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Placebo response

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https://www.readbyqxmd.com/read/28544774/safety-pharmacokinetics-and-pharmacodynamics-of-hetrombopag-olamine-a-novel-tpo-r-agonist-in-healthy-subjects
#1
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/28544533/efficacy-and-safety-of-secukinumab-in-asian-patients-with-active-ankylosing-spondylitis-52-week-pooled-results-from-two-phase-3-studies
#2
James C-C Wei, Dominique Baeten, Joachim Sieper, Atul Deodhar, Vaishali Bhosekar, Ruvie Martin, Brian Porter
AIM: To evaluate efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis (AS) via a pooled subgroup analysis from two phase 3 studies, MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). METHODS: In MEASURE 1, patients were randomized to intravenous secukinumab 10 mg/kg or placebo at baseline, Weeks 2 and 4, followed by subcutaneous (s.c.) secukinumab 150 mg, 75 mg or placebo every 4 weeks (q4w) at Week 8. In MEASURE 2, patients were randomized to s...
May 25, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/28542447/exploratory-plasma-proteomic-analysis-in-a-randomized-crossover-trial-of-aspirin-among-healthy-men-and-women
#3
Xiaoliang Wang, Ali Shojaie, Yuzheng Zhang, David Shelley, Paul D Lampe, Lisa Levy, Ulrike Peters, John D Potter, Emily White, Johanna W Lampe
Long-term use of aspirin is associated with lower risk of colorectal cancer and other cancers; however, the mechanism of chemopreventive effect of aspirin is not fully understood. Animal studies suggest that COX-2, NFκB signaling and Wnt/β-catenin pathways may play a role, but no clinical trials have systematically evaluated the biological response to aspirin in healthy humans. Using a high-density antibody array, we assessed the difference in plasma protein levels after 60 days of regular dose aspirin (325 mg/day) compared to placebo in a randomized double-blinded crossover trial of 44 healthy non-smoking men and women, aged 21-45 years...
2017: PloS One
https://www.readbyqxmd.com/read/28541742/warm-communication-style-strengthens-expectations-and-increases-perceived-improvement
#4
Xiaoyu He, Qinhua Sun, Cinnamon Stetler
Communication, both verbal and nonverbal, between healthcare providers and patients has been shown to affect treatment outcomes in clinical settings. Separately, accumulating research suggests a role for response expectations in altering treatment outcomes, especially in the context of inert or placebo treatment. However, few studies have examined which aspects of patient-provider communication strengthen expectations, leading to better treatment outcomes. The goal of this study is to test the effect of both verbal and nonverbal aspects of communication on response expectations and treatment outcomes in the context of a placebo exercise program...
May 25, 2017: Health Communication
https://www.readbyqxmd.com/read/28541090/sixty-years-of-placebo-controlled-antipsychotic-drug-trials-in-acute-schizophrenia-systematic-review-bayesian-meta-analysis-and-meta-regression-of-efficacy-predictors
#5
Stefan Leucht, Claudia Leucht, Maximilian Huhn, Anna Chaimani, Dimitris Mavridis, Bartosz Helfer, Myrto Samara, Matteo Rabaioli, Susanne Bächer, Andrea Cipriani, John R Geddes, Georgia Salanti, John M Davis
OBJECTIVE: Antipsychotic drug efficacy may have decreased over recent decades. The authors present a meta-analysis of all placebo-controlled trials in patients with acute exacerbations of schizophrenia, and they investigate which trial characteristics have changed over the years and which are moderators of drug-placebo efficacy differences. METHOD: The search included multiple electronic databases. The outcomes were overall efficacy (primary outcome); responder and dropout rates; positive, negative, and depressive symptoms; quality of life; functioning; and major side effects...
May 25, 2017: American Journal of Psychiatry
https://www.readbyqxmd.com/read/28537764/gefitinib-and-egfr-gene-copy-number-aberrations-in-esophageal-cancer
#6
Russell D Petty, Asa Dahle-Smith, David A J Stevenson, Aileen Osborne, Doreen Massie, Caroline Clark, Graeme I Murray, Susan J Dutton, Corran Roberts, Irene Y Chong, Wasat Mansoor, Joyce Thompson, Mark Harrison, Anirban Chatterjee, Stephen J Falk, Sean Elyan, Angel Garcia-Alonso, David Walter Fyfe, Jonathan Wadsley, Ian Chau, David R Ferry, Zosia Miedzybrodzka
Purpose The Cancer Esophagus Gefitinib trial demonstrated improved progression-free survival with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor gefitinib relative to placebo in patients with advanced esophageal cancer who had disease progression after chemotherapy. Rapid and durable responses were observed in a minority of patients. We hypothesized that genetic aberration of the EGFR pathway would identify patients benefitting from gefitinib. Methods A prespecified, blinded molecular analysis of Cancer Esophagus Gefitinib trial tumors was conducted to compare efficacy of gefitinib with that of placebo according to EGFR copy number gain (CNG) and EGFR, KRAS, BRAF, and PIK3CA mutation status...
May 24, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28537062/evaluation-of-the-immunogenicity-and-impact-on-the-latent-hiv-1-reservoir-of-a-conserved-region-vaccine-mva-hivconsv-in-antiretroviral-therapy-treated-subjects
#7
REVIEW
Gemma Hancock, Sara Morón-López, Jakub Kopycinski, Maria C Puertas, Eleni Giannoulatou, Annie Rose, Maria Salgado, Emma-Jo Hayton, Alison Crook, Catharine Morgan, Brian Angus, Fabian Chen, Hongbing Yang, Javier Martinez-Picado, Tomas Hanke, Lucy Dorrell
INTRODUCTION: Vaccines may be key components of a curative strategy for HIV-1. We investigated whether a novel immunogen, HIVconsv, designed to re-direct T cell responses to conserved viral epitopes, could impact the HIV-1 reservoir in chronic antiretroviral therapy (ART)-treated subjects when delivered by modified vaccinia virus Ankara (MVA). METHODS: Nineteen virologically suppressed individuals were randomized to receive vaccinations with MVA.HIVconsv (5.5 × 10(7) plaque-forming units, pfu, n = 8; 2...
May 19, 2017: Journal of the International AIDS Society
https://www.readbyqxmd.com/read/28536866/a-placebo-controlled-study-of-quetiapine-xr-in-bipolar-depression-accompanied-by-generalized-anxiety-with-and-without-a-recent-history-of-alcohol-and-cannabis-use
#8
Keming Gao, Stephen J Ganocy, Carla Conroy, Brittany Brownrigg, Mary Beth Serrano, Joseph R Calabrese
OBJECTIVE: This study aims to compare treatment response in bipolar I or II depression and generalized anxiety disorder (GAD) with and without recent alcohol and/or cannabis use disorder (ALC/CAN) to quetiapine-XR (extended release) or placebo. METHODS: A randomized, double-blind, 8-week study of quetiapine-XR versus placebo in patients with bipolar I or II depression and GAD with or without a recent ALC/CAN was used to compare changes in Hamilton Depression Rating Scale-17, Hamilton Anxiety Rating Scale, the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), Clinical Global Impression for Bipolar Disorder-Severity (CGI-BP-S), and Timeline Follow Back within and between groups...
May 24, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28536491/helicobacter-pylori-antibody-responses-in-association-with-eradication-outcome-and-recurrence-a-population-based-intervention-trial-with-7-3-year-follow-up-in-china
#9
Tianyi Wang, Yang Zhang, Huijuan Su, Zhexuan Li, Lian Zhang, Junling Ma, Weidong Liu, Tong Zhou, Weicheng You, Kaifeng Pan
OBJECTIVE: To identify serum biomarkers that may predict the short or long term outcomes of anti-Helicobacter pylori (H. pylori) treatment, a follow-up study was performed based on an intervention trial in Linqu County, China. METHODS: A total of 529 subjects were selected randomly from 1,803 participants to evaluate total anti-H. pylori immunoglobulin G (IgG) and 10 specific antibody levels before and after treatment at 1-, 2- and 7.3-year. The outcomes of anti-H...
April 2017: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
https://www.readbyqxmd.com/read/28536308/immune-correlates-of-gm-csf-and-melanoma-peptide-vaccination-in-a-randomized-trial-for-the-adjuvant-therapy-of-resected-high-risk-melanoma-e4697
#10
Lisa H Butterfield, Fengmin Zhao, Sandra Lee, Ahmad A Tarhini, Kim A Margolin, Richard L White, Michael Atkins, Gary I Cohen, Theresa L Whiteside, John M Kirkwood, David H Lawson
Purpose: E4697 was a multi-center intergroup randomized placebo-controlled Phase III trial of adjuvant GM-CSF and/or a multi-epitope melanoma peptide vaccine for patients with completely resected, high-risk stage III/IV melanoma. <p>Experimental Design: 815 patients were enrolled from 12/99 to 10/06 into this 6-arm study. GM-CSF was chosen to promote the numbers and functions of dendritic cells (DC). The melanoma antigen peptide vaccine (Tyrosinase368-376 (370D), gp100209-217 (210M), MART-127-35) in Montanide was designed to promote melanoma specific CD8(+) T cell responses...
May 23, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28535810/fibrates-for-the-treatment-of-cholestatic-itch-fitch-study-protocol-for-a-randomized-controlled-trial
#11
Ruth Bolier, Elsemieke S de Vries, Albert Parés, Jeltje Helder, E Marleen Kemper, Koos Zwinderman, Ronald P Oude Elferink, Ulrich Beuers
BACKGROUND: Pruritus (itch) is a frequent, burdensome and difficult-to-treat symptom in patients with cholestasis. Fibrates are currently under investigation for the treatment of primary biliary cholangitis in patients with a suboptimal response to ursodeoxycholic acid. Moreover, there is empirical evidence for a possible antipruritic effect. We aim to prove this in a randomized controlled trial, including patients with cholestatic liver diseases other than primary biliary cholangitis that are accompanied by pruritus...
May 23, 2017: Trials
https://www.readbyqxmd.com/read/28535809/safety-and-tolerability-of-adjunctive-rosiglitazone-treatment-for-children-with-uncomplicated-malaria
#12
Rosauro Varo, Valerie M Crowley, Antonio Sitoe, Lola Madrid, Lena Serghides, Rubao Bila, Helio Mucavele, Alfredo Mayor, Quique Bassat, Kevin C Kain
BACKGROUND: Despite the widespread use and availability of rapidly acting anti-malarials, the fatality rate of severe malaria in sub-Saharan Africa remains high. Adjunctive therapies that target the host response to malaria infection may further decrease mortality over that of anti-malarial agents alone. Peroxisome proliferator-activated receptor-gamma agonists (e.g. rosiglitazone) have been shown to act on several pathways implicated in the pathogenesis of severe malaria and may improve clinical outcome as an adjunctive intervention...
May 23, 2017: Malaria Journal
https://www.readbyqxmd.com/read/28535237/effect-of-intravenous-ferric-carboxymaltose-on-hemoglobin-response-among-patients-with-acute-isovolemic-anemia-following-gastrectomy-the-fairy-randomized-clinical-trial
#13
Young-Woo Kim, Jae-Moon Bae, Young-Kyu Park, Han-Kwang Yang, Wansik Yu, Jeong Hwan Yook, Sung Hoon Noh, Mira Han, Keun Won Ryu, Tae Sung Sohn, Hyuk-Joon Lee, Oh Kyoung Kwon, Seung Yeob Ryu, Jun-Ho Lee, Sung Kim, Hong Man Yoon, Bang Wool Eom, Min-Gew Choi, Beom Su Kim, Oh Jeong, Yun-Suhk Suh, Moon-Won Yoo, In Seob Lee, Mi Ran Jung, Ji Yeong An, Hyoung-Il Kim, Youngsook Kim, Hannah Yang, Byung-Ho Nam
Importance: Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. Objective: To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. Design, Setting, and Participants: The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea...
May 23, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28534875/dose-dependent-social-cognitive-effects-of-intranasal-oxytocin-delivered-with-novel-breath-powered-device-in-adults-with-autism-spectrum-disorder-a-randomized-placebo-controlled-double-blind-crossover-trial
#14
D S Quintana, L T Westlye, S Hope, T Nærland, T Elvsåshagen, E Dørum, Ø Rustan, M Valstad, L Rezvaya, H Lishaugen, E Stensønes, S Yaqub, K T Smerud, R A Mahmoud, P G Djupesland, O A Andreassen
The neuropeptide oxytocin has shown promise as a treatment for symptoms of autism spectrum disorders (ASD). However, clinical research progress has been hampered by a poor understanding of oxytocin's dose-response and sub-optimal intranasal delivery methods. We examined two doses of oxytocin delivered using a novel Breath Powered intranasal delivery device designed to improve direct nose-to-brain activity in a double-blind, crossover, randomized, placebo-controlled trial. In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks...
May 23, 2017: Translational Psychiatry
https://www.readbyqxmd.com/read/28534446/blood-fatty-acid-changes-in-healthy-young-americans-in-response-to-a-10-week-diet-that-increased-n-3-and-reduced-n-6-fatty-acid-consumption-a-randomised-controlled-trial
#15
Andrew J Young, Bernadette P Marriott, Catherine M Champagne, Michael R Hawes, Scott J Montain, Neil M Johannsen, Kevin Berry, Joseph R Hibbeln
Military personnel generally under-consume n-3 fatty acids and overconsume n-6 fatty acids. In a placebo-controlled, double-blinded study, we investigated whether a diet suitable for implementation in military dining facilities and civilian cafeterias could benefit n-3/n-6 fatty acid status of consumers. Three volunteer groups were provided different diets for 10 weeks. Control (CON) participants consumed meals from the US Military's Standard Garrison Dining Facility Menu. Experimental, moderate (EXP-Mod) and experimental-high (EXP-High) participants consumed the same meals, but high n-6 fatty acid and low n-3 fatty acid containing chicken, egg, oils and food ingredients were replaced with products having less n-6 fatty acids and more n-3 fatty acids...
May 23, 2017: British Journal of Nutrition
https://www.readbyqxmd.com/read/28533925/low-dose-oral-curcumin-is-not-effective-in-induction-of-remission-in-mild-to-moderate-ulcerative-colitis-results-from-a-randomized-double-blind-placebo-controlled-trial
#16
Saurabh Kedia, Vikram Bhatia, Sandeep Thareja, Sushil Garg, Venigalla Pratap Mouli, Sawan Bopanna, Veena Tiwari, Govind Makharia, Vineet Ahuja
AIM: To evaluate the role of oral curcumin in inducing clinical remission in patients with mild to moderate ulcerative colitis (UC). METHODS: A prospective randomized double-blind placebo-controlled trial comparing the remission inducing effect of oral curcumin and mesalamine 2.4 g with placebo and mesalamine 2.4 g in patients of ulcerative colitis with mild to moderate severity was conducted from January 2003 to March 2005. The included patients received 1 capsule thrice a day of placebo or curcumin (150 mg) for 8 wk...
May 6, 2017: World Journal of Gastrointestinal Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28533889/effects-of-low-dose-acetazolamide-on-exercise-performance-in-simulated-altitude
#17
Ernst Elisabeth, Gatterer Hannes, Burtscher Johannes, Faulhaber Martin, Pocecco Elena, Burtscher Martin
Preventive effects of acetazolamide (ACZ) on acute mountain sickness (AMS) are well established but effects on exercise performance at high altitude or in hypoxia have been less considered and are still inconsistent. We hypothesized that low-dose ACZ would not impair exercise performance at simulated high altitude. Thus, the aim of this study was to evaluate the interaction between low-dose ACZ and exercise performance in normobaric hypoxia. Sixteen subjects (8 males and 8 females) were randomly assigned either to receive low-dose ACZ (3×125 mg in 36 hours) or placebo...
2017: International Journal of Physiology, Pathophysiology and Pharmacology
https://www.readbyqxmd.com/read/28533517/vortioxetine-reduces-bold-signal-during-performance-of-the-n-back-working-memory-task-a-randomised-neuroimaging-trial-in-remitted-depressed-patients-and-healthy-controls
#18
J Smith, M Browning, S Conen, R Smallman, J Buchbjerg, K G Larsen, C K Olsen, S R Christensen, G R Dawson, J F Deakin, P Hawkins, R Morris, G Goodwin, C J Harmer
Cognitive dysfunction is common in depression during both acute episodes and remission. Vortioxetine is a novel multimodal antidepressant that has improved cognitive function including executive function in depressed patients in randomised placebo-controlled clinical trials. However, it is unclear whether vortioxetine is able to target directly the neural circuitry implicated in the cognitive deficits in depression. Remitted depressed (n=48) and healthy volunteers (n=48) were randomised to receive 14 days treatment with 20 mg vortioxetine or placebo in a double-blind design...
May 23, 2017: Molecular Psychiatry
https://www.readbyqxmd.com/read/28533093/safety-and-immunogenicity-of-a-live-attenuated-influenza-h5-candidate-vaccine-strain-a-17-turkey-turkey-05-133-h5n2-and-its-priming-effects-for-potential-pre-pandemic-use-a-randomised-double-blind-placebo-controlled-trial
#19
Punnee Pitisuttithum, Kobporn Boonnak, Supat Chamnanchanunt, Pilaipan Puthavathana, Viravarn Luvira, Hatairat Lerdsamran, Jaranit Kaewkungwal, Saranath Lawpoolsri, Vipa Thanachartwet, Udomsak Silachamroon, Wanibtisam Masamae, Alexandra Schuetz, Ponthip Wirachwong, Sit Thirapakpoomanunt, Larisa Rudenko, Erin Sparrow, Martin Friede, Marie-Paule Kieny
BACKGROUND: The emergence of highly pathogenic avian influenza H5N1 viruses has raised concerns about their pandemic potential. Vaccination is the most effective way of preventing influenza. In this study, we investigated the safety and immunogenicity of an avian H5N2 live attenuated influenza vaccine (LAIV H5N2) in healthy Thai adults and its priming immune responses with an H5N1 inactivated vaccine boost. METHODS: This study was done at the Vaccine Trial Centre at Mahidol University, Bangkok, Thailand and was divided into two parts...
May 19, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28531784/gut-microbiota-mediated-benefits-of-barley-kernel-products-on-metabolism-gut-hormones-and-inflammatory-markers-as-affected-by-co-ingestion-of-commercially-available-probiotics-a-randomized-controlled-study-in-healthy-subjects
#20
Anne Nilsson, Elin Johansson-Boll, Jonna Sandberg, Inger Björck
BACKGROUND AND AIMS: Barley kernel based products have been shown to induce benefits on blood glucose regulation, cardio-metabolic risk markers and appetite regulating hormones in a time perspective of 11-16 h after intake. The mechanisms have been assigned to gut fermentation of indigestible carbohydrates. The purpose of the present study was to evaluate if the modulatory effects of barley on markers of metabolic- and appetite regulation are affected by a dietary background including a mixture of commercially available probiotics...
October 2016: Clinical Nutrition ESPEN
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