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Randomized placebo controlled double blind

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https://www.readbyqxmd.com/read/28432619/assessment-of-saxagliptin-efficacy-meta-analysis-of-14-phase-2-and-3-clinical-trials
#1
Mikaela Sjöstrand, Cheryl Wei, William Cook, Kristina Johnsson, Pia S Pollack, Christina Stahre, Boaz Hirshberg
INTRODUCTION: This meta-analysis of data from 14 phase 2 and 3, double-blind, randomized, controlled 12- and 24-week studies (N = 4632) summarizes saxagliptin efficacy in patients with type 2 diabetes (T2D) across treatment regimens. METHODS: Patients received saxagliptin 5 mg/d or control as either monotherapy (n = 1196 vs placebo), add-on therapy (n = 2139 vs placebo and n = 514 vs uptitrated sulfonylurea), or initial combination therapy (n = 619 vs control monotherapy)...
April 21, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28432265/artemida-trial-a-randomized-trial-of-efficacy-12-months-international-double-blind-actovegin-a-randomized-controlled-trial-to-assess-the-efficacy-of-actovegin-in-poststroke-cognitive-impairment
#2
Alla Guekht, Ingmar Skoog, Sally Edmundson, Vladimir Zakharov, Amos D Korczyn
BACKGROUND AND PURPOSE: Poststroke cognitive impairment is a debilitating consequence of stroke. The aim of this study was to assess whether Actovegin confers cognitive benefit in patients who have had an ischemic stroke. METHODS: This was a 12-month, parallel-group, randomized, multicenter, double-blind, placebo-controlled study. Eligible patients were ≥60 years of age with a Montreal Cognitive Assessment test score of ≤25 points. Patients were randomized into 2 groups within 1 week of acute supratentorial ischemic stroke in a 1:1 ratio: Actovegin (a deproteinized hemoderivative of calf blood, 2000 mg/d for ≤20 intravenous infusions followed by 1200 mg/d orally) or placebo for 6 months...
April 21, 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28432049/randomized-controlled-trial-of-different-aspirin-regimens-for-reduction-of-niacin-induced-flushing
#3
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/28431885/safety-of-adding-oats-to-a-gluten-free-diet-for-patients-with-celiac-disease-systematic-review-and-meta-analysis-of-clinical-and-observational-studies
#4
María Inés Pinto-Sánchez, Natalia Causada-Calo, Premysl Bercik, Alexander C Ford, Joseph A Murray, David Armstrong, Carol Semrad, Sonia S Kupfer, Armin Alaedini, Paul Moayyedi, Daniel A Leffler, Elena F Verdú, Peter Green
BACKGROUND & AIMS: Patients with celiac disease should maintain a gluten-free diet (GFD), excluding wheat, rye, and barley. Oats might increase the nutritional value of a GFD, but their including is controversial. We performed a systematic review and meta-analysis to evaluate the safety of oats as part of a GFD in patients with celiac disease. METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases for clinical trials and observational studies of the effects of including oats in GFD of patients with celiac disease...
April 18, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28431766/analysis-of-2-week-data-from-two-randomized-controlled-trials-conducted-in-subjects-with-frequent-heartburn-treated-with-esomeprazole-20-mg
#5
Philip O Katz, Anne Le Moigne, Charles Pollack
PURPOSE: These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. METHODS: Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44...
April 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28431557/the-effect-of-vitamin-b12-supplementation-in-nepalese-infants-on-growth-and-development-study-protocol-for-a-randomized-controlled-trial
#6
Tor A Strand, Manjeswori Ulak, Ram K Chandyo, Ingrid Kvestad, Mari Hysing, Merina Shrestha, Sudha Basnet, Suman Ranjitkar, Laxman Shrestha, Prakash S Shrestha
BACKGROUND: Vitamin B12 deficiency is one of the most common micronutrient deficiencies and is associated with poor cognitive development and growth. Vitamin B12 is crucial for normal cell division and differentiation, and it is necessary for the development and myelination of the central nervous system. The aim of the present study is to measure the effect of daily supplementation of vitamin B12 on the neurodevelopment and growth of young children in Nepal. METHODS/DESIGN: We are conducting an individually randomized, double-blind, placebo-controlled trial with 600 marginally stunted children 6-11 months old (length for age less than -1 z-score)...
April 21, 2017: Trials
https://www.readbyqxmd.com/read/28431534/the-effects-of-spirulina-platensis-on-anthropometric-indices-appetite-lipid-profile-and-serum-vascular-endothelial-growth-factor-vegf-in-obese-individuals-a-randomized-double-blinded-placebo-controlled-trial
#7
Reihaneh Zeinalian, Mahdieh Abbasalizad Farhangi, Atefeh Shariat, Maryam Saghafi-Asl
BACKGROUND: In recent years, a great attention has been focused on Spirulina platensis as a source of potential valuable nutrients for prevention and treatment of chronic diseases. The objectives of the current study were to determine the effects of Spirulina platensis on anthropometric parameters, serum lipids, appetite and serum Vascular Endothelial Growth Factor (VEGF) in obese individuals. METHODS: In the current study sixty four obese individuals aged 20-50 years were enrolled and randomly allocated into two groups of intervention and placebo...
April 21, 2017: BMC Complementary and Alternative Medicine
https://www.readbyqxmd.com/read/28431278/intranasal-oxytocin-does-not-modulate-jumping-to-conclusions-in-schizophrenia-potential-interactions-with-caudate-volume-and-baseline-social-functioning
#8
Fernando Caravaggio, Philip Gerretsen, Wanna Mar, Jun Ku Chung, Eric Plitman, Shinichiro Nakajima, Julia Kim, Yusuke Iwata, Raihaan Patel, M Mallar Chakravarty, Gary Remington, Ariel Graff-Guerrero, Mahesh Menon
BACKGROUND: Patients with schizophrenia (SCZ) tend to sample less information when making a decision, jumping to conclusions (JTC) without sufficient evidence. This "JTC bias" may be a trait marker of the disease and may not improve with antipsychotic treatment. We conducted a double-blind, placebo-controlled trial to test whether intranasal oxytocin could reduce JTC in stable, medicated patients with SCZ and healthy controls (HCs). We also explored whether striatal volume, clinical symptoms, and baseline social functioning (SF) was related to JTC performance...
March 31, 2017: Psychoneuroendocrinology
https://www.readbyqxmd.com/read/28431160/editorial-to-6-month-safety-data-of-ebola-zaire-vaccine-rvsv%C3%AE-g-zebov-gp-in-a-phase-iii-double-blind-placebo-controlled-randomized-study-in-healthy-adults
#9
Matthias J Schnell
No abstract text is available yet for this article.
April 18, 2017: Journal of Infectious Diseases
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
#10
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
#11
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/28430976/acute-and-chronic-noradrenergic-effects-on-cortical-excitability-in-healthy-humans
#12
Hsiao-I Kuo, Walter Paulus, Giorgi Batsikadze, Asif Jamil, Min-Fang Kuo, Michael A Nitsche
Background: Noradrenaline is a major neuromodulator in the central nervous system, and it is involved in the pathophysiology of diverse neuropsychiatric diseases. Previous transcranial magnetic stimulation (TMS) studies suggested that acute application of selective noradrenaline reuptake inhibitors (NRI) enhances cortical excitability in the human brain. However, other, such like clinical effects, usually require prolonged NRI treatment, which might go along with different physiological effects...
April 19, 2017: International Journal of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28430785/medical-expulsive-therapy-for-ureter-stone-using-naftopidil-a-multicenter-randomized-double-blind-and-placebo-controlled-trial
#13
Sung Yong Cho, Woong Na, Sang Wook Lee, Min Chul Cho, Jong Jin Oh, Sangchul Lee, Juhyun Park, Soyeon Ahn, Chang Wook Jeong
OBJECTIVES: A prospective, multicenter, randomized, double-blind, placebo-controlled trial evaluated the effects of naftopidil 75 mg for medical expulsive therapy for a single ureter stone. MATERIALS AND METHODS: Patients diagnosed with a ureter stone were prescribed aceclofenac 100 mg or a combined medication of tramadol 37.5 mg and acetaminophen 325 mg. Patients then randomly received either naftopidil 75 mg or placebo. Primary endpoint was the stone passage rate at 14 days after medication...
2017: PloS One
https://www.readbyqxmd.com/read/28430684/flurbiprofen-axetil-provides-effective-analgesia-without-changing-the-pregnancy-rate-in-ultrasound-guided-transvaginal-oocyte-retrieval-a-double-blind-randomized-controlled-trial
#14
Hong Zhao, Yi Feng, Yan Jiang, Qun Lu
BACKGROUND: In this prospective double-blind randomized study, we evaluated the analgesic effect and potential effect on pregnancy rate of the nonsteroidal anti-inflammatory drug flurbiprofen axetil in patients undergoing ultrasound-guided transvaginal oocyte retrieval under propofol-remifentanil anesthesia. METHODS: A total of 200 patients scheduled to undergo ultrasound-guided transvaginal oocyte retrieval were randomly allocated to receive 1.5 mg/kg of flurbiprofen axetil (FA group) or placebo (control group) 30 minutes before the procedure...
April 19, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28429904/effect-of-lutein-supplementation-on-visual-function-in-nonproliferative-diabetic-retinopathy
#15
Ping-Chuan Zhang, Chang-Rui Wu, Zhi-Lun Wang, Li-Yuan Wang, Yue Han, Shu-Liu Sun, Qing-Shan Li, Le Ma
BACKGROUND AND OBJECTIVES: The purpose of this study was to determine whether supplementation with lutein improved visual function in patients with nonproliferative diabetic retinopathy (NPDR). METHODS AND STUDY DESIGN: In this randomized, double-blind, placebo-controlled trial, 31 patients with NPDR were assigned randomly to 10 mg/d of lutein or identical placebo for 36 weeks. Visual performance indices, including visual acuity (VA), contrast sensitivity (CS) and glare sensitivity (GS) at four different spatial frequencies, were measured at baseline, week 18 and 36...
May 2017: Asia Pacific Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28429843/pooled-analysis-of-three-randomized-double-blind-placebo-controlled-trials-with-rimonabant-for-smoking-cessation
#16
Jason D Robinson, Paul M Cinciripini, Maher Karam-Hage, Henri-Jean Aubin, Lowell C Dale, Raymond Niaura, Robert M Anthenelli
Despite the withdrawal of CB1 antagonists, such as rimonabant, from the market and from active clinical development because of concerns about their side effect profiles, research suggests that the endocannabinoid system may play an important role in modulating nicotine's effects. We report the combined results, using a pooled analysis, of three previously unpublished trials assessing rimonabant as a smoking cessation pharmacotherapy conducted between 2002 and 2004. Smokers (n = 2097) motivated to quit were enrolled in three randomized, double-blind, placebo-controlled trials, STRATUS EU, US, and META, which consisted of a 10-week treatment period with either rimonabant 20 mg (n = 789), 5 mg (n = 518; used in only two of the three studies), or placebo (n = 790), in conjunction with brief counseling...
April 21, 2017: Addiction Biology
https://www.readbyqxmd.com/read/28429134/systematic-review-of-quality-of-life-and-functional-outcomes-in-randomized-placebo-controlled-studies-of-medications-for-attention-deficit-hyperactivity-disorder
#17
REVIEW
David R Coghill, Tobias Banaschewski, César Soutullo, Matthew G Cottingham, Alessandro Zuddas
Children, adolescents and adults with attention-deficit/hyperactivity disorder (ADHD) experience functional impairment and poor health-related quality of life (HRQoL) in addition to symptoms of inattention/hyperactivity-impulsivity. To synthesize qualitatively the published evidence from randomized, double-blind, placebo-controlled trials of the effectiveness of pharmacotherapy on functional impairment or HRQoL in patients with ADHD, a systematic PubMed searching and screening strategy was designed to identify journal articles meeting pre-specified criteria...
April 20, 2017: European Child & Adolescent Psychiatry
https://www.readbyqxmd.com/read/28429067/neuronal-oscillations-and-synchronicity-associated-with-gamma-hydroxybutyrate-during-resting-state-in-healthy-male-volunteers
#18
Robin von Rotz, Michael Kometer, Dario Dornbierer, Jürg Gertsch, M Salomé Gachet, Franz X Vollenweider, Erich Seifritz, Oliver G Bosch, Boris B Quednow
RATIONALE: Gamma-hydroxybutyrate (GHB) is a putative neurotransmitter, a drug of abuse, an anesthetic agent, and a treatment for neuropsychiatric disorders. In previous electroencephalography (EEG) studies, GHB was shown to induce an electrophysiological pattern of "paradoxical EEG-behavioral dissociation" characterized by increased delta and theta oscillations usually associated with sleep during awake states. However, no detailed source localization of these alterations and no connectivity analyses have been performed yet...
April 20, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28427929/corrigendum-to-long-term-cariprazine-treatment-for-the-prevention-of-relapse-in-patients-with-schizophrenia-a-randomized-double-blind-placebo-controlled-trial-schizophr-res-176-2016-264-271
#19
Suresh Durgam, Willie Earley, Rui Li, Dayong Li, Kaifeng Lu, István Laszlovszky, W Wolfgang Fleischhacker, Henry A Nasrallah
No abstract text is available yet for this article.
April 17, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28427826/suvorexant-in-elderly-patients-with-insomnia-pooled-analyses-of-data-from-phase-iii-randomized-controlled-clinical-trials
#20
W Joseph Herring, Kathryn M Connor, Ellen Snyder, Duane B Snavely, Ying Zhang, Jill Hutzelmann, Deborah Matzura-Wolfe, Ruth M Benca, Andrew D Krystal, James K Walsh, Christopher Lines, Thomas Roth, David Michelson
OBJECTIVE: Suvorexant is an orexin receptor antagonist approved for treating insomnia at doses of 10-20 mg. Previously reported phase III results showed that suvorexant was effective and well-tolerated in a combined-age population (elderly and nonelderly adults). The present analysis evaluated the clinical profile of suvorexant specifically in the elderly. METHODS: Prespecified subgroup analyses of pooled 3-month data from two (efficacy) and three (safety) randomized, double-blind, placebo-controlled, parallel-group trials...
March 8, 2017: American Journal of Geriatric Psychiatry
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