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Placebo response

Pang Yao, Liang Sun, Ling Lu, Hong Ding, Xiafei Chen, Lixin Tang, Xinming Xu, Gang Liu, Yao Hu, Yiwei Ma, Feijie Wang, Qianlu Jin, He Zheng, Huiyong Yin, Rong Zeng, Yan Chen, Frank B Hu, Huaixing Li, Xu Lin
CONTEXT: Little is known how genetic and non-genetic factors modify responses of vitamin D supplementation in nonwhite populations. OBJECTIVE: To investigate factors modifying 25-hydroxyvitamin D (25[OH]D) and bioavailable 25(OH)D (25[OH]DBio) responses after vitamin D3 supplementation. Design, Setting, Participants, and Intervention: In this randomized, double-blinded, placebo-controlled trial, 448 Chinese with vitamin D deficiency (25[OH]D<50 nmol/L) received 2000 IU/d vitamin D3 or placebo for 20 weeks...
October 21, 2016: Journal of Clinical Endocrinology and Metabolism
Charlotte J W Connell, Benjamin Thompson, Gustav Kuhn, Nicholas Gant
Fatigue resulting from strenuous exercise can impair cognition and oculomotor control. These impairments can be prevented by administering psychostimulants such as caffeine. This study used two experiments to explore the influence of caffeine administered at rest and during fatiguing physical exercise on spatial attention-a cognitive function that is crucial for task-based visually guided behavior. In independent placebo-controlled studies, cohorts of 12 healthy participants consumed caffeine and rested or completed 180 min of stationary cycling...
2016: PloS One
Scott C Forbes, Nathan Sletten, Cody Durrer, Étienne Myette-Cote, Darren Candow, Jonathan P Little
High-intensity interval training (HIIT) has been shown to improve cardiorespiratory fitness, performance, body composition, and insulin sensitivity. Creatine (Cr) supplementation may augment responses to HIIT, leading to even greater physiological adaptations. The purpose of this study was to determine the effects of four weeks of HIIT (three sessions/week) combined with Cr supplementation in recreationally active females. Seventeen females (age = 23 ± 4 yrs; BMI = 23.4 ± 2.4) were randomly assigned to either Cr (Cr; 0...
October 21, 2016: International Journal of Sport Nutrition and Exercise Metabolism
K Reich, M Gooderham, L Green, A Bewley, Z Zhang, I Khanskaya, R M Day, J Goncalves, K Shah, V Piguet, J Soung
BACKGROUND: Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate to severe psoriasis. OBJECTIVE: Evaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate to severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299). METHODS: 250 patients were randomized to placebo (n=84), apremilast 30 mg BID (n=83) or etanercept 50 mg QW (n=83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104...
October 21, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
H Esfandiari, M Pakravan, Z Zakeri, S Ziaie, P Pakravan, V Ownagh
PurposeThe purpose of the study was to investigate ocular hypertensive effect of exogenous glucosamine in comparison with placebo in patients with osteoarthritis.Patients and methodsIn this double-masked randomized clinical trial, 88 patients with osteoarthritis were included. Forty-four patients were randomized into either glucosamine sulfate or the placebo group.Comprehensive ophthalmologic exam including intraocular pressure (IOP) at baseline, month 1, and 3 was performed. Ocular response analyzer parameters were also checked at baseline and month 3...
October 21, 2016: Eye
David Jarrard, Badrinath Konety, Wei Huang, Tracy Downs, Jill Kolesar, Kyung Mann Kim, Tom Havighurst, Joel Slaton, Margaret G House, Howard L Parnes, Howard H Bailey
INTRODUCTION AND OBJECTIVES: Prostate cancer (PCa) represents an important target for chemoprevention given its prolonged natural history and high prevalence. Epidemiologic and laboratory data suggest that vitamin D and genistein (soy isoflavone) may decrease PCa progression. The effect of vitamin D on prostate epithelial cell proliferation and differentiation is well documented and genistein may augment this affect through inhibition of the CYP24 enzyme, which is responsible for intracellular vitamin D metabolism...
2016: American Journal of Clinical and Experimental Urology
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
Wojciech Kosmala, Aleksandra Rojek, Monika Przewlocka-Kosmala, Leah Wright, Andrzej Mysiak, Thomas H Marwick
BACKGROUND: Impaired functional capacity is a hallmark of patients with heart failure with preserved ejection fraction (HFpEF). Despite the association of HFpEF with reduced myocardial compliance attributed to fibrosis, spironolactone has not been shown to alter outcomes-perhaps reflecting the heterogeneity of underlying pathological mechanisms. OBJECTIVES: The authors sought to identify improvement in exercise capacity with spironolactone in the subset of patients with HFpEF with exercise-induced increase in ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e') reflecting elevation of left ventricular (LV) filling pressure...
October 25, 2016: Journal of the American College of Cardiology
Monica L Castro-Acosta, Leanne Smith, Rosalind J Miller, Danielle I McCarthy, Jonathan A Farrimond, Wendy L Hall
Blackcurrants are rich in polyphenolic glycosides called anthocyanins, which may inhibit postprandial glycemia. The aim was to determine the dose-dependent effects of blackcurrant extract on postprandial glycemia. Men and postmenopausal women (14M, 9W, mean age 46 years, S.D.=14) were enrolled into a randomized, double-blind, crossover trial. Low sugar fruit drinks containing blackcurrant extract providing 150-mg (L-BE), 300-mg (M-BE) and 600-mg (H-BE) total anthocyanins or no blackcurrant extract (CON) were administered immediately before a high-carbohydrate meal...
September 14, 2016: Journal of Nutritional Biochemistry
Achraf Ammar, Mouna Turki, Hamdi Chtourou, Omar Hammouda, Khaled Trabelsi, Choumous Kallel, Osama Abdelkarim, Anita Hoekelmann, Mohamed Bouaziz, Fatma Ayadi, Tarak Driss, Nizar Souissi
PURPOSE: The aim of this study was to investigate the effect of natural Pomegranate juice supplementation on performance and acute and delayed responses of muscle soreness and biomarkers of muscle damage after a weightlifting training session. METHODS: Nine elite weightlifters (21±0.5 years) performed two Olympic-Weightlifting-sessions after either placebo (PLA) or natural pomegranate juice (POMj) supplementations. Heart rate, blood pressure and blood samples (hematological parameters, muscle damage and C-reactive protein (CRP)) were collected at rest, 3min and 48h after each session...
2016: PloS One
Brian J Martin, Chris McGlory, Martin J MacInnis, Mary K Allison, Stuart M Phillips, Martin J Gibala
We reported that supplementation with green tea extract (GTE) lowered the glycemic response to an oral glucose load following exercise but via an unknown mechanism. Here we examined the effect of supplementation with GTE on plasma glucose kinetics upon ingestion of a glucose beverage during exercise recovery. Eleven healthy, sedentary men (21±2 y; BMI=23±4 kg•m(-2), VO2peak=38±7 ml•kg(-1)•min(-1); mean±SD) ingested GTE (350 mg) or placebo (PLA) thrice daily for 7-d in a double-blind, crossover design...
October 7, 2016: Journal of Applied Physiology
A Molina, M García-Gargallo, E Montero, A Tobías, M Sanz, C Martín
OBJECTIVE: This systematic review aimed to evaluate the scientific evidence on the efficacy of desensitizing mouthwashes for the treatment of dentin hypersensitivity (DH) and root sensitivity (RS). MATERIAL AND METHODS: A thorough search in MEDLINE, PubMed and Cochrane Plus Library was conducted up to February 2015. Randomized clinical trials, parallel, double-blinded and placebo-controlled, with a follow-up of at least 6 weeks, reporting changes on response to tactile stimuli, thermal/evaporative stimuli or patients' subjective assessment of the pain experienced during their daily life after the home use of desensitizing mouthwashes were considered for inclusion...
October 20, 2016: International Journal of Dental Hygiene
Priyamvada Gupta, Durga Jethava, Ruchika Choudhary, Dharam Das Jethava
BACKGROUND AND AIMS: Laryngoscopy and endotracheal intubation are considered as potent stimuli which lead to an increase in heart rate and blood pressure. Melatonin (N-acetyl-5-methoxytryptamine) has been studied for pre-operative anxiolysis and sedation in Intensive Care Unit. We made a hypothesis that melatonin can provide haemodynamic stability during laryngoscopy and intubation when given 120 min before the procedure. METHODS: Sixty American Society of Anesthesiologists physical status Grade I and II patients of either gender, 20-45 years old, 40-65 kg body weight, scheduled to undergo elective surgical procedures under general anaesthesia were assigned into two equal groups - Group C (control) and Group M (melatonin)...
October 2016: Indian Journal of Anaesthesia
Marius N Stan, Mario Salvi
Rituximab (RTX) use in open label series has been associated with very encouraging responses in patients with active and moderate-to-severe Graves' Orbitopathy (GO). Recently randomized controlled trials of RTX have been performed in such patients in order to answer the question of clinical efficacy and the safety profile of this agent. That data, reported separately, focused on Clinical Activity Score (CAS) and indicated in one trial a strong benefit of RTX in comparison with IV glucocorticoids while the other trial noted the absence of a benefit by comparison with placebo...
October 19, 2016: European Journal of Endocrinology
Corinna La Rosa, Jeff Longmate, Joy Martinez, Qiao Zhou, Teodora I Kaltcheva, Weimin Tsai, Jennifer Drake, Mary Carroll, Felix Wussow, Flavia Chiuppesi, Nicola Hardwick, Sanjeet Dadwal, Ibrahim Aldoss, Ryotaro Nakamura, John A Zaia, Don J Diamond
Attenuated poxvirus Modified vaccinia Ankara (MVA) is a useful viral-based vaccine for clinical investigation, because of its excellent safety profile and property of inducing potent immune responses against recombinant (r) antigens. We developed Triplex by constructing an rMVA encoding three immunodominant CMV antigens which stimulates a host anti-viral response: UL83 (pp65), UL123 (IE1-exon4), and UL122 (IE2-exon5). We completed the first clinical evaluation of the Triplex vaccine in 24 healthy adults, with or without immunity to CMV and vaccinia virus (previous DryVax smallpox vaccination)...
October 19, 2016: Blood
Kristian Reich, Craig Leonardi, Mark Lebwohl, Francisco Kerdel, Yukari Okubo, Ricardo Romiti, Orin Goldblum, Ellen B Dennehy, Lisa Kerr, Howard Sofen
BACKGROUND: Scalp is a frequently affected and difficult-to-treat area in psoriasis patients. OBJECTIVES: We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI). METHODS: In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224), and UNCOVER-3 (N = 1346) were randomized to subcutaneous 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12...
October 19, 2016: Journal of Dermatological Treatment
H-L Che, M S Kanthimathi, R Loganathan, K H Yuen, A T B Tan, K R Selvaduray, K Nesaretnam, K-T Teng
BACKGROUND/OBJECTIVES: Evidence shows that tocotrienols potentially reverse various chronic disease progressions caused by the metabolic syndrome. We aimed to investigate the acute effects of a single-dose supplementation of gamma and delta tocotrienols (γδ-T3, 1:4 ratio) compared with those in placebo on the insulinemic, anti-inflammatory and anti-thrombogenic responses in metabolic syndrome subjects. SUBJECTS/METHODS: Thirty metabolic syndrome subjects (15 men and 15 women) were recruited to a randomized, double-blinded and crossover study...
October 19, 2016: European Journal of Clinical Nutrition
J Quiralte-Castillo, M Del Robledo Ávila-Castellano, S Cimbollek, P Benaixa, S Leguisamo, K Baynova, M Labella, J Quiralte
BACKGROUND: Safer and less time consuming alternatives to single-blind placebo-controlled oral challenge (SBPCOC) in order to diagnose aspirin-exacerbated respiratory disease (AERD) have been searched for. Nasal challenges with different non-steroidal anti-inflammatory drugs and assessment methods have been developed. OBJECTIVE: Our objective was to evaluate the utility and safety of nasal ketorolac challenge (NKC) using an acoustic rhinomether in patients with suspected AERD Methods: Thirty-six patients with suspected AERD were included in the study...
October 19, 2016: Journal of Investigational Allergology & Clinical Immunology
Andrew Zloza, Neal D Dharmadhikari, Erica J Huelsmann, Joseph R Broucek, Tasha Hughes, Frederick J Kohlhapp, Howard L Kaufman
Recombinant interleukin-2 (rIL-2) is associated with objective responses in 15-20 % of patients with metastatic melanoma and renal cell carcinoma. More recently, rIL-2 has also demonstrated improved clinical activity in patients with melanoma. Given the toxicity of high-dose rIL-2 and the availability of many new immunotherapy agents, it has been suggested that lower doses of rIL-2 may be preferred for combination clinical studies. In order to determine the impact of low doses of rIL-2 on anti-tumor immunity and therapeutic effectiveness, we challenged C57BL/6 mice with poorly immunogenic B16-F10 melanoma and treated them with varying doses of rIL-2 (range 10(3)-10(5) IU)...
October 18, 2016: Cancer Immunology, Immunotherapy: CII
Helena H Borba, Astrid Wiens, Laiza M Steimbach, Cassio M Perlin, Fernanda S Tonin, Maria L A Pedroso, Fernando Fernandez-Llimos, Roberto Pontarolo
PURPOSE: This study aimed to compare the efficacy among direct-acting antiviral agents (first and second-generation direct-acting antiviral agents (DAAs)) with placebo and with standard dual therapy (pegylated interferon + ribavirin (Peg-IFN + RBV)) in terms of rapid virologic response (RVR) and sustained virologic response (SVR) in chronic hepatitis C genotype 1 treatment. METHODS: We performed a systematic review of randomized controlled trials (RCTs) in MEDLINE, International Pharmaceutical Abstracts, Cochrane Library, SCIELO, and Scopus and conducted a network meta-analysis to compare the efficacy of boceprevir (BOC), daclatasvir (DCV), grazoprevir, simeprevir (SMV) and telaprevir (TVR), in treatment-naive and treatment-experienced patients...
October 19, 2016: European Journal of Clinical Pharmacology
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