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Placebo response

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https://www.readbyqxmd.com/read/28212463/efficacy-and-tolerability-of-an-inhaled-selective-glucocorticoid-receptor-modulator-azd5423-in-copd-patients-phase-ii-study-results
#1
Piotr Kuna, Magnus Aurivillius, Carin Jorup, Susanne Prothon, Ziad Taib, Staffan Edsbäcker
AZD5423 is a novel, inhaled, selective glucocorticoid receptor modulator (SGRM), which in an allergen challenge model in asthmatics improved lung function and airway hyper-reactivity. In the current trial, AZD5423 was for the first time tested in patients with chronic obstructive pulmonary disease (COPD). In this double-blind, randomised and parallel group study, we examined airway and systemic effects of two doses of AZD5423, inhaled via Turbuhaler for 12 weeks, in 353 symptomatic COPD patients (average pre-bronchodilator forced expiratory volume in one second (FEV1) at screening was 50-52% of predicted normal)...
February 17, 2017: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/28212067/the-treatment-of-severe-childhood-aggression-study-12-weeks-of-extended-blinded-treatment-in-clinical-responders
#2
Robert L Findling, Lisa Townsend, Nicole V Brown, L Eugene Arnold, Kenneth D Gadow, David J Kolko, Nora K McNamara, Devin S Gary, Dana B Kaplin, Cristan A Farmer, Heidi Kipp, Craig Williams, Eric M Butter, Oscar G Bukstein, Robert Rice, Kristin Buchan-Page, Brooke S G Molina, Michael G Aman
OBJECTIVES: Previous "Treatment of Severe Childhood Aggression" (TOSCA) reports demonstrated that many children with severe physical aggression and attention-deficit/hyperactivity disorder (ADHD) responded well to two randomized treatments (parent training [PT]+stimulant+placebo = Basic vs. PT+stimulant+risperidone = Augmented) for 9 weeks. An important clinical question is whether these favorable outcomes are maintained over longer times. METHODS: Clinical responders to the 9-week trial (n = 103/168), defined as Clinical Global Impressions (CGI)-Improvement of much/very much improved plus substantial reduction in parent ratings of disruptiveness, were followed another 12 weeks (21 weeks total) while remaining on blinded treatment...
February 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28210930/emotion-specific-nocebo-effects-an-fmri-study
#3
Anne Schienle, Carina Höfler, Sonja Übel, Albert Wabnegger
The neurobiological mechanisms of nocebos are still poorly understood. Thirty-eight women participated in a 'smell study' using functional magnetic resonance imaging. They were presented with an odorless stimulus (distilled water) together with the verbal suggestion that this fluid has an aversive odor which enhances disgust feelings. The nocebo was presented while the participants viewed disgusting, fear-inducing, and neutral images. Participants' affective and neuronal responses during nocebo administration were compared with those in a control condition without nocebo...
February 16, 2017: Brain Imaging and Behavior
https://www.readbyqxmd.com/read/28209746/a-phase-ii-randomized-trial-go27827-of-first-line-folfox-plus-bevacizumab-with-or-without-the-met-inhibitor-onartuzumab-in-patients-with-metastatic-colorectal-cancer
#4
Johanna C Bendell, Howard Hochster, Lowell L Hart, Irfan Firdaus, Joseph R Mace, Joshua J McFarlane, Mark Kozloff, Daniel Catenacci, Jessie J Hsu, Stephen P Hack, David S Shames, See-Chun Phan, Hartmut Koeppen, Allen L Cohn
BACKGROUND: Dysregulated hepatocyte growth factor/mesenchymal-epithelial transition (MET) signaling is associated with poor prognosis and resistance to vascular endothelial growth factor inhibition in metastatic colorectal cancer (mCRC). We report outcomes from a double-blind, multicenter phase II trial of the MET inhibitor onartuzumab in combination with mFOLFOX-6 and bevacizumab for mCRC (GO27827; NCT01418222). MATERIALS AND METHODS: Patients were randomized 1:1 to receive onartuzumab (10 mg/kg intravenously [IV]) or placebo plus mFOLFOX-6 and bevacizumab (5 mg/kg IV)...
February 16, 2017: Oncologist
https://www.readbyqxmd.com/read/28209624/tofacitinib-for-induction-and-maintenance-therapy-of-crohn-s-disease-results-of-two-phase-iib-randomised-placebo-controlled-trials
#5
Julian Panés, William J Sandborn, Stefan Schreiber, Bruce E Sands, Séverine Vermeire, Geert D'Haens, Remo Panaccione, Peter D R Higgins, Jean-Frederic Colombel, Brian G Feagan, Gary Chan, Michele Moscariello, Wenjin Wang, Wojciech Niezychowski, Amy Marren, Paul Healey, Eric Maller
OBJECTIVE: Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). DESIGN: We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks...
February 16, 2017: Gut
https://www.readbyqxmd.com/read/28209155/intranasal-oxytocin-reduces-provoked-symptoms-in-female-patients-with-posttraumatic-stress-disorder-despite-exerting-sympathomimetic-and-positive-chronotropic-effects-in-a-randomized-controlled-trial
#6
M Sack, D Spieler, L Wizelman, G Epple, J Stich, M Zaba, U Schmidt
BACKGROUND: Posttraumatic stress disorder (PTSD) is a severe psychiatric disease accompanied by neuroendocrine changes such as adrenergic overdrive and hence an elevated cardiovascular morbidity. Current pharmacotherapeutic options for PTSD are less than suboptimal, necessitating the development of PTSD-specific drugs. Although the neuropeptide oxytocin has been repeatedly suggested to be effective in PTSD treatment, there are, to our knowledge, only three studies that have assessed its efficacy on the intensity of PTSD symptoms in PTSD patients - among them one symptom provocation study in male veterans...
February 17, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28208806/orange-pomace-improves-postprandial-glycemic-responses-an-acute-randomized-placebo-controlled-double-blind-crossover-trial-in-overweight-men
#7
C-Y Oliver Chen, Helen Rasmussen, Alison Kamil, Peng Du, Jeffrey B Blumberg
Orange pomace (OP), a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-controlled, double blind, crossover trial with 34 overweight men who consumed either a 255 g placebo (PLA), a low (35% OP (LOP)), or a high (77% (HOP)) dose OP beverage with breakfast. Blood was collected at 0, 10, 20, 30, and 45 min and at 1, 1...
February 13, 2017: Nutrients
https://www.readbyqxmd.com/read/28206898/fluoride-varnish-applications-in-preschoolers-and-dental-fluorosis-in-permanent-incisors-results-of-a-nested-cohort-study-within-a-clinical-trial
#8
Ana Paula Pires Dos Santos, Marcella Cristina Bordallo Malta, Mirian de Waele Souchois de Marsillac, Branca Heloisa de Oliveira
PURPOSE: To compare the prevalence and severity of fluorosis in the permanent maxillary incisors of children who had participated in a two-year randomized placebo-controlled clinical trial on fluoride varnish application in the primary dentition and to assess children's esthetic perception of their teeth. METHODS: Parents of 200 one- to four-year-old children who had received biannual applications of fluoride or placebo varnish were contacted four years after the end of the trial...
October 15, 2016: Pediatric Dentistry
https://www.readbyqxmd.com/read/28206892/influence-of-the-amount-of-dentifrice-and-fluoride-concentrations-on-salivary-fluoride-levels-in-children
#9
Kevin Bruce Hall, Alberto Carlos Botazzo Delbem, Mariana Emi Nagata, Thayse Yumi Hosida, Felipe Ricardo Nunes de Moraes, Marcelle Danelon, Robson Frederico Cunha, Juliano Pelim Pessan
PURPOSE: This study evaluated fluoride (F) concentrations in saliva of children after brushing with dentifrices containing different F concentrations (zero, 550, and 1,100 ppm F) in different quantities (full bristles, transversal technique, and pea-sized). METHODS: Eight- to 10-year-old volunteers (<small>N</small>=24) were randomly assigned into nine experimental groups (dentifrice type versus amounts) following a double-blind, crossover protocol. After a one-week washout period (use of placebo toothpaste), stimulated saliva was collected prior to toothbrushing (baseline) and at five, 15, 30, 60, and 120 minutes after toothbrushing with one of the possible combinations...
October 15, 2016: Pediatric Dentistry
https://www.readbyqxmd.com/read/28203319/iron-supplementation-effects-on-redox-status-following-aseptic-skeletal-muscle-trauma-in-adults-and-children
#10
Chariklia K Deli, Ioannis G Fatouros, Vassilis Paschalis, Athanasios Tsiokanos, Kalliopi Georgakouli, Athanasios Zalavras, Alexandra Avloniti, Yiannis Koutedakis, Athanasios Z Jamurtas
Exercise-induced skeletal muscle microtrauma is characterized by loss of muscle cell integrity, marked aseptic inflammatory response, and oxidative stress. We examined if iron supplementation would alter redox status after eccentric exercise. In a randomized, double blind crossover study, that was conducted in two cycles, healthy adults (n = 14) and children (n = 11) received daily either 37 mg of elemental iron or placebo for 3 weeks prior to and up to 72 h after an acute eccentric exercise bout. Blood was drawn at baseline, before exercise, and 72 h after exercise for the assessment of iron status, creatine kinase activity (CK), and redox status...
2017: Oxidative Medicine and Cellular Longevity
https://www.readbyqxmd.com/read/28202358/a-prospective-multicenter-double-blind-randomized-trial-of-bladder-instillation-of-liposome-formulation-onabotulinumtoxina-for-interstitial-cystitis-bladder-pain-syndrome
#11
Yao-Chi Chuang, Hann-Chorng Kuo
BACKGROUND: Intravesical instillation of liposomal-formulated botulinum toxin A (lipotoxin) has shown therapeutic effects on treatment of refractory overactive bladder without needle injections. We hereby assessed lipotoxin for the treatment of refractory interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: This two-center, double-blind, randomized, placebo-controlled physician-initiated study enrolled patients with refractory IC/BPS. The patients were assigned to intravesical instillation of lipotoxin (onabotulinumtoxinA 200 U with 80mg sphingomyelin) (n=31), onabotulinumtoxinA 200 U in normal saline (n=28), or normal saline alone (n=31)...
February 12, 2017: Journal of Urology
https://www.readbyqxmd.com/read/28199814/baricitinib-versus-placebo-or-adalimumab-in-rheumatoid-arthritis
#12
Peter C Taylor, Edward C Keystone, Désirée van der Heijde, Michael E Weinblatt, Liliana Del Carmen Morales, Jaime Reyes Gonzaga, Sergey Yakushin, Taeko Ishii, Kahaku Emoto, Scott Beattie, Vipin Arora, Carol Gaich, Terence Rooney, Douglas Schlichting, William L Macias, Stephanie de Bono, Yoshiya Tanaka
Background Baricitinib is an oral, reversible inhibitor of the Janus kinases JAK1 and JAK2 that may have therapeutic value in patients with rheumatoid arthritis. Methods We conducted a 52-week, phase 3, double-blind, placebo- and active-controlled trial in which 1307 patients with active rheumatoid arthritis who were receiving background therapy with methotrexate were randomly assigned to one of three regimens in a 3:3:2 ratio: placebo (switched to baricitinib after 24 weeks), 4 mg of baricitinib once daily, or 40 mg of adalimumab (an anti-tumor necrosis factor α monoclonal antibody) every other week...
16, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28197931/pharmacokinetics-and-pharmacodynamics-of-lysergic-acid-diethylamide-in-healthy-subjects
#13
Patrick C Dolder, Yasmin Schmid, Andrea E Steuer, Thomas Kraemer, Katharina M Rentsch, Felix Hammann, Matthias E Liechti
BACKGROUND AND OBJECTIVE: Lysergic acid diethylamide (LSD) is used recreationally and in clinical research. The aim of the present study was to characterize the pharmacokinetics and exposure-response relationship of oral LSD. METHODS: We analyzed pharmacokinetic data from two published placebo-controlled, double-blind, cross-over studies using oral administration of LSD 100 and 200 µg in 24 and 16 subjects, respectively. The pharmacokinetics of the 100-µg dose is shown for the first time and data for the 200-µg dose were reanalyzed and included...
February 14, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28196341/suppressing-the-endocrine-and-autonomic-stress-systems-does-not-impact-the-emotional-stress-experience-after-psychosocial-stress
#14
Nida Ali, Jonas P Nitschke, Cory Cooperman, Jens C Pruessner
Acute psychosocial stress activates the physiological and endocrine stress systems and increases the subjective emotional experience of stress. While considerable efforts have been made to link changes in the activity of the biological stress systems with changes in the subjective emotional experience of stress, results so far have been mixed, at best. To investigate this association in a study employing experimental manipulation, we pharmacologically suppressed both the autonomic and the endocrine stress responses, and investigated the effects of acute psychosocial stress on the emotional stress experience...
January 28, 2017: Psychoneuroendocrinology
https://www.readbyqxmd.com/read/28196255/effect-of-2-years-of-treatment-with-sublingual-grass-pollen-immunotherapy-on-nasal-response-to-allergen-challenge-at-3-years-among-patients-with-moderate-to-severe-seasonal-allergic-rhinitis-the-grass-randomized-clinical-trial
#15
Guy W Scadding, Moises A Calderon, Mohamed H Shamji, Aarif O Eifan, Martin Penagos, Florentina Dumitru, Michelle L Sever, Henry T Bahnson, Kaitie Lawson, Kristina M Harris, Audrey G Plough, Joy Laurienzo Panza, Tielin Qin, Noha Lim, Nadia K Tchao, Alkis Togias, Stephen R Durham
Importance: Sublingual immunotherapy and subcutaneous immunotherapy are effective in seasonal allergic rhinitis. Three years of continuous treatment with subcutaneous immunotherapy and sublingual immunotherapy has been shown to improve symptoms for at least 2 years following discontinuation of treatment. Objective: To assess whether 2 years of treatment with grass pollen sublingual immunotherapy, compared with placebo, provides improved nasal response to allergen challenge at 3-year follow-up...
February 14, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28195931/should-antipsychotic-medications-for-schizophrenia-be-given-for-a-lifetime-a-naturalistic-long-term-follow-up-study
#16
Ira D Glick, John M Davis, Daisy Zamora, Jacob Ballon, Meena Nuthi
BACKGROUND: Schizophrenia remains a major health problem despite antipsychotic medications that, for most patients, can decrease acute symptoms, decrease relapses, and contribute to partial and sometimes strong positive response in patients with chronic symptoms. What has not been clear-because a double-blind, randomized, placebo-controlled trial is not feasible or ethical-is how many years after the initial episode, or onset of antipsychotic treatment, should medication be continued to achieve the best global outcome...
February 13, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28194525/low-dose-solumatrix-diclofenac-in-patients-with-osteoarthritis-pain-impact-on-quality-of-life-in-a-controlled-trial
#17
Vibeke Strand, Martin Bergman, Jasvinder A Singh, Allan Gibofsky, Alan Kivitz, Clarence Young
Low-dose SoluMatrix diclofenac was developed to provide effective pain relief for osteoarthritis pain. We evaluated the effects of SoluMatrix diclofenac on health-related quality of life (HRQoL) measures in patients with osteoarthritis, hypothesizing that SoluMatrix-treated patients would experience significant improvement compared with placebo. In this 12-week, phase 3 randomized controlled trial, 305 patients with osteoarthritis of the hip or knee received SoluMatrix diclofenac 35 mg three times (TID) or twice (BID) daily or placebo...
February 13, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28193304/physiological-response-and-semen-quality-of-rabbit-bucks-supplemented-with-moringa-leaves-ethanolic-extract-during-summer-season
#18
N I El-Desoky, N M Hashem, A Elkomy, Z R Abo-Elezz
Exposure of rabbit bucks to summer heat stress reduces their homeostasis and semen quality leading to a temporal subfertility. The potentiality of ethanolic extract of Moringa oleifera leaves (M. oleifera ethanolic extract (MLEE)) to reduce negative impacts of heat stress on physiological and semen quality traits was investigated. A total of 28 adult V-line rabbit bucks were randomly distributed among four experimental groups of seven rabbits each. The first group received water (placebo) and served as a control (M0)...
February 14, 2017: Animal: An International Journal of Animal Bioscience
https://www.readbyqxmd.com/read/28192517/neutrophils-and-neutrophil-serine-proteases-are-increased-in-the-spleens-of-estrogen-treated-c57bl-6-mice-and-several-strains-of-spontaneous-lupus-prone-mice
#19
Rujuan Dai, Catharine Cowan, Bettina Heid, Deena Khan, Zhihong Liang, Christine T N Pham, S Ansar Ahmed
Estrogen, a natural immunomodulator, regulates the development and function of diverse immune cell types. There is now renewed attention on neutrophils and neutrophil serine proteases (NSPs) such as neutrophil elastase (NE), proteinase 3 (PR3), and cathepsin G (CG) in inflammation and autoimmunity. In this study, we found that although estrogen treatment significantly reduced total splenocytes number, it markedly increased the splenic neutrophil absolute numbers in estrogen-treated C57BL/6 (B6) mice when compared to placebo controls...
2017: PloS One
https://www.readbyqxmd.com/read/28192113/a-randomised-clinical-trial-comparing-the-effects-of-antitussives-on-respiratory-centre-output-in-patients-with-chronic-cough
#20
Claudia Mannini, Federico Lavorini, Alessandro Zanasi, Federico Saibene, Luigi Lanata, Giovanni Fontana
BACKGROUND: Cough is produced by the same neuronal pool implicated in respiratory rhythm generation and antitussive drugs acting at the central level, such as the opioids, may depress ventilation. Levodropropizine is classified as a non-opioid, peripherally-acting antitussive drug acting at the level of airway sensory nerves. However, the lack of a central action by Levodropropizine remains to be fully established. We set out to compare the effects of Levodropropizine and the opioid antitussive agent Dihydrocodeine on the respiratory responses to a conventional CO2 re-breathing test in patients with chronic cough of any origin...
February 10, 2017: Chest
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