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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/29779201/clinical-acceptability-of-trimetazidine-modified-release-80-mg-once-daily-versus-trimetazidine-modified-release-35-mg-twice-daily-in-stable-angina-pectoris
#2
Yuri M Pozdnyakov
INTRODUCTION: Trimetazidine (TMZ) is an anti-ischemic metabolic agent that has been shown to be efficacious in angina treatment, both in monotherapy and in combination. A new formulation of TMZ modified-release (MR) 80 mg was developed, which is to be taken once daily (od), instead of twice daily (bid) for the currently available TMZ MR 35 mg, with the aim of simplifying the medication regimen. METHODS: The present study was an international, multicenter, randomized, double-blind, parallel-group phase III study with a 12-week treatment period...
May 19, 2018: Cardiology and Therapy
https://www.readbyqxmd.com/read/29779195/efficacy-and-safety-of-alirocumab-in-individuals-with-diabetes-mellitus-pooled-analyses-from-five-placebo-controlled-phase-3-studies
#3
Henry N Ginsberg, Michel Farnier, Jennifer G Robinson, Christopher P Cannon, Naveed Sattar, Marie T Baccara-Dinet, Alexia Letierce, Maja Bujas-Bobanovic, Michael J Louie, Helen M Colhoun
INTRODUCTION: Diabetes mellitus (DM) carries an elevated risk for cardiovascular disease. Here, we assessed alirocumab efficacy and safety in people with/without DM from five placebo-controlled phase 3 studies. METHODS: Data from up to 78 weeks were analyzed in individuals on maximally tolerated background statin. In three studies, alirocumab 75 mg every 2 weeks (Q2W) was increased to 150 mg Q2W at week 12 if week 8 low-density lipoprotein cholesterol (LDL-C) was ≥ 70 mg/dL; two studies used alirocumab 150 mg Q2W throughout...
May 19, 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29779086/retrospective-study-of-nivolumab-for-patients-with-recurrent-high-grade-gliomas
#4
Megan Mantica, Ashley Pritchard, Frank Lieberman, Jan Drappatz
INTRODUCTION: Patients with recurrent high-grade gliomas (HGG) have limited treatment options. HGG utilize the PD-1 pathway to evade immune responses. Checkpoint inhibitors have demonstrated safety and clinical activity in patients with recurrent glioblastoma. We explored the efficacy of nivolumab in recurrent HGG with a primary objective of progression free survival (PFS) and overall survival (OS). METHODS: We retrospectively analyzed HGG patients treated with nivolumab in our institution...
May 19, 2018: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/29779024/a-randomized-clinical-trial-of-metformin-to-treat-autosomal-dominant-polycystic-kidney-disease
#5
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/29778846/efficacy-and-tolerability-of-treatment-with-lacosamide-postmarketing-experience-from-the-middle-east-region
#6
Maher Arabi, Taoufik Alsaadi, Wassim Nasreddine, Jasem Al-Hashel, Maya Dirani, Ahmad Beydoun
PURPOSE: Lacosamide (LCM) was recently introduced in the Middle East. The aim of this study was to evaluate the safety, tolerability, and efficacy of LCM in patients with focal onset seizures and determine if our results are comparable with those derived from Western countries. METHODS: This is a retrospective analysis from two medical centers on consecutive patients diagnosed as having focal onset seizures and treated with add-on LCM. The primary efficacy variables were the 50% responder and seizure-free rates, and the secondary outcome variables included the percentages of patients who achieved seizure remission during the last 6-month follow-up period and the percentages of discontinuation due to lack of efficacy or tolerability...
May 17, 2018: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/29778606/avatrombopag-before-procedures-reduces-need-for-platelet-transfusion-in-patients-with-chronic-liver-disease-and-thrombocytopenia
#7
Norah Terrault, Yi-Cheng Chen, Namiki Izumi, Zeid Kayali, Paul Mitrut, Won Young Tak, Lee F Allen, Tarek Hassanein
BACKGROUND & AIMS: Patients with thrombocytopenia and chronic liver disease (CLD) may require platelet transfusions before scheduled procedures to decrease risk of bleeding. We performed 2 randomized, placebo-controlled, phase 3 trials in patients with thrombocytopenia and CLD undergoing scheduled procedures to evaluate the safety and efficacy of avatrombopag in increasing platelet counts in this patient population METHODS: In the ADAPT-1 and ADAPT-2 studies, adults with thrombocytopenia and CLD (n=231 and n= 204, respectively) were in 1 of 2 cohorts according to their baseline platelet count (below 40x109 /L or 40-50x109 /L) and within each cohort randomized (2:1) to 5 daily doses of avatrombopag (60 mg if baseline platelet count below 40x109 /L or 40 mg if 40-50x109 /L) or placebo...
May 17, 2018: Gastroenterology
https://www.readbyqxmd.com/read/29778515/safety-and-immunogenicity-of-fractional-dose-intradermal-injection-of-two-quadrivalent-conjugated-meningococcal-vaccines
#8
Emile F F Jonker, Mariëtte B van Ravenhorst, Guy A M Berbers, Leo G Visser
BACKGROUND: Vaccination with conjugated meningococcal vaccines is the best way to prevent invasive meningococcal disease. Changes in serogroup epidemiology have led to the inclusion of quadrivalent vaccines in the national immunization programs of several countries, but vaccines are frequently in short supply. Intradermal administration has the potential to increase vaccine availability through dose reduction, without sacrificing efficacy. It has never before been investigated for glycoconjugate meningococcal vaccines...
May 16, 2018: Vaccine
https://www.readbyqxmd.com/read/29778368/oral-dydrogesterone-for-luteal-phase-support-in-fresh-in-vitro-fertilization-cycles-a-new-standard
#9
REVIEW
Georg Griesinger, Christophe Blockeel, Herman Tournaye
Oral dydrogesterone has been used for luteal phase support on an empirical basis since the early days of in vitro fertilization (IVF) treatment. Systematic comparisons of oral dydrogesterone with vaginal progesterone, so far considered to be the standard of care, started to appear in the middle 2000s. Recently, a large, randomized, double-blind, double-dummy phase III trial on the use of daily 30 mg oral dydrogesterone versus daily 600 mg micronized vaginal progesterone for LPS in IVF was published. This company-sponsored trial confirmed the efficacy findings from previous independent researchers and firmly established the noninferiority of daily 30 mg oral dydrogesterone for luteal phase support...
May 2018: Fertility and Sterility
https://www.readbyqxmd.com/read/29778364/prevention-of-cardiovascular-events-in-asian-patients-with-ischaemic-stroke-at-high-risk-of-cerebral-haemorrhage-picasso-a-multicentre-randomised-controlled-trial
#10
Bum Joon Kim, Eun-Jae Lee, Sun U Kwon, Jong-Ho Park, Yong-Jae Kim, Keun-Sik Hong, Lawrence K S Wong, Sungwook Yu, Yang-Ha Hwang, Ji Sung Lee, Juneyoung Lee, Joung-Ho Rha, Sung Hyuk Heo, Sung Hwan Ahn, Woo-Keun Seo, Jong-Moo Park, Ju-Hun Lee, Jee-Hyun Kwon, Sung-Il Sohn, Jin-Man Jung, Jose C Navarro, Dong-Wha Kang
BACKGROUND: The optimal treatment for patients with ischaemic stroke with a high risk of cerebral haemorrhage is unclear. We assessed the efficacy and safety of cilostazol versus aspirin, with and without probucol, in these patients. METHODS: In this randomised, controlled, 2 × 2 factorial trial, we enrolled patients with ischaemic stroke with a history of or imaging findings of intracerebral haemorrhage or two or more microbleeds from 67 centres in three Asian countries...
June 2018: Lancet Neurology
https://www.readbyqxmd.com/read/29778347/management-of-diabetic-trigger-finger
#11
REVIEW
Alexander S Kuczmarski, Andrew P Harris, Joseph A Gil, Arnold-Peter C Weiss
Diabetics have a much greater prevalence of trigger finger than nondiabetics and are more likely to have severe symptoms. Diabetic trigger finger may be more accurately described on a spectrum of diabetic hand pathology alongside carpal tunnel syndrome and cheiroarthropathy. Recent publications have called into question the current treatment algorithm for diabetic trigger finger. Although some evidence supports the use of corticosteroid injections, a recent cost analysis reported that immediate surgical release of the A1 pulley in the clinic is the most cost-effective management of diabetic trigger finger...
May 16, 2018: Journal of Hand Surgery
https://www.readbyqxmd.com/read/29778107/photorefractive-intrastromal-corneal-crosslinking-for-treatment-of-myopic-refractive-error-findings-from-12-month-prospective-study-using-an-epithelium-off-protocol
#12
Matthias Elling, Inga Kersten-Gomez, H Burkhard Dick
PURPOSE: To assess the long-term effectiveness and safety of photorefractive intrastromal corneal crosslinking (CXL) in patients with low myopia. SETTING: Ruhr University Eye Hospital, Bochum, Germany. DESIGN: Prospective case series. METHODS: Healthy eyes with myopia were treated with photorefractive intrastromal CXL using the Mosaic System. Riboflavin 0.1% solution (VibeX Rapid) was topically administered, followed by 365 nm ultraviolet-A (30 mW/cm2 ) irradiance...
April 2018: Journal of Cataract and Refractive Surgery
https://www.readbyqxmd.com/read/29777975/geriatric-analysis-from-prodige-20-randomized-phase-ii-trial-evaluating-bevacizumab-chemotherapy-versus-chemotherapy-alone-in-older-patients-with-untreated-metastatic-colorectal-cancer
#13
T Aparicio, O Bouché, E Francois, F Retornaz, E Barbier, J Taieb, S Kirscher, P-L Etienne, R Faroux, F Khemissa Akouz, F El Hajbi, C Locher, Y Rinaldi, T Lecomte, S Lavau-Denes, M Baconnier, A Oden-Gangloff, D Genet, L Bedenne, E Paillaud
BACKGROUND: Older patients have frailty characteristics that impair the transposition of treatment results found in younger patients. Predictive factors are needed to help with treatment choices for older patients. The PRODIGE 20 study is a randomized phase II study that evaluated chemotherapy associated with bevacizumab (BEV) or not (CT) in patients aged 75 years or older. PATIENTS AND METHODS: Patients underwent a geriatric assessment at randomization and at each evaluation...
May 16, 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29777878/pulmonary-delivery-of-polyplexes-for-combined-pai-1-gene-silencing-and-cxcr4-inhibition-to-treat-lung-fibrosis
#14
B S Ling Ding, B S Chenfei Zhu, M S Fei Yu, M S Pengkai Wu, M S Gang Chen, B S Aftab Ullah, Kaikai Wang, Minjie Sun, Jing Li, David Oupický
This report describes the development of polyplexes based on CXCR4-inhibiting poly(ethylenimine) derivative (PEI-C) for pulmonary delivery of siRNA to silence plasminogen activator inhibitor-1 (siPAI-1) as a new combination treatment of pulmonary fibrosis (PF). Safety and delivery efficacy of the PEI-C/siPAI-1 polyplexes was investigated in vitro in primary lung fibroblasts isolated from mice with bleomycin-induced PF. Biodistribution analysis following intratracheal administration of fluorescently labeled polyplexes showed prolonged retention in the lungs...
May 16, 2018: Nanomedicine: Nanotechnology, Biology, and Medicine
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
#15
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/29777840/negative-pressure-wound-therapy-to-promote-fixation-and-remodeling-of-omental-flap-in-patients-with-revascularized-limbs-a-case-series
#16
Nicla Settembre, Mario D'oria, Charbel Saba, Zakariyae Bouziane, Sergueï Malikov
We present our experience with five patients with CLTI treated with distal revascularization and omental flap coverage. We decided to investigate the efficacy and safety of NPWT (negative-pressure wound therapy) in promoting the fixation and remodeling of the omental flap as there is some evidence in the literature about the optimization of results for skin graft and dermal substitutes. Surgical revascularization was always the first procedure attempted; wound coverage was realized 3-5 days after the primary procedure (omental free-flap in three patients and omental flow-through flap in two patients)...
May 16, 2018: Annals of Vascular Surgery
https://www.readbyqxmd.com/read/29777823/updated-efficacy-analysis-including-secondary-population-results-for-oak-a-randomized-phase-iii-study-of-atezolizumab-vs-docetaxel-in-patients-with-previously-treated-advanced-non-small-cell-lung-cancer
#17
L Fehrenbacher, J von Pawel, K Park, A Rittmeyer, D R Gandara, S Ponce Aix, J-Y Han, S M Gadgeel, T Hida, D L Cortinovis, M Cobo, D M Kowalski, F De Marinis, M Gandhi, B Danner, C Matheny, M Kowanetz, P He, F Felizzi, H Patel, A Sandler, M Ballinger, F Barlesi
INTRODUCTION: The efficacy and safety of atezolizumab vs docetaxel as second- or third-line treatment in patients with advanced non-small cell lung cancer in the primary (n=850; ITT850) and secondary (n=1225; ITT1225) efficacy populations of the randomized phase III OAK study at an updated data cutoff were assessed. METHODS: Patients received atezolizumab 1200mg or docetaxel 75mg/m2 intravenously every 3 weeks until loss of clinical benefit or disease progression, respectively...
May 16, 2018: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/29777781/screen-related-parenting-practices-in-low-income-mexican-american-families
#18
Darcy A Thompson, Sarah J Schmiege, Susan L Johnson, Elizabeth A Vandewater, Richard E Boles, Ruth E Zambrana, Jerusha Lev, Jeanne M Tschann
OBJECTIVES: To (1) examine whether the Information, Motivation, and Behavioral Skills Model predicts maternal screen-related parenting practices and (2) evaluate the relationship of American Academy of Pediatrics(AAP)-recommended parenting practices with child television (TV) use behaviors. METHODS: In this cross-sectional study, 312 Spanish- and/or English-speaking female primary caregivers of Mexican descent with a child 3-5 years of age were recruited from safety-net pediatric clinics...
May 16, 2018: Academic Pediatrics
https://www.readbyqxmd.com/read/29777520/relationship-of-eating-patterns-and-metabolic-parameters-and-teneligliptin-treatment-interim-results-from-post-marketing-surveillance-in-japanese-type-2-diabetes-patients
#19
Takashi Kadowaki, Masakazu Haneda, Hiroshi Ito, Kazuyo Sasaki, Sonoe Hiraide, Miyuki Matsukawa, Makoto Ueno
INTRODUCTION: Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyperglycemia after all three daily meals. This interim analysis of data from the large-scale post-marketing surveillance of teneligliptin (RUBY) in Japan examined eating patterns and their relationship with metabolic parameters and diabetic complications...
May 17, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29777441/mucosal-ablation-in-patients-with-barrett-s-esophagus-fry-or-freeze
#20
REVIEW
Kavel Visrodia, Liam Zakko, Kenneth K Wang
The management of Barrett's esophagus and early esophageal adenocarcinoma has shifted away from esophagectomy and toward endoscopic techniques, including endoscopic resection and ablative therapies. The most commonly used ablative therapies are radiofrequency ablation and cryotherapy. Radiofrequency ablation has risen to the top of the management algorithm due to its favorable safety profile and established track record of efficacy in patients with dysplastic Barrett's. Cryotherapy offers early promise as an alternatively safe and effective ablative modality...
May 17, 2018: Digestive Diseases and Sciences
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