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Two-stage enrichment clinical trial design with adjustment for misclassification in predictive biomarkers.

Lin Y, Shih WJ, Lu SE.

Stat Med. 2019 Dec 20;38(29):5445-5469. doi: 10.1002/sim.8370. Epub 2019 Oct 17.


Tinagl1 Suppresses Triple-Negative Breast Cancer Progression and Metastasis by Simultaneously Inhibiting Integrin/FAK and EGFR Signaling.

Shen M, Jiang YZ, Wei Y, Ell B, Sheng X, Esposito M, Kang J, Hang X, Zheng H, Rowicki M, Zhang L, Shih WJ, Celià-Terrassa T, Liu Y, Cristea I, Shao ZM, Kang Y.

Cancer Cell. 2019 Jan 14;35(1):64-80.e7. doi: 10.1016/j.ccell.2018.11.016. Epub 2019 Jan 3.


Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV).

Cannon CP, McGuire DK, Pratley R, Dagogo-Jack S, Mancuso J, Huyck S, Charbonnel B, Shih WJ, Gallo S, Masiukiewicz U, Golm G, Cosentino F, Lauring B, Terra SG; VERTIS-CV Investigators.

Am Heart J. 2018 Dec;206:11-23. doi: 10.1016/j.ahj.2018.08.016. Epub 2018 Sep 5.


Tocopherols inhibit estrogen-induced cancer stemness and OCT4 signaling in breast cancer.

Bak MJ, Furmanski P, Shan NL, Lee HJ, Bao C, Lin Y, Shih WJ, Yang CS, Suh N.

Carcinogenesis. 2018 Jul 30;39(8):1045-1055. doi: 10.1093/carcin/bgy071.


A phase II trial of riluzole, an antagonist of metabotropic glutamate receptor 1 (GRM1) signaling, in patients with advanced melanoma.

Mehnert JM, Silk AW, Lee JH, Dudek L, Jeong BS, Li J, Schenkel JM, Sadimin E, Kane M, Lin H, Shih WJ, Zloza A, Chen S, Goydos JS.

Pigment Cell Melanoma Res. 2018 Jul;31(4):534-540. doi: 10.1111/pcmr.12694. Epub 2018 Apr 10.


Relative efficiency of precision medicine designs for clinical trials with predictive biomarkers.

Shih WJ, Lin Y.

Stat Med. 2018 Feb 28;37(5):687-709. doi: 10.1002/sim.7562. Epub 2017 Dec 4.


Differential Gene Regulation and Tumor-Inhibitory Activities of Alpha-, Delta-, and Gamma-Tocopherols in Estrogen-Mediated Mammary Carcinogenesis.

Das Gupta S, Patel M, Wahler J, Bak MJ, Wall B, Lee MJ, Lin Y, Shih WJ, Cai L, Yang CS, Suh N.

Cancer Prev Res (Phila). 2017 Dec;10(12):694-703. doi: 10.1158/1940-6207.CAPR-17-0190. Epub 2017 Sep 28.


On study designs and hypotheses for clinical trials with predictive biomarkers.

Shih WJ, Lin Y.

Contemp Clin Trials. 2017 Nov;62:140-145. doi: 10.1016/j.cct.2017.08.014. Epub 2017 Aug 31.


Effects of Soybean Lipid Infusion on Unbound Free Fatty Acids and Unbound Bilirubin in Preterm Infants.

Hegyi T, Kleinfeld A, Huber A, Weinberger B, Memon N, Shih WJ, Carayannopoulos M, Oh W.

J Pediatr. 2017 May;184:45-50.e1. doi: 10.1016/j.jpeds.2016.12.026. Epub 2017 Jan 17.


Methods for flexible sample-size design in clinical trials: Likelihood, weighted, dual test, and promising zone approaches.

Shih WJ, Li G, Wang Y.

Contemp Clin Trials. 2016 Mar;47:40-8. doi: 10.1016/j.cct.2015.12.007. Epub 2015 Dec 7. Review.


Erratum to: Odanacatib for the treatment of postmenopausal osteoporosis: development history and design and participant characteristics of LOFT, the Long-Term Odanacatib Fracture Trial.

Bone HG, Dempster DW, Eisman JA, Greenspan SL, McClung MR, Nakamura T, Papapoulos S, Shih WJ, Rybak-Feiglin A, Santora AC, Verbruggen N, Leung AT, Lombardi A.

Osteoporos Int. 2015 Nov;26(11):2721. doi: 10.1007/s00198-015-3274-z. No abstract available.


Dietary γ-Tocopherol-Rich Mixture Inhibits Estrogen-Induced Mammary Tumorigenesis by Modulating Estrogen Metabolism, Antioxidant Response, and PPARγ.

Das Gupta S, Sae-tan S, Wahler J, So JY, Bak MJ, Cheng LC, Lee MJ, Lin Y, Shih WJ, Shull JD, Safe S, Yang CS, Suh N.

Cancer Prev Res (Phila). 2015 Sep;8(9):807-16. doi: 10.1158/1940-6207.CAPR-15-0154. Epub 2015 Jun 30.


Odanacatib for the treatment of postmenopausal osteoporosis: development history and design and participant characteristics of LOFT, the Long-Term Odanacatib Fracture Trial.

Bone HG, Dempster DW, Eisman JA, Greenspan SL, McClung MR, Nakamura T, Papapoulos S, Shih WJ, Rybak-Feiglin A, Santora AC, Verbruggen N, Leung AT, Lombardi A.

Osteoporos Int. 2015 Feb;26(2):699-712. doi: 10.1007/s00198-014-2944-6. Epub 2014 Nov 29. Erratum in: Osteoporos Int. 2015 Nov;26(11):2721.


Phase 2 trial of paclitaxel, 13-cis retinoic acid, and interferon alfa-2b in the treatment of advanced stage or recurrent cervical cancer.

Song M, DiPaola RS, Cracchiolo BM, Gibbon DG, Hellmann M, Nieves-Neira W, Vaidya A, Wagreich AR, Shih WJ, Rodriguez-Rodriguez L.

Int J Gynecol Cancer. 2014 Nov;24(9):1636-41. doi: 10.1097/IGC.0000000000000258.


A triple combination of atorvastatin, celecoxib and tipifarnib strongly inhibits pancreatic cancer cells and xenograft pancreatic tumors.

Ding N, Cui XX, Gao Z, Huang H, Wei X, Du Z, Lin Y, Shih WJ, Rabson AB, Conney AH, Hu C, Zheng X.

Int J Oncol. 2014 Jun;44(6):2139-45. doi: 10.3892/ijo.2014.2350. Epub 2014 Mar 19.


Multi-regional clinical trial design and consistency assessment of treatment effects.

Quan H, Mao X, Chen J, Shih WJ, Ouyang SP, Zhang J, Zhao PL, Binkowitz B.

Stat Med. 2014 Jun 15;33(13):2191-205. doi: 10.1002/sim.6108. Epub 2014 Feb 11.


Extension of a Cox proportional hazards cure model when cure information is partially known.

Wu Y, Lin Y, Lu SE, Li CS, Shih WJ.

Biostatistics. 2014 Jul;15(3):540-54. doi: 10.1093/biostatistics/kxu002. Epub 2014 Feb 7.


Methods of designing two-stage winner trials with survival outcomes.

Fang F, Lin Y, Shih WJ, Li Y, Yang J, Zhang X.

Stat Med. 2014 Apr 30;33(9):1539-63. doi: 10.1002/sim.6070. Epub 2013 Dec 18.


Oral caffeine during voluntary exercise markedly inhibits skin carcinogenesis and decreases inflammatory cytokines in UVB-treated mice.

Lou Y, Peng Q, Li T, Nolan B, Bernard JJ, Wagner GC, Lin Y, Shih WJ, Conney AH, Lu Y.

Nutr Cancer. 2013;65(7):1002-13. doi: 10.1080/01635581.2013.812224. Epub 2013 Sep 26.


Feasibility and incremental benefit of puffed-cheek 18F-FDG PET/CT on oral cancer patients.

Chang CY, Yang BH, Lin KH, Liu RS, Wang SJ, Shih WJ.

Clin Nucl Med. 2013 Oct;38(10):e374-8. doi: 10.1097/RLU.0b013e31826390cf.


Oral administration of a gemini vitamin D analog, a synthetic triterpenoid and the combination prevents mammary tumorigenesis driven by ErbB2 overexpression.

So JY, Wahler JE, Yoon T, Smolarek AK, Lin Y, Shih WJ, Maehr H, Uskokovic M, Liby KT, Sporn MB, Suh N.

Cancer Prev Res (Phila). 2013 Sep;6(9):959-70. doi: 10.1158/1940-6207.CAPR-13-0087. Epub 2013 Jul 15.


Mutagenicity and tumorigenicity of the four enantiopure bay-region 3,4-diol-1,2-epoxide isomers of dibenz[a,h]anthracene.

Chang RL, Wood AW, Huang MT, Xie JG, Cui XX, Reuhl KR, Boyd DR, Lin Y, Shih WJ, Balani SK, Yagi H, Jerina DM, Conney AH.

Carcinogenesis. 2013 Sep;34(9):2184-91. doi: 10.1093/carcin/bgt164. Epub 2013 May 13.


The properties of sintered calcium phosphate with [Ca]/[P] = 1.50.

Hung IM, Shih WJ, Hon MH, Wang MC.

Int J Mol Sci. 2012 Oct 22;13(10):13569-86. doi: 10.3390/ijms131013569.


Inhibition of progression of androgen-dependent prostate LNCaP tumors to androgen independence in SCID mice by oral caffeine and voluntary exercise.

Zheng X, Cui XX, Huang MT, Liu Y, Wagner GC, Lin Y, Shih WJ, Lee MJ, Yang CS, Conney AH.

Nutr Cancer. 2012;64(7):1029-37. doi: 10.1080/01635581.2012.716899.


The prevention and treatment of missing data in clinical trials.

Little RJ, D'Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, Frangakis C, Hogan JW, Molenberghs G, Murphy SA, Neaton JD, Rotnitzky A, Scharfstein D, Shih WJ, Siegel JP, Stern H.

N Engl J Med. 2012 Oct 4;367(14):1355-60. doi: 10.1056/NEJMsr1203730. No abstract available.


Dietary administration of δ- and γ-tocopherol inhibits tumorigenesis in the animal model of estrogen receptor-positive, but not HER-2 breast cancer.

Smolarek AK, So JY, Burgess B, Kong AN, Reuhl K, Lin Y, Shih WJ, Li G, Lee MJ, Chen YK, Yang CS, Suh N.

Cancer Prev Res (Phila). 2012 Nov;5(11):1310-20. doi: 10.1158/1940-6207.CAPR-12-0263. Epub 2012 Sep 10.


Empirical shrinkage estimator for consistency assessment of treatment effects in multi-regional clinical trials.

Quan H, Li M, Shih WJ, Ouyang SP, Chen J, Zhang J, Zhao PL.

Stat Med. 2013 May 10;32(10):1691-706. doi: 10.1002/sim.5543. Epub 2012 Aug 1.


Estimation of treatment effect following a clinical trial with adaptive design.

Luo X, Li M, Shih WJ, Ouyang P.

J Biopharm Stat. 2012;22(4):700-18. doi: 10.1080/10543406.2012.676534.


Surgical removal of the parametrial fat pads stimulates apoptosis and inhibits UVB-induced carcinogenesis in mice fed a high-fat diet.

Lu YP, Lou YR, Bernard JJ, Peng QY, Li T, Lin Y, Shih WJ, Nghiem P, Shapses S, Wagner GC, Conney AH.

Proc Natl Acad Sci U S A. 2012 Jun 5;109(23):9065-70. doi: 10.1073/pnas.1205810109. Epub 2012 May 21.


A Bayesian-frequentist two-stage single-arm phase II clinical trial design.

Dong G, Shih WJ, Moore D, Quan H, Marcella S.

Stat Med. 2012 Aug 30;31(19):2055-67. doi: 10.1002/sim.5330. Epub 2012 Mar 13.


The antioxidant and anti-inflammatory activities of tocopherols are independent of Nrf2 in mice.

Li G, Lee MJ, Liu AB, Yang Z, Lin Y, Shih WJ, Yang CS.

Free Radic Biol Med. 2012 Apr 1;52(7):1151-8. doi: 10.1016/j.freeradbiomed.2011.12.005. Epub 2011 Dec 17.


Automated framework for digital radiation dose index reporting from CT dose reports.

Shih G, Lu ZF, Zabih R, Kennedy D, Loftus M, Shih WJ, Osborne J, Nickoloff E, Schwartz L.

AJR Am J Roentgenol. 2011 Nov;197(5):1170-4. doi: 10.2214/AJR.11.6650.


Rationally designed treatment for solid tumors with MAPK pathway activation: a phase I study of paclitaxel and bortezomib using an adaptive dose-finding approach.

Mehnert JM, Tan AR, Moss R, Poplin E, Stein MN, Sovak M, Levinson K, Lin H, Kane M, Gounder M, Lin Y, Shih WJ, White E, Rubin EH, Karantza V.

Mol Cancer Ther. 2011 Aug;10(8):1509-19. doi: 10.1158/1535-7163.MCT-10-0944. Epub 2011 Jun 16.


Inhibitory effect of dietary atorvastatin and celecoxib together with voluntary running wheel exercise on the progression of androgen-dependent LNCaP prostate tumors to androgen independence.

Zheng X, Cui XX, Gao Z, Zhao Y, Shi Y, Huang MT, Liu Y, Wagner GC, Lin Y, Shih WJ, Rao CV, Yang CS, Conney AH.

Exp Ther Med. 2011 Mar;2(2):221-228.


Effects of high-fat diets rich in either omega-3 or omega-6 fatty acids on UVB-induced skin carcinogenesis in SKH-1 mice.

Lou YR, Peng QY, Li T, Medvecky CM, Lin Y, Shih WJ, Conney AH, Shapses S, Wagner GC, Lu YP.

Carcinogenesis. 2011 Jul;32(7):1078-84. doi: 10.1093/carcin/bgr074. Epub 2011 Apr 27.


Langerhans cell histiocytosis of the lung with probably skeletal involvement.

Shih WJ, Shih GL, Milan P.

Hell J Nucl Med. 2011 Jan-Apr;14(1):65-7.


δ-tocopherol is more active than α - or γ -tocopherol in inhibiting lung tumorigenesis in vivo.

Li GX, Lee MJ, Liu AB, Yang Z, Lin Y, Shih WJ, Yang CS.

Cancer Prev Res (Phila). 2011 Mar;4(3):404-13. doi: 10.1158/1940-6207.CAPR-10-0130.


Normal Tc-99m tetrofosmin cardiac SPECT images with three-vessel coronary artery disease.

Allen C, Shih WJ.

Clin Nucl Med. 2010 Dec;35(12):944-7. doi: 10.1097/RLU.0b013e3181f9de68. No abstract available.


Follow-up 18F-FDG-PET for the detection of inguinal metastatic penile squamous cell carcinoma: an ultrasound guided fine-needle aspiration.

Shih WJ, Shih GL, Milan PP.

Hell J Nucl Med. 2010 Sep-Dec;13(3):283-4. No abstract available.


Reversible solid-state structural transformation of a 1D-2D coordination polymer by thermal De/rehydration processes.

Wang CC, Yang CC, Yeh CT, Cheng KY, Chang PC, Ho ML, Lee GH, Shih WJ, Sheu HS.

Inorg Chem. 2011 Jan 17;50(2):597-603. doi: 10.1021/ic1018345. Epub 2010 Dec 14.


An optimal adaptive design to address local regulations in global clinical trials.

Luo X, Shih WJ, Ouyang SP, Delap RJ.

Pharm Stat. 2010 Jul-Sep;9(3):179-89. doi: 10.1002/pst.456.


Xenon 133 ventilation studies as an alternative for detecting and quantifying fatty infiltration of the liver.

Shih WJ, Shih GL, Milan PP.

Radiographics. 2010 Jul-Aug;30(4):958-9; author reply 959-60. No abstract available.


Intrathoracic gastric activity on cholescintigraphy results in a large hiatus hernia with duodenogastric reflux.

Shih WJ, Shih G, Milan PP, Chang CY, Huang WS.

Clin Nucl Med. 2010 May;35(5):376-8. doi: 10.1097/RLU.0b013e3181d6269c. No abstract available.


A longitudinal study of the impact of interviews on medical school admissions in Taiwan.

Fan AP, Tsai TC, Su TP, Kosik RO, Morisky DE, Chen CH, Shih WJ, Lee CH.

Eval Health Prof. 2010 Jun;33(2):140-63. doi: 10.1177/0163278710361920. Epub 2010 Mar 31.


On Simon's two-stage design for single-arm phase IIA cancer clinical trials under beta-binomial distribution.

Liu J, Lin Y, Shih WJ.

Stat Med. 2010 May 10;29(10):1084-95. doi: 10.1002/sim.3805.


Atorvastatin and celecoxib in combination inhibits the progression of androgen-dependent LNCaP xenograft prostate tumors to androgen independence.

Zheng X, Cui XX, Gao Z, Zhao Y, Lin Y, Shih WJ, Huang MT, Liu Y, Rabson A, Reddy B, Yang CS, Conney AH.

Cancer Prev Res (Phila). 2010 Jan;3(1):114-24. doi: 10.1158/1940-6207.CAPR-09-0059.


A phase 0 trial of riluzole in patients with resectable stage III and IV melanoma.

Yip D, Le MN, Chan JL, Lee JH, Mehnert JA, Yudd A, Kempf J, Shih WJ, Chen S, Goydos JS.

Clin Cancer Res. 2009 Jun 1;15(11):3896-902. doi: 10.1158/1078-0432.CCR-08-3303. Epub 2009 May 19.


FDG uptake in an abdominal surgical scar from an exploratory laparotomy.

Shih GL, Shih WJ, Milan PP.

Br J Radiol. 2009 Jun;82(978):523-5. doi: 10.1259/bjr/33452580. No abstract available.


Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/ hyperactivity disorder in children 6 to 17 years of age.

Blumer JL, Findling RL, Shih WJ, Soubrane C, Reed MD.

Pediatrics. 2009 May;123(5):e770-6. doi: 10.1542/peds.2008-2945.


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