büscheck F, Sauter G, Dahlem R, Soave A, Fisch M, Rink M.

Urol Int. 2018;101(3):285-292. doi: 10.1159/000493369. Epub 2018 Sep 20.


MetaHCR: a web-enabled metagenome data management system for hydrocarbon resources.

Marks PC, Bigler M, Alsop EB, Vigneron A, Lomans BP, De Paula R, Geissler B, Tsesmetzis N.

Database (Oxford). 2018 Jan 1;2018:1-10. doi: 10.1093/database/bay087.


Bulk phase behavior of lithium imide-metal nitride ammonia decomposition catalysts.

Makepeace JW, Wood TJ, Marks PL, Smith RI, Murray CA, David WIF.

Phys Chem Chem Phys. 2018 Sep 12;20(35):22689-22697. doi: 10.1039/c8cp02824a.


Evaluation of a Hepatitis C Virus Core Antigen Assay in Plasma and Dried Blood Spot Samples.

Lamoury FMJ, Hajarizadeh B, Soker A, Martinez D, Quek C, Cunningham P, Catlett B, Cloherty G, Marks P, Amin J, Grebely J, Dore GJ, Applegate TL.

J Mol Diagn. 2018 Sep;20(5):621-627. doi: 10.1016/j.jmoldx.2018.05.010. Epub 2018 Jun 26.


Germline pathogenic variants in PALB2 and other cancer-predisposing genes in families with hereditary diffuse gastric cancer without CDH1 mutation: a whole-exome sequencing study.

Fewings E, Larionov A, Redman J, Goldgraben MA, Scarth J, Richardson S, Brewer C, Davidson R, Ellis I, Evans DG, Halliday D, Izatt L, Marks P, McConnell V, Verbist L, Mayes R, Clark GR, Hadfield J, Chin SF, Teixeira MR, Giger OT, Hardwick R, di Pietro M, O'Donovan M, Pharoah P, Caldas C, Fitzgerald RC, Tischkowitz M.

Lancet Gastroenterol Hepatol. 2018 Jul;3(7):489-498. doi: 10.1016/S2468-1253(18)30079-7. Epub 2018 Apr 27.


Shortened therapy of eight weeks with paritaprevir/ritonavir/ombitasvir and dasabuvir is highly effective in people with recent HCV genotype 1 infection.

Martinello M, Bhagani S, Gane E, Orkin C, Cooke G, Dore GJ, Petoumenos K, Applegate TL, Tu E, Marks P, Pagani N, Grebely J, Nelson M, Matthews GV.

J Viral Hepat. 2018 Oct;25(10):1180-1188. doi: 10.1111/jvh.12917. Epub 2018 May 8.


Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay.

Lamoury FMJ, Bajis S, Hajarizadeh B, Marshall AD, Martinello M, Ivanova E, Catlett B, Mowat Y, Marks P, Amin J, Smith J, Ezard N, Cock V, Hayllar J, Persing DH, Kleman M, Cunningham P, Dore GJ, Applegate TL, Grebely J; LiveRLife Study Group.

J Infect Dis. 2018 May 25;217(12):1889-1896. doi: 10.1093/infdis/jiy114.


Balancing Safety and Innovation for Cell-Based Regenerative Medicine.

Marks P, Gottlieb S.

N Engl J Med. 2018 Mar 8;378(10):954-959. doi: 10.1056/NEJMsr1715626. No abstract available.


Impact of the Ki-67 labeling index and p53 expression status on disease-free survival in pT1 urothelial carcinoma of the bladder.

Vetterlein MW, Roschinski J, Gild P, Marks P, Soave A, Doh O, Isbarn H, Höppner W, Wagner W, Shariat SF, Brausi M, Büscheck F, Sauter G, Fisch M, Rink M.

Transl Androl Urol. 2017 Dec;6(6):1018-1026. doi: 10.21037/tau.2017.11.10.


Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial.

Grebely J, Dalgard O, Conway B, Cunningham EB, Bruggmann P, Hajarizadeh B, Amin J, Bruneau J, Hellard M, Litwin AH, Marks P, Quiene S, Siriragavan S, Applegate TL, Swan T, Byrne J, Lacalamita M, Dunlop A, Matthews GV, Powis J, Shaw D, Thurnheer MC, Weltman M, Kronborg I, Cooper C, Feld JJ, Fraser C, Dillon JF, Read P, Gane E, Dore GJ; SIMPLIFY Study Group.

Lancet Gastroenterol Hepatol. 2018 Mar;3(3):153-161. doi: 10.1016/S2468-1253(17)30404-1. Epub 2018 Jan 6.


Clinical Development Strategies and Considerations for Zika Vaccine Licensure.

Gruber MF, Farizo KM, Pratt RD, Fink DL, Finn TM, Krause PR, Borio LL, Marks PW.

J Infect Dis. 2017 Dec 16;216(suppl_10):S964-S970. doi: 10.1093/infdis/jix433. Review.


Effect of repeat prostate biopsies on functional outcomes after radical prostatectomy.

Rosenbaum CM, Mandel P, Tennstedt P, Preisser F, Marks P, Chun FK, Graefen M, Tilki D, Salomon G.

Urol Oncol. 2018 Mar;36(3):91.e17-91.e22. doi: 10.1016/j.urolonc.2017.11.016. Epub 2017 Dec 13.


Ultrasound Determination of the Femoral Head-Neck Alpha Angle.

Robinson DJ, Lee S, Marks P, Schneider ME.

Ultrasound Med Biol. 2018 Feb;44(2):495-501. doi: 10.1016/j.ultrasmedbio.2017.10.006. Epub 2017 Nov 29.


Introduction to the Special Issue: 20th-Century Origins and 21st-Century Developments of Peer Nomination Methodology.

Marks PEL.

New Dir Child Adolesc Dev. 2017 Sep;2017(157):7-19. doi: 10.1002/cad.20205.


Methodological Choices in Peer Nomination Research.

Cillessen AHN, Marks PEL.

New Dir Child Adolesc Dev. 2017 Sep;2017(157):21-44. doi: 10.1002/cad.20206. Review.


Safety, tolerability, clinical, and joint structural outcomes of a single intra-articular injection of allogeneic mesenchymal precursor cells in patients following anterior cruciate ligament reconstruction: a controlled double-blind randomised trial.

Wang Y, Shimmin A, Ghosh P, Marks P, Linklater J, Connell D, Hall S, Skerrett D, Itescu S, Cicuttini FM.

Arthritis Res Ther. 2017 Aug 2;19(1):180. doi: 10.1186/s13075-017-1391-0.


Changes in risk behaviours during and following treatment for hepatitis C virus infection among people who inject drugs: The ACTIVATE study.

Midgard H, Hajarizadeh B, Cunningham EB, Conway B, Backmund M, Bruggmann P, Bruneau J, Bourgeois S, Dunlop A, Foster GR, Hellard M, Robaeys G, Thurnheer MC, Weltman M, Amin J, Marks PS, Quiene S, Dore GJ, Dalgard O, Grebely J; ACTIVATE Study Group.

Int J Drug Policy. 2017 Sep;47:230-238. doi: 10.1016/j.drugpo.2017.05.040. Epub 2017 Jun 19.


Efficacy of response-guided directly observed pegylated interferon and self-administered ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: The ACTIVATE study.

Grebely J, Dalgard O, Cunningham EB, Hajarizadeh B, Foster GR, Bruggmann P, Conway B, Backmund M, Robaeys G, Swan T, Amin J, Marks PS, Quiene S, Applegate TL, Weltman M, Shaw D, Dunlop A, Hellard M, Bruneau J, Midgard H, Bourgeois S, Staehelin C, Dore GJ; ACTIVATE Study Group.

Int J Drug Policy. 2017 Sep;47:177-186. doi: 10.1016/j.drugpo.2017.05.020. Epub 2017 Jun 16.


Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study.

Cunningham EB, Hajarizadeh B, Dalgard O, Amin J, Hellard M, Foster GR, Bruggmann P, Conway B, Backmund M, Robaeys G, Swan T, Marks PS, Quiene S, Applegate TL, Weltman M, Shaw D, Dunlop A, Bruneau J, Midgard H, Bourgeois S, Thurnheer MC, Dore GJ, Grebely J; ACTIVATE Study Group.

BMC Infect Dis. 2017 Jun 13;17(1):420. doi: 10.1186/s12879-017-2517-3.


A Randomized Controlled Trial of the Rochester Forensic Assertive Community Treatment Model.

Lamberti JS, Weisman RL, Cerulli C, Williams GC, Jacobowitz DB, Mueser KT, Marks PD, Strawderman RL, Harrington D, Lamberti TA, Caine ED.

Psychiatr Serv. 2017 Oct 1;68(10):1016-1024. doi: 10.1176/ Epub 2017 Jun 1.


Hepatitis C virus core antigen: A simplified treatment monitoring tool, including for post-treatment relapse.

Lamoury FMJ, Soker A, Martinez D, Hajarizadeh B, Cunningham EB, Cunningham P, Bruggmann P, Foster GR, Dalgard O, Backmund M, Conway B, Robaeys G, Swan T, Cloherty G, Marks P, Grebely J, Dore GJ, Applegate TL.

J Clin Virol. 2017 Jul;92:32-38. doi: 10.1016/j.jcv.2017.05.007. Epub 2017 May 11.


Rectus Abdominis Rhabdomyolysis: Report of 2 Cases.

Boyle J, Marks P, Read J.

J Ultrasound Med. 2017 Oct;36(10):2165-2171. doi: 10.1002/jum.14242. Epub 2017 May 15.


Evaluation of the Xpert HCV Viral Load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort study.

Grebely J, Lamoury FMJ, Hajarizadeh B, Mowat Y, Marshall AD, Bajis S, Marks P, Amin J, Smith J, Edwards M, Gorton C, Ezard N, Persing D, Kleman M, Cunningham P, Catlett B, Dore GJ, Applegate TL; LiveRLife Study Group.

Lancet Gastroenterol Hepatol. 2017 Jul;2(7):514-520. doi: 10.1016/S2468-1253(17)30075-4. Epub 2017 Apr 22.


Ultrasound Screening for Adverse Local Tissue Reaction after Hip Arthroplasty.

Robinson DJ, Lee S, Marks P, Schneider ME.

Ultrasound Med Biol. 2017 Jul;43(7):1549-1556. doi: 10.1016/j.ultrasmedbio.2017.02.001. Epub 2017 Apr 12.


The Blood Supply and Men Who Have Sex with Men.

Marks PW.

N Engl J Med. 2017 Apr 13;376(15):1486. doi: 10.1056/NEJMc1701828. No abstract available.


Decision making in the face of uncertainty: the challenge of emerging infectious diseases.

Marks PW, Petersen LR.

Transfusion. 2017 Mar;57(3pt2):723-728. doi: 10.1111/trf.14037. No abstract available.


The role of genetic counsellors in genomic healthcare in the United Kingdom: a statement by the Association of Genetic Nurses and Counsellors.

Middleton A, Marks P, Bruce A, Protheroe-Davies LK, King C, Claber O, Houghton C, Giffney C, Macleod R, Dolling C, Kenwrick S, Scotcher D, Hall G, Patch C, Boyes L.

Eur J Hum Genet. 2017 Mar 22;25(6):659-661. doi: 10.1038/ejhg.2017.28. Epub 2017 Mar 22.


A Systematic Review and Appraisal of Clinical Practice Guidelines for Musculoskeletal Soft Tissue Injuries and Conditions.

Pincus D, Kuhn JE, Sheth U, Rizzone K, Colbenson K, Dwyer T, Karpinos A, Marks PH, Wasserstein D.

Am J Sports Med. 2017 May;45(6):1458-1464. doi: 10.1177/0363546516667903. Epub 2016 Oct 17. Review.


Transforming Evidence Generation to Support Health and Health Care Decisions.

Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, Coster TS, Cunningham FE, De Lew N, DeSalvo KB, Dymek C, Dzau VJ, Fleurence RL, Frank RG, Gaziano JM, Kaufmann P, Lauer M, Marks PW, McGinnis JM, Richards C, Selby JV, Shulkin DJ, Shuren J, Slavitt AM, Smith SR, Washington BV, White PJ, Woodcock J, Woodson J, Sherman RE.

N Engl J Med. 2016 Dec 15;375(24):2395-2400. No abstract available.


Clarifying Stem-Cell Therapy's Benefits and Risks.

Marks PW, Witten CM, Califf RM.

N Engl J Med. 2017 Mar 16;376(11):1007-1009. doi: 10.1056/NEJMp1613723. Epub 2016 Nov 30. No abstract available.


Real-World Evidence - What Is It and What Can It Tell Us?

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM.

N Engl J Med. 2016 Dec 8;375(23):2293-2297. No abstract available.


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