tbuckley/cabot-search huggingface dataset:
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus
Authors: Abhinav Sharma, Neha J. Pagidipati, Robert M. Califf, Darren K. McGuire, Jennifer B. Green, Dave Demets, Jyothis Thomas George, Hertzel C. Gerstein, Todd Hobbs, Rury R. Holman, Francesca C. Lawson, Lawrence A. Leiter, Marc A. Pfeffer, Jane Reusch, Jeffrey S. Riesmeyer, Matthew T. Roe, Yves Rosenberg, Robert Temple, Stephen Wiviott, John McMurray, Christopher Granger
Journal: Circulation (2020)

Responding to concerns about the potential for increased risk of adverse cardiovascular outcomes, specifically myocardial infarction, associated with certain glucose-lowering therapies, the US Food and Drug Administration and the Committee for Medicinal Products for Human Use of the European Medicines Agency issued guidance to the pharmaceutical industry in 2008. Glucose-lowering therapies were granted regulatory approval primarily from smaller studies that have demonstrated reductions in glycated hemoglobin concentration. Such studies were overall underpowered and of insufficient duration to show any effect on cardiovascular outcomes. The 2008 guidance aimed to ensure the cardiovascular safety of new glucose-lowering therapies to treat patients with type 2 diabetes mellitus. This resulted in a plethora of new cardiovascular outcome trials, most designed primarily as placebo-controlled noninferiority trials, but with many also powered for superiority. Several of these outcome trials demonstrated cardiovascular benefits of the newer agents, resulting in the first-ever cardiovascular protection indications for glucose-lowering therapies. Determining whether the guidance continues to have value in its current form is critically important as we move forward after the first decade of implementation. In February 2018, a think tank comprising representatives from academia, industry, and regulatory agencies convened to consider the guidance in light of the findings of the completed cardiovascular outcome trials. The group made several recommendations for future regulatory guidance and for cardiovascular outcome trials of glucose-lowering therapies. These recommendations include requiring only the 1.3 noninferiority margin for regulatory approval, conducting trials for longer durations, considering studying glucose-lowering therapies as first-line management of type 2 diabetes mellitus, considering heart failure or kidney outcomes within the primary outcome, considering head-to-head active comparator trials, increasing the diversity of patients enrolled, evaluating strategies to streamline registries and the study of unselected populations, and identifying ways to improve translation of trial results to general practice.
Corrigendum to Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial
Authors: N.W. Clarke, A. Ali, F.C. Ingleby, A. Hoyle, C.L. Amos, G. Attard, C.D. Brawley, J. Calvert, S. Chowdhury, A. Cook, W. Cross, D.P. Dearnaley, H. Douis, D. Gilbert, S. Gillessen, R.J. Jones, R.E. Langley, A. MacNair, Z. Malik, M.D. Mason, D. Matheson, R. Millman, C.C. Parker, A.W.S. Ritchie, H. Rush, J.M. Russell, J. Brown, S. Beesley, A. Birtle, L. Capaldi, J. Gale, S. Gibbs, A. Lydon, A. Nikapota, A. Omlin, J.M. O’Sullivan, O. Parikh, A. Protheroe, S. Rudman, N.N. Srihari, M. Simms, J.S. Tanguay, S. Tolan, J. Wagstaff, J. Wallace, J. Wylie, A. Zarkar, M.R. Sydes, M.K.B. Parmar, N.D. James
Journal: Annals of Oncology (2020)

The authors regret that Fig.2F has been incorrectly titled. The correct title is "Failure-free survival high burden M1". Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trialAnnals of OncologyVol. 30Issue 12PreviewSTAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients. Full-Text PDF Open Access
Accuracy of pre-hospital trauma triage and field triage decision rules in children (P2-T2 study): an observational study
Authors: Rogier van der Sluijs, Robin D Lokerman, Job F Waalwijk, Mariska A C de Jongh, Michael J R Edwards, Dennis den Hartog, Georgios F Giannakópoulos, Pierre M van Grunsven, Martijn Poeze, Luke P H Leenen, Mark van Heijl, Koen W.W. Lansink, Wim Breeman, Timo Bevelander, Arjen Siegers, Risco van Vliet, Thijs M.F. Verhagen, Margreet W.M.J. Hoogeveen, Leontien M. Sturms
Journal: The Lancet Child & Adolescent Health (2020)
Angiogenic peptide hydrogels for treatment of traumatic brain injury
Authors: Xiaotang Ma, Agnieszka Agas, Zain Siddiqui, KaKyung Kim, Patricia Iglesias-Montoro, Jagathi Kalluru, Vivek Kumar, James Haorah
Journal: Bioactive Materials (2020)

Traumatic brain injury (TBI) impacts over 3.17 million Americans. Management of hemorrhage and coagulation caused by vascular disruption after TBI is critical for the recovery of patients. Cerebrovascular pathologies play an important role in the underlying mechanisms of TBI. The objective of this study is to evaluate a novel regenerative medicine for the injured tissue after brain injury. We utilized a recently described synthetic growth factor with angiogenic potential to facilitate vascular growth in situ at the injury site. Previous work has shown how this injectable self-assembling peptide-based hydrogel (
Early clip-with-line method for colorectal endoscopic submucosal dissection
Authors: Hideyuki Takashiro, Hirofumi Saito, Shinichi Tazawa, Masatoshi Usui, Katsunobu Tawada, Hiromasa Nomoto, Kazuhiko Kita
Journal: Endoscopy (2020)

Colorectal endoscopic submucosal dissection (ESD) is a widely accepted procedure but involves technical difficulties and a high risk of perforation [1]. To overcome these problems, several methods for exerting traction have been reported. Most of these methods start after the creation of the mucosal flap, which is time-consuming [2] [3]. To obtain good visualization at the stage of the mucosal incision, we developed an early clip-with-line (ECL) method. Traction by this method was started immediately after the injection of hyaluronic acid solution into the submucosal layer.
Bidirectional association between alopecia areata and major depressive disorder among probands and unaffected siblings: A nationwide population-based study
Authors: Ying-Xiu Dai, Ying-Hsuan Tai, Chih-Chiang Chen, Yun-Ting Chang, Tzeng-Ji Chen, Mu-Hong Chen
Journal: Journal of the American Academy of Dermatology (2020)
US electronic records company fined $145 million for pushing doctors to prescribe opioids
Authors: Janice Hopkins Tanne
Journal: BMJ (2020)

Practice Fusion, an electronic health records company, agreed to pay $145m (£110.7m; €131.5m) to settle civil and criminal charges with the US Department of Justice for encouraging doctors to prescribe opioids. The company got a $1m kickback from pharmaceutical company “Pharma X” to promote opioid prescribing through its programmes for doctors.1

Most of the fine will go to the federal government and other payments will go to individual states. Pharma X, a major opioid company, was not identified in the settlement.

From 1999 to 2017 the US opioid epidemic has killed more than 700 ​000 Americans.2

Practice Fusion offered free electronic health records software and sometimes computers to small and single doctor practices. Its electronic health records received certifications from the Office of the National Coordinator for Health Information Technology and were highly rated by users.3 Electronic health records could …
Prognostic Factors and Treatment of Cervical Cancer (CC) in Elderly
Authors: I.Q.S. Caires, R.C.A.D. Lima, R. Barroso-Sousa, E.M.P.D. Andrade, J.R.D. Silva, F.B. Sanchez, P.M. Hoff, M. Diz
Journal: Annals of Oncology (2012)
Too Much Screen Time for Young Children, Experts Say
Authors: Rita Rubin
Journal: JAMA (2020)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors Podcasts Clinical Reviews Editors' Summary Medical News Author Interviews More Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal
On Duty in the Surgery Waiting Room
Authors: Lawrence J. Hergott
Journal: Annals of Internal Medicine (2020)

Ad Libitum4 February 2020On Duty in the Surgery Waiting RoomLawrence J. Hergott, MDLawrence J. Hergott, MDUniversity of Colorado, Denver, Colorado (L.J.H.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-1008 Audio Reading - “On Duty in the Surgery Waiting Room” Audio. Michael A. Lacombe, MD, Annals Associate Editor, reads “On Duty in the Surgery Waiting Room” by Lawrence J. Hergott, MD Your browser does not support the audio element. Audio player progress bar Step backward in current audio track Play current audio trackPause current audio track Step forward in current audio track Mute current audio trackUnmute current audio track 00:00/ SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Walking in, I recognized the wood floorand furniture in the room.Having worked in that hospital for twenty yearsI had been in the room many timesattending to patients' loved ones.This time it was I whowaited for the doctor,and the news.My beloved was having a medium-risk procedure.Though not believing the legendthat medical familieshave more complications than others,I still worried about the worst,and took a seat in the corner.A family entered,led by an elderly, stately man—Irish-looking, I thought.with numerous pierced jewelry on her face ... Author, Article, and Disclosure InformationAffiliations: University of Colorado, Denver, Colorado (L.J.H.)Current Author Address: Lawrence J. Hergott, MD; e-mail, lawrence.[email protected]edu. PreviousarticleNextarticle Advertisement Audio Reading - “On Duty in the Surgery Waiting Room” Audio. Michael A. Lacombe, MD, Annals Associate Editor, reads “On Duty in the Surgery Waiting Room” by Lawrence J. Hergott, MD Your browser does not support the audio element. Audio player progress bar Step backward in current audio track Play current audio trackPause current audio track Step forward in current audio track Mute current audio trackUnmute current audio track 00:00/ FiguresReferencesRelatedDetails Metrics 4 February 2020Volume 172, Issue 3Page: 220KeywordsElderlySurgeryWalking ePublished: 4 February 2020 Issue Published: 4 February 2020 Copyright & PermissionsCopyright © 2020 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...
An Invited Commentary on “Critical appraisal of the techniques of pancreatic anastomosis following pancreaticoduodenectomy: A network meta-analysis. Network meta-analysis” (Int J Surg 2020;73:72–77)-Defining the better surgical management for achieving a better prognosis after pancreatic surgery
Authors: Duilio Pagano, Salvatore Gruttadauria
Journal: International Journal of Surgery (2020)
Abstract 14794: Is Plasma Renin Activity Associated With Worse Outcomes in Acute Heart Failure? A Secondary Analysis From the BLAST-AHF Trial
Authors: Peter S Pang, Beth Davison, Gad Cotter, Phillip Levy, Javed Butler, Justin Ezekowitz, Adriaan Voors, Rudolf DeBoer, Sean Collins, Gerasimos Filippatos, Marco Metra, Piotr Ponikowski, Stefanie Senger, David Soergel, John Teerlink, Michael Felker
Journal: Circulation (2018)

Background: Neurohormonal (NH) activation characterizes the heart failure (HF) syndrome and is a well-established therapeutic target. Acute HF (AHF) presumably results from or is due to even greate...
Structure, property, biogenesis, and activity of diterpenoid alkaloids containing a sulfonic acid group from Aconitum carmichaelii
Authors: Qinglan Guo, Huan Xia, Yuzhuo Wu, Shuai Shao, Chengbo Xu, Tiantai Zhang, Jiangong Shi
Journal: Acta Pharmaceutica Sinica B (2020)

Three new C
Brivanib (B) in Advanced Ovarian Cancer (OC): Subset Results of a Phase 2 Randomized Discontinuation Trial (RDT)
Authors: S.B. Kaye, L.L. Siu, J. Jassem, J. Medioni, P.M.M.B. Soetekouw, S. Slater, C.M. Rudin, G.K. Schwartz, M. De Jonge, P. O'Dwyer, C. Baudelet, A. Chen, M.J. Ratain
Journal: Annals of Oncology (2012)
Opioid Prescribing Behaviors — Prescription Behavior Surveillance System, 11 States, 2010–2016
Authors: Gail K. Strickler, Peter W. Kreiner, John F. Halpin, Erin Doyle, Leonard J. Paulozzi
Journal: MMWR Surveillance Summaries (2020)

Trends in opioid prescribing in 11 states during 2010-2016 indicate improvements in both physician prescribing practices. These encouraging trends may have resulted from federal and state policies instituted in these states.
Methodological Flaws in Improving Physician Role Identification via “Doctor” Badges
Authors: Bo Zhou, Wenquan Niu
Journal: JAMA Internal Medicine (2020)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Internal Medicine HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Internal Medicine journal
Preclinical Rational, Safety, and Preliminary Efficacy Results of Weekly Everolimus, Carboplatin and Paclitaxel as An Induction Therapy for Patients with Unresectable Locally Advanced Head &amp; Neck Squamous Cell Carcinoma (CAPRA): A GERCOR-IRC Phase I/II Study
Authors: S. Faivre, C. Dreyer, E. Raymond, J. Fayette, J.P. Delord, M. Gatineau, B. Chibaudel, N. Aissat, K. Slimane, C. Le Tourneau
Journal: Annals of Oncology (2012)
Exercise‐Induced Hyperammonemia Does Not Precipitate Overt Hepatic Encephalopathy
Authors: Fei‐Pi Lin, Arny A. Ferrando, Richard A. Dennis, Michael A. Dunn, W. Ray Kim, Andrés Duarte‐Rojo
Journal: Hepatology (2020)

Lin, Fei‐Pi; Ferrando, Arny A.; Dennis, Richard A.; Dunn, Michael A.; Kim, W. Ray; Duarte‐Rojo, Andrés Author Information
Regenerating gene 1α (REG 1α) expression and new treatment strategies in early non-small cell lung cancer
Authors: T. Tojo, T. Tojo, H. Naito, M. Kimura, S. Takasawa, Y. Dohi, Y. Nagata, S. Taniguchi
Journal: Journal of Clinical Oncology (2009)

e22178 Background: Regenerating gene (REG) I was originally isolated as an endogenous growth factor from pancreatic islet β cells. REG Iα protein is suggested to be involved in carcinogenesis in various gastroenterologic tissues. In the present study, to elucidate roles for REG Iα in non-small cell lung cancer (NSCLC), we investigated REG Iα expression in NSCLCs, focusing especially on its relationship with prognosis. Methods: We enrolled 70 NSCLCs (adenocarcinoma (AC)(n=48) and squamous cell carcinoma (SCC)(n=22)) who received surgery at Nara Medical University Hospital. Total RNA was extracted from each tumor tissue and corresponding normal lung tissue (NL)(n=70), cDNA was then reverse-transcribed from total RNA, and quantitative real-time reverse transcriptase-polymerase chain reaction was then carried out. The expression level of REG Iα in each sample was normalized with respect to that of β-actin, and the cutoff level was set at average+3SD expression of the 70 NLs. We also examined the relationship between REG 1α expression in the tumor tissue and the prognosis. Results: Six (12.5%) of the 48 ACs and 5 (22.7%) of the 22 SCCs were positive for REG Iα gene, and which is higher than that of NLs (2 of 70: 2.9%). After median follow-up of 26.2 months, 12 patients died due to disease progression. The survival rate among the REG 1α positive patients was significantly worse than among the REG 1α negative patients in ACs (P&lt;0.05), and not significantly but worse in SCCs (P=0.07). In case of stage I, none of REG 1α negative patient died in both ACs and SCCs compared with 4 patients died of positive patients (AC:2, SCC:2), and also the survival rate among the REG 1α positive patients was significantly worse than among the negative patients in ACs (P&lt;0.01) and SCCs (P&lt;0.05). Disease free survival of REG 1α positive patients was also worse than negative patients in ACs (P&lt;0.05) and SCCs (P=0.16). Conclusions: REG Iα expression in NSCLCs may be the risk factor for poor prognosis, and we anticipate that it will enable us to provide more appropriate and individualized treatment to patients of early NSCLC. No significant financial relationships to disclose.
A Novel GUCY2C-CD3 T-Cell Engaging Bispecific Construct (PF-07062119) for the Treatment of Gastrointestinal Cancers
Authors: Divya Mathur, Adam R. Root, Bozena Bugaj-Gaweda, Stephanie Bisulco, Xingzhi Tan, Wei Fang, Jessica C. Kearney, Justin Lucas, Magali Guffroy, Jonathan Golas, Cynthia M. Rohde, Chad Stevens, Cris Kamperschroer, Kerry Kelleher, Rosemary F. Lawrence-Henderson, Erik Upeslacis, Johnny Yao, Jatin Narula, Edward R. LaVallie, Diane R. Fernandez, Bernard S. Buetow, Edward Rosfjord, Laird Bloom, Lindsay E. King, Lioudmila Tchistiakova, Anhco Nguyen, Puja Sapra
Journal: Clinical Cancer Research (2020)

Gastrointestinal cancers remain areas of high unmet need despite advances in targeted and immunotherapies. Here, we demonstrate potent, tumor-selective efficacy with PF-07062119, a T-cell engaging CD3 bispecific targeting tumors expressing Guanylyl Cyclase C (GUCY2C), which is expressed widely across colorectal cancer and other gastrointestinal malignancies. In addition, to address immune evasion mechanisms, we explore combinations with immune checkpoint blockade agents and with antiangiogenesis therapy.PF-07062119 activity was evaluated in vitro in multiple tumor cell lines, and in vivo in established subcutaneous and orthotopic human colorectal cancer xenograft tumors with adoptive transfer of human T cells. Efficacy was also evaluated in mouse syngeneic tumors using human CD3ε transgenic mice. IHC and mass cytometry were performed to demonstrate drug biodistribution, recruitment of activated T cells, and to identify markers of immune evasion. Combination studies were performed with anti-PD-1/PD-L1 and anti-VEGF antibodies. Toxicity and pharmacokinetic studies were done in cynomolgus macaque.We demonstrate that GUCY2C-positive tumors can be targeted with an anti-GUCY2C/anti-CD3ε bispecific, with selective drug biodistribution to tumors. PF-07062119 showed potent T-cell-mediated in vitro activity and in vivo efficacy in multiple colorectal cancer human xenograft tumor models, including KRAS- and BRAF-mutant tumors, as well as in the immunocompetent mouse syngeneic tumor model. PF-07062119 activity was further enhanced when combined with anti-PD-1/PD-L1 treatment or in combination with antiangiogenic therapy. Toxicity studies in cynomolgus indicated a monitorable and manageable toxicity profile.These data highlight the potential for PF-07062119 to demonstrate efficacy and improve patient outcomes in colorectal cancer and other gastrointestinal malignancies.
Impact of sleeve gastrectomy and dietary change on metabolic and hepatic function in an obesity rat model - Experimental research
Authors: Jonas Dohmen, Michael Praktiknjo, Anna Rudeloff, Frank Erhard Uschner, Sabine Klein, Andreas Plamper, Hanno Matthaei, Karl-Peter Rheinwalt, Sven Wehner, Jörg C Kalff, Jonel Trebicka, Philipp Lingohr
Journal: International Journal of Surgery (2020)
Baby at centre of legal battle can have life support removed, says judge
Authors: Clare Dyer
Journal: BMJ (2020)

A High Court judge has ruled that a 4 month old baby at the centre of a legal battle between his parents and an NHS trust over whether to keep him on life support is brainstem dead and can legally have his ventilation withdrawn.1

Courts usually weigh up the best interests of brain damaged babies to decide whether to withdraw treatment. But Mrs Justice Lieven held that, once she had decided that Midrar Namiq (also known as Midrar Ali) was brainstem dead, there was no need to go on to consider his best interests.

“If a patient is brainstem dead then there are no best interests to consider,” she said. “Once those criteria are met the patient has irreversibly lost whatever one might define as life.” She granted Manchester …
Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) Evolution under Treatment by Cetuximab and Links with Treatment Outcome in Locally Advanced Head and Neck (LAHNSCC) and in Metastatic Colorectal Cancer (MCRC) Patients
Authors: C. Lo Nigro, M. Monteverde, G. Strola, M. Maffi, E. Miraglio, L. Lattanzio, D. Vivenza, F. Messa, G. Milano, M. Merlano
Journal: Annals of Oncology (2012)