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randomized, double-blind, trial

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https://www.readbyqxmd.com/read/28647677/buprenorphine-augmentation-improved-symptoms-of-ocd-compared-to-placebo-results-from-a-randomized-double-blind-and-placebo-controlled-clinical-trial
#1
Mohammad Ahmadpanah, Amin Reihani, Ali Ghaleiha, Alireza Soltanian, Mohammad Haghighi, Leila Jahangard, Dena Sadeghi Bahmani, Edith Holsboer-Trachsler, Serge Brand
BACKGROUND: In the search for new psychopharmacologic options in the treatment of obsessive-compulsive disorders (OCD), some findings suggested that augmentation with buprenorphine, a partial-opioid agonist used to treat opioid addiction, moderate acute pain and moderate chronic pain, is worthy of consideration. Accordingly, to explore this possibility further, a double-blinded, placebo-controlled clinical trial was performed. METHOD: A total of 43 patients (mean age: 34...
June 13, 2017: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/28647339/the-effects-of-amoxicillin-and-vancomycin-on-parameters-reflecting-cholesterol-metabolism
#2
S Baumgartner, D Reijnders, M C J M Konings, A K Groen, D Lütjohann, G H Goossens, E E Blaak, J Plat
BACKGROUND: Changes in the microbiota composition have been implicated in the development of obesity and type 2 diabetes. However, not much is known on the involvement of gut microbiota in lipid and cholesterol metabolism. In addition, the gut microbiota might also be a potential source of plasma oxyphytosterol and oxycholesterol concentrations (oxidation products of plant sterols and cholesterol). Therefore, the aim of this study was to modulate the gut microbiota by antibiotic therapy to investigate effects on parameters reflecting cholesterol metabolism and oxyphytosterol concentrations...
June 21, 2017: Chemistry and Physics of Lipids
https://www.readbyqxmd.com/read/28647291/genistein-supplementation-improves-insulin-resistance-and-inflammatory-state-in-non-alcoholic-fatty-liver-patients-a-randomized-controlled-trial
#3
Sasan Amanat, Mohammad Hassan Eftekhari, Mohammad Fararouei, Kamran Bagheri Lankarani, Seyed Jalil Massoumi
BACKGROUND & AIMS: The beneficial effect of genistein has indicated on metabolic disorders and inflammatory state. The aim of this study was to investigate the effect of genistein supplementation on non-alcoholic fatty liver disease (NAFLD) as the hepatic manifest of metabolic syndrome. METHODS: In the present randomized double-blind controlled trial, patients with NAFLD were daily supplemented with either 250 mg genistein (n = 41) or placebo (n = 41) for 8-weeks...
June 1, 2017: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/28647064/efficacy-of-the-doktormitsdm-training-module-in-supporting-shared-decision-making-results-from-a-multicenter-double-blind-randomized-controlled-trial
#4
Friedemann Geiger, Katrin Liethmann, Daniela Reitz, Razvan Galalae, Jürgen Kasper
OBJECTIVE: Training to improve physicians' shared decision making (SDM) competencies with proven effectiveness and efficiency is rare. This study evaluated the brief in situ training module 'doktormitSDM'. METHODS: In a multicenter RCT, each physician recorded four consultations, each of which included a diagnostic or treatment decision (N=152 consultations from seven medical specialties). The doktormitSDM training module included two video-based individual coaching sessions (15min) at the physicians' workplaces, supplemented by a manual and a video tutorial...
June 19, 2017: Patient Education and Counseling
https://www.readbyqxmd.com/read/28646732/effects-of-stimulants-and-atomoxetine-on-emotional-lability-in-adults-a-systematic-review-and-meta-analysis
#5
T R Moukhtarian, R E Cooper, E Vassos, P Moran, P Asherson
BACKGROUND: Emotional lability (EL) is an associated feature of attention-deficit/hyperactivity disorder (ADHD) in adults, contributing to functional impairment. Yet the effect of pharmacological treatments for ADHD on EL symptoms is unknown. We conducted a systematic review and meta-analysis to examine the effects of stimulants and atomoxetine on symptoms of EL and compare these with the effects on core ADHD symptoms. METHODS: A systematic search was conducted on the databases Embase, PsychInfo, and Ovid Medline(®) and the clinicaltrials...
May 25, 2017: European Psychiatry: the Journal of the Association of European Psychiatrists
https://www.readbyqxmd.com/read/28646590/randomized-controlled-double-blind-trial-comparing-haloperidol-combined-with-conventional-therapy-to-conventional-therapy-alone-in-patients-with-symptomatic-gastroparesis
#6
Carlos J Roldan, Kimberly A Chambers, Linda Paniagua, Sonali Patel, Marylou Cardenas-Turanzas, Yashwant Chathampally
OBJECTIVE: Gastroparesis is a debilitating condition that causes nausea, vomiting, and abdominal pain. Management includes analgesics and antiemetics, but symptoms are often refractory. Haloperidol has been utilized in the palliative care setting for similar symptoms. The study objective was to determine whether haloperidol as an adjunct to conventional therapy would improve symptoms in gastroparesis patients presenting to the emergency department. METHODS AND TRIAL DESIGN: This was a randomized, double-blind, placebo-controlled trial of adult emergency department patients with acute exacerbation of previously diagnosed gastroparesis...
June 24, 2017: Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine
https://www.readbyqxmd.com/read/28646344/does-biomarker-information-impact-breast-cancer-patients-preferences-and-physician-recommendation-for-adjuvant-chemotherapy
#7
Ann H Partridge, Karen Sepucha, Anne O'Neill, Kathy D Miller, Emily Baker, Chau T Dang, Donald W Northfelt, George W Sledge, Bryan P Schneider
PURPOSE: This study aimed to examine how biomarker information would impact patients' preferences and physicians' recommendations for adjuvant breast cancer therapy. METHODS: At the 18-month follow-up, participants in a large, double-blind randomized controlled trial of adjuvant chemotherapy with bevacizumab or placebo (E5103) were surveyed about their preferred treatment (either chemotherapy A alone or chemotherapy A+B) in two hypothetical scenarios: (1) without biomarker information; and (2) after learning that they tested positive for a "B-receptor" which modestly increased both the benefit and toxicity expected with chemotherapy A+B...
June 23, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28645853/anterior-pallidal-deep-brain-stimulation-for-tourette-s-syndrome-a-randomised-double-blind-controlled-trial
#8
Marie-Laure Welter, Jean-Luc Houeto, Stéphane Thobois, Benoit Bataille, Marc Guenot, Yulia Worbe, Andreas Hartmann, Virginie Czernecki, Eric Bardinet, Jerome Yelnik, Sophie Tezenas du Montcel, Yves Agid, Marie Vidailhet, Philippe Cornu, Audrey Tanguy, Solène Ansquer, Nematollah Jaafari, Emmanuel Poulet, Giulia Serra, Pierre Burbaud, Emmanuel Cuny, Bruno Aouizerate, Pierre Pollak, Stephan Chabardes, Mircea Polosan, Michel Borg, Denys Fontaine, Bruno Giordana, Sylvie Raoul, Tiphaine Rouaud, Anne Sauvaget, Isabelle Jalenques, Carine Karachi, Luc Mallet
BACKGROUND: Deep brain stimulation (DBS) has been proposed to treat patients with severe Tourette's syndrome, and open-label trials and two small double-blind trials have tested DBS of the posterior and the anterior internal globus pallidus (aGPi). We aimed to specifically assess the efficacy of aGPi DBS for severe Tourette's syndrome. METHODS: In this randomised, double-blind, controlled trial, we recruited patients aged 18-60 years with severe and medically refractory Tourette's syndrome from eight hospitals specialised in movement disorders in France...
June 20, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28645636/theobromine-does-not-affect-postprandial-lipid-metabolism-and-duodenal-gene-expression-but-has-unfavorable-effects-on-postprandial-glucose-and-insulin-responses-in-humans
#9
Lotte Smolders, Ronald P Mensink, Mark V Boekschoten, Rogier J J de Ridder, Jogchum Plat
BACKGROUND & AIMS: Chocolate consumption is associated with a decreased risk for CVD. Theobromine, a compound in cocoa, may explain these effects as it favorably affected fasting serum lipids. However, long-term effects of theobromine on postprandial metabolism as well as underlying mechanisms have never been studied. The objective was to evaluate the effects of 4-week theobromine consumption (500 mg/day) on fasting and postprandial lipid, lipoprotein and glucose metabolism, and duodenal gene expression...
June 10, 2017: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/28643477/red-wine-polyphenols-do-not-improve-obesity-associated-insulin-resistance-a-randomized-controlled-trial
#10
Jorn Woerdeman, Daniele Del Rio, Luca Calani, Etto C Eringa, Yvo M Smulders, Erik H Serné
Preclinical studies have suggested that polyphenols extracted from red wine (RWPs) favorably affect insulin sensitivity, but controversy exists on whether RWPs exert similar effects in humans. This study aimed to determine whether RWPs improve insulin sensitivity in obese volunteers. Obese (BMI>30) volunteers were randomly allocated to RWPs 600 mg/day (n = 14) or matched placebo (n = 15) in a double-blind fashion (parallel-arm) for 8 weeks. Subjects were investigated at baseline and at the end of the study (EOS)...
June 23, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28642891/safety-tolerability-of-the-anti-semaphorin-4d-antibody-vx15-2503-in-a-randomized-phase-1-trial
#11
Christopher LaGanke, Lawrence Samkoff, Keith Edwards, Lily Jung Henson, Pavle Repovic, Sharon Lynch, Lael Stone, David Mattson, Aaron Galluzzi, Terrence L Fisher, Christine Reilly, Laurie A Winter, John E Leonard, Maurice Zauderer
OBJECTIVE: To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX15/2503 in a randomized, single-dose, dose-escalation, double-blind, placebo-controlled study enrolling adult patients with MS. METHODS: Single IV doses of VX15/2503 or placebo were administered. Ten patients each were randomized (4:1 randomization ratio) into 5 ascending dose cohorts of 1, 3, 6, 10, or 20 mg/kg. Safety, immunogenicity, PK/PD, MRI, ECG, and lymphocyte subset levels were evaluated...
July 2017: Neurology® Neuroimmunology & Neuroinflammation
https://www.readbyqxmd.com/read/28642082/clinical-trial-of-the-effects-of-vitamin-d-supplementation-on-psychological-symptoms-and-metabolic-profiles-in-maintenance-methadone-treatment-patients
#12
Amir Ghaderi, Hamid Reza Banafshe, Maryam Motmaen, Morad Rasouli-Azad, Fereshteh Bahmani, Zatollah Asemi
BACKGROUND: Vitamin D deficiency may be associated with some complications including nonspecific musculoskeletal pain and periodontal disease in maintenance methadone treatment (MMT) patients. This study was designed to determine the effect of vitamin D supplementation on psychological symptoms and metabolic profiles in MMT patients. METHODS: This randomized, double-blind, placebo-controlled, clinical trial was carried out among 68 MMT patients. Participants were randomly allocated to receive either 50,000IU vitamin D supplements (n=34) or placebo (n=34) every 2weeks for 12weeks...
June 19, 2017: Progress in Neuro-psychopharmacology & Biological Psychiatry
https://www.readbyqxmd.com/read/28642024/rtms-with-a-two-coil-array-safety-and-efficacy-for-treatment-resistant-major-depressive-disorder
#13
Linda L Carpenter, Scott T Aaronson, Gregory N Clarke, Paul E Holtzheimer, Clark W Johnson, William M McDonald, Elizabeth L Stannard, M Bret Schneider
BACKGROUND: Therapeutic repetitive Transcranial Magnetic Stimulation (rTMS) has emerged as a standard of care for individuals with major depressive disorder (MDD) who do not benefit from, or are unable to tolerate, antidepressant pharmacotherapy. Depth of stimulation is limited with currently approved figure-eight coils and larger coils capable of deeper penetration may be associated with loss of stimulation focality and undesired recruitment of motor cortex. A second generation 2-coil array rTMS system was designed to target converging brain pathways for potentially deeper prefrontal cortex stimulation...
June 9, 2017: Brain Stimulation
https://www.readbyqxmd.com/read/28641925/safety-pharmacokinetics-and-sialic-acid-production-after-oral-administration-of-n-acetylmannosamine-mannac-to-subjects-with-gne-myopathy
#14
Xin Xu, Amy Q Wang, Lea L Latham, Frank Celeste, Carla Ciccone, May Christine Malicdan, Barry Goldspiel, Pramod Terse, James Cradock, Nora Yang, Selwyn Yorke, John C McKew, William A Gahl, Marjan Huizing, Nuria Carrillo
GNE myopathy is a rare, autosomal recessive, inborn error of sialic acid metabolism, caused by mutations in GNE, the gene encoding UDP-N-acetyl-glucosamine-2-epimerase/N-acetylmannosamine kinase. The disease manifests as an adult-onset myopathy characterized by progressive skeletal muscle weakness and atrophy. There is no medical therapy available for this debilitating disease. Hyposialylation of muscle glycoproteins likely contributes to the pathophysiology of this disease. N-acetyl-D-mannosamine (ManNAc), an uncharged monosaccharide and the first committed precursor in the sialic acid biosynthetic pathway, is a therapeutic candidate that prevents muscle weakness in the mouse model of GNE myopathy...
April 26, 2017: Molecular Genetics and Metabolism
https://www.readbyqxmd.com/read/28641875/prevention-of-incisional-hernia-with-prophylactic-onlay-and-sublay-mesh-reinforcement-versus-primary-suture-only-in-midline-laparotomies-prima-2-year-follow-up-of-a-multicentre-double-blind-randomised-controlled-trial
#15
An P Jairam, Lucas Timmermans, Hasan H Eker, Robert E G J M Pierik, David van Klaveren, Ewout W Steyerberg, Reinier Timman, Arie C van der Ham, Imro Dawson, Jan A Charbon, Christoph Schuhmacher, André Mihaljevic, Jakob R Izbicki, Panagiotis Fikatas, Philip Knebel, René H Fortelny, Gert-Jan Kleinrensink, Johan F Lange, Hans J Jeekel
BACKGROUND: Incisional hernia is a frequent long-term complication after abdominal surgery, with a prevalence greater than 30% in high-risk groups. The aim of the PRIMA trial was to evaluate the effectiveness of mesh reinforcement in high-risk patients, to prevent incisional hernia. METHODS: We did a multicentre, double-blind, randomised controlled trial at 11 hospitals in Austria, Germany, and the Netherlands. We included patients aged 18 years or older who were undergoing elective midline laparotomy and had either an abdominal aortic aneurysm or a body-mass index (BMI) of 27 kg/m(2) or higher...
June 19, 2017: Lancet
https://www.readbyqxmd.com/read/28641363/a-phase-iii-randomized-controlled-study-on-the-efficacy-and-improved-bowel-function-of-prolonged-release-pr-oxycodone-naloxone-up-to-160-80-mg-daily-vs-oxycodone-pr
#16
D Dupoiron, A Stachowiak, O Loewenstein, A Ellery, W Kremers, B Bosse, M Hopp
BACKGROUND: Oxycodone/naloxone (OXN PR) is a prolonged-release formulation containing oxycodone and naloxone in a 2:1 ratio. This study aimed to evaluate the tolerability and efficacy of doses up to OXN160/80 mg PR compared with oxycodone prolonged-release formulation (OxyPR) in a randomised controlled trial. METHODS: Two hundred and forty-three patients were randomised to treatment with OXN PR (n = 123) or OxyPR (n = 120) during the 5-week double-blind study...
June 22, 2017: European Journal of Pain: EJP
https://www.readbyqxmd.com/read/28641022/a-randomized-single-dose-parallel-study-on-enhancement-of-nitric-oxide-in-serum-and-saliva-with-the-use-of-natural-sports-supplement-in-healthy-adults
#17
Joby Jacob, Sreeraj Gopi, Chandradhara Divya
Sports supplements that stimulate the production of nitric oxide (NO) are widely promoted agents in the sports nutrition domain, and nitric oxide plays an important role to enhance the cardiovascular and physical fitness of the sports participants. The purpose of the study is to investigate whether oral intake of a sports nutritional supplement (Fitnox) is able to increase nitrate (NO3(-)) and nitrite (NO2(-)) levels in blood serum and saliva of healthy adults. Fitnox is a unique blend of Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins...
June 22, 2017: Journal of Dietary Supplements
https://www.readbyqxmd.com/read/28640990/opiate-antagonists-do-not-interfere-with-the-clinical-benefits-of-stimulants-in-adhd-a-double-blind-placebo-controlled-trial-of-the-mixed-opioid-receptor-antagonist-naltrexone
#18
Thomas J Spencer, Pradeep Bhide, Jinmin Zhu, Stephen V Faraone, Maura Fitzgerald, Amy M Yule, Mai Uchida, Andrea E Spencer, Anna M Hall, Ariana J Koster, Joseph Biederman
OBJECTIVE: Methylphenidate activates μ-opioid receptors, which are linked to euphoria. μ-Opioid antagonists, such as naltrexone, may attenuate the euphoric effects of stimulants, thereby minimizing their abuse potential. This study assessed whether the combination of naltrexone with methylphenidate is well-tolerated while preserving the clinical benefits of stimulants in subjects with attention-deficit/hyperactivity disorder (ADHD). METHODS: We conducted a 6-week, double-blind, placebo-controlled, randomized clinical trial of naltrexone in adults with DSM-IV ADHD receiving open treatment with a long-acting formulation of methylphenidate from January 2013 to July 2015...
June 20, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/28639229/pharmacokinetics-of-mhaa4549a-an-anti-influenza-a-monoclonal-antibody-in-healthy-subjects-challenged-with-influenza%C3%A2-a-virus-in-a-phase-iia-randomized-trial
#19
Rong Deng, Ai Ping Lee, Mauricio Maia, Jeremy J Lim, Tracy Burgess, Priscilla Horn, Michael A Derby, Elizabeth Newton, Jorge A Tavel, William D Hanley
BACKGROUND AND OBJECTIVES: MHAA4549A, a human anti-influenza immunoglobulin (Ig) G1 monoclonal antibody, is being developed to treat patients hospitalized for influenza A infection. This study examined the pharmacokinetics (PKs) of MHAA4549A in a phase IIa, randomized, double-blind, dose-ranging trial in healthy volunteers challenged with influenza A virus. METHODS: Serum PK data were collected from 60 subjects in three single-dose groups (400, 1200, or 3600 mg) who received MHAA4549A intravenously 24-36 h after inoculation with the influenza A virus...
June 21, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28639011/guselkumab-for-the-treatment-of-psoriasis-a-review-of-phase-iii-trials
#20
REVIEW
Mio Nakamura, Katherine Lee, Caleb Jeon, Sahil Sekhon, Ladan Afifi, Di Yan, Kristina Lee, Tina Bhutani
INTRODUCTION: Interleukin (IL)-23 inhibitors are a new class of biologics currently undergoing clinical trials for the treatment of moderate-to-severe psoriasis. Phase III studies of guselkumab, an IL-23 receptor monoclonal antibody, are currently underway. METHODS: We summarize the available phase III results to date, establishing the efficacy and safety of guselkumab in patients with moderate-to-severe plaque psoriasis. RESULTS: Currently, there are available data of up to 48 weeks from two Phase III, multicenter, randomized, double-blind, placebo- and comparator-controlled clinical trials, VOYAGE 1 and VOYAGE 2...
June 21, 2017: Dermatology and Therapy
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