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Randomized double blinded controlled studies

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https://www.readbyqxmd.com/read/28821906/comparing-pain-reduction-following-kyphoplasty-and-vertebroplasty-a-meta-analysis-of-randomized-and-non-randomized-controlled-trials
#1
Chen Chen, Xiaofeng Shen, Jiangping Wang, Zhigang Zhang, Yuwei Li, Hua Chen
PURPOSE: The aim of the study was to compare the extent of pain reduction with kyphoplasty (KP) and vertebroplasty (VP) in the treatment of osteoporotic vertebral compression fractures (OVCF) using a visual analog scale (VAS). METHODS: A computerized database search was performed to compare pain relief from VP and KP in OVCF. The available literature was analysed to quantify the amount of pain reduction using VAS as the primary outcome. RESULTS: A total of 10 studies encompassing 902 patients met the inclusion criteria...
August 18, 2017: Der Orthopäde
https://www.readbyqxmd.com/read/28820793/codeine-plus-acetaminophen-for-pain-after-photorefractive-keratectomy-a-randomized-double-blind-placebo-controlled-add-on-trial
#2
Vinicius B P Pereira, Renato Garcia, Andre A M Torricelli, Adriana Mukai, Samir J Bechara
BACKGROUND: Pain after photorefractive keratectomy (PRK) is significant, and the analgesic efficacy and safety of oral opioids in combination with acetaminophen has not been fully investigated in PRK trials. PURPOSE: To assess the efficacy and safety of the combination of codeine plus acetaminophen (paracetamol) versus placebo as an add-on therapy for pain control after PRK. STUDY DESIGN: Randomized, double-blind, placebo-controlled trial...
August 17, 2017: Cornea
https://www.readbyqxmd.com/read/28820746/no-effects-of-d-cycloserine-enhancement-in-exposure-with-response-prevention-therapy-in-panic-disorder-with-agoraphobia-a-double-blind-randomized-controlled-trial
#3
Mieke Klein Hofmeijer-Sevink, Puck Duits, Marleen M Rijkeboer, Adriaan W Hoogendoorn, Harold J van Megen, Nienke C Vulink, Damiaan A Denys, Marcel A van den Hout, Anton J van Balkom, Danielle C Cath
PURPOSE/BACKGROUND: D-cycloserine (DCS) is a partial N-methyl-D-aspartate receptor agonist that potentially augments response to exposure therapy in anxiety disorders by enhancing extinction learning. This randomized, double-blinded, placebo-controlled augmentation trial examined (1) the effectiveness of adding 125 mg of DCS to exposure therapy (before or directly after the first 6 treatment sessions) in patients with panic disorder with agoraphobia and (2) the effectiveness of DCS augmentation preceding exposure relative to DCS augmentation directly postexposure...
August 18, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28819993/lactobacillus-helveticus-fermented-milk-containing-lactononadecapeptide-nippltqtpvvvppflqpe-improves-cognitive-function-in-healthy-middle-aged-adults-a-randomised-double-blind-placebo-controlled-trial
#4
Kazuhito Ohsawa, Fumiya Nakamura, Naoto Uchida, Seiichi Mizuno, Hidehiko Yokogoshi
This study aimed to determine the effects of a Lactobacillus helveticus-fermented milk drink containing lactononadecapeptide (NIPPLTQTPVVVPPFLQPE) on the cognitive function of healthy middle-aged adults. A randomised, double-blind controlled study was conducted in healthy participants who were randomly assigned to receive a L. helveticus-fermented milk drink (190 g/day) or the equivalent amount of a placebo drink once a day for eight weeks. Cognitive function was evaluated using the Japanese version of the repeatable battery for the assessment of neuropsychological status (RBANS) test...
August 18, 2017: International Journal of Food Sciences and Nutrition
https://www.readbyqxmd.com/read/28819003/skeletal-muscle-signaling-metabolism-and-performance-during-sprint-exercise-in-severe-acute-hypoxia-after-the-ingestion-of-antioxidants
#5
David Morales-Alamo, Borja Guerra, Jesus Gustavo Ponce-Gonzalez, Amelia Guadalupe-Grau, Alfredo Santana, Marcos Martin-Rincon, Miriam Gelabert-Rebato, Joan Aureli Cadefau, Roser Cussó, Cecilia Dorado, Jose A L Calbet
The aim of this study was to determine reactive oxygen species (ROS) could play a role in blunting Thr(172)-AMPKα phosphorylation in human skeletal muscle after sprint exercise in hypoxia and to elucidate the potential signaling mechanisms responsible for this response. Nine volunteers performed a single 30s sprint (Wingate test) in two occasions while breathing hypoxic gas (PIO2=75 mmHg): one after the ingestion of placebo (P) and another following the intake of antioxidants (A) (α-lipoic acid, vitamin C, and vitamin E), with a randomized double-blind design...
August 17, 2017: Journal of Applied Physiology
https://www.readbyqxmd.com/read/28818518/seladelpar-mbx-8025-a-selective-ppar-%C3%AE-agonist-in-patients-with-primary-biliary-cholangitis-with-an-inadequate-response-to-ursodeoxycholic-acid-a-double-blind-randomised-placebo-controlled-phase-2-proof-of-concept-study
#6
David Jones, Pol F Boudes, Mark G Swain, Christopher L Bowlus, Michael R Galambos, Bruce R Bacon, Yvonne Doerffel, Norman Gitlin, Stuart C Gordon, Joseph A Odin, David Sheridan, Markus-Alexander Wörns, Virginia Clark, Linsey Corless, Heinz Hartmann, Mark E Jonas, Andreas E Kremer, George F Mells, Peter Buggisch, Bradley L Freilich, Cynthia Levy, John M Vierling, David E Bernstein, Marek Hartleb, Ewa Janczewska, Fedja Rochling, Hemant Shah, Mitchell L Shiffman, John H Smith, Yun-Jung Choi, Alexandra Steinberg, Monika Varga, Harinder Chera, Robert Martin, Charles A McWherter, Gideon M Hirschfield
BACKGROUND: Many patients with primary biliary cholangitis have an inadequate response to first-line therapy with ursodeoxycholic acid. Seladelpar is a potent, selective agonist for the peroxisome proliferator-activated receptor-delta (PPAR-δ), which is implicated in bile acid homoeostasis. This first-in-class study evaluated the anti-cholestatic effects and safety of seladelpar in patients with an inadequate response to ursodeoxycholic acid. METHODS: The study was a 12-week, double-blind, placebo-controlled, phase 2 trial of patients with alkaline phosphatase of at least 1·67 times the upper limit of normal (ULN) despite treatment with ursodeoxycholic acid...
August 14, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28817491/speed-of-improvement-in-symptoms-of-depression-with-desvenlafaxine-50-mg-and-100-mg-compared-with-placebo-in-patients-with-major-depressive-disorder
#7
Martin A Katzman, Andrew A Nierenberg, Dalia B Wajsbrot, Ellen Meier, Rita Prieto, Elizabeth Pappadopulos, Joan Mackell, Matthieu Boucher
PURPOSE/BACKGROUND: This post hoc analysis examined the time point at which clinically significant improvement in major depressive disorder (MDD) symptoms occurs with desvenlafaxine versus placebo. METHODS: Data were pooled from 9 short-term, double-blind, placebo-controlled studies in adults with MDD randomly assigned to desvenlafaxine 50 mg/d, 100 mg/d, or placebo. A mixed-effects model for repeated-measures analysis of change from baseline score was used to determine the time point at which desvenlafaxine treatment groups separated from placebo on the 17-item Hamilton Rating Scale for Depression and psychosocial outcomes...
August 16, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28816924/treatment-of-premenstrual-breakthrough-of-depression-with-adjunctive-oral-contraceptive-pills-compared-with-placebo
#8
Whitney Peters, Marlene P Freeman, Semmie Kim, Lee S Cohen, Hadine Joffe
PURPOSE/BACKGROUND: Two-thirds of women with depressive disorders report reemergence of depression premenstrually, or premenstrual exacerbation (PME), despite effective treatment of the underlying mood disorder during the remainder of the cycle. There is a paucity of studies that rigorously assess treatments targeting PME. Open-label data suggest that augmentation of antidepressants with the oral contraceptive pill (OCP) drospirenone and ethinyl estradiol (DRSP/EE) improves depressive symptoms that break through treatment premenstrually...
August 15, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28816893/periarticular-liposomal-bupivacaine-injection-versus-intra-articular-bupivacaine-infusion-catheter-for-analgesia-after-total-knee-arthroplasty-a-double-blinded-randomized-controlled-trial
#9
Eric B Smith, Gregory S Kazarian, Mitchell G Maltenfort, Jess H Lonner, Peter F Sharkey, Robert P Good
BACKGROUND: Intra-articular bupivacaine hydrochloride (HCl) infusion catheters and periarticular injections of liposomal bupivacaine are often used as postoperative local anesthetics. The purpose of this study was to compare the efficacies of these local anesthetics following total knee arthroplasty. METHODS: This study was a superiority trial with a randomized, controlled, double-blinded design. Patients were randomly assigned to either delivery of bupivacaine HCl by the ON-Q* Pain Relief System pump (n = 96) or by an injection of Exparel (liposomal bupivacaine) (n = 104)...
August 16, 2017: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/28816704/comparison-between-corticosteroid-and-lidocaine-injection-in-the-treatment-of-tennis-elbow-a-randomized-double-blinded-controlled-trial
#10
Lin-Fen Hsieh, Ying-Chen Kuo, Chia-Cheng Lee, Ya-Fang Liu, Yu-Chia Liu, Vincent Huang
OBJECTIVE: The aim of the study was to compare the effects of corticosteroid injection with lidocaine injection in treating tennis elbow. DESIGN: It is a prospective, double-blinded, randomized controlled trial. Patients with tennis elbow for more than 1 mo were recruited from a hospital-based rehabilitation outpatient clinic. A total of 70 patients were recruited, and 61 patients completed the study. Patients received an injection of either 10 mg (1 ml) of triamcinolone (corticosteroid group, n = 30) or 1 ml of 1% lidocaine (lidocaine group, n = 31)...
August 14, 2017: American Journal of Physical Medicine & Rehabilitation
https://www.readbyqxmd.com/read/28816509/shp465-mixed-amphetamine-salts-in-the-treatment-of-attention-deficit-hyperactivity-disorder-in-children-and-adolescents-results-of-a-randomized-double-blind-placebo-controlled-study
#11
Matthew Brams, Ann C Childress, Michael Greenbaum, Ming Yu, Brian Yan, Margo Jaffee, Brigitte Robertson
OBJECTIVE: The aim of this study was to evaluate the efficacy, safety, and tolerability of SHP465 mixed amphetamine salts (MAS) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: This randomized, double-blind dose-optimization study enrolled children and adolescents (6-17 years) meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision ADHD criteria and having baseline ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥28...
August 17, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28816242/effect-of-the-mglur5-nam-basimglurant-on-behavior-in-adolescents-and-adults-with-fragile-x-syndrome-in-a-randomized-double-blind-placebo-controlled-trial-fragxis-phase-2-results
#12
Eriene A Youssef, Elizabeth Berry-Kravis, Christian Czech, Randi J Hagerman, David Hessl, Chin Y Wong, Michael Rabbia, Dennis Deptula, Amy John, Russell Kinch, Philip Drewitt, Lothar Lindemann, Moritz Marcinowski, Rachel Langland, Carsten Horn, Paulo Fontoura, Luca Santarelli, Jorge A Quiroz
Preclinical data suggests that inhibition of the mGluR5 receptor might hold therapeutic benefits in Fragile X syndrome (FXS). Treatment of Fmr1 knockout mice with mGluR5-negative allosteric modulators (NAMs) has been reported to correct a broad range of phenotypes related to FXS. The early short-term clinical trials with mGluR5 NAMs, including basimglurant, assessing the effects in individuals with FXS, were supportive of further exploration in larger, well-controlled trials. We evaluated basimglurant, a potent and selective mGluR5 NAM, in a 12-week, double-blind, parallel-group study of 183 adults and adolescents (aged 14-50, mean 23...
August 17, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28815639/safety-tolerability-and-pharmacokinetic-characteristics-of%C3%A2-a-novel-nonopioid-analgesic-vvz-149-injections-in-healthy-volunteers-a-first-in-class-first-in-human-study
#13
Jaeseong Oh, SeungHwan Lee, Anhye Kim, Jangsoo Yoon, Kyungho Jang, Doo H Lee, Sunyoung Cho, Sang Rim Lee, Kyung-Sang Yu, Jae-Yong Chung
VVZ-149, a dual antagonist of GlyT2 and 5HT2 A receptors, is an investigational analgesic with a novel mechanism of action that is currently under early-stage clinical development as an injectable agent for the treatment of postoperative pain. Here, the safety, tolerability, and pharmacokinetics of VVZ-149 injections in healthy male volunteers were explored in a randomized, double-blind, single- and multiple-ascending-dose (SAD and MAD, respectively), placebo-controlled clinical study. Subjects randomly received a 4-hour intravenous infusion of 0...
August 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28815614/resveratrol-for-alzheimer-s-disease
#14
REVIEW
Christine Sawda, Charbel Moussa, R Scott Turner
The amyloid hypothesis suggests that the progressive accumulation and deposition of central nervous system (CNS) amyloid with aging is the proximate cause of Alzheimer's disease (AD). Thus, targeting molecular mechanisms of aging may be a viable treatment approach. Caloric restriction prevents diseases of aging, including AD, in animal models, perhaps by activation of sirtuins. The sirtuins (e.g., mammalian SIRT1) are deacetylases that link energy balance (NAD(+) /NADH) to regulation of gene transcription. Resveratrol is a potent activator of SIRT1, and thus may mimic caloric restriction to prevent diseases of aging...
August 16, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28815560/comparison-of-indirubin-concentrations-in-indigo-naturalis-ointment-for-psoriasis-treatment-a-randomized-double-blind-dosage-controlled-trial
#15
Y K Lin, L C See, Y H Huang, C C Chi, R C Y Hui
BACKGROUND: Indigo naturalis and its refined formulation, Lindioil, are effective in treating psoriatic symptoms topically. Indirubin is the active ingredient in indigo naturalis. OBJECTIVES: To determine the efficacy and safety of different concentrations of indirubin in Lindioil ointment for treating psoriasis. METHODS: In this randomized, double-blind trial, adult patients presenting with chronic plaque psoriasis for >1 year and with <20% of the body surface area (BSA) affected were randomized to apply Lindioil ointment containing 200 μg/g, 100 μg/g, 50 μg/g, or 10 μg/g of indirubin twice daily for 8 weeks followed by an additional 12-week safety/extension period...
August 17, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28814871/exploring-the-long-term-safety-of-asenapine-in-adults-with-schizophrenia-in-a-double-blind-fixed-dose-extension-study
#16
Suresh Durgam, Ronald P Landbloom, Mary Mackle, Xiao Wu, Maju Mathews, Henry A Nasrallah
PURPOSE: The primary objective of this study was to assess long-term safety with sublingual asenapine 2.5 or 5 mg twice daily (BID) in patients with schizophrenia. PATIENTS AND METHODS: Actively treated patients on asenapine 2.5 mg BID, asenapine 5 mg BID, or olanzapine 15 mg once daily (QD) who completed a 6-week randomized, double-blind, placebo- and olanzapine-controlled study continued lead-in treatment in this 26-week, multicenter, double-blind, double-dummy, olanzapine-controlled Phase IIIB extension study; placebo patients were assigned to asenapine 2...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28814664/pulmonary-arterial-hypertension-treatment-with-carvedilol-for-heart-failure-a-randomized-controlled-trial
#17
Samar Farha, Didem Saygin, Margaret M Park, Hoi I Cheong, Kewal Asosingh, Suzy Aa Comhair, Olivia R Stephens, Emir C Roach, Jacqueline Sharp, Kristin B Highland, Frank P DiFilippo, Donald R Neumann, W H Wilson Tang, Serpil C Erzurum
BACKGROUND: Right-sided heart failure is the leading cause of death in pulmonary arterial hypertension (PAH). Similar to left heart failure, sympathetic overactivation and β-adrenoreceptor (βAR) abnormalities are found in PAH. Based on successful therapy of left heart failure with β-blockade, the safety and benefits of the nonselective β-blocker/vasodilator carvedilol were evaluated in PAH. METHODS: PAH Treatment with Carvedilol for Heart Failure (PAHTCH) is a single-center, double-blind, randomized, controlled trial...
August 17, 2017: JCI Insight
https://www.readbyqxmd.com/read/28814387/effects-of-nk1-receptors-on-gastric-motor-functions-and-satiation-in-healthy-humans-results-from-a-controlled-trial-with-the-nk1-antagonist-aprepitant
#18
Deepti Jacob, Irene A Busciglio, Duane D Burton, Houssam Halawi, Ibironke Oduyebo, Deborah Rhoten, Michael Ryks, W Scott Harmsen, Michael Camilleri
Aprepitant, an NK1 receptor antagonist, is approved for the treatment of chemotherapy-induced or postoperative emesis by blocking NK1 receptors in the brain stem vomiting center. Effects of NK1 receptors on gastric functions and postprandial symptoms in humans are unclear; a single, crossover study did not show a significant effect of aprepitant on gastrointestinal transit. Our aim was to compare, in a randomized, double-blind, placebo-controlled, parallel-group study (12 healthy volunteers per group), effects of aprepitant vs...
August 16, 2017: American Journal of Physiology. Gastrointestinal and Liver Physiology
https://www.readbyqxmd.com/read/28811808/prevention-of-anesthesia-induced-injection-pain-of-propofol-in-pediatric-anesthesia
#19
Dabin Cheng, Lu Liu, Zheng Hu
OBJECTIVE: Propofol is a new anesthetic agent in clinical practice, but randomized double-blinded prospective studies on its role in pediatric anesthesia remain limited. We aimed to compare the preventive effects of pre-injected lidocaine or ketamine and its pre-mixture on the anesthesia-induced injection pain of propofol using a randomized double-blinded prospective method, and to compare the outcomes with those of medium-/long-chain propofol (M/LCT). METHODS: A total of 360 pediatric patients (aged 5-12 years old) who received elective surgery were randomly divided into six groups (n= 60) as follows...
May 2017: Pakistan Journal of Medical Sciences Quarterly
https://www.readbyqxmd.com/read/28811749/acute-cocoa-flavanols-intake-has-minimal-effects-on-exercise-induced-oxidative-stress-and-nitric-oxide-production-in-healthy-cyclists-a-randomized-controlled-trial
#20
Lieselot Decroix, Cajsa Tonoli, Danusa Dias Soares, Amandine Descat, Marie-José Drittij-Reijnders, Antje R Weseler, Aalt Bast, Wilhelm Stahl, Elsa Heyman, Romain Meeusen
BACKGROUND: Cocoa flavanols (CF) can stimulate vasodilation by improved nitric oxide (NO) synthesis and have antioxidant and anti-inflammatory capacities. This study aimed to examine whether acute CF intake can affect exercise-induced changes in antioxidant capacity, oxidative stress, inflammation and NO production, as well as exercise performance and recovery in well-trained cyclists. METHODS: Twelve well-trained male cyclists (mean ± SD age, VO2max: 30 ± 3 years, 63...
2017: Journal of the International Society of Sports Nutrition
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