39 results match your criteria: "Global Clinical Affairs[Affiliation]"

The systemic inflammatory response following hand instrumentation versus ultrasonic instrumentation-A randomized controlled trial.

J Clin Periodontol

September 2020

Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.

Objective: This study sought to investigate whether the immediate systemic inflammatory response following full-mouth debridement differs following use of hand compared with ultrasonic instruments.

Methods: Thirty-nine periodontitis patients were randomized to treatment with full-mouth debridement using either hand or ultrasonic instrumentation completed within 24 hr. Serum and periodontal clinical parameters were collected at baseline, day 1, day 7 and day 90 post-treatment.

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Lessons Learned About Peristomal Skin Complications: Secondary Analysis of the ADVOCATE Trial.

J Wound Ostomy Continence Nurs

July 2021

Ginger Salvadalena, PhD, RN, CWOCN, Global Clinical Affairs, Hollister Incorporated, Libertyville, Illinois.

Purpose: The aims of this study were to (1) describe the demographic and clinical characteristics of the individuals with peristomal skin complications (PSCs); (2) describe the PSCs; (3) examine the relationship of PSC occurrence and severity with possible risk factors, and (4) describe how PSCs were managed clinically.

Design: Secondary analysis of data from randomized controlled study, the ADVOCATE trial.

Subjects And Setting: Study participants (n = 153) were divided into 2 groups: those who did not experience a PSC (n = 80) and those who did (n = 73).

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Background: Identifying Streptococcus pneumoniae serotypes by urinary antigen detection (UAD) assay is the most sensitive way to evaluate the epidemiology of nonbacteremic community-acquired pneumonia (CAP). We first described a UAD assay to detect the S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, covered by the licensed 13-valent S.

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Piperacillin-tazobactam (P/T) is a β-lactam-β-lactamase inhibitor combination frequently used in the hospital setting. Etest is a gradient diffusion method that represents an alternative to broth microdilution (BMD) for performing antimicrobial susceptibility testing. We conducted a multicenter evaluation of the performance of the new P/T Etest compared to that of BMD following U.

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A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix.

Adv Skin Wound Care

September 2019

Shawn Cazzell, DPM, FAPWCA, FAPWH, is Chief Medical Officer, Limb Preservation Platform, Fresno, California. Peter M. Moyer, DPM, FACFAS, AAPWCA, is Podiatrist, Purvis Moyer Foot and Ankle Center, Rocky Mount, North Carolina. At LifeNet Health, Virginia Beach, Virginia, Brian Samsell, BS, is Scientific Writer; Kimberly Dorsch, BS, CCRP, CRCP, is Director of Global Clinical Affairs; Julie McLean, PhD, is Senior Manager of Scientific Affairs; and Mark A. Moore, PhD, is Global Senior Director of Scientific Affairs. Acknowledgments: The authors thank Collin Smith for data analysis support. This study was funded by LifeNet Health, a nonprofit organization that processes the studied acellular dermal matrix. Dr Cazzell and Dr Moyer were among the clinical trial investigators for this study and received research funding. Mr Samsell, Ms Dorsch, Dr McLean, and Dr Moore are employees of LifeNet Health. All patient outcomes were evaluated solely by the investigators to minimize potential for bias. The authors have disclosed no other financial relationships related to this article. Submitted January 3, 2019; accepted in revised form March 8, 2019; published online ahead of print, July 9, 2019.

Objective: This prospective, multicenter study evaluated the efficacy and safety of an acellular dermal matrix allograft, DermACELL (D-ADM; LifeNet Health, Virginia Beach, Virginia), in the treatment of large, complex diabetic foot ulcers (DFUs) that probed to tendon or bone.

Methods: Inclusion criteria were Wagner grade 3 or 4 DFUs between 4 weeks and 1 year in duration. All participants received one application of D-ADM at baseline and could receive one additional application if wound healing arrested.

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Long-term treatment with pegvisomant: observations from 2090 acromegaly patients in ACROSTUDY.

Eur J Endocrinol

December 2018

Endocrine Care Global Medical Affairs, Pfizer Inc., New York City, New York, USA.

Objectives ACROSTUDY is an international, non-interventional study of acromegaly patients treated with pegvisomant (PEGV), a growth hormone receptor antagonist and has been conducted since 2004 in 15 countries to study the long-term safety and efficacy of PEGV. This report comprises the second interim analysis of 2090 patients as of May 12, 2016. Methods Descriptive analyses of safety, pituitary imaging and outcomes on PEGV treatment up to 12 years were performed.

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Objective: To evaluate the efficacy and safety of celecoxib versus placebo in the prevention and treatment of colorectal polyposis in children with familial adenomatous polyposis (FAP).

Methods: In this Phase III, double-blind, randomized, placebo-controlled, multicenter trial patients aged 10-17 years with FAP were randomized to celecoxib (16 mg/kg/day) or placebo for up to 5 years. Patients underwent annual assessments, including colonoscopies, to detect the time from randomization to the earliest occurrence of ≥20 polyps (>2 mm in size) or colorectal malignancy.

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We carried out a dose-response model-based meta-analysis to assess venous thromboembolism (VTE) and bleeding with factor Xa (FXa) inhibitors (apixaban, edoxaban, rivaroxaban) and a thrombin inhibitor (dabigatran) compared with European (EU) (40 mg q.d.) and North American (NA) (30 mg Q12H) dose regimens of a low molecular weight heparin (enoxaparin) following orthopedic surgery.

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Age-related Macular Degeneration (AMD) is the leading cause of visual impairment and blindness in the elderly in developed countries. Neovascular/exudative (wet) AMD is the aggressive form of AMD and can involve choroidal neovascularization and vascular leakage. Anti-vascular endothelial growth factor (anti-VEGF) medications have significantly improved treatment of wet-AMD.

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Background: Approximately 50% of norovirus cases in the United States occur in long-term care facilities; many incidences of rotavirus, sapovirus, and adenovirus also occur. The primary objectives of this study were to demonstrate movement of pathogenic viruses through a long-term care facility and to determine the impact of a hygiene intervention on viral transmission.

Methods: The coliphage MS-2 was seeded onto a staff member's hands, and samples were collected after 4 hours from fomites and hands.

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Background: Daily measurements of left atrial pressure (LAP) may be useful for guiding adjustments in medical therapy that prevent clinical decompensation in patients with severe heart failure (HF).

Study Design: LAPTOP-HF is a prospective, multicenter, randomized, controlled clinical trial in ambulatory patients with advanced heart failure in which the safety and clinical effectiveness of a physician-directed patient self-management therapeutic strategy based on LAP measured twice daily by means of an implantable sensor will be compared with a control group receiving optimal medical therapy. The trial will enroll up to 730 patients with New York Heart Association functional class III symptoms and either a hospitalization for HF during the previous 12 months or an elevated B-type natriuretic peptide level, regardless of ejection fraction, at up to 75 investigational centers.

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WOCN Society and ASCRS Position Statement on Preoperative Stoma Site Marking for Patients Undergoing Colostomy or Ileostomy Surgery.

J Wound Ostomy Continence Nurs

December 2016

Task Force Chair Ginger Salvadalena, PhD, RN, CWOCN, Global Clinical Affairs, Hollister Incorporated, Libertyville, Illinois. Task Force Members Samantha Hendren, MD, MPH, Surgery, University of Michigan, Ann Arbor. Linda McKenna, MSN, RN, CWOCN, Ostomy & Wound, Memorial Medical Center, Springfield, Illinois. Roberta Muldoon, MD, FACS, Surgery, Vanderbilt University Medical Center, Nashville, Tennessee. Debra Netsch, DNP, RN, CNP, FNP-BC, CWOCN, Mankato Clinic, Ltd, Mankato, Minnesota. Ian Paquette, MD, Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio. Joyce Pittman, PhD, ANP-BC, FNP-BC, CWOCN, Wound/Ostomy, Indiana University School of Nursing, Indiana University Health-Methodist, Indianapolis, Indiana. Janet Ramundo, MSN, RN, CWOCN, WOC Nurse, Houston Methodist Hospital, Houston, Texas. Gary Steinberg, MD, Urologic Oncology and Section of Urology, The University of Chicago Medicine, Chicago, Illinois.

Marking the optimal location for a stoma preoperatively enhances the likelihood of a patient's independence in stoma care, predictable pouching system wear times, and resumption of normal activities. Colon and rectal surgeons and certified ostomy nurses are the optimal clinicians to select and mark stoma sites, as this skill is a part of their education, practice, and training. However, these providers are not always available, particularly in emergency situations.

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WOCN Society and AUA Position Statement on Preoperative Stoma Site Marking for Patients Undergoing Urostomy Surgery.

J Wound Ostomy Continence Nurs

December 2016

Task Force Chair Ginger Salvadalena, PhD, RN, CWOCN, Global Clinical Affairs, Hollister Incorporated, Libertyville, Illinois. Task Force Members Samantha Hendren, MD, MPH, Surgery, University of Michigan, Ann Arbor, Michigan. Linda McKenna, MSN, RN, CWOCN, Memorial Medical Center, Springfield, Illinois. Roberta Muldoon, MD, FACS, Vanderbilt University Medical Center, Nashville, Tennessee. Debra Netsch, DNP, RN, CNP, FNP-BC, CWOCN, Mankato Clinic, Ltd, Mankato, Minnesota. Ian Paquette, MD, University of Cincinnati College of Medicine, Cincinnati, Ohio. Joyce Pittman, PhD, ANP-BC, FNP-BC, CWOCN, Indiana University School of Nursing, Indiana University Health-Methodist, Indianapolis, Indiana. Janet Ramundo, MSN, RN, CWOCN, WOC Nurse, Houston Methodist Hospital, Houston, Texas. Gary Steinberg, MD, The University of Chicago Medicine, Chicago, Illinois.

Marking the optimal location for a stoma preoperatively enhances the likelihood of a patient's independence in stoma care, predictable pouching system wear times, and resumption of normal activities. Urologists and certified ostomy nurses are the optimal clinicians to select and mark stoma sites, as this skill is a part of their education, practice, and training. However, these providers are not always available, particularly in emergency situations.

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