Scholars@Duke
Jyotsna Garg

Jyotsna Garg

Biostatistician, Principal
Duke Clinical Research Institute
200 Morris St.,, Office #:5112, Durham, NC 27710
200 Morris St.,, Office 5112, Durham, NC 27701

Scholarly Works

Evaluating fitness-for-use of electronic health records in ascertaining baseline characteristics and clinical outcomes in clinical trials: insights from the VESALIUS EHR demonstration project.

Journal article Trials · April 25, 2026 INTRODUCTION: A tremendous amount of clinical data is collected and stored in electronic health records (EHRs). Whether this data can be harnessed at scale to facilitate clinical trial conduct remains to be seen. METHODS: The Effect of Evolocumab in Patien ... Full text Link to item Cite

Characterization of serum phosphate levels over time with intravenous ferric carboxymaltose versus placebo as treatment for heart failure with reduced ejection fraction and iron deficiency: An exploratory prospective substudy from HEART-FID.

Journal article Eur J Heart Fail · May 2025 AIMS: Ferric carboxymaltose (FCM) is guideline-recommended for iron deficiency (ID) in heart failure with reduced ejection fraction (HFrEF). Despite a well-established safety profile, the magnitude and clinical significance of FCM-induced hypophosphataemia ... Full text Link to item Cite

Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy.

Journal article N Engl J Med · January 11, 2024 BACKGROUND: Transthyretin amyloid cardiomyopathy is characterized by the deposition of misfolded monomeric transthyretin (TTR) in the heart. Acoramidis is a high-affinity TTR stabilizer that acts to inhibit dissociation of tetrameric TTR and leads to more ... Full text Link to item Cite

Baseline characteristics of patients in the randomized study to investigate the efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency: HEART-FID trial.

Journal article Am Heart J · December 2023 BACKGROUND: Prior clinical trials have investigated intravenous iron in patients with heart failure (HF) and iron deficiency, but the safety and efficacy of this therapy remains unclear. METHODS: We report the baseline demographics and clinical characteris ... Full text Link to item Cite

Ferric Carboxymaltose in Heart Failure with Iron Deficiency.

Journal article N Engl J Med · September 14, 2023 BACKGROUND: Ferric carboxymaltose therapy reduces symptoms and improves quality of life in patients who have heart failure with a reduced ejection fraction and iron deficiency. Additional evidence about the effects of ferric carboxymaltose on clinical even ... Full text Link to item Cite

Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ).

Conference Int J Infect Dis · April 2023 OBJECTIVES: To determine whether hydroxychloroquine (HCQ) is safe and effective at preventing COVID-19 infections among health care workers (HCWs). METHODS: In a 1: 1 randomized, placebo-controlled, double-blind, parallel-group, superiority trial at 34 US ... Full text Link to item Cite

Patterns of Health Services Use Before Age 1 in Children Later Diagnosed With ADHD.

Journal article J Atten Disord · October 2021 Background: Children with ADHD have 2 to 3 times increased health care utilization and annual costs once diagnosed, but little is known about utilization patterns early in life, prior to diagnosis. Quantifying early health services use among children later ... Full text Link to item Cite

Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design.

Journal article Circ Heart Fail · May 2021 BACKGROUND: Iron deficiency (ID) has a prevalence of ≈40% to 50% among patients in heart failure (HF) with reduced ejection fraction and is associated with worse prognosis. Several trials demonstrated that intravenous ferric carboxymaltose leads to early a ... Full text Link to item Cite

Health system utilization before age 1 among children later diagnosed with autism or ADHD.

Journal article Sci Rep · October 19, 2020 Children with autism spectrum disorder (ASD) or attention deficit hyperactivity disorder (ADHD) have 2-3 times increased healthcare utilization and annual costs once diagnosed, but little is known about their utilization patterns early in life. Quantifying ... Full text Link to item Cite

Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease.

Journal article Ann Intern Med · July 19, 2016 BACKGROUND: PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain) found that initial use of at least 64-slice multidetector computed tomography angiography (CTA) versus functional diagnostic testing strategies did not improve clinica ... Full text Open Access Link to item Cite

Association Between Sitagliptin Use and Heart Failure Hospitalization and Related Outcomes in Type 2 Diabetes Mellitus: Secondary Analysis of a Randomized Clinical Trial.

Journal article JAMA Cardiol · May 1, 2016 IMPORTANCE: Previous trial results have suggested that dipeptidyl peptidase 4 inhibitor (DPP4i) use might increase heart failure (HF) risk in type 2 diabetes mellitus (T2DM). The DPP4i sitagliptin has been shown to be noninferior to placebo with regard to ... Full text Link to item Cite

Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.

Journal article N Engl J Med · July 16, 2015 BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind st ... Full text Link to item Cite

Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study.

Journal article Clin Gastroenterol Hepatol · April 2015 BACKGROUND & AIMS: Liver biopsy is invasive and associated with complications, sampling errors, and observer variability. Vibration-controlled transient elastography (VCTE) with FibroScan can be used to immediately assess liver stiffness. We aimed to defin ... Full text Link to item Cite

Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.

Journal article Eur Heart J · July 21, 2014 AIMS: There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors. METHODS AND RESULTS: Using data from ROCKET AF, we analysed the management and outcomes of major bleeding overall and acc ... Full text Link to item Cite

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

Journal article N Engl J Med · September 8, 2011 BACKGROUND: The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagula ... Full text Link to item Cite

Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery.

Journal article N Engl J Med · September 9, 2010 BACKGROUND: Despite the routine use of prophylactic systemic antibiotics, surgical-site infection continues to be associated with significant morbidity and cost after colorectal surgery. The gentamicin-collagen sponge, an implantable topical antibiotic age ... Full text Link to item Cite

Effect of an implantable gentamicin-collagen sponge on sternal wound infections following cardiac surgery: a randomized trial.

Journal article JAMA · August 18, 2010 CONTEXT: Despite the routine use of prophylactic systemic antibiotics, sternal wound infection still occurs in 5% or more of cardiac surgical patients and is associated with significant excess morbidity, mortality, and cost. The gentamicin-collagen sponge, ... Full text Link to item Cite

Telaprevir for Previously Treated Chronic HCV Infection (vol 362, pg 1292, 2010)

Journal article NEW ENGLAND JOURNAL OF MEDICINE · April 29, 2010 Link to item Cite

Telaprevir for previously treated chronic HCV infection.

Journal article N Engl J Med · April 8, 2010 BACKGROUND: Patients with genotype 1 hepatitis C virus (HCV) who do not have a sustained response to therapy with peginterferon alfa and ribavirin have a low likelihood of success with retreatment. METHODS: We randomly assigned patients with HCV genotype 1 ... Full text Link to item Cite

Clinical and angiographic outcomes with sirolimus-eluting stents in total coronary occlusions: the ACROSS/TOSCA-4 (Approaches to Chronic Occlusions With Sirolimus-Eluting Stents/Total Occlusion Study of Coronary Arteries-4) trial.

Journal article JACC Cardiovasc Interv · February 2009 OBJECTIVES: We sought to examine angiographic and clinical outcomes with sirolimus-eluting stents (SES) in total coronary occlusion (TCO) revascularization. BACKGROUND: Despite evaluation of drug-eluting stents beyond approved indications, few studies have ... Full text Link to item Cite

Clinical and angiographic outcomes in diabetic patients following single or multivessel stenting in the COSTAR II randomized trial.

Journal article J Invasive Cardiol · July 2008 BACKGROUND: Percutaneous coronary intervention (PCI) is associated with increased clinical and angiographic restenosis in diabetic patients. Stent-based elution of paclitaxel from a biostable polymer reduces restenosis and major adverse cardiovascular even ... Link to item Cite

A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study.

Journal article J Am Coll Cardiol · April 22, 2008 OBJECTIVES: The aim was to compare safety and effectiveness of the CoStar drug-eluting stent (DES) (Conor MedSystems, Menlo Park, California) with those of the Taxus DES (Boston Scientific, Maple Grove, Minnesota) in de novo single- and multivessel percuta ... Full text Link to item Cite

The impact of anthropomorphic indices on clinical outcomes in patients with acute ST-elevation myocardial infarction.

Journal article Eur Heart J · February 2007 AIMS: Multiple studies have focused on the relationship of body anthropometric measures with clinical events in ST-elevation myocardial infarction (STEMI) patients, highlighting the 'obesity paradox'. However, the relative prognostic importance of these me ... Full text Link to item Cite

Racial differences in the characteristics of patients admitted for acute decompensated heart failure and their relation to outcomes: results from the OPTIME-CHF trial.

Journal article J Card Fail · December 2006 BACKGROUND: Recent data suggest that differences in response to therapy and survival exist between African Americans and Caucasians with heart failure. Whether these differences exist in acute decompensated heart failure (ADHF) is uncertain. METHODS AND RE ... Full text Link to item Cite

Glucose, insulin, and acute myocardial infarction: Reply [4]

Journal article European Heart Journal · September 1, 2006 Full text Cite

Prognostic significance of the change in glucose level in the first 24 h after acute myocardial infarction: results from the CARDINAL study.

Journal article Eur Heart J · June 2006 AIMS: In acute myocardial infarction (AMI), baseline hyperglycaemia predicts adverse outcomes, but the relation between subsequent change in glucose levels and outcomes is unclear. We evaluated the prognostic significance of baseline glucose and the change ... Full text Link to item Cite

High-risk patients with acute coronary syndromes treated with low-molecular-weight or unfractionated heparin: outcomes at 6 months and 1 year in the SYNERGY trial.

Journal article JAMA · November 23, 2005 CONTEXT: The SYNERGY trial comparing enoxaparin and unfractionated heparin in high-risk patients with acute coronary syndromes (ACS) showed that enoxaparin was not inferior to unfractionated heparin in reducing death or nonfatal myocardial infarction (MI) ... Full text Link to item Cite

Direct thrombin inhibitors in acute coronary syndromes: effect in patients undergoing early percutaneous coronary intervention.

Journal article Eur Heart J · November 2005 AIMS: We evaluated the effect of direct thrombin inhibitors (DTIs) in patients undergoing early percutaneous coronary intervention (PCI), using the DTI Trialists' Collaboration database of 35,970 patients from 11 randomized trials of DTIs vs. heparin. METH ... Full text Link to item Cite

Electrocardiographic infarct size assessment after thrombolysis: insights from the Acute Myocardial Infarction STudy ADenosine (AMISTAD) trial.

Journal article Am Heart J · October 2005 BACKGROUND: Noninvasive methods are needed to evaluate reperfusion success in patients with acute myocardial infarction (MI). The AMISTAD trial was analyzed to compare MI size and myocardial salvage determined by electrocardiogram (ECG) with technetium Tc ... Full text Link to item Cite

Association of height with outcomes in patients with acute myocardial infarction receiving reperfusion therapy.

Journal article Am J Cardiol · June 1, 2005 Data were evaluated for patients with acute ST-elevation myocardial infarction (n = 94,182) enrolled in 6 large clinical trials evaluating the efficacy of various reperfusion strategies. It was found that compared with the tallest quartile, incidences of i ... Full text Link to item Cite

Relationship of incorrect dosing of fibrinolytic therapy and clinical outcomes.

Journal article JAMA · April 13, 2005 CONTEXT: Incorrect dosing of alteplase has been associated with worse clinical outcomes in patients. However, patients at high risk of adverse events are more prone to dosing errors, thus confounding this relationship. OBJECTIVE: To determine if the associ ... Full text Link to item Cite

Feasibility of endovascular cooling as an adjunct to primary percutaneous coronary intervention (results of the LOWTEMP pilot study).

Journal article Am J Cardiol · March 1, 2004 In a nonrandomized feasibility study of therapeutic hypothermia in acute myocardial infarction, 18 patients were treated with endovascular cooling (Alsius, Irvine, California) as adjunctive therapy to primary percutaneous coronary intervention to assess me ... Full text Link to item Cite