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Placebo response

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https://www.readbyqxmd.com/read/28432376/mdma-does-not-alter-responses-to-the-trier-social-stress-test-in-humans
#1
Anya K Bershad, Melissa A Miller, Harriet de Wit
RATIONALE: ±3,4-Methylenedioxymethamphetamine (MDMA, "ecstasy") is a stimulant-psychedelic drug with unique social effects. It may dampen reactivity to negative social stimuli such as social threat and rejection. Perhaps because of these effects, MDMA has shown promise as a treatment for post-traumatic stress disorder (PTSD). However, the effect of single doses of MDMA on responses to an acute psychosocial stressor has not been tested. OBJECTIVES: In this study, we sought to test the effects of MDMA on responses to stress in healthy adults using a public speaking task...
April 21, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28432049/randomized-controlled-trial-of-different-aspirin-regimens-for-reduction-of-niacin-induced-flushing
#2
Sahil S Banka, Rosy Thachil, Alexander Levine, Hsin Lin, Haytham Kaafarani, Jarone Lee
PURPOSE: Results of a study to test the hypothesis that taking niacin simultaneously with different forms of aspirin would reduce the occurrence of niacin-induced flushing are reported. METHODS: Traditionally, taking enteral absorbed aspirin 30 minutes before a niacin dose has been shown to reduce flushing by 30-50% relative to nonuse of aspirin. The objective of the study was to evaluate the efficacy of enteral absorbed and orally dissolved aspirin, taken at the same time as niacin, in reducing the frequency of moderate-to-severe flushing...
April 21, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28431800/genetic-predictors-of-antipsychotic-response-to-lurasidone-identified-in-a-genome-wide-association-study-and-by-schizophrenia-risk-genes
#3
Jiang Li, Akane Yoshikawa, Mark D Brennan, Timothy L Ramsey, Herbert Y Meltzer
Biomarkers which predict response to atypical antipsychotic drugs (AAPDs) increases their benefit/risk ratio. We sought to identify common variants in genes which predict response to lurasidone, an AAPD, by associating genome-wide association study (GWAS) data and changes (Δ) in Positive And Negative Syndrome Scale (PANSS) scores from two 6-week randomized, placebo-controlled trials of lurasidone in schizophrenia (SCZ) patients. We also included SCZ risk SNPs identified by the Psychiatric Genomics Consortium using a polygenic risk analysis...
April 18, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28431010/clinical-trial-of-the-anti-pd-l1-antibody-bms-936559-in-hiv-1-infected-participants-on-suppressive-antiretroviral-therapy
#4
Cynthia L Gay, Ronald J Bosch, Justin Ritz, Jason M Hataye, Evgenia Aga, Randall L Tressler, Stephen W Mason, Carey K Hwang, Dennis M Grasela, Neelanjana Ray, Josh C Cyktor, John M Coffin, Edward P Acosta, Richard A Koup, John W Mellors, Joseph J Eron
Background.: Reversing immune exhaustion with an anti-PD-L1 antibody may improve HIV-1-specific immunity and increase clearance of HIV-1 expressing cells. Methods.: Phase I, randomized, double-blind, placebo-controlled dose-escalating study of BMS-936559including HIV-1-infected adults ≥18 to ≤70 years on suppressive antiretroviral therapy with CD4+ counts ≥350 cells/μL and detectable plasma HIV-1 RNA by single copy assay. Data on single infusions of BMS-936559 (0...
April 18, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28431003/intracoronary-autologous-bone-marrow-cell-transfer-after-myocardial-infarction-the-boost-2-randomised-placebo-controlled-clinical-trial
#5
Kai C Wollert, Gerd P Meyer, Jochen Müller-Ehmsen, Carsten Tschöpe, Vernon Bonarjee, Alf Inge Larsen, Andreas E May, Klaus Empen, Emmanuel Chorianopoulos, Ulrich Tebbe, Johannes Waltenberger, Heiko Mahrholdt, Benedikta Ritter, Jens Pirr, Dieter Fischer, Mortimer Korf-Klingebiel, Lubomir Arseniev, Hans-Gert Heuft, Jan E Brinchmann, Diethelm Messinger, Bernd Hertenstein, Arnold Ganser, Hugo A Katus, Stephan B Felix, Meinrad P Gawaz, Kenneth Dickstein, Heinz-Peter Schultheiss, Dennis Ladage, Simon Greulich, Johann Bauersachs
Aims: Intracoronary infusion of autologous nucleated bone marrow cells (BMCs) enhanced the recovery of left ventricular ejection fraction (LVEF) after ST-segment elevation myocardial infarction (STEMI) in the randomised-controlled, open-label BOOST trial. We reassessed the therapeutic potential of nucleated BMCs in the randomised placebo-controlled, double-blind BOOST-2 trial conducted in 10 centres in Germany and Norway. Methods and results: Using a multiple arm design, we investigated the dose-response relationship and explored whether γ-irradiation which eliminates the clonogenic potential of stem and progenitor cells has an impact on BMC efficacy...
April 19, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28430367/effect-of-dalteparin-administration-on-thrombin-generation-kinetics-in-healthy-dogs
#6
Carolyn Gara-Boivin, Jérôme R E Del Castillo, Marilyn E Dunn, Christian Bédard
BACKGROUND: Dalteparin is used to prevent thrombotic complications in dogs. Measurement of anti-factor Xa (anti-FXa) activity is currently used for monitoring therapy, but remains a nonfunctional test. The calibrated automated thrombogram (CAT) could be a suitable approach for functional monitoring. OBJECTIVES: We hypothesized that the CAT will detect decreased endogenous thrombin potential (ETP) in healthy dogs receiving dalteparin. METHODS: Twenty-four healthy adult Beagles were randomly allocated to 4 equal groups...
April 21, 2017: Veterinary Clinical Pathology
https://www.readbyqxmd.com/read/28429311/improving-animal-welfare-using-continuous-nalbuphine-infusion-in-a-long-term-rat-model-of-sepsis
#7
Victor Jeger, Mattia Arrigo, Florian F Hildenbrand, Daniel Müller, Paulin Jirkof, Till Hauffe, Burkhardt Seifert, Margarete Arras, Donat R Spahn, Dominique Bettex, Alain Rudiger
BACKGROUND: Sepsis research relies on animal models to investigate the mechanisms of the dysregulated host response to infection. Animal welfare concerns request the use of potent analgesics for the Refinement of existing sepsis models, according to the 3Rs principle. Nevertheless, adequate analgesia is often missing, partly because the effects of analgesics in this particular condition are unknown. We evaluated the use of nalbuphine, an opioid with kappa agonistic and mu antagonistic effects, in rats with and without experimental sepsis...
December 2017: Intensive Care Medicine Experimental
https://www.readbyqxmd.com/read/28427507/is-still-there-a-place-for-orteronel-in-management-of-prostate-cancer-data-from-a-literature-based-meta-analysis-of-randomized-trials
#8
REVIEW
Giandomenico Roviello, Chiara Pacifico, Giorgio Chiriacò, Daniele Generali
Orteronel (TAK-700) is an oral, non-steroidal 17,20-lyase inhibitor with higher specificity for 17,20 lyase over 17 hydroxylase. The first phase III studies showed an advantage with orteronel compared with placebo in terms of progression free survival and response of PSA. Unfortunately orteronel did not significantly prolong the overall survival. In order to assess the efficacy of orteronel in prostate cancer, we evaluated all available data on orteronel in the management of prostate cancer. A total of 2716 patients were evaluated from 3 randomized trials...
May 2017: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/28426476/autologous-myoblasts-for-the-treatment-of-fecal-incontinence-results-of-a-phase-2-randomized-placebo-controlled-study-mias
#9
Olivier Boyer, Valérie Bridoux, Camille Giverne, Aurélie Bisson, Edith Koning, Anne-Marie Leroi, Pascal Chambon, Justine Déhayes, Stephanie Le Corre, Serge Jacquot, Dominique Bastit, Jérémie Martinet, Estelle Houivet, Jean-Jacques Tuech, Jacques Benichou, Francis Michot
OBJECTIVE: The aim of this study was to evaluate the efficacy of intrasphincteric injections of autologous myoblasts (AMs) in fecal incontinence (FI) in a controlled study. SUMMARY OF BACKGROUND DATA: Adult stem cell therapy is expected to definitively cure FI by regenerating damaged sphincter. Preclinical data and results of open-label trials suggest that myoblast therapy may represent a noninvasive treatment option. METHODS: We conducted a phase 2 randomized, double-blind, placebo-controlled study of intrasphincteric injections of AM in 24 patients...
April 19, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28426350/lenalidomide-maintenance-compared-with-placebo-in-responding-elderly-patients-with-diffuse-large-b-cell-lymphoma-treated-with-first-line-rituximab-plus-cyclophosphamide-doxorubicin-vincristine-and-prednisone
#10
Catherine Thieblemont, Hervé Tilly, Maria Gomes da Silva, Rene-Olivier Casasnovas, Christophe Fruchart, Franck Morschhauser, Corinne Haioun, Julien Lazarovici, Anida Grosicka, Aurore Perrot, Judith Trotman, Catherine Sebban, Dolores Caballero, Richard Greil, Koen van Eygen, Amos M Cohen, Hugo Gonzalez, Reda Bouabdallah, Lucie Oberic, Bernadette Corront, Bachra Choufi, Armando Lopez-Guillermo, John Catalano, Achiel Van Hoof, Josette Briere, Jose Cabeçadas, Gilles Salles, Philippe Gaulard, Andre Bosly, Bertrand Coiffier
Purpose The standard treatment of patients with diffuse large B-cell lymphoma (DLBCL) is rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Lenalidomide, an immunomodulatory agent, has shown activity in DLBCL. This randomized phase III trial compared lenalidomide as maintenance therapy with placebo in elderly patients with DLBCL who achieved a complete response (CR) or partial response (PR) to R-CHOP induction. Methods Patients with previously untreated DLBCL or other aggressive B-cell lymphoma were 60 to 80 years old, had CR or PR after six or eight cycles of R-CHOP, and were randomly assigned to lenalidomide maintenance 25 mg/d or placebo for 21 days of every 28-day cycle for 24 months...
April 20, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28426123/cabozantinib-in-hepatocellular-carcinoma-results-of-a-phase-2-placebo-controlled-randomized-discontinuation-study
#11
R K Kelley, C Verslype, A L Cohn, T-S Yang, W-C Su, H Burris, F Braiteh, N Vogelzang, A Spira, P Foster, Y Lee, E Van Cutsem
Background: Cabozantinib, an orally bioavailable inhibitor of tyrosine kinases including MET, AXL, and VEGF receptors, was assessed in patients with hepatocellular carcinoma (HCC) as part of a phase 2 randomized discontinuation trial with nine tumor-type cohorts. Patients and methods: Eligible patients had Child-Pugh A liver function and ≤1 prior systemic anticancer regimen, completed ≥4 weeks before study entry. The cabozantinib starting dose was 100 mg daily...
March 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28425497/single-dose-memantine-improves-cortical-oscillatory-response-dynamics-in-patients-with-schizophrenia
#12
Gregory A Light, Wen Zhang, Yash B Joshi, Savita Bhakta, Jo A Talledo, Neal R Swerdlow
Aberrant gamma band (30-80 Hz) oscillations may underlie cognitive deficits in schizophrenia (SZ). Gamma oscillations and their regulation by NMDA receptors can be studied via their evoked power (γEP) and phase locking (γPL) in response to auditory steady state stimulation; these Auditory Steady State Responses (ASSRs) may be biomarkers for target engagement and early therapeutic effects. We previously reported that memantine, an NMDA receptor antagonist, enhanced 2 biomarkers of early auditory information processing: prepulse inhibition (PPI) and mismatch negativity (MMN) in SZ patients and healthy subjects (HS)...
April 20, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28425024/lesinurad-a-review-in-hyperuricaemia-of-gout
#13
Emma D Deeks
Lesinurad (Zurampic(®)) is an oral selective inhibitor of the URAT1 and OAT4 uric acid (UA) transporters of the kidney, via which it inhibits UA reabsorption and thus increases renal UA excretion and lowers serum UA (sUA) levels. Lesinurad 200 mg once daily is indicated for use in combination with a xanthine oxidase inhibitor (XOI) to treat hyperuricaemia in adults with gout who have not achieved target sUA levels with an XOI alone. Approval was based on three 12-month phase 3 trials that evaluated lesinurad in combination with allopurinol in adults with gout inadequately responsive to allopurinol (CLEAR 1 and 2) and in combination with febuxostat in adults with tophaceous gout (CRYSTAL)...
April 19, 2017: Drugs & Aging
https://www.readbyqxmd.com/read/28424775/second-line-treatment-of-non-small-cell-lung-cancer-focus-on-the-clinical-development-of-dacomitinib
#14
REVIEW
Jon Zugazagoitia, Asunción Díaz, Elisabeth Jimenez, Juan Antonio Nuñez, Lara Iglesias, Santiago Ponce-Aix, Luis Paz-Ares
Dacomitinib is a second-generation, irreversible, covalent pan-HER tyrosine-kinase inhibitor (TKI). It showed potent EGFR signaling inhibition in experimental models, including first-generation TKI-resistant non-small cell lung cancer (NSCLC) cell lines. This preclinical efficacy did not translate into clinically meaningful treatment benefits for advanced, pretreated, molecularly unselected NSCLC patients enrolled in two parallel phase III trials. Dacomitinib and erlotinib showed overlapping efficacy data in chemotherapy-pretreated EGFR wild-type (WT) patients in the ARCHER 1009 trial...
2017: Frontiers in Medicine
https://www.readbyqxmd.com/read/28424273/certainty-of-genuine-treatment-increases-drug-responses-among-intellectually-disabled-patients
#15
Karin B Jensen, Irving Kirsch, Moa Pontén, Annelie Rosén, Kathy Yang, Randy L Gollub, Vincent des Portes, Ted J Kaptchuk, Aurore Curie
OBJECTIVE: To determine the placebo component of treatment responses in patients with intellectual disability (ID). METHODS: A statistical meta-analysis comparing bias-corrected effect sizes (Hedges g) of drug responses in open-label vs placebo-controlled clinical trials was performed, as these trial types represent different certainty of receiving genuine treatment (100% vs 50%). Studies in fragile X, Down, Prader-Willi, and Williams syndrome published before June 2015 were considered...
April 19, 2017: Neurology
https://www.readbyqxmd.com/read/28422539/the-effect-of-nitrate-supplementation-on-cycling-performance-in-the-heat-in-well-trained-cyclists
#16
Joseph A McQuillan, Julia R Casadio, Deborah K Dulson, Paul B Laursen, Andrew E Kilding
PURPOSE: The aim of this study was to determine the effect of NO3(-) consumption on measures of perception, thermoregulation and cycling performance in hot conditions. METHODS: Using a randomised, double-blind, crossover-design, 8 well-trained cyclists (mean ± SD: age: 25 ± 8 y, V̇O2peak: 64 ± 5 ml·kg(-1)·min(-1)) performed 2 separate trials, in hot (35°C, 60% relative humidity) environments, having ingested either 140 ml NO3(-)-rich beetroot juice ~8 mmol NO3(-) (NIT), or placebo (PLA), daily for 3-days with a 7-day washout period separating trials...
April 19, 2017: International Journal of Sports Physiology and Performance
https://www.readbyqxmd.com/read/28422514/vitamin-c-prevents-offspring-dna-methylation-changes-associated-with-maternal-smoking-in-pregnancy
#17
Lyndsey E Shorey-Kendrick, Cindy T McEvoy, Betsy Ferguson, Julja Burchard, Byung S Park, Lina Gao, Brittany H Vuylsteke, Kristin F Milner, Cynthia D Morris, Eliot R Spindel
BACKGROUND: Infants whose mothers smoked during pregnancy demonstrate lifelong decreases in pulmonary function. DNA methylation changes associated with maternal smoking during pregnancy have been described in placenta and cord blood at delivery, in fetal lung, and in buccal epithelium and blood during childhood. We recently demonstrated in a randomized clinical trial (NCT00632476) that vitamin C supplementation to pregnant smokers can lessen the impact of maternal smoking on offspring pulmonary function and decrease the incidence of wheeze at one year of age...
April 19, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28421648/placebo-like-analgesia-via-response-imagery
#18
K J Peerdeman, A I M van Laarhoven, D J P Bartels, M L Peters, A W M Evers
BACKGROUND: Placebo effects on pain are reliably observed in the literature. A core mechanism of these effects is response expectancies. Response expectancies can be formed by instructions, prior experiences and observation of others. Whether mental imagery of a response can also induce placebo-like expectancy effects on pain has not yet been studied systematically. METHODS: In Study 1, 80 healthy participants were randomly allocated to (i) response imagery or (ii) control imagery...
April 19, 2017: European Journal of Pain: EJP
https://www.readbyqxmd.com/read/28419462/modeling-and-simulation-of-pivotal-clinical-trials-using-linked-models-for-multiple-endpoints-in-chronic-obstructive-pulmonary-disease-with-roflumilast
#19
Axel Facius, Andreas Krause, Laurent Claret, Rene Bruno, Gezim Lahu
Roflumilast is a selective phosphodiesterase 4 inhibitor (PDE4i) for the treatment of severe chronic obstructive pulmonary disease (COPD). In 2 large phase 3 trials in a broader population of COPD patients (BY217/M2-111, ClinicalTrials.gov: NCT00076089 and BY217/M2-112, ClinicalTrials.gov: NCT00430729), treatment with roflumilast reduced the rate of exacerbations; however, the reduction did not reach statistical significance. Two linked dose-response models for the primary (annualized COPD exacerbation counts) and secondary (change from baseline in forced expiratory volume in 1 second [FEV1 ]) end points were therefore developed to characterize and quantify effect sizes and the patient characteristics influencing them...
April 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419379/central-sensitization-is-modulated-following-trigger-point-anesthetization-in-patients-with-chronic-pain-from-whiplash-trauma-a-double-blind-placebo-controlled-crossover-study
#20
N Ake Nystrom, Michael D Freeman
Objective. : Central sensitization (CS) with low peripheral pain thresholds (PPTs) is a common finding among patients with chronic pain after whiplash (CPWI). While it has been proposed that myofascial myofascial trigger points (MTrPs) may act as modulators of central sensitization, previously reported findings are conflicting and inconclusive. The present study was designed to investigate immediate responsiveness of CS to alterations in nociceptive input. Design.:  Controlled, double-blind, cross-over...
April 17, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
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