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https://www.readbyqxmd.com/read/27923090/association-between-end-of-rotation-resident-transition-in-care-and-mortality-among-hospitalized-patients
#1
Joshua L Denson, Ashley Jensen, Harry S Saag, Binhuan Wang, Yixin Fang, Leora I Horwitz, Laura Evans, Scott E Sherman
Importance: Shift-to-shift transitions in care among house staff are associated with adverse events. However, the association between end-of-rotation transition (in which care of the patient is transferred) and adverse events is uncertain. Objective: To examine the association of end-of-rotation house staff transitions with mortality among hospitalized patients. Design, Setting, and Participants: Retrospective multicenter cohort study of patients admitted to internal medicine services (N = 230 701) at 10 university-affiliated US Veterans Health Administration hospitals (2008-2014)...
December 6, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27923043/clonal-evolutionary-analysis-during-her2-blockade-in-her2-positive-inflammatory-breast-cancer-a-phase-ii-open-label-clinical-trial-of-afatinib-vinorelbine
#2
Gerald Goh, Ramona Schmid, Kelly Guiver, Wichit Arpornwirat, Imjai Chitapanarux, Vinod Ganju, Seock-Ah Im, Sung-Bae Kim, Arunee Dechaphunkul, Jedzada Maneechavakajorn, Neil Spector, Thomas Yau, Mehdi Afrit, Slim Ben Ahmed, Stephen R Johnston, Neil Gibson, Martina Uttenreuther-Fischer, Javier Herrero, Charles Swanton
BACKGROUND: Inflammatory breast cancer (IBC) is a rare, aggressive form of breast cancer associated with HER2 amplification, with high risk of metastasis and an estimated median survival of 2.9 y. We performed an open-label, single-arm phase II clinical trial (ClinicalTrials.gov NCT01325428) to investigate the efficacy and safety of afatinib, an irreversible ErbB family inhibitor, alone and in combination with vinorelbine in patients with HER2-positive IBC. This trial included prospectively planned exome analysis before and after afatinib monotherapy...
December 2016: PLoS Medicine
https://www.readbyqxmd.com/read/27922936/the-rejoice-trial-a-phase-3-randomized-controlled-trial-evaluating-the-safety-and-efficacy-of-a-novel-vaginal-estradiol-soft-gel-capsule-for-symptomatic-vulvar-and-vaginal-atrophy
#3
Ginger D Constantine, James A Simon, James H Pickar, David F Archer, Harvey Kushner, Brian Bernick, Gina Gasper, Shelli Graham, Sebastian Mirkin
OBJECTIVE: To evaluate the safety and efficacy of TX-004HR vaginal estradiol soft-gel capsules for moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy. METHODS: In this randomized, double-blind, placebo-controlled, phase 3 study, postmenopausal women with a self-identified most bothersome symptom of dyspareunia received 4, 10, or 25 μg TX-004HR or placebo for 12 weeks. Four co-primary efficacy endpoints were change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia...
December 5, 2016: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/27922810/impact-of-chronic-total-occlusion-revascularization-attempts-on-subsequent-clinical-outcomes
#4
Ahmad Jabbar, Georgios Christopoulos, Aris Karatasakis, Omar M Jeroudi, Georgios E Christakopoulos, Abdallah El Sabbagh, Barbara Danek, Judit Karacsonyi, Michele Roesle, Bavana V Rangan, Jerrold Grodin, Michael Luna, Shuaib Abdullah, Subhash Banerjee, Emmanouil S Brilakis
OBJECTIVES: We examined a contemporary, unselected cohort of patients with coronary chronic total occlusions (CTOs) to determine the impact of CTO revascularization on long-term outcomes. METHODS: We retrospectively assessed the impact of CTO revascularization on clinical outcomes of consecutive patients found to have a CTO during coronary angiography performed at our institution during 2011 and 2012. The primary endpoint was the incidence of a major adverse cardiac event (MACE, defined as a composite of death, myocardial infarction, stroke, and target-vessel revascularization [TVR])...
December 2016: Journal of Invasive Cardiology
https://www.readbyqxmd.com/read/27922809/impact-of-coronary-artery-disease-on-postoperative-outcomes-in-patients-undergoing-transcatheter-aortic-valve-replacement-tavr-is-preoperative-coronary-revascularization-necessary
#5
Dhaval Chauhan, Mohammad Thawabi, Nicky Haik, Bruce J Haik, Chunguang Chen, Marc Cohen, Mark Russo
BACKGROUND: There remains much controversy on impact of preoperative coronary artery disease (CAD) and necessity of preoperative coronary revascularization on postoperative outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: Data were collected retrospectively for 364 consecutive patients undergoing TAVR at Newark Beth Israel Medical Center, New Jersey, from May 15, 2012 to September 17, 2015. Preoperative CAD burden was calculated by three different measures of CAD: SYNTAX score, Duke Myocardial Jeopardy score (DMJS), and number of diseased coronary arteries...
December 2016: Journal of Invasive Cardiology
https://www.readbyqxmd.com/read/27922765/therapeutic-drug-monitoring-of-anti-tumour-necrosis-factor-%C3%AE-agents-in-inflammatory-bowel-disease
#6
Nikola Mitrev, Rupert W Leong
Anti-TNFα therapy has revolutionised treatment of inflammatory bowel disease, however primary non-response and secondary loss of response are a significant problem. Therapeutic drug monitoring (TDM) has recently emerged as a means of optimising use of anti-TNFα agents. Areas covered: TDM of anti-TNFα agents can guide clinical decisions during treatment failure events, prevent treatment failure events, and potentially result in significant healthcare cost saving. TDM for anti-TNFα agent involves measurement of drug levels and anti-drug antibodies, and can be performed reactively or proactively...
December 6, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27922722/topiramate-versus-carbamazepine-monotherapy-for-epilepsy-an-individual-participant-data-review
#7
REVIEW
Sarah J Nolan, Maria Sudell, Catrin Tudur Smith, Anthony G Marson
BACKGROUND: Epilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy, the majority of which may be able to achieve remission with a single antiepileptic drug (AED).The correct choice of first-line antiepileptic therapy for individuals with newly diagnosed seizures is of great importance...
December 6, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27922453/safety-and-efficacy-of-the-hiv-1-attachment-inhibitor-prodrug-fostemsavir-in-antiretroviral-experienced-subjects-week-48-analysis-of-ai438011-a-phase-iib-randomized-controlled-trial
#8
Melanie Thompson, Jacob P Lalezari, Richard Kaplan, Yvett Pinedo, Otto A Sussmann Pena, Pedro Cahn, David A Stock, Samit R Joshi, George J Hanna, Max Lataillade
BACKGROUND: Fostemsavir is a prodrug of temsavir, an attachment inhibitor that binds directly to HIV-1 gp120, blocking initial viral attachment and entry into host CD4 cells. Efficacy, safety, and dose-response data of fostemsavir in treatment-experienced, HIV-1-infected subjects, through Week 48, are reported. METHODS: AI438011 is an ongoing Phase IIb, randomized, active-controlled trial (NCT01384734). Subjects were randomized 1:1:1:1:1 into five arms: fostemsavir (400 mg twice daily [BID], 800 mg BID, 600 mg once daily [QD], or 1200 mg QD), and a reference arm (ritonavir-boosted atazanavir [ATV/r] 300/100 mg QD), each with a backbone of raltegravir 400 mg BID + tenofovir disoproxil fumarate 300 mg QD...
December 6, 2016: Antiviral Therapy
https://www.readbyqxmd.com/read/27922040/functional-urological-disorders-a-sensitized-defence-response-in-the-bladder-gut-brain-axis
#9
REVIEW
Carsten Leue, Joanna Kruimel, Desiree Vrijens, Adrian Masclee, Jim van Os, Gommert van Koeveringe
Functional urological and gastrointestinal disorders are interrelated and characterized by a chronic course and considerable treatment resistance. Urological disorders associated with a sizeable functional effect include overactive bladder (OAB), interstitial cystitis/bladder pain syndrome (IC/BPS), and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Poor treatment outcomes might be attributable to untreated underlying psychological and psychiatric disorders, as the co-occurrence of functional urological and gastrointestinal disorders with mood and anxiety disorders is common...
December 6, 2016: Nature Reviews. Urology
https://www.readbyqxmd.com/read/27922029/safety-of-eluxadoline-in-patients-with-irritable-bowel-syndrome-with-diarrhea
#10
Brooks D Cash, Brian E Lacy, Philip S Schoenfeld, Leonard S Dove, Paul S Covington
OBJECTIVES: Eluxadoline is a mixed μ-opioid receptor (OR) and κ-OR agonist and δ-OR antagonist, approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D). This analysis evaluated the safety and tolerability of eluxadoline 75 and 100 mg twice daily (BID) in one Phase 2 (IBS-2001) and two Phase 3 (IBS-3001 and IBS-3002) studies. METHODS: Adults with IBS-D (Rome III criteria) were randomized to placebo or eluxadoline (75 or 100 mg) BID for 12 (IBS-2001), 26 (IBS-3002), or 52 (IBS-3001) weeks...
December 6, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27922028/a-randomized-double-blind-placebo-controlled-trial-to-examine-the-effectiveness-of-lubiprostone-on-constipation-symptoms-and-colon-transit-time-in-diabetic-patients
#11
Jennifer Christie, Sagar Shroff, Nikrad Shahnavaz, Latoya A Carter, Melanie S Harrison, Karan A Dietz-Lindo, John Hanfelt, Shanthi Srinivasan
OBJECTIVES: Constipation is the most common GI symptom in patients with diabetes mellitus (DM). Importantly, patients with constipation have lower health-related quality of life than those without constipation. Effective therapies for constipation are limited and there is a paucity of data evaluating the treatment of constipation in diabetics. METHODS: Diabetic patients with chronic idiopathic constipation (CIC) as defined by Rome III criteria were recruited from outpatient clinics at a tertiary-care center and a Veterans Administration Hospital...
December 6, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27922026/percutaneous-gastrostomy-device-for-the-treatment-of-class-ii-and-class-iii-obesity-results-of-a-randomized-controlled-trial
#12
Christopher C Thompson, Barham K Abu Dayyeh, Robert Kushner, Shelby Sullivan, Alan B Schorr, Anastassia Amaro, Caroline M Apovian, Terrence Fullum, Amir Zarrinpar, Michael D Jensen, Adam C Stein, Steven Edmundowicz, Michel Kahaleh, Marvin Ryou, J Matthew Bohning, Gregory Ginsberg, Christopher Huang, Daniel D Tran, Joseph P Glaser, John A Martin, David L Jaffe, Francis A Farraye, Samuel B Ho, Nitin Kumar, Donna Harakal, Meredith Young, Catherine E Thomas, Alpana P Shukla, Michele B Ryan, Miki Haas, Heidi Goldsmith, Jennifer McCrea, Louis J Aronne
OBJECTIVES: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. METHODS: In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m(2) were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42...
December 6, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27922020/efficacy-of-losartan-in-the-management-of-post-dialysis-euvolemic-hypertension-held-trial-a-single-blind-randomized-control-trial
#13
Raja Ahsan Aftab, Amer Hayat Khan, Azreen Syazril Adnan, Syed Azhar Syed Sulaiman, Tahir Mehmood Khan
To assess the effectiveness of losartan 50 mg on post dialysis euvolemic hypertensive patients against standard antihypertensive pharmacotherapy. A multicentre, prospective, randomized, single-blind trial was conducted to assess the effect of losartan 50 mg every other day (EOD), once a morning (OM) among post-dialysis euvolemic hypertensive patients. Covariate-adaptive randomization was used to allocate participants to a standard or treatment arm, and they were followed up for eight weeks. Pre-, intra- and post-dialysis session blood pressure (BP) measurements were recorded along with any adverse events...
December 6, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27921320/cardiac-effects-of-amiselimod-compared-with-fingolimod-and-placebo-results-of-a-randomised-parallel-group-phase-i-study-in-healthy-subjects
#14
Tomohiko Harada, Darren Wilbraham, Guillemette de La Borderie, Shinsuke Inoue, Jim Bush, A John Camm
AIM: Amiselimod (MT-1303) is a selective sphingosine 1-phosphate 1 (S1P1 ) receptor modulator which is currently being developed for the treatment of various autoimmune diseases. Unlike some other S1P receptor modulators, amiselimod seemed to show a favourable cardiac safety profile in pre-clinical, phase I and II studies. The aim of this study was to characterise the cardiac effects of amiselimod by directly comparing it with fingolimod and placebo. METHODS: Eighty-one (81) healthy subjects aged 18-55 years were equally randomised to receive amiselimod 0...
December 6, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27921276/relationship-between-physician-adjudicated-adverse-events-and-patient-reported-health-related-quality-of-life-in-a-phase-ii-clinical-trial-nct01143402-of-patients-with-metastatic-uveal-melanoma
#15
Thomas M Atkinson, Jennifer L Hay, Alexander Shoushtari, Yuelin Li, Daniel J Paucar, Sloane C Smith, Ragini R Kudchadkar, Austin Doyle, Jeffrey A Sosman, Jorge Fernando Quevedo, Mohammed M Milhem, Anthony M Joshua, Gerald P Linette, Thomas F Gajewski, Jose Lutzky, David H Lawson, Christopher D Lao, Patrick J Flynn, Mark R Albertini, Takami Sato, Karl Lewis, Brian Marr, David H Abramson, Mark Andrew Dickson, Gary K Schwartz, Richard D Carvajal
PURPOSE: Clinical trials commonly use physician-adjudicated adverse event (AE) assessment via the common terminology criteria for adverse events (CTCAE) for decision-making. Patient-reported health-related quality of life (HRQoL) data are becoming more frequent in oncology; however, the relationship between physician-adjudicated AE assessment and HRQoL is understudied. METHODS: Data from a phase II trial (clinicaltrials.gov identifier: NCT01143402) where patients with metastatic uveal melanoma were randomized to receive selumetinib, an oral MEK inhibitor, or chemotherapy were analyzed...
December 5, 2016: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/27921252/opioid-induced-bowel-dysfunction-in-patients-undergoing-spine-surgery-comparison-of-oxycodone-and-oxycodone-naloxone-treatment
#16
Merja Kokki, Moona Kuronen, Toivo Naaranlahti, Timo Nyyssönen, Ira Pikkarainen, Sakari Savolainen, Hannu Kokki
INTRODUCTION: Opioids are needed for postoperative pain in spine surgery patients, but opioid-induced constipation is a harmful adverse event. The aim of this clinical trial was to compare the use of a controlled-release oxycodone-naloxone combination product with oxycodone controlled-release tablets in these patients. The main outcome measure was the prevalence of constipation at 7 days postoperatively assessed with a Bowel Function Index questionnaire. A follow-up assessment at 21 days after surgery was also included...
December 5, 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27921221/safety-and-efficacy-of-natalizumab-in-japanese-patients-with-relapsing-remitting-multiple-sclerosis-open-label-extension-study-of-a-phase-2-trial
#17
Takahiko Saida, Jun-Ichi Kira, Shuji Kishida, Takashi Yamamura, Nobuhisa Ohtsuka, Yan Ling, Shinichi Torii, Nisha Lucas, Geoffrey Kuesters, Deb Steiner, J T Tibung
INTRODUCTION: The efficacy of natalizumab was evaluated in Japanese patients with relapsing-remitting multiple sclerosis (RRMS) in a 24-week, phase 2 bridging study. An open-label, 2-year extension study from this trial was conducted to assess the safety and efficacy of natalizumab treatment in Japanese patients. METHODS: A total of 97 patients (43 previously on placebo; 54 previously on natalizumab) who had completed the bridging study were treated with 300 mg natalizumab every 4 weeks...
December 5, 2016: Neurology and Therapy
https://www.readbyqxmd.com/read/27921057/endoscopic-management-of-an-intramural-sinus-leak-after-per-oral-endoscopic-myotomy
#18
Haider Al Taii, Bradley Confer, Scott Gabbard, Matthew Kroh, Sunguk Jang, John Rodriguez, Mansour A Parsi, John J Vargo, Jeffrey Ponsky, Amit Bhatt
Per-oral endoscopic myotomy (POEM) was developed less than a decade ago for the treatment of achalasia. Its minimally invasive approach and the favorable short-term outcome have led to rapid adoption of the technique throughout the world. As with any new technique, there will be adverse events, and it is important that effective treatments for these adverse events be discussed. We present a case of successful endoscopic management of an intramural sinus leak after a POEM procedure using tandem fully covered esophageal stents...
August 2016: ACG Case Reports Journal
https://www.readbyqxmd.com/read/27921028/two-year-results-after-convective-radiofrequency-water-vapor-thermal-therapy-of-symptomatic-benign-prostatic-hyperplasia
#19
Christopher M Dixon, Edwin Rijo Cedano, Dalibor Pacik, Vítězslav Vit, Gabriel Varga, Lennart Wagrell, Thayne R Larson, Lance A Mynderse
OBJECTIVE: The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations. PATIENTS AND METHODS: Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20-120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System...
2016: Research and Reports in Urology
https://www.readbyqxmd.com/read/27921017/factors-impacting-mortality-in-the-pre-hospital-period-after-road-traffic-accidents-in-urban-india
#20
Ananthnarayan Chandrasekharan, Aditya J Nanavati, Sandhya Prabhakar, Subramaniam Prabhakar
BACKGROUND: India currently has the dubious distinction of experiencing the highest number of road traffic accidents in the world. OBJECTIVES: We believe that this study on road traffic accidents may help to identify factors in the pre-hospital setting that may influence mortality rates. PATIENTS AND METHODS: A prospective observational study was carried out in a metro area in India over a period of one year. The study included consecutive patients admitted to the trauma service after road traffic accidents...
July 2016: Trauma Monthly
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