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https://www.readbyqxmd.com/read/28230450/characteristics-and-medication-use-of-psoriasis-patients-who-may-or-may-not-qualify-for-randomized-controlled-trials
#1
William Malatestinic, Beth Nordstrom, Jashin J Wu, Orin Goldblum, Kathleen Solotkin, Chen-Yen Lin, Kristin Kistler, Kathy Fraeman, Joseph Johnston, Lcdr Lesley Hawley, Nicholas Sicignano, Andre Araujo
BACKGROUND: Clinical trials impose exclusion criteria that may limit the generalizability of results. OBJECTIVES: To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. METHODS: Moderate-to-severe psoriasis patients were identified from the U...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28212060/pembrolizumab-as-second-line-therapy-for-advanced-urothelial-carcinoma
#2
Joaquim Bellmunt, Ronald de Wit, David J Vaughn, Yves Fradet, Jae-Lyun Lee, Lawrence Fong, Nicholas J Vogelzang, Miguel A Climent, Daniel P Petrylak, Toni K Choueiri, Andrea Necchi, Winald Gerritsen, Howard Gurney, David I Quinn, Stéphane Culine, Cora N Sternberg, Yabing Mai, Christian H Poehlein, Rodolfo F Perini, Dean F Bajorin
Background Patients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options. Methods In this open-label, international, phase 3 trial, we randomly assigned 542 patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy to receive pembrolizumab (a highly selective, humanized monoclonal IgG4κ isotype antibody against programmed death 1 [PD-1]) at a dose of 200 mg every 3 weeks or the investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine...
February 17, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28202490/merck-ends-trial-of-potential-alzheimer-s-drug-verubecestat
#3
Nigel Hawkes
No abstract text is available yet for this article.
February 15, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28196978/ivermectin-enigmatic-multifaceted-wonder-drug-continues-to-surprise-and-exceed-expectations
#4
REVIEW
Andy Crump
Over the past decade, the global scientific community have begun to recognize the unmatched value of an extraordinary drug, ivermectin, that originates from a single microbe unearthed from soil in Japan. Work on ivermectin has seen its discoverer, Satoshi Ōmura, of Tokyo's prestigious Kitasato Institute, receive the 2014 Gairdner Global Health Award and the 2015 Nobel Prize in Physiology or Medicine, which he shared with a collaborating partner in the discovery and development of the drug, William Campbell of Merck & Co...
February 15, 2017: Journal of Antibiotics
https://www.readbyqxmd.com/read/28179454/fda-approval-summary-pembrolizumab-for-the-treatment-of-patients-with-unresectable-or-metastatic-melanoma
#5
Amy Barone, Maitreyee Hazarika, Marc R Theoret, Pallavi Mishra-Kalyani, Huanyu Chen, Kun He, Rajeshwari Sridhara, Sriram Subramaniam, Elimika Pfuma, Yaning Wang, Hongshan Li, Hong Zhao, Jeanne Fourie Zirkelbach, Patricia Keegan, Richard Pazdur
On December 18, 2015, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (KEYTRUDA®; Merck Sharp & Dohme Corp.) for treatment of patients with unresectable or metastatic melanoma, based on results of two randomized, open-label, active-controlled clinical trials. In Trial PN006, 834 patients with ipilimumab-naïve metastatic melanoma were randomized (1:1:1) to pembrolizumab 10 mg/kg intravenously (IV) every 2 (q2w) or 3 (q3w) weeks until disease progression or ipilimumab 3 mg/kg q3w for up to four doses...
February 8, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28137754/efficacy-and-safety-of-follitropin-alfa-lutropin-alfa-in-art-a-randomized-controlled-trial-in-poor-ovarian-responders
#6
P Humaidan, W Chin, D Rogoff, T D'Hooghe, S Longobardi, J Hubbard, J Schertz
STUDY QUESTION: How does the efficacy and safety of a fixed-ratio combination of recombinant human FSH plus recombinant human LH (follitropin alfa plus lutropin alfa; r-hFSH/r-hLH) compare with that of r-hFSH monotherapy for controlled ovarian stimulation (COS) in patients with poor ovarian response (POR)? SUMMARY ANSWER: The primary and secondary efficacy endpoints were comparable between treatment groups and the safety profile of both treatment regimens was favourable...
January 30, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28130435/cumulative-live-birth-rates-after-one-art-cycle-including-all-subsequent-frozen-thaw-cycles-in-1050-women-secondary-outcome-of-an-rct-comparing-gnrh-antagonist-and-gnrh-agonist-protocols
#7
M Toftager, J Bogstad, K Løssl, L Prætorius, A Zedeler, T Bryndorf, L Nilas, A Pinborg
STUDY QUESTION: Are cumulative live birth rates (CLBRs) similar in GnRH-antagonist and GnRH-agonist protocols for the first ART cycle including all subsequent frozen-thaw cycles from the same oocyte retrieval? SUMMARY ANSWER: The chances of at least one live birth following utilization of all fresh and frozen embryos after the first ART cycle are similar in GnRH-antagonist and GnRH-agonist protocols. WHAT IS KNOWN ALREADY: Reproductive outcomes of ART treatment are traditionally reported as pregnancies per cycle or per embryo transfer...
January 26, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28126017/ruptured-aortic-aneurysm-due-to-mycobacterium-bovis-bcg-with-a-delayed-bacteriological-diagnosis-due-to-false-negative-result-of-the-mpb-64-immunochromatographic-assay
#8
J Simar, L Belkhir, B Tombal, E André
BACKGROUND: Adjuvant therapy with bacillus Calmette-Guerin (BCG), a live attenuated strain of Mycobacterium bovis, has become the treatment of choice for low-risk superficial bladder carcinoma following transurethral resection of the bladder. Complications following vesical BCG instillations are uncommon but, in some cases, severe side-effects can occur such as sepsis or mycotic aneurysm. Besides usual laboratory techniques used for the diagnosis of Mycobacterium tuberculosis complex (MTBC) infections (smear microscopy and cultures), commercial immunochromatographic assays detecting MBP64, a 24 kDa M...
January 26, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28125365/cost-effectiveness-of-pembrolizumab-versus-ipilimumab-in-ipilimumab-na%C3%A3-ve-patients-with-advanced-melanoma-in-the-united-states
#9
Jingshu Wang, Bartosz Chmielowski, James Pellissier, Ruifeng Xu, Kendall Stevinson, Frank Xiaoqing Liu
BACKGROUND: Recent clinical trials have shown that pembrolizumab significantly prolonged progression-free survival and overall survival compared with ipilimumab in ipilimumab-naïve patients with unresectable or metastatic melanoma. However, there has been no published evidence on the cost-effectiveness of pembrolizumab for this indication. OBJECTIVE: To assess the long-term cost-effectiveness of pembrolizumab versus ipilimumab in ipilimumab-naïve patients with unresectable or meta-static melanoma from a U...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28121597/zinplava-tackles-toxins-of-hard-to-treat-c-difficile
#10
Thomas Morrow
Merck has recently received FDA approval for bezlotoxumab (Zinplava), as a treatment to reduce recurrence of C. diffcile in patients 18 years of age or older who are receiving antibiotic treatment for the infection and for whom there is a high risk of recurrence.
January 2017: Managed Care
https://www.readbyqxmd.com/read/28121498/bezlotoxumab-for-prevention-of-recurrent-clostridium-difficile-infection
#11
RANDOMIZED CONTROLLED TRIAL
Mark H Wilcox, Dale N Gerding, Ian R Poxton, Ciaran Kelly, Richard Nathan, Thomas Birch, Oliver A Cornely, Galia Rahav, Emilio Bouza, Christine Lee, Grant Jenkin, Werner Jensen, You-Sun Kim, Junichi Yoshida, Lori Gabryelski, Alison Pedley, Karen Eves, Robert Tipping, Dalya Guris, Nicholas Kartsonis, Mary-Beth Dorr
Background Clostridium difficile is the most common cause of infectious diarrhea in hospitalized patients. Recurrences are common after antibiotic therapy. Actoxumab and bezlotoxumab are human monoclonal antibodies against C. difficile toxins A and B, respectively. Methods We conducted two double-blind, randomized, placebo-controlled, phase 3 trials, MODIFY I and MODIFY II, involving 2655 adults receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection. Participants received an infusion of bezlotoxumab (10 mg per kilogram of body weight), actoxumab plus bezlotoxumab (10 mg per kilogram each), or placebo; actoxumab alone (10 mg per kilogram) was given in MODIFY I but discontinued after a planned interim analysis...
26, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28117904/the-effect-of-accelerated-mineral-trioxide-aggregate-on-odontoblastic-differentiation-in-dental-pulp-stem-cell-niches
#12
P Kulan, O Karabiyik, G T Kose, B Kargul
AIM: To investigate the effect of accelerated-set mineral trioxide aggregate (MTA) on the proliferation and odontoblastic differentiation of human dental pulp cell niches (DPSC). METHODOLOGY: ProRoot White MTA (WMTA) (Dentsply Tulsa Dental, Johnson City, TN, USA) was mixed with various additives, which included distilled water, 2.5% disodium hydrogen phosphate (Na2 HPO4 )(Merck, Darmstadt, Germany) and 5% calcium chloride (CaCl2 )(Merck). DPSC niches extracted from third molars were cultured directly on MTA in the culture medium...
January 24, 2017: International Endodontic Journal
https://www.readbyqxmd.com/read/28105986/canagliflozin-dapagliflozin-and-empagliflozin-monotherapy-for-treating-type-2-diabetes-systematic-review-and-economic-evaluation
#13
Rhona Johnston, Olalekan Uthman, Ewen Cummins, Christine Clar, Pamela Royle, Jill Colquitt, Bee Kang Tan, Andrew Clegg, Saran Shantikumar, Rachel Court, J Paul O'Hare, David McGrane, Tim Holt, Norman Waugh
BACKGROUND: Most people with type 2 diabetes are overweight, so initial treatment is aimed at reducing weight and increasing physical activity. Even modest weight loss can improve control of blood glucose. If drug treatment is necessary, the drug of first choice is metformin. However, some people cannot tolerate metformin, which causes diarrhoea in about 10%, and it cannot be used in people with renal impairment. This review appraises three of the newest class of drugs for monotherapy when metformin cannot be used, the sodium-glucose co-transporter 2 (SGLT2) inhibitors...
January 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28086819/efficacy-safety-and-effectiveness-of-licensed-rotavirus-vaccines-a-systematic-review-and-meta-analysis-for-latin-america-and-the-caribbean
#14
Raúl F Velázquez, Alexandre C Linhares, Sergio Muñoz, Pamela Seron, Pedro Lorca, Rodrigo DeAntonio, Eduardo Ortega-Barria
BACKGROUND: RotaTeq™ (RV5; Merck & Co. Inc., USA) and Rotarix™ (RV1, GlaxoSmithKline, Belgium) vaccines, developed to prevent rotavirus diarrhea in children under five years old, were both introduced into national immunization programs in 2006. As many countries in Latin America and the Caribbean have included either RV5 or RV1 in their routine childhood vaccination programs, we conducted a systematic review and meta-analysis to analyze efficacy, safety and effectiveness data from the region...
January 13, 2017: BMC Pediatrics
https://www.readbyqxmd.com/read/28077428/reproductive-experiences-of-women-who-cryopreserved-oocytes-for-non-medical-reasons
#15
Karin Hammarberg, Maggie Kirkman, Natasha Pritchard, Martha Hickey, Michelle Peate, John McBain, Franca Agresta, Chris Bayly, Jane Fisher
STUDY QUESTION: What are the reproductive experiences of women who cryopreserve oocytes for non-medical reasons? SUMMARY ANSWER: One in three women had been pregnant at some stage in their lives and while most still wanted to have a child or another child, very few had used their stored oocytes, predominantly because they did not want to be single parents. WHAT IS KNOWN ALREADY: The number of healthy women who freeze oocytes to avoid age-related infertility is increasing...
January 6, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28047431/su-f-r-51-radiomics-in-ct-perfusion-maps-of-head-and-neck-cancer
#16
M Nesteruk, O Riesterer, R Bundschuh, P Veit-Haibach, M Huellner, G Studer, S Stieb, S Glatz, M Pruschy, M Guckenberger, S Tanadini-Lang
PURPOSE: The aim of this study was to test the predictive value of radiomics features of CT perfusion (CTP) for tumor control, based on a preselection of radiomics features in a robustness study. METHODS: 11 patients with head and neck cancer (HNC) and 11 patients with lung cancer were included in the robustness study to preselect stable radiomics parameters. Data from 36 HNC patients treated with definitive radiochemotherapy (median follow-up 30 months) was used to build a predictive model based on these parameters...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28046700/mo-de-207b-11-reliability-of-pet-ct-radiomics-features-in-functional-and-morphological-components-of-nsclc-lesions-a-repeatability-analysis-in-a-prospective-multicenter-cohort
#17
M Desseroit, F Tixier, M Majdoub, W Weber, B Siegel, C Cheze Le Rest, D Visvikis, M Hatt
PURPOSE: The goal of this study was to evaluate the repeatability of radiomics features (intensity, shape and heterogeneity) in both PET and low-dose CT components of test-retest FDG-PET/CT images in a prospective multicenter cohort of 74 NSCLC patients from ACRIN 6678 and a similar Merck trial. METHODS: Seventy-four patients with stage III-IV NCSLC were prospectively included. The primary tumor and up to 3 additional lesions per patient were analyzed. The Fuzzy Locally Adaptive Bayesian algorithm was used to automatically delineate metabolically active volume (MAV) in PET...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28043367/effectiveness-of-intrauterine-treatment-with-cephapirin-in-dairy-cows-with-purulent-vaginal-discharge
#18
N Tison, E Bouchard, L DesCôteaux, R C Lefebvre
The objective of this study was to assess the efficacy of cephapirin intrauterine treatment preceding a timed artificial insemination protocol in lactating dairy cows with purulent vaginal discharges (PVDs). Holstein dairy cows (n = 1247) from 18 herds were enrolled in a controlled randomized clinical trial. At 34 days in milk (DIM; ±7 days), cows had a genital examination (transrectal palpation, vaginoscopy, and uterine bacteriology). They were randomly assigned to either the control group (CONT, no treatment) or the treatment group (CEPH) consisting of 1 intrauterine infusion of 500-mg cephapirin benzathine (RCL) (Metricure, Merck Animal Health, Montreal, Canada) regardless of the uterine health status...
February 2017: Theriogenology
https://www.readbyqxmd.com/read/28034886/sustained-antibody-responses-six-years-following-one-two-or-three-doses-of-quadrivalent-hpv-vaccine-in-adolescent-fijian-girls-and-subsequent-responses-to-a-single-dose-of-bivalent-hpv-vaccine-a-prospective-cohort-study
#19
Zheng Quan Toh, Fiona M Russell, Rita Reyburn, James Fong, Evelyn Tuivaga, Tupou Ratu, Cattram D Nguyen, Rachel Devi, Mike Kama, Silivia Matanitobua, Sepehr N Tabrizi, Suzanne M Garland, Rohit Sinha, Ian Frazer, Lisi Tikoduadua, Joseph Kado, Eric Rafai, Edward K Mulholland, Paul V Licciardi
BACKGROUND: The antibody response following reduced HPV vaccine doses has not been determined. We compared the antibody responses in girls previously vaccinated with zero, one, two or three doses of 4vHPV (Gardasil(®),Merck Inc.) six years previously. METHODS: A prospective cohort study was undertaken in 200 Fijian girls (15-19 years old). Approximately equal numbers of girls from two main ethnic groups (Fijians-of-Indian-Descent;FIDs) and (Indigenous-Fijians;iTaukei) in Fiji were recruited for each dosage groups...
December 28, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#20
(no author information available yet)
: Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
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