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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/29779046/sex-differences-in-the-long-term-prognostic-value-of-13-n-ammonia-myocardial-perfusion-positron-emission-tomography
#5
Catherine Gebhard, Michael Fiechter, Bernhard A Herzog, Christine Lohmann, Susan Bengs, Valerie Treyer, Michael Messerli, Dominik C Benz, Andreas A Giannopoulos, Christoph Gräni, Aju P Pazhenkottil, Ronny R Buechel, Philipp A Kaufmann
PURPOSE: Evidence to date on the unique female determinants of cardiovascular risk is inadequate. Positron Emission Tomography (PET) is considered to have the highest accuracy for the assessment of myocardial perfusion in patients with suspected coronary artery disease (CAD), but its long-term prognostic accuracy in women has not been established. METHODS: A total of 619 consecutive patients (138 women, mean age 60.0 ± 11.8 years) underwent clinically indicated 13 N-ammonia PET at our institution and were followed up (median 5...
May 19, 2018: European Journal of Nuclear Medicine and Molecular Imaging
https://www.readbyqxmd.com/read/29779028/dietary-changes-involving-bifidobacterium-longum-and-other-nutrients-delays-chronic-kidney-disease-progression
#6
Yuko Iwashita, Masaki Ohya, Mitsuru Yashiro, Tomohiro Sonou, Kazuki Kawakami, Yuri Nakashima, Takuro Yano, Yu Iwashita, Toru Mima, Shigeo Negi, Kaoru Kubo, Koichi Tomoda, Toshitaka Odamaki, Takashi Shigematsu
BACKGROUND: Recent studies suggest that prebiotic and/or probiotic treatments ameliorate kidney function in humans and animals by improving the gut environment. However, the gut microbiota and kidney disease interactions remain to be determined. This study investigated whether synbiotics modulate the gut microbiota and ameliorate kidney function using a rat model of chronic kidney disease (CKD). As uremic toxins are associated with CKD-related mineral and bone disorder, the secondary aim was to evaluate the relationship between synbiotics and secondary hyperparathyroidism (SHPT)...
May 18, 2018: American Journal of Nephrology
https://www.readbyqxmd.com/read/29779024/a-randomized-clinical-trial-of-metformin-to-treat-autosomal-dominant-polycystic-kidney-disease
#7
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
#8
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/29778738/risk-adapted-therapy-for-young-children-with-medulloblastoma-sjyc07-therapeutic-and-molecular-outcomes-from-a-multicentre-phase-2-trial
#9
Giles W Robinson, Vasilisa A Rudneva, Ivo Buchhalter, Catherine A Billups, Sebastian M Waszak, Kyle S Smith, Daniel C Bowers, Anne Bendel, Paul G Fisher, Sonia Partap, John R Crawford, Tim Hassall, Daniel J Indelicato, Frederick Boop, Paul Klimo, Noah D Sabin, Zoltan Patay, Thomas E Merchant, Clinton F Stewart, Brent A Orr, Jan O Korbel, David T W Jones, Tanvi Sharma, Peter Lichter, Marcel Kool, Andrey Korshunov, Stefan M Pfister, Richard J Gilbertson, Robert P Sanders, Arzu Onar-Thomas, David W Ellison, Amar Gajjar, Paul A Northcott
BACKGROUND: Young children with medulloblastoma have a poor overall survival compared with older children, due to use of radiation-sparing therapy in young children. Radiotherapy is omitted or reduced in these young patients to spare them from debilitating long-term side-effects. We aimed to estimate event-free survival and define the molecular characteristics associated with progression-free survival in young patients with medulloblastoma using a risk-stratified treatment strategy designed to defer, reduce, or delay radiation exposure...
May 16, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29778726/incidence-determinants-and-outcomes-of-left-and-right-radial-access-use-in-patients-undergoing-percutaneous-coronary-intervention-in-the-united-kingdom-a-national-perspective-using-the-bcis-dataset
#10
Muhammad Rashid, Claire Lawson, Jessica Potts, Evangelos Kontopantelis, Chun Shing Kwok, Olivier F Bertrand, Ahmad Shoaib, Peter Ludman, Tim Kinnaird, Mark de Belder, James Nolan, Mamas Mamas
OBJECTIVES: The authors sought to determine the relationships between left radial access (LRA) or right radial access (RRA) and clinical outcomes using the British Cardiovascular Intervention Society (BCIS) database. BACKGROUND: LRA has been shown to offer procedural advantages over RRA in percutaneous coronary intervention (PCI) although few data exist from a national perspective around its use and association with clinical outcomes. METHODS: The authors investigated the relationship between use of LRA or RRA and clinical outcomes of in-hospital or 30-day mortality, major adverse cardiovascular events, in-hospital stroke, and major bleeding complications in patients undergoing PCI between 2007 and 2014...
May 11, 2018: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/29778690/vasopressin-during-laparoscopic-myomectomy-does-it-really-extend-its-limits-%C3%A2-%C3%A2-%C3%A2
#11
Athanasios Protopapas, George Giannoulis, Ioannis Chatzipapas, Stavros Athanasiou, Themistoklis Grigoriadis, Nikolaos Kathopoulis, Dimitrios Vlachos, Dimitrios Zaharakis, Dimitrios Loutradis
STUDY OBJECTIVE: Τo investigate whether the use of vasopressin played an important role in the safe expansion of the indications of laparoscopic myomectomy in our practice. DESIGN: A retrospective comparison of prospectively collected data (Canadian Task Force Classification II2) SETTING: A Gynecologic Endoscopy Unit in a Tertiary University Hospital PATIENTS: 150 cases undergoing laparoscopic myomectomy (-ies), of whom 50 treated without the use of any vasoconstrictive agent (group1), and 100 treated with intraoperative intramyometrial injection of dilute vasopressin (20 IU/100mL normal saline) (group 2)...
May 17, 2018: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/29778606/avatrombopag-before-procedures-reduces-need-for-platelet-transfusion-in-patients-with-chronic-liver-disease-and-thrombocytopenia
#12
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
#13
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/29778502/hematopoietic-stem-cell-transplantation-for-progressive-combined-immunodeficiency-and-lymphoproliferation-in-activated-pi3k-delta-syndrome-type-1
#14
Tsubasa Okano, Kohsuke Imai, Yuki Tsujita, Noriko Mitsuiki, Kenichi Yoshida, Chikako Kamae, Kenichi Honma, Kanako Mitsui-Sekinaka, Yujin Sekinaka, Tamaki Kato, Katsuyuki Hanabusa, Eri Endo, Takehiro Takashima, Haruka Hiroki, Tzu-Wen Yeh, Keisuke Tanaka, Masakazu Nagahori, Ikuya Tsuge, Yuki Bando, Fuminori Iwasaki, Yoshiaki Shikama, Masami Inoue, Tomiko Kimoto, Naohiko Moriguchi, Yuki Yuza, Takashi Kaneko, Kyoko Suzuki, Tomoyo Matsubara, Yoshihiro Maruo, Tomoaki Kunitsu, Tomoko Waragai, Hideki Sano, Yuko Hashimoto, Kazuhiro Tasaki, Osamu Suzuki, Toshihiko Shirakawa, Motohiro Kato, Toru Uchiyama, Masataka Ishimura, Tetsuzo Tauchi, Hiroshi Yagasaki, Shiann-Tarng Jou, Hsin-Hui Yu, Hirokazu Kanegane, Sven Kracker, Anne Durandy, Daiei Kojima, Hideki Muramatsu, Taizo Wada, Yuzaburo Inoue, Hidetoshi Takada, Seiji Kojima, Seishi Ogawa, Osamu Ohara, Shigeaki Nonoyama, Tomohiro Morio
BACKGROUND: Activated phosphatidylinositol-3-OH kinase-delta (PI3Kδ) syndrome type 1 (APDS1) is a recently described primary immunodeficiency syndrome characterized by recurrent respiratory infections, lymphoid hyperplasia, and herpesviridae infections due to germline gain-of-function mutations of PIK3CD. Hematopoietic stem cell transplantation (HSCT) may be considered to ameliorate progressive immunodeficiency and associated malignancy, but appropriate indications, method, and outcomes of HSCT for APDS1 remain undefined...
May 17, 2018: Journal of Allergy and Clinical Immunology
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
#15
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/29778342/one-year-outcomes-associated-with-a-novel-stented-bovine-pericardial-aortic-bioprosthesis
#16
Joseph F Sabik, Vivek Rao, Rüdiger Lange, A Pieter Kappetein, Francois Dagenais, Louis Labrousse, Vinayak Bapat, Michael Moront, Neil J Weissman, Himanshu J Patel, Michael J Reardon, Federico M Asch, Cathy Zeng, Robert J M Klautz
OBJECTIVES: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve. METHODS: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval...
April 18, 2018: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/29778325/tranexamic-acid-for-hyperacute-primary-intracerebral-haemorrhage-tich-2-an-international-randomised-placebo-controlled-phase-3-superiority-trial
#17
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/29778107/photorefractive-intrastromal-corneal-crosslinking-for-treatment-of-myopic-refractive-error-findings-from-12-month-prospective-study-using-an-epithelium-off-protocol
#18
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/29778090/massive-pericardial-effusion-without-cardiac-tamponade-due-to-subclinical-hypothyroidism-hashimoto-s-disease
#19
Panteleimon E Papakonstantinou, Nikolaos Gourniezakis, Christos Skiadas, Alexandros Patrianakos, Achilleas Gikas
CONTEXT: Hypothyroidism is a significant cause of pericardial effusion. However, large pericardial effusions due to hypothyroidism are extremely rare. Hormone replacement therapy is the cornerstone of treatment for hypothyroidism and regular follow-up of patients after initiation of the therapy is indicated. Herein, the case of a 70-year-old woman with a massive pericardial effusion due to Hashimoto's disease is presented. ISSUES: A 70-year-old female from a rural village on the island of Crete, Greece, was admitted to our hospital due to a urinary tract infection...
May 2018: Rural and Remote Health
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
#20
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
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