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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
#1
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/29451082/the-short-term-placebo-response-in-children-with-attention-deficit-hyperactivity-disorder-adhd
#2
Ayala Cohen, Moran Plonsky-Toder, Emanuel Tirosh
To assess short-term placebo response in 6- to 13-year-old children with ADHD, children who were administered a double-blind placebo-methylphenidate trial, 1 week each, were included in the analysis. Conners' parents and Teacher Rating scales, the Aggregate Neurobehavioral Student Health and Educational Review inventory, and the Matching Familiar Figure Test were employed. A reduction of 30% or more in one or more of the teachers report subscales was observed in 18.8% of the participants. Attention test performance resulted in 58% of children exhibiting reduction in error rates and 36...
January 1, 2018: Journal of Child Neurology
https://www.readbyqxmd.com/read/29451036/pharmaceutical-grade-chondroitin-sulfate-in-the-management-of-knee-osteoarthritis
#3
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/29450747/efficacy-of-bifidobacterium-breve-fermented-milk-in-maintaining-remission-of-ulcerative-colitis
#4
Katsuyoshi Matsuoka, Yukari Uemura, Takanori Kanai, Reiko Kunisaki, Yasuo Suzuki, Kaoru Yokoyama, Naoki Yoshimura, Toshifumi Hibi
BACKGROUND: Fermented milk products containing Bifidobacterium breve strain Yakult (BFM) may improve clinical status in ulcerative colitis (UC) patients. AIMS: To assess efficacy of BFM in maintaining remission in Japanese patients with quiescent UC. METHODS: This double-blind study (B-FLORA) enrolled 195 patients with quiescent UC, randomized to receive one pack of BFM fermented milk per day [Bifidobacterium breve strain Yakult (10 billion bacteria) and Lactobacillus acidophilus (1 billion bacteria)] (n = 98) or matching placebo (n = 97) for 48 weeks...
February 15, 2018: Digestive Diseases and Sciences
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
#5
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/29450728/winter-vitamin-d-3-supplementation-does-not-increase-muscle-strength-but-modulates-the-igf-axis-in-young-children
#6
Charlotte Mortensen, Christian Mølgaard, Hanne Hauger, Michael Kristensen, Camilla T Damsgaard
PURPOSE: To explore whether muscle strength, the insulin-like growth factor axis (IGF-axis), height, and body composition were associated with serum 25-hydroxyvitamin D [25(OH)D] and affected by winter vitamin D supplementation in healthy children, and furthermore to explore potential sex differences. METHODS: We performed a double-blind, placebo-controlled, dose-response winter trial at 55ºN. A total of 117 children aged 4-8 years were randomly assigned to either placebo, 10, or 20 µg/day of vitamin D 3 for 20 weeks...
February 15, 2018: European Journal of Nutrition
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
#7
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
#8
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
#9
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/29449506/whole-body-magnetic-resonance-imaging-in-axial-spondyloarthritis-reduction-of-sacroiliac-spinal-and-entheseal-inflammation-in-a-placebo-controlled-trial-of-adalimumab
#10
Simon Krabbe, Mikkel Østergaard, Iris Eshed, Inge J Sørensen, Bente Jensen, Jakob M Møller, Lone Balding, Ole R Madsen, Karsten Asmussen, Grith Eng, Niklas R Jørgensen, Susanne J Pedersen
OBJECTIVE: To investigate whether adalimumab (ADA) reduces whole-body (WB-) magnetic resonance imaging (MRI) indices for inflammation in the entheses, peripheral joints, sacroiliac joints, spine, and the entire body in patients with axial spondyloarthritis (axSpA). METHODS: An investigator-initiated, randomized, placebo-controlled, double-blinded 48-week followup trial included 49 patients with axSpA, who had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4...
February 15, 2018: Journal of Rheumatology
https://www.readbyqxmd.com/read/29448936/chitinase-3-like-1-is-a-biomarker-of-acute-kidney-injury-and-mortality-in-paediatric-severe-malaria
#11
Andrea L Conroy, Michael T Hawkes, Robyn Elphinstone, Robert O Opoka, Sophie Namasopo, Christopher Miller, Chandy C John, Kevin C Kain
BACKGROUND: Chitinase-3-like 1 (CHI3L1) is a glycoprotein elevated in paediatric severe malaria, and an emerging urinary biomarker of acute kidney injury (AKI). Based on the hypothesis that elevated CHI3L1 levels in malaria are associated with disease severity, the relationship between plasma CHI3L1 levels, AKI and mortality was investigated in Ugandan children enrolled in a clinical trial evaluating inhaled nitric oxide (iNO) as an adjunctive therapy for severe malaria. METHODS: Plasma CHI3L1 levels were measured daily for 4 days in children admitted to hospital with severe malaria and at day 14 follow up...
February 15, 2018: Malaria Journal
https://www.readbyqxmd.com/read/29448886/augmenting-treatment-efficiency-in-exposure-therapy-for-ptsd-a-randomized-double-blind-placebo-controlled-trial-of-yohimbine-hcl
#12
Peter W Tuerk, Bethany C Wangelin, Mark B Powers, Jasper A J Smits, Ron Acierno, Ursula S Myers, Scott P Orr, Edna B Foa, Mark B Hamner
The alpha-2 adrenergic receptor antagonist, yohimbine, can facilitate fear extinction in animals and humans. One potential mechanism is increased noradrenergic activity and associated arousal in the presence of conditioned stimuli. Accordingly, yohimbine might augment prolonged exposure (PE) therapy for posttraumatic stress disorder (PTSD), where heightened exposure-oriented arousal is a theorized driver and empirical predictor of treatment success. A double-blind placebo-controlled randomized trial (NCT 01031979) piloted yohimbine augmentation in 26 males with combat-related PTSD...
February 15, 2018: Cognitive Behaviour Therapy
https://www.readbyqxmd.com/read/29448852/memantine-in-japanese-patients-with-moderate-to-severe-alzheimer-s-disease-meta-analysis-of-multiple-index-responder-analyses
#13
Kaoru Okuizumi, Teruyoshi Kamata, Daiju Matsui, Kengo Saito, Takuyuki Matsumoto, Yoshikazu Fukuchi
BACKGROUND: Responder analyses assessing clinical worsening have attempted to clarify clinically meaningful drug efficacy enhancements in patients with Alzheimer's disease (AD). RESEARCH DESIGN AND METHODS: This was a meta-analysis of two multicenter, randomized, double-blind, parallel-group, 24-week studies of 633 Japanese patients with moderate to severe AD receiving memantine 20 mg/day (n = 318) or placebo (n = 315). The clinical trial registration number is UMIN000026013...
February 16, 2018: Expert Opinion on Pharmacotherapy
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
#14
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
#15
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/29447427/vestibulo-ocular-reflex-gain-values-in-the-suppression-head-impulse-test-of-healthy-subjects
#16
Jorge Rey-Martinez, Izaskun Thomas-Arrizabalaga, Juan Manuel Espinosa-Sanchez, Angel Batuecas-Caletrio, Gabriel Trinidad-Ruiz, Eusebi Matiño-Soler, Nicolas Perez-Fernandez
OBJECTIVE: To assess whether there are differences in vestibulo-ocular reflex (VOR) gain for suppression head impulse (SHIMP) and head impulse (HIMP) video head impulse test paradigms, and if so, what are their causes. METHODS: Prospective multicenter observational double-blind nonrandomized clinical study was performed by collecting 80 healthy subjects from four reference hospitals. SHIMP data was postprocessed to eliminate impulses in which early SHIMP saccades were detected...
February 15, 2018: Laryngoscope
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
#17
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/29446851/non-commercial-versus-commercial-clinical-trials-a-retrospective-study-of-the-applications-submitted-to-a-research-ethics-committee
#18
Inmaculada Fuentes Camps, Alexis Rodríguez, Antonia Agustí
There are a lot of difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study some design characteristics, the clinical trial public register and the publication rate of non-commercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16...
February 15, 2018: British Journal of Clinical Pharmacology
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
#19
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/29446084/an-assessment-of-injection-site-reaction-and-injection-site-pain-of-1-month-and-3-month-long-acting-injectable-formulations-of-paliperidone-palmitate
#20
Jennifer Kern Sliwa, Adam Savitz, Isaac Nuamah, Maju Mathews, Srihari Gopal, Erica Elefant, Dean Najarian, Larry Alphs
PURPOSE: To evaluate injection site reactions and pain following paliperidone palmitate 1-month (PP1M) and 3-month (PP3M) administration using safety data of double-blind (DB), noninferiority study. METHODS: Patients (n = 1,429) with schizophrenia, treated with PP1M (50-150 mg-eq, 17-week open-label [OL] phase) were randomized to PP1M or PP3M in 48-week DB phase. FINDINGS: PP1M and PP3M injections were well tolerated. Incidence of induration, redness, and swelling were low in both phases (OL: 9-12%; DB: 7-13%), and were mostly mild in both groups...
February 14, 2018: Perspectives in Psychiatric Care
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