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Blinded end-point

James C Jackson, Dariush Mozaffarian, Amy J Graves, Nancy J Brown, Roberto Marchioli, Amy L Kiehl, E Wesley Ely
Background: Cognitive decline has been reported following cardiac surgery, leading to great interest in interventions to minimize its occurrence. Long-chain n-3 (ω-3) polyunsaturated fatty acids (PUFAs) have been associated with less cognitive decline in observational studies, yet no trials have tested the effects of n-3 PUFAs on cognitive decline after surgery. Objective: We sought to determine whether perioperative n-3 PUFA supplementation reduces postoperative cognitive decline in patients postcardiac surgery...
March 1, 2018: Journal of Nutrition
Darren M Brenner, Ronald Fogel, Spencer D Dorn, Richard Krause, Paul Eng, Robert Kirshoff, Anhthu Nguyen, Robert A Crozier, Leslie Magnus, Patrick H Griffin
OBJECTIVES: Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C). METHODS: Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks. The primary efficacy end point was the percentage of overall responders (patients reporting ≥30% reduction from baseline in worst abdominal pain plus an increase of ≥1 complete spontaneous bowel movement (CSBM)/week from baseline in the same week for ≥6 of 12 treatment weeks)...
March 15, 2018: American Journal of Gastroenterology
V Bhatia, V Gupta, D Khurana, R R Sharma, N Khandelwal
BACKGROUND AND PURPOSE: Stroke is a debilitating illness for which treatment window is limited. Most patients present to the healthcare facility beyond that window. Autologous stem cells have shown some promise for this group of patients. This study was performed to evaluate the safety and the efficacy of intra-arterial infusion of bone marrow-derived mononuclear cells in patients with middle cerebral artery ischemic stroke. MATERIALS AND METHODS: A prospective, randomized, open-label, blinded-end point study was performed from July 2015 to June 2016...
March 15, 2018: AJNR. American Journal of Neuroradiology
Shun Lu, Jianhua Chang, Xiaoqing Liu, Jianhua Shi, You Lu, Wei Li, Jin-Ji Yang, Jianying Zhou, Jie Wang, Tongtong An, Lei Yang, Zhe Liu, Xiangdong Zhou, Mo Chen, Ye Hua, Weiguo Su
Purpose Patients with advanced non‒small-cell lung cancer (NSCLC) who fail two lines of chemotherapy have unmet medical needs. The kinase inhibitor fruquintinib selectively targets vascular endothelial growth factor receptors and, hence, tumor angiogenesis and lymphogenesis. This randomized, double-blind, placebo-controlled, multicenter phase II trial evaluated the efficacy and safety of fruquintinib in patients with advanced nonsquamous NSCLC who experienced disease progression after second-line chemotherapy...
March 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Richard D Carvajal, Sophie Piperno-Neumann, Ellen Kapiteijn, Paul B Chapman, Stephen Frank, Anthony M Joshua, Josep M Piulats, Pascal Wolter, Veronique Cocquyt, Bartosz Chmielowski, T R Jeffry Evans, Lauris Gastaud, Gerald Linette, Carola Berking, Jacob Schachter, Manuel J Rodrigues, Alexander N Shoushtari, Delyth Clemett, Dana Ghiorghiu, Gabriella Mariani, Shirley Spratt, Susan Lovick, Peter Barker, Elaine Kilgour, Zhongwu Lai, Gary K Schwartz, Paul Nathan
Purpose Uveal melanoma is the most common primary intraocular malignancy in adults with no effective systemic treatment option in the metastatic setting. Selumetinib (AZD6244, ARRY-142886) is an oral, potent, and selective MEK1/2 inhibitor with a short half-life, which demonstrated single-agent activity in patients with metastatic uveal melanoma in a randomized phase II trial. Methods The Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) study was a phase III, double-blind trial ( ClinicalTrial...
March 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
William B White, Kenneth G Saag, Michael A Becker, Jeffrey S Borer, Philip B Gorelick, Andrew Whelton, Barbara Hunt, Majin Castillo, Lhanoo Gunawardhana
Background Cardiovascular risk is increased in patients with gout. We compared cardiovascular outcomes associated with febuxostat, a nonpurine xanthine oxidase inhibitor, with those associated with allopurinol, a purine base analogue xanthine oxidase inhibitor, in patients with gout and cardiovascular disease. Methods We conducted a multicenter, double-blind, noninferiority trial involving patients with gout and cardiovascular disease; patients were randomly assigned to receive febuxostat or allopurinol and were stratified according to kidney function...
March 12, 2018: New England Journal of Medicine
Otavio Berwanger, Jose C Nicolau, Antonio C Carvalho, Lixin Jiang, Shaun G Goodman, Stephen J Nicholls, Alexander Parkhomenko, Oleg Averkov, Carlos Tajer, Germán Malaga, Jose F K Saraiva, Francisco A Fonseca, Fábio A De Luca, Helio P Guimaraes, Pedro G M de Barros E Silva, Lucas P Damiani, Denise M Paisani, Camila M R Lasagno, Carolina T Candido, Nanci Valeis, Diogo D F Moia, Leopoldo S Piegas, Christopher B Granger, Harvey D White, Renato D Lopes
Importance: The bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy remains uncertain. Objective: To evaluate the short-term safety of ticagrelor when compared with clopidogrel in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy. Design, Setting and Participants: We conducted a multicenter, randomized, open-label with blinded end point adjudication trial that enrolled 3799 patients (younger than 75 years) with ST-segment elevation myocardial infarction receiving fibrinolytic therapy in 152 sites from 10 countries from November 2015 through November 2017...
March 11, 2018: JAMA Cardiology
Steven E Nissen, Sreekumar G Pillai, Stephen J Nicholls, Kathy Wolski, Jeffrey S Riesmeyer, Govinda J Weerakkody, Wendra M Foster, Ellen McErlean, Lin Li, Pallav Bhatnagar, Giacomo Ruotolo, A Michael Lincoff
Importance: A pharmacogenetic analysis of dalcetrapib, a cholesteryl ester transfer protein inhibitor, reported an association between a single-nucleotide polymorphism (SNP) in the ADCY9 gene (rs1967309) and reduction in major adverse cardiovascular events despite a neutral result for the overall trial. Objective: To determine whether the association between the SNP in the ADCY9 gene and a reduction in major adverse cardiovascular events could be replicated for another cholesteryl ester transfer protein inhibitor, evacetrapib, in patients with high-risk vascular disease...
March 11, 2018: JAMA Cardiology
Dana E Rathkopf, Tomasz M Beer, Yohann Loriot, Celestia S Higano, Andrew J Armstrong, Cora N Sternberg, Johann S de Bono, Bertrand Tombal, Teresa Parli, Suman Bhattacharya, De Phung, Andrew Krivoshik, Howard I Scher, Michael J Morris
Importance: Drug development for metastatic castration-resistant prostate cancer has been limited by a lack of clinically relevant trial end points short of overall survival (OS). Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients. Objective: To demonstrate the robustness of the PCWG2 definition and to examine the relationship between rPFS and OS...
March 8, 2018: JAMA Oncology
Yuchi Wu, Lihong Yang, Lingli Li, Xiuqing Wu, Zhicong Zhong, Zhiren He, Hongyan Ma, Lixin Wang, Zhaoyu Lu, Cun Cai, Daixin Zhao, Xiangxin Meng, Airong Qi, Aicheng Yang, Guobin Su, Xinfeng Guo, Xusheng Liu, Chuan Zou, Qizhan Lin
BACKGROUND: Patients on maintenance hemodialysis (MHD) frequently complain of insomnia. Poor sleep quality impairs their quality of life and adversely affects long-term outcome. Previously we applied auricular acupressure therapy (AAT) for MHD patients with insomnia and yielded favorable results. AAT probably improves sleep quality by stimulating the vagus nerve and inhibiting sympathetic overactivity. However, the efficacy of AAT for insomnia in this population is still lacking. The proposed randomized controlled trial (RCT) will evaluate the efficacy and safety of AAT for improvement of sleep quality in MHD patients with insomnia...
March 7, 2018: Trials
Gonzague Jourdain, Nicole Ngo-Giang-Huong, Linda Harrison, Luc Decker, Woottichai Khamduang, Camlin Tierney, Nicolas Salvadori, Tim R Cressey, Wasna Sirirungsi, Jullapong Achalapong, Prapap Yuthavisuthi, Prateep Kanjanavikai, Orada P Na Ayudhaya, Thitiporn Siriwachirachai, Sinart Prommas, Prapan Sabsanong, Aram Limtrakul, Supang Varadisai, Chaiwat Putiyanun, Pornnapa Suriyachai, Prateung Liampongsabuddhi, Suraphan Sangsawang, Wanmanee Matanasarawut, Sudanee Buranabanjasatean, Pichit Puernngooluerm, Chureeratana Bowonwatanuwong, Thanyawee Puthanakit, Virat Klinbuayaem, Satawat Thongsawat, Sombat Thanprasertsuk, George K Siberry, Diane H Watts, Nahida Chakhtoura, Trudy V Murphy, Noele P Nelson, Raymond T Chung, Stanislas Pol, Nantasak Chotivanich
BACKGROUND: Pregnant women with an elevated viral load of hepatitis B virus (HBV) have a risk of transmitting infection to their infants, despite the infants' receiving hepatitis B immune globulin. METHODS: In this multicenter, double-blind clinical trial performed in Thailand, we randomly assigned hepatitis B e antigen (HBeAg)-positive pregnant women with an alanine aminotransferase level of 60 IU or less per liter to receive tenofovir disoproxil fumarate (TDF) or placebo from 28 weeks of gestation to 2 months post partum...
March 8, 2018: New England Journal of Medicine
So-Yeon Jeon, Hye Sook Han, Woo Kyun Bae, Moo-Rim Park, Hyeok Shim, Sang-Cheol Lee, Se-Il Go, Hwan Jung Yun, Yong-Jin Im, Eun-Kee Song
Purpose: Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC. Materials and Methods: We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting...
February 27, 2018: Cancer Research and Treatment: Official Journal of Korean Cancer Association
Margaret Noyes Essex, Hee-Youn Choi, Pritha Bhadra Brown, Raymond Cheung
Purpose: Parecoxib is an injectable cyclooxygenase-2 inhibitor with proven postoperative analgesic efficacy in a variety of settings, including total knee arthroplasty (TKA). The effect of ethnicity on the efficacy of parecoxib for post-TKA pain has not been studied. Patients and methods: This was a parallel-group, double-blind, randomized, placebo- controlled study of ethnically Korean patients aged ≥18 years who had unilateral TKA. Patients who reported moderate or severe pain 6 hours after the end of postoperative opioid analgesia were randomized to receive a single intravenous dose of parecoxib sodium 40 mg or placebo...
2018: Journal of Pain Research
S Keisin Wang, Linden A Green, Ashley R Gutwein, Natalie A Drucker, Clifford M Babbey, Alok K Gupta, Andres Fajardo, Raghu L Motaganahalli, Michael G Wilson, Michael P Murphy
OBJECTIVE: Ethnic minorities (nonwhites) with critical limb ischemia (CLI) have historically performed worse compared with whites with regard to major amputation risk reduction and amputation-free survival (AFS) after peripheral vascular intervention. This post hoc analysis was completed to determine whether this precedent also extended to treatment of CLI without a suitable revascularization option with intramuscular injections of concentrated bone marrow aspirate (cBMA). METHODS: The treatment arm of the randomized, double-blind, multicenter MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease (MOBILE) trial was stratified by ethnicity and evaluated for demographics, comorbidities, and outcomes...
March 1, 2018: Journal of Vascular Surgery
James A Simon, Leonard Derogatis, David Portman, Louise Brown, James Yuan, Robert Kissling
BACKGROUND: To evaluate the safety of flibanserin in premenopausal and naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) in an open-label extension (OLE) study. AIM: To examine the safety and tolerability of flibanserin 100 mg once daily at bedtime in the treatment of premenopausal and naturally postmenopausal women with HSDD in a multicenter 28-week OLE study. METHODS: Patients entering this study received flibanserin or placebo in the double-blinded, placebo-controlled trials of premenopausal and postmenopausal women and in a pharmacokinetic study of postmenopausal women...
March 2018: Journal of Sexual Medicine
Xavier Pivot, Jean Paul Deslypere, Lisa Soyeon Park, Michael Jinwoo Kim, Wonjae Lee, Jeonghyeon Lee
PURPOSE: This first-in-human study of HD201 was designed to evaluate the pharmacokinetic (PK) equivalence between this biosimilar candidate and trastuzumab sourced in the European Union (EU-trastuzumab)*. METHODS: In this randomized, blinded, single-dose comparative PK study, healthy male subjects were randomized to receive a single 6 mg/kg IV dose of HD201 or EU-trastuzumab. The primary PK end point was AUC0-∞ . Equivalence was determined by using the predefined margins of 0...
March 1, 2018: Clinical Therapeutics
Dan Siskind, Nadia Friend, Anthony Russell, John J McGrath, Carmen Lim, Sue Patterson, Dylan Flaws, Terry Stedman, Vikas Moudgil, Savio Sardinha, Shuichi Suetani, Steve Kisely, Karl Winckel, Andrea Baker
INTRODUCTION: Clozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation. METHODS AND ANALYSIS: A 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement...
March 2, 2018: BMJ Open
Gianluca Moroncini, Elena Maccaroni, Ilaria Fiordoliva, Chiara Pellei, Armando Gabrielli, Rossana Berardi
Lartruvo® (olaratumab) is a fully human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that inhibits platelet-derived growth factor receptor alpha (PDGFRα). The antitumor activity of olaratumab has been tested in vitro and in vivo, and inhibition of tumor growth has been observed in cancer cell lines, including glioblastoma and leiomyosarcoma cells. It represents the first-in-class antibody to be approved by regulatory authorities for the treatment of advanced soft-tissue sarcomas (STSs) in combination with doxorubicin, based on the results of the Phase Ib/II trial by Tap et al...
2018: OncoTargets and Therapy
Joseph C Cappelleri, Li-Jung Tseng, Vera J Stecher, Stanley E Althof
AIM: To determine what constitutes a clinically important difference (CID) on the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), an 11-item validated questionnaire assessing treatment satisfaction used in clinical trials for patients with erectile dysfunction (ED). METHODS: Erectile Dysfunction Inventory of Treatment Satisfaction data were evaluated from a double-blind, fixed-dose trial of 279 men aged 18-65 years with ED who were treated with sildenafil 50 or 100 mg or placebo...
March 1, 2018: International Journal of Clinical Practice
Lei Zhang, Yi Li, Bai-Song Yang, Lu Li, Xiao-Zeng Wang, Mei-Ling Ge, Quan-Min Jing, Ying-Yan Ma, Geng Wang, Hai-Wei Liu, Xin Zhao, Bin Wang, Kai Xu, Ya-Ling Han
Background: High platelet reactivity (HPR) during clopidogrel treatment predicts postpercutaneous coronary intervention (PCI) ischemic events strongly and independently. Tongxinluo capsules (TCs) are a traditional Chinese medicine formulation used as antiplatelet treatment. However, its efficacy against HPR is not known. The aim of the present study was to evaluate the effects of TCs in acute coronary syndrome (ACS) patients with HPR. Methods: This multicenter, randomized, double-blind, placebo-controlled study prospectively analyzed 136 ACS patients with HPR who underwent PCI...
March 5, 2018: Chinese Medical Journal
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