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https://www.readbyqxmd.com/read/28549771/calcineurin-and-mtor-inhibitor-free-post-transplantation-cyclophosphamide-and-bortezomib-combination-for-graft-versus-host-disease-prevention-after-peripheral-blood-allogeneic-hematopoietic-stem-cell-transplantation-a-phase-i-ii-study
#1
A Samer Al-Homsi, Kelli Cole, Marlee Muilenburg, Austin Goodyke, Muneer Abidi, Ulrich Duffner, Stephanie Williams, Jessica Parker, Aly Abdel-Mageed
Graft-versus-host disease (GvHD) hampers the utility of allogeneic hematopoietic stem cell transplantation (AHSCT). The purpose of this study was to determine the feasibility, safety, and efficacy of a novel combination of post-transplantation cyclophosphamide (PTC) and bortezomib for the prevention of GvHD. Patients undergoing peripheral blood AHSCT for hematological malignancies following reduced-intensity conditioning with grafts from human leukocyte antigen (HLA)-matched related or unrelated donors were enrolled in a phase I-II clinical trial...
May 23, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28549676/exposure-response-relationship-of-regorafenib-efficacy-in-patients-with-hepatocellular-carcinoma
#2
Alexander Solms, Isabel Reinecke, Sabine Fiala-Buskies, Anne Keunecke, Henk-Jan Drenth, Jordi Bruix, Gerold Meinhardt, Adriaan Cleton, Bart Ploeger
PURPOSE: To explore the relationship between regorafenib exposure and efficacy in patients with hepatocellular carcinoma (HCC) who had disease progression during sorafenib treatment (RESORCE). METHODS: Exposure-response (ER) analyses for regorafenib were performed using data from a phase 3, randomized, placebo-controlled trial (RESORCE). Patients received 160mg regorafenib or placebo once daily (3weeks on/1week off in a 4-week cycle) with best supportive care until disease progression, death, or unacceptable toxicity...
May 23, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28549414/phase-i-ii-study-of-induction-chemotherapy-using-carboplatin-plus-irinotecan-and-sequential-thoracic-radiotherapy-trt-for-elderly-patients-with-limited-disease-small-cell-lung-cancer-ld-sclc-torg-0604
#3
Yuki Misumi, Hiroaki Okamoto, Jiichiro Sasaki, Noriyuki Masuda, Mari Ishii, Tsuneo Shimokawa, Yukio Hosomi, Yusuke Okuma, Makoto Nagamata, Takashi Ogura, Terufumi Kato, Masafumi Sata, Sakiko Otani, Akira Takakura, Koichi Minato, Yosuke Miura, Takuma Yokoyama, Saori Takata, Katsuhiko Naoki, Koshiro Watanabe
BACKGROUND: The role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated. METHODS: Patients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0-2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions)...
May 26, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28549402/indications-for-medical-compression-stockings-in-venous-and-lymphatic-disorders-an-evidence-based-consensus-statement
#4
Eberhard Rabe, Hugo Partsch, Juerg Hafner, Christopher Lattimer, Giovanni Mosti, Martino Neumann, Tomasz Urbanek, Monika Huebner, Sylvain Gaillard, Patrick Carpentier
Objective Medical compression stockings are a standard, non-invasive treatment option for all venous and lymphatic diseases. The aim of this consensus document is to provide up-to-date recommendations and evidence grading on the indications for treatment, based on evidence accumulated during the past decade, under the auspices of the International Compression Club. Methods A systematic literature review was conducted and, using PRISMA guidelines, 51 relevant publications were selected for an evidence-based analysis of an initial 2407 unrefined results...
January 1, 2017: Phlebology
https://www.readbyqxmd.com/read/28548305/development-and-validation-of-an-lc-ms-ms-method-to-quantify-lysergic-acid-diethylamide-lsd-iso-lsd-2-oxo-3-hydroxy-lsd-and-nor-lsd-and-identify-novel-metabolites-in-plasma-samples-in-a-controlled-clinical-trial
#5
Patrick C Dolder, Matthias E Liechti, Katharina M Rentsch
BACKGROUND: Lysergic acid diethylamide (LSD) is a widely used recreational drug. The aim of this study was to develop and validate a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for the quantification of LSD, iso-LSD, 2-oxo-3-hydroxy LSD (O-H-LSD), and nor-LSD in plasma samples from 24 healthy subjects after controlled administration of 100 μg LSD in a clinical trial. In addition, metabolites that have been recently described in in vitro studies, including lysergic acid monoethylamide (LAE), lysergic acid ethyl-2-hydroxyethylamide (LEO), 2-oxo-LSD, trioxylated-LSD, and 13/14-hydroxy-LSD, should be identified...
May 26, 2017: Journal of Clinical Laboratory Analysis
https://www.readbyqxmd.com/read/28545998/a-randomized-phase-ii-study-to-determine-the-effect-of-2-different-doses-of-aflibercept-in-patients-with-metastatic-renal-cell-carcinoma-ecog-acrin-e4805
#6
Roberto Pili, Opeyemi Jegede, Michael A Carducci, Judith Manola, David L Groteluschen, Leonard L Appleman, Glenn Liu, James C Shanks, Shaker R Dakhil, Janice Dutcher, Robert S DiPaola
BACKGROUND: Aflibercept is a recombinantly produced fusion protein that has potent anti-vascular endothelial growth factor (VEGF) activity. We tested whether aflibercept has clinical activity in clear-cell renal cell carcinoma (ccRCC). The recommended phase II dose was 4 mg/kg but several patients (pts) treated at 1 mg/kg showed prolonged progression-free survival. We therefore tested both doses in a parallel group randomized trial. PATIENTS AND METHODS: Eligible pts had histologically confirmed advanced or metastatic ccRCC and previous treatments included exposure to a VEGF receptor tyrosine kinase inhibitor...
April 26, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28545978/benralizumab-for-patients-with-mild-to-moderate-persistent-asthma-bise-a-randomised-double-blind-placebo-controlled-phase-3-trial
#7
Gary T Ferguson, J Mark FitzGerald, Eugene R Bleecker, Michel Laviolette, David Bernstein, Craig LaForce, Lyndon Mansfield, Peter Barker, Yanping Wu, Maria Jison, Mitchell Goldman
BACKGROUND: Benralizumab is a humanised, anti-interleukin 5 receptor α monoclonal antibody that directly and rapidly depletes eosinophils, reduces asthma exacerbations, and improves lung function for patients with severe eosinophilic asthma. The objective of this trial was to assess the safety and efficacy of benralizumab for patients with mild to moderate, persistent asthma. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients aged 18-75 years, weighing at least 40 kg, and with a postbronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of at least 12% at screening, from 52 clinical research centres in six countries...
May 22, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28544923/unfavorable-prognostic-role-of-tumor-infiltrating-lymphocytes-in-hormone-receptor-positive-her2-negative-metastatic-breast-cancer-treated-with-metronomic-chemotherapy
#8
Emilia Montagna, Andrea Vingiani, Patrick Maisonneuve, Giuseppe Cancello, Federica Contaldo, Giancarlo Pruneri, Marco Colleoni
BACKGROUND: High levels of tumor-infiltrating lymphocytes (TILs) in primary triple negative and HER2-positive breast cancer (BC) have been associated with an improved patients' outcome. The role of TILs in Luminal (hormone receptor positive and HER2 negative) tumors remains to be elucidated. Moreover, the association between TILs and prognosis in the metastatic setting is still unknown. PATIENTS AND METHODS: We evaluated the relationship between TILs and time to progression (TTP) in metastatic BC patients enrolled in a prospective phase II trial of metronomic chemotherapy, that used cyclophosphamide 50 mg daily, capecitabine 500 mg thrice daily and vinorelbine 40 mg orally three times a week (VEX combination)...
May 22, 2017: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28544422/assessment-of-clinically-relevant-bleeding-as-a-surrogate-outcome-for-major-bleeding-validation-by-meta-analysis-of-randomized-controlled-trials
#9
S Laporte, C Chapelle, L Bertoletti, E Ollier, P Zufferey, J-C Lega, A Merah, H Décousus, S Schulman, G Meyer, M Cucherat, P Mismetti
BACKGROUND: Clinically relevant bleeding (CRB), comprising major bleeding and clinically relevant non-major bleeding, has been used as a surrogate for major bleeding in most anticoagulant trials, but its validity for estimating compromise between thrombotic and bleeding events has never been assessed. METHODS: We systematically reviewed randomized phase III trials comparing new anticoagulants with standard of care for venous thromboembolism prevention following major orthopedic surgery, venous thromboembolism (VTE) treatment, or stroke and systemic embolism prevention in atrial fibrillation (AF), and reporting both major bleeding and CRB rates...
May 20, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28543541/human-schwann-cells-exhibit-long-term-cell-survival-are-not-tumorigenic-and-promote-repair-when-transplanted-into-the-contused-spinal-cord
#10
Johana Bastidas, Gagani Athauda, Gabriela De La Cruz, Wai-Man Chan, Roozbeh Golshani, Yerko Berrocal, Martha Henao, Anil Lalwani, Chikato Mannoji, Mazen Assi, P Anthony Otero, Aisha Khan, Alexander E Marcillo, Michael Norenberg, Allan D Levi, Patrick M Wood, James D Guest, W Dalton Dietrich, Mary Bartlett Bunge, Damien D Pearse
The transplantation of rodent Schwann cells (SCs) provides anatomical and functional restitution in a variety of spinal cord injury (SCI) models, supporting the recent translation of SCs to phase 1 clinical trials for human SCI. Whereas human (Hu)SCs have been examined experimentally in a complete SCI transection paradigm, to date the reported behavior of SCs when transplanted after a clinically relevant contusive SCI has been restricted to the use of rodent SCs. Here, in a xenotransplant, contusive SCI paradigm, the survival, biodistribution, proliferation and tumorgenicity as well as host responses to HuSCs, cultured according to a protocol analogous to that developed for clinical application, were investigated...
May 22, 2017: Glia
https://www.readbyqxmd.com/read/28543263/randomised-clinical-trial-mesalazine-versus-placebo-in-the-prevention-of-diverticulitis-recurrence
#11
W Kruis, V Kardalinos, T Eisenbach, M Lukas, T Vich, I Bunganic, J Pokrotnieks, J Derova, J Kondrackiene, R Safadi, D Tuculanu, Z Tulassay, J Banai, A Curtin, A E Dorofeyev, S F Zakko, N Ferreira, S Björck, M M Diez Alonso, J Mäkelä, N J Talley, K Dilger, R Greinwald, R Mohrbacher, R Spiller
BACKGROUND: Previous studies have reached conflicting conclusions regarding the efficacy of mesalazine in the prevention of recurrent diverticulitis. AIM: To investigate the efficacy and safety of mesalazine granules in the prevention of recurrence of diverticulitis after acute uncomplicated diverticulitis. METHODS: Two phase 3, randomised, placebo-controlled, double-blind multicentre trials (SAG-37 and SAG-51) investigated mesalazine granules in patients with prior episodes (<6 months) of uncomplicated left-sided diverticulitis...
May 23, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28541820/assessment-of-the-effects-of-2-methoxyethyl-antisense-oligonucleotides-on-platelet-count-in-cynomolgus-nonhuman-primates
#12
Scott P Henry, Padmakumar Narayanan, Lijiang Shen, Sanjay Bhanot, Husam S Younis, Sebastien A Burel
Decreases in platelet (PLT) counts observed in nonhuman primates (NHPs) given 2'-O-methoxyethyl modified antisense inhibitors (2'-MOE ASOs) have been reported, but the incidence and severity of the change vary considerably between sequences, studies, and animals. This article will broadly illustrate the spectrum of effects on PLT count in NHPs. From queries of an NHP safety database representing over 102 independent 2'-MOE ASOs, from 61 studies and >2200 NHPs, two patterns of PLT changes emerged. The first is a consistent and reproducible decrease in group mean values, observed with about 30% of the compounds, in which PLT count typically remains ≥150K cells/μL...
May 25, 2017: Nucleic Acid Therapeutics
https://www.readbyqxmd.com/read/28541500/prophylactic-efficacy-of-hyperimmune-bovine-colostral-antiadhesin-antibodies-against-enterotoxigenic-escherichia-coli-diarrhea-a-randomized-double-blind-placebo-controlled-phase-1-trial
#13
Stephen J Savarino, Robin McKenzie, David R Tribble, Chad K Porter, Aisling O'Dowd, Joyce A Cantrell, Stephanie A Sincock, Steven T Poole, Barbara DeNearing, Colleen M Woods, Hye Kim, Shannon L Grahek, Carl Brinkley, Joseph H Crabb, A Louis Bourgeois
Background.: Tip-localized adhesive proteins of bacterial fimbriae from diverse pathogens confer protection in animal models, but efficacy in humans has not been reported. Enterotoxigenic Escherichia coli (ETEC) commonly elaborate colonization factors comprising a minor tip adhesin and major stalk-forming subunit. We assessed the efficacy of antiadhesin bovine colostral IgG (bIgG) antibodies against ETEC challenge in volunteers. Methods.: Adults were randomly assigned (1:1:1) to take oral hyperimmune bIgG raised against CFA/I minor pilin subunit (CfaE) tip adhesin or colonization factor I (CFA/I) fimbraie (positive control) or placebo...
May 24, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28539888/safety-and-immunogenicity-of-a-human-epidermal-growth-factor-receptor-1-her1-based-vaccine-in-prostate-castration-resistant-carcinoma-patients-a-dose-escalation-phase-i-study-trial
#14
Iraida Caballero, Lazaro E Aira, Anabel Lavastida, Xitlally Popa, Javier Rivero, Joaquín González, Mónica Mesa, Narjara González, Kelly Coba, Patricia Lorenzo-Luaces, Barbara Wilkinson, Yuliannis Santiesteban, Yanela Santiesteban, Mayelin Troche, Eduardo Suarez, Tania Crombet, Belinda Sánchez, Angel Casacó, Amparo Macías, Zaima Mazorra
Metastatic castration-resistant prostate cancer (CRPC) remains incurable due to the lack of effective therapies. Activation of the human epidermal growth factor receptor 1 (HER1) in prostate cancer contributes to metastatic progression as well as to disease relapse. Here, we determined the toxicity and immunogenicity of a HER1-based cancer vaccine in CRPC patients included in a phase I clinical trial. CRPC patients (n = 24) were intramuscularly vaccinated with HER1 vaccine consisting of the extracellular domain of HER1 molecule (ECD) and very small size proteoliposome from Neisseria meningitidis (VSSP) and Montanide ISA-51 VG as adjuvants...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28539464/phase-ib-pilot-study-to-evaluate-reparixin-in-combination-with-weekly-paclitaxel-in-patients-with-her-2-negative-metastatic-breast-cancer-mbc
#15
Anne F Schott, Lori Goldstein, Massimo Cristofanilli, Pier Adelchi Ruffini, Susan McCanna, James M Reuben, Raymond Perez, Giraldo Kato, Max S Wicha
CXCR1 is recognized as an actionable receptor selectively expressed by breast cancer stem cells (BCSC). Reparixin is an investigational allosteric inhibitor of chemokine receptors 1 and 2 (CXCR1/2), and demonstrates activity against BCSC in human breast cancer xenografts. This Phase Ib clinical trial examined dose, safety, and pharmacokinetics of paclitaxel plus reparixin therapy, and explored effects of reparixin on BCSCs in metastatic breast cancer (MBC) patients (Trial registration ID: NCT02001974). <p>Experimental Design: Eligible patients had MBC and were candidates for paclitaxel therapy...
May 24, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28538644/validation-of-a-clinical-trial-composite-endpoint-for-patients-with-necrotizing-soft-tissue-infections
#16
Eileen M Bulger, Addison May, Wayne Dankner, Greg Maislin, Bryce Robinson, Anat Shirvan
OBJECTIVE: Our objective was to develop and validate a composite endpoint for patients with necrotizing soft tissue infections (NSTI) that incorporates: local tissue injury, systemic organ dysfunction, and mortality. METHODS: The Necrotizing Infection Clinical Composite Endpoint (NICCE) was defined as follows:(i) Alive at day 28 (ii) ≤3 debridements prior to day 14 (iii) No amputation beyond first debridement (iv) Modified SOFA score (mSOFA) at day 14 ≤1. To be considered a success, all individual criteria must be met...
May 22, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28536670/evidence-based-treatment-options-in-recurrent-and-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck
#17
REVIEW
Athanassios Argiris, Kevin J Harrington, Makoto Tahara, Jeltje Schulten, Pauline Chomette, Ana Ferreira Castro, Lisa Licitra
The major development of the past decade in the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) was the introduction of cetuximab in combination with platinum plus 5-fluorouracil chemotherapy (CT), followed by maintenance cetuximab (the "EXTREME" regimen). This regimen is supported by a phase 3 randomized trial and subsequent observational studies, and it confers well-documented survival benefits, with median survival ranging between approximately 10 and 14 months, overall response rates between 36 and 44%, and disease control rates of over 80%...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28536494/adjuvant-chemotherapy-with-paclitaxel-and-cisplatin-in-lymph-node-positive-thoracic-esophageal-squamous-cell-carcinoma
#18
Liangze Zhang, Weiwei Li, Xiao Lyu, Yan Song, Yousheng Mao, Shaoming Wang, Jing Huang
OBJECTIVE: No standard postoperative adjuvant chemotherapy has ever been established in node-positive esophageal squamous cell carcinoma (ESCC). This is a study to explore the effect of postoperative paclitaxel (PTX) and cisplatin (DDP) in lymph node-positive, completely resected thoracic ESCC patients. METHODS: We conducted a prospective phase II trial. Patients had pathologically node-positive thoracic ESCC with negative margins. Outcomes of disease-free survival (DFS) and overall survival (OS) were compared with a matched historical control cohort...
April 2017: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
https://www.readbyqxmd.com/read/28536084/long-term-treatment-with-onabotulinumtoxina-results-in-consistent-durable-improvements-in-health-related-quality-of-life-in-patients-with-overactive-bladder
#19
David A Ginsberg, Marcus J Drake, Albert Kaufmann, Sidney Radomski, Angelo Gousse, Christopher J Chermansky, Andrew Magyar, Jean Paul Nicandro, Victor W Nitti
PURPOSE: To present the long-term effects of repeat onabotulinumtoxinA 100U treatment on health-related quality of life in overactive bladder patients with urinary incontinence who had an inadequate response to/were intolerant of an anticholinergic. MATERIALS AND METHODS: Patients completing either of two 24-week, phase III trials could enter a 3-year extension study and request multiple onabotulinumtoxinA 100U treatments as needed. Results for the I-QOL (Incontinence-Quality of Life) and KHQ (King's Health Questionnaire) are reported for upto 6 treatments...
May 20, 2017: Journal of Urology
https://www.readbyqxmd.com/read/28535887/discrepancies-between-protocols-and-publications-of-clinical-drug-trials-results-of-an-inception-cohort-study
#20
Cornelis A van den Bogert, Patrick C Souverein, Cecile Tm Brekelmans, Susan Wj Janssen, Gerard H Koëter, Hubert Gm Leufkens, Lex M Bouter
OBJECTIVE: To identify the occurrence and determinants of protocol-publication discrepancies in clinical drug trials. STUDY DESIGN AND SETTING: All published clinical drug trials reviewed by the Dutch Institutional Review Boards in 2007 were analyzed. Discrepancies between trial protocols and publications were measured among key reporting aspects. We evaluated the association of trial characteristics with discrepancies in primary endpoints by calculating the risk ratio (RR) and 95% confidence interval (CI)...
May 20, 2017: Journal of Clinical Epidemiology
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