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https://www.readbyqxmd.com/read/28239939/combining-the-gpr40-agonist-fasiglifam-with-sitagliptin-improves-glycemic-control-in-patients-with-type-2-diabetes-with-or-without-metformin-a-randomized-12-week-trial
#1
Xuejun V Peng, John F Marcinak, Marsha G Raanan, Charlie Cao
AIMS: To evaluate the efficacy and safety of fasiglifam, an orally active G protein-coupled receptor 40 agonist, in combination with the dipeptidyl peptidase-4 inhibitor sitagliptin, in patients with type 2 diabetes inadequately controlled with diet/exercise (± metformin). METHODS: In this randomized, double-blind, phase II study, 368 patients received once-daily placebo, sitagliptin 100 mg, fasiglifam 25 or 50 mg, or the combination of sitagliptin 100 mg plus fasiglifam 25 or 50 mg...
February 27, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28239907/effects-of-oral-%C3%AE-lipoic-acid-administration-on-body-weight-in-overweight-or-obese-subjects-a-crossover-randomized-double-blind-placebo-controlled-trial
#2
Nong Li, Weili Yan, Xiaojuan Hu, Yongdi Huang, Fugang Wang, Weiguo Zhang, Qian Wang, Xiaoling Wang, Kehong Sun
OBJECTIVE: Alpha-lipoic acid (ALA) has shown beneficial properties on diabetes and obesity. The aim of this study was to examine the effects of oral ALA on body weight in subjects with overweight or obese. DESIGN: Single-centre, randomized, double-blind, crossover controlled study. PARTICIPANTS: A total of 166 subjects of Chinese Han ethnicity with a BMI ≥25 kg/m(2) were screened and 103 subjects fulfilled the study requirements, in terms of informed consent and participation to the study...
January 12, 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/28239652/estrogens-regulate-glycosylation-of-igg-in-women-and-men
#3
Altan Ercan, Wendy M Kohrt, Jing Cui, Kevin D Deane, Marija Pezer, Elaine W Yu, Jonathan S Hausmann, Harry Campbell, Ursula B Kaiser, Pauline M Rudd, Gordan Lauc, James F Wilson, Joel S Finkelstein, Peter A Nigrovic
The immunologic potency of IgG is modulated by glycosylation, but mechanisms regulating this process are undefined. A role for sex hormones is suggested by differences in IgG glycans between women and men, most prominently with respect to galactose. We therefore assessed IgG galactosylation in 713 healthy adults from 2 cohorts as well as in 159 subjects from 4 randomized controlled studies of endocrine manipulation: postmenopausal women receiving conjugated estrogens, raloxifene, or placebo; premenopausal women deprived of gonadal hormones with leuprolide and treated with estradiol or placebo; men deprived of gonadal hormones with goserelin and given testosterone or placebo; and men deprived of gonadal hormones with goserelin and given testosterone or placebo together with anastrozole to block conversion of testosterone to estradiol...
February 23, 2017: JCI Insight
https://www.readbyqxmd.com/read/28239586/triamcinolone-impregnated-nasal-pack-in-endoscopic-sinus-surgery-our-experience
#4
V Sabarinath, M R Harish, Shilpa Divakaran
The selection of an effective packing method to prevent postoperative complications and recurrence following Endoscopic Sinus Surgery remains ambiguous at present. This study was conducted to evaluate the efficacy of Triamcinolone impregnated nasal pack in Endoscopic Sinus Surgery, in the prevention of postoperative crusting, edema, infection and recurrence. This study was an interventional randomized placebo-controlled study, conducted at a tertiary care centre in South India between February 2015 and May 2016, after getting approval from Institute Ethical Committee...
March 2017: Indian Journal of Otolaryngology and Head and Neck Surgery
https://www.readbyqxmd.com/read/28238742/molecular-signatures-order-the-potency-of-topically-applied-anti-inflammatory-drugs-in-atopic-dermatitis-patients
#5
Emma Guttman-Yassky, Benjamin Ungar, Kunal Malik, Daniel Dickstein, Maria Suprun, Yeriel D Estrada, Hui Xu, Xiangyu Peng, Margeaux Oliva, Dan Todd, Tord Labuda, Mayte Suarez-Farinas, Robert Bissonnette
BACKGROUND: Atopic Dermatitis (AD) presents a large unmet need for treatments with better safety and efficacy. To facilitate development of topical therapeutics, we need an efficient model for assessing different formulations and concentrations. The "plaque model" has been successfully implemented in psoriasis, another common inflammatory disease, to assess efficacy of topical treatments. This model has not been validated for AD, which has higher placebo responses and less stable lesions than psoriasis...
February 23, 2017: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28238631/four-year-persistence-of-type-specific-immunity-after-quadrivalent-human-papillomavirus-vaccination-in-hiv-infected-children-effect-of-a-fourth-dose-of-vaccine
#6
Myron J Levin, Sharon Huang, Anna-Barbara Moscicki, Lin-Ye Song, Jennifer S Read, William A Meyer, Alfred J Saah, Kelly Richardson, Adriana Weinberg
OBJECTIVE: Although HIV-infected children are recommended to receive quadrivalent human papillomavirus vaccine (QHPV) there is limited information on their response to QHPV. This study in HIV-infected children, evaluated the magnitude and duration of immune responses to QHPV. This report describes type-specific serum antibody responses over a 4-to-5year period after either 3 or 4 doses of QHPV. DESIGN/METHODS: HIV-infected children, ages 7-to-11years, received 3 doses of QHPV (n=96) or placebo (n=30)...
February 23, 2017: Vaccine
https://www.readbyqxmd.com/read/28238563/the-development-and-use-of-vascular-targeted-therapy-in-ovarian-cancer
#7
REVIEW
Dana M Chase, David J Chaplin, Bradley J Monk
Combination vascular-targeted therapies (VTTs) represent a promising approach for patients with platinum-resistant recurrent ovarian cancer (OC). VTTs include two mechanistically distinct classes of agents: anti-angiogenic agents (AAs) and vascular-disrupting agents (VDAs). AAs suppress growth of new tumor vasculature through inhibition of vascular endothelial growth factor (VEGF) and other pro-angiogenic molecules. Bevacizumab, a monoclonal antibody that binds to VEGF, has improved progression-free survival (PFS) when given with chemotherapy in patients with advanced OC...
February 23, 2017: Gynecologic Oncology
https://www.readbyqxmd.com/read/28238556/bile-acid-sequestrants-for-glycemic-control-in-patients-with-type-2-diabetes-a-systematic-review-with-meta-analysis-of-randomized-controlled-trials
#8
Morten Hansen, David P Sonne, Kristian H Mikkelsen, Lise Lotte Gluud, Tina Vilsbøll, Filip K Knop
AIM: To evaluate the effects of bile acid sequestrants (BASs) versus placebo, no intervention or active comparators on glycemic control in type 2 diabetes. METHODS: Data were retrieved and a systematic review with meta-analyses was performed. We evaluated bias control and subgroup and sensitivity analyses were performed to evaluate heterogeneity and bias. RESULTS: We included 17 trials with a total of 2950 patients randomized to BASs (colesevelam or colestimide) versus placebo, no intervention, statins or sitagliptin...
January 24, 2017: Journal of Diabetes and its Complications
https://www.readbyqxmd.com/read/28238332/randomized-clinical-trial-of-the-effectiveness-of-complementary-therapies-for-recurrent-aphthous-stomatitis
#9
Alberto Rodríguez-Archilla, Tarik Raissouni
BACKGROUND AND OBJECTIVE: Despite the high prevalence of recurrent aphthous stomatitis (RAS), its etiology is not yet completely clear and there is no completely remedial treatment available at present. The objective of this study was to evaluate the clinical efficacy and safety of 4 treatments (silver nitrate, propolis, rhubarb and walnut) for RAS. PATIENTS AND METHOD: A randomized clinical trial was conducted with 125 patients with minor aphthae, including 25 patients per group: cauterization with silver nitrate, propolis, rhubarb extract, walnut extract and placebo...
February 18, 2017: Medicina Clínica
https://www.readbyqxmd.com/read/28238223/glucose-lowering-agents-for-treating-pre-existing-and-new-onset-diabetes-in-kidney-transplant-recipients
#10
REVIEW
Clement Lo, Min Jun, Sunil V Badve, Helen Pilmore, Sarah L White, Carmel Hawley, Alan Cass, Vlado Perkovic, Sophia Zoungas
BACKGROUND: Kidney transplantation is the preferred form of kidney replacement therapy for patients with end-stage kidney disease (ESKD) and is often complicated by worsening or new-onset diabetes. Management of hyperglycaemia is important to reduce post-transplant and diabetes-related complications. The safety and efficacy of glucose-lowering agents after kidney transplantation is largely unknown. OBJECTIVES: To evaluate the efficacy and safety of pharmacological interventions for lowering glucose levels in patients who have undergone kidney transplantation and have diabetes...
February 27, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28238203/population-pharmacokinetic-modeling-of-jnj-53718678-a-novel-fusion-inhibitor-for-the-treatment-of-respiratory-syncytial-virus-results-from-a-phase-i-double-blind-randomized-placebo-controlled-first-in-human-study-in-healthy-adult-subjects
#11
Dymphy R H Huntjens, Sivi Ouwerkerk-Mahadevan, Anne Brochot, Sarah Rusch, Marita Stevens, Rene Verloes
BACKGROUND: JNJ-53718678 is a potent small-molecule inhibitor of the F-glycoprotein-mediated complex membrane fusion process of the respiratory syncytial virus. Here, we report the pharmacokinetics, the population pharmacokinetic modeling, and the safety and tolerability of JNJ-53718678 from the first-in-human, double-blind, randomized, placebo-controlled phase I study. METHODS: Healthy subjects were randomized (6:3) into five single-dose groups (25-1000 mg) or three multiple-dose groups [250 mg every 24 h (q24h), 500 mg q24h, 250 mg every 12 h; fed conditions for 8 days] to receive JNJ-53718678 or placebo...
February 25, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28238190/effects-of-6%C3%A2-months-of-resveratrol-versus-placebo-on-pentraxin-3-in-patients-with-type-2-diabetes-mellitus-a-double-blind-randomized-controlled-trial
#12
S Bo, V Ponzo, A Evangelista, G Ciccone, I Goitre, F Saba, M Procopio, M Cassader, R Gambino
AIMS: The anti-inflammatory effects of the polyphenol resveratrol in patients with type 2 diabetes mellitus (T2DM) are controversial. Its role on pentraxin 3 (PTX3) concentrations, a human acute phase protein, has never been evaluated. Our aim was to determine whether a two-dosage resveratrol supplementation (500 and 40 mg/day) has an impact on PTX3 values in T2DM patients from a double-blind randomized placebo-controlled trial. Variations in total antioxidant status (TAS) were evaluated too...
February 25, 2017: Acta Diabetologica
https://www.readbyqxmd.com/read/28237870/the-treatment-of-premenstrual-syndrome-with-preparations-of-vitex-agnus-castus-a-systematic-review-and-meta-analysis
#13
REVIEW
Saskia Verkaik, Astrid M Kamperman, Roos van Westrhenen, Peter F J Schulte
OBJECTIVE: The objective is to determine the efficacy, tolerability and acceptability of Vitex agnus castus (VAC) preparations for treatment of premenstrual syndrome. DATA SOURCES: All journals in the OVID software from inception to January 2016 were searched, including the Cochrane Central Register of Controlled Trials, MEDLINE, Embase and PsycINFO. Gray literature was searched by Google Scholar and manufacturers of VAC preparations were contacted for information about unpublished trials...
February 22, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28237854/a-randomized-trial-of-relamorelin-for-constipation-in-parkinson-s-disease-move-pd-trial-results-and-lessons-learned
#14
Ronald F Pfeiffer
BACKGROUND: Bowel dysfunction, including both slow transit constipation and defecatory dysfunction, is a frequent and often troubling nonmotor manifestation of Parkinson's disease (PD). A variety of agents are employed for the treatment of constipation in PD, but dissatisfaction with available treatment approaches is common. Relamorelin is a synthetic ghrelin agonist that has demonstrated prokinetic properties within the gastrointestinal tract. METHODS: We carried out a multi-center, randomized, double-blind, placebo-controlled study of relamorelin in patients with PD experiencing chronic, inadequately controlled constipation...
February 14, 2017: Parkinsonism & related Disorders
https://www.readbyqxmd.com/read/28237673/the-placebo-and-nocebo-phenomena-their-clinical-management-and-impact-on-treatment-outcomes
#15
REVIEW
Victor Chavarria, João Vian, Círia Pereira, João Data-Franco, Brisa S Fernandes, Michael Berk, Seetal Dodd
PURPOSE: This overview focuses on placebo and nocebo effects in clinical trials and routine care. Our goal was to propose strategies to improve outcomes in clinical practice, maximizing placebo effects and reducing nocebo effects, as well as managing these phenomena in clinical trials. METHODS: A narrative literature search of PubMed was conducted (January 1980-September 2016). Systematic reviews, randomized controlled trials, observational studies, and case series that had an emphasis on placebo or nocebo effects in clinical practice were included in the qualitative synthesis...
February 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28237629/effectiveness-of-pre-treatment-with-chlorhexidine-in-restoration-retention-a-36-month-follow-up-randomized-clinical-trial
#16
Morgana Favetti, Thaiane Schroeder, Anelise Fernandes Montagner, Marcos Britto Correa, Tatiana Pereira-Cenci, Maximiliano Sergio Cenci
OBJECTIVES: This study evaluated the effect of the pre-treatment with 2% chlorhexidine digluconate (CHX) as coadjutant in restoration retention of noncarious cervical lesions (NCCL), after 36 months of follow-up. METHODS: A randomized controlled split-mouth and triple-blind (operators, patients and evaluator) trial was carried out. Patients (n=42) with at least two non-carious cervical lesions were included. The teeth with NCCL were randomly assigned to two treatment groups: application of 2% CHX (experimental group) or a placebo solution (control group) for 60 s after acid etching and before the adhesive application...
February 22, 2017: Journal of Dentistry
https://www.readbyqxmd.com/read/28237612/effects-of-chondroitin-sulfate-on-brain-response-to-painful-stimulation-in-knee-osteoarthritis-patients-a-randomized-double-blind-placebo-controlled-functional-magnetic-resonance-imaging-study
#17
Jordi Monfort, Jesús Pujol, Oren Contreras-Rodríguez, Jone Llorente-Onaindia, Marina López-Solà, Laura Blanco-Hinojo, Josep Vergés, Marta Herrero, Laura Sánchez, Hector Ortiz, Francisco Montañés, Joan Deus, Pere Benito
INTRODUCTION: Knee osteoarthritis is causing pain and functional disability. One of the inherent problems with efficacy assessment of pain medication was the lack of objective pain measurements, but functional magnetic resonance imaging (fMRI) has emerged as a useful means to objectify brain response to painful stimulation. We have investigated the effect of chondroitin sulfate (CS) on brain response to knee painful stimulation in patients with knee osteoarthritis using fMRI. METHODS: Twenty-two patients received CS (800mg/day) and 27 patients placebo, and were assessed at baseline and after 4 months of treatment...
February 22, 2017: Medicina Clínica
https://www.readbyqxmd.com/read/28237552/kinesio-taping-in-dysphonic-patients
#18
Chiara Mezzedimi, Walter Livi, Maria Carla Spinosi
OBJECTIVE: Kinesio taping (KT) is a method of elastic bandaging that produces a biomechanical effect on the organism. This study aims to evaluate its use in dysphonic patients tratment, as integrated part of speech therapy. STUDY DESIGN: Randomized controlled MATERIALS AND METHODS: Fifteen dysphonic patients were given the option to complement the speech therapy treatment with KT (DG1). 15 dysphonic patients suffering from similar conditions (DG2) who underwent traditional speech therapy were the control group...
February 23, 2017: Journal of Voice: Official Journal of the Voice Foundation
https://www.readbyqxmd.com/read/28237535/a-small-cohort-omega-3-pufa-supplement-study-implications-of-stratifying-according-to-lipid-membrane-incorporation-in-cardiac-surgical-patients
#19
Wendy T K Ip, Chanchal Chandramouli, Julian A Smith, Peter L McLennan, Salvatore Pepe, Lea M D Delbridge
BACKGROUND: Epidemiological studies and randomised clinical trials (RCTs) report disparate findings in relation to omega-3 polyunsaturated fatty acids (n-3 PUFA) benefit for cardiac patients. With RCTs interpretation is potentially confounded by background n-3 PUFA intake. The goal of this pilot, small cohort, pre-surgical supplementation study was to evaluate postoperative atrial fibrillation (AF) and cardiac molecular expression profiles employing two data analysis approaches - by treatment randomisation and by stratification using measured n-3 PUFA...
February 6, 2017: Heart, Lung & Circulation
https://www.readbyqxmd.com/read/28237126/the-association-between-leukoaraiosis-and-poor-outcome-in-intracerebral-hemorrhage-is-not-mediated-by-hematoma-growth
#20
Marek Sykora, Christian Herweh, Thorsten Steiner
BACKGROUND: The significance of white matter lesions (WMLs) in intracerebral hemorrhage (ICH) remains unclear. We investigated the effects of WML on initial hematoma volume, hematoma growth, intraventricular extension, and clinical outcome in patients with spontaneous ICH. METHODS: Computed tomography scans of 262 patients included in a placebo arm of a prospective, multicenter trial were used for a semi-quantitative analysis of white matter changes. A logistic regression analysis was used to explore the effects on hematoma volume, volume changes, intraventricular hemorrhage, and clinical outcome after 90 days...
February 22, 2017: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
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