104 results match your criteria: "and the Duke Clinical Research Institute[Affiliation]"
Attacking the Research-Practice Barrier.
Phys Ther
December 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, 300 W Morgan Street, Durham, North Carolina, 27701USA.
All I Really Needed to Know as a Researcher I Learned Playing D&D.
Phys Ther
November 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
My View of PTJ: 10 Months Later….
Phys Ther
October 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Association of Medication Adherence and Health Status in Heart Failure With Reduced Ejection Fraction: Insights From the CHAMP-HF Registry.
Circ Cardiovasc Qual Outcomes
September 2024
University of Missouri - Kansas City's Healthcare Institute for Innovation in Quality and Saint Luke's Mid America Heart Institute, Kansas City (R.S.E.-Z., M.M., D.D.N., M.N., J.A.S.).
Article Synopsis
- The study focuses on patients with heart failure with reduced ejection fraction (HFrEF) and the importance of adhering to prescribed medication guidelines to improve health status.
- Researchers analyzed the self-reported medication adherence of 3,495 outpatient participants over a 12-month period and found that nonadherent patients had worse health status at baseline and showed less improvement over time compared to those who followed their medication regimen.
- Additionally, for patients who improved their adherence, there was a trend toward better health outcomes, highlighting the significance of medication adherence in managing HFrEF.
A Tension Not Mentioned: When Clinical Research Favors Internal Over External Validity.
Phys Ther
June 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
Drug-Induced Liver Injury in Pregnancy: The U.S. Drug-Induced Liver Injury Network Experience.
Obstet Gynecol
June 2024
Division of Liver Diseases and the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, New York; Duke University School of Medicine and the Duke Clinical Research Institute, Durham, and Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina; National Institutes of Health, Bethesda, Maryland; Indiana University School of Medicine, Indianapolis, Indiana; and Albert Einstein Medical Center, Philadelphia, Pennsylvania.
There are limited data on the causative agents and characteristics of drug-induced liver injury in pregnant individuals. Data from patients with drug-induced liver injury enrolled in the ongoing multicenter Drug-Induced Liver Injury Network between 2004 and 2022 and occurring during pregnancy or 6 months postpartum were reviewed and compared with cases of drug-induced liver injury in nonpregnant women of childbearing age. Among 325 individuals of childbearing age in the Drug-Induced Liver Injury Network, 16 cases of drug-induced liver injury (5%) occurred during pregnancy or postpartum.
View Article and Find Full Text PDFEmpagliflozin after Acute Myocardial Infarction.
N Engl J Med
April 2024
From Baylor Scott and White Research Institute, Dallas (J. Butler); the Department of Medicine, University of Mississippi, Jackson (J. Butler); the Division of Cardiology, Department of Medicine, Duke University Medical Center (W.S.J., J.H., A.F.H.), and the Duke Clinical Research Institute (R.D.L.) - both in Durham, NC; Women's College Hospital (J.A.U.), the Peter Munk Cardiac Centre, University Health Network, University of Toronto (J.A.U., S.G.G.), and the Division of Cardiology, Department of Medicine, St. Michael's Hospital, Unity Health Toronto (S.G.G.), Toronto, the Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Section of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg (S.Z.) - all in Canada; the Department of Cardiology, German Heart Center Charité, Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim Pharma (M.M., I.Z.) and Boehringer Ingelheim International (T.G., W.J., M.B., M. Sumin), Ingelheim, the Department of Cardiology and Angiology, Hannover Medical School, Hannover (J. Bauersachs), and the First Department of Medicine, Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M.B.) - all in Germany; the School of Cardiovascular and Medical Sciences, British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (M.C.P.); the Heart Institute, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem (O.A.); Instituto de Neurología (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); the Heart Institute, Hospital Universitari Germans Trias i Pujol, and the Department of Medicine, Universitat Autònomoa de Barcelona, Barcelona (A.B.-G.), and Son Espases University Hospital, Health Research Institute of the Balearic Islands, University of the Balearic Islands, Palma de Mallorca (X.R.) - all in Spain; the Department of Cardiology, First Medical Center of Chinese People's Liberation Army General Hospital, Beijing (Y.C.), and the Department of Cardiology, Zhongshan Hospital, Fudan University, and the Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai (J.G.) - both in China; the Department of Cardiology, Medanta, Gurgaon, India (V.K.C.); the Faculty of Medicine and Health, University of Sydney, Sydney (G.F.); the Department of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (N.G.); Tokai University School of Medicine, Isehara, Japan (S.G.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.L.J.); Chonnam National University Hospital and Medical School, Gwangju, South Korea (M.H.J.); Volgograd State Medical University, Volgograd, Russia (Y.L.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); the Division of Cardiovascular Medicine, Department of Medicine, State University of New York at Stony Brook, Stony Brook (P.B.P.), and Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York (D.L.B.) - both in New York; the Ukrainian Institute of Cardiology M.D. Strazhesko, National Academy of Medical Sciences, Kyiv, Ukraine (A.P.); Collegium Medicum-Faculty of Medicine, WSB University, Dąbrowa Górnicza (T.G.), and the Institute for Heart Diseases Medical University (P.P.) and Jan Mikulicz-Radecki University Clinical Hospital (J.S.), Wrocław - all in Poland; the Department of Cardiology, Herlev and Gentofte University Hospital, Copenhagen (M. Schou); the Department of Cardiovascular Diseases, University Clinical Center Belgrade, Belgrade, Serbia (D.S.); Université Paris-Cité, French Alliance for Cardiovascular Trials, INSERM Unité 1148, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris (P.G.S.); the Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (P.M.); and University and Emergency Hospital of Bucharest, Bucharest, Romania (D.V.).
Article Synopsis
- Empagliflozin is known to improve cardiovascular outcomes in various patient groups, but its safety and effectiveness in those who have experienced an acute myocardial infarction were previously unclear.
- In a study involving 6522 patients at risk for heart failure after a heart attack, participants were given either empagliflozin or a placebo, with their health monitored over about 18 months.
- The results showed that empagliflozin did not significantly reduce the risk of hospitalization for heart failure or death compared to placebo, though it did show some potential benefits regarding hospitalizations specifically for heart failure.
My View of PTJ: How Potential for Impact Is Factored Into Article Review.
Phys Ther
April 2024
Departments of Orthopaedic Surgery and Population Health Sciences and the Duke Clinical Research Institute, Duke University, Durham NC, USA.
Leadless pacemaker tine damage and fracture: novel complications of a novel device fixation mechanism.
Heart Rhythm O2
January 2024
Division of Cardiovascular Medicine, University of Utah Health Sciences Center, Salt Lake City, Utah.
Background: Leadless pacemakers represent a paradigm-changing advancement. However, they required innovative and novel device design, including the use of nitinol tines for fixation.
Objective: We aimed to understand the potential for fracture in the novel tine-based fixation mechanism.
Cardiac Implantable Electronic Devices.
N Engl J Med
February 2024
From the Division of Cardiology and the Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Aim: To investigate the effects of Cimlanod, a nitroxyl donor with vasodilator properties, on water and salt excretion after an administration of an intravenos bolus of furosemide.
Methods And Results: In this randomized, double-blind, mechanistic, crossover trial, 21 patients with left ventricular ejection fraction <45%, increased plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and receiving loop diuretics were given, on separate study days, either an 8 h intravenous (IV) infusion of cimlanod (12 μg/kg/min) or placebo. Furosemide was given as a 40 mg IV bolus four hours after the start of infusion.
Outcomes According to Coronary Revascularization Modality in the ISCHEMIA Trial.
J Am Coll Cardiol
February 2024
Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York, USA. Electronic address:
Article Synopsis
- - In the ISCHEMIA trial, patients with stable coronary artery disease showed similar risk levels for ischemic events whether they underwent invasive treatments (like PCI or CABG) or conservative medical therapy.
- - The study specifically analyzed outcomes after revascularization, finding that CABG had a higher incidence of early primary outcome events compared to PCI, with 16.4% vs. 9.8% respectively, and many events occurring shortly after the procedures.
- - Overall, while early revascularization increased immediate risks of cardiovascular events, both CABG and PCI were linked to lower risks in the long term compared to conservative treatment, suggesting a complex risk-benefit scenario.
Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.
N Engl J Med
June 2023
From the Larner College of Medicine, University of Vermont, Burlington (L.W.Y.); the Departments of Biostatistics (S.T.O., Z.H., J.Y.L.) and Pediatrics (J.N.S.), University of Arkansas for Medical Sciences, Little Rock; the University of Cincinnati College of Medicine and Perinatal Institute and the Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati (S.L.M., W.R., J.M.M.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.), and the Department of Pediatrics, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus (E.F.B.); the Institutional Development Awards Program of the States Pediatric Clinical Trials Network, Environmental Influences on Child Health Outcomes (ECHO) Program, National Institutes of Health, Rockville (A.E.S.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda (A.A.B., R.D.H., M.C.W.) - both in Maryland; the Social, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park (A.D., M.M.C.), and the Duke Clinical Research Institute, Duke University School of Medicine (R.G.G., P.B.S.), and the Department of Pediatrics, Duke University (S.K.S.), Durham - all in North Carolina; Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (B.B.P.); the Office of Research and Sponsored Programs, Florida Gulf Coast University, Fort Myers (R.D.H.), and the Department of Pediatrics, University of South Florida, Tampa (T.W.); St. Elizabeth Healthcare, Edgewood (W.R.), and the Department of Pediatrics, University of Louisville, Louisville (S.T., L.A.D.) - both in Kentucky; the Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, DE (D.A.P.); the University of New Mexico School of Medicine, Albuquerque (J.R.M.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (C.M.F.); the Department of Pediatrics, University at Buffalo, Buffalo (A.M.R.), and the University of Rochester School of Medicine and Dentistry, Rochester (J. Riccio) - both in New York; the Oklahoma University Health Sciences Center, Oklahoma City (D.W.H.); the Medical University of South Carolina, Health Shawn Jenkins Children's Hospital, Charleston (J. Ross), and the Department of Pediatrics, Spartanburg Regional Medical Center, Spartanburg (J.B.) - both in South Carolina; the Section on Newborn Medicine, Pennsylvania Hospital (K.M.P.), and the Hospital of the University of Pennsylvania (L.C.), Philadelphia; the Kapiolani Medical Center for Women and Children, Honolulu (K.W.R., A.); the Department of Pediatrics, University of Mississippi Medical Center, Jackson (L.T.); Winchester Hospital, Winchester, MA (K.R.M.); the Department of Pediatrics, University of Kansas Medical Center (K.D.), and Children's Mercy Hospital (J.W.) - both in Kansas City, MO; Sanford Health, Sioux Falls, SD (J.R.W.); Tulane University School of Medicine, New Orleans (M.P.H.); and the University of Nebraska Medical Center, Omaha (S.N.).
Background: Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whether the new approach can safely reduce the time until infants are medically ready for discharge when it is applied broadly across diverse sites is unknown.
Methods: In this cluster-randomized, controlled trial at 26 U.
The Data Monitoring Committee: A Collective or a Collection?
Ther Innov Regul Sci
July 2023
Florida Atlantic University, Boca Raton, FL, USA.
In this commentary, we urge that a Data Monitoring Committee (DMC) should operate as a collective, that is, as a unitary whole. In so doing, its recommendations should emerge through a consensus development process, not through a vote of the members. The summary notes of its closed session, that is, its minutes, should report the recommendations of the DMC and, if necessary, the justification for those recommendations; it should not attribute opinions to individual members.
View Article and Find Full Text PDFMethylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial.
N Engl J Med
December 2022
From the Duke Pediatric and Congenital Heart Center (K.D.H., J.W.T., J.S.L.) and the Duke Clinical Research Institute (K.D.H., S.M.O., J.L.K., D.S.G., J.S.L.) - both in Durham, NC; Vanderbilt University Medical Center, Nashville (P.J.K., H.S.B., D.P.B.); the University of Florida Congenital Heart Center, Gainesville (J.P.J., M.B.); Johns Hopkins University School of Medicine, Baltimore (M.L.J., B.M.); the Medical University of South Carolina, Charleston (E.M.G.); the UPMC Children's Hospital of Pittsburgh, Pittsburgh (B.B.); the Section of Pediatric Cardiac Anesthesiology, Texas Children's Hospital, Department of Anesthesiology, Baylor College of Medicine, Houston (A.R., D.F.V.), and the Division of Cardiology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (R.B.); the University of Utah-Primary Children's Hospital, Salt Lake City (A.S.H.); the University of Southern California and the Heart Institute, Children's Hospital of Los Angeles - both in Los Angeles (S.R.K.); the University of Cincinnati, Cincinnati Children's Hospital Medical Center, Cincinnati (A.B.), the Division of Pediatric Cardiac Surgery, Heart Vascular and Thoracic Institute, Cleveland Clinic Children's, Cleveland (T.K.), and the Department of Cardiothoracic Surgery, Nationwide Children's Hospital, and Ohio State University, Columbus (P.I.M.) - all in Ohio; the Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago (E.W.), and the Advocate Children's Heart Institute, Advocate Children's Hospital, Division of Pediatric Cardiac Critical Care, Oak Lawn (A.H.V.B.) - both in Illinois; the Division of Cardiovascular Surgery, Children's Minnesota, Minneapolis (D.O.); the Section of Pediatric Cardiothoracic Surgery, Washington University School of Medicine, St. Louis (P.E.); the Division of Cardiology, Department of Pediatrics, Heart Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (J.S.K.); Children's Wisconsin, Medical College of Wisconsin, Milwaukee (J.P.S.); and the Division of Pediatric Cardiology, New York-Presbyterian Hospital-Columbia University Irving Medical Center, New York (B.R.A.), and the University of Rochester Medical Center, Rochester (M.F.S.) - both in New York.
Background: Although perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown.
Methods: We conducted a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry data were used in the evaluation of outcomes.
Self-Management of Chronic Pain: Psychologically Guided Core Competencies for Providers.
Pain Med
October 2022
Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, Iowa, USA.
Dronedarone for the treatment of atrial fibrillation with concomitant heart failure with preserved and mildly reduced ejection fraction: a post-hoc analysis of the ATHENA trial.
Eur J Heart Fail
June 2022
Division of Clinical Electrophysiology, Department of Cardiology, J. W. Goethe University, Frankfurt, Germany.
Aims: Limited therapeutic options are available for the management of atrial fibrillation/flutter (AF/AFL) with concomitant heart failure (HF) with preserved (HFpEF) and mildly reduced ejection fraction (HFmrEF). Dronedarone reduces the risk of cardiovascular events in patients with AF, but sparse data are available examining its role in patients with AF complicated by HFpEF and HFmrEF.
Methods And Results: ATHENA was an international, multicentre trial that randomized 4628 patients with paroxysmal or persistent AF/AFL and cardiovascular risk factors to dronedarone 400 mg twice daily versus placebo.
Cases of Azygous Coil Extraction.
Heart Rhythm O2
February 2022
Cardiac Electrophysiology Section, Division of Cardiology, Duke University Medical Center and the Duke Clinical Research Institute, Durham, North Carolina.
Article Synopsis
- Two patients with a history of significant heart issues underwent extraction of devices with azygous coils in place, highlighting the lack of existing data on this procedure.
- Both patients experienced successful removal of the coils using laser technology, with no intraoperative complications reported.
- The results suggest that azygous coils can be safely removed using standard techniques similar to those used for other lead extractions, despite their varied dwell times.
Low Blood Pressure Threshold for Adverse Outcomes During Left Ventricular Assist Device Support.
Am J Cardiol
April 2022
Division of Cardiology, Department of Medicine.
It has been suggested that maintaining low mean arterial pressure (MAP) in left ventricular assist device (LVAD) recipients is associated with a reduced risk of stroke/death. However, the lower limit of the optimal MAP range has not been established. We aimed to identify this lower limit in a contemporary cohort of LVAD recipients with frequent longitudinal MAP measurements.
View Article and Find Full Text PDFHIPAA and the Leak of "Deidentified" EHR Data.
N Engl J Med
June 2021
From the Computational Health Informatics Program, Boston Children's Hospital, and the Department of Biomedical Informatics, Harvard Medical School - both in Boston (K.D.M.); and the Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (E.D.P.).
Association between sacubitril/valsartan initiation and real-world health status trajectories over 18 months in heart failure with reduced ejection fraction.
ESC Heart Fail
August 2021
Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City, 4401 Wornall Road, Kansas City, MO, 64111, USA.
Aims: Improving the health status (symptoms, function, and quality of life) of patients with heart failure with reduced ejection fraction (HFrEF) is a primary treatment goal. Angiotensin receptor neprilysin inhibitors (ARNI) improve short-term health status in clinical practice, but the sustainability of these improvements is unknown.
Methods And Results: In CHAMP-HF, a multicentre observational study of outpatients with HFrEF, patients initiated on ARNI were propensity score matched 1:2 to patients not using ARNI with Cox regression modelling time to ARNI initiation, adjusted for sociodemographic and clinical variables, medical history, medications, and baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.
Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study.
JACC Heart Fail
February 2021
Bristol-Myers-Squibb, Princeton, New Jersey, USA.
Objectives: The primary objective was to identify well-tolerated doses of cimlanod in patients with acute heart failure (AHF). Secondary objectives were to identify signals of efficacy, including biomarkers, symptoms, and clinical events.
Background: Nitroxyl (HNO) donors have vasodilator, inotropic and lusitropic effects.
Understanding of Perceived Infectiousness and Its Influence on Sexual Behavior Among Individuals With Acute HIV Infection in Lilongwe, Malawi (HPTN 062).
AIDS Educ Prev
June 2020
Department of Population Health Sciences, School of Medicine, Duke University, and the Duke Clinical Research Institute, Duke University.
We implemented HPTN 062, an acceptability and feasibility study of a motivational-interviewing (MI) intervention to reduce HIV transmission among individuals with acute HIV infection (AHI) in Lilongwe, Malawi. Participants were randomly assigned to receive either brief education or the MI intervention over 24 weeks; all participants received the same messages about AHI. We used mixed methods to assess participants' understanding of the association between AHI and viral load, and its connection to sexual behavior at 8 weeks.
View Article and Find Full Text PDFA change of heart: Preliminary results of the US 2018 adult heart allocation revision.
Am J Transplant
October 2020
Duke University School of Medicine and the Duke Clinical Research Institute, Durham, North Carolina, USA.
In 2018, the Organ Procurement and Transplantation Network (OPTN) modified adult heart allocation to better stratify candidates and provide broader access to the most medically urgent candidates. We analyzed OPTN data that included waiting list and transplant characteristics, geographical distribution, and early outcomes 1 year before (pre: October 18, 2017-October 17, 2018) and following (post: October 18, 2018-October 17, 2019) implementation. The number of adult heart transplants increased from 2954 pre- to 3032 postimplementation.
View Article and Find Full Text PDF