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Subject Areas on Research
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'Smooth' inference for survival functions with arbitrarily censored data.
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2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards).
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2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards).
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2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards).
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2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
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2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
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A Critical Appraisal of Short-Term End Points in Acute Heart Failure Clinical Trials.
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A comparison of least squares and conditional maximum likelihood estimators under volume endpoint censoring in tumor growth experiments.
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A general formulation for a one-sided group sequential design.
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A global rank end point for clinical trials in acute heart failure.
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A global ranking approach to end points in trials of mechanical circulatory support devices.
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A hybrid Bayesian adaptive design for dose response trials.
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A novel test to compare two treatments based on endpoints involving both nonfatal and fatal events.
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A phase I surrogate endpoint study of SU6668 in patients with solid tumors.
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A randomized trial comparing the efficacy and safety of imiglucerase (Cerezyme) infusions every 4 weeks versus every 2 weeks in the maintenance therapy of adult patients with Gaucher disease type 1.
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A tale of two trials: a comparison of the post-acute coronary syndrome lipid-lowering trials A to Z and PROVE IT-TIMI 22.
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Abciximab survival advantage following percutaneous coronary intervention is predicted by clinical risk profile.
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Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials.
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Alopecia areata investigational assessment guidelines--Part II. National Alopecia Areata Foundation.
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An evidence-based approach to perioperative nutrition support in the elective surgery patient.
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An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors.
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Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials.
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Analysis of time-to-event data with nonuniform patient entry and loss to follow-up under a two-stage seamless adaptive design with weibull distribution.
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Analysis strategies for adaptive designs with multiple endpoints.
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Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.
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Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial.
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Assessment of myocardial infarction by cardiac magnetic resonance imaging and long-term mortality.
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Assessment of myocardial scarring improves risk stratification in patients evaluated for cardiac defibrillator implantation.
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Azimilide for the treatment of atrial fibrillation, atrial flutter, and paroxysmal supraventricular tachycardia: results of a randomized trial and insights on the concordance of symptoms and recurrent arrhythmias.
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Benefit of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes and troponin t-positive status: the paragon-B troponin T substudy.
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Benefits and risks of abciximab use in primary angioplasty for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.
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Benefits, challenges and obstacles of adaptive clinical trial designs.
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Biomarkers and Surrogate Endpoints: Lessons Learned From Glaucoma.
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Biomarkers and correlative endpoints for immunotherapy trials.
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Biomarkers and surrogate endpoints in glaucoma clinical trials.
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Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum.
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Characterization of cardiovascular clinical events and impact of event adjudication on the treatment effect of darapladib versus placebo in patients with stable coronary heart disease: Insights from the STABILITY trial.
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Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium.
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Clinical endpoints for drug development in prostate cancer.
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Clinical studies of angiogenesis inhibitors: the University of Texas MD Anderson Center Trial of Human Endostatin.
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Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium.
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Clinical trials of pharmacological therapies in acute heart failure syndromes: lessons learned and directions forward.
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Comments on concurrent and adjuvant chemotherapy for nasopharyngeal carcinoma: a mist of mysterious results.
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Comparison of omapatrilat and enalapril in patients with chronic heart failure: the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE).
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Comparison of one-year outcomes following coronary artery stenting in diabetic versus nondiabetic patients (from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy [ESPRIT] Trial).
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Comparison of outcomes of patients with myocardial infarction when living alone versus those not living alone.
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Composite End Points in Acute Heart Failure Research: Data Simulations Illustrate the Limitations.
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Composite End Points in Clinical Research: A Time for Reappraisal.
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Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.
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Connecting genetic risk to disease end points through the human blood plasma proteome.
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Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study.
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Criteria for dose-finding in two-stage seamless adaptive design.
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Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document.
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Cystatin C and estimated glomerular filtration rate as predictors for adverse outcome in patients with ST-elevation and non-ST-elevation acute coronary syndromes: results from the Platelet Inhibition and Patient Outcomes study.
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Cytokine profiling for prediction of symptomatic radiation-induced lung injury.
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Death: The Simple Clinical Trial Endpoint.
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Decade-Long Profile of Imaging Biomarker Use in Ophthalmic Clinical Trials.
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Defining heart failure end points in ST-segment elevation myocardial infarction trials: integrating past experiences to chart a path forward.
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Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access.
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Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.
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Design of clinical trials in AKI: a report from an NIDDK workshop. Trials of patients with sepsis and in selected hospital settings.
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Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology.
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Designing phase II studies in cancer with time-to-event endpoints.
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Designs for randomized phase II clinical trials with two treatment arms.
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Determination of the falloff constant (k(f)) from modeling biochemical marker release: a new variable for discriminating therapies.
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Determining the efficacy of antiplatelet therapies for the individual: lessons from clinical trials.
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Determining the most appropriate components for a composite clinical trial outcome.
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Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease.
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Do cardiac troponins provide prognostic insight in hemodialysis patients?
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Effect of abciximab on angiographic complications during percutaneous coronary stenting in the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT).
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Effect of antihypertensive therapy on incident stroke in cohorts with prehypertensive blood pressure levels: a meta-analysis of randomized controlled trials.
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Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients (EXACT-HF) Study.
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Efficacy and safety of extended-release venlafaxine in the treatment of generalized anxiety disorder in children and adolescents: two placebo-controlled trials.
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Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.
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End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer--Alliance for Clinical Trials in Oncology--International Society Of Geriatric Oncology position article.
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End points for clinical trials in acute heart failure syndromes.
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Endpoints for clinical trials testing treatment of acute graft-versus-host disease: a joint statement.
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Enhanced response to enzyme replacement therapy in Pompe disease after the induction of immune tolerance.
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Estimating Clinical Trial Bleeding Events Using Electronic Health Record Data.
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Estimating suicidality as an outcome measure in clinical trials of suicide in schizophrenia.
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Ethics and equipoise: rationale for a placebo-controlled study design of platelet glycoprotein IIb/IIIa inhibition in coronary intervention.
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Evaluating treatment efficacy by multiple end points in phase II acute heart failure clinical trials: analyzing data using a global method.
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Evaluation of Continuous Tumor-Size-Based End Points as Surrogates for Overall Survival in Randomized Clinical Trials in Metastatic Colorectal Cancer.
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Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint.
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Evaluation of progressive neuroretinal rim loss as a surrogate end point for development of visual field loss in glaucoma.
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Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation.
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Evolving Landscape of Clinical Trials in Heart Failure: Patient Populations, Endpoint Selection, and Regions of Enrollment.
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Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials.
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Growth as a part of the composite endpoint in paediatric antiretroviral clinical trials.
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Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues.
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Hospitalization for Recently Diagnosed Versus Worsening Chronic Heart Failure: From the ASCEND-HF Trial.
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How can modeling best contribute to the assessment of secondary stroke prevention strategies?
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Hypocaloric compared with eucaloric nutritional support and its effect on infection rates in a surgical intensive care unit: a randomized controlled trial.
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ISCHEMIA: Establishing the Primary End Point.
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Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials.
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Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis.
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Impact of weighted composite compared to traditional composite endpoints for the design of randomized controlled trials.
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Implantable cardioverter defibrillator in high-risk long QT syndrome patients.
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Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review.
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Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop.
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Increased Risk of Severe Hypoglycemic Events Before and After Cardiovascular Outcomes in TECOS Suggests an At-Risk Type 2 Diabetes Frail Patient Phenotype.
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Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial.
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Influence of Clinical Trial Site Enrollment on Patient Characteristics, Protocol Completion, and End Points: Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure).
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Influence of obesity on surgical regional anesthesia in the ambulatory setting: an analysis of 9,038 blocks.
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Inhaled nitric oxide after left ventricular assist device implantation: a prospective, randomized, double-blind, multicenter, placebo-controlled trial.
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Innovative Thinking on Endpoint Selection in Clinical Trials.
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Interim analysis of binary outcome data in clinical trials: a comparison of five estimators.
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Interpreting measures of treatment effect in cancer clinical trials.
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K-Sample comparisons using propensity analysis.
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Latent-model robustness in joint models for a primary endpoint and a longitudinal process.
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Lessons learned from recent cardiovascular clinical trials: Part I.
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Level and Prevalence of Spin in Published Cardiovascular Randomized Clinical Trial Reports With Statistically Nonsignificant Primary Outcomes: A Systematic Review.
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Long-term healthcare and cost outcomes of disease management in a large, randomized, community-based population with heart failure.
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Long-term intraocular pressure fluctuations and risk of conversion from ocular hypertension to glaucoma.
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Making genuine progress against metastatic breast cancer.
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Measuring the unmeasurable: automated bone scan index as a quantitative endpoint in prostate cancer clinical trials.
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Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements.
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Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer.
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Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events.
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Metoprolol and coronary artery bypass grafting surgery: does intraoperative metoprolol attenuate acute beta-adrenergic receptor desensitization during cardiac surgery?
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Metrics to assess the quantity of antibiotic use in the outpatient setting: a systematic review followed by an international multidisciplinary consensus procedure.
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Monitoring liver safety in drug development: the GSK experience.
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More sensitive assays for better drug resistance prediction?
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Multicenter randomized controlled trial on Duration of Therapy for Thrombosis in Children and Young Adults (the Kids-DOTT trial): pilot/feasibility phase findings.
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Multicenter study of acetaminophen hepatotoxicity reveals the importance of biological endpoints in genomic analyses.
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Multiple testing of treatment-effect-modifying biomarkers in a randomized clinical trial with a survival endpoint.
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Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer.
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Objective outcome measures: Collecting meaningful data on alopecia areata.
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Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis.
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On Enrichment Strategies for Biomarker Stratified Clinical Trials.
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On Two-stage Seamless Adaptive Design in Clinical Trials.
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Opioid-volatile anesthetic synergy: a response surface model with remifentanil and sevoflurane as prototypes.
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Outcomes of patients with acute coronary syndromes and prior coronary artery bypass grafting: results from the platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using integrilin therapy (PURSUIT) trial.
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Outcomes research in cardiovascular imaging: report of a workshop sponsored by the National Heart, Lung, and Blood Institute.
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Outcomes-Based CV Imaging Research Endpoints and Trial Design: From Pixels to Patient Satisfaction.
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P-value calculation for multistage phase II cancer clinical trials.
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Patient-centered outcomes composites: a glimpse of the future.
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Patients with acute coronary syndromes without persistent ST elevation undergoing percutaneous coronary intervention benefit most from early intervention with protection by a glycoprotein IIb/IIIa receptor blocker.
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Patients' understanding of oncology clinical endpoints: A literature review.
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Patterns of platelet response in idiopathic TTP/HUS: frequency of declining platelet counts with plasma exchange and the recognition and significance of a pseudo refractory state.
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Peer-assessed outcomes in the multimodal treatment study of children with attention deficit hyperactivity disorder.
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Performance of GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Statistical Simulation.
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Permutation criteria to evaluate multiple clinical endpoints in a proof-of-concept study: lessons from Pre-RELAX-AHF.
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Phase I/II study of mocetinostat in combination with gemcitabine for patients with advanced pancreatic cancer and other advanced solid tumors.
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Phase II cancer clinical trials for biomarker-guided treatments.
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Placebo-controlled, randomized clinical trial of azimilide for prevention of ventricular tachyarrhythmias in patients with an implantable cardioverter defibrillator.
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Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials.
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Preclinical Alzheimer Disease Drug Development: Early Considerations Based on Phase 3 Clinical Trials.
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Predictive probability of serum prostate-specific antigen for prostate cancer: an approach using Bayes rule.
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Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic renal cell carcinoma.
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Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.
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Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.
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Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis: a consensus effort from the multinational interdisciplinary working group for uveitis in childhood.
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Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.
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Prospective randomized study of mode switching in a clinical trial of pacemaker therapy for sinus node dysfunction.
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Prostate-specific antigen endpoints in hormone-refractory prostate cancer.
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Quetiapine as monotherapy for social anxiety disorder: a placebo-controlled study.
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Rationale and design of the pilot randomized study of nesiritide versus dobutamine in heart failure (PRESERVD-HF).
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Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure.
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Recent developments in therapeutic cancer vaccines.
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Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank.
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Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points.
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Relationship of T2-Weighted MRI Myocardial Hyperintensity and the Ischemic Area-At-Risk.
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Reliability of the triple-timed up-and-go test.
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Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial.
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Reply: idiopathic pulmonary fibrosis: perspectives on clinically meaningful primary endpoints in phase 3 clinical trials.
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Review of the accumulated PLATO documentation supports reliable and consistent superiority of ticagrelor over clopidogrel in patients with acute coronary syndrome: Commentary on: DiNicolantonio JJ, Tomek A, Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: serious concerns over the reliability of the PLATO trial, International Journal of Cardiology, 2013.
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Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.
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Scientific factors and current issues in biosimilar studies.
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Seeking the optimal aspirin dose in acute coronary syndromes.
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Serum CA19-9 response as a surrogate for clinical outcome in patients receiving fixed-dose rate gemcitabine for advanced pancreatic cancer.
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Simultaneous in vivo optical quantification of key metabolic and vascular endpoints reveals tumor metabolic diversity in murine breast tumor models.
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Slowed ST segment recovery despite early infarct artery patency in patients with Q waves at presentation with a first acute myocardial infarction. Implications of initial Q waves on myocyte reperfusion.
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Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium.
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Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium.
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Statistical analysis for two-stage seamless design with different study endpoints.
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Statistical methods in translational medicine.
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Steroid-Responsive Acute Rejection Should Not Be the End Point for Immunosuppressive Trials.
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Stiffness After Pan-Lumbar Arthrodesis for Adult Spinal Deformity Does Not Significantly Impact Patient Functional Status or Satisfaction Irrespective of Proximal Endpoint.
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Study of the biologic effects of lapatinib, a reversible inhibitor of ErbB1 and ErbB2 tyrosine kinases, on tumor growth and survival pathways in patients with advanced malignancies.
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Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report.
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Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes.
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Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: infection and sepsis.
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Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes.
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Testing homogeneity of two zero-inflated Poisson populations.
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Tests for inter-subject and total variabilities under crossover designs.
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The American College of Rheumatology response criteria for proliferative and membranous renal disease in systemic lupus erythematosus clinical trials.
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The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP).
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The Impact of Surgical Amputation and Valproic Acid on Pain and Functional Trajectory: Results from the Veterans Integrated Pain Evaluation Research (VIPER) Randomized, Double-Blinded Placebo-Controlled Trial.
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The National Lung Screening Trial: overview and study design.
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The challenge of systematic reviews of diagnostic and staging studies in cancer.
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The clinician as investigator: participating in clinical trials in the practice setting: Appendix 1: fundamentals of study design.
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The clinician as investigator: participating in clinical trials in the practice setting: Appendix 2: statistical concepts in study design and analysis.
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The effects of inpatient exercise therapy on the length of hospital stay in stages I-III colon cancer patients: randomized controlled trial.
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The imaging viewpoint: how imaging affects determination of progression-free survival.
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The impact of arrhythmias in acute heart failure.
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The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design.
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The rate of structural change: the confocal scanning laser ophthalmoscopy ancillary study to the ocular hypertension treatment study.
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Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: the HERO-2 randomised trial.
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Translational toxicology: a developmental focus for integrated research strategies.
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Trends in Heart Failure Clinical Trials From 2001-2012.
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Troponin T levels and risk of 30-day outcomes in patients with the acute coronary syndrome: prospective verification in the GUSTO-IV trial.
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Understanding prognostic benefits of exercise and antidepressant therapy for persons with depression and heart disease: the UPBEAT study--rationale, design, and methodological issues.
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Undertaking positive control studies as part of developmental neurotoxicity testing: a report from the ILSI Research Foundation/Risk Science Institute expert working group on neurodevelopmental endpoints.
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Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases.
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Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.
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Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.
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Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.
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Use of alternative methodologies for evaluation of composite end points in trials of therapies for critical limb ischemia.
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Visual Function Metrics in Early and Intermediate Dry Age-related Macular Degeneration for Use as Clinical Trial Endpoints.
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Keywords of People
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Halabi, Susan,
Professor of Biostatistics and Bioinformatics,
Biostatistics & Bioinformatics
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Milano, Carmelo Alessio,
Professor of Surgery,
Surgery, Cardiovascular and Thoracic Surgery
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Nielsen, Karen Cristina,
Associate Professor of Anesthesiology,
Anesthesiology, Ambulatory
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O'Connor, Christopher Michael,
Richard Sean Stack, M.D. Distinguished Professor,
Medicine, Clinical Pharmacology
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Patz Jr., Edward F.,
James and Alice Chen Distinguished Professor of Radiology,
Pathology
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Sullivan, Daniel Carl,
Professor Emeritus of Radiology,
Radiology
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Swaminathan, Madhav,
Professor of Anesthesiology,
Anesthesiology, Cardiothoracic