51,467 results match your criteria safety long-term


Prognostic factors in patients with advanced non-small cell lung cancer after long-term Anti-PD-1 therapy (HOT1902).

Lung Cancer 2021 Apr 15;156:12-19. Epub 2021 Apr 15.

Department of Respiratory Medicine, KKR Sapporo Medical Center, Sapporo, Japan.

Objectives: Limited information is available on the appropriate treatment duration of immune checkpoint inhibitors (ICIs). We aimed to identify candidates who would benefit from ICI discontinuation after one year of treatment for metastatic non-small cell lung cancer (NSCLC).

Materials And Methods: This retrospective multi-institutional observational study examined medical records of all consecutive patients with advanced or recurrent NSCLC, who started ICI monotherapy at 15 institutions in Japan between December 2015 and December 2017. Read More

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Stereoelectroencephalography-guided radiofrequency thermocoagulation for hypothalamic hamartoma: Electroclinical patterns and the relationship with surgical prognosis.

Epilepsy Behav 2021 Apr 16;118:107957. Epub 2021 Apr 16.

Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Department of Stereotactic and Functional Neurosurgery, Beijing Neurosurgical Institute, Beijing, China. Electronic address:

Background: Radiofrequency thermocoagulation (RFTC) guided by stereo-electroencephalography (SEEG) has been proved to be a safe method to reduce seizure frequency in patients with drug-resistant epilepsy. However, there are few reports addressing the value and safety of this procedure in hypothalamic hamartoma (HH).

Objective: To present the results of our experience using SEEG-guided RFTC in HH patients with drug-resistant epilepsy, and identify outcome predictors. Read More

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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

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The clinical applications of five-alpha reductase inhibitors.

Authors:
Kevin R Loughlin

Can J Urol 2021 Apr;28(2):10584-10588

Harvard Medical School, Vascular Biology Laboratory, Boston Children's Hospital, Boston, Massachusetts, USA.

INTRODUCTION Five-alpha reductase (5-AR) deficiency was first identified by Imperato-McGinley and Walsh as the cause of pseudohermaphroditism in two separate studies. The discoveries led to the development of finasteride (inhibitor of type 2 isoenzyme of 5-AR) and dutasteride (inhibitor of type 1 and type 2 isoenzymes of 5-AR. Both drugs have been proven effective for the treatment of benign prostatic hyperplasia and improve voiding symptoms, reduce the risk of urinary retention and the need for prostate surgery. Read More

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Storage of Carbon Dioxide in Saline Aquifers: Physicochemical Processes, Key Constraints, and Scale-Up Potential.

Annu Rev Chem Biomol Eng 2021 Apr 19. Epub 2021 Apr 19.

Equinor Research Center, 7053 Trondheim, Norway; email:

CO storage in saline aquifers offers a realistic means of achieving globally significant reductions in greenhouse gas emissions at the scale of billions of tonnes per year. We review insights into the processes involved using well-documented industrial-scale projects, supported by a range of laboratory analyses, field studies, and flow simulations. The main topics we address are () the significant physicochemical processes, () the factors limiting CO storage capacity, and () the requirements for global scale-up. Read More

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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

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High willingness to vaccinate against COVID-19 despite safety concerns: a Twitter poll analysis on public health opinion.

J Med Internet Res 2021 Apr 17. Epub 2021 Apr 17.

Ludwig Boltzmann Institute Digital Health and Patient Safety, Medical University of Vienna, Spitalgasse 23, Vienna, AT.

Background: On the 30th of January 2020, the WHO's Emergency Committee declared the rapid worldwide spread of COVID-19, a global health emergency. Since then tireless efforts have been made to mitigate the spread of the disease and its impact, mostly relying on non-pharmaceutical interventions. By December 2020, the safety and efficacy of the first COVID-19 vaccines have been demonstrated. Read More

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Stimulant treatment effectiveness, safety and risk for psychosis in individuals with 22q11.2 deletion syndrome.

Eur Child Adolesc Psychiatry 2021 Apr 19. Epub 2021 Apr 19.

Child Psychiatry Division, Edmond and Lily Safra Children's Hospital, Sheba Medical Center, 5262000, Tel Hashmoer, Israel.

This study aimed to retrospectively evaluate an association between stimulant treatment for attention-deficit/hyperactivity disorder (ADHD) in individuals with 22q11.2DS and the development of psychotic disorders, to evaluate long-term effectiveness and safety of stimulant treatment in individuals with 22q11.2DS compared to individuals with idiopathic ADHD, and to explore effects of catechol-O-methyltransferase (COMT) genotype on 22q11. Read More

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Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors.

Rheumatology (Oxford) 2021 Apr 19. Epub 2021 Apr 19.

Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany.

Objective: To evaluate long-term safety and efficacy of sarilumab over 5 years in patients with RA refractory to TNF inhibitors (TNFi).

Methods: Patients in the 24-week randomized controlled trial (RCT) TARGET (NCT01709578) whoreceived double-blind placebo or sarilumab 150 or 200 mg every 2 weeks (q2w), plus conventionalsynthetic DMARDs (csDMARDs), were eligible to receive open-label sarilumab 200 mg q2w pluscsDMARDs in the open-label extension (OLE), EXTEND (NCT01146652). OLE dose reduction to 150 mg q2w was permitted per investigators' judgement or protocol-mandated safety concerns. Read More

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Safety issues in endoscopy ultrasound-guided interventions using lumen apposing metal stents: a review of the literature.

Minerva Gastroenterol (Torino) 2021 Apr 19. Epub 2021 Apr 19.

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy -

Lumen-apposing metal stents (LAMS) are recently introduced devices that allow to create anastomoses. The indications for LAMS placement are increasing and currently these stents can be used in multiple clinical situations such as endoscopic drainage of pancreatic fluid collections (PFCs), endoscopic ultrasound-guided choledocho-duodenostomy (EUS-CDS), endoscopic ultrasound gallbladder drainage (EUS-GBD), endoscopic ultrasound gastrojejunostomy (EUS-GJ). Since their introduction, they have revealed to allow a higher rate of technical and clinical success, and potentially lower risk of adverse events (AEs) compared with previously available devices. Read More

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Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev 2021 Apr 19;4:CD011535. Epub 2021 Apr 19.

Department of Dermatology, Hôpital Henri Mondor, Créteil, France.

Background: Psoriasis is an immune-mediated disease for which some people have a genetic predisposition. The condition manifests in inflammatory effects on either the skin or joints, or both, and it has a major impact on quality of life. Although there is currently no cure for psoriasis, various treatment strategies allow sustained control of disease signs and symptoms. Read More

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Efficacy and safety of supplemental melatonin for delayed sleep-wake phase disorder in children: an overview.

Sleep Med X 2020 Dec 19;2:100022. Epub 2020 Aug 19.

Utrecht Institute for Pharmaceutical Sciences (UIPS), Department of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, and Faculty of Veterinary Medicine, Pharmacy Department Utrecht University, Utrecht, The Netherlands.

Delayed sleep-wake phase disorder (DSPD) is the most frequently occurring intrinsic circadian rhythm sleep-wake disorder, with the highest prevalence in adolescence. Melatonin is the first-choice drug treatment. However, to date melatonin (in a controlled-release formulation) is only authorised for the treatment of insomnia in children with autism or Smiths-Magenis syndrome. Read More

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December 2020

Patient selection for hemophilia gene therapy: Real-life data from a single center.

Res Pract Thromb Haemost 2021 Mar 14;5(3):390-394. Epub 2021 Mar 14.

Hemostasis and Thrombosis Unit Division of Hematology Cliniques Universitaires Saint-Luc Université Catholique de Louvain (UCLouvain) Brussels Belgium.

Background: While the number of individuals with hemophilia who are expected to be or have already been included in gene therapy trials has been regularly reported, the number of unscreened or excluded individuals, in addition to the reasons for exclusion, is mostly not reported.

Methods: We conducted an eligibility assessment of all people with severe hemophilia for gene therapy trials in one large Belgian hemophilia treatment center based on patient selection criteria of gene therapy trials and patients' profiling.

Results: Among 87 adult patients with severe hemophilia A and B, 11 aged ≥65 years and two women were excluded from analysis. Read More

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Psychological pressure and changes in food consumption: the effect of COVID-19 crisis.

Heliyon 2021 Apr 29;7(4):e06607. Epub 2021 Mar 29.

Department of Veterinary Science for Health, Animal Production and Food Safety - University of Milan, "Carlo Cantoni" - VESPA, Italy.

In this paper, we investigate the short-term and long-term effects of the COVID-19 emergency on consumers' decision of changing dietary habit. We used a certified dataset reporting information about 456 Italian consumers during the lockdown in the first wave of the pandemic emergency (April 2020). The survey collected data about changes in food purchases, respondents' mood during the lockdown, conspiracist beliefs, exposure to the virus, and planned food purchasing behavior after the lockdown. Read More

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Scientific justifications for the political decision-making on environmental remediation carried out after the Fukushima nuclear accident.

Heliyon 2021 Mar 29;7(3):e06588. Epub 2021 Mar 29.

Graduate School of Energy Science, Kyoto University, Yoshidahonmachi, Sakyo-ku, Kyoto 606-8501, Japan.

The Japanese government decided to implement environmental remediation after the Fukushima Daiichi Nuclear Power Plant (termed "1F" in Japan) accident on 11th March 2011. As the initial additional annual dose target was set to be 1 mSv or less as a long-term goal, we examined the decision-making process undertaken by the then leaders, particularly the Minister of the Ministry of the Environment (MOE) who was responsible for the final decision. We found that technically based assessment of dose targets, health effects and risk-based approaches justified by scientific experts were not communicated to the then Minister and officials of the MOE before the remediation strategy was decided. Read More

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Improvement of HSV-1 based amplicon vectors for a safe and long-lasting gene therapy in non-replicating cells.

Mol Ther Methods Clin Dev 2021 Jun 29;21:399-412. Epub 2021 Mar 29.

Department of Neuroscience and Rehabilitation, Section of Pharmacology, University of Ferrara, 44121 Ferrara, Italy.

A key factor for developing gene therapy strategies for neurological disorders is the availability of suitable vectors. Currently, the most advanced are adeno-associated vectors that, while being safe and ensuring long-lasting transgene expression, have a very limited cargo capacity. In contrast, herpes simplex virus-based amplicon vectors can host huge amounts of foreign DNA, but concerns exist about their safety and ability to express transgenes long-term. Read More

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Prescribing Antibiotics in Rural China: The Influence of Capital on Clinical Realities.

Front Sociol 2020 4;5:66. Epub 2020 Sep 4.

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.

Primary care clinicians in rural China are required to balance their immediate duty of care to their patients with patient expectations for antibiotics, financial pressures, and their wider responsibilities to public health. The clinicians in our sample appear to make greater efforts in managing immediate clinical risks and personal reputation than in considering the long-term consequences of their actions as potentially contributing to antimicrobial resistance. This paper employs Bourdieu's theory of capital to examine the perspectives and practices of Chinese primary care clinicians prescribing antibiotics at low-level health facilities in rural Anhui province, China. Read More

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September 2020

Prevalence and Recovery from Newly Onset Anosmia and Ageusia in Covid 19 Patients at our Teritary Care Centre.

Indian J Otolaryngol Head Neck Surg 2021 Apr 10:1-8. Epub 2021 Apr 10.

Department of ENT, Vilasrao Deshmukh Government Institute of Medical Sciences, Latur, Maharashtra India.

Anosmia (loss of smell) and Ageusia (loss of taste) are newly presenting independent symptoms in association with multiple symptoms such as Fever, Dry cough and Breathlessness in COVID 19 Patients.The Study of aims is to estimate Prevalence of Anosmia & Ageusia in Confirmed Covid 19 cases and to assess their Recovery rates. A Study conducted between June 2020 and September 2020 at a tertiary care COVID Dedicated hospital. Read More

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Sub-chronic toxicity of ethanol leaf extract of on the biochemical parameters and histopathology of liver and kidney in the rats.

Toxicol Rep 2021 3;8:822-828. Epub 2021 Apr 3.

Department of Anatomy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.

Background: Wall. leaf is being used as a traditional medicine against hypertension and diabetes mellitus. Unlike its efficacy, the safety profile of this plant upon long-term administration has not been investigated yet. Read More

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Interspinous Process (ISP) Devices in Comparison to the Use of Traditional Posterior Spinal Instrumentation.

Cureus 2021 Mar 14;13(3):e13886. Epub 2021 Mar 14.

Neurosurgery, Hoag Memorial Hospital, Newport Beach, USA.

A systematic literature review was conducted on studies comparing interspinous process (ISP) devices to traditional methods of posterior spinal instrumentation (pedicle screw-rod construct), in terms of indications of use, complications, pain assessment, estimated blood loss, length of hospital stay, reoperation rates, and return to work. The objective was to analyze, evaluate and summarize the current published literature on the proposed efficacy and clinical and surgical long-term outcomes of the ISP device in comparison to the traditional posterior spinal instrumentation (pedicle screw-rod construct). The ISP device is a minimally invasive and less disruptive alternative to traditional methods of posterior spinal instrumentation (pedicle screw-rod construct). Read More

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Functionalized lipid nanoparticles for subcutaneous administration of mRNA to achieve systemic exposures of a therapeutic protein.

Mol Ther Nucleic Acids 2021 Jun 13;24:369-384. Epub 2021 Mar 13.

Oligonucleotide Discovery, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, 43183 Gothenburg, Sweden.

Lipid nanoparticles (LNPs) are the most clinically advanced delivery system for RNA-based drugs but have predominantly been investigated for intravenous and intramuscular administration. Subcutaneous administration opens the possibility of patient self-administration and hence long-term chronic treatment that could enable messenger RNA (mRNA) to be used as a novel modality for protein replacement or regenerative therapies. In this study, we show that subcutaneous administration of mRNA formulated within LNPs can result in measurable plasma exposure of a secreted protein. Read More

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Development and implementation of a potential coronavirus disease 2019 (COVID-19) vaccine: A systematic review and meta-analysis of vaccine clinical trials.

Nepal J Epidemiol 2021 Mar 31;11(1):959-982. Epub 2021 Mar 31.

Rumailah Hospital, Hamad Medical Corporation, Doha, Qatar.

Background: To date, there is no comprehensive systematic review and meta-analysis to assess the suitability of COVID-19 vaccines for mass immunization. The current systematic review and meta-analysis was conducted to evaluate the safety and immunogenicity of novel COVID-19 vaccine candidates under clinical trial evaluation and present a contemporary update on the development and implementation of a potential vaccines.

Methods: For this study PubMed, MEDLINE, and Embase electronic databases were used to search for eligible studies on the interface between novel coronavirus and vaccine design until December 31, 2020. Read More

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Dietary and behavior changes following rdn-led corporate wellness counseling: A secondary analysis.

Work 2021 Apr 14. Epub 2021 Apr 14.

Department of Public Health, University of North Florida, Jacksonville, FL, USA.

Background: Worksite wellness programs have the ability to activate health promotion and stimulate behavior change.

Objective: To measure longitudinal associations between visits with a Registered Dietitian Nutritionist (RDN), as part of worksite wellness programs, on dietary and lifestyle behavior changes.

Methods: The study sample included 1,123 employees with 77 different worksite wellness programs across the United States from March to December 2017. Read More

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[The use of anti-pollution masks in daily life - a review].

Authors:
D Charpin

Rev Mal Respir 2021 Apr 15. Epub 2021 Apr 15.

Association pour la prévention de la pollution atmosphérique - A.P.P.A., Aix-Marseille université, Marseille, France; Hôtel technologique, 45, rue Joliot-Curie, 13013 Marseille, France. Electronic address:

Introduction: "Anti-pollution" masks are a form of personal protective equipment intended to ensure filtration of ambient particulate air pollution.

State Of The Art: Although according to tests performed in the lab, their filtration power is high, the filtering efficiency of these masks in real conditions of use, that is to say, during physical effort, is generally lower than that established in the laboratory and this information is rarely available on commercial products on sale. Clinical studies, which are rarely double-blind, demonstrate a lower incidence of symptoms and a somewhat better cardiac performance when exercise is performed while wearing a mask. Read More

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An Update on the Available and Emerging Pharmacotherapy for adults with Testosterone Deficiency available in the USA.

Expert Opin Pharmacother 2021 Apr 19. Epub 2021 Apr 19.

Department of Urology, University of Miami Miller School of Medicine, Miami, FL, United States.

: Testosterone deficiency (TD) is defined as low serum testosterone associated with symptoms and signs. There is an increasing prevalence of TD in recent decades, especially in males aged 15-39. Many of these men will require long-term testosterone therapy (TT). Read More

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Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events.

Circ Heart Fail 2021 Apr 19:CIRCHEARTFAILURE120006912. Epub 2021 Apr 19.

Department of Thoracic and CV Surgery, Loyola University Medical Center, Maywood, IL (E.C.M.).

Background: The LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system.

Methods: AEs from the LATERAL trial were evaluated over 2 years postimplant. Read More

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Increased Risk of Congestive Heart Failure Following Carbon Monoxide Poisoning.

Circ Heart Fail 2021 Apr 19:CIRCHEARTFAILURE120007267. Epub 2021 Apr 19.

Department of Environmental and Occupational Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan (C.-C. Huang, T.-H.C., H.-R.G.).

Background: Carbon monoxide poisoning (COP) is an important public health issue around the world. It may increase the risk of myocardial injury, but the association between COP and congestive heart failure (CHF) remains unclear. We conducted a study incorporating data from epidemiological and animal studies to clarify this issue. Read More

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Renal Implications of Left Renal Vein Ligation for Portal Flow Augmentation in Liver Transplantation.

World J Surg 2021 Apr 17. Epub 2021 Apr 17.

The Institute of Liver Disease and Transplantation, Dr. Rela Institute and Medical Centre, Bharath Institute of Higher Education and Research, Chromepet, Chennai, 600044, India.

Background: Spontaneous lienorenal shunts (SLS) siphon blood away from the portal circulation and may compromise portal inflow in liver transplantation (LT). Performing a left renal vein ligation (LRVL) is a relatively easy and efficacious method of overcoming this portal 'steal'. However, given the delicate state of renal function in these patients, its short and long term effects remain undefined. Read More

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Cushing's disease: Does low-dose pasireotide offer a comparable efficacy and safety to high-dose?

Endocrinol Diabetes Metab Case Rep 2021 Feb 26;2021. Epub 2021 Feb 26.

Department of Diabetes and Endocrinology, Townsville University Hospital, Queensland, Australia.

Summary: Whilst literature is expanding on pasireotide use in the management of Cushing's disease (CD), there is still currently much unknown about long-term and low-dose pasireotide use in CD. We present a 60-year-old female with residual CD after transphenoidal surgery (TSS), being successfully managed with S.C. Read More

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February 2021