74 results match your criteria: "Clinical and Medical Affairs[Affiliation]"
Catheter Cardiovasc Interv
January 2025
Department of Cardiology, Turku University Hospital, Turku, Finland.
Background: Vascular and bleeding complications remain a concern after transfemoral transcatheter aortic valve replacement (TAVR). The impact of the sheath type on these complications remains unclear.
Methods: The prospective MARVEL registry study analyzed enrolled 500 patients undergoing large-bore transfemoral procedures and arteriotomy closure with the MANTA vascular closure device from 10 hospitals in Europe and Canada.
Background: We aimed to quantify the incidence of atrial fibrillation (AF) in patients with cryptogenic stroke globally, as well as separately in patients in and outside of Japan, using an implantable loop recorder from a prospective, observational, Reveal LINQ Registry.
Methods And Results: Patients developing cryptogenic stroke and monitored by implantable loop recorder for searching AF were studied. The primary end point was incidence of AF within 36 months after insertion.
Womens Health Rep (New Rochelle)
September 2024
Global Clinical and Medical Affairs, Smith and Nephew, Fort Worth, Texas, USA.
Background: Acute and chronic wounds in the acute hospital setting are commonly managed with soft silicone multilayer foam dressings (SSMFDs). While many SSMFDs are indicated for wear time of up to 7 days, they are often changed more frequently.
Objective: To use real-world data on dressing change practices and clinical outcomes to examine whether a built-in indicator on a proprietary SSMFD could reduce unnecessary dressing changes.
Am J Infect Control
November 2024
Clinical and Medical Affairs, Vascular and Interventional Divisions, Teleflex Incorporated, Morrisville, NC, USA.
Background: Candida auris is an emerging multidrug-resistant fungus associated with catheter-related bloodstream infections. In vitro efficacy of chlorhexidine (CHX) and CHX-silver sulfadiazine-impregnated (CHX-S) antimicrobial central venous catheters (CVCs) against C auris was investigated.
Methods: Minimum inhibitory and bactericidal CHX concentrations were determined against 19 C auris isolates.
Compend Contin Educ Dent
March 2024
Clinical Development Director, Philips Oral Healthcare, Bothell, Washington.
The study objective was to evaluate the effect of different interdental oral cleaning modalities on gingivitis and plaque following a 6-week period of home use. This was a randomized, parallel, examiner-blinded study. Study subjects were routine manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years.
View Article and Find Full Text PDFIndian J Urol
April 2024
Department of Urology, Medanta, Gurugram, Haryana, India.
Introduction: There is an unmet need for high-quality data for Robot-assisted partial nephrectomy (RAPN) in the Indian population. Indian study group on partial nephrectomy (ISGPN) is a consortium of Indian centers contributing to the partial nephrectomy (PN) database. The current study is a descriptive analysis of perioperative and functional outcomes following RAPN.
View Article and Find Full Text PDFClin Ophthalmol
April 2024
Global Clinical and Medical Affairs, Hoya Surgical Optics, Irvine, CA, USA.
Purpose: To evaluate clinical outcomes after bilateral or contralateral implantation of the Gemetric™ (G) and Gemetric™ Plus (GPlus) diffractive trifocal intraocular lenses (IOLs).
Methods: This was a prospective, randomized, multi-center open-label study comparing clinical results and subjective patient responses around 6 months after implantation of the study lenses (toric and non-toric) in three different groups (bilateral G, bilateral GPlus and contralateral G/GPlus implantation). Results included the manifest refraction, uncorrected and distance corrected monocular and binocular visual acuity (VA) at distance, intermediate and near; the defocus curve; contrast sensitivity; and patient reported outcomes regarding spectacle independence, satisfaction and visual disturbances.
Brain Stimul
April 2024
LivaNova PLC (or a Subsidiary), Department of Clinical and Medical Affairs, London, UK. Electronic address:
Background: Vagus nerve stimulation (VNS) at low frequencies (≤30 Hz) has been an established treatment for drug-resistant epilepsy (DRE) for over 25 years.
Objective: To examine the initial safety and efficacy performance of an investigational, high-frequency (≥250 Hz) VNS paradigm herein called "Microburst VNS" (μVNS). μVNS consists of short, high-frequency bursts of electrical pulses believed to preferentially modulate certain brain regions.
Epilepsia
January 2024
Clinical and Medical Affairs, Epilepsy, LivaNova USA, Houston, Texas, USA.
Cancer Sci
January 2024
Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
In a real‐world database of metastatic colorectal cancer (mCRC) in the United States, comprehensive genomic profiling (CGP) using plasma‐based next‐generation sequencing identified potentially actionable profiles for approximately one‐third of the patients with both the first test and again with a second test after disease progression, with around 60% of all patients tested receiving therapy consistent with the CGP results at each line of treatment. This suggests a role for CGP prior to more than one line of mCRC treatment.
View Article and Find Full Text PDFAm J Surg
February 2024
Global Clinical and Medical Affairs, Smith and Nephew, Hull, UK. Electronic address:
Background: To evaluate whether a single-use negative pressure wound therapy (sNPWT) device can reduce the incidence of surgical site infection (SSI) in at-risk patients with closed surgical incisions across a range of surgical specialties, compared with standard care.
Methods: PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched from the period January 2011 to April 2021.
J Pain Res
October 2023
Division of Gastroenterology and Hepatology, University of Michigan, Michigan Medicine, Ann Arbor, MI, USA.
Purpose: We evaluated the impact of baseline patient characteristics on safety and efficacy of methylnaltrexone, a peripherally acting µ-opioid receptor antagonist, in patients with advanced illness with opioid-induced constipation (OIC).
Patients And Methods: This analysis pooled data from 2 randomized, double-blind, placebo-controlled studies (study 302: NCT00402038; study 4000: NCT00672477) in patients with advanced illness, including cancer, and OIC. Patients were randomized to receive subcutaneous methylnaltrexone (study 302: 0.
Crit Care Nurse
October 2023
Mandy Spitzer is a senior clinical strategy manager, Global Clinical and Medical Affairs, Smith and Nephew, Fort Worth, Texas.
Background: Pressure injuries remain the most common hospital-acquired condition, according to the Agency for Healthcare Research and Quality. Patients hospitalized with COVID-19 are at especially high risk for pressure injuries, including those related to medical devices, because of their lower tissue tolerance, prolonged intubation, and common treatment with prone positioning.
Local Problem: The COVID-19 pandemic brought an increased incidence of hospital-acquired pressure injury.
Am J Perinatol
May 2024
Global Clinical and Medical Affairs, Smith + Nephew, Hull, United Kingdom.
This paper aims to evaluate whether there is a device-dependent effect on the reduction of surgical site complications in obese patients (body mass index [BMI] ≥ 30 kg/m) undergoing cesarean section (C-section). PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched for the period, January 2011 to September 2021.
View Article and Find Full Text PDFNeurourol Urodyn
January 2024
Department of Urology, University of Toronto, Toronto, Ontario, Canada.
Introduction: Incontinence impacts the quality-of-life of people suffering from the disease. However, there is limited information on the prevalence of incontinence due to the stigma, lack of awareness, and underdiagnosis.
Objective: This study aims to conduct a systematic review and meta-analysis of overactive bladder (OAB) and nonobstructive urinary retention (NOUR).
Cells
August 2023
Clinical Experimental Research, Glostrup Research Institute, Rigshospitalet, 2600 Glostrup, Denmark.
Endothelin-1 (ET-1) overactivity has been implicated as a factor contributing to glaucomatous neuropathy, and it has been utilized in animal models of retinal ischemia. The functional effects of long-term ET-1 exposure and possible compensatory mechanisms have, however, not been investigated. This was therefore the purpose of our study.
View Article and Find Full Text PDFJ Pain Res
July 2023
Bausch Health US, LLC, Clinical and Medical Affairs, Bridgewater, NJ, USA.
Purpose: Opioid-induced constipation (OIC) is a common side effect of opioid therapy. Methylnaltrexone (MNTX) is a selective, peripherally acting μ-opioid receptor antagonist, with demonstrated efficacy in treating OIC. We pooled results from MNTX clinical trials to compare responses to an initial dose in patients with chronic cancer and noncancer pain.
View Article and Find Full Text PDFWounds
July 2023
Senior Clinical Strategy Manager, Global Clinical and Medical Affairs, Smith and Nephew, Fort Worth, TX, USA.
Introduction: A variety of NPWT products have become commercially available in the last 30 years. Utilizing advanced wound therapies appropriately can improve patient outcomes and decrease health care expenditures. Due to the increasing number of available product options, Hurd and colleagues published 10 Consensus Statements and a clinical decision tree to provide guidance on how and when to use NPWT and when to transition between device types.
View Article and Find Full Text PDFDermatol Surg
August 2023
Clinical and Medical Affairs Department, Teoxane SA, Geneva, Switzerland.
Background: Validated clinical scales are needed to assess aesthetic improvement of the infraorbital hollows (IOHs) after treatment with dermal fillers.
Objective: To develop an IOHs scale and establish its reliability and sensitivity for grading subjects in clinical trials or routine practice.
Methods And Materials: The Teoxane IOHs Scale (TIOHS), a 5-grade photonumeric scale, was developed based on real-subject photographs and validated through photographic and live subjects' evaluation.
Expert Opin Biol Ther
November 2023
Clinical and Medical Affairs, Alvotech Germany GmbH, Jülich, Germany.
Background: This study compared efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity between AVT04 and reference product (RP) ustekinumab (Stelara®) in patients with moderate-to-severe chronic plaque psoriasis (PsO).
Patients And Methods: This multicenter, double-blind, 52-week study randomized patients in 1:2 ratio to AVT04 or RP. At week 16, responsive patients (≥50% improvement in psoriasis area and severity index (PASI)) previously on AVT04 continued on AVT04, while those on RP were re-randomized 1:1 to switch to AVT04 or stay on RP.
Front Neurol
June 2023
Clinical and Medical Affairs, LivaNova PLC (or a subsidiary), London, United Kingdom.
Vagus nerve stimulation (VNS) was the first device-based therapy for epilepsy, having launched in 1994 in Europe and 1997 in the United States. Since then, significant advances in the understanding of the mechanism of action of VNS and the central neurocircuitry that VNS modulates have impacted how the therapy is practically implemented. However, there has been little change to VNS stimulation parameters since the late 1990s.
View Article and Find Full Text PDFJ Allergy Clin Immunol Pract
July 2023
Clinical and Medical Affairs, Propeller Health, Madison, Wis.
Background: Patients with asthma and chronic obstructive pulmonary disease (COPD) may be prescribed once- or twice-daily dosing of controller inhalers.
Objective: To assess differences in controller adherence by dosing schedule and age.
Methods: Electronic medication monitors (EMMs) captured the date and time of inhaler actuations over 90 days in patients using the Propeller Health platform.
JAMA Otolaryngol Head Neck Surg
June 2023
Division of Sleep Medicine, Department of Otorhinolaryngology, University Hospital Mannheim, Mannheim, Germany.
Importance: Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA).
Objective: To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA.
Design, Setting, And Participants: This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less.
OTO Open
February 2023
Paediatric Otolaryngology Department, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital Manchester University Hospitals NHS Foundation Trust Manchester UK.
Objective: To determine whether intracapsular tonsillectomy, using plasma ablation, results in differences in postoperative patient outcomes to total tonsillectomy.
Data Sources: A systematic review of two databases (Embase and PubMed) was conducted in March 2022 to identify published English-language randomized controlled trials and observational studies which provided a comparison between intracapsular tonsillectomy, using plasma ablation, and total tonsillectomy.
Review Methods: Qualitative synthesis and meta-analysis were used to compare outcomes between techniques.