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https://www.readbyqxmd.com/read/27933698/sofosbuvir-plus-ribavirin-in-treatment-na%C3%A3-ve-patients-with-chronic-hepatitis-c-virus-genotype-1-or-3-infection-in-india
#1
S R Shah, A Chowdhury, R Mehta, D Kapoor, A Duseja, A Koshy, A Shukla, A Sood, K Madan, R Sud, S Nijhawan, R Pawan, M Prasad, K Kersey, D Jiang, E Svarovskaia, B Doehle, B Kanwar, M Subramanian, S K Acharya, S Sarin
Until 2014, pegylated interferon plus ribavirin was the recommended standard of care for the treatment of chronic hepatitis C virus (HCV) infection in India. This open-label phase 3b study, conducted across 14 sites in India between 31 March 2014 and 30 November 2015, evaluated the efficacy and safety of sofosbuvir plus ribavirin therapy among treatment-naïve patients with chronic genotype 1 or 3 HCV infection. A total of 117 patients with genotype 1 or 3 HCV infection were randomized 1:1 to receive sofosbuvir 400 mg and weight-based ribavirin (1000 or 1200 mg) daily for 16 or 24 weeks...
December 9, 2016: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/27933145/ensuring-timely-thromboprophylaxis-on-a-medical-assessment-unit
#2
Oluwatosin Akinbobuyi, Louise Shalders, Tim Nokes
The Department of Health has defined hospital acquired venous thromboembolism (VTE) as any VTE event occurring within 90 days of hospital admission or surgery. (1) Hospital acquired thrombosis (HAT) is common during and after hospital admission and is considered a major patient safety issue. Current NICE guideline (CG 92) 2010, recommends that medical patients assessed at risk of VTE should have pharmacological prophylaxis commenced as soon as possible after risk assessment has been completed and continued until the patient is no longer at increased risk of VTE...
2016: BMJ Quality Improvement Reports
https://www.readbyqxmd.com/read/27932884/a-randomized-trial-of-aripiprazole-vs-blonanserin-for-the-treatment-of-acute-schizophrenia-and-related-disorders
#3
Taro Kishi, Yuki Matsuda, Shinji Matsunaga, Tomohiko Mukai, Masatsugu Moriwaki, Hideaki Tabuse, Kiyoshi Fujita, Nakao Iwata
OBJECTIVE: There has been no direct comparison of aripiprazole and blonanserin for schizophrenia treatment. We conducted a 24-week, rater-masked, randomized trial of aripiprazole (6-30 mg/d) vs blonanserin (4-24 mg/d) in schizophrenia patients who were not taking any antipsychotic medication for more than 2 weeks before enrollment (UMIN000011194). METHODS: The primary outcome measure for efficacy was improvement of Positive and Negative Syndrome Scale (PANSS) total score at week 24...
2016: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/27932871/efficacy-and-safety-outcomes-of-fractional-flow-reserve-in-guiding-clinical-therapy-of-non-st-segment-elevation-myocardial-infarction-compared-with-angiography-alone-in-elderly-chinese-patients
#4
Zhao Zhang, Ke Li, Jinwen Tian
OBJECTIVE: Fractional flow reserve (FFR) is an innovative method for evaluating the physiological significance of a coronary stenosis, but its validity is less certain in patients with non-ST-segment elevation myocardial infarction (NSTEMI). It is important to assess whether FFR is effective and safe in patients, especially elderly Chinese patients, with NSTEMI. As the first one in China, the purpose of this study was to establish the efficacy and safety outcomes of FFR in guiding clinical therapy of NSTEMI compared with angiography alone in elderly Chinese patients...
2016: Clinical Interventions in Aging
https://www.readbyqxmd.com/read/27932607/randomized-open-label-phase-1-2a-study-to-determine-the-maximum-tolerated-dose-of-intraventricular-sustained-release-nimodipine-for-subarachnoid-hemorrhage-newton-nimodipine-microparticles-to-enhance-recovery-while-reducing-toxicity-after-subarachnoid-hemorrhage
#5
Daniel Hänggi, Nima Etminan, Francois Aldrich, Hans Jakob Steiger, Stephan A Mayer, Michael N Diringer, Brian L Hoh, J Mocco, Herbert J Faleck, R Loch Macdonald
BACKGROUND AND PURPOSE: We conducted a randomized, open-label, phase 1/2a, dose-escalation study of intraventricular sustained-release nimodipine (EG-1962) to determine safety, tolerability, pharmacokinetics, and clinical effects in aneurysmal subarachnoid hemorrhage. METHODS: Subjects with aneurysmal subarachnoid hemorrhage repaired by clipping or coiling were randomized to EG-1962 or enteral nimodipine. Subjects were World Federation of Neurological Surgeons grade 2 to 4 and had an external ventricular drain...
December 8, 2016: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/27932510/embolization-of-intracranial-dural-arteriovenous-fistulas-using-phil-liquid-embolic-agent-in-26-patients-a-multicenter-study
#6
S Lamin, H S Chew, S Chavda, A Thomas, M Piano, L Quilici, G Pero, M Holtmannspolter, M E Cronqvist, A Casasco, L Guimaraens, L Paul, A Gil Garcia, A Aleu, R Chapot
BACKGROUND AND PURPOSE: The introduction of liquid embolic agents has revolutionized endovascular approach to cranial vascular malformations. The aim of the study was to retrospectively assess the efficacy and safety of Precipitating Hydrophobic Injectable Liquid (PHIL), a new nonadhesive liquid embolic agent, in the treatment of patients with cranial dural arteriovenous fistulas. The primary end point was the rate of complete occlusion of dural arteriovenous fistulas. Secondary end points included the incidence of adverse events and clinical status at 3-month follow-up...
December 8, 2016: AJNR. American Journal of Neuroradiology
https://www.readbyqxmd.com/read/27932427/retrieval-of-the-leadless-cardiac-pacemaker-a-multicenter-experience
#7
Vivek Y Reddy, Marc A Miller, Reinoud E Knops, Petr Neuzil, Pascal Defaye, Werner Jung, Rahul Doshi, Mark Castellani, Adam Strickberger, R Hardwin Mead, Harish Doppalapudi, Dhanunjaya Lakkireddy, Matthew Bennett, Johannes Sperzel
BACKGROUND: Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans. METHODS AND RESULTS: This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt...
December 2016: Circulation. Arrhythmia and Electrophysiology
https://www.readbyqxmd.com/read/27932411/mod-4023-a-long-acting-carboxy-terminal-peptide-ctp-modified-human-growth-hormone-results-of-a-phase-2-study-in-growth-hormone-deficient-adults
#8
Christian J Strasburger, Peter Vanuga, Juraj Payer, Marija Pfeifer, Vera Popović, Laszlo Bajnok, Miklós I Góth, Věra Olšovská, Ľudmila Trejbalová, Janos Vadasz, Eyal Fima, Ronit Koren, Leanne Amitzi, Martin Bidlingmaier, Gili Hart, Beverly M K Biller
OBJECTIVE: Growth hormone (GH) replacement therapy currently requires daily injections, which may cause distress and low compliance. C-terminal peptide (CTP)-modified growth hormone (MOD-4023) is being developed as a once-weekly dosing regimen in patients with GH deficiency (GHD). This study's objective is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MOD-4023 administered once weekly in GHD adults. DESIGN: 54 adults with GHD currently treated with daily GH were normalized and randomized into 4 weekly dosing cohorts of MOD-4023 at 18...
December 8, 2016: European Journal of Endocrinology
https://www.readbyqxmd.com/read/27932335/multicentre-randomised-placebo-controlled-trial-of-oral-anticoagulation-with-apixaban-in-systemic-sclerosis-related-pulmonary-arterial-hypertension-the-sphinx-study-protocol
#9
Alicia Calderone, Wendy Stevens, David Prior, Harshal Nandurkar, Eli Gabbay, Susanna M Proudman, Trevor Williams, David Celermajer, Joanne Sahhar, Peter K K Wong, Vivek Thakkar, Nathan Dwyer, Jeremy Wrobel, Weng Chin, Danny Liew, Margaret Staples, Rachelle Buchbinder, Mandana Nikpour
INTRODUCTION: Systemic sclerosis (SSc) is a severe and costly multiorgan autoimmune connective tissue disease characterised by vasculopathy and fibrosis. One of the major causes of SSc-related death is pulmonary arterial hypertension (PAH), which develops in 12-15% of patients with SSc and accounts for 30-40% of deaths. In situ thrombosis in the small calibre peripheral pulmonary vessels resulting from endothelial dysfunction and an imbalance of anticoagulant and prothrombotic mediators has been implicated in the complex pathophysiology of SSc-related PAH (SSc-PAH), with international clinical guidelines recommending the use of anticoagulants for some types of PAH, such as idiopathic PAH...
December 8, 2016: BMJ Open
https://www.readbyqxmd.com/read/27932315/design-and-testing-of-the-safety-agenda-mobile-app-for-managing-health-care-managers-patient-safety-responsibilities
#10
José Joaquín Mira, Irene Carrillo, Cesar Fernandez, Maria Asuncion Vicente, Mercedes Guilabert
BACKGROUND: Adverse events are a reality in clinical practice. Reducing the prevalence of preventable adverse events by stemming their causes requires health managers' engagement. OBJECTIVE: The objective of our study was to develop an app for mobile phones and tablets that would provide managers with an overview of their responsibilities in matters of patient safety and would help them manage interventions that are expected to be carried out throughout the year...
December 8, 2016: JMIR MHealth and UHealth
https://www.readbyqxmd.com/read/27932229/regorafenib-for-patients-with-hepatocellular-carcinoma-who-progressed-on-sorafenib-treatment-resorce-a-randomised-double-blind-placebo-controlled-phase-3-trial
#11
Jordi Bruix, Shukui Qin, Philippe Merle, Alessandro Granito, Yi-Hsiang Huang, György Bodoky, Marc Pracht, Osamu Yokosuka, Olivier Rosmorduc, Valeriy Breder, René Gerolami, Gianluca Masi, Paul J Ross, Tianqiang Song, Jean-Pierre Bronowicki, Isabelle Ollivier-Hourmand, Masatoshi Kudo, Ann-Lii Cheng, Josep M Llovet, Richard S Finn, Marie-Aude LeBerre, Annette Baumhauer, Gerold Meinhardt, Guohong Han
BACKGROUND: There are no systemic treatments for patients with hepatocellular carcinoma (HCC) whose disease progresses during sorafenib treatment. We aimed to assess the efficacy and safety of regorafenib in patients with HCC who have progressed during sorafenib treatment. METHODS: In this randomised, double-blind, parallel-group, phase 3 trial done at 152 sites in 21 countries, adults with HCC who tolerated sorafenib (≥400 mg/day for ≥20 of last 28 days of treatment), progressed on sorafenib, and had Child-Pugh A liver function were enrolled...
December 5, 2016: Lancet
https://www.readbyqxmd.com/read/27932134/efficacy-and-safety-of-therapy-with-simeprevir-and-sofosbuvir-in-liver-transplant-recipients-infected-by-hepatitis-c-virus-genotype-4-cohort-spanish-society-of-liver-transplantation-cohort
#12
G Sanchez Antolin, M Testillano, J M Pascasio, I Narvaez Rodriguez, M Prieto, A Otero, J I Herrero, M Londoño, I Fernandez Vazquez, L Castells
BACKGROUND: Patients with hepatitis C virus (HCV) genotype 4 infection are poorly represented in clinical trials of 2nd-generation direct-acting antivirals (DAAs), and more data are needed to help guide treatment decisions. We still have even fewer data concerning liver transplant patients. Simeprevir (SIM) and sofosbuvir (SOF) combination is useful to treat this genotype. The aim of this study was to know the efficacy and safety of the combination SIM + SOF ± ribavirin (RBV) in a group of liver transplant patients with HCV genotype 4 infection in Spain in real life...
November 2016: Transplantation Proceedings
https://www.readbyqxmd.com/read/27932068/rovalpituzumab-tesirine-a-dll3-targeted-antibody-drug-conjugate-in-recurrent-small-cell-lung-cancer-a-first-in-human-first-in-class-open-label-phase-1-study
#13
Charles M Rudin, M Catherine Pietanza, Todd M Bauer, Neal Ready, Daniel Morgensztern, Bonnie S Glisson, Lauren A Byers, Melissa L Johnson, Howard A Burris, Francisco Robert, Tae H Han, Sheila Bheddah, Noah Theiss, Sky Watson, Deepan Mathur, Bharathi Vennapusa, Hany Zayed, Satwant Lally, Donald K Strickland, Ramaswamy Govindan, Scott J Dylla, Stanford L Peng, David R Spigel
BACKGROUND: Rovalpituzumab tesirine is a first-in-class antibody-drug conjugate directed against delta-like protein 3 (DLL3), a novel target identified in tumour-initiating cells and expressed in more than 80% of patients with small-cell lung cancer. We aimed to assess the safety and activity of rovalpituzumab tesirine in patients who progressed after one or more previous regimen. METHODS: We conducted a phase 1 open-label study at ten cancer centres in the USA...
December 2, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27932067/nivolumab-plus-ipilimumab-as-first-line-treatment-for-advanced-non-small-cell-lung-cancer-checkmate-012-results-of-an-open-label-phase-1-multicohort-study
#14
Matthew D Hellmann, Naiyer A Rizvi, Jonathan W Goldman, Scott N Gettinger, Hossein Borghaei, Julie R Brahmer, Neal E Ready, David E Gerber, Laura Q Chow, Rosalyn A Juergens, Frances A Shepherd, Scott A Laurie, William J Geese, Shruti Agrawal, Tina C Young, Xuemei Li, Scott J Antonia
BACKGROUND: Nivolumab has shown improved survival in the treatment of advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy. We assessed the safety and activity of combination nivolumab plus ipilimumab as first-line therapy for NSCLC. METHODS: The open-label, phase 1, multicohort study (CheckMate 012) cohorts reported here were enrolled at eight US academic centres. Eligible patients were aged 18 years or older with histologically or cytologically confirmed recurrent stage IIIb or stage IV, chemotherapy-naive NSCLC...
December 2, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27931828/targeting-mtor-pathway-in-gynecological-malignancies-biological-rationale-and-systematic-review-of-published-data
#15
REVIEW
Loay Kassem, Omar Abdel-Rahman
BACKGROUND: mTOR inhibitors are widely used in different malignancies with several trials testing their efficacy and safety in gynecological malignancies. We aimed to review the current evidence that support the expansion of using such drugs in the treatment of advanced gynecological cancers. METHODS: A comprehensive systematic review of literature has been conducted to include prospective trials that used everolimus, temsirolimus or ridaforolimus in the management of gynecological cancers and have available efficacy and toxicity results...
December 2016: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/27931638/complications-of-diagnostic-and-therapeutic-endoscopic-ultrasound
#16
REVIEW
Sundeep Lakhtakia
Endoscopic Ultrasound (EUS) provides the unique opportunity to visualize, interrogate and intervene gastrointestinal (GI) luminal, mural or peri-luminal structures and pathology with negligible adverse effects. Diagnostic, upper GI and rectal EUS is feasible, extremely safe, and efficacious. Most EUS guided interventions are safe, effective and minimally invasive, compared to peers in the percutaneous radiological or surgical procedures. As with any endoscopic procedure, EUS and its guided interventions may be accompanied by adverse events...
October 2016: Best Practice & Research. Clinical Gastroenterology
https://www.readbyqxmd.com/read/27931631/complications-of-diagnostic-colonoscopy-upper-endoscopy-and-enteroscopy
#17
REVIEW
Idan Levy, Ian M Gralnek
Endoscopy is an inherent and an invaluable tool in every gastroenterologist's armamentarium. The prerequisite for quality and safety remains foremost. Adverse events should be minimized and proactive steps should taken before, during and after the endoscopic procedure. Upper endoscopy and colonoscopy are part of basic endoscopy and their major complications will be reviewed here, together with those of enteroscopy. The most common of all endoscopy related complications are cardiopulmonary and thus they will be addressed in detail first...
October 2016: Best Practice & Research. Clinical Gastroenterology
https://www.readbyqxmd.com/read/27931543/efficacy-and-safety-of-the-intensive-dose-of-rosuvastatin-40mg-day-in-patients-with-acute-coronary-syndrome-and-at-high-risk-of-cardiovascular-disease-rosuvees-2
#18
Chetan P Shah, Bhaskar P Shah, Sameer I Dani, B B Channa, S S Lakshmanan, N C Krishnamani, Ashwani Mehta, P Moorthy
BACKGROUND: Randomized clinical trials have established the benefits of statin therapy in acute coronary syndromes (ACS) via their pleiotropic effects. AIM OF THE STUDY: This was a 12-week, open-label, multicenter, postmarketing observational study evaluating the efficacy and safety of rosuvastatin 40 mg/day in very high-risk or high-risk Indian patients according to NCEP ATP III guidelines. METHODOLOGY: One hundred and sixty two patients (age: 30 to 69 years) with evidence of coronary artery disease, hospitalized with chest pain with/without electrocardiogram changes and with non-ST segment elevation ACS and ST segment elevation ACS who received optimal reperfusion therapy were enrolled...
November 2016: Indian Heart Journal
https://www.readbyqxmd.com/read/27931515/autologous-adipose-derived-mesenchymal-stromal-cells-for-the-treatment-of-psoriasis-vulgaris-and-psoriatic-arthritis-a-case-report
#19
Miguel M De Jesus, Jayson S Santiago, Camille V Trinidad, Melvin E See, Kimberly R Semon, Manuel O Fernandez, Francisco S Chung
Psoriasis is a dermatologic disease of immune origins with no definitive cure. We report the Makati Medical Center experience of utilizing autologous mesenchymal stromal cells (MSCs) for one patient with psoriasis vulgaris (PV) and another with psoriatic arthritis (PA). Patients were educated and gave informed consent, according to the principles of the Declaration of Helsinki. The protocol was approved by the Cellular Transplantation Ethics Committee of the Makati Medical Center. Autologous MSCs were cultured from lipoaspirate and expanded in a clean room class 100 facility (Cellular Therapeutics Center, Makati Medical Center)...
November 2016: Cell Transplantation
https://www.readbyqxmd.com/read/27931305/subcutaneous-administration-of-human-c1-inhibitor-with-recombinant-human-hyaluronidase-in-patients-with-hereditary-angioedema
#20
Marc A Riedl, William R Lumry, H Henry Li, Aleena Banerji, Jonathan A Bernstein, Murat Ba, Janne Bjrkander, Markus Magerl, Marcus Maurer, Kevin Rockich, Hongzi Chen, Jennifer Schranz
BACKGROUND: The currently approved method of C1 inhibitor (C1 INH) administration for patients with hereditary angioedema with C1 INH deficiency (HAE) is by intravenous injection. A C1 INH subcutaneous formulation may provide an attractive mode of administration for some patients. OBJECTIVE: To evaluate efficacy and safety of two doses of subcutaneous, plasma-derived C1 INH with the dispersing agent, recombinant human hyaluronidase (rHuPH20) to prevent angioedema attacks in patients with HAE...
November 2016: Allergy and Asthma Proceedings:
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