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Weisberg I.S.,Mount Sinai Beth Israel Medical Center | Jacobson I.M.,Mount Sinai Beth Israel Medical Center
Expert Opinion on Pharmacotherapy | Year: 2017

Introduction: Hepatitis C virus (HCV) infects nearly 170 million people worldwide and is a leading cause of progressive liver damage, cirrhosis, and hepatocellular carcinoma. Curative therapies have historically relied on interferon-based treatments and were limited by significant toxicity and poor response rates, particularly among patients with prior treatment failure and advanced hepatic fibrosis. The recent advent of direct acting antiviral (DAA) agents which target key steps in the HCV viral life cycle has transformed the landscape of HCV treatment by offering highly effective and well tolerated interferon-free treatments. However, current therapies are genotype-specific and have variable efficacy amongst less prevalent HCV variants. Areas covered: This review covers the preclinical and clinical development of sofosbuvir/velpatasvir (SOF/VEL), an interferon-free, once daily, pangenotypic treatment for the treatment of chronic hepatitis C virus (HCV) infection. All relevant literature from 2014 through September of 2016 is included. Expert opinion: SOF/VEL offers the promise of a single tablet, interferon- and ribavirin-free treatment that has extremely high efficacy in persons with chronic HCV infection regardless of genotype, subtype, treatment history or fibrosis status. It is expected to play a major role on a global scale in the therapeutic armamentarium against this ubiquitous threat to human health. © 2017 Informa UK Limited, trading as Taylor & Francis Group

Perriera L.K.,Thomas Jefferson University | Arslan A.A.,New York University | Masch R.,Mount Sinai Beth Israel Medical Center
Australian and New Zealand Journal of Obstetrics and Gynaecology | Year: 2017

Background: There are few reports in the literature of the risks associated with second trimester abortion in women with placenta praevia (PP). We hypothesise that PP increases the risk of complications. Aims: We sought to determine if PP is associated with a higher risk of blood loss and blood transfusion at the time of dilation and evacuation (D&E). Materials and methods: The records of 612 consecutive women undergoing abortion at 15–24 weeks of gestation were reviewed. Participant characteristics, need for blood transfusion, estimated blood loss (EBL) during the abortion and other complications were compared between women with and without ultrasound-documented PP. Results: Eighty-seven of 612 (14.2%, 95% CI 11.5-17.2%) women had ultrasound-documented PP. The rate of blood transfusion was 3.4 and 1.3% in the group with PP and without PP, respectively (adjusted relative risk (RR = 2.8, 95% CI 0.7–11.3). An estimated blood loss of 500 cc or greater during the D&E procedure was observed in 12.6% of women in the PP group compared with 4.2% of women in the group without PP (adjusted RR 3.1, 95% CI 1.4–6.8, P = 0.004). Conclusions: Second-trimester abortion in women with PP is associated with a higher risk of blood loss of 500 cc or greater. Our study represents a larger sample size of patients with PP undergoing second-trimester abortion than previously reported in the literature. Women with PP may have a higher estimated blood loss and may require access to blood transfusion. © 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Nicholas Lukens J.,University of Pennsylvania | Hu K.,Mount Sinai Beth Israel Medical Center | Harrison L.B.,Moffitt Cancer Center
Seminars in Oncology | Year: 2014

Brachytherapy consists of placing radioactive sources within, or directly adjacent to a tumor, and is a means of delivering highly targeted and conformal radiation. While its history dates back to the origins of the field, in recent years brachytherapy treatment paradigms have been evolving considerably. This has been driven primarily by advancements in imaging, which allow for precise placement of sources and applicators under image guidance, and volume-based optimization to ensure adequate tumor coverage while sparing adjacent normal tissue. There has been a shift towards high-dose-rate (HDR) brachytherapy for many of the disease sites treated with brachytherapy. Simultaneously, with increasingly conformal treatment, there has been a shift towards utilization of higher doses per fraction, over fewer fractions, for specific disease sites where hypofractionation is believed to confer a radiobiological benefit. Here we review recent data and trends for those disease sites and conditions that are commonly treated with brachytherapy, including prostate, gynecologic, breast, head and neck, and skin cancers and salvage of recurrent disease. © 2014 Elsevier Inc. All rights reserved.

Silverberg J.I.,Northwestern University | Silverberg J.I.,Beth Israel Deaconess Medical Center | Braunstein M.,New York University | Lee-Wong M.,Mount Sinai Beth Israel Medical Center
Journal of Allergy and Clinical Immunology | Year: 2015

Background Climate factors and pollen counts may play a role in hay fever. Objective We sought to determine the impact of specific climate factors and pollen counts on the US prevalence of hay fever and statewide variation in prevalence. Methods We used a merged analysis of the 2007 National Survey of Children's Health from a representative sample of 91,642 children aged 0 to 17 years and the 2006-2007 National Climate Data Center and Weather Service measurements of relative humidity (%), indoor heating degree days, precipitation, Palmer Hydrological Drought Index, clear sky and issued ultraviolet indices, stratospheric ozone levels, and outdoor air temperature and National Allergy Bureau total pollen counts. Multivariate survey logistic regression models controlled for sex, race/ethnicity, age, household income, and birthplace. Results The US prevalence of hay fever in childhood was 18.0% (95% CI, 17.7% to 18.2%), with the highest prevalence in southeastern and southern states. Hay fever prevalence was significantly lower with second and third quartile mean annual relative humidity (logistic regression, P ≤.01 for both), fourth quartile mean annual Palmer Hydrological Drought Index (P =.02), third and fourth quartile mean annual heating degree days (P <.0001 for both), and third and fourth quartile mean annual stratospheric ozone levels but increased with second, third, and fourth quartile mean annual temperature (P ≤.02 for both), fourth quartile mean annual precipitation (P =.0007), mean total pollen counts (P =.01), and second, third, and fourth quartile issued ultraviolet index (P ≤.0001 for all). Principal-component analysis was also used to determine the combined effects of correlated climate variables and pollen counts. Conclusions This study provides evidence of the influence of climate on the US prevalence of childhood hay fever. © 2014 American Academy of Allergy, Asthma & Immunology.

Habib R.H.,American University of Beirut | Dimitrova K.R.,Mount Sinai Beth Israel Medical Center | Badour S.A.,American University of Beirut | Yammine M.B.,American University of Beirut | And 5 more authors.
Journal of the American College of Cardiology | Year: 2015

Background Treatment of multivessel coronary artery disease with traditional single-arterial coronary artery bypass graft (SA-CABG) has been associated with superior intermediate-term survival and reintervention compared with percutaneous coronary intervention (PCI) using either bare-metal stents (BMS) or drug-eluting stents (DES). Objectives This study sought to investigate longer-term outcomes including the potential added advantage of multiarterial coronary artery bypass graft (MA-CABG). Methods We studied 8,402 single-institution, primary revascularization, multivessel coronary artery disease patients: 2,207 BMS-PCI (age 66.6 ± 11.9 years); 2,381 DES-PCI (age 65.9 ± 11.7 years); 2,289 SA-CABG (age 69.3 ± 9.0 years); and 1,525 MA-CABG (age 58.3 ± 8.7 years). Patients with myocardial infarction within 24 h, shock, or left main stents were excluded. Kaplan-Meier analysis and Cox regression were used to separately compare 9-year all-cause mortality and unplanned reintervention for BMS-PCI and DES-PCI to respective propensity-matched SA-CABG and MA-CABG cohorts. Results BMS-PCI was associated with worse survival than SA-CABG, especially from 0 to 7 years (p = 0.015) and to a greater extent than MA-CABG was (9-year follow-up: 76.3% vs. 86.9%; p < 0.001). The surgery-to-BMS-PCI hazard ratios (HR) were as follows: versus SA-CABG, HR: 0.87; and versus MA-CABG, HR: 0.38. DES-PCI showed similar survival to SA-CABG except for a modest 0 to 3 years surgery advantage (HR: 1.06; p = 0.615). Compared with MA-CABG, DES-PCI exhibited worse survival at 5 (86.3% vs. 95.6%) and 9 (82.8% vs. 89.8%) years (HR: 0.45; p <0.001). Reintervention was substantially worse with PCI for all comparisons (all p <0.001). Conclusions Multiarterial surgical revascularization, compared with either BMS-PCI or DES-PCI, resulted in substantially enhanced death and reintervention-free survival. Accordingly, MA-CABG represents the optimal therapy for multivessel coronary artery disease and should be enthusiastically adopted by multidisciplinary heart teams as the best evidence-based therapy. © 2015 American College of Cardiology Foundation.

Bangalore S.,New York University | Fakheri R.,New York University | Toklu B.,Mount Sinai Beth Israel Medical Center | Messerli F.H.,Mount Sinai School of Medicine
BMJ (Online) | Year: 2016

Objective To evaluate the outcomes with use of renin angiotensin system (RAS) blockers compared with other antihypertensive agents in people with diabetes. Design Meta-analysis. Data sources and study selection PubMed, Embase, and the Cochrane central register of controlled trials databases for randomized trials of RAS blockers versus other antihypertensive agents in people with diabetes mellitus. Outcomes were death, cardiovascular death, myocardial infarction, angina, stroke, heart failure, revascularization, and end stage renal disease. Results The search yielded 19 randomized controlled trials that enrolled 25 414 participants with diabetes for a total of 95 910 patient years of follow-up. When compared with other antihypertensive agents, RAS blockers were associated with a similar risk of death (relative risk 0.99, 95% confidence interval 0.93 to 1.05), cardiovascular death (1.02, 0.83 to 1.24), myocardial infarction (0.87, 0.64 to 1.18), angina pectoris (0.80, 0.58 to 1.11), stroke (1.04, 0.92 to 1.17), heart failure (0.90, 0.76 to 1.07), and revascularization (0.97, 0.77 to 1.22). There was also no difference in the hard renal outcome of end stage renal disease (0.99, 0.78 to 1.28) (power of 94% to show a 23% reduction in end stage renal disease). Conclusions In people with diabetes, RAS blockers are not superior to other antihypertensive drug classes such as thiazides, calcium channel blockers, and β blockers at reducing the risk of hard cardiovascular and renal endpoints. These findings support the recommendations of the guidelines of the European Society of Cardiology/European Society of Hypertension and eighth Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure to also use other antihypertensive agents in people with diabetes but without kidney disease.

Silverberg J.I.,Northwestern University | Ratner D.,Mount Sinai Beth Israel Medical Center
Journal of the European Academy of Dermatology and Venereology | Year: 2015

Background Non-melanoma skin cancer (NMSC) and melanoma are common malignancies in the US and may be associated with other types of cancer. Objectives We sought to determine whether NMSC and melanoma are associated with extra-cutaneous cancers and identify modifiable risk factors for such an association. Methods We analysed data from 447 801 adult participants in the 1997-2011 National Health Interview Surveys. Survey logistic regression models were constructed that accounted for the complex sample weights. History of NMSC, melanoma and 27 primary extra-cutaneous cancers was assessed. Results NMSC was associated with increased odds of one (multinomial survey logistic regression, unadjusted odds ratio [95% CI]: 2.43 [2.20-2.68]) or multiple (2.94 [2.21-3.92]) extra-cutaneous malignancies. Melanoma was also associated with increased odds of one (3.25 [2.70-3.90]) or multiple (6.11 [4.34-8.61]) extra-cutaneous malignancies. Extra-cutaneous cancers were more common in younger patients (ages 18-39 and 40-49 years) and Caucasians with NMSC or melanoma (P < 0.0001). Smokers with a history of NMSC or melanoma had even higher odds of extra-cutaneous malignancy at ages 18-39 and 40-49 years compared to smokers without NMSC or melanoma (P < 0.0001). History of NMSC was associated with higher odds of malignancies of the bladder, brain, breast, colon, oesophagus, kidney, lung, lymphoma, melanoma, prostate, soft tissue, throat/pharynx, thyroid and uterus. Melanoma was associated with malignancies of the bladder, breast, colon, kidney, lung, pancreas, prostate, soft tissue, throat/pharynx, thyroid and uterus. The prevalence of extra-cutaneous cancers increased between 1997 and 2011 in all subjects (4.51% and 5.73%, P < 0.0001), with even higher rates of increase in those with history of NMSC or melanoma. Conclusions Patients with history of NMSC and melanoma have increased odds of developing extra-cutaneous cancers, especially those with younger age and smoking history. © 2014 European Academy of Dermatology and Venereology.

Vaughan B.,Columbia University | Goldstein M.H.,Mount Sinai Beth Israel Medical Center | Alikakos M.,Mount Sinai Beth Israel Medical Center | Cohen L.J.,Mount Sinai Beth Israel Medical Center | Serby M.J.,Mount Sinai Beth Israel Medical Center
Comprehensive Psychiatry | Year: 2014

Background Psychopharmacology and psychotherapy are the two main therapies in mental health. It is common practice to consider adverse events (AEs) of medications, but it's not clear this occurs with psychotherapy. Aim This study investigates the frequency with which reports of AEs occur in clinical trials using either psychopharmacology alone, psychotherapy alone, or combined approaches. Methods Forty-five articles of randomized trials published in high-impact journals were chosen from a Medline search, and separated into three groups of 15 articles: pharmacotherapy alone (M), psychotherapy alone (T) and combined studies that looked at the effect of both a psychotherapeutic (CT) and psychopharmacologic (CM) intervention. Criteria for what defines an AE were established and the papers were rated for mentions of AEs in papers as a whole and by each section. Results The χ2-analysis of AE mentions showed significant differences between the four study conditions in terms of each paper as a whole (χ2: 10.1, p < 0.018), and by section. Medication (M + CM) and psychotherapy papers (T + CT) were then combined into two groups to compare the odds that one was more likely to mention AEs than the other. Bivariate logistic regression yielded statistically significant odds ratios ranging from 9.33 to 20.99, with medications being far more likely to mention AEs. Conclusion We believe the difference in reports of AEs mirrors the attitudes researchers and providers. It's critical to consider, and standardize the definition of, AEs in psychotherapy, and imperative to identify and address potential AEs in psychotherapy research.

Doty N.,Mount Sinai Beth Israel Medical Center | MacIsaac L.,Mount Sinai Beth Israel Medical Center
Contraception | Year: 2015

Introduction Intrauterine devices (IUDs) are used by only 5.6% of contraceptive users in the United States. One barrier to IUD uptake is fear of pain during insertion, particularly among nulliparous women. Many interventions to reduce pain during IUD insertion have proven unsuccessful. Comparisons of different tenaculae have not been previously reported. Methods This was a single-blinded, randomized control trial of 80 women randomized to the use of a vulsellum or a single-tooth tenaculum during IUD insertion. The primary outcome was reported pain on a 100-mm visual analog scale at the time of vulsellum placement. Secondary outcomes included pain at other intervals during IUD insertion and bleeding from the tenaculum site. Pain scores were analyzed with a Mann-Whitney test because they were not normally distributed. Results Pain scores at the time of single-tooth tenaculum (33.3 mm) and vulsellum (35.0 mm) placement were the same in both groups (p=0.58). It took longer to control bleeding in the single-tooth tenaculum versus the vulsellum group (1.1 vs. 0.4 min, p=0.001), although there was no statistically significant difference in the number of maneuvers required to control bleeding at the tenaculum site between the two groups. Preprocedure anxiety appeared to correlate with more pain during IUD insertion. Conclusion This is the first randomized trial comparing tenaculae. There was no difference in reported pain, but the vulsellum may be associated with less bleeding than a single-tooth tenaculum. Women with higher preprocedure anxiety may experience more pain during IUD insertion. Future research could investigate an anxiolytic's effect on pain during IUD insertion. © 2015 Elsevier Inc. All rights reserved.

Quick M.,Mount Sinai Beth Israel Medical Center
Explore: The Journal of Science and Healing | Year: 2015

Background Probiotics may improve a person's health by regulating their immune function. Some trials have shown that probiotic strains can prevent respiratory infections. Even though the previous version of our review showed benefits of probiotics for acute upper respiratory tract infections (URTIs), several new studies have been published. Objectives To assess the effectiveness and safety of probiotics (any specified strain or dose), compared with placebo, in the prevention of acute URTIs in people of all ages, who are at risk of acute URTIs. Search Methods We searched CENTRAL (2014, Issue 6), MEDLINE (1950 to July week 3, 2014), EMBASE (1974 to July 2014), Web of Science (1900 to July 2014), the Chinese Biomedical Literature Database, which includes the China Biological Medicine Database (from 1978 to July 2014), the Chinese Medicine Popular Science Literature Database (from 2000 to July 2014) and the Masters Degree Dissertation of Beijing Union Medical College Database (from 1981 to July 2014). We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and for completed and ongoing trials on 31 July 2014. Selection Criteria Randomised controlled trials (RCTs) comparing probiotics with placebo to prevent acute URTIs. Data Collection and Analysis Two review authors independently assessed the eligibility and quality of trials, and extracted data using the standard methodological procedures expected by The Cochrane Collaboration. Main Results We included 13 RCTs, although we could only extract data to meta-analyze 12 trials, which involved 3720 participants including children, adults (aged around 40 years) and older people. We found that probiotics were better than placebo when measuring the number of participants experiencing episodes of acute URTI [at least one episode: odds ratio (OR): 0.53; 95% CI = 0.37-0.76, P <.001, low quality evidence; at least three episodes: OR: 0.53; 95% CI = 0.36-0.80, P =.002, low quality evidence]; the mean duration of an episode of acute URTI [mean difference (MD): -1.89; 95% CI = -2.03 to -1.75, P <.001, low quality evidence]; reduced antibiotic prescription rates for acute URTIs (OR: 0.65; 95% CI = 0.45-0.94, moderate quality evidence) and cold-related school absence (OR: 0.10; 95% CI = 0.02-0.47, very low quality evidence). Probiotics and placebo were similar when measuring the rate ratio of episodes of acute URTI (rate ratio: 0.83; 95% CI = 0.66-1.05, P =.12, very low quality evidence) and adverse events (OR: 0.88; 95% CI = 0.65-1.19, P =.40, low quality evidence). Side effects of probiotics were minor and gastrointestinal symptoms were the most common. We found that some subgroups had a high level of heterogeneity when we conducted pooled analyses and the evidence level was low or very low quality. Authors' Conclusions Probiotics were better than placebo in reducing the number of participants experiencing episodes of acute URTI, the mean duration of an episode of acute URTI, antibiotic use and cold-related school absence. This indicates that probiotics may be more beneficial than placebo for preventing acute URTIs. However, the quality of the evidence was low or very low. © 2015 Published by Elsevier Inc.

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