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H H Yoon, J C Bendell, F S Braiteh, I Firdaus, P A Philip, A L Cohn, N Lewis, D M Anderson, E Arrowsmith, J D Schwartz, L Gao, Y Hsu, Y Xu, D Ferry, S R Alberts, Z A Wainberg
BACKGROUND: We report the first randomized, Phase II trial of ramucirumab, an anti-vascular endothelial growth factor receptor-2 monoclonal antibody, as front-line therapy in patients with advanced adenocarcinoma of the esophagus or gastric/gastroesophageal junction (GEJ). PATIENTS AND METHODS: Patients from the USA with advanced esophageal, gastric, or GEJ adenocarcinoma randomly received (1:1) mFOLFOX6 plus ramucirumab (8 mg/kg) or mFOLFOX6 plus placebo every 2 weeks...
October 20, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Vahideh Lajevardi, Afsaneh Ghayoumi, Robabeh Abedini, Hamed Hosseini, Azadeh Goodarzi, Zahra Akbari, Kosar Hedayat
BACKGROUND: Melasma's high prevalence and profound psychological impact on patients necessitate efficacious, economical, and safe therapeutic interventions. Adjunctive therapies such as tranexamic acid (TA) can enhance the therapeutic effect of standard treatments like hydroquinone 4% cream (HQ). OBJECTIVE: To conduct an assessor- and analyst-blinded, parallel, superiority, randomized controlled trial to compare the clinical efficacy and safety of oral TA plus HQ vs...
October 20, 2016: Journal of Cosmetic Dermatology
Francisco J Tinahones, Baptist Gallwitz, Matias Nordaby, Sophia Götz, Mario Maldonado-Lutomirsky, Hans J Woerle, Uli C Broedl
AIM: To evaluate the efficacy and safety of linagliptin versus placebo as add-on to empagliflozin and metformin in patients with type 2 diabetes. MATERIALS AND METHODS: Patients with inadequate glycaemic control despite stable-dose metformin received open-label empagliflozin 10 mg (study 1) or 25 mg (study 2) as add-on therapy for 16 weeks. Subsequently, those with HbA1c ≥7.0 and ≤10.5% (>53 and ≤91 mmol/mol) (N = 482) were randomized to 24 weeks' double-blind, double-dummy treatment with linagliptin 5 mg or placebo in study 1, or linagliptin 5 mg or placebo in study 2; all patients continued treatment with metformin and empagliflozin 10 mg (study 1) or metformin and empagliflozin 25 mg (study 2)...
October 20, 2016: Diabetes, Obesity & Metabolism
Teresa Liu-Ambrose, John R Best, Jennifer C Davis, Janice J Eng, Philip E Lee, Claudia Jacova, Lara A Boyd, Penelope M Brasher, Michelle Munkacsy, Winnie Cheung, Ging-Yuek R Hsiung
OBJECTIVE: To assess the efficacy of a progressive aerobic exercise training program on cognitive and everyday function among adults with mild subcortical ischemic vascular cognitive impairment (SIVCI). METHODS: This was a proof-of-concept single-blind randomized controlled trial comparing a 6-month, thrice-weekly, progressive aerobic exercise training program (AT) with usual care plus education on cognitive and everyday function with a follow-up assessment 6 months after the formal cessation of aerobic exercise training...
October 19, 2016: Neurology
James A Simon, Tatiana Gaines, Katherine D LaGuardia
OBJECTIVE: Assess effects of once-daily, extended-release oxybutynin chloride on frequency and severity of vasomotor symptoms in healthy, postmenopausal symptomatic women. METHODS: A 12-week, multicenter, double-blind, placebo-controlled, phase 2 clinical trial randomized naturally postmenopausal women experiencing at least seven moderate-to-severe vasomotor symptoms daily to oxybutynin 15 mg once daily (n = 73) or placebo (n = 75). Co-primary outcomes were the change from baseline to week 12 in the frequency and severity of moderate-to-severe vasomotor symptoms...
October 10, 2016: Menopause: the Journal of the North American Menopause Society
Sergio Amaro, Carlos Laredo, Arturo Renú, Laura Llull, Salvatore Rudilosso, Víctor Obach, Xabier Urra, Anna M Planas, Ángel Chamorro
BACKGROUND AND PURPOSE: Identification of neuroprotective therapies in acute ischemic stroke is imperative. We report a predefined analysis of the URICO-ICTUS trial (Efficacy Study of Combined Treatment With Uric Acid and r-tPA in Acute Ischemic Stroke) assessing the efficacy of uric acid (UA) compared with placebo to prevent early ischemic worsening (EIW) and the relevance of collateral circulation. METHODS: URICO-ICTUS was a double-blind, placebo-controlled, phase 2b trial where a total of 411 patients treated with alteplase within 4...
October 6, 2016: Stroke; a Journal of Cerebral Circulation
Joan Montaner, Alejandro Bustamante, Silvia García-Matas, Maite Martínez-Zabaleta, Carmen Jiménez, Javier de la Torre, Francisco R Rubio, Tomás Segura, Jaime Masjuán, David Cánovas, Mar Freijo, Raquel Delgado-Mederos, Javier Tejada, Aida Lago, Yolanda Bravo, Natália Corbeto, Dolors Giralt, Bárbara Vives-Pastor, Anna de Arce, Francisco Moniche, Pilar Delgado, Marc Ribó
BACKGROUND AND PURPOSE: The STARS trial (Stroke Treatment With Acute Reperfusion and Simvastatin) was conducted to demonstrate the efficacy and safety of simvastatin treatment in acute stroke. METHODS: STARS07 was a multicentre, phase IV, prospective, randomized, double-blind, placebo-controlled trial. Patients with Acute ischemic stroke recruited within 12 hours from symptom onset were randomized to oral simvastatin 40 mg or placebo, once daily for 90 days. Primary outcome was proportion of independent patients (modified Rankin Scale score of ≤2) at 90 days...
October 6, 2016: Stroke; a Journal of Cerebral Circulation
Jonathan G Moss, Anna-Maria Belli, Antonio Coca, Michael Lee, Giuseppe Mancia, Jan H Peregrin, Josep Redon, Jim A Reekers, Costas Tsioufis, Dierk Vorwerk, Roland E Schmieder
Renal denervation (RDN) was reported as a novel exciting treatment for resistant hypertension in 2009. An initial randomized trial supported its efficacy and the technique gained rapid acceptance across the globe. However, a subsequent large blinded, sham arm randomized trial conducted in the USA (to gain Food and Drug Administration approval) failed to achieve its primary efficacy end point in reducing office blood pressure at 6 months. Published in 2014 this trial received both widespread praise and criticism...
October 17, 2016: Journal of Hypertension
Sui Cheung Man, Xian-Bin Li, Huai-Hai Wang, Hai-Ning Yuan, Hua-Ning Wang, Rui-Guo Zhang, Qing-Rong Tan, Hei Kiu Wong, Grainne M McAlonan, Chuan-Yue Wang, Zhang-Jin Zhang
OBJECTIVES: An herbal preparation called peony-glycyrrhiza decoction (PGD) may have the potential in reducing antipsychotic-related hyperprolactinemia (hyperPRL). This double-blind, randomized placebo-controlled study aimed to reevaluate the efficacy of PGD against antipsychotic-related hyperPRL. METHODS: Ninety-nine schizophrenic women who were under antipsychotic therapy and had symptomatic hyperPRL were randomly assigned to additional treatment with placebo (n = 50) or PGD (n = 49, 45 g/d) for 16 weeks...
October 13, 2016: Journal of Clinical Psychopharmacology
Cynthia L Huffman, James N Goldenberg, James Weintraub, Luis Sanin, Joseph Driscoll, Ruoyong Yang, Marci L Chew, Joseph M Scavone
OBJECTIVES: To assess efficacy and safety of once-daily controlled-release (CR) formulation of pregabalin in patients with postherpetic neuralgia (PHN). METHODS: A randomized withdrawal trial, with 6-week single-blind pregabalin treatment phase and 13-week double-blind phase, where patients with ≥50% decrease in mean pain score at single-blind end point from baseline were randomized (1:1) to pregabalin CR (82.5-660 mg d) or placebo. Primary efficacy outcome was time to loss of therapeutic response (LTR; <30% decrease in weekly mean pain score from single-blind baseline or discontinuation due to adverse event [AE] or lack of efficacy)...
October 6, 2016: Clinical Journal of Pain
Susan Young, Brynjar Emilsson, Jon Fridrik Sigurdsson, Mizanur Khondoker, Florence Philipp-Wiegmann, Gisli Baldursson, Halldora Olafsdottir, Gisli Gudjonsson
Studies assessing psychological treatment of attention deficit hyperactivity disorder (ADHD) in adults are increasingly reported. However, functional outcomes are often neglected in favour of symptom outcomes. We investigated functional outcomes in 95 adults with ADHD who were already treated with medication and randomized to receive treatment as usual (TAU/MED) or psychological treatment (CBT/MED) using a cognitive-behavioural programme, R&R2ADHD, which employs both group and individual modalities. RATE-S functional outcomes associated with ADHD symptoms, social functioning, emotional control and antisocial behaviour were given at baseline, end of treatment and three-month follow-up...
October 17, 2016: European Archives of Psychiatry and Clinical Neuroscience
L X Quan, H X An, D X Wang
OBJECTIVE: To observe the effects of 0.4 μg/(kg×h) dose of dexmedetomidine on intra-operative wake-up test in children patients undergoing scoliosis surgery. METHODS: Sixty patients for posterior scoliosis correction (ASA I-II, aged 5-16 years) from March 2013 to April 2015 were enrolled in this prospective, double-blinded, randomized, placebo-controlled study, The patients were randomly classified into two groups to receive dexmedetomidine (group RD, n=30) or saline solution (group R, n=30)...
October 18, 2016: Beijing da Xue Xue Bao. Yi Xue Ban, Journal of Peking University. Health Sciences
Lauren Ball, Katelyn Barnes, Michael Leveritt, Lana Mitchell, Lauren T Williams, Dianne Ball, Elizabeth Patterson
Research priority setting is an important component of research planning, particularly when research options exceed available resources. This study identified the research priorities for supporting healthy lifestyle behaviours in the Australian primary healthcare setting. A five-step stakeholder engagement process was undertaken. Ten stakeholder organisations participated in the process, including patient representatives, health professional associations, health educators, researchers, government advisors and policymakers...
October 17, 2016: Australian Journal of Primary Health
Sang-Hyun Kim, Sang-Ho Jo, Sang-Cheol Lee, Sung-Yoon Lee, Myung-Ho Yoon, Hyang-Lim Lee, Nae-Hee Lee, Jong-Won Ha, Nam-Ho Lee, Dong-Woon Kim, Gyu-Rok Han, Min-Su Hyon, Deok-Gyu Cho, Chang-Gyu Park, Young-Dae Kim, Gyu-Hyung Ryu, Cheol-Ho Kim, Kee-Sik Kim, Myung-Ho Chung, Sung-Chul Chae, Ki-Bae Seung, Byung-Hee Oh
PURPOSE: A fixed-dose combination of a stain and an antihypertensive drug may be useful for the treatment of patients with hypertension and hyperlipidemia. It may also improve patient drug compliance to help control risk factors of cardiovascular disease. This study was designed to evaluate the blood pressure-lowering and cholesterol-lowering effect of a fixed-dose combination of irbesartan-atorvastatin compared with monotherapy by either agent over an 8-week treatment period. METHODS: Patients with comorbid hypertension and hypercholesterolemia were screened for this randomized, double-blind, Phase III study...
October 11, 2016: Clinical Therapeutics
Bernard P Schachtel, Adrian Shephard, Timothy Shea, Kathleen Sanner, Laurie Savino, Jeanne Rezuke, Emily Schachtel, Sue Aspley
AIM: This study assessed multiple doses of flurbiprofen 8.75 mg lozenges for the relief of three prominent symptoms of acute pharyngitis: pain intensity (primary end point), difficulty swallowing and swollen throat. PATIENTS & METHODS: A total of 204 patients (102 in each group) with confirmed pharyngitis (onset ≤4 days) were randomly assigned to take up to five flurbiprofen or placebo lozenges every 3-6 h, for 7 days. Using validated rating scales (sore throat pain intensity, difficulty swallowing and swollen throat) patients rated their symptoms for the duration of the study...
November 2016: Pain Management
Sunhee Park, Tsion Abdi, Mark Gentry, Loren Laine
OBJECTIVES: Endoscopic remission in ulcerative colitis (UC) is associated with improved clinical outcomes. We assessed whether histological remission predicts clinical outcomes, estimated the magnitude of effect, and determined whether histological remission provides additional prognostic utility beyond clinical or endoscopic remission. METHODS: Bibliographic databases were searched for studies in inflammatory bowel disease providing baseline histological status and relation to an outcome of clinical relapse or exacerbation...
October 11, 2016: American Journal of Gastroenterology
Gilles Guerrier, David Boutboul, Cedric Chanat, Charles Marc Samama, Christophe Baillard
BACKGROUND: To compare self-reported pain during injection of plain versus alkalinised 0.75% ropivacaine - 2% mepivacaine solution for anaesthesia performed at the medial caruncle site for eye surgery. METHODS: This prospective, monocentric, double blind, randomised, controlled trial involved 40 consecutive patients who received either a standard local anaesthetic solution (0.75% ropivacaine 5ml and 2% mepivacaine 5ml with a pH of 5.9), or an alkalinised solution composed with a pH-adjusted solution of 7...
October 6, 2016: Anaesthesia, Critical Care & Pain Medicine
Chang Gyu Park, Tae Hun Ahn, Eun Ju Cho, Won Kim, Hyung Seob Kim, Ju Yeong Yang, Jae Geun Ryu, Cheol Ho Kim, Min Soo Hyeon, Seung Je Tak, Se Jung Im, Jong Won Ha, Wook Beom Pyeon, Je Geon Jae, Gyu Rok Han, Jun Hyung Doh, Sang Wook Im, Myeong Muk Lee
PURPOSE: The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy. METHODS: this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy...
October 6, 2016: Clinical Therapeutics
Martin Reck, Delvys Rodríguez-Abreu, Andrew G Robinson, Rina Hui, Tibor Csőszi, Andrea Fülöp, Maya Gottfried, Nir Peled, Ali Tafreshi, Sinead Cuffe, Mary O'Brien, Suman Rao, Katsuyuki Hotta, Melanie A Leiby, Gregory M Lubiniecki, Yue Shentu, Reshma Rangwala, Julie R Brahmer
Background Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1). Methods In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene to receive either pembrolizumab (at a fixed dose of 200 mg every 3 weeks) or the investigator's choice of platinum-based chemotherapy...
October 8, 2016: New England Journal of Medicine
Alain Ravaud, Robert J Motzer, Hardev S Pandha, Daniel J George, Allan J Pantuck, Anup Patel, Yen-Hwa Chang, Bernard Escudier, Frede Donskov, Ahmed Magheli, Giacomo Carteni, Brigitte Laguerre, Piotr Tomczak, Jan Breza, Paola Gerletti, Mariajose Lechuga, Xun Lin, Jean-Francois Martini, Krishnan Ramaswamy, Michelle Casey, Michael Staehler, Jean-Jacques Patard
Background Sunitinib, a vascular endothelial growth factor pathway inhibitor, is an effective treatment for metastatic renal-cell carcinoma. We sought to determine the efficacy and safety of sunitinib in patients with locoregional renal-cell carcinoma at high risk for tumor recurrence after nephrectomy. Methods In this randomized, double-blind, phase 3 trial, we assigned 615 patients with locoregional, high-risk clear-cell renal-cell carcinoma to receive either sunitinib (50 mg per day) or placebo on a 4-weeks-on, 2-weeks-off schedule for 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal...
October 9, 2016: New England Journal of Medicine
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