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https://www.readbyqxmd.com/read/29786964/a-thorough-qt-qtc-study-with-laquinimod-a-novel-immunomodulator-in-development-for-multiple-sclerosis-and-huntington-disease
#1
Ofer Spiegelstein, Dorit Mimrod, Laura Rabinovich, Eli Eyal, Craig Sprenger, Anna Elgart, Emil Samara, Joel Morganroth
In this randomized double-blind study, 4 groups of healthy subjects (50 per arm) participated to evaluate the effect of laquinimod, an oral treatment in development for multiple sclerosis and Huntington disease, on the QTc interval. Subjects received a dose of either 0.6 or 1.2 mg/day laquinimod for 14 days, placebo for 14 days, or 13 days of placebo followed by a dose of 400 mg moxifloxacin on day 14. Continuous 12-lead electrocardiograms were recorded on day -1 (baseline) and days 14 to 17,  and quadruplicate electrocardiograms were extracted at predefined time points...
May 22, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29786535/evaluating-the-importance-of-sham-controlled-trials-in-the-investigation-of-medical-devices-in-interventional-cardiology
#2
Robert A Byrne, Davide Capodanno, Felix Mahfoud, Jean Fajadet, Stephan Windecker, Peter Jüni, Andreas Baumbach, William Wijns, Michael Haude
Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomized clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants...
May 22, 2018: EuroIntervention
https://www.readbyqxmd.com/read/29786471/the-effects-of-polyphenol-supplementation-on-adipose-tissue-morphology-and-gene-expression-in-overweight-and-obese-humans
#3
Jasper Most, Ines Warnke, Mark V Boekschoten, Johan W E Jocken, Philip de Groot, Angelika Friedel, Igor Bendik, Gijs H Goossens, Ellen E Blaak
Dietary polyphenols have beneficial effects on adipose tissue mass and function in rodents, but human studies are scarce. In a randomized, placebo-controlled study, 25 (10 women) overweight and obese humans received a combination of the polyphenols epigallocatechin-gallate and resveratrol (282 mg/d, 80 mg/d, respectively, EGCG+RES, n = 11) or placebo (PLA, n = 14) supplementation for 12 weeks. Abdominal subcutaneous adipose tissue (SAT) biopsies were collected for assessment of adipocyte morphology and micro-array analysis...
May 1, 2018: Adipocyte
https://www.readbyqxmd.com/read/29785915/the-effects-of-a-synthetic-analogue-of-the-bovine-appeasing-pheromone-on-milk-yield-and-composition-in-valdostana-dairy-cows-during-the-move-from-winter-housing-to-confined-lowland-pastures
#4
Maria Cristina Osella, Alessandro Cozzi, Claudio Spegis, Germano Turille, Andrea Barmaz, Céline Lafont Lecuelle, Eva Teruel, Cécile Bienboire-Frosini, Camille Chabaud, Laurent Bougrat, Patrick Pageat
This Research Communication describes the effects of a synthetic analogue of the Bovine Appeasing Pheromone (BAP) on milk parameters in Valdostana dairy cows during the first turning out from tie-stalls to confined lowland pastures around the farms. Thirty healthy lactating Valdostana cows were enroled in the study and randomly divided into 2 groups: experimental group (EG, n = 15) and control group (CG, n = 15). The two groups were separately housed in the same farm and managed outside in two different pens...
May 2018: Journal of Dairy Research
https://www.readbyqxmd.com/read/29785788/effects-of-levosimendan-on-mortality-in-patients-undergoing-cardiac-surgery-a-systematic-review-and-meta-analysis
#5
Peili Chen, Xiaoqiang Wu, Zhiwei Wang, Zhenya Li, Xiangyong Tian, Junpeng Wang, Tianzhong Yan
PURPOSE: We sought to determine the impact of levosimendan on mortality following cardiac surgery based on large-scale randomized controlled trials (RCTs). METHODS: We searched PubMed, Web of Science, Cochrane databases, and ClinicalTrials.gov for RCTs published up to December 2017, on levosimendan for patients undergoing cardiac surgery. RESULTS: A total of 25 RCTs enrolling 2960 patients met the inclusion criteria; data from 15 placebo-controlled randomized trials were included for meta-analysis...
May 21, 2018: Journal of Cardiac Surgery
https://www.readbyqxmd.com/read/29785555/folic-acid-methylfolate-for-the-treatment-of-psychopathology-in-schizophrenia-a-systematic-review-and-meta-analysis
#6
Kenji Sakuma, Shinji Matsunaga, Ikuo Nomura, Makoto Okuya, Taro Kishi, Nakao Iwata
RATIONALE: This study aims to examine whether folate/folic acid/methylfolate/folinic acid supplemented to antipsychotics (FA + AP) is beneficial in schizophrenia treatment. OBJECTIVE: We conducted a comprehensive systematic review and meta-analysis of double-blind, placebo-controlled, randomized clinical trials (RCTs) of FA + AP for schizophrenia. METHODS: The primary outcome was an improvement in total symptoms. Other outcomes were psychopathology subscales (positive, negative, general, and depressive symptoms), discontinuation due to all-cause and adverse events, and individual adverse events...
May 22, 2018: Psychopharmacology
https://www.readbyqxmd.com/read/29785539/the-effect-of-spironolactone-on-the-incidence-of-contrast-induced-nephropathy-in-patients-undergoing-cardiac-catheterization-study-design-and-rationale
#7
Alhasan Mujtaba, Mohammed A Taher, Mazin A Hazza, Hassan M Al-Rubaye, Asaad H Kata, Hamid AbdulWahab, AbdulAmeer AbdulBari, Hayder K AlRubay
INTRODUCTION: Patients undergoing coronary catheterization are at high risk of developing contrast-induced nephropathy (CIN) acute kidney injury (AKI). Several approaches have been supposed to limit such an effect but with mixed results or non-practical methods. Spironolactone is supposed to be effective as a nephroprotective agent in animal studies. This study will try to measure the effect of spironolactone on the incidence of CIN-AKI in patients undergoing coronary catheterization (angiography angioplasty)...
May 21, 2018: Cardiology and Therapy
https://www.readbyqxmd.com/read/29785233/therapeutic-outcome-of-intralesional-immunotherapy-in-cutaneous-warts-using-the-mumps-measles-and-rubella-vaccine-a-randomized-placebo-controlled-trial
#8
Guneet Awal, Simplepreet Kaur
Background: Various treatment modalities have been described in the literature for treating warts, but none thus far have demonstrated optimal results. Recently, the mumps, measles, and rubella (MMR) antigen has gained popularity because of its proven efficacy in the treatment of warts. Aim: The goal was to evaluate the efficacy and safety of intralesional MMR antigen in the treatment of cutaneous warts. Methods: Patients were divided into an MMR (study) group and a normal saline (control) group. Injections were administered into the single largest wart on each patient every two weeks...
May 2018: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/29785101/exacerbation-recovery-patterns-in-newly-diagnosed-or-maintenance-treatment-na%C3%A3-ve-patients-with-copd-secondary-analyses-of-ticari-1-trial-data
#9
David M Mannino, Emmanuelle M Clerisme-Beaty, Joanne Franceschina, Naitee Ting, Nancy K Leidy
Background: Little is known about the recovery patterns from acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in newly diagnosed or maintenance treatment-naïve patients with COPD. This study describes the course of AECOPD in these patients at the time of treatment for the symptoms of acute respiratory tract infection (RTI). Methods: This study was a secondary analysis of data from a 12-week, randomized clinical trial (TICARI 1) testing the efficacy and safety of once-daily tiotropium 18 µg maintenance therapy versus placebo in newly diagnosed or maintenance treatment-naïve COPD patients with acute RTI symptoms for ≤7 days...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29785045/an-initial-study-on-the-effect-of-functional-electrical-stimulation-in-erectile-dysfunction-a-randomized-controlled-trial
#10
Cristiane Carboni, Alexandre Fornari, Karoline C Bragante, Marcio A Averbeck, Patrícia Vianna da Rosa, Rodrigo Della Mea Plentz
Erectile dysfunction (ED) affects approximately 150 million men worldwide. Functional electrical stimulation (FES) therapy has shown a high regenerative capacity for smooth muscle cells and, therefore, is being increasingly adopted. FES can be a beneficial treatment option when the cause of ED is related to degeneration of cavernous smooth muscle. To evaluate the impact of FES on erectile function in men with erectile dysfunction. Twenty-two patients with ED participated in this randomized clinical trial. Participants were randomly assigned to two groups: intervention (IG) or control (CG)...
May 22, 2018: International Journal of Impotence Research
https://www.readbyqxmd.com/read/29784554/renal-stress-and-kidney-injury-biomarkers-in-response-to-endurance-cycling-in-the-heat-with-and-without-ibuprofen
#11
Brendon P McDermott, Cody R Smith, Cory L Butts, Aaron R Caldwell, Elaine C Lee, Jakob L Vingren, Colleen X Munoz, Laura J Kunces, Keith Williamson, Matthew S Ganio, Lawrence E Armstrong
Exercise, especially in the heat, can contribute to acute kidney injury, which can expedite chronic kidney disease onset. The additional stress of ibuprofen use is hypothesized to increase renal stress. OBJECTIVES: To observe the effects of endurance cycling in the heat on renal function. Secondarily, we investigated the effect of ibuprofen ingestion on kidney stress. DESIGN: Randomized, placebo controlled and observational methods were utilized. METHODS: Forty cyclists (52±9y, 21...
May 16, 2018: Journal of Science and Medicine in Sport
https://www.readbyqxmd.com/read/29784458/efficacy-of-antiepileptic-drugs-in-the-adjunctive-treatment-of-refractory-partial-onset-seizures-meta-analysis-of-pivotal-trials
#12
Jeremy Slater, Steve Chung, Lynn Huynh, Mei Sheng Duh, Brian Gorin, Carolyn McMicken, Adam Ziemann, Jouko Isojarvi
OBJECTIVE: In the absence of randomized clinical trials (RCTs) assessing the relative efficacy of antiepileptic drugs (AEDs), meta-analyses are useful resources for informing treatment choices. This meta-analysis assesses the relative efficacy and tolerability of AEDs for adjunctive treatment of refractory partial onset seizures (POS). METHODS: A systematic literature review was conducted to identify pivotal AED trials serving as the basis for US Food and Drug Administration (FDA) approval...
July 2018: Epilepsy Research
https://www.readbyqxmd.com/read/29784193/adjuvant-vascular-endothelial-growth-factor-targeted-therapy-in-renal-cell-carcinoma-a-systematic-review-and-pooled-analysis
#13
REVIEW
Maxine Sun, Lorenzo Marconi, Tim Eisen, Bernard Escudier, Rachel H Giles, Naomi B Haas, Lauren C Harshman, David I Quinn, James Larkin, Sumanta K Pal, Thomas Powles, Christopher W Ryan, Cora N Sternberg, Robert Uzzo, Toni K Choueiri, Axel Bex
CONTEXT: Contradictory data exist with regard to adjuvant vascular endothelial growth factor receptor (VEGFR)-targeted therapy in surgically managed patients for localized renal cell carcinoma (RCC). OBJECTIVE: To systematically evaluate the current evidence regarding the therapeutic benefit (disease-free survival [DFS] and overall survival [OS]) and grade 3-4 adverse events (AEs) for adjuvant VEGFR-targeted therapy for resected localized RCC. EVIDENCE ACQUISITION: A critical review of PubMed/Medline, Embase, and the Cochrane Library in January 2018 according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement was performed...
May 18, 2018: European Urology
https://www.readbyqxmd.com/read/29783950/effects-of-the-cardiac-myosin-activator-omecamtiv-mecarbil-on-severe-chronic-aortic-regurgitation-in-wistar-rats
#14
Bachar El-Oumeiri, Kathleen Mc Entee, Filippo Annoni, Antoine Herpain, Frédéric Vanden Eynden, Pascal Jespers, Guido Van Nooten, Philippe van de Borne
BACKGROUND: Aortic regurgitation (AR) is a valvular disease that can lead to systolic heart failure. Treatment options besides cardiac surgery are limited and consequently severe AR is associated with higher mortality and morbidity when not operated. In this investigation, we examined the effects of a novel cardiac myosin activator, Omecamtiv-mecarbil (OM), in rats with chronic severe AR. METHODS: AR was created by retrograde puncture of the aortic valve leaflets in 20 adults Wistar rats...
May 21, 2018: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/29783900/the-efficacy-comparison-of-citalopram-fluoxetine-and-placebo-on-motor-recovery-after-ischemic-stroke-a-double-blind-placebo-controlled-randomized-controlled-trial
#15
Marjan Asadollahi, Mahtab Ramezani, Ziba Khanmoradi, Ehsan Karimialavijeh
OBJECTIVE: The present study aimed to assess the effectiveness of oral citalopram, compared with fluoxetine and a placebo, in patients with post-stroke motor disabilities. DESIGN: A randomized double-blind placebo-controlled clinical trial was conducted between January 2015 and January 2016. SETTING: The neurology department of a university-affiliated urban hospital in Tehran, Iran. SUBJECTS: Ninety adult patients with acute ischemic stroke, hemiplegia, or hemiparesis and a Fugl-Meyer Motor Scale score of below 55 were included...
May 1, 2018: Clinical Rehabilitation
https://www.readbyqxmd.com/read/29783863/phase-1-randomized-parallel-group-double-blind-placebo-controlled-trial-to-evaluate-the-effects-of-erenumab-amg-334-and-concomitant-sumatriptan-on-blood-pressure-in-healthy-volunteers
#16
Jan de Hoon, Anne Van Hecken, Corinne Vandermeulen, Marissa Herbots, Yumi Kubo, Ed Lee, Osa Eisele, Gabriel Vargas, Kristin Gabriel
Objectives The aim of this study was to assess the effects of concomitant administration of erenumab and sumatriptan on resting blood pressure, pharmacokinetics, safety, and tolerability in healthy subjects. Methods In this phase 1, parallel-group, one-way crossover, double-blind, placebo-controlled study, healthy adult subjects were randomized (1:2) to receive either intravenous placebo and subcutaneous sumatriptan 12 mg (i.e. two 6-mg injections separated by 1 hour) or intravenous erenumab 140 mg and subcutaneous sumatriptan 12 mg...
January 1, 2018: Cephalalgia: An International Journal of Headache
https://www.readbyqxmd.com/read/29783587/re-randomized-phase-iii-trial-of-adjuvant-pazopanib-versus-placebo-after-nephrectomy-in-patients-with-localized-or-locally-advanced-renal-cell-carcinoma
#17
https://www.readbyqxmd.com/read/29783269/adding-paracetamol-to-ibuprofen-for-the-treatment-of-patent-ductus-arteriosus-in-preterm-infants-a-double-blind-randomized-placebo-controlled-pilot-study
#18
Ori Hochwald, Gur Mainzer, Liron Borenstein-Levin, Huda Jubran, Gil Dinur, Meirav Zucker, Malka Mor, Asaad Khoury, Amir Kugelman
OBJECTIVE:  The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 316/7 weeks postmenstrual age. STUDY DESIGN:  This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol ( n  = 12) or ibuprofen + placebo ( n  = 12)...
May 21, 2018: American Journal of Perinatology
https://www.readbyqxmd.com/read/29782907/analgesic-effect-of-intrathecal-baclofen-bolus-on-neuropathic-pain-in-spinal-cord-injury-patients
#19
Hatice Kumru, Jesus Benito-Penalva, Markus Kofler, Joan Vidal
BACKGROUND: GABA-ergic neurons are widely distributed throughout the central nervous system, including the spinal cord which is important for the transmission of pain impulses to the brain. Here we hypothesized that intrathecal baclofen (ITB) which is a GABA analogue might exert analgesic effects on neuropathic pain, which could be related to subtypes of pain in spinal cord injury (SCI). METHODS: SCI patients with a cervical or thoracic lesion and neuropathic pain were randomized to receive either a single ITB bolus or placebo...
May 18, 2018: Brain Research Bulletin
https://www.readbyqxmd.com/read/29782468/potential-role-of-gut-microbiota-in-als-pathogenesis-and-possible-novel-therapeutic-strategies
#20
Letizia Mazzini, Luca Mogna, Fabiola De Marchi, Angela Amoruso, Marco Pane, Irene Aloisio, Nicole Bozzi Cionci, Francesca Gaggìa, Ausiliatrice Lucenti, Enrica Bersano, Roberto Cantello, Diana Di Gioia, Giovanni Mogna
BACKGROUND: Recent preclinical studies suggest that dysfunction of gastrointestinal tract may play a role in amyotrophic lateral sclerosis (ALS) pathogenesis through a modification of the gut microbiota brain axis. Our study is the first focused on microbiota analysis in ALS patients. AIM: Our aim was to study the main human gut microbial groups and the overall microbial diversity in ALS and healthy subjects. Moreover we have examined the influence of a treatment with a specific bacteriotherapy composed of Lactobacillus strains (Lactobacillus fermentum, Lactobacillus delbrueckii, Lactobacillus plantarum, Lactobacillus salivarius) acting on the gastrointestinal barrier...
May 18, 2018: Journal of Clinical Gastroenterology
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