Search Results - "Mehta, Cyrus R"

Testing a Primary and a Secondary Endpoint in a Group Sequential Design by Tamhane, Ajit C., Mehta, Cyrus R., Liu, Lingyun

“…Summary We consider a clinical trial with a primary and a secondary endpoint where the secondary endpoint is tested only if the primary endpoint is…”
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Adaptive extensions of a two-stage group sequential procedure for testing primary and secondary endpoints (I): unknown correlation between the endpoints by Tamhane, Ajit C., Wu, Yi, Mehta, Cyrus R.

“…In a previous paper we studied a two‐stage group sequential procedure (GSP) for testing primary and secondary endpoints where the primary endpoint serves as a…”
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The distance of the femoral neurovascular bundle from the hip joint: an intraoperative guide to reduce iatrogenic injury by Mehta, Cyrus R, Constantinidis, Alex, Farhat, Moussa, Suthersan, Mayuran, Graham, Edward, Kanawati, Andrew

“…Iatrogenic injury to the femoral neurovascular bundle is not uncommon during primary and revision total hip replacement (THR) and can result in permanent…”
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Adaptive extensions of a two-stage group sequential procedure for testing primary and secondary endpoints (II): sample size re-estimation by Tamhane, Ajit C., Wu, Yi, Mehta, Cyrus R.

“…In this part II of the paper on adaptive extensions of a two‐stage group sequential procedure (GSP) for testing primary and secondary endpoints, we focus on…”
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Adaptive increase in sample size when interim results are promising: A practical guide with examples by Mehta, Cyrus R., Pocock, Stuart J.

“…This paper discusses the benefits and limitations of adaptive sample size re‐estimation for phase 3 confirmatory clinical trials. Comparisons are made with…”
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Repeated confidence intervals for adaptive group sequential trials by Mehta, Cyrus R., Bauer, Peter, Posch, Martin, Brannath, Werner

“…This paper proposes a method for computing conservative confidence intervals for a group sequential test in which an adaptive design change is made one or more…”
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Bifocal disruption to the extensor mechanism of the knee: A case report by Kim, Raymond G., Mehta, Cyrus R., Martin, Brian

“…Bifocal disruptions to the extensor mechanism of the knee are extremely rare injuries that are difficult to repair due to the lack of ligamentotaxis. There is…”
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The potential role and rationale for treatment of heart failure with sodium–glucose co‐transporter 2 inhibitors by Butler, Javed, Hamo, Carine E., Filippatos, Gerasimos, Pocock, Stuart J., Bernstein, Richard A., Brueckmann, Martina, Cheung, Alfred K., George, Jyothis T., Green, Jennifer B., Januzzi, James L., Kaul, Sanjay, Lam, Carolyn S.P., Lip, Gregory Y.H., Marx, Nikolaus, McCullough, Peter A., Mehta, Cyrus R., Ponikowski, Piotr, Rosenstock, Julio, Sattar, Naveed, Salsali, Afshin, Scirica, Benjamin M., Shah, Sanjiv J., Tsutsui, Hiroyuki, Verma, Subodh, Wanner, Christoph, Woerle, Hans‐Juergan, Zannad, Faiez, Anker, Stefan D.

“…Heart failure (HF) and type 2 diabetes mellitus (T2DM) are both growing public health concerns contributing to major medical and economic burdens to society…”
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Pathophysiological Sex Differences in Heart Failure Progression After Acute Coronary Syndrome: Insights From the EXAMINE Trial by Razaghizad, Amir, Aziz, Haya, Zhang, Guang K., Ferreira, João Pedro, White, William B., Mehta, Cyrus R., Bakris, George L., Zannad, Faiez, Sharma, Abhinav

“…•This research investigates sex-specific differences in the development and progression of heart failure in individuals with type 2 diabetes after acute…”
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Optimal promising zone designs by Hsiao, Samuel T., Liu, Lingyun, Mehta, Cyrus R.

“…Clinical trials with adaptive sample size reassessment based on an unblinded analysis of interim results are perhaps the most popular class of adaptive designs…”
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A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks by Tamhane, Ajit C., Gou, Jiangtao, Jennison, Christopher, Mehta, Cyrus R., Curto, Teresa

“…Glimm et al. (2010) and Tamhane et al. (2010) studied the problem of testing a primary and a secondary endpoint, subject to a gatekeeping constraint, using a…”
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Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) by Cavender, Matthew A, White, William B, Jarolim, Petr, Bakris, George L, Cushman, William C, Kupfer, Stuart, Gao, Qi, Mehta, Cyrus R, Zannad, Faiez, Cannon, Christopher P, Morrow, David A

“…BACKGROUND:We aimed to describe the relationship between changes in high-sensitivity cardiac troponin I (hsTnI) and cardiovascular outcomes. METHODS:The…”
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External validation and extension of the TIMI risk score for heart failure in diabetes for patients with recent acute coronary syndrome: An analysis of the EXAMINE trial by Razaghizad, Amir, Sharma, Abhinav, Ni, Jiayi, Ferreira, João Pedro, White, William B., Mehta, Cyrus R., Bakris, George L., Zannad, Faiez

“…Aims The Thrombolysis in Myocardial Infarction Risk Score for Heart Failure (HF) in Diabetes (TRS‐HFDM) prognosticates HF hospitalization in people with type 2…”
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Adaptive clinical trial designs with pre-specified rules for modifying the sample size: a different perspective by Mehta, Cyrus R.

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Comments on "Some Challenges with Statistical Inference in Adaptive Designs" by Hung, Wang, and Yang by Mehta, Cyrus R.

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Fasiglifam-Induced Liver Injury in Patients With Type 2 Diabetes: Results of a Randomized Controlled Cardiovascular Outcomes Safety Trial by Menon, Venu, Lincoff, A Michael, Nicholls, Stephen J, Jasper, Susan, Wolski, Kathy, McGuire, Darren K, Mehta, Cyrus R, Rosenstock, Julio, Lopez, Claudia, Marcinak, John, Cao, Charlie, Nissen, Steven E

“…To evaluate the cardiovascular (CV) safety of fasiglifam, a first-in-man G-protein-coupled receptor 40 (GPR40) agonist, in patients with type 2 diabetes. A…”
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Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndrome events: The EXAMINE trial by Heller, Simon R., Bergenstal, Richard M., White, William B., Kupfer, Stuart, Bakris, George L., Cushman, William C., Mehta, Cyrus R., Nissen, Steven E., Wilson, Craig A., Zannad, Faiez, Liu, Yuyin, Gourlie, Noah M., Cannon, Christopher P.

“…Aims To investigate relationships between glycated haemoglobin (HbA1c) and reported hypoglycaemia and risk of major adverse cardiovascular events (MACE)…”
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Efficient Monte Carlo Methods for Conditional Logistic Regression by Mehta, Cyrus R., Patel, Nitin R., Senchaudhuri, Pralay

“…Exact inference for the logistic regression model is based on generating the permutation distribution of the sufficient statistics for the regression…”
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Efficiency Considerations for Group Sequential Designs with Adaptive Unblinded Sample Size Re-assessment by Liu, Lingyun, Hsiao, Sam, Mehta, Cyrus R.

“…Clinical trials with adaptive sample size re-assessment, based on an analysis of the unblinded interim results (ubSSR), have gained in popularity due to…”
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Exact Confidence Bounds Following Adaptive Group Sequential Tests by Brannath, Werner, Mehta, Cyrus R., Posch, Martin

“…We provide a method for obtaining confidence intervals, point estimates, and p-values for the primary effect size parameter at the end of a two-arm group…”
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