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https://www.readbyqxmd.com/read/28527421/a-phase-iii-randomized-multi-center-double-blind-placebo-controlled-study-of-safety-and-efficacy-of-lofexidine-for-relief-of-symptoms-in-individuals-undergoing-inpatient-opioid-withdrawal
#1
Charles W Gorodetzky, Sharon L Walsh, Peter R Martin, Andrew J Saxon, Kristen L Gullo, Kousick Biswas
BACKGROUND: Lofexidine is an alpha-2-adrenergic receptor agonist approved in the United Kingdom (UK) for the treatment of opioid withdrawal symptoms. Lofexidine has demonstrated better efficacy than placebo for reducing opioid withdrawal symptoms in patients undergoing opioid withdrawal with less reported hypotension than clonidine. METHODS: Designed as an FDA registration trial, this 8-day, randomized, double-blind, placebo-controlled, parallel-group study in 264 patients dependent on short-acting opioids evaluated the efficacy of lofexidine hydrochloride in reducing withdrawal symptoms in patients undergoing opioid withdrawal...
May 10, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28527204/levetiracetam-alters-oscillatory-connectivity-in-alzheimer-s-disease
#2
Christian S Musaeus, Mouhsin M Shafi, Emiliano Santarnecchi, Susan T Herman, Daniel Z Press
Seizures occur at a higher frequency in people with Alzheimer's disease (AD) but overt, clinically obvious events are infrequent. Evidence from animal models and studies in mild cognitive impairment suggest that subclinical epileptic discharges may play a role in the clinical and pathophysiological manifestations of AD. In this feasibility study, the neurophysiological and cognitive effects of acute administration of levetiracetam (LEV) are measured in patients with mild AD to test whether it could have a therapeutic benefit...
May 17, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28526920/effects-of-semaglutide-on-beta-cell-function-and-glycaemic-control-in-participants-with-type-2-diabetes-a-randomised-double-blind-placebo-controlled-trial
#3
Christoph Kapitza, Kirsten Dahl, Jacob B Jacobsen, Mads B Axelsen, Anne Flint
AIMS/HYPOTHESIS: Semaglutide is a glucagon-like peptide-1 analogue in development for the treatment of type 2 diabetes. Its effects on first- and second-phase insulin secretion and other measures of beta cell function and glycaemic control were assessed. METHODS: In this single-centre, double-blind, placebo-controlled, parallel-group trial, conducted at the Profil Institut für Stoffwechselforschung, Germany, 75 adult (aged 18-64 years) participants with type 2 diabetes (eligibility: HbA1c of 6...
May 19, 2017: Diabetologia
https://www.readbyqxmd.com/read/28526386/the-effects-of-folic-acid-and-pyridoxine-supplementation-on-characteristics-of-migraine-attacks-in-migraine-patients-with-aura-a-double-blind-randomized-placebo-controlled-clinical-trial
#4
Gholamreza Askari, Morteza Nasiri, Hassan Mozaffari-Khosravi, Masod Rezaie, Mahdieh Bagheri-Bidakhavidi, Omid Sadeghi
OBJECTIVE: The aim of this study was to assess the effects of folic acid alone and in combination with pyridoxine on characteristics of migraine attacks in adult migraine patients with aura. METHODS: This double-blind, randomized placebo-controlled, clinical trial was conducted on 95 migraine patients with aura (age range 18-65 y) in Isfahan, Islamic Republic of Iran, in 2014. Patients were randomly allocated to receive folic acid (5 mg/d) plus pyridoxine (80 mg/d) or folic acid alone (5 mg/d) or placebo (lactose) for 3 mo...
June 2017: Nutrition
https://www.readbyqxmd.com/read/28526381/medium-term-effect-of-sublingual-l-glutathione-supplementation-on-flow-mediated-dilation-in-subjects-with-cardiovascular-risk-factors
#5
Jonica Campolo, Stefano Bernardi, Lorena Cozzi, Silvia Rocchiccioli, Cinzia Dellanoce, Antonella Cecchettini, Annamaria Tonini, Marina Parolini, Benedetta De Chiara, Gianpaolo Micheloni, Gualtiero Pelosi, Claudio Passino, Cristina Giannattasio, Oberdan Parodi
OBJECTIVE: Supplementation of glutathione (GSH) may be a positive strategy to improve the endogenous antioxidant defense required to counteract many acute and chronic diseases. However, the efficacy of GSH treatment seems to be closely related to type of administration, degree of absorption, and increase of its concentrations. The aim of this study was to test a new sublingual formulation of L-GSH, which enters directly the systemic circulation, to assess its efficacy on circulating biochemical markers of hepatic metabolism, lipid profile, and oxidative stress and on peripheral vascular function compared with placebo in patients with cardiovascular risk factors (CVRF)...
June 2017: Nutrition
https://www.readbyqxmd.com/read/28526374/impact-of-high-dose-vitamin-d3-on-plasma-free-25-hydroxyvitamin-d-concentrations-and-antimicrobial-peptides-in-critically-ill-mechanically-ventilated-adults
#6
Jenny E Han, Jessica A Alvarez, Jennifer L Jones, Vin Tangpricha, Mona A Brown, Li Hao, Lou Ann S Brown, Greg S Martin, Thomas R Ziegler
OBJECTIVES: High-dose vitamin D3 increases plasma total 25-hydroxyvitamin D [25(OH)D] in critically ill, ventilated patients; however, to our knowledge, the effect on plasma levels of free (nonprotein-bound) 25(OH)D has not been investigated in critical illness. Moreover, the relationship of free 25(OH)D and the regulation of endogenous antimicrobial peptides (AMPs) remains unknown. The aims of this study were to determine in critically ill adults with respiratory failure the effect of previous high-dose regimens of vitamin D3 on free 25(OH)D concentrations, the relationship of free 25(OH)D with circulating cathelicidin (LL-37) and human beta-defensin-2 (hBD-2), and the associations between plasma levels of free 25(OH)D and these AMPs to alveolar macrophage phagocytosis function...
June 2017: Nutrition
https://www.readbyqxmd.com/read/28526233/keratinocyte-growth-factor-for-the-treatment-of-the-acute-respiratory-distress-syndrome-kare-a-randomised-double-blind-placebo-controlled-phase-2-trial
#7
Daniel F McAuley, Lj Mark Cross, Umar Hamid, Evie Gardner, J Stuart Elborn, Kathy M Cullen, Ahilanandan Dushianthan, Michael Pw Grocott, Michael A Matthay, Cecilia M O'Kane
BACKGROUND: Data from in-vitro, animal, and human lung injury models suggest that keratinocyte growth factor (KGF) might be beneficial in acute respiratory distress syndrome (ARDS). The objective of this trial was to investigate the effect of KGF in patients with ARDS. METHODS: We did a double-blind, allocation concealed, randomised, placebo-controlled phase 2 trial in two intensive care units in the UK, involving patients fulfilling the American-European Consensus Conference Definition of ARDS...
May 16, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28526048/men-s-and-women-s-response-to-treatment-and-perceptions-of-outcomes-in-a-randomized-controlled-trial-of-injectable-opioid-assisted-treatment-for-severe-opioid-use-disorder
#8
Heather Palis, Kirsten Marchand, Daphne Guh, Suzanne Brissette, Kurt Lock, Scott MacDonald, Scott Harrison, Aslam H Anis, Michael Krausz, David C Marsh, Martin T Schechter, Eugenia Oviedo-Joekes
BACKGROUND: To test whether there are gender differences in treatment outcomes among patients receiving injectable opioids for the treatment of long-term opioid-dependence. The study additionally explores whether men and women have different perceptions of treatment effectiveness. METHODS: This study is a secondary analysis from SALOME, a double-blind, phase III, randomized controlled trial testing the non-inferiorirty of injectable hydromorphone to injectable diacetylmorphine among 202 long-term street opioid injectors in Vancouver (Canada)...
May 19, 2017: Substance Abuse Treatment, Prevention, and Policy
https://www.readbyqxmd.com/read/28525984/study-protocol-evaluation-of-the-probiotic-lactobacillus-fermentum-cect5716-for-the-prevention-of-mastitis-in-breastfeeding-women-a-randomised-controlled-trial
#9
Diana M Bond, Jonathan M Morris, Natasha Nassar
BACKGROUND: Mastitis and accompanying pain have been associated with the cessation of breastfeeding. Mastitis is an inflammatory condition of the breast and may be a result of decreased immunity and a lowered resistance to infection. Mastitis affects up to one in five breastfeeding women with most episodes occurring in the first 6-8 weeks postpartum. Antibiotics are often used in the treatment of mastitis, but have not been popular or proven effective as a preventative agent. The WHO has highlighted significant concerns relating to adverse harms of antibiotic use with the production of antibiotic-resistant strains of disease organisms...
May 19, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28525632/effect-of-baseline-characteristics-on-the-pain-response-to-pregabalin-in-fibromyalgia-patients-with-comorbid-depression
#10
Stuart L Silverman, Miroslav Backonja, Lynne Pauer, Jaren Landen, Pritha Bhadra Brown, Joseph M Scavone, Richard Vissing, Andrew Clair
Objective. : To evaluate the effect of baseline characteristics on the treatment response to pregabalin in fibromyalgia (FM) patients with depression. Design. : Post hoc analysis from a randomized, double-blind, placebo-controlled, two-way crossover study of pregabalin (300 or 450 mg/day, twice daily). Subjects. : A total of 193 FM patients taking an antidepressant for comorbid depression. Methods. : The effect of patient baseline characteristics on the treatment response to pregabalin vs placebo was assessed for the primary efficacy end point (mean pain score on an 11-point numeric rating scale)...
May 19, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/28525569/comparative-effects-of-methylphenidate-modafinil-and-mdma-on-response-inhibition-neural-networks-in-healthy-subjects
#11
André Schmidt, Felix Müller, Patrick C Dolder, Yasmin Schmid, Davide Zanchi, Matthias E Liechti, Stefan Borgwardt
Background: Psychostimulants such as methylphenidate (MPH) and modafinil are increasingly used by healthy people for cognitive enhancement purposes, whereas the acute effect of 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) on cognitive functioning in healthy subjects remains unclear. This study directly compared the acute effects of MPH, modafinil and MDMA on the neural mechanisms underlying response inhibition in healthy subjects. Methods: Using a double-blind within-subject placebo-controlled cross-over design, MPH, modafinil and MDMA were administrated to 21 healthy subjects, while performing a Go/No-Go event-related functional magnetic resonance imaging task to assess brain activation during motor response inhibition...
May 19, 2017: International Journal of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28525543/fermentable-carbohydrates-fodmaps-exacerbate-functional-gastrointestinal-symptoms-in-patients-with-inflammatory-bowel-disease-a-randomised-double-blind-placebo-controlled-cross-over-re-challenge-trial
#12
Selina R Cox, Alexis C Prince, Clio E Myers, Peter M Irving, James O Lindsay, Miranda C Lomer, Kevin Whelan
Background and Aims: Preliminary evidence suggests fermentable carbohydrate restriction might ameliorate functional gastrointestinal symptoms (FGS) in quiescent inflammatory bowel disease (IBD). Our aim was to determine whether fermentable carbohydrates exacerbate FGS in quiescent IBD using a randomised, double-blinded, placebo-controlled, cross-over, re-challenge trial. Methods: Patients with quiescent IBD and FGS responsive to a low FODMAP diet were allocated to a series of 3-day fermentable carbohydrate challenges in random order (fructan, 12 g/d; galacto-oligosaccharides, GOS, 6 g/d; sorbitol, 6 g/d; and glucose placebo, 12 g/d), each separated by a standardised washout period...
May 19, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28525512/parecoxib-supplementation-to-morphine-analgesia-decreases-incidence-of-delirium-in-elderly-patients-after-hip-or-knee-replacement-surgery-a-randomized-controlled-trial
#13
Dong-Liang Mu, Da-Zhi Zhang, Dong-Xin Wang, Geng Wang, Chun-Jing Li, Zhao-Ting Meng, Ya-Wei Li, Chao Liu, Xue-Ying Li
BACKGROUND: Severe pain and high-dose opioids are both associated with increased risk of postoperative delirium. The authors investigated whether parecoxib-supplemented IV morphine analgesia could decrease the incidence of delirium in elderly patients after total hip or knee replacement surgery. METHODS: In a randomized, double-blind, 2-center trial, patients of 60 years or older who underwent elective total hip or knee replacement surgery were assigned in a 1:1 ratio to receive either parecoxib (40 mg at the end of surgery and then every 12 hours for 3 days) or placebo (normal saline)...
June 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28525389/biological-and-clinical-evidence-for-somatic-mutations-in-brca1-and-brca2-as-predictive-markers-for-olaparib-response-in-high-grade-serous-ovarian-cancers-in-the-maintenance-setting
#14
Brian A Dougherty, Zhongwu Lai, Darren R Hodgson, Maria C M Orr, Matthew Hawryluk, James Sun, Roman Yelensky, Stuart K Spencer, Jane D Robertson, Tony W Ho, Anitra Fielding, Jonathan A Ledermann, J Carl Barrett
To gain a better understanding of the role of somatic mutations in olaparib response, next-generation sequencing (NGS) of BRCA1 and BRCA2 was performed as part of a planned retrospective analysis of tumors from a randomized, double-blind, Phase II trial (Study 19; D0810C00019; NCT00753545) in 265 patients with platinum-sensitive high-grade serous ovarian cancer. BRCA1/2 loss-of-function mutations were found in 55% (114/209) of tumors, were mutually exclusive, and demonstrated high concordance with Sanger-sequenced germline mutations in matched blood samples, confirming the accuracy (97%) of tumor BRCA1/2 NGS testing...
May 4, 2017: Oncotarget
https://www.readbyqxmd.com/read/28525302/treatment-of-endometriosis-associated-pain-with-elagolix-an-oral-gnrh-antagonist
#15
Hugh S Taylor, Linda C Giudice, Bruce A Lessey, Mauricio S Abrao, Jan Kotarski, David F Archer, Michael P Diamond, Eric Surrey, Neil P Johnson, Nelson B Watts, J Chris Gallagher, James A Simon, Bruce Carr, W Paul Dmowski, Nicholas Leyland, Jean P Rowan, W Rachel Duan, Juki Ng, Brittany Schwefel, James W Thomas, Rita I Jain, Kristof Chwalisz
Background Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. Methods We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain...
May 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28524639/high-dose-intravenous-steroid-pulse-therapy-in-ocular-involvement-of-behcet-s-disease-a-pilot-double-blind-control-study
#16
Mastaneh Mohammadi, Farhad Shahram, Hormoz Shams, Massoomeh Akhlaghi, Farimah Ashofteh, Fereydoun Davatchi
AIM: To evaluate the efficacy of intravenous high-dose pulses of methylprednisolone (IVPM) for treatment of ocular involvement in Behcet's disease (BD). METHOD: In a double-blind control study, we randomized BD patients with posterior uveitis (PU) and/or retinal vasculitis (RV) into two groups. They received either IVPM (1000 mg methylprednisolone) or placebo for 3 consecutive days. Both groups received combination therapy with IV cyclophosphamide, azathioprine and prednisolone for 6 months...
May 19, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/28524457/cyclization-of-motor-cortex-stimulation-for-neuropathic-pain-a-prospective-randomized-blinded-trial
#17
Zurab Ivanishvili, Anujan Poologaindran, Christopher R Honey
OBJECTIVES: Programming guidelines for motor cortex stimulation (MCS) in neuropathic pain requires further investigation. After optimizing voltage as a percentage of motor threshold, we evaluated the effect of cyclizing time of stimulation on pain relief for chronic neuropathic pain. METHODS: Six patients were enrolled into this trial. In a prospective, randomized, double-blinded manner, patients were programmed to receive stimulation 100, 83.3, 66.7, or 50% of the time in 30-min intervals...
May 19, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/28523988/myofascial-techniques-have-no-additional-beneficial-effects-to-a-standard-physical-therapy-programme-for-upper-limb-pain-after-breast-cancer-surgery-a-randomized-controlled-trial
#18
An De Groef, Marijke Van Kampen, Nele Vervloesem, Sophie De Geyter, Marie-Rose Christiaens, Patrick Neven, Lore Vos, Tessa De Vrieze, Inge Geraerts, Nele Devoogdt
OBJECTIVE: To investigate the effects of myofascial techniques, in addition to a standard physical therapy programme for upper limb pain shortly after breast cancer surgery. DESIGN: Double-blinded (patient and assessor) randomized controlled trial with two groups. SETTING: University Hospitals Leuven, Belgium Patients: A total of 147 patients with unilateral axillary clearance for breast cancer. INTERVENTION: All participants received a standard physical therapy programme starting immediately after surgery for four months...
May 1, 2017: Clinical Rehabilitation
https://www.readbyqxmd.com/read/28523945/prevention-of-postmenopausal-osteoporosis-in-chinese-women-a-5-year-double-blind-randomized-parallel-placebo-controlled-study
#19
S Y Ran, Q Yu, Y Chen, S Q Lin
OBJECTIVES: To observe the effectiveness and safety of menopause-related hormone therapy (MHT) to prevent bone loss in Chinese women during the menopausal transition and early menopause, as well as to evaluate the effects of 5-year MHT on overall health to add Level I evidence for the prevention of osteoporosis using MHT. DESIGN: This clinical study was a prospective, double-blind, randomized, parallel placebo-controlled study. Chinese women in the menopausal transition and early menopause were randomly allocated to the MHT group or the placebo group...
May 19, 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28523393/flavored-anesthetic-masks-for-inhalational-induction-in-children
#20
Aakriti Gupta, Preethy Joseph Mathew, Neerja Bhardwaj
OBJECTIVES: To evaluate the clinical efficacy of masking the odor of inhalational agents using fruit flavors on the anxiety behavior and compliance of children for inhalational induction. METHODS: A prospective randomized double blind, placebo controlled study was conducted on 60 unpremedicated children in the age group of 4-12 y. Thirty children received anesthetic masks smeared with a flavor of child's choice while the other 30 children were induced using masks without flavor...
May 19, 2017: Indian Journal of Pediatrics
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