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Randomized placebo controlled double blind

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https://www.readbyqxmd.com/read/28719227/simvastatin-as-an-adjunctive-therapy-to-risperidone-in-treatment-of-autism-a-randomized-double-blind-placebo-controlled-clinical-trial
#1
Ehsan Moazen-Zadeh, Fatemeh Shirzad, Mohammad-Ali Karkhaneh-Yousefi, Rasoul Khezri, Mohammad-Reza Mohammadi, Shahin Akhondzadeh
OBJECTIVES: Providing novel treatments for autism has been a subject of long-standing research. Based on etiopathological findings, we aim at assessing potential therapeutic effects of statins, here simvastatin, on autism symptoms for the first time. METHODS: In this randomized, double-blind, placebo-controlled, parallel-group 10-week clinical trial, 70 drug-free children aged 4 to 12 years old with diagnosis of autistic disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, who had an Aberrant Behavior Checklist-Community (ABC-C) scale irritability subscale score of ≥12, were equally randomized to receive either simvastatin (20-40 mg/day) or placebo as an adjunct to risperidone (1-2 mg/day) whereas administration of both drugs was started simultaneously from baseline...
July 18, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28719008/comparative-efficacy-and-safety-of-gemigliptin-versus-linagliptin-in-type-2-diabetes-patients-with-renal-impairment-a-40-week-extension-of-the-guard-randomized-study
#2
Sang Youb Han, Sun Ae Yoon, Byoung Geun Han, Sung Gyun Kim, Young-Il Jo, Kyung Hwan Jeong, Kook-Hwan Oh, Hyeong Cheon Park, Sun-Hee Park, Shin-Wook Kang, Ki-Ryang Na, Sun Woo Kang, Nam-Ho Kim, Younghwan Jang, Bogyeong Kim, Seonghye Shin, Dae Ryong Cha
AIMS: The present extension study evaluated the long-term safety and efficacy of gemigliptin during a 40-week follow-up period after a 12-week study. METHODS: The main study was a randomized, placebo-controlled, double-blinded, phase IIIb study in which 50 mg of gemigliptin (N = 66) or placebo (N = 66) was administered to patients with type 2 diabetes mellitus (T2DM) with moderate or severe renal impairment over a 12-week period. Patients with a glycated haemoglobin (HbA1c) level of 7-11% and an estimated glomerular filtration rate (eGFR) of 15-59 mL/min/1...
July 18, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28718700/use-of-single-dose-oral-gabapentin-to-attenuate-fear-responses-in-cage-trap-confined-community-cats-a-double-blind-placebo-controlled-field-trial
#3
Katherine E Pankratz, Kelli K Ferris, Emily H Griffith, Barbara L Sherman
Objectives This double-blind, placebo-controlled study evaluated the safety and efficacy of single-dose oral gabapentin administered for the attenuation of fear responses in cage-trap confined community cats. Methods Community cats presented in cage traps for trap-neuter-return (TNR) were recruited and screened for inclusion. Each enrolled cat was randomly assigned and administered one of three equal-volume, single-dose treatments: placebo, low-dose gabapentin (50 mg) or high-dose gabapentin (100 mg). At baseline, 1, 2, 3 and 12 h post-administration, a single, blinded observer scored each cat for signs of fear and sedation using published paradigms, calculated the respiratory rate and documented any observable facial injuries...
July 1, 2017: Journal of Feline Medicine and Surgery
https://www.readbyqxmd.com/read/28718506/felbamate-as-an-add-on-therapy-for-refractory-partial-epilepsy
#4
REVIEW
Li Li Shi, JianCheng Dong, HengJian Ni, JinSong Geng, Taixiang Wu
BACKGROUND: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews (Issue 7, 2014) on 'Felbamate as an add-on therapy for refractory epilepsy'. Epilepsy is a chronic and disabling neurologic disorder, affecting approximately 1% of the population. Up to 30% of people with epilepsy have seizures that are resistant to currently available drugs. Felbamate is one of the second-generation antiepileptic drugs and we have assessed its effects as an add-on therapy to standard drugs in this review...
July 18, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28718346/effect-of-desvenlafaxine-50-mg-and-100-mg-on-energy-and-lassitude-in-patients-with-major-depressive-disorder-a-pooled-analysis
#5
Raymond W Lam, Dalia B Wajsbrot, Ellen Meier, Elizabeth Pappadopulos, Joan A Mackell, Matthieu Boucher
Nine randomized, double-blind, placebo-controlled studies of major depressive disorder were pooled to evaluate the effects of desvenlafaxine 50- and 100-mg/d on energy and lassitude in adults with major depressive disorder ( n=4279). Changes from baseline to endpoint in 17-item Hamilton Rating Scale for Depression (HAM-D17) Work and Activities, Retardation, and Somatic Symptoms General items, HAM-D17 psychomotor retardation factor, and Montgomery-Åsberg Depression Rating Scale Lassitude item were analyzed with a mixed model for repeated measures analysis of variance...
July 1, 2017: Journal of Psychopharmacology
https://www.readbyqxmd.com/read/28718320/oral-prednisolone-for-4-days-does-not-increase-exercise-tolerance-in-men-with-copd
#6
S L Karlsson, V Backer, Nina Skavlan Godtfredsen
One of the primary objectives in management of chronic obstructive pulmonary disease (COPD) is preventing decrease in lung function and reducing the annual number of acute exacerbations of COPD (AECOPD). An oral course of systemic corticosteroids is a commonly used treatment in AECOPD. We hypothesize that this treatment also increases exercise performance and decreases muscle fatigue. In a randomized double-blinded, parallel, placebo-controlled trial, we investigated 14 men (8 on prednisolone 37.5 mg vs. 6 on placebo) with severe and very severe COPD...
January 1, 2017: Chronic Respiratory Disease
https://www.readbyqxmd.com/read/28717941/the-comparative-safety-of-tnf-inhibitors-in-ankylosing-spondylitis-a-meta-analysis-update-of-14-randomized-controlled-trials
#7
Li-Qiong Hou, Ga-Xue Jiang, Yan-Fei Chen, Xi-Mei Yang, Lei Meng, Miao Xue, Xiao-Guang Liu, Xi-Chao Chen, Xiao Li
TNF inhibitors have been used in ankylosing spondylitis (AS). The efficacy of TNF inhibitors was already evaluated by meta-analysis of randomized controlled trials (RCTs). However, the safety of TNF inhibitors is still unclear. Therefore, we aimed to evaluate and update the safety data from RCTs of TNF inhibitors in patients treated for AS. A systematic literature search was conducted from 1990 through May 31, 2016. All studies included were randomized, double-blind, controlled trials of patients with ankylosing spondylitis that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab treatment...
July 17, 2017: Clinical Reviews in Allergy & Immunology
https://www.readbyqxmd.com/read/28717347/effect-of-eicosapentaenoic-acids-rich-fish-oil-supplementation-on-motor-nerve-function-after-eccentric-contractions
#8
Eisuke Ochi, Yosuke Tsuchiya, Kenichi Yanagimoto
BACKGROUND: This study investigated the effect of supplementation with fish oil rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on the M-wave latency of biceps brachii and muscle damage after a single session of maximal elbow flexor eccentric contractions (ECC). METHODS: Twenty-one men were completed the randomized, double-blind, placebo-controlled, and parallel-design study. The subjects were randomly assigned to the fish oil group (n = 10) or control group (n = 11)...
2017: Journal of the International Society of Sports Nutrition
https://www.readbyqxmd.com/read/28717270/antioxidant-therapy-in-idiopathic-oligoasthenoteratozoospermia
#9
REVIEW
Ahmad Majzoub, Ashok Agarwal
INTRODUCTION: Idiopathic oligoasthenoteratozoospermia (iOAT) is commonly encountered during the evaluation of men with infertility. Antioxidants have been utilized empirically in the treatment of iOAT based on their ability to reverse oxidative stress (OS)-induced sperm dysfunction often encountered in this patient population. METHODS: A literature search was performed using MEDLINE/PubMed, focusing on publications of antioxidant therapies for iOAT. The main objective of our review article was to report the rationale and available evidence supporting the use of antioxidants...
July 2017: Indian Journal of Urology: IJU: Journal of the Urological Society of India
https://www.readbyqxmd.com/read/28716357/clinical-and-metabolic-response-to-flaxseed-oil-omega-3-fatty-acids-supplementation-in-patients-with-diabetic-foot-ulcer-a-randomized-double-blind-placebo-controlled-trial
#10
Zahra Soleimani, Fatemeh Hashemdokht, Fereshteh Bahmani, Mohsen Taghizadeh, Mohammad Reza Memarzadeh, Zatollah Asemi
BACKGROUND: Data on the effects of flaxseed oil omega-3 fatty acids supplementation on wound healing and metabolic status in subjects with diabetic foot ulcer (DFU) are scarce. OBJECTIVE: This study was conducted to evaluate the effects of flaxseed oil omega-3 fatty acids supplementation on wound healing and metabolic status in subjects with DFU. METHODS: The current randomized, double-blind, placebo-controlled trial was conducted among 60 subjects (aged 40-85years old) with grade 3 DFU...
June 28, 2017: Journal of Diabetes and its Complications
https://www.readbyqxmd.com/read/28716314/safety-and-efficacy-of-ebselen-for-the-prevention-of-noise-induced-hearing-loss-a-randomised-double-blind-placebo-controlled-phase-2-trial
#11
Jonathan Kil, Edward Lobarinas, Christopher Spankovich, Scott K Griffiths, Patrick J Antonelli, Eric D Lynch, Colleen G Le Prell
BACKGROUND: Noise-induced hearing loss is a leading cause of occupational and recreational injury and disease, and a major determinant of age-related hearing loss. No therapeutic agent has been approved for the prevention or treatment of this disorder. In animal models, glutathione peroxidase 1 (GPx1) activity is reduced after acute noise exposure. Ebselen, a novel GPx1 mimic, has been shown to reduce both temporary and permanent noise-induced hearing loss in preclinical studies. We assessed the safety and efficacy of ebselen for the prevention of noise-induced hearing loss in young adults in a phase 2 clinical trial...
July 14, 2017: Lancet
https://www.readbyqxmd.com/read/28716168/a-randomized-double-blind-placebo-controlled-trial-of-sublingual-immunotherapy-with-house-dust-mite-extract-for-allergic-rhinitis
#12
Yu Guo, Yanqing Li, Dehui Wang, Quan Liu, Zhuofu Liu, Li Hu
OBJECTIVE: This study was designed to evaluate the efficacy and safety of sublingual immunotherapy (SLIT) with house-dust mite (HDM) extract in Chinese patients with HDM-induced allergic rhinitis (AR). METHODS: A randomized, double-blind, placebo controlled trial was conducted with the outpatients of the Eye, Ear, Nose, and Throat Hospital, Fudan University. Forty-eight patients were eligible for randomization to SLIT with a mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae extract or placebo for 1 year...
July 1, 2017: American Journal of Rhinology & Allergy
https://www.readbyqxmd.com/read/28715540/predictors-of-hand-foot-syndrome-and-pyridoxine-for-prevention-of-capecitabine-induced-hand-foot-syndrome-a-randomized-clinical-trial
#13
Yoon-Sim Yap, Li-Lian Kwok, Nicholas Syn, Wen Yee Chay, John Whay Kuang Chia, Chee Kian Tham, Nan Soon Wong, Soo Kien Lo, Rebecca Alexandra Dent, Sili Tan, Zuan Yu Mok, King Xin Koh, Han Chong Toh, Wen Hsin Koo, Marie Loh, Raymond Chee Hui Ng, Su Pin Choo, Richie Chuan Teck Soong
Importance: Hand-foot syndrome (HFS) is a common adverse effect of capecitabine treatment. Objective: To compare the incidence and time to onset of grade 2 or greater HFS in patients receiving pyridoxine vs placebo and to identify biomarkers predictive of HFS. Design, Setting, and Participants: This single-center, randomized double-blind, placebo-controlled phase 3 trial conducted at National Cancer Centre Singapore assessed whether oral pyridoxine could prevent the onset of grade 2 or higher HFS in 210 patients scheduled to receive single-agent capecitabine chemotherapy for breast, colorectal, and other cancers...
July 13, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28715142/cholinesterase-inhibition-reduces-arrhythmias-in-asymptomatic-chagas-disease
#14
Renata Rodrigues Teixeira de Castro, Graciema Porphirio, Sergio Salles Xavier, Ruy Silveira Moraes, Elton Luis Ferlin, Jorge Pinto Ribeiro, Antonio Claudio Lucas da Nóbrega
INTRODUCTION: Parasympathetic dysfunction may play a role in the genesis of arrhythmias in Chagas disease. AIM: This study evaluates the acute effects of pyridostigmine (PYR), a reversible cholinesterase inhibitor, on the occurrence of arrhythmias in patients with Chagas cardiac disease. METHOD: Following a double-blind, randomized, placebo-controlled, cross-over protocol, 17 patients (age 50±2 years) with Chagas cardiac disease type B underwent 24-hour Holter recordings after oral administration of either pyridostigmine bromide (45 mg, 3 times/day) or placebo (PLA)...
July 17, 2017: Cardiovascular Therapeutics
https://www.readbyqxmd.com/read/28715141/walnut-consumption-increases-activation-of-the-insula-to-highly-desirable-food-cues-a-randomized-double-blind-placebo-controlled-cross-over-fmri-study
#15
Olivia M Farr, Dario Tuccinardi, Jagriti Upadhyay, Sabrina M Oussaada, Christos S Mantzoros
AIMS: The use of walnuts is recommended for obesity and type 2 diabetes, although the mechanisms through which walnuts may improve appetite and/or glycemic control remain largely unknown. MATERIALS AND METHODS: To determine whether short-term walnut consumption could alter the neural control of appetite using functional magnetic resonance imaging, we performed a randomized, placebo-controlled, double-blind, cross-over trial of 10 patients who received, while living in the controlled environment of a clinical research center, either walnuts or placebo (using a validated smoothie delivery system) for 5 days each, separated by a wash-out period of one month...
July 17, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28714882/vitamin-d-supplementation-enhances-c18-dihydro-ceramide-levels-in-type-2-diabetes-patients
#16
Alexander Koch, Georgios Grammatikos, Sandra Trautmann, Yannick Schreiber, Dominique Thomas, Franziska Bruns, Josef Pfeilschifter, Klaus Badenhoop, Marissa Penna-Martinez
Sphingolipids are characterized by a broad range of bioactive properties. Particularly, the development of insulin resistance, a major pathophysiological hallmark of Type 2 Diabetes mellitus (T2D), has been linked to ceramide signaling. Since vitamin D supplementation may slow down T2D progression by improving glucose concentrations and insulin sensitivity, we investigated whether vitamin D supplementation impacts on plasma sphingolipid levels in T2D patients. Thus, plasma samples of 59 patients with non-insulin-requiring T2D from a placebo-controlled, randomized, and double-blind study were retrospectively analyzed...
July 15, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28714753/pediatric-acute-onset-neuropsychiatric-syndrome-response-to-oral-corticosteroid-bursts-an-observational-study-of-patients-in-an-academic-community-based-pans-clinic
#17
Kayla Brown, Cristan Farmer, Bahare Farhadian, Joseph Hernandez, Margo Thienemann, Jennifer Frankovich
BACKGROUND: Sudden-onset severe obsessive-compulsive symptoms and/or severely restrictive food intake with at least two coinciding, similarly debilitating neuropsychiatric symptoms define Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). When associated with Group A Streptococcus, the syndrome is labeled Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal infections (PANDAS). An abnormal immune response to infection and subsequent neuroinflammation is postulated to play an etiologic role...
July 17, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28712371/visual-systemizing-preference-in-children-with-autism-a-randomized-controlled-trial-of-intranasal-oxytocin
#18
Lane Strathearn, Sohye Kim, D Anthony Bastian, Jennifer Jung, Udita Iyengar, Sheila Martinez, Robin P Goin-Kochel, Peter Fonagy
Several studies have suggested that the neuropeptide oxytocin may enhance aspects of social communication in autism. Little is known, however, about its effects on nonsocial manifestations, such as restricted interests and repetitive behaviors. In the empathizing-systemizing theory of autism, social deficits are described along the continuum of empathizing ability, whereas nonsocial aspects are characterized in terms of an increased preference for patterned or rule-based systems, called systemizing. We therefore developed an automated eye-tracking task to test whether children and adolescents with autism spectrum disorder (ASD) compared to matched controls display a visual preference for more highly organized and structured (systemized) real-life images...
July 17, 2017: Development and Psychopathology
https://www.readbyqxmd.com/read/28712074/efficacy-and-safety-of-shp465-mixed-amphetamine-salts-in-the-treatment-of-attention-deficit-hyperactivity-disorder-in-adults-results-of-a-randomized-double-blind-placebo-controlled-forced-dose-clinical-study
#19
Richard H Weisler, Michael Greenbaum, Valerie Arnold, Ming Yu, Brian Yan, Margo Jaffee, Brigitte Robertson
OBJECTIVE: The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and safety of SHP465 mixed amphetamine salts (MAS) in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: Eligible adults [aged 18-55 years; meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ADHD criteria; baseline ADHD Rating Scale with Adult Prompts (ADHD-RS-AP) total scores ≥28] were randomized 1:1:1 to placebo or forced-dose SHP465 MAS (12...
July 15, 2017: CNS Drugs
https://www.readbyqxmd.com/read/28712000/predictors-of-weight-loss-in-early-treated-parkinson-s-disease-from-the-net-pd-ls-1-cohort
#20
Anne-Marie Wills, Ruosha Li, Adriana Pérez, Xuehan Ren, James Boyd
Weight loss is a common symptom of Parkinson's disease and is associated with impaired quality of life. Predictors of weight loss have not been studied in large clinical cohorts. We previously observed an association between change in body mass index and change in Unified Parkinson's Disease Rating Scale (UPDRS) motor and total scores. In this study, we performed a secondary analysis of longitudinal data (1-6 years) from 1619 participants in the NINDS Exploratory Trials in PD Long-term Study-1 (NET-PD LS1) to explore predictors of weight loss in a large prospective clinical trial cohort of early treated Parkinson's disease...
July 15, 2017: Journal of Neurology
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