66,823 results match your criteria assess safety


A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy and Safety of a Transdermal Gel that Delivers CO2 in the Treatment of Vulvovaginal Atrophy.

Surg Technol Int 2021 Apr 20;38. Epub 2021 Apr 20.

Faculty of Medicine, University of Buenos Aires, Buenos Aires, Argentina.

This prospective study aimed to assess the efficacy of a transdermal CO2 gel in promoting regeneration in the vulvovaginal area in postmenopausal women experiencing symptoms as part of genitourinary syndrome of menopause (GSM). Transdermal carboxytherapy refers to the application of CO2 through the skin's superficial layer, which is intended to increase oxygenation (through the Bohr effect) and angiogenesis, thus helping to reduce symptoms of GSM. In this study, 20 women with moderate or severe signs or symptoms of vulvovaginal atrophy were randomized to receive either transdermal CO2 therapy (n=10) or a placebo gel (ultrasound gel, n=10). Read More

View Article and Full-Text PDF

Micro/nanoplastic mediated pathophysiological changes in rodents, rabbits, and chicken.

J Food Prot 2021 Apr 20. Epub 2021 Apr 20.

USDA-ARS.

Plastics provide tremendous societal benefits and are an indispensable part of our lives. However, fragmented plastics or those intentionally manufactured in small sizes (microplastics or nanoplastics) are of concern because they can infiltrate soils and enter the human food chain through trophic transfer. The pathophysiological impacts of micro/nanoplastics in humans are not characterized but their effects in terrestrial mammals may help elucidate their potential effects in human beings. Read More

View Article and Full-Text PDF

COVID-19 Vaccine Perceptions Among Patients With Chronic Disease in a Large Gastroenterology and Hepatology Practice.

Am J Gastroenterol 2021 Apr 19. Epub 2021 Apr 19.

Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Center for Health Care Innovation, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Introduction: To assess beliefs about safety, effectiveness, and delivery of the coronavirus disease 2019 (COVID-19) vaccine among chronic Gastroenterology and Hepatology patients at an academic health system.

Methods: We asked about vaccine beliefs, vaccine concerns, and preferred location to receive the COVID-19 vaccine.

Results: A total of 1,215 patients responded (response rate: 37%). Read More

View Article and Full-Text PDF

SLL-PEEP Ventilation to Improve Exposure in Minimally Invasive Right Anterolateral Minithoracotomy Aortic Valve Replacement.

Innovations (Phila) 2021 Apr 20:15569845211004265. Epub 2021 Apr 20.

14929 Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Germany.

Objective: An accepted landmark to assess feasibility of surgical aortic valve replacement (SAVR) via right anterolateral minithoracotomy (RALT) is the aortic-midpoint to right-sternal-edge distance. We aimed to evaluate single left lung positive-end-expiratory-pressure (SLL-PEEP) ventilation inducing an intraoperative rightward shift of the ascending aorta to improve exposure.

Methods: Nineteen patients with aortic stenosis undergoing SAVR via RALT were prospectively analyzed. Read More

View Article and Full-Text PDF

Efficacy and safety of Chinese herbal medicine Jianpi formulas for atopic dermatitis: Evidence from 11 randomized controlled trials.

J Cosmet Dermatol 2021 Apr 20. Epub 2021 Apr 20.

Nanjing University of Chinese Medicine, Nanjing, China.

Background: Jianpi formulas have been widely used to treat atopic dermatitis (AD) by traditional Chinese medicine (TCM) practitioners, but the efficacy and safety need further evaluation. A meta-analysis of randomized controlled trials was performed to assess the efficacy and tolerability of Jianpi formulas for AD.

Methods: We searched the following databases up to Oct 2020: Pubmed, Embase, China National Knowledge Infrastructure database (CNKI), and Wanfang database. Read More

View Article and Full-Text PDF

Delayed intracranial hemorrhage after mild traumatic brain injury in patients on oral anticoagulants: is the juice worth the squeeze?

Eur Rev Med Pharmacol Sci 2021 Apr;25(7):3066-3073

Emergency Medicine, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.

Objective: Mild Traumatic Brain Injury (MTBI) in anticoagulated patients is a common challenge for Emergency Department (ED) Physicians. Anticoagulation is considered a risk factor for developing delayed intracranial hemorrhage (ICH) after MTBI. The occurrence of this event in patients on Vitamin K Antagonists (VKA) or Direct Oral Anticoagulants (DOACs) remains unclear. Read More

View Article and Full-Text PDF

Lenvatinib in combination with transarterial chemoembolization for treatment of unresectable hepatocellular carcinoma (uHCC): a retrospective controlled study.

Hepatol Int 2021 Apr 20. Epub 2021 Apr 20.

Department II of Interventional Radiology, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.

Purpose: To compare the efficacy and safety of combined treatment with lenvatinib and transarterial chemoembolization (TACE) versus TACE only in patients with unresectable hepatocellular carcinoma (uHCC).

Methods: Of the 120 patients enrolled in this study, 60 patients received treatment with TACE only, and 60 patients received TACE plus lenvatinib. We retrospectively compared the clinical outcomes including overall survival (OS), progression-free survival (PFS), and tumor response between the two groups. Read More

View Article and Full-Text PDF

[EMA approval procedures and assessment of innovation by AIFA: a cross sectional analysis.]

Authors:
Ruggero Lasala

Recenti Prog Med 2021 Apr;112(4):273-284

Farmacia PO Corato, ASL Bari.

Introduction: Innovativeness of medicines is a much debated topic: the Italian Medicines Agency (AIFA) has established criteria according to which new medicines are classified as innovative, while European Medicine Agency (EMA) has established, for medicines of major interest for public health, accelerated assessment procedures to allow faster availability of drugs for patients. The aim of this study is to evaluate the association between the AIFA innovation requirement and the marketing authorization procedures by EMA.

Materials And Methods: All the medicines for which AIFA has produced an innovation evaluation report were considered, for these same drugs were extracted, from the EMA website, data on: "accelerated assessment", "orphan medicines", "conditional marketing" and authorizations "under exceptional circumstances". Read More

View Article and Full-Text PDF

Study Designs: Diagnostic Studies.

Indian Pediatr 2021 Apr 20. Epub 2021 Apr 20.

Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Dr Rakesh Lodha, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110 029, India.

Diagnostic tests are evolving with betterment of technology, quest for patient safety with less invasive medicine, and evolution of new diseases. It is important to assess diagnostic accuracy of a new test, and clinical impact of introduction of new test on outcomes and cost. A diagnostic study is planned for the index test based on place of new test in diagnostic pathway (screening, triage, diagnostic or add-on test) and established information of the test. Read More

View Article and Full-Text PDF

Management of Osteoarthritis: Expert Opinion on NSAIDs.

Pain Ther 2021 Apr 19. Epub 2021 Apr 19.

Department of Medical Biotechnology and Translational Medicine, Università degli Studi di Milano, Via Vanvitelli, 32, 20133, Milan, Italy.

Osteoarthritis (OA) is a leading cause of disability among older adults worldwide. Treatment aims are to alleviate inflammatory pain and improve physical function through non-pharmacological and pharmacological interventions. Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line therapy. Read More

View Article and Full-Text PDF

Interventional radiologists have a higher rate of chromosomal damage due to occupational radiation exposure: a dicentric chromosome assay.

Eur Radiol 2021 Apr 19. Epub 2021 Apr 19.

Laboratory of Biological Dosimetry, National Radiation Emergency Medical Center, Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea.

Objectives: There are growing concerns regarding radiation exposure in medical workers who perform interventional fluoroscopy procedures. Owing to the nature of certain interventional procedures, workers may be subjected to partial-body radiation exposure that is high enough to cause local damage. We aimed to investigate the level of radiation exposure in interventional radiologists in South Korea by performing cytogenetic biodosimetry, particularly focusing on partial-body exposure. Read More

View Article and Full-Text PDF

Clinical performance of presbyopia correction with a multifocal corneoscleral lens.

Int J Ophthalmol 2021 18;14(4):529-535. Epub 2021 Apr 18.

Department of Ophthalmology, Dong-A University College of Medicine, Busan 49201, Republic of Korea.

Aim: To assess the clinical performance of a multifocal corneoscleral lens for the presbyopia correction.

Methods: A prospective clinical trial of the Onefit™ A multifocal corneoscleral lens was conducted with 40 participants with presbyopia. At 4wk of continuous wear of the corneoscleral lens, changes in the distance, intermediate, and near visual acuity (VA) were evaluated. Read More

View Article and Full-Text PDF

One-year results of a clinical trial of olipudase alfa enzyme replacement therapy in pediatric patients with acid sphingomyelinase deficiency.

Genet Med 2021 Apr 19. Epub 2021 Apr 19.

Sanofi, Bridgewater, NJ, USA.

Purpose: To assess olipudase alfa enzyme replacement therapy for non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in children.

Methods: This phase 1/2, international, multicenter, open-label trial (ASCEND-Peds/NCT02292654) administered intravenous olipudase alfa every 2 weeks with intrapatient dose escalation to 3 mg/kg. Primary outcome was safety through week 64. Read More

View Article and Full-Text PDF

The effectiveness of interruptive prescribing alerts in ambulatory CPOE to change prescriber behaviour & improve safety.

BMJ Qual Saf 2021 Apr 19. Epub 2021 Apr 19.

Department of Internal Medicine, The University of Oklahoma School of Community Medicine, Tulsa, Oklahoma, USA

Background: Prescribing alerts of an electronic health record are meant to be protective, but often are disruptive to providers. Our goal was to assess the effectiveness of interruptive medication-prescriber alerts in changing prescriber behaviour and improving patient outcomes in ambulatory care settings via computerised provider order entry (CPOE) systems.

Methods: A standardised search strategy was developed and applied to the following key bibliographical databases: PubMed, Embase, CINAHL and The Cochrane Library. Read More

View Article and Full-Text PDF

Clinical and Neuroimaging Outcomes of Direct Thrombectomy vs Bridging Therapy in Large Vessel Occlusion: Analysis of the SELECT Cohort Study.

Neurology 2021 Apr 19. Epub 2021 Apr 19.

The University of Tennessee Health Science Center, Memphis, USA.

Objective: To evaluate the comparative safety and efficacy of direct endovascular thrombectomy(dEVT) compared to bridging therapy(BT:IV-tPA+EVT) and assess if BT potential benefit relates to stroke severity, size and initial presentation to EVT vs. non-EVT center.

Methods: In a prospective multicenter cohort-study of imaging selection for endovascular thrombectomy[SELECT], anterior-circulation large vessel occlusion (LVO) patients presenting to EVT-capable centers within 4. Read More

View Article and Full-Text PDF

Glucagon-Like Peptide 1 Receptor Agonists and Chronic Lower Respiratory Disease Exacerbations Among Patients With Type 2 Diabetes.

Diabetes Care 2021 Apr 19. Epub 2021 Apr 19.

Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Florida, Gainesville, FL.

Objective: Emerging data from animal and human pilot studies suggest potential benefits of glucagon-like peptide 1 receptor agonists (GLP-1RA) on lung function. We aimed to assess the association of GLP-1RA and chronic lower respiratory disease (CLRD) exacerbation in a population with comorbid type 2 diabetes (T2D) and CLRD.

Research Design And Methods: A new-user active-comparator analysis was conducted with use of a national claims database of beneficiaries with employer-sponsored health insurance spanning 2005-2017. Read More

View Article and Full-Text PDF

Hunted game birds - Carriers of foodborne pathogens.

Food Microbiol 2021 Sep 19;98:103768. Epub 2021 Feb 19.

Department of Food Hygiene and Environmental Health, Faculty of Veterinary Medicine, University of Helsinki, Finland.

Game birds may carry zoonotic bacteria in their intestines and transmit them to hunters through bird handling or through the handling and consumption of contaminated meat. In this study, the prevalence of foodborne bacteria was screened from game bird faeces and mallard breast meat using PCR. The sampling occurred in southern Finland from August to December during the hunting season. Read More

View Article and Full-Text PDF
September 2021

Effect of Secondary Tasks on Police Officer Cognitive Workload and Performance Under Normal and Pursuit Driving Situations.

Hum Factors 2021 Apr 19:187208211010956. Epub 2021 Apr 19.

14736 Texas A&M University, USA.

Objective: The objective of this study was to assess the effects of single and multiple secondary tasks on officers' performance and cognitive workload under normal and pursuit driving conditions.

Background: Motor vehicle crashes are a leading cause of police line of duty injuries and deaths. These crashes are mainly attributed to the use of in-vehicle technologies and multi-tasking while driving. Read More

View Article and Full-Text PDF

EXPRESS: Health economic evaluations of medical tests: translating laboratory information into value- a case study example.

Ann Clin Biochem 2021 Apr 19:45632211013852. Epub 2021 Apr 19.

Drajon Health, Perth, Western Australia, Australia.

Healthcare providers and funders are focused on identifying value in all their services and that includes laboratories. This means that in order to gain a share of scarce resources laboratory professionals must also understand and assess the value of tests and that includes their economic impact. This can be assessed using health economic modelling tools which, when used in conjunction with a detailed value proposition for the test, can translate laboratory information into value. Read More

View Article and Full-Text PDF

Variation in xylem structure and function in stems and roots of trees to 20 m depth.

New Phytol 2004 Sep;163(3):507-517

Department of Biology, Duke University, Durham, NC 27708, USA.

•  To assess hydraulic architecture and limitations to water transport across whole trees, we compared xylem anatomy, vulnerability to cavitation (Ψ ) and specific hydraulic conductivity (K ) of stems, shallow roots and deep roots (from caves to 20 m depth) for four species: Juniperus ashei, Bumelia lanuginosa, Quercus fusiformis and Quercus sinuata. •  Mean, maximum and hydraulically weighted (D ) conduit diameters and K were largest in deep roots, intermediate in shallow roots, and smallest in stems (P < 0.05 for each). Read More

View Article and Full-Text PDF
September 2004

Using SHRP2 NDS data to examine infrastructure and other factors contributing to older driver crashes during left turns at signalized intersections.

Accid Anal Prev 2021 Apr 16;156:106141. Epub 2021 Apr 16.

Department of Civil & Environmental Engineering, University of Massachusetts Amherst, 214 Marston Hall, 130 Natural Resources Road, Amherst, MA, 01003, USA.

Drivers age 65 and over have higher rates of crashes and crash-related fatalities than other adult drivers and are especially over-represented in crashes during left turns at intersections. This research investigated the use of SHRP2 Naturalistic Driving Study (NDS) data to assess infrastructure and other factors contributing to left turn crashes at signalized intersections, and how to improve older driver safety during such turns. NDS data for trips involving signalized intersections and crash or near-crash events were obtained for two driver age groups: drivers age 65 and over (older drivers) and a sample of drivers age 30-49, along with NDS pre-screening and questionnaire data. Read More

View Article and Full-Text PDF

Single center experience of inferior vena cava filter retrieval in trauma patients: contrast-enhanced CT-based retrieval within hospital stay.

Clin Imaging 2021 Apr 13;79:43-47. Epub 2021 Apr 13.

Department of Orthopedic Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea. Electronic address:

Purpose: To assess the safety and retrieval rate of a predischarge inferior vena cava (IVC) filter retrieval strategy based on contrast computed tomography (CT).

Methods: IVC filter insertion for trauma patients from 2010 to 2018 were reviewed. An active filter retrieval strategy was established in March 2017. Read More

View Article and Full-Text PDF

Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial.

Lancet Respir Med 2021 Apr 16. Epub 2021 Apr 16.

Department of ENT, Guy's Hospital, London, UK; St Thomas' Hospital, King's College London, London, UK.

Background: Chronic rhinosinusitis with nasal polyps affects approximately 2-4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps.

Methods: SYNAPSE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done at 93 centres, mainly hospitals, in 11 countries. Read More

View Article and Full-Text PDF

Pathological characteristics of the large renal mass: potential implication for clinical role of renal biopsy.

Can J Urol 2021 Apr;28(2):10620-10624

Fox Chase Cancer Center, Temple University, Philadelphia, Pennsylvania, USA.

Introduction: To assess whether patients with a large renal mass, treated by radical nephrectomy (RN), could have benefited from preoperative renal mass biopsy (RMB). The decision to perform partial nephrectomy (PN) for an organ-confined > 4 cm renal mass can be complex. Albeit often feasible, oncologic safety of PN in this cohort is debated. Read More

View Article and Full-Text PDF

Preoperative oral antibiotics with vs without mechanical bowel preparation to reduce surgical site infections following colonic resection: protocol for an International randomized controlled trial (ORALEV2).

Colorectal Dis 2021 Apr 19. Epub 2021 Apr 19.

Colorectal Surgery Unit, University Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.

Aim: Surgical site infections (SSI) are common after colonic surgery. SSI can cause relevant morbidity and increase costs of care. Preoperative oral antibiotics can reduce the incidence of SSI after resection of the colon, but the role of mechanical bowel preparation (MBP) is debated. Read More

View Article and Full-Text PDF

Progestogens for preventing miscarriage: a network meta-analysis.

Cochrane Database Syst Rev 2021 Apr 19;4:CD013792. Epub 2021 Apr 19.

Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health Research, University of Birmingham, Birmingham, UK.

Background: Miscarriage, defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, is common with approximately 25% of women experiencing a miscarriage in their lifetime, and 15% to 20% of pregnancies ending in a miscarriage. Progesterone has an important role in maintaining a pregnancy, and supplementation with different progestogens in early pregnancy has been attempted to rescue a pregnancy in women with early pregnancy bleeding (threatened miscarriage), and to prevent miscarriages in asymptomatic women who have a history of three or more previous miscarriages (recurrent miscarriage).

Objectives: To estimate the relative effectiveness and safety profiles for the different progestogen treatments for threatened and recurrent miscarriage, and provide rankings of the available treatments according to their effectiveness, safety, and side-effect profile. Read More

View Article and Full-Text PDF

Association of US Food and Drug Administration Removal of Indications for Use of Oral Quinolones With Prescribing Trends.

JAMA Intern Med 2021 Apr 19. Epub 2021 Apr 19.

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville.

Importance: In May 2016, due to concerns of the risks outweighing the benefits, the US Food and Drug Administration (FDA) removed systemic quinolones' indications for acute, uncomplicated urinary tract infection (uUTI), acute sinusitis (AS), and acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). How the change influenced oral quinolone use is unknown.

Objective: To assess the association of oral quinolone safety warnings and indication restrictions with use. Read More

View Article and Full-Text PDF

Development of the Benefit-Risk Assessment of Complementary and Alternative Medicine Use in People With Diabetes: A Delphi-Analytic Hierarchy Process Approach.

Comput Inform Nurs 2021 Apr 16. Epub 2021 Apr 16.

Author Affiliations: School of Nursing (Dr Chang) and Department of Health-Business Administration, Fooyin University, Kaohsiung (Dr Lo); and Department of Medicine, Tao-Yuan General Hospital, Taoyuan (Dr Chang), Taiwan.

This study aimed to develop consensus on a decision-making algorithm for benefit-risk assessment of complementary and alternative medicine use in people with diabetes. Delphi-analytic hierarchy process was used with an anonymous voting scheme, based on a three-round procedure, to achieve consensus regarding the important criteria of decision-making algorithm to assess the benefit-risk ratio of complementary and alternative medicine use in people with diabetes. A total of five criteria were considered, namely, the safety of usage (weightage: 46. Read More

View Article and Full-Text PDF

Education and training for preventing sharps injuries and splash exposures in healthcare workers.

Cochrane Database Syst Rev 2021 Apr 14;4:CD012060. Epub 2021 Apr 14.

University of Helsinki, Helsinki, Finland.

Background: In healthcare settings, health care workers (HCWs) are at risk of acquiring infectious diseases through sharps injuries and splash exposures to blood or bodily fluids. Education and training interventions are widely used to protect workers' health and safety and to prevent sharps injuries. In certain countries, they are part of obligatory professional development for HCWs. Read More

View Article and Full-Text PDF

RBD-specific polyclonal F(ab´) fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial.

EClinicalMedicine 2021 Apr 11:100843. Epub 2021 Apr 11.

Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Argentina.

Background: passive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of scalable neutralizing antibodies against SARS-CoV-2.

Methods: we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Read More

View Article and Full-Text PDF