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https://www.readbyqxmd.com/read/28535410/effect-of-enzyme-inhibition-on-perampanel-pharmacokinetics-why-study-design-matters
#1
Barry E Gidal, Rama Maganti, Antonio Laurenza, Haichen Yang, David A Verbel, Edgar Schuck, Jim Ferry
OBJECTIVES: Perampanel, a selective, noncompetitive AMPA receptor antagonist, is indicated as adjunctive therapy for the treatment of partial seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy aged 12years and older. In vitro studies and Phase I trials indicate that perampanel is metabolized almost exclusively by CYP3A, with an elimination half-life (t1/2) averaging approximately 105h. Understanding of pharmacokinetic (PK) interactions-enzyme inhibition or induction-and anticipating their occurrence are important for management of patients with epilepsy...
April 26, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28535237/effect-of-intravenous-ferric-carboxymaltose-on-hemoglobin-response-among-patients-with-acute-isovolemic-anemia-following-gastrectomy-the-fairy-randomized-clinical-trial
#2
Young-Woo Kim, Jae-Moon Bae, Young-Kyu Park, Han-Kwang Yang, Wansik Yu, Jeong Hwan Yook, Sung Hoon Noh, Mira Han, Keun Won Ryu, Tae Sung Sohn, Hyuk-Joon Lee, Oh Kyoung Kwon, Seung Yeob Ryu, Jun-Ho Lee, Sung Kim, Hong Man Yoon, Bang Wool Eom, Min-Gew Choi, Beom Su Kim, Oh Jeong, Yun-Suhk Suh, Moon-Won Yoo, In Seob Lee, Mi Ran Jung, Ji Yeong An, Hyoung-Il Kim, Youngsook Kim, Hannah Yang, Byung-Ho Nam
Importance: Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. Objective: To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. Design, Setting, and Participants: The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea...
May 23, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28535181/everolimus-with-paclitaxel-and-carboplatin-as-first-line-treatment-for-metastatic-large-cell-neuroendocrine-lung-carcinoma-a-multicenter-phase-ii-trial
#3
P Christopoulos, W Engel-Riedel, C Grohé, C Kropf-Sanchen, J von Pawel, S Gütz, J Kollmeier, W Eberhardt, D Ukena, V Baum, I Nimmrich, C Sieder, P A Schnabel, M Serke, M Thomas
Background: Large cell neuroendocrine carcinoma of the lung (LCNEC) is a rare disease with poor prognosis and limited treatment options. Neuroendocrine tumors frequently show overactivation of the mTOR pathway. Based on the good activity of the mTOR inhibitor everolimus in different types of neuroendocrine tumors and the results of a previous phase I trial we evaluated the efficacy and safety of everolimus in combination with carboplatin and paclitaxel as upfront treatment for patients with advanced LCNEC...
May 23, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28534645/the-mitochondria-targeting-peptide-elamipretide-diminishes-circulating-htra2-in-st-segment-elevation-myocardial-infarction
#4
Marcus Hortmann, Samuel Robinson, Moritz Mohr, Maximillian Mauler, Daniela Stallmann, Jochen Reinöhl, Daniel Duerschmied, Karlheinz Peter, James Carr, C Michael Gibson, Christoph Bode, Ingo Ahrens
BACKGROUND: The extent of myocardial damage in patients with ST-segment elevation myocardial infarction (STEMI) depends on both the time to reperfusion as well as injury induced by ischaemia-reperfusion resulting in a cascade of cellular and humoral reactions. As a consequence of ischaemia-reperfusion in the heart, the high-temperature requirement serine peptidase 2 (HtrA2) is translocated from the mitochondria to the cytosol, whereupon it induces protease activity-dependent apoptosis mediated via caspases...
May 1, 2017: European Heart Journal. Acute Cardiovascular Care
https://www.readbyqxmd.com/read/28534381/evaluation-of-complementary-and-alternative-medicine-trials-registered-in-clinicaltrials-gov-database
#5
Omer Dizdar, Emre Bilgin, Serkan Akin, Saadettin Kilickap, Mutlu Hayran
PURPOSE: Complementary and alternative medicine (CAM) products are increasingly used because they are perceived as natural, relatively low-cost and probably effective therapies for various diseases including cancer. We aimed to determine the quantity and major characteristics of recent herbal/alternative medicine trials registered in clinicaltrials. gov in patients with cancer. METHODS: "Cancer AND (herbal OR complementary OR alternative)" key words were used to query clinicaltrials...
March 2017: Journal of B.U.ON.: Official Journal of the Balkan Union of Oncology
https://www.readbyqxmd.com/read/28533474/weekly-low-dose-versus-three-weekly-high-dose-cisplatin-for-concurrent-chemoradiation-in-locoregionally-advanced-non-nasopharyngeal-head-and-neck-cancer-a-systematic-review-and-meta-analysis-of-aggregate-data
#6
Petr Szturz, Kristien Wouters, Naomi Kiyota, Makoto Tahara, Kumar Prabhash, Vanita Noronha, Ana Castro, Lisa Licitra, David Adelstein, Jan B Vermorken
BACKGROUND: Three-weekly high-dose cisplatin (100 mg/m(2)) is considered the standard systemic regimen given concurrently with postoperative or definitive radiotherapy in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, due to unsatisfactory patient tolerance, various weekly low-dose schedules have been increasingly used in clinical practice. The aim of this meta-analysis was to compare the efficacy, safety, and compliance between these two approaches...
May 22, 2017: Oncologist
https://www.readbyqxmd.com/read/28533226/igf1r-protein-expression-is-not-associated-with-differential-benefit-to-concurrent-trastuzumab-in-early-stage-her2-breast-cancer-from-the-north-central-cancer-treatment-group-alliance-adjuvant-trastuzumab-trial-n9831
#7
Monica M Reinholz, Beiyun Chen, Amylou C Dueck, Kathleen Tenner, Karla Ballman, Darren Riehle, Robert B Jenkins, Xochiquetzal J Geiger, Ann E McCullough, Edith A Perez
Background: Preclinical evidence indicates that increased insulin-like growth factor receptor-1 (IGF1R) signaling interferes with the action of trastuzumab suggesting a possible mechanism of trastuzumab resistance. Thus, we evaluated IGF1R prevalence, relationship with demographic data, and association with disease-free survival (DFS) of patients randomized to chemotherapy alone (Arm A) or chemotherapy with sequential (Arm B) or concurrent trastuzumab (Arm C) in the prospective phase III HER2(+) adjuvant N9831 trial...
May 22, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28533209/rationale-and-design-of-a-clinical-trial-to-evaluate-the-safety-and-efficacy-of-intracoronary-infusion-of-allogeneic-human-cardiac-stem-cells-in-patients-with-acute-myocardial-infarction-and-left-ventricular-dysfunction-the-randomized-multicenter-double-blind
#8
Ricardo Sanz-Ruiz, Ana Casado Plasencia, Luis R Borlado, María Eugenia Fernández-Santos, Reem Al-Daccak, Piet Claus, Itziar Palacios, Rafael Sádaba, Dominique Charron, Jan Bogaert, Miguel Mulet, Raquel Yotti, Inmaculada Gilaberte, Antonio Bernad, Javier Bermejo, Stefan Janssens, Francisco Fernández-Avilés
Rationale: Stem cell therapy has increased the therapeutic armamentarium in the fight against ischemic heart disease and heart failure (HF). The administration of exogenous stem cells has been investigated in patients suffering an acute myocardial infarction (AMI) with the final aim of salvaging jeopardized myocardium and preventing left ventricular adverse remodeling and functional deterioration. However, phase I and II clinical trials with autologous and "first-generation" stem cells have yielded inconsistent benefits and mixed results...
May 22, 2017: Circulation Research
https://www.readbyqxmd.com/read/28533054/reduced-schedules-of-4cmenb-vaccine-in-infants-and-catch-up-series-in-children-immunogenicity-and-safety-results-from-a-randomised-open-label-phase-3b-trial
#9
Federico Martinón-Torres, Marco Aurelio P Safadi, Alfonso Carmona Martinez, Pilar Infante Marquez, Juan Carlos Tejedor Torres, Lily Yin Weckx, Edson Duarte Moreira, Ilhem Mensi, Marco Calabresi, Daniela Toneatto
BACKGROUND: This study evaluated the immunogenicity and safety of a licensed meningococcal serogroup B vaccine (4CMenB) administered alone according to reduced schedules in infants or catch-up series in children. METHODS: In this open-label, multicentre, phase 3b study (NCT01339923), infants randomised 1:1:1 received 4CMenB: 2+1 doses at 3½-5-11months or 6-8-11months of age, 3+1 doses at ages 2½-3½-5-11months. Children aged 2-10years received 2 catch-up doses administered 2months apart...
May 19, 2017: Vaccine
https://www.readbyqxmd.com/read/28531888/right-trac%C3%A2-post-hospitalization-care-transitions-program-to-reduce-readmissions-for-hemodialysis-patients
#10
Rebecca L Wingard, Kathryn McDougall, Billie Axley, Andrew Howard, Cathleen O'Keefe, Nancy Armistead, Janet R Lynch, Sophia Rosen, Len Usvyat, Franklin W Maddux
BACKGROUND: Hemodialysis (HD) patients have high hospitalization rates. This nonrandomized trial tested the effect of a bundle of renal-specific "Right TraC™" strategies on 30-day all-cause readmission rates and, secondarily, 90-day readmissions and overall admissions among HD patients. METHODS: Twenty-six Fresenius clinics in West Virginia, Ohio, and Kentucky participated in the interventions. Eighteen matched clinics served as controls; intervention clinics also served as their own controls...
May 23, 2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28531881/first-in-man-dose-escalation-and-pharmacokinetic-study-of-cap7-1-a-novel-prodrug-of-etoposide-in-adults-with-refractory-solid-tumours
#11
U Keilholz, L Rohde, P Mehlitz, M Knoedler, A Schmittel, V Kümmerlen, K Klinghammer, P Treasure, M Lassus, G Steventon, M Machacek, N Utku
AIM: An open-label, phase I dose-escalation trial was performed in adult patients with various solid cancers to identify the maximum tolerated dose (MTD), to assess the safety, pharmacokinetic profile and anti-tumour activity of the new prodrug CAP7.1. The prodrug is converted to its active moiety etoposide via carboxylesterases in selective cells leading to a better tolerability and higher efficacy in therapeutic resistance cells and children with refractory neuroblastoma. PATIENTS AND METHODS: Eligible adult patients with advanced, refractory, solid malignancies received CAP7...
May 19, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28531305/impact-of-age-and-antibody-type-on-progression-from-single-to-multiple-autoantibodies-in-type-1-diabetes-relatives
#12
Emanuele Bosi, David C Boulware, Dorothy J Becker, Jane H Buckner, Susan Geyer, Peter A Gottlieb, Courtney Henderson, Amanda Kinderman, Jay M Sosenko, Andrea K Steck, Polly J Bingley
Context: Islet autoantibodies are markers of type 1 diabetes and an increase in number of autoantibodies detected during the preclinical phase is predictive of progression to overt disease. Objective: To refine the impact of age in relation to islet antibody type on the progression from single to multiple autoantibodies in relatives of people with type 1 diabetes. Research design and methods: We examined 994 relatives with normal glucose tolerance and positive for a single autoantibody, followed prospectively in the TrialNet Pathway to Prevention...
May 22, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28530513/a-cluster-randomized-trial-of-strategies-to-increase-uptake-amongst-young-women-invited-for-their-first-cervical-screen-the-strategic-trial
#13
H Kitchener, M Gittins, M Cruickshank, C Moseley, S Fletcher, R Albrow, A Gray, L Brabin, D Torgerson, E J Crosbie, A Sargent, C Roberts
Objectives To measure the feasibility and effectiveness of interventions to increase cervical screening uptake amongst young women. Methods A two-phase cluster randomized trial conducted in general practices in the NHS Cervical Screening Programme. In Phase 1, women in practices randomized to intervention due for their first invitation to cervical screening received a pre-invitation leaflet and, separately, access to online booking. In Phase 2, non-attenders at six months were randomized to one of: vaginal self-sample kits sent unrequested or offered; timed appointments; nurse navigator; or the choice between nurse navigator or self-sample kits...
January 1, 2017: Journal of Medical Screening
https://www.readbyqxmd.com/read/28530067/-stereotactic-ablative-body-radiation-sabr-a-new-therapeutic-option-for-treatment-of-stage-i-lung-cancer
#14
REVIEW
Sarit Appel, Zvi Symon
Stereotactic ablative radiotherapy (SABR) also known as stereotactic body radiation therapy (SBRT) offers a new therapeutic option for stage 1 lung cancer that cannot undergo surgery due to co-morbidities or patient refusal. This treatment evolved in the last decade thanks to technologic advancement of radiation therapy planning and delivery that allow real time imaging of the tumor and real time position correction before every treatment. Ultra high doses of radiation cause ablation of the target with very low collateral scatter dose to surrounding tissue...
November 2016: Harefuah
https://www.readbyqxmd.com/read/28529750/phase-i-study-of-weekly-palliative-chemotherapy-with-low-dose-third-line-paclitaxel-for-biliary-tract-cancer
#15
Hidehiro Tajima, Tetsuo Ohta, Hiroyuki Shinbashi, Atsushi Hirose, Mitsuyoshi Okazaki, Takahisa Yamaguchi, Yoshinao Ohbatake, Koichi Okamoto, Shinichi Nakanuma, Seisho Sakai, Jun Kinoshita, Isamu Makino, Keishi Nakamura, Hironori Hayashi, Katsunobu Oyama, Masafumi Inokuchi, Tomoharu Miyashita, Hiroyuki Takamura, Itasu Ninomiya, Sachio Fushida, Hiroyuki Nakamura
The prognosis of patients with unresectable and recurrent biliary tract cancer (BTC) is very poor. Although gemcitabine (GEM) plus cisplatin therapy is useful for unresectable cases, the median overall survival (OS) of the patients is <1 year, and third-line chemotherapy following failure of 5-fluorouracil (5-FU) and GEM plus cisplatin is currently unavailable. The clinical efficacy and basic effects of low-dose paclitaxel (PTX) therapy for patients with BTC was previously reported. We herein present the results of a phase I clinical trial of weekly low-dose PTX as third-line palliative chemotherapy...
May 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28529748/local-modulated-electro-hyperthermia-in-combination-with-traditional-chinese-medicine-vs-intraperitoneal-chemoinfusion-for-the-treatment-of-peritoneal-carcinomatosis-with-malignant-ascites-a-phase-ii-randomized-trial
#16
Clifford L K Pang, Xinting Zhang, Zhen Wang, Junwen Ou, Yimin Lu, Pengfei Chen, Changlin Zhao, Xiaopu Wang, Hongyu Zhang, Sergey V Roussakow
The purpose of this study was to develop a safe and non-toxic alternative to the conventional conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) by investigating the efficacy and safety of local modulated electro-hyperthermia (mEHT) combined with the traditional Chinese medicine (TCM) 'Shi Pi' herbal decoction, compared with standard intraperitoneal chemoinfusion (IPCI). A randomized, controlled, single-center, open-label clinical trial (phase II) with two parallel groups (allocation ratio, 1:1) was conducted to investigate the efficacy and safety of mEHT+TCM (study group, SG) vs...
May 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28529147/norursodeoxycholic-acid-improves-cholestasis-in-primary-sclerosing-cholangitis
#17
Peter Fickert, Gideon M Hirschfield, Gerald Denk, Hanns-Ulrich Marschall, Istvan Altorjay, Martti Färkkilä, Christoph Schramm, Ulrich Spengler, Roger Chapman, Annika Bergquist, Erik Schrumpf, Frederik Nevens, Palak Trivedi, Florian P Reiter, Istvan Tornai, Emina Halilbasic, Roland Greinwald, Markus Pröls, Michael P Manns, Michael Trauner
Primary sclerosing cholangitis (PSC) represents a devastating bile duct disease lacking effective medical therapy. 24-norursodeoxycholic acid (norUDCA) is a side chain-shortened C23 homologue of UDCA and has shown potent anti-cholestatic, anti-inflammatory and anti-fibrotic properties in a preclinical PSC mouse model. AIM: To evaluate the safety and efficacy of 3 doses of oral norUDCA (500mg/d, 1000mg/d or 1500 mg/d) compared with placebo in PSC in a RCT including 38centers from 12European countries...
May 18, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28527985/long-term-follow-up-and-impact-of-comorbidity-prior-to-allogeneic-hematopoietic-stem-cell-transplantation-in-patients-with-relapsed-or-refractory-aml-lessons-learned-from-the-prospective-bridge-trial-clofarabine-salvage-therapy-prior-to-allogeneic-transplantation
#18
Jan Moritz Middeke, Regina Herbst, Stefani Parmentier, Gesine Bug, Mathias Hänel, Gernot Stuhler, Kerstin Schäfer-Eckart, Wolf Rösler, Stefan Klein, Wolfgang Bethge, Ulrich Bitz, Bozena Büttner, Holger Knoth, Nael Alakel, Markus Schaich, Anke Morgner, Michael Kramer, Katja Sockel, Malte von Bonin, Friedrich Stölzel, Uwe Platzbecker, Christoph Röllig, Christian Thiede, Gerhard Ehninger, Martin Bornhäuser, Johannes Schetelig
In patients with relapsed or refractory (r/r) AML, allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is considered to be the only treatment providing long-term disease control. The BRIDGE trial studied the safety and efficacy of a clofarabine-based salvage therapy prior to HSCT in patients with r/r AML. Here, we report the long-term follow up of this Phase II, multi-center trial and exploratory analyses on the impact of comorbidity on outcome. Eighty-four patients with a median age of 61 years (range 40 - 75) were enrolled...
May 17, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28527926/initial-and-midterm-results-of-the-bolton-relay-thoracic-aortic-endovascular-pivotal-trial
#19
Mark A Farber, W Anthony Lee, Wilson Y Szeto, Jean M Panneton, Christopher J Kwolek
OBJECTIVE: To report the initial and midterm results of the Bolton Relay Thoracic Stent Graft for the endovascular treatment of thoracic aortic lesions [thoracic endovascular aortic repair (TEVAR)]. METHODS: The Bolton Relay Thoracic Aortic Endovascular Pivotal Trial was a prospective, nonrandomized, multicenter, U.S. Investigational Device Exemption study conducted at 27 U.S. investigational sites. One hundred twenty TEVAR subjects were treated with the Relay device between January 2007 and May 2010, with 13 patients enrolled during the continued access phase through September 2012...
June 2017: Journal of Vascular Surgery
https://www.readbyqxmd.com/read/28527704/anti-madcam-antibody-pf-00547659-for-ulcerative-colitis-turandot-a-phase-2-randomised-double-blind-placebo-controlled-trial
#20
Séverine Vermeire, William J Sandborn, Silvio Danese, Xavier Hébuterne, Bruce A Salzberg, Maria Klopocka, Dino Tarabar, Tomas Vanasek, Miloš Greguš, Paul A Hellstern, Joo Sung Kim, Miles P Sparrow, Kenneth J Gorelick, Michelle Hinz, Alaa Ahmad, Vivek Pradhan, Mina Hassan-Zahraee, Robert Clare, Fabio Cataldi, Walter Reinisch
BACKGROUND: PF-00547659 is a fully human monoclonal antibody that binds to human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) to selectively reduce lymphocyte homing to the intestinal tract. We aimed to assess the efficacy and safety of PF-00547659 in patients with moderate to severe ulcerative colitis. METHODS: This phase 2, randomised, double-blind, placebo-controlled clinical trial recruited patients aged 18-65 years from 105 centres in 21 countries, with a history (≥3 months) of active ulcerative colitis extending more than 15 cm beyond the anal verge (with a total Mayo score ≥6 and a Mayo endoscopic subscore ≥2) who had failed or were intolerant to at least one conventional therapy...
May 17, 2017: Lancet
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