Publications by authors named "Kilaru R"

Objective: We assessed adolescent relationship abuse (ARA) prevalence and ARA intervention acceptability and perceived benefit among hospitalized adolescents and young adults (AYA).

Methods: This was a planned secondary analysis of a cross-sectional survey exploring sexual and reproductive health among a convenience sample of AYA (14-25 years) hospitalized in medical/surgical units at two Midwest children's hospitals. Survey items assessed history of dating, lifetime prevalence of four types of ARA (physical abuse, sexual abuse, reproductive coercion, sexual exploitation), and demographics.

View Article and Find Full Text PDF

Background: In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated its efficacy guideline for good clinical practice and introduced predefined quality tolerance limits (QTLs) as a quality control in clinical trials. QTLs are complementary to Quality by Design (QbD) principles (ICH-E8) and are one of the components of the risk-based clinical trial quality management system.

Methods: Currently the framework for QTLs process is well established, extensively describing the operational aspects of Defining, Monitoring and Reporting, but a single source of commonly used methods to establish QTLs and secondary limits is lacking.

View Article and Find Full Text PDF

Glucokinase (GK) is a potential therapeutic target of type 2 diabetes and GK activators (GKAs) represent a promising class of small organic molecules which enhance GK activity. Based on the configuration and conformation of the allosteric site of GK, we have designed a novel class of amino phosphonate derivatives in order to develop potent GKAs. The QSAR model developed using numerous descriptors revealed its potential with the best effective statistical values of RMSE=1.

View Article and Find Full Text PDF

Since inhibitors of mucin onco proteins are potential targets for breast cancer therapy, a series of novel 4-methylthiazole-5-carboxylic acid (1) derivatives 3a-k were synthesized by the reaction of 1 with SOCl2 followed by different bases/alcohols in the presence of triethylamine. Once synthesized and characterized, their binding modes with MUC1 were studied by molecular docking analysis using Aruglab 4.0.

View Article and Find Full Text PDF

Darunavir is a synthetic nonpeptidic protease inhibitor which has been tested for anticancer properties. To deduce and enhance the anticancer activity of the Darunavir, we have modified its reactive moiety in an effective way. We designed 9 analogues in ChemBioOffice 2010 and minimized using the LigPrep tool of Schrödinger 2011.

View Article and Find Full Text PDF

Background: Apixaban, an oral, direct factor Xa inhibitor, may reduce the risk of recurrent ischemic events when added to antiplatelet therapy after an acute coronary syndrome.

Methods: We conducted a randomized, double-blind, placebo-controlled clinical trial comparing apixaban, at a dose of 5 mg twice daily, with placebo, in addition to standard antiplatelet therapy, in patients with a recent acute coronary syndrome and at least two additional risk factors for recurrent ischemic events.

Results: The trial was terminated prematurely after recruitment of 7392 patients because of an increase in major bleeding events with apixaban in the absence of a counterbalancing reduction in recurrent ischemic events.

View Article and Find Full Text PDF

Context: Acute ST-segment elevation myocardial infarction (STEMI) is a leading cause of morbidity and mortality. In experimental models of MI, erythropoietin reduces infarct size and improves left ventricular (LV) function.

Objective: To evaluate the safety and efficacy of a single intravenous bolus of epoetin alfa in patients with STEMI.

View Article and Find Full Text PDF

Objectives: This study aimed to evaluate whether synthetic secretin is effective in reducing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis.

Methods: This is a single academic medical center, prospective, randomized, double-blind, placebo-controlled trial using secretin (dose of 16 μg) administered intravenously immediately before ERCP. Patients were evaluated for the primary outcome of post-ERCP pancreatitis as diagnosed by a single investigator.

View Article and Find Full Text PDF

Background: Acute myocardial infarction (MI) remains a leading cause of death despite advances in pharmacologic and percutaneous therapies. Animal models of ischemia/reperfusion have demonstrated that single-dose erythropoietin may reduce infarct size, decrease apoptosis, and increase neovascularization, possibly through mobilization of endothelial progenitor cells.

Study Design: REVEAL is a randomized, double-blind, placebo-controlled, multicenter trial evaluating the effects of epoetin α on infarct size and left ventricular remodeling in patients with large MIs.

View Article and Find Full Text PDF

HMG CoA reductase inhibition suppresses in vitro HCV replication through depletion of cellular sterol proteins such as geranylgeraniol. Our aims were to prospectively evaluate the changes in serum and lipid fraction HCV RNA with Rosuvastatin in non-responder (NR) patients with CHC. A total of 11 patients with CHC genotype-1 received Rosuvastatin at 20 mg qd (weeks 0-4), 40 mg qd (weeks 5-12), with 4 week follow up.

View Article and Find Full Text PDF

Background: Inhibition of the P2Y12 ADP-receptor with oral antiplatelet agents given to patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is associated with improved outcomes, but this strategy is limited by the time required for maximal antiplatelet effect after administration. We examined the safety and tolerability of a novel, direct-acting, reversible, intravenous P2Y12 ADP-receptor antagonist, elinogrel, versus placebo when administered to STEMI patients before primary PCI.

Methods: The ERASE MI trial was a pilot, phase IIA, randomized, double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety and tolerability of escalating doses (10, 20, 40, and 60 mg) of elinogrel administered as a single intravenous bolus before the start of the diagnostic angiogram preceding primary PCI.

View Article and Find Full Text PDF

Sustained ventricular arrhythmias and heart failure are well-recognized complications after acute myocardial infarction (AMI) and have been associated with worse outcomes and increased mortality. The use of and outcomes associated with acute beta-blocker therapy in patients with AMI complicated by sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) and heart failure were investigated. Of 5,391 patients in the VALIANT Registry, sustained VT/VF occurred in 306 (5.

View Article and Find Full Text PDF

Background: Venous thromboembolism (VTE) is a potentially preventable postoperative complication. Accurate risk prediction is an essential first step toward limiting serious, and sometimes fatal, postoperative VTE. We sought to develop and test a model to predict patients at high risk for postoperative VTE.

View Article and Find Full Text PDF

Aims: To assess the significance of creatine kinase (CK)-MB elevations in outcomes of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) who have undergone coronary artery bypass grafting (CABG) surgery.

Methods And Results: This analysis includes data from 26 465 patients with NSTE ACS enrolled in four major trials. In total, 4626 (17.

View Article and Find Full Text PDF

Background: Few antihypertensive therapies have been systematically studied in children and dosages for many agents are either extrapolated from adult studies or obtained from small homogenous pediatric populations. It is well established that adult patients of different races show disparate response to angiotensin-converting enzyme (ACE) inhibitors, however no such studies have been performed in children.

Methods: Two hundred fifty three children ages 6-16 with hypertension or with high normal blood pressure with an associated medical condition requiring antihypertensive therapy were enrolled at 78 clinical sites in the US, Russia, and Israel in a double blind study to evaluate the efficacy of fosinopril compared to placebo.

View Article and Find Full Text PDF

We investigated the severity of coronary artery disease (CAD) diagnosed by coronary angiography performed because of suspected CAD in 102 persons, mean age 68 years, with rheumatoid arthritis (RA) and in 102 age-matched and sex-matched persons. CAD was diagnosed by coronary angiography in 80 of 102 persons (78%) with RA and in 79 of 102 persons (77%) without RA (P not significant). Three-vessel CAD was present in 31 of 102 persons (30%) with RA and in 8 of 102 persons (8%) without RA (P < 0.

View Article and Find Full Text PDF

Anidulafungin is an echinocandin with activity against Candida species and Aspergillus species. Adult dosages under study are 50 mg/day for esophageal candidiasis and 100 mg/day for invasive candidiasis and aspergillosis. Little is known, however, about the safety and pharmacokinetics of anidulafungin in children.

View Article and Find Full Text PDF

Background: How often echocardiography and cardiac catheterization are used to evaluate left ventricular (LV) function in patients with myocardial infarction (MI) and how they are associated with quality of care is unknown.

Methods: Patients with MI in the Valsartan in Acute Myocardial Infarction (VALIANT) registry were divided into those with (n = 1423) and without (n = 3968) heart failure (HF), and the use of either echocardiography or cardiac catheterization for LV assessment in each group was compared along with associated baseline characteristics. We evaluated the association between LV assessment and discharge medications.

View Article and Find Full Text PDF

Background: In the fibrinolytic era, several studies have suggested that the rate of atrioventricular block (AVB) in the setting of acute myocardial infarction (MI) is high and is associated with increased short-term mortality. We sought to delineate predictors of AVB and determine long-term mortality of patients developing AVB in the setting of ST-segment elevation MI (STEMI) treated with thrombolytic therapy.

Methods: We combined data on patients from 4 similar studies of STEMI.

View Article and Find Full Text PDF

Aims: We sought to assess the relative contribution of heart failure (HF) on admission for an acute myocardial infarction (MI) to the subsequent in-hospital stroke risk.

Methods And Results: The VALsartan In Acute myocardial iNfarcTion (VALIANT) registry enrolled 5573 consecutive MI patients at 84 international sites from 1999 to 2001. We calculated odds ratios (ORs) for stroke and adjusted for baseline characteristics, Killip Class, and risk factors for stroke, such as diabetes and prior HF.

View Article and Find Full Text PDF

Myocardial infarction (MI) is a key component of composite end points in trials that evaluate new therapies in non-ST-segment elevation acute coronary syndromes. Types of MI events in these trials have not been well characterized. A similar clinical-events classification process adjudicated all suspected MI end points in the PURSUIT and PARAGON B trials.

View Article and Find Full Text PDF

Aims: We analysed the contemporary incidence, outcomes, and predictors of heart failure (HF) and/or left ventricular systolic dysfunction (LVSD) before discharge in patients with acute myocardial infarction (MI). The baseline presence of HF or LVSD, or its development during hospitalisation, increases short- and long-term risk after MI, yet its incidence, predictors, and outcomes have not been well described in a large, international, general MI population.

Methods And Results: The VALIANT registry included 5573 consecutive MI patients at 84 hospitals in nine countries from 1999 to 2001.

View Article and Find Full Text PDF