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Placebo response

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https://www.readbyqxmd.com/read/29679487/allergen-specific-immunotherapy-induces-regulatory-t-cells-in-an-atopic-dermatitis-mouse-model
#1
Jung U Shin, Seo Hyeong Kim, Ji Yeon Noh, Ji Hye Kim, Kim Hye Ran, Kyoung Yong Jeong, Kyung Hee Park, Jungsoo Lee, Howard Chu, Jae-Hyun Lee, Tai-Soon Yong, Jung-Won Park, Kwang Hoon Lee
BACKGROUND: Several studies have demonstrated that allergen-specific immunotherapy (SIT) can be an effective treatment for atopic dermatitis (AD). However, there is no relevant mouse model to investigate the mechanism and validate the novel modality of SIT in AD. METHODS: NC/Nga mice with induced AD-like skin lesions received a subcutaneous injection of SIT (an extract of the house dust mite Dermatophagoides farinae [DfE]) or placebo for 5 weeks). Clinical and histological improvements of AD-like skin lesions were examined...
April 21, 2018: Allergy
https://www.readbyqxmd.com/read/29678370/the-response-of-the-central-and-peripheral-tremor-component-to-octanoic-acid-in-patients-with-essential-tremor
#2
Hongmei Cao, Johanna Thompson-Westra, Mark Hallett, Dietrich Haubenberger
OBJECTIVE: To investigate the effect of octanoic acid (OA) on the peripheral component of tremor, as well as OA's differential effects on the central and peripheral tremor component in essential tremor (ET) patients. METHODS: We analyzed postural tremor accelerometry data from a double-blind placebo-controlled cross-over study evaluating the effect of 4 mg/kg OA in ET. The weighted condition was used to identify tremor power for both the central and peripheral tremor components...
April 3, 2018: Clinical Neurophysiology: Official Journal of the International Federation of Clinical Neurophysiology
https://www.readbyqxmd.com/read/29678158/dexmedetomidine-infusion-as-an-analgesic-adjuvant-during-laparoscopic-%C3%B1-holecystectomy-a-randomized-controlled-study
#3
Kateryna Bielka, Iurii Kuchyn, Volodymyr Babych, Kseniia Martycshenko, Oleksii Inozemtsev
BACKGROUND: Dexmedetomidine (DEX) has sedative, sympatholytic and analgesic effects and might be beneficial if used as an adjuvant to: improve analgesia; modulate haemodynamic responses to intubation and pneumoperitoneum and; reduce the number of opioid-associated adverse events. The aim of this study was to evaluate the efficacy and safety of DEX infusion during elective laparoscopic cholecystectomy (LC). METHODS: A randomized, single-centre, parallel-group, placebo-controlled study was carried out between May 2016 and June 2017...
April 20, 2018: BMC Anesthesiology
https://www.readbyqxmd.com/read/29677196/catechol-o-methyltransferase-moderates-effect-of-stress-mindset-on-affect-and-cognition
#4
Alia J Crum, Modupe Akinola, Bradley P Turnwald, Ted J Kaptchuk, Kathryn T Hall
There is evidence that altering stress mindset-the belief that stress is enhancing vs. debilitating-can change cognitive, affective and physiological responses to stress. However individual differences in responsiveness to stress mindset manipulations have not been explored. Given the previously established role of catecholamines in both placebo effects and stress, we hypothesized that genetic variation in catechol-O-methyltransferase (COMT), an enzyme that metabolizes catecholamines, would moderate responses to an intervention intended to alter participants' mindsets about stress...
2018: PloS One
https://www.readbyqxmd.com/read/29676640/a-pilot-study-assessing-the-ability-of-5-aminosalicylic-acid-to-modulate-the-immune-response-in-chronic-beryllium-disease
#5
Brian J Day, Jie Huang, Briana Q Barkes, May Gillespie, Li Li, Lisa A Maier
Chronic beryllium disease is a granulomatous lung disease, characterized by the accumulation of macrophages and beryllium-specific CD4+ T-cells that proliferate and produce T-helper cell type 1 cytokines. Previous studies indicate that beryllium-mediated oxidative stress enhances cytokine response in chronic beryllium disease CD4+ T-cells. 5-Aminosalicylic acid (5-ASA) is currently used to treat inflammatory bowel disease and has both antioxidant and antiinflammatory actions. We hypothesized that 5-ASA therapy may be a beneficial therapy in chronic beryllium disease...
April 2018: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/29675680/a-randomized-double-blind-phase-2-study-of-ruxolitinib-or-placebo-in-combination-with-capecitabine-in-patients-with-advanced-her2-negative-breast-cancer-and-elevated-c-reactive-protein-a-marker-of-systemic-inflammation
#6
Joyce O'Shaughnessy, Angela DeMichele, Cynthia X Ma, Paul Richards, Denise A Yardley, Gail Shaw Wright, Kevin Kalinsky, Ronald Steis, Sami Diab, Gerard Kennealey, Ryan Geschwindt, Wei Jiang, Hope S Rugo
PURPOSE: The Janus-associated kinase (JAK)/signal transducer and activator of transcription pathway is a key regulator of inflammatory signaling, associated with tumorigenesis, cell survival, and progression. This randomized phase 2 trial evaluated the efficacy and safety of the addition of ruxolitinib, a JAK1/JAK2 inhibitor, to capecitabine in patients with HER2-negative advanced breast cancer and high systemic inflammation (modified Glasgow Prognostic Score [mGPS] ≥ 1). METHODS: Patients with ≤ 2 prior chemotherapy regimens for advanced or metastatic disease or hormone receptor-positive patients with disease progression on prior hormonal therapies were randomized 1:1 to 21-day cycles of ruxolitinib (n = 76) or placebo (n = 73) plus capecitabine...
April 19, 2018: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29674270/response-inhibition-and-emotional-cognition-improved-by-atomoxetine-in-children-and-adolescents-with-adhd-the-action-randomized-controlled-trial
#7
Kristi R Griffiths, John E Leikauf, Tracey W Tsang, Simon Clarke, Daniel F Hermens, Daryl Efron, Leanne M Williams, Michael R Kohn
Although the non-stimulant medication atomoxetine is effective for attention-deficit hyperactivity disorder (ADHD) in children and adolescents, there are still significant gaps in our knowledge about whether atomoxetine improves anxiety symptoms or cognition in children. Furthermore, while cognition has been proposed as an intermediate phenotype for ADHD dysfunction, the relationships between clinical and cognitive outcomes are not yet understood. We addressed these knowledge gaps in a controlled trial using objective assessments of both general and emotional cognitive functions implicated in ADHD and in anxiety, which commonly co-occurs with ADHD...
March 27, 2018: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/29673620/effects-of-opioid-and-non-opioid-analgesics-on-responses-to-psychosocial-stress-in-humans
#8
Anya K Bershad, Melissa A Miller, Greg J Norman, Harriet de Wit
Both preclinical and clinical evidence suggests that the endogenous opioid system is involved in responses to stress. For example, in animal models opioid agonists reduce isolation distress whereas opioid antagonists increase isolation distress. We recently reported that the mixed mu agonist and kappa antagonist buprenorphine dampened responses to acute psychosocial stress in humans. Now we extend this to study the effects of a pure mu-opioid agonist, hydromorphone, and a non-opioid analgesic, acetaminophen, on response to social stress...
April 16, 2018: Hormones and Behavior
https://www.readbyqxmd.com/read/29672965/acute-hematological-and-mood-perception-effects-of-bitter-orange-extract-p-synephrine-consumed-alone-and-in-combination-with-caffeine-a-placebo-controlled-double-blind-study
#9
Jill A Bush, Nicholas A Ratamess, Sidney J Stohs, Nicole L Ellis, Ira T Vought, Elizabeth A O'Grady, Jeremy D Kuper, Jie Kang, Avery D Faigenbaum
The purpose of this study was to examine acute hematological and mood perception responses to supplementation with p-synephrine alone and in combination with caffeine during quiet sitting. Sixteen subjects visited the laboratory on 6 occasions and were given (in randomized double-blind manner) 103-mg p-synephrine (S), 233-mg caffeine + 104-mg p-synephrine, 240-mg caffeine, 337-mg caffeine + 46-mg p-synephrine, 325-mg caffeine, or a placebo (PL). The subjects sat quietly for 3 hr while completing mood state questionnaires every 30 min...
April 19, 2018: Phytotherapy Research: PTR
https://www.readbyqxmd.com/read/29672626/engystol-reduces-onset-of-experimental-respiratory-syncytial-virus-induced-respiratory-inflammation-in-mice-by-modulating-macrophage-phagocytic-capacity
#10
Sabine Wronski, Julia Dannenmaier, Sabine Schild, Olaf Macke, Laura Müller, Yvonne Burmeister, Bernd Seilheimer, Meike Müller
BACKGROUND: Respiratory viruses such as respiratory syncytial virus (RSV) or rhinovirus are one of the major causes for respiratory tract infections causing common cold disease. Respiratory viral infections range from mild symptoms in adults to serious illness especially in the very young or elderly as well as patients suffering from lung diseases or being immunocompromised due to other reasons. Engystol (EGY-2) is a multicomponent, multitarget preparation consisting of Vincetoxicum hirundinaria and Sulfur in various dilutions...
2018: PloS One
https://www.readbyqxmd.com/read/29671942/comparative-efficacy-and-safety-of-biosimilar-infliximab-and-originator-infliximab-in-combination-with-methotrexate-in-patients-with-active-rheumatoid-arthritis-a-meta-analysis-of-randomized-controlled-trials
#11
Sang-Cheol Bae, Young Ho Lee
OBJECTIVE: We aimed to assess the relative efficacy and safety of biosimilar-infliximab and originator-infliximab in combination with methotrexate (MTX) compared to placebo plus MTX in active rheumatoid arthritis (RA). METHODS: We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of biosimilar + MTX and infliximab + MTX and placebo + MTX (MTX group) in patients with active RA despite treatment with MTX...
April 19, 2018: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/29671280/efficacy-and-safety-of-subcutaneous-belimumab-in-anti-dsdna-positive-hypocomplementemic-patients-with-systemic-lupus-erythematosus
#12
A Doria, W Stohl, A Schwarting, M Okada, M Scheinberg, R van Vollenhoven, A E Hammer, J Groark, D Bass, N L Fox, D Roth, D Gordon
OBJECTIVE: To investigate the efficacy and safety of belimumab, a human immunoglobulin monoclonal antibody against B lymphocyte stimulator, in a subset of patients with systemic lupus erythematosus (SLE) who were hypocomplementemic (C3 [<90 mg/dL] and/or C4 [<10 mg/dL]) and anti-double-stranded(ds)DNA-positive (≥30 IU/mL) at baseline. METHODS: This Phase III, double-blind, placebo-controlled study (BEL112341; NCT01484496) randomized patients (2:1) with moderate-to-severe SLE (Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index ≥8) to weekly subcutaneous (SC) belimumab 200 mg or placebo, plus standard SLE therapy, for 52 weeks...
April 18, 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29670761/improvements-in-workplace-and-household-productivity-with-certolizumab-pegol-treatment-in-axial-spondyloarthritis-results-to-week-96-of-a-phase-iii-study
#13
Désirée van der Heijde, Jürgen Braun, Martin Rudwaleit, Oana Purcaru, Arthur F Kavanaugh
Objectives: To evaluate the effect of certolizumab pegol (CZP) on work and household productivity, and on participation in family, social and leisure activities in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic (nr-) axSpA. Methods: RAPID-axSpA (NCT01087762) was a phase III, double-blind, placebo-controlled trial to week (Wk) 24, dose-blind to Wk48 and open-label to Wk204. A total of 325 patients were randomised 1:1:1 to placebo, CZP 200 mg Q2W or CZP 400 mg Q4W...
2018: RMD Open
https://www.readbyqxmd.com/read/29669938/canagliflozin-triggers-the-fgf23-1-25-dihydroxyvitamin-d-pth-axis-in-healthy-volunteers-in-a-randomized-crossover-study
#14
Jenny E Blau, Viviana Bauman, Ellen M Conway, Paolo Piaggi, Mary F Walter, Elizabeth C Wright, Shanna Bernstein, Amber B Courville, Michael T Collins, Kristina I Rother, Simeon I Taylor
BACKGROUND: Sodium glucose cotransporter-2 (SGLT2) inhibitors are the most recently approved class of drugs for type 2 diabetes and provide both glycemic efficacy and cardiovascular risk reduction. A number of safety issues have been identified, including treatment-emergent bone fractures. To understand the overall clinical profile, these safety issues must be balanced against an attractive efficacy profile. Our study was designed to investigate pathophysiological mechanisms mediating treatment-emergent adverse effects on bone health...
April 19, 2018: JCI Insight
https://www.readbyqxmd.com/read/29669604/confirm-a-double-blind-placebo-controlled-phase-iii-clinical-trial-investigating-the-effect-of-nivolumab-in-patients-with-relapsed-mesothelioma-study-protocol-for-a-randomised-controlled-trial
#15
Dean A Fennell, Emma Kirkpatrick, Kelly Cozens, Mavis Nye, Jason Lester, Gerard Hanna, Nicola Steele, Peter Szlosarek, Sarah Danson, Joanne Lord, Christian Ottensmeier, Daniel Barnes, Stephanie Hill, Mihalis Kalevras, Tom Maishman, Gareth Griffiths
BACKGROUND: Mesothelioma is an incurable, apoptosis-resistant cancer caused in most cases by previous exposure to asbestos and is increasing in incidence. It represents a growing health burden but remains under-researched, with limited treatment options. Early promising signals of activity relating to both PD-L1- and PD-1-targeted treatment in mesothelioma implicate a dependency of mesothelioma on this immune checkpoint. There is a need to evaluate checkpoint inhibitors in patients with relapsed mesothelioma where treatment options are limited...
April 18, 2018: Trials
https://www.readbyqxmd.com/read/29669026/first-in-human-randomized-controlled-trial-of-mosaic-hiv-1-immunogens-delivered-via-a-modified-vaccinia-ankara-vector
#16
Lindsey R Baden, Stephen R Walsh, Michael S Seaman, Yehuda Z Cohen, Jennifer A Johnson, J Humberto Licona, Rachel D Filter, Jane A Kleinjan, Jon A Gothing, Julia Jennings, Lauren Peter, Joseph Nkolola, Peter Abbink, Erica N Borducchi, Marinela Kirilova, Kathryn E Stephenson, Poonam Pegu, Michael A Eller, Hung V Trinh, Mangala Rao, Julie A Ake, Michal Sarnecki, Steven Nijs, Katleen Callewaert, Hanneke Schuitemaker, Jenny Hendriks, Maria G Pau, Frank Tomaka, Bette T Korber, Galit Alter, Raphael Dolin, Patricia L Earl, Bernard Moss, Nelson L Michael, Merlin L Robb, Dan H Barouch
Background: Mosaic immunogens are bioinformatically engineered HIV-1 sequences designed to elicit clade independent coverage against globally circulating HIV-1 strains. Methods: This Phase 1 double-blind, randomized, placebo-controlled trial enrolled healthy HIV uninfected adults who received two doses of a modified vaccinia Ankara (MVA) vectored HIV-1 bivalent mosaic immunogen vaccine or placebo on days 0 and 84. Two groups were enrolled: those who were HIV-1 vaccine naïve (N=15) and those who had received an HIV-1 vaccine four to six years earlier (Ad26...
April 13, 2018: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29668990/vitamin-d-receptor-activation-raises-soluble-thrombomodulin-levels-in-chronic-kidney-disease-patients-a-double-blind-randomized-trial
#17
Graziella D'arrigo, Patrizia Pizzini, Sebastiano Cutrupi, Rocco Tripepi, Giovanni Tripepi, Francesca Mallamaci, Carmine Zoccali
Background: Thrombomodulin (TM) is a proteoglycan highly represented in the endothelial glycocalix that regulates the haemostasis and the endothelial response to inflammation. High soluble TM levels underlie a lower risk for coronary heart disease in population studies. Activation of vitamin D receptor (VDR) upregulates TM, but the effect of this intervention on soluble TM has never been tested in chronic kidney disease (CKD) patients. Methods: We performed a post hoc analysis of a 12 weeks double blind, randomized, placebo-controlled trial testing the effect of VDR activation by paricalcitol (PCT) on endothelium-dependent flow-mediated vasodilatation (FMD) in the forearm (ClinicalTrials...
April 13, 2018: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/29668919/performance-of-crohn-s-disease-clinical-trial-endpoints-based-upon-different-cutoffs-for-patient-reported-outcomes-or-endoscopic-activity-analysis-of-extend-data
#18
Brian Feagan, William J Sandborn, Paul Rutgeerts, Barrett G Levesque, Reena Khanna, Bidan Huang, Qian Zhou, Jen-Fue Maa, Kori Wallace, Ana Lacerda, Roopal B Thakkar, Anne M Robinson
Background: Clinical trial endpoints for Crohn's disease (CD) activity correlate poorly with mucosal inflammation; to assess treatment efficacy, patient-reported outcomes and endoscopic assessments are preferred. This study assessed the impact on treatment efficacy estimations of using different definitions of clinical and endoscopic remission and endoscopic response, and of using site- or central-based endoscopy evaluation. Methods: This post hoc analysis of data fromEXTEND (extend the safety and efficacy of adalimumab through endoscopic healing), a placebo (PBO)-controlled, randomized trial of adalimumab (ADA) for mucosal healing, included adults with moderate-to-severe CD...
April 14, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29668918/glutamatergic-signaling-drives-ketamine-mediated-response-in-depression-evidence-from-dynamic-causal-modeling
#19
Jessica R Gilbert, Julia S Yarrington, Kathleen E Wills, Allison C Nugent, Carlos A Zarate
Background: The glutamatergic modulator ketamine has rapid antidepressant effects in individuals with major depressive disorder (MDD) and bipolar depression. Thus, modulating glutamatergic transmission may be critical to effectively treating depression, though the mechanisms by which this occurs are not fully understood. Methods: This double-blind, crossover, placebo-controlled study analyzed data from 18 drug-free MDD subjects and 18 heathy controls who received a single intravenous infusion of ketamine hydrochloride (0...
April 13, 2018: International Journal of Neuropsychopharmacology
https://www.readbyqxmd.com/read/29668699/brief-exposure-to-swedish-snus-causes-divergent-vascular-responses-in-healthy-male-and-female-volunteers
#20
Lukasz Antoniewicz, Mirza Novo, Jenny Bosson, Magnus Lundbäck
INTRODUCTION: The use of Swedish oral moist snuff, known as snus, has for a long time been limited to the Scandinavian countries. With declining cigarette sales in the western world, tobacco companies have looked to the development of alternative tobacco products. In 2006 snus products were launched in the US. Even though several studies have demonstrated negative health effects, snus is often depicted as harmless. The aim of the present study was to investigate acute vascular effects of snus as measured by arterial stiffness as well as blood pressure and heart rate...
2018: PloS One
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