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Randomized double blinded controlled studies

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https://www.readbyqxmd.com/read/29454255/effects-of-adjunctive-eslicarbazepine-acetate-on-neurocognitive-functioning-in-children-with-refractory-focal-onset-seizures
#1
Sergiusz Jóźwiak, P Veggiotti, J Moreira, H Gama, F Rocha, P Soares-da-Silva
PURPOSE: This was a phase-II, randomized, double-blind (DB), placebo-controlled study aimed to evaluate neurocognitive effects of eslicarbazepine acetate (ESL) as adjunctive therapy in pediatric patients with refractory focal-onset seizures (FOS). METHODS: Children (6-16years old) with FOS were randomized (2:1) to ESL or placebo. Treatment started at 10mg/kg/day, was up-titrated up to 30mg/kg/day (target dose), and maintained for 8weeks, followed by one-year open-label follow-up...
February 13, 2018: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/29454039/effect-of-long-term-selenium-supplementation-on-mortality-results-from-a-multiple-dose-randomised-controlled-trial
#2
REVIEW
Margaret P Rayman, Kristian Hillert Winther, Roberto Pastor-Barriuso, Frederick Cold, Marianne Thvilum, Saverio Stranges, Eliseo Guallar, Søren Cold
BACKGROUND: Selenium, an essential trace element, is incorporated into selenoproteins with a wide range of health effects. Selenoproteins may reach repletion at a plasma selenium concentration of ~125µg/L, at which point the concentration of selenoprotein P reaches a plateau; whether sustained concentrations higher than this are beneficial, or indeed detrimental, is unknown. OBJECTIVE: In a population of relatively low selenium status, we aimed to determine the effect on mortality of long-term selenium supplementation at different dose levels...
February 14, 2018: Free Radical Biology & Medicine
https://www.readbyqxmd.com/read/29453383/hyperbaric-oxygen-therapy-is-well-tolerated-and-effective-for-ulcerative-colitis-patients-hospitalized-for-moderate-severe-flares-a-phase-2a-pilot-multi-center-randomized-double-blind-sham-controlled-trial
#3
Parambir S Dulai, Jay C Buckey, Laura E Raffals, Jason M Swoger, Paul L Claus, Kevin O'Toole, Judy A Ptak, Michael W Gleeson, Christella E Widjaja, John T Chang, Jeffery M Adler, Nihal Patel, Laurie A Skinner, Shawn P Haren, Kimberly Goldby-Reffner, Kimberly D Thompson, Corey A Siegel
BACKGROUND: Hyperbaric oxygen therapy (HBOT) markedly increases tissue oxygen delivery. Case series suggest it may have a potential therapeutic benefit in ulcerative colitis (UC). We investigated the therapeutic potential of HBOT as an adjunct to steroids for UC flares requiring hospitalization. METHODS: The study was terminated early due to poor recruitment with 18 of the planned 70 patients enrolled. UC patients hospitalized for moderate-severe flares (Mayo score ≥6, endoscopic sub-score ≥2) were block randomized to steroids + daily HBOT (n = 10) or steroids + daily sham hyperbaric air (n = 8)...
February 16, 2018: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/29453232/a-randomized-multicenter-phase-ii-study-of-docosahexaenoic-acid-in-patients-with-a-history-of-breast-cancer-premalignant-lesions-or-benign-breast-disease
#4
Ayca Gucalp, Xi K Zhou, Elise D Cook, Judy E Garber, Katherine D Crew, Julie R Nangia, Priya Bhardwaj, Dilip D Giri, Olivier Elemento, Akanksha Verma, Hanhan Wang, J Jack Lee, Lana A Vornik, Carrie Mays, Diane Weber, Valerie Sepeda, Holly O'Kane, Margaret Krasne, Samantha Williams, Patrick G Morris, Brandy M Heckman-Stoddard, Barbara K Dunn, Clifford A Hudis, Powel H Brown, Andrew J Dannenberg
Obesity, a cause of subclinical inflammation, is a risk factor for the development of postmenopausal breast cancer (BC) and is associated with poorer cancer outcomes. Docosahexaenoic acid (DHA), an omega-3 fatty acid, possesses anti-inflammatory properties. We hypothesized that treatment with DHA would reduce the expression of proinflammatory genes and aromatase, the rate-limiting enzyme for estrogen biosynthesis, in benign breast tissue of overweight/obese women. A randomized, placebo-controlled, double-blind phase II study of DHA given for 12 weeks to overweight/obese women with a history of stage I-III BC, DCIS/LCIS, Paget's disease, or proliferative benign breast disease was carried out...
February 16, 2018: Cancer Prevention Research
https://www.readbyqxmd.com/read/29452684/evaluation-of-the-safety-tolerability-and-efficacy-of-pimavanserin-versus-placebo-in-patients-with-alzheimer-s-disease-psychosis-a-phase-2-randomised-placebo-controlled-double-blind-study
#5
Clive Ballard, Carol Banister, Zunera Khan, Jeffrey Cummings, George Demos, Bruce Coate, James M Youakim, Randall Owen, Srdjan Stankovic
BACKGROUND: Pimavanserin is a selective 5-HT 2A receptor inverse agonist and antagonist approved in the USA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. No safe or effective pharmacological treatment is approved for psychosis in patients with Alzheimer's disease. Therefore, we aimed to evaluate the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis. METHODS: We did a phase 2, randomised, double-blind, placebo-controlled, single-centre (with multiple affiliated nursing home sites across the UK) study...
March 2018: Lancet Neurology
https://www.readbyqxmd.com/read/29452584/high-phosphorus-intake-and-gut-related-parameters-results-of-a-randomized-placebo-controlled-human-intervention-study
#6
Ulrike Trautvetter, Amélia Camarinha-Silva, Gerhard Jahreis, Stefan Lorkowski, Michael Glei
BACKGROUND: In recent years, high phosphate intakes were discussed critically. In the small intestine, a part of the ingested phosphate and calcium precipitates to amorphous calcium phosphate (ACP), which in turn can precipitate other intestinal substances, thus leading to a beneficial modulation of the intestinal environment. Therefore, we analysed faecal samples obtained from a human intervention study regarding gut-related parameters. METHODS: Sixty-two healthy subjects (men, n = 30; women, n = 32) completed the double-blind, placebo-controlled and parallel designed study (mean age: 29 ± 7 years; mean BMI: 24 ± 3 kg/m 2 )...
February 16, 2018: Nutrition Journal
https://www.readbyqxmd.com/read/29451914/correction-effects-of-low-dose-metformin-on-metabolic-traits-in-clozapine-treated-schizophrenia-patients-an-exploratory-twelve-week-randomized-double-blind-placebo-controlled-study
#7
Chih-Chiang Chiu, Mong-Liang Lu, Ming-Chyi Huang, Po-Yu Chen, Yen-Kuang Lin, Shih-Ku Lin, Chun-Hsin Chen
[This corrects the article DOI: 10.1371/journal.pone.0168347.].
2018: PloS One
https://www.readbyqxmd.com/read/29451036/pharmaceutical-grade-chondroitin-sulfate-in-the-management-of-knee-osteoarthritis
#8
Olivier Bruyère
Chondroitin Sulfate (CS) is a drug which is available as pharmaceutical-grade and nutriceutical-grade products, with important variations in preparation, composition, purity and therapeutic effects. Previous studies using pharmaceutical-grade CS suggested that the compound improves pain and function and delays structural progression in knee osteoarthritis (OA), whereas discrepant results were observed when lower grade preparations were investigated. The recently published chondroitin versus celecoxib versus Placebo Trial (CONCEPT) assessed the symptomatic effect of pharmaceutical-grade CS 800 mg/day in symptomatic knee OA...
February 16, 2018: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29450738/double-blind-randomized-controlled-clinical-trial-on-analgesic-efficacy-of-local-anesthetics-articaine-and-bupivacaine-after-impacted-third-molar-extraction
#9
Maria Victoria Olmedo-Gaya, Francisco Javier Manzano-Moreno, Jose Luis Muñoz-López, Manuel Francisco Vallecillo-Capilla, Candela Reyes-Botella
OBJECTIVE: The objective of this randomized controlled clinical trial (RCT) was to compare the effect of bupivacaine and articaine at habitual doses on pain intensity and the need for analgesics after lower third molar extraction. MATERIALS AND METHODS: The final study sample comprised 50 Caucasian volunteers (26 males and 24 females; age range, 18-30 years) undergoing scheduled surgical extraction of impacted lower third molar. A computer-generated random sequence was used to allocate participants to the articaine (4%) or bupivacaine (0...
February 15, 2018: Clinical Oral Investigations
https://www.readbyqxmd.com/read/29450585/effect-of-isolated-vitamin-d-supplementation-on-bone-turnover-markers-in-younger-postmenopausal-women-a-randomized-double-blind-placebo-controlled-trial
#10
J Nahas-Neto, L M Cangussu, C L Orsatti, F N Bueloni-Dias, P F Poloni, E B Schmitt, E A P Nahas
Vitamin D (VD) plays an important role in bone mineralization. The present study investigates the effect of VD supplementation alone on bone turnover markers in younger postmenopausal women. It has been shown that VD supplementation in postmenopausal women with hypovitaminosis D is associated with a reduction in bone turnover markers. PURPOSE: The purpose of this study is to evaluate the effect of VD supplementation alone on bone turnover markers in younger postmenopausal women. METHODS: In this double-blind, placebo-controlled trial, 160 women were randomized into the VD group (supplementation with 1000 IU of vitamin D3/day, orally; n = 80) or placebo group (n = 80)...
February 15, 2018: Osteoporosis International
https://www.readbyqxmd.com/read/29449960/physician-initiated-clinical-study-of-limb-ulcers-treated-with-a-functional-peptide-sr-0379-from-discovery-to-a-randomized-double-blind-placebo-controlled-trial
#11
Hironori Nakagami, Ken Sugimoto, Takahiro Ishikawa, Taku Fujimoto, Toshifumi Yamaoka, Misa Hayashi, Eiji Kiyohara, Hiroshi Ando, Yuta Terabe, Yoichi Takami, Koichi Yamamoto, Yasushi Takeya, Minoru Takemoto, Masaya Koshizaka, Tamotsu Ebihara, Ayumi Nakamura, Mitsunori Nishikawa, Xiang Jing Yao, Hideki Hanaoka, Ichiro Katayama, Koutaro Yokote, Hiromi Rakugi
SR-0379 is a functional peptide that has wound healing effect with anti-microbial action, making it an ideal drug to prevent infection. To evaluate the safety, efficacy, and pharmacokinetics of SR-0379 for the treatment of leg ulcers, a physician-initiated, phase I/IIa, first-in-patient clinical study was designed. A multi-center, double-blind, randomized clinical study was conducted from October 2015 to September 2016. The inclusion criteria for leg ulcers were (1) diabetes or critical limb ischemia and (2) wound size <6 cm in diameter...
2018: NPJ Aging and Mechanisms of Disease
https://www.readbyqxmd.com/read/29449791/influence-of-acute-consumption-of-caffeine-vs-placebo-over-bia-derived-measurements-of-body-composition-a-randomized-double-blind-crossover-design
#12
Cassie M Williamson, Brett S Nickerson, Emily E Bechke, Cherilyn N McLester, Brian M Kliszczewicz
Background: Bioelectrical impedance analysis (BIA) is often used to estimate total body water (TBW), intracellular body water (ICW), extracellular body water (ECW), and body fat percentage (BF%). A common restriction for BIA analysis is abstinence from caffeine 12-h prior to testing. However, research has yet to determine whether the consumption of caffeine influences BIA testing results. The purpose of this study was to determine if the consumption of caffeine influences BIA-derived BF% and body water values in habitual caffeine users...
2018: Journal of the International Society of Sports Nutrition
https://www.readbyqxmd.com/read/29448833/efficacy-and-safety-of-luseogliflozin-added-to-insulin-therapy-in-japanese-patients-with-type-2-diabetes-a-multicenter-52-week-clinical-study-with-a-16-week-double-blind-period-and-a-36-week-open-label-period
#13
Yutaka Seino, Takashi Sasaki, Atsushi Fukatsu, Hisae Imazeki, Hidekazu Ochiai, Soichi Sakai
OBJECTIVE: To evaluate the efficacy and safety of luseogliflozin in Japanese patients with type 2 diabetes (T2D) inadequately controlled with insulin monotherapy. METHODS: This 52-week multicenter study entailed a 16-week, double-blind period followed by a 36-week, open-label period. Patients were randomized to receive either luseogliflozin 2.5 mg (n = 159) or placebo (n = 74) during the double-blind period. All patients who entered the open-label period received luseogliflozin...
February 15, 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29447788/the-influence-of-febuxostat-on-coronary-artery-endothelial-dysfunction-in-patients-with-coronary-artery-disease-a-phase-4-randomized-placebo-controlled-double-blind-crossover-trial
#14
Allison G Hays, Micaela Iantorno, Michael Schär, Shenghan Lai, Matthew Czarny, Elayne Breton, Robert N Palmer, Andrew Whelton, Robert G Weiss, Gary Gerstenblith
BACKGROUND: The xanthine oxidase (XO) system is a significant source of vascular oxidative stress, which is believed to impair endothelial function, an important contributor to atherosclerotic disease. We tested whether febuxostat, a potent XO inhibitor, improves coronary endothelial function (CEF) in patients with stable coronary artery disease (CAD) in a single-center, randomized, placebo-controlled, double-blind crossover trial. METHODS: CEF was measured using noninvasive magnetic resonance imaging (MRI) assessment of changes in 30 patients with stable CAD and baseline impaired CEF...
March 2018: American Heart Journal
https://www.readbyqxmd.com/read/29447076/a-double-blind-placebo-controlled-randomised-clinical-study-of-the-effect-of-pork-collagen-peptide-supplementation-on-atherosclerosis-in-healthy-older-individuals
#15
Michiya Igase, Katsuhiko Kohara, Yoko Okada, Masayuki Ochi, Keiji Igase, Naoki Inoue, Tatsuhiko Kutsuna, Hiromasa Miura, Yasumasa Ohyagi
We examined whether baPWV could be affected by pork collagen peptide (CP) ingestion. Seventy subjects were randomized into two groups (2.5 g/day CP and 2.5 g/day placebo). A significant reduction in baPWV was observed in the CP group compared to the placebo group. This study demonstrated that pork CP may contribute to the prevention of atherosclerosis in elderly.
February 15, 2018: Bioscience, Biotechnology, and Biochemistry
https://www.readbyqxmd.com/read/29446654/hypouricaemic-effects-of-yogurt-containing-lactobacillus-gasseri-pa-3-in-patients-with-hyperuricaemia-and-or-gout-a-randomized-double-blind-placebo-controlled-study
#16
Hisashi Yamanaka, Atsuo Taniguchi, Hiroshi Tsuboi, Hiroshi Kano, Yukio Asami
PURPOSE: Lactobacillus gasseri PA-3 (PA-3) has been previously shown to decrease serum uric acid (SUA) levels in subjects with increased SUA. In this study, we investigated whether PA-3 is also capable of decreasing SUA levels in patients with hyperuricaemia and/or gout. METHODS: Twenty-five patients with hyperuricaemia and/or gout completed this study. Urate-lowering drugs were discontinued for 12 weeks (week -4 to week 8). After flushing of urate-lowering drugs for 4 weeks (week 0), patients were randomized equally to receive diets containing yogurt beverages with PA-3 or without PA-3 for a duration of 8 weeks (week 8)...
February 15, 2018: Modern Rheumatology
https://www.readbyqxmd.com/read/29445520/efficacy-and-safety-of-azilsartan-medoxomil-an-angiotensin-receptor-blocker-in-korean-patients-with-essential-hypertension
#17
Attila Juhasz, Jingtao Wu, Michie Hisada, Tomoka Tsukada, Myung Ho Jeong
Background: This was a phase 3, randomized, double-blind, placebo-controlled study. Methods: Adult Korean patients with essential hypertension and a baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg were randomized to 6-week treatment with placebo ( n = 65), azilsartan medoxomil (AZL-M) 40 mg ( n = 132), or AZL-M 80 mg ( n = 131). The primary endpoint was the change from baseline to week 6 in trough scSBP. Results: The least-squares mean (standard error) change from baseline in trough scSBP in the placebo, AZL-M 40-mg, and 80-mg groups at week 6 were - 8...
2018: Clinical Hypertension
https://www.readbyqxmd.com/read/29445329/the-effects-of-transcranial-direct-current-stimulation-tdcs-on-psychomotor-and-visual-perception-functions-related-to-driving-skills
#18
Alexander Brunnauer, Felix M Segmiller, Sabine Löschner, Valérie Grun, Frank Padberg, Ulrich Palm
Objective: It could be demonstrated that anodal transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPFC) enhances accuracy in working memory tasks and reaction time in healthy adults and thus may also have an influence on complex everyday tasks like driving a car. However, no studies have applied tDCS to psychomotor skills related to a standard driving test so far. Methods: 10 female and 5 male healthy adults without any medication and history of psychiatric or neurological illness were randomly assigned to two groups receiving active and sham stimulation in a double blind, cross-over study design...
2018: Frontiers in Behavioral Neuroscience
https://www.readbyqxmd.com/read/29444778/efficacy-and-safety-of-the-shexiang-baoxin-pill-for-the-treatment-of-coronary-artery-disease-not-amenable-to-revascularisation-study-protocol-for-a-randomised-placebo-controlled-double-blinded-trial
#19
Pan-Pan Tian, Jun Li, Jian Gao, Ying Li
INTRODUCTION: Coronary artery disease (CAD) not amenable to revascularisation indicates that the coronary arteries have severe diffuse lesions or calcifications, or that CAD is complicated with severe multiple-organ disease. Currently, Western medicines available for the treatment of CAD not amenable to revascularisation are limited. Shexiang Baoxin Pill (SBP), a type of Chinese patent medicine, has been widely used to treat CAD in China for many years. Previous studies have shown that long-term administration of SBP (1-2 pills three times daily, for at least 6 months) for treatment of CAD is effective and safe, with a significant, long-term effect...
February 14, 2018: BMJ Open
https://www.readbyqxmd.com/read/29444699/the-hyster-study-the-effect-of-intracervically-administered-terlipressin-versus-placebo-on-the-number-of-gaseous-emboli-and-fluid-intravasation-during-hysteroscopic-surgery-study-protocol-for-a-randomized-controlled-clinical-trial
#20
Lucilla E Overdijk, Bart M P Rademaker, Paul J M van Kesteren, Peter de Haan, Robert K Riezebos, Oscar C H Haude
BACKGROUND: Transcervical resection of myoma or endometrium is a safe, hysteroscopic, minimally invasive procedure. However, intravasation of distension fluid is a common phenomenon during these procedures. In a previous study we observed venous gas emboli in almost every patient. The severity of hysteroscopic-derived embolization has been shown to be correlated to the amount of intravasation. In addition, paradoxical gas embolism, which is potentially dangerous, was observed in several patients...
February 14, 2018: Trials
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