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https://www.readbyqxmd.com/read/29779247/randomised-controlled-trials-define-shape-of-dose-response-for-pollinex-quattro-birch-allergoid-immunotherapy
#1
Margitta Worm, Tim Higenbottam, Oliver Pfaar, Ralph Mösges, Werner Aberer, Kulasiri Gunawardena, Dorothea Wessiepe, Denise Lee, Matthias F Kramer, Murray Skinner, Bev Lees, Stefan Zielen
BACKGROUND: The Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX® Quattro Plus 1.0 ml Birch 100%) is an effective, well-tolerated short course subcutaneous immunotherapy. We performed two phase II studies to determine its optimal cumulative dose. METHODS: The studies were conducted in Germany, Austria and Poland (EudraCT numbers: 2012-004336-28 PQBirch203 and 2015-000984-15 PQBirch204) using a wide range of cumulative doses. In both studies, subjects were administered 6 therapy injections weekly outside the pollen season...
May 19, 2018: Allergy
https://www.readbyqxmd.com/read/29779170/histological-improvement-of-non-alcoholic-steatohepatitis-with-a-prebiotic-a-pilot-clinical-trial
#2
Marc R Bomhof, Jill A Parnell, Hena R Ramay, Pam Crotty, Kevin P Rioux, Chris S Probert, Saumya Jayakumar, Maitreyi Raman, Raylene A Reimer
PURPOSE: In obesity and diabetes the liver is highly susceptible to abnormal uptake and storage of fat. In certain individuals hepatic steatosis predisposes to the development of non-alcoholic steatohepatitis (NASH), a disease marked by hepatic inflammation and fibrosis. Although the precise pathophysiology of NASH is unknown, it is believed that the gut microbiota-liver axis influences the development of this disease. With few treatment strategies available for NASH, exploration of gut microbiota-targeted interventions is warranted...
May 19, 2018: European Journal of Nutrition
https://www.readbyqxmd.com/read/29779024/a-randomized-clinical-trial-of-metformin-to-treat-autosomal-dominant-polycystic-kidney-disease
#3
Stephen L Seliger, Kaleab Z Abebe, Kenneth R Hallows, Dana C Miskulin, Ronald D Perrone, Terry Watnick, Kyongtae Tae Bae
BACKGROUND: Metformin inhibits cyclic AMP generation and activates AMP-activated protein kinase (AMPK), which inhibits the cystic fibrosis transmembrane conductance regulator and Mammalian Target of Rapamycin pathways. Together these effects may reduce cyst growth in autosomal dominant polycystic kidney disease (ADPKD). METHODS: A phase II, double-blinded randomized placebo-controlled trial of 26 months duration. Participants will include nondiabetic adults (n = 96) aged 18-60 years, with an estimated glomerular filtration rate (eGFR) ≥50 mL/min/1...
May 18, 2018: American Journal of Nephrology
https://www.readbyqxmd.com/read/29779020/acetaminophen-reduces-acute-and-persistent-incisional-pain-after-hysterectomy
#4
Onur Koyuncu, Sedat Hakimoglu, Mustafa Ugur, Cagla Akkurt, Selim Turhanoglu, Daniel Sessler, Alparslan Turan
OBJECTIVE: Acetaminophen is effective for acute surgical pain, but whether it reduces persistent incision pain remains unknown. We tested the primary hypothesis that patients given perioperative acetaminophen have less incisional pain three months after surgery. Our secondary hypotheses were that patients randomized to acetaminophen have less postoperative pain and analgesic consumption, and better functional recovery at three months. METHODS: 140 patients having abdominal hysterectomy were randomly assigned to: 1)intravenous acetaminophen (4 g/day for 72 postoperative hours); or, 2) saline placebo...
May 15, 2018: Annali Italiani di Chirurgia
https://www.readbyqxmd.com/read/29778325/tranexamic-acid-for-hyperacute-primary-intracerebral-haemorrhage-tich-2-an-international-randomised-placebo-controlled-phase-3-superiority-trial
#5
Nikola Sprigg, Katie Flaherty, Jason P Appleton, Rustam Al-Shahi Salman, Daniel Bereczki, Maia Beridze, Hanne Christensen, Alfonso Ciccone, Ronan Collins, Anna Czlonkowska, Robert A Dineen, Lelia Duley, Juan Jose Egea-Guerrero, Timothy J England, Kailash Krishnan, Ann Charlotte Laska, Zhe Kang Law, Serefnur Ozturk, Stuart J Pocock, Ian Roberts, Thompson G Robinson, Christine Roffe, David Seiffge, Polly Scutt, Jegan Thanabalan, David Werring, David Whynes, Philip M Bath
BACKGROUND: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. METHODS: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset...
May 15, 2018: Lancet
https://www.readbyqxmd.com/read/29778203/evaluation-of-the-immune-response-afforded-by-a-subunit-vaccine-candidate-against-bluetongue-virus-in-mice-and-sheep
#6
Darien Kheder Ali Mohamed, Junzheng Du, Shandian Gao, Zhancheng Tian, Guorui Zhang, Dexuan Huang, Rongsheng Du, Biao Kang, Guangyuan Liu, Jianxun Luo, Hong Yin
Bluetongue virus (BTV), a vector-borne pathogen, is the causative agent of bluetongue disease in ruminants. In view of the recent emergence of BTV in regions previously known to be free from the disease and/or specific serotypes or strains, optimization of the currently available vaccination strategies to control the spread of vector-borne bluetongue is crucial. The main objective of the current study was to develop a subunit vaccine candidate targeting BTV-16, a strain previously isolated in China from sheep with obvious clinical signs...
June 2018: Veterinary Microbiology
https://www.readbyqxmd.com/read/29778041/the-efficacy-of-vitamin-d-in-multiple-sclerosis-a-meta-analysis
#7
REVIEW
Chao Zheng, Liang He, Lingling Liu, Jie Zhu, Tao Jin
BACKGROUND: Multiple sclerosis (MS) is a chronic inflammatory demyelination disorder in the central nervous system (CNS) leading to a high level of neurological disability. The pathogenesis of MS remains largely unknown, which explains the lack of significant efficacy of therapy in MS. Vitamin D deficiency is widely considered to be an environmental risk factor for MS. Many studies investigating the therapeutic effects of vitamin D on MS have been applied. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of vitamin D in MS patients...
May 12, 2018: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/29777868/comparative-efficacy-and-safety-of-different-antiviral-agents-for-cytomegalovirus-prophylaxis-in-allogeneic-hematopoietic-cell-transplantation-a-systematic-review-and-meta-analysis
#8
Nico Gagelmann, Per Ljungman, Jan Styczynski, Nicolaus Kröger
Over the past 25 years, several randomized controlled trials have investigated the efficacy of different antiviral agents for cytomegalovirus (CMV) prophylaxis in allogeneic hematopoietic-cell transplantation. We performed a systematic literature review, conventional meta-analysis and network meta-analysis using a random-effects model and risk ratios (RR) with corresponding 95% confidence intervals (CI) as effect estimates. Fifteen randomized controlled trials were identified, including seven different antiviral agents: acyclovir, ganciclovir, maribavir, brincidofovir, letermovir, valacyclovir, and vaccine...
May 16, 2018: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/29777633/hypertrophic-effect-of-inhaled-beta-2-agonist-with-and-without-concurrent-exercise-training-a-randomized-controlled-trial
#9
Søren Jessen, Johan Onslev, Anders Lemminger, Vibeke Backer, Jens Bangsbo, Morten Hostrup
INTRODUCTION: Due to a high prevalence of asthma and exercise-induced bronchoconstriction in elite athletes, there is a high use of beta2 -adrenoceptor agonists (beta2 -agonists) in the athletic population. While anabolic in rodents, no study has been able to detect hypertrophy in humans after chronic beta2 -agonist inhalation. METHODS: We investigated if inhaled beta2 -agonist, terbutaline, alters body composition and metabolic rate with and without concurrent exercise training in healthy young men...
May 19, 2018: Scandinavian Journal of Medicine & Science in Sports
https://www.readbyqxmd.com/read/29777625/is-methotrexate-an-effective-and-safe-treatment-for-maintaining-hair-regrowth-in-people-with-alopecia-totalis-a-critically-appraised-topic
#10
R Browne, L Stewart, H C Williams
AIM: To assess the effects of methotrexate for maintaining hair regrowth in alopecia totalis. METHODS: We critically appraised the literature identified from searching PubMed, Ovid MEDLINE, Ovid Embase and Cochrane Central (October 2017), using the search terms ("alopecia areata" OR "alopecia totalis" OR "alopecia universalis") AND (methotrexate). RESULTS: Two prospective studies and 11 retrospective case series were included comprising 226 patients with alopecia varying from 30% hair loss to alopecia universalis at baseline...
May 19, 2018: British Journal of Dermatology
https://www.readbyqxmd.com/read/29777328/a-systematic-review-on-the-off-label-use-of-montelukast-in-atopic-dermatitis-treatment
#11
Weng Khong Chin, Shaun Wen Huey Lee
Background Atopic dermatitis (AD) is the most common form of eczema. As leukotriene mediators are involved in the inflammatory phase of atopic dermatitis, montelukast has been suggested as a possible therapy. Aim of the review To evaluate the safety and efficacy of montelukast off-label use for the treatment atopic dermatitis. Method A search was performed from database inception until March 2018 in six electronic databases for randomized-controlled-trials examining the use of montelukast for AD. Results Among 301 articles screened, 11 studies met the inclusion criteria and were included in the review...
May 18, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29777264/empagliflozin-reduces-cardiovascular-events-mortality-and-renal-events-in-participants-with-type-2-diabetes-after-coronary-artery-bypass-graft-surgery-subanalysis-of-the-empa-reg-outcome%C3%A2-randomised-trial
#12
Subodh Verma, C David Mazer, David Fitchett, Silvio E Inzucchi, Egon Pfarr, Jyothis T George, Bernard Zinman
AIMS/HYPOTHESIS: After coronary artery bypass graft (CABG) surgery in individuals with type 2 diabetes, there remains a considerable residual cardiovascular risk. In the EMPA-REG OUTCOME® trial in participants with type 2 diabetes and established cardiovascular disease, empagliflozin reduced the risk of cardiovascular death by 38%, all-cause mortality by 32%, hospitalisation for heart failure by 35% and incident or worsening nephropathy by 39% vs placebo when given in addition to standard of care...
May 19, 2018: Diabetologia
https://www.readbyqxmd.com/read/29777228/effects-of-clomiphene-citrate-on-male-obesity-associated-hypogonadism-a-randomized-double-blind-placebo-controlled-study
#13
Andressa Heimbecher Soares, Nidia Celeste Horie, Lucas Augusto Piccinin Chiang, Bruno Caramelli, Mariana Gomes Matheus, Alexandre Holthausen Campos, Luciana Cavalheiro Marti, Fernanda Agostini Rocha, Marcio C Mancini, Elaine Maria Frade Costa, Cintia Cercato
BACKGROUND: Obesity causes secondary hypogonadism (HG) in men. Standard testosterone (T) replacement therapy improves metabolic parameters but leads to infertility. OBJECTIVE: To evaluate clomiphene citrate (CC) treatment of adult men with male obesity-associated secondary hypogonadism (MOSH). DESIGN: Single-center, randomized, double-blind, placebo-controlled trial. PARTICIPANTS: Seventy-eight men aged 36.5 ± 7...
May 17, 2018: International Journal of Obesity: Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/29777003/impact-of-reference-target-region-selection-on-amyloid-pet-standard-uptake-value-ratios-in-the-phase-1b-prime-study-of-aducanumab
#14
Ping Chiao, Barry J Bedell, Brian Avants, Alex P Zijdenbos, Marilyn Grand'Maison, Paul O'Neill, John O'Gorman, Tianle Chen, Robert Koeppe
Standardized uptake value ratios (SUVRs) are commonly used to quantify tracer uptake in amyloid beta positron emission tomography (Aβ-PET). Here, we explore the impact of target and reference region of interest (ROI) selection on SUVR effect size using interventional data from the ongoing Phase Ib PRIME study (NCT01677572) of aducanumab (BIIB037) in patients with prodromal or mild Alzheimer's disease (AD). Methods: Florbetapir PET SUVR was calculated at baseline (screening) and Weeks 26 and 54 for patients randomized to placebo and each of four aducanumab doses (1, 3, 6, and 10 mg/kg), using whole cerebellum, cerebellar grey matter, cerebellar white matter, pons, and subcortical white matter as reference regions...
May 18, 2018: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/29776990/effect-of-2-psoriasis-treatments-on-vascular-inflammation-and-novel-inflammatory-cardiovascular-biomarkers-a-randomized-placebo-controlled-trial
#15
Nehal N Mehta, Daniel B Shin, Aditya A Joshi, Amit K Dey, April W Armstrong, Kristina Callis Duffin, Zelma Chiesa Fuxench, Charlotte L Harrington, Rebecca A Hubbard, Robert E Kalb, Alan Menter, Daniel J Rader, Muredach P Reilly, Eric L Simpson, Junko Takeshita, Drew A Torigian, Thomas J Werner, Andrea B Troxel, Stephen K Tyring, Suzette Baez Vanderbeek, Abby S Van Voorhees, Martin P Playford, Mark A Ahlman, Abass Alavi, Joel M Gelfand
BACKGROUND: Psoriasis is a chronic inflammatory disease associated with dyslipidemia, cardiovascular events, and mortality. We aimed to assess and compare the effect of treatment of moderate-to-severe psoriasis with adalimumab or phototherapy on vascular inflammation and cardiovascular biomarkers. METHODS AND RESULTS: Randomized, double-blind, trial of adalimumab, phototherapy, and placebo (1:1:1) for 12 weeks, with crossover to adalimumab for 52 weeks total. Outcomes included vascular inflammation by 18 F-fluorodeoxyglucose positron emission tomography/computed tomography and biomarkers of inflammation, insulin resistance, and lipoproteins...
June 2018: Circulation. Cardiovascular Imaging
https://www.readbyqxmd.com/read/29776960/effect-of-combined-treatment-with-folic-acid-vitamin-b-6-and-vitamin-b-12-on-plasma-biomarkers-of-inflammation-and-endothelial-dysfunction-in-women
#16
William G Christen, Nancy R Cook, Martin Van Denburgh, Elaine Zaharris, Christine M Albert, JoAnn E Manson
BACKGROUND: The aim of this study was to determine whether reducing plasma homocysteine concentrations with long-term, combined treatment with folic acid, vitamin B6 , and vitamin B12 alters plasma biomarkers of inflammation and endothelial dysfunction in women at increased risk of cardiovascular disease. METHODS AND RESULTS: We conducted a blood substudy of 300 treatment-adherent participants (150 in the active treatment group, 150 in the placebo group) in the WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), a randomized, double-blind, placebo-controlled trial testing a daily combination of folic acid (2...
May 18, 2018: Journal of the American Heart Association
https://www.readbyqxmd.com/read/29776349/randomised-controlled-trial-rct-of-cannabinoid-replacement-therapy-nabiximols-for-the-management-of-treatment-resistant-cannabis-dependent-patients-a-study-protocol
#17
Anjali K Bhardwaj, David J Allsop, Jan Copeland, Iain S McGregor, Adrian Dunlop, Marian Shanahan, Raimondo Bruno, Nghi Phung, Mark Montebello, Craig Sadler, Jessica Gugusheff, Melissa Jackson, Jennifer Luksza, Nicholas Lintzeris
BACKGROUND: The cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches. METHODS/DESIGN: A phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment...
May 18, 2018: BMC Psychiatry
https://www.readbyqxmd.com/read/29775960/strategies-to-decrease-oxidative-stress-biomarker-levels-in-human-medical-conditions-a-meta-analysis-on-8-iso-prostaglandin-f-2%C3%AE
#18
Thomas J van 't Erve
The widespread detection of elevated oxidative stress levels in many medical conditions has led to numerous efforts to design interventions to reduce its effects. Efforts have been wide-ranging, from dietary changes to administration of antioxidants, supplements, e.g., omega-3-fatty acids, and many medications. However, there is still no systemic assessment of the efficacy of treatments for oxidative stress reduction across a variety of medical conditions. The goal of this meta-analysis is, by combining multiple studies, to quantitate the change in the levels of the popular oxidative stress biomarker 8-iso-prostaglandin F2α (8-iso-PGF2α ) after a variety of treatment strategies in human populations...
May 9, 2018: Redox Biology
https://www.readbyqxmd.com/read/29775246/tramadol-hydrochloride-at-steady-state-lacks-clinically-relevant-qtc-interval-increases-in-healthy-adults
#19
Joseph Massarella, Jay Ariyawansa, Jaya Natarajan, Stephan Francke, Thomas Murtaugh, Byron DeLemos, Subusola Vaughan, Sergio Fonseca
We evaluated the effects of therapeutic and supratherapeutic doses of tramadol hydrochloride on the corrected QT (QTc) interval in healthy adults (aged 18-55 years) in a randomized, phase I, double-blind, placebo- and positive-controlled, multiple-dose, 4-way crossover study. Participants were randomized to receive 1 of 4 treatments (A-D), 1 each in 4 treatment periods (1-4), separated by a washout period (7-15 days). Treatment A comprised tramadol 400 mg (therapeutic dose) on days 1 through 3, tramadol 100 mg and moxifloxacin-matched placebo on day 4, and placebo on all 4 days...
May 18, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29774768/the-effects-of-boswellia-serrata-gum-resin-on-the-blood-glucose-and-lipid-profile-of-diabetic-patients-a-double-blind-randomized-placebo-controlled-clinical-trial
#20
Saeed Mehrzadi, Bahreh Tavakolifar, Hasan Fallah Huseini, Seyed Hamdollah Mosavat, Mojtaba Heydari
Regarding preclinical evidence for antidiabetic effects of Boswellia serrata, we evaluated antihyperglycemic and lipid-lowering effects of Boswellia serrata gum resin in type 2 diabetic patients. Fifty-six diabetic patients were randomly allocated to 2 groups to receive 250 mg of the Boswellia serrata gum resin or placebo twice daily for 8 weeks in addition to their routine antidiabetic treatments. Although there was a considerable reduction after the intervention in the field of fasting blood sugar, glycosylated hemoglobin, and triglyceride in the Boswellia serrata gum resin group, no significant difference was observed in all outcome measures between the 2 groups at the end of the study...
January 2018: Journal of evidence-based integrative medicine
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