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https://www.readbyqxmd.com/read/28550712/combined-immune-checkpoint-blockade-anti-pd-1-anti-ctla-4-evaluation-and-management-of-adverse-drug-reactions
#1
REVIEW
Jessica C Hassel, Lucie Heinzerling, Jens Aberle, Oliver Bähr, Thomas K Eigentler, Marc-Oliver Grimm, Victor Grünwald, Jan Leipe, Niels Reinmuth, Julia K Tietze, Jörg Trojan, Lisa Zimmer, Ralf Gutzmer
Combined immune checkpoint blockade (ICB) provides unprecedented efficacy gains in numerous cancer indications, with PD-1 inhibitor nivolumab plus CTLA-4 inhibitor ipilimumab in advanced melanoma as first-ever approved therapies for combined ICB. However, gains in efficacy must be balanced against a higher frequency and severity of adverse drug reactions (ADR). Because delays in diagnosis and management might result in symptom worsening and further complications, clinicians shall be well trained to identify ADR promptly and monitor patients adequately...
May 18, 2017: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/28549789/systematic-approaches-to-adverse-events-in-obstetrics-part-i-event-identification-and-classification
#2
Christian M Pettker
Despite our best intentions to improve health when a patient presents for care, adverse events are ubiquitous in medical practice today. Known complications related to the course of a patient's illness or condition or to the characteristics of the treatment have been an openly stated part of taking care of patients for centuries. However, it is only in the past decade that preventable adverse events, instances of harm related to error and deviations in accepted practice have become a primary part of these conversations...
May 23, 2017: Seminars in Perinatology
https://www.readbyqxmd.com/read/28549436/efficacy-and-safety-of-single-injection-of-cross-linked-sodium-hyaluronate-vs-three-injections-of-high-molecular-weight-sodium-hyaluronate-for-osteoarthritis-of-the-knee-a-double-blind-randomized-multi-center-non-inferiority-study
#3
Chul-Won Ha, Yong-Beom Park, Chong-Hyuk Choi, Hee-Soo Kyung, Ju-Hong Lee, Jae Doo Yoo, Ju-Hyung Yoo, Choong-Hyeok Choi, Chang-Wan Kim, Hee-Chun Kim, Kwang-Jun Oh, Seong-Il Bin, Myung Chul Lee
BACKGROUND: This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. METHODS: Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness...
May 26, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28549238/risk-factors-and-mechanisms-contributing-to-tki-induced-vascular-events-in-patients-with-cml
#4
REVIEW
Peter Valent, Emir Hadzijusufovic, Gregor Hoermann, Wolfgang Füreder, Gerit-Holger Schernthaner, Wolfgang R Sperr, Rudolf Kirchmair, Dominik Wolf
Vascular adverse events (VAE) are an emerging problem in patients with chronic myeloid leukemia (CML) receiving second-generation BCR-ABL1 tyrosine kinase inhibitors (TKI). Relevant VAE comprise peripheral, cerebral, and coronary artery changes in patients receiving nilotinib, venous and arterial occlusive events during ponatinib therapy, and pulmonary hypertension in patients receiving dasatinib. Although each TKI binds to a unique profile of molecular targets in leukemic cells and vascular cells, the exact etiology of drug-induced vasculopathies remains uncertain...
May 12, 2017: Leukemia Research
https://www.readbyqxmd.com/read/28549119/systematic-review-of-cost-effectiveness-of-myocardial-perfusion-scintigraphy-in-patients-with-ischaemic-heart-disease-a-report-from-the-cardiovascular-committee-of-the-european-association-of-nuclear-medicine-endorsed-by-the-european-association-of-cardiovascular
#5
Elin Trägårdh, Siok Swan Tan, Jan Bucerius, Alessia Gimelli, Oliver Gaemperli, Oliver Lindner, Denis Agostini, Christopher Übleis, Roberto Sciagrà, Riemer H Slart, S Richard Underwood, Fabien Hyafil, Marcus Hacker, Hein J Verberne
Coronary artery disease (CAD) is a major cause of death and disability. Several diagnostic tests, such as myocardial perfusion scintigraphy (MPS), are accurate for the detection of CAD, as well as having prognostic value for the prediction of cardiovascular events. Nevertheless, the diagnostic and prognostic value of these tests should be cost-effective and should lead to improved clinical outcome. We have reviewed the literature on the cost-effectiveness of MPS in different circumstances: (i) the diagnosis and management of CAD; (ii) comparison with exercise electrocardiography (ECG) and other imaging tests; (iii) as gatekeeper to invasive coronary angiography (ICA), (iv) the impact of appropriate use criteria; (v) acute chest pain, and (vi) screening of asymptomatic patients with type-2 diabetes...
May 26, 2017: European Heart Journal Cardiovascular Imaging
https://www.readbyqxmd.com/read/28548196/-declaration-of-the-chilean-academy-of-medicine-of-law-20-850-%C3%A2-on-clinical-trials-of-pharmaceutical-products-and-medical-devices%C3%A2-and-of-the-bylaw-that-will-regulate-its-application
#6
Gloria López S, Gloria Valdés S, Emilio Roessler B, Vicente Valdivieso D
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3...
March 2017: Revista Médica de Chile
https://www.readbyqxmd.com/read/28547578/academic-health-center-psychology-representation-to-the-council-of-faculty-and-academic-societies-cfas-of-the-association-of-american-medical-colleges-aamc
#7
Barbara A Cubic, Laura A Shaffer
This paper outlines the perspectives of the two currently appointed representatives of the Association of Psychologists in Academic Health Centers (APAHC) to the Council of Faculty and Academic Societies (CFAS) of the Association of American Medical Colleges (AAMC). The authors focus on why it is important for psychologists, especially those in academic health centers (AHCs), to be part of CFAS. The goal of the paper is to demonstrate how involvement in organizations like the AAMC helps AHC psychologists serve as ambassadors for psychology in AHCs and assists AHC psychologists in staying fluent regarding hot topics within academic medicine...
May 25, 2017: Journal of Clinical Psychology in Medical Settings
https://www.readbyqxmd.com/read/28546660/can-we-deliver-better
#8
REVIEW
Ajay Rane, Jay Iyer, Harsha Ananthram, Thomas Currie
Human childbirth has been described as an "obstetrical dilemma". Evolution favours enlargement of the foetal brain, whilst bipedal locomotion demands a reduction in pelvic breadth for improvements in biomechanical efficiency. The result of this conflict is a human pelvis incongruous with the dynamics of childbirth. Acute genital distortion at delivery can inflict lasting damage to female pelvic function. Pelvic organ prolapse, urinary, faecal incontinence and sexual dysfunction are long-term sequelae rarely discussed at antenatal care, impacting upon the expectant mother's ability to make an informed decision...
June 2017: Journal of Obstetrics and Gynaecology of India
https://www.readbyqxmd.com/read/28546050/shared-decision-making-in-argentina-in-2017
#9
Mariela Barani, Karin Kopitowski, Carolina Carrara, María Victoria Ruiz Yanzi
Argentina is a high-middle income country located in Southern South America with an estimated population of 44 million inhabitants. The epidemiological profile of the population is characterised by an increase of non-communicable diseases. The health system is heterogeneous, fragmented and loosely integrated. There are no unified research agenda or government initiatives encouraging the implementation of and research on Shared Decision-Making (SDM). Progress has been made lately to respect patient autonomy through the enactment of the 'Patients' Rights Act', which expressly enshrines the right of patients to get information as a key element of decision-making...
May 22, 2017: Zeitschrift Für Evidenz, Fortbildung und Qualität Im Gesundheitswesen
https://www.readbyqxmd.com/read/28545741/-performance-and-optimisation-of-a-trigger-tool-for-the-detection-of-adverse-events-in-hospitalised-adult-patients
#10
Óscar Guzmán Ruiz, Juan José Pérez Lázaro, Pedro Ruiz López
OBJECTIVE: To characterise the performance of the triggers used in the detection of adverse events (AE) of hospitalised adult patients and to define a simplified panel of triggers to facilitate the detection of AE. METHOD: Cross-sectional study of charts of patients from a service of internal medicine to detect EA through systematic review of the charts and identification of triggers (clinical event often related to AE), determining if there was AE as the context in which it appeared the trigger...
May 22, 2017: Gaceta Sanitaria
https://www.readbyqxmd.com/read/28545653/systematic-approaches-to-adverse-events-in-obstetrics-part-ii-event-analysis-and-response
#11
Christian M Pettker
The critical arm of improvement and change comes after events are identified and classified. Getting and making things right when things go wrong defines a successful safety program. This article reviews the important tasks that should be familiar to any team approaching a serious event on an obstetrics unit. Root cause analysis is a critical, but often misunderstood, tool for dissecting the contributing factors leading to an adverse event. Successful root cause analyses have a standardized approach that result in meaningful action plans...
May 22, 2017: Seminars in Perinatology
https://www.readbyqxmd.com/read/28545391/a-random-effects-model-for-the-identification-of-differential-splicing-reids-using-exon-and-hta-arrays
#12
Marijke Van Moerbeke, Adetayo Kasim, Willem Talloen, Joke Reumers, Hinrick W H Göhlmann, Ziv Shkedy
BACKGROUND: Alternative gene splicing is a common phenomenon in which a single gene gives rise to multiple transcript isoforms. The process is strictly guided and involves a multitude of proteins and regulatory complexes. Unfortunately, aberrant splicing events do occur which have been linked to genetic disorders, such as several types of cancer and neurodegenerative diseases (Fan et al., Theor Biol Med Model 3:19, 2006). Therefore, understanding the mechanism of alternative splicing and identifying the difference in splicing events between diseased and healthy tissue is crucial in biomedical research with the potential of applications in personalized medicine as well as in drug development...
May 25, 2017: BMC Bioinformatics
https://www.readbyqxmd.com/read/28545322/cardiovascular-events-during-carfilzomib-therapy-for-relapsed-myeloma-practical-management-aspects-from-two-case-studies
#13
Andrzej J Jakubowiak, Jeanne M DeCara, Khalid Mezzi
Objectives and importance: Patients with multiple myeloma (MM) have an increased risk of cardiovascular comorbidities due to disease burden and treatment-related risk factors. Proteasome inhibitors, including bortezomib and carfilzomib, are effective and generally well tolerated anti-MM agents. However, cardiovascular-related toxicities have been reported with this class of agents, the mechanisms of which are not fully understood. We discuss the practical management of cardiovascular events during carfilzomib therapy for relapsed MM...
May 25, 2017: Hematology (Amsterdam, Netherlands)
https://www.readbyqxmd.com/read/28545283/-clinical-efficacy-and-safety-of-thrombolytic-treatment-with-reteplase-in-patients-with-intermediate-risk-acute-pulmonary-embolism
#14
H G Zhao, S X Wang, Z N Lu, X X Yan, Z C Lyu, F H Peng, Y Wu, X Gao, L Hua, Z C Jing, X Q Xu
Objective: To assess the efficacy and safety of thrombolytic treatment with reteplase in patients with intermediate-risk acute pulmonary embolism. Methods: Ten consecutive patients with intermediate-risk acute pulmonary embolism who received thrombolytic treatment with reteplase at Thrombosis and Vascular Medicine Center, Fuwai Hospital from March to November in 2016 were included.Vital signs, right ventricular diameter, systolic pulmonary artery pressure, and biochemical markers were assessed before and after thrombolytic therapy with reteplase, and bleeding complications were also observed during 3 months follow up...
April 24, 2017: Zhonghua Xin Xue Guan Bing za Zhi
https://www.readbyqxmd.com/read/28544855/descriptive-study-of-relationship-between-cardio-ankle-vascular-index-and-biomarkers-in-vascular-related-diseases
#15
Jinbo Liu, Huan Liu, Hongwei Zhao, Guangyun Shang, Yingyan Zhou, Lihong Li, Hongyu Wang
BACKGROUND: Cardio-ankle vascular index (CAVI) was supposed to be an independent predictor for vascular-related events. Biomarkers such as homocysteine (Hcy), N-terminal pro-brain natriuretic peptide (NT-proBNP), and urine albumin(microalbumin) (UAE) have involved the pathophysiological development of arteriosclerosis. The present study was to investigate relationship between CAVI and biomarkers in vascular-related diseases. METHODS: A total of 656 subjects (M/F 272/384) from department of Vascular Medicine were enrolled into our study...
May 25, 2017: Clinical and Experimental Hypertension: CHE
https://www.readbyqxmd.com/read/28544774/safety-pharmacokinetics-and-pharmacodynamics-of-hetrombopag-olamine-a-novel-tpo-r-agonist-in-healthy-subjects
#16
Li Zheng, Mao-Zhi Liang, Xiao-Ling Zeng, Cai-Zheng Li, Yi-Fan Zhang, Xiao-Yan Chen, Xi Zhu, An-Bo Xiang
Hetrombopag olamine (hetrombopag) is a novel small-molecule, orally bioavailable, non-peptide thrombopoietin (TPO) receptor agonist that is being developed as the treatment for thrombocytopenia. Two randomized, placebo-controlled phase I studies were conducted in 72 healthy subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of hetrombopag. Hetrombopag was orally administered with a single dose in 5 dose cohorts (5 mg, 10 mg, 20 mg, 30 mg or 40 mg) in the first study, and given once daily for 10 days in 3 dose cohorts (2...
May 24, 2017: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/28544662/tracheal-replacement-therapy-with-a-stem-cell-seeded-graft-lessons-from-compassionate-use-application-of-a-gmp-compliant-tissue-engineered-medicine
#17
Martin J Elliott, Colin R Butler, Aikaterini Varanou-Jenkins, Leanne Partington, Carla Carvalho, Edward Samuel, Claire Crowley, Peggy Lange, Nicholas J Hamilton, Robert E Hynds, Tahera Ansari, Paul Sibbons, Anja Fierens, Claire McLaren, Derek Roebuck, Colin Wallis, Nagarajan Muthialu, Richard Hewitt, David Crabbe, Sam M Janes, Paolo De Coppi, Mark W Lowdell, Martin A Birchall
Tracheal replacement for the treatment of end-stage airway disease remains an elusive goal. The use of tissue-engineered tracheae in compassionate use cases suggests that such an approach is a viable option. Here, a stem cell-seeded, decellularized tissue-engineered tracheal graft was used on a compassionate basis for a girl with critical tracheal stenosis after conventional reconstructive techniques failed. The graft represents the first cell-seeded tracheal graft manufactured to full good manufacturing practice (GMP) standards...
June 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28544284/the-national-healthcare-system-claims-databases-in-france-sniiram-and-egb-powerful-tools-for-pharmacoepidemiology
#18
Julien Bezin, Mai Duong, Régis Lassalle, Cécile Droz, Antoine Pariente, Patrick Blin, Nicholas Moore
The French health care system is based on universal coverage by one of several health care insurance plans. The SNIIRAM database merges anonymous information of reimbursed claims from all these plans, linked to the national hospital-discharge summaries database system (PMSI) and the national death registry. It now covers 98.8% of the French population, over 66 million persons, from birth (or immigration) to death (or emigration), making it possibly the world's largest continuous homogeneous claims database...
May 24, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28543877/it-s-time-to-move-on-from-the-bell-curve
#19
Lawrence R Robinson
The bell-curve was first described in the 18(th) century by de Moivre and Gauss to depict the distribution of binomial events, such as coin tossing, or repeated measures of physical objects. In the 19(th) and 20(th) centuries, the bell-curve was appropriated, or perhaps misappropriated, to apply to biologic and social measures across people. For many years we used it to derive reference values for our electrophysiologic studies. There is, however, no reason to believe that electrophysiologic measures should approximate a bell curve distribution, and empiric evidence suggests they do not...
May 23, 2017: Muscle & Nerve
https://www.readbyqxmd.com/read/28543626/smooth-semi-nonparametric-snp-estimation-of-the-cumulative-incidence-function
#20
Anh Nguyen Duc, Marcel Wolbers
This paper presents a novel approach to estimation of the cumulative incidence function in the presence of competing risks. The underlying statistical model is specified via a mixture factorization of the joint distribution of the event type and the time to the event. The time to event distributions conditional on the event type are modeled using smooth semi-nonparametric densities. One strength of this approach is that it can handle arbitrary censoring and truncation while relying on mild parametric assumptions...
May 23, 2017: Statistics in Medicine
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