NEW! Information, resources, and support needed to approach rotations - and life as a resident. Paik S, Shak S, Tang G, et al. Original Article from The New England Journal of Medicine Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients The most trusted, influential source of new medical knowledge and clinical best practices in the world. Outcomes were assessed in time-to-event analyses. S2). NEW! The authorized source of trusted medical research and education for the Chinese-language medical community. For the one in nine hospitalized U.S. adults who have SUD, hospital-based addiction care has critical health benefits. Health worker burnout, exacerbated by Covid-19, is not only about long hours. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. 387 No. Lachin JM, Foulkes MA. Cancer Res 2017;78:Suppl:GS4-03-GS4-03. ), and Duke University Medical Center, Durham (J.A.O.) Women who participated in the trial provided written informed consent, including a statement of willingness to have treatment assigned or randomly assigned on the basis of the recurrence-score results. Both vaccines provided a high level of protection against severe Covid-19. NEW! The results of the as-treated analyses were consistent with those of the intention-to-treat analyses for invasive diseasefree survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.14; 95% CI, 0.99 to 1.31; P=0.06), freedom from recurrence of breast cancer at a distant site (hazard ratio for recurrence, 1.03; P=0.81), freedom from recurrence of breast cancer at a distant or localregional site (hazard ratio for recurrence, 1.12; P=0.28), and overall survival (hazard ratio for death, 0.97; P=0.78) (Fig. If the recurrence score was 10 or lower, the patient was assigned to receive endocrine therapy alone. Welcome to books on Oxford Academic | Journals | Oxford NEW! A causal relationship between any adverse event and administration of finerenone or placebo was based on the opinion of the reporting investigator. Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services. In our trial involving patients with type 2 diabetes and advanced CKD, finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. The incidences of the components were lower with finerenone than with placebo except for nonfatal stroke, which had a similar incidence in the two groups (Figure 2). The work at DukeNational University of Singapore was supported by grants (NRF2012NRFCRP001-056 and NRF2016NRF-NSFC002-013) from the National Research Foundation and by a grant (OFLCG19May-0034) from the National Medical Research Council, Singapore. Filter Hide Filters. Images in Clinical Medicine Oct 27, 2022 Necrotizing Myositis M. Arajo and I. M. Gonalves More from the week of July 27, 2017 On the basis of an absolute between-group difference of 3.4 percentage points (95% CI, 0.6 to 6.2) after 3 years, the number of patients who needed to be treated with finerenone to prevent one primary outcome event was 29 (95% CI, 16 to 166). The estimated 9-year rates of invasive diseasefree survival in the as-treated population were 83.1% for patients who received endocrine therapy alone and 84.7% for those who received chemoendocrine therapy. Applying an intersectional lens encompassing structural racism, reproductive injustice, and mental health makes it clear that the Dobbs decision will exacerbate health inequities. Health care workers in Israel were given a fourth dose of BNT162b2 or mRNA-1273 vaccine during a period of omicron-variant predominance. This symposium, held on April 21, 2020, with the Harvard T.H. Design and baseline characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease trial. 16. Diabetes Care 2020;43:Suppl 1:S135-S151. Tilt the patients head back slightly, so that the nasal passages become more accessible. 5. Recent trends in chemotherapy use and oncologists treatment recommendations for early-stage breast cancer. The incidence of the primary composite outcome of kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes was significantly lower in the finerenone group than in the placebo group, occurring in 504 patients (17.8%) and 600 patients (21.1%), respectively (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P=0.001) (Figure 1A and Figure 2). Sequential schlieren images during a cough, shown in a video, were recorded at 3000 frames per second. J Am Coll Cardiol 2020;75:422-434. 9. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Finerenone on Chronic Kidney Disease Outcomes in N Engl J Med 2004;351:2817-2826. These agents included sodium polystyrene sulfonate, calcium polystyrene sulfonate, and potassium-binding agents. NEW! 3. Open the collection tube and insert the swab into the tube. Effect of Colonoscopy Screening on Risks of Colorectal Cancer In this double-blind trial, we randomly assigned 5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive finerenone or placebo. Am J Nephrol 2019;50:333-344. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. The key secondary composite outcome, also assessed in a time-to-event analysis, was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Fleming G, Francis PA, Lng I, et al. 2. A small study assessed the neutralization of pseudoviruses composed of the recombinant deltacron and omicron BA.3 variants. A radiograph of the pelvis showed an irregularly shaped, radiopaque stone. Letters responding to this article are now published: Protection by a Fourth Dose of BNT162b2 against Omicron in Israel. Percentages may not total 100 because of rounding. Evidence supports a pathophysiological role for overactivation of the mineralocorticoid receptor in cardiorenal diseases, including CKD and diabetes, through inflammation and fibrosis that lead to progressive kidney and cardiovascular dysfunction.5-8 Although a meta-analysis showed a 31% reduction in urinary protein or albumin excretion after treatment with a steroidal mineralocorticoid receptor antagonist in patients with CKD, data on hard clinical outcomes are lacking.9 Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, had more potent antiinflammatory and antifibrotic effects than steroidal mineralocorticoid receptor antagonists in preclinical models.10-13 Finerenone has been shown to reduce the urinary albumin-to-creatinine ratio in patients with CKD treated with an RAS blocker, while having smaller effects on serum potassium levels than spironolactone.14,15 The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) trial was designed to test the hypothesis that finerenone slows CKD progression and reduces cardiovascular morbidity and mortality among patients with advanced CKD and type 2 diabetes. J Natl Cancer Inst 1997;89:1673-1682. 1. N Engl J Med 2016;375:717-729. A new equation to estimate glomerular filtration rate. Patients in the finerenone group also had a significantly lower risk of a key secondary outcome event (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure), which occurred in 367 patients (13.0%) in the finerenone group and 420 patients (14.8%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P=0.03) (Figure 2 and Fig. A study in Qatar assessed the effectiveness of previous infection, vaccination, and both against symptomatic SARS-CoV-2 caused by omicron BA.1 and BA.2 and against severe, critical, or fatal Covid-19. While hoping for the best, prepare for the worst by engaging in these five treatment simulations that mimic the real-life, unforgiving uncertainty of medicine. Two doses of the BNT162b2 vaccine were associated mainly with low-grade local adverse effects that lasted 2 days or less and afforded nearly 50% protection against omicron infection and symptomatic illness, which was lower than that seen against delta. Correspondence from The New England Journal of Medicine A Zoonotic Henipavirus in Febrile Patients in China The content of this site is intended for health care professionals. In this trial involving patients with chronic kidney disease, empagliflozin resulted in a lower risk of disease progression or death from cardiovascular causes than placebo. This event-driven trial was designed to have 90% power to detect a 20% lower risk of a primary outcome event with finerenone than with placebo, on the basis of 1068 patients with a primary outcome event. The trial consisted of run-in, screening, and double-blind treatment periods (Fig. No other potential conflict of interest relevant to this article was reported. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. The first draft of the manuscript was prepared by the first author and was reviewed and edited by all the authors. NEW! Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry. Articles Figures/Multimedia. Early Transmission Dynamics in Wuhan, China Medical writing assistance was funded by Bayer. In this study, neutralization against the SARS-CoV-2 omicron subvariants was reduced with both the inactivated and ZF2001 vaccines. S5). S12 and S13 in the Supplementary Appendix) but not for freedom of recurrence of breast cancer at a distant site or distant or localregional site. Additional statistical methods are described in the Supplementary Appendix. Welcome to books on Oxford Academic. Gliflozins sodiumglucose cotransporter 2 inhibitors lower blood glucose and glycated hemoglobin in patients with type 2 diabetes without causing hypoglycemia. The characteristics of the trial population that was included in the main analysis are shown in Table 1, and in Table S1 in the Supplementary Appendix. Treatment effects are expressed as hazard ratios with corresponding confidence intervals from stratified Cox proportional-hazards models. In the intention-to-treat population, endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive diseasefree survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval [CI], 0.94 to 1.24; P=0.26) (Figure 2A). N Engl J Med 2013;369:1892-1903. 15. ), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) Efficacy of adjuvant chemotherapy in high-risk node-negative breast cancer: an intergroup study. The outcomes were unlikely to have been affected by incomplete follow-up information (Section 6E in the Supplementary Appendix). Original Article from The New England Journal of Medicine PD-1 Blockade in Mismatch RepairDeficient, Locally Advanced Rectal Cancer Breast Cancer 2001;8:298-304. A total of 14 patients were not treated with either an ACE inhibitor or an angiotensin-receptor blocker at baseline; 7 patients received treatment with both an ACE inhibitor and an angiotensin-receptor blocker. In our trial, which combined a single RAS blocker with a drug, finerenone, targeting the mineralocorticoid receptor, patients in the finerenone and placebo groups had a similar risk of acute kidney injuryrelated adverse events. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. Finerenone, a novel selective nonsteroidal mineralocorticoid receptor antagonist protects from rat cardiorenal injury. Requiring new, well-designed warning labels on alcohol containers could provide information to consumers and reduce harm. 28. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. The final analysis took place on March 2, 2018, at which time the prespecified number of events required for full information (835 events) had occurred. In persons who had received the BNT162b2 vaccine in Qatar, the incidence of infection with the omicron variant after 35 days of observation was 2.4% among those who had received three doses and 4.5% among those who were vaccinated but not boosted; among those who had received the mRNA-1273 vaccine, the incidence was 1.0% with a boost and 1.9% without. In a randomized, placebo-controlled trial, patients with acute decompensated heart failure and volume overload who received intravenous acetazolamide plus a loop diuretic had a higher incidence of decongestion. Glycated hemoglobin levels (Fig. The stratification factors that were used in randomization were tumor size (2 cm vs. >2 cm), menopausal status (pre- vs. postmenopausal), planned chemotherapy (taxane-containing vs. not), planned radiation therapy (whole breast and no boost irradiation planned vs. whole breast and boost irradiation planned vs. partial breast irradiation planned vs. no planned radiation therapy for patients who had undergone a mastectomy), and recurrence-score group (11 to 15 vs. 16 to 20 vs. 21 to 25), which was added midway through the trial. Collection of specimens from the surface of the respiratory mucosa with nasopharyngeal swabs is a procedure used for the diagnosis of Covid-19 in adults and children.1-4 The procedure is also commonly used to evaluate patients with suspected respiratory infection caused by other viruses and some bacteria. Insert the swab into the nostril, parallel to the palate. Acute upper gastrointestinal bleeding is a common emergency condition associated with high morbidity and mortality. Finerenone on Chronic Kidney Disease Outcomes in Gently insert the swab along the nasal septum, just above the floor of the nasal passage, to the nasopharynx, until resistance is felt (Figure 3). Information and tools for librarians about site license offerings. Disclosure forms provided by the authors are available with the full text of this video at NEJM.org. In this double-blind, randomized, placebo-controlled trial, ivermectin that was administered within 7 days after Covid-19 symptom onset was shown not to be of any clinical benefit. Only the 1000 most recent citing articles are listed here. New England Journal of Medicine Put on a new pair of gloves, and then remove your face shield and either dispose of it or clean and store it in accordance with the guidelines at your institution. J Natl Cancer Inst 2009;101:1446-1452. Eur Heart J (in press). 8. On the basis of previous information regarding the clinical validity and usefulness of the 21-gene assay, the use of adjuvant chemotherapy has declined substantially in hormone-receptorpositive, HER2-negative, axillary nodenegative breast cancer.32 The results of our trial suggest that the 21-gene assay may identify up to 85% of women with early breast cancer who can be spared adjuvant chemotherapy, especially those who are older than 50 years of age and have a recurrence score of 25 or lower, as well as women 50 years of age or younger with a recurrence score of 15 or lower. 12. This article reports the efficacy of the fourth dose among Israeli citizens 60 years of age or older. NEW! An Oncotype DX recurrence-score assay was performed in a central laboratory (Genomic Health) on samples obtained from every woman who participated in the trial.10 Additional details are provided in the Supplementary Appendix and the protocol, both of which are available with the full text of this article at NEJM.org. Chan School of Public Health and NEJM, presents a timely conversation with public health leaders on Covid-19 and collective next steps, from securing crucial supplies to hopes for treatments and vaccines and the lifting of restrictions. Original Article from The New England Journal of Medicine Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke A Zoonotic Henipavirus in Febrile Patients in China | NEJM Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. 70-Gene signature as an aid to treatment decisions in early-stage breast cancer. Valuable tools for building a rewarding career in health care. Stemmer SM, Steiner M, Rizel S, et al. N Engl J Med 2015;373:2005-2014. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. Eligible patients were then randomly assigned in a 1:1 ratio to receive oral finerenone or placebo; patients with an eGFR of 25 to less than 60 ml per minute per 1.73 m2 at the screening visit received an initial dose of 10 mg once daily, and those with an eGFR of 60 ml per minute per 1.73 m2 or more at the screening visit received an initial dose of 20 mg once daily. 22. A diagnostic test was performed. From September 2015 through June 2018, a total of 13,911 patients in 48 countries underwent screening, and 5734 patients underwent randomization (Fig. However, clinicians should be cautious if the patient has had recent nasal trauma or surgery, has a markedly deviated nasal septum, or has a history of chronically blocked nasal passages or severe coagulopathy. Effect of systemic adjuvant treatment on risk for contralateral breast cancer in the Womens Environment, Cancer and Radiation Epidemiology Study. The most advanced way to teach, practice, and assess clinical reasoning skills. ); Cancer Trials Ireland, Dublin (M.M.K. Data from Singapore on BNT162b2 vaccination in children 5 to 11 years of age showed that during a period of omicron-variant predominance, BNT162b2 reduced the risks of SARS-CoV-2 infection and Covid-19related hospitalization. and University of Pittsburgh (A.M.B. Adult influenza vaccination rates decreased in states with below-average Covid-19 vaccination rates, a finding that raises the possibility that mistrust in Covid-19 vaccines adversely affected influenza vaccination. Goetz and Kaklamani; Dr. Paik reports holding a patent issued and licensed to Genomic Health, with all rights transferred to the National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation. Previous kidney-outcome trials that involved patients with CKD and type 2 diabetes targeting dual RAS blockade have shown a lack of efficacy and increased risk (including increased incidences of acute kidney injury, hypotension, and hyperkalemia)20-22; such adverse events may be due to the inhibition of two proximal targets in the RAS cascade. Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkins Lymphoma, Early Amino Acids in Extremely Preterm Infants and Neurodisability at 2 Years, Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression, https://medlineplus.gov/ency/article/003747.htm, https://apps.who.int/iris/bitstream/handle/10665/331329/WHO-COVID-19-laboratory-2020.4-eng.pdf, https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html, Prone Positioning of Intubated Patients with an Elevated Body-Mass Index, Use of eFAST in Patients with Injury to the Thorax or Abdomen, Placement of a Double-Lumen Endotracheal Tube, Nasal Cauterization with Silver Nitrate for Recurrent Epistaxis, NEJM Catalyst Innovations in Care Delivery. Early Breast Cancer Trialists Collaborative Group (EBCTCG). All eGFR outcome events required confirmation with a second consecutive central laboratory measurement at least 4 weeks after the initial measurement. Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m2 of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m2. Third, the primary outcomes differed: there was a kidney-specific composite in our trial and a cardiorenal composite in the CREDENCE trial. Outpatients with Covid-19 were followed serially with frequent PCR and viral-culture assessments. But she is not OK. and Indiana University Hospital (G.W.S. *Plusminus values indicate means SD. Among the 14 patients for whom menopausal status was not reported, those who were 50 years of age or younger were classified as premenopausal. Hypertension 2017;69:870-878. *Plusminus values are means SD. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. It is important to use approved PPE and the appropriate technique to minimize the possibility of spreading the virus. Gritzfeld JF, Roberts P, Roche L, El Batrawy S, Gordon SB. By Topic. Kidney failure was defined as end-stage kidney disease or an eGFR of less than 15 ml per minute per 1.73 m2; end-stage kidney disease was defined as the initiation of long-term dialysis (for 90 days) or kidney transplantation. The mean adherence to the trial regimen (the percentage of administered doses relative to the number of planned doses) was 92.1% in the finerenone group and 92.6% in the placebo group, and the mean daily dose was 15.1 mg and 16.5 mg in the respective groups. Neutralizing autoantibodies to interleukin-1 receptor antagonist were present in the circulation of the majority of patients with biopsy-confirmed myocarditis after SARS-CoV-2 vaccination. J Clin Oncol 2017;35:2838-2847. NEW! In the present trial, patients with CKD and type 2 diabetes who received finerenone had a lower risk of a primary outcome event (kidney failure, a sustained decrease of 40% in the eGFR from baseline, or death from renal causes) than those who received placebo. The key secondary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. This video captures the emission of a sneeze cloud. 4. Left Atrial Appendage Occlusion during Cardiac Surgery to 23. Books from Oxford Scholarship Online, Oxford Handbooks Online, Oxford Medicine Online, Oxford Clinical Psychology, and Very Short Introductions, as well as the AMA Manual of Style, have all migrated to Oxford Academic.. Read more about books migrating to Oxford Academic.. You can now search across all these OUP At the end of the run-in period, patients were reassessed for eligibility. Defibrillation after Cardiac Arrest Is It Time to Change Practice? Close the labeled collection tube, wipe the tube with a surface-disinfectant wipe, and insert the tube into an open biohazard bag held by an assistant (Figure 4). Authors who reported serving as paid consultants for Genomic Health within 36 months before publication include Drs. The content of this site is intended for health care professionals. A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. Clinical Outcomes among Patients with a Recurrence Score of 11 to 25. Kidney Int 2019;96:302-319. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. DOI: 10.1056/NEJMc2202705. Local reactions were common but mild and transient. Showing 1-20 of 2174 results. NPJ Breast Cancer 2016;2:16017-16017. Additional details regarding these end points are provided in Figure S2 and Section 6B in the Supplementary Appendix. Sign In or Create Account to save this article, Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension, Progression of Atrial Fibrillation after Cryoablation or Drug Therapy, Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia, Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease, Duration of Device-Based Fever Prevention after Cardiac Arrest. More than 80% of vaccine recipients had local or systemic adverse effects, which were generally mild and short-lived. Valuable tools for building a rewarding career in health care. Obtaining the Nasopharyngeal Swab Specimen. ), QUICK TAKE21-Gene Expression Assay in Breast Cancer01:42. It was a prospective clinical trial, a type of trial that provides the highest level of evidence supporting the clinical usefulness of a biomarker.17 Another objective of the trial was to prospectively confirm that a low recurrence score of 0 to 10 is associated with a low rate of distant recurrence when patients are treated with endocrine therapy alone.18. 20. From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B. Selective mineralocorticoid receptor cofactor modulation as molecular basis for finerenones antifibrotic activity. Handb Exp Pharmacol 2017;243:271-305. The New England Journal of Medicine Latest in Emergency Medicine. May 28, 2020N Engl J Med 2020; 382:e76 PD-1 Blockade in Mismatch RepairDeficient, Locally Advanced J Clin Oncol 2008;26:721-728. The authorized source of trusted medical research and education for the Chinese-language medical community. Additional details on efficacy and safety analyses are provided in the trial protocol and the statistical analysis plan. NEW! The New England Journal of Medicine remove ureteral or contralateral stones resulted in less relapse than nonremoval and in similar numbers of subsequent emergency department visits. This study showed that despite a recent decline, a high incidence of CKD in the United States persists. Welcome to books on Oxford Academic. AZD7442 was found to have approximately 77% efficacy in preventing symptomatic infection. We performed exploratory analyses to determine whether any subgroups might have derived some benefit from chemotherapy in the intention-to-treat population, with a focus on covariates that were prognostic or associated with greater benefit from chemotherapy, such as younger age (Section 6F and Fig. Remove your PPE as shown in the video and described here or in accordance with the standards at your institution. Additional information, including outcome definitions, is provided in the Supplementary Appendix and the trial protocol. Breast cancer is the most common cancer in women in the United States and worldwide.1 Hormone-receptorpositive, axillary nodenegative disease accounts for approximately half of all cases of breast cancer in the United States.2 Adjuvant chemotherapy reduces the risk of recurrence,3-5 with effects that are proportionally greater in younger women but that are little affected by nodal status, grade, or the use of adjuvant endocrine therapy.6,7 These findings led a National Institutes of Health consensus panel to recommend adjuvant chemotherapy for most patients,8 a practice that has contributed to declining breast cancer mortality.9 However, the majority of patients may receive chemotherapy unnecessarily.
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