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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/28546769/treatment-of-chronic-low-back-pain-new-approaches-on-the-horizon
#2
REVIEW
Nebojsa Nick Knezevic, Shane Mandalia, Jennifer Raasch, Ivana Knezevic, Kenneth D Candido
Back pain is the second leading cause of disability among American adults and is currently treated either with conservative therapy or interventional pain procedures. However, the question that remains is whether we, as physicians, have adequate therapeutic options to offer to the patients who suffer from chronic low back pain but fail both conservative therapy and interventional pain procedures before they consider surgical options such as discectomy, disc arthroplasty, or spinal fusion. The purpose of this article is to review the potential novel therapies that are on the horizon for the treatment of chronic low back pain...
2017: Journal of Pain Research
https://www.readbyqxmd.com/read/28546065/external-beam-radiotherapy-affects-serum-testosterone-in-patients-with-localized-prostate-cancer
#3
Raisa S Pompe, Pierre I Karakiewicz, Emanuele Zaffuto, Ariane Smith, Marco Bandini, Michele Marchioni, Zhe Tian, Sami-Ramzi Leyh-Bannurah, Jonas Schiffmann, Guila Delouya, Carole Lambert, Jean-Paul Bahary, Marie Claude Beauchemin, Maroie Barkati, Cynthia Ménard, Markus Graefen, Fred Saad, Derya Tilki, Daniel Taussky
BACKGROUND: Previous studies have examined testosterone levels after external beam radiation (EBRT) monotherapy, but since 2002 only sparse contemporary data have been reported. AIM: To examine testosterone kinetics in a large series of contemporary patients after EBRT. METHODS: The study was conducted in 425 patients who underwent definitive EBRT for localized prostate cancer from 2002 through 2014. Patients were enrolled in several phase II and III trials...
May 22, 2017: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/28545624/drug-development-for-heart-failure-with-preserved-ejection-fraction-what-pieces-are-missing-from-the-puzzle
#4
REVIEW
Michele Senni, Stephen J Greene, Javed Butler, Gregg C Fonarow, Mihai Gheorghiade
Despite the growing number of patients with heart failure with preserved ejection fraction (HFpEF) and event rates comparable with many cancers, there remain no pharmacologic agents definitively proven to improve patient outcomes. Although phase II trials have intermittently yielded encouraging results, none have translated into successful achievement of a phase III primary end point. Thus, because of the urgent need to discover proven therapies, it is prudent to reevaluate our current approach to HFpEF drug development...
June 2017: Canadian Journal of Cardiology
https://www.readbyqxmd.com/read/28545574/initiating-change-locally-in-bullying-and-aggression-through-the-school-environment-inclusive-trial-update-to-cluster-randomised-controlled-trial-protocol
#5
Chris Bonell, Anne Mathiot, Elizabeth Allen, Leonardo Bevilacqua, Deborah Christie, Diana Elbourne, Adam Fletcher, Richard Grieve, Rosa Legood, Stephen Scott, Emily Warren, Meg Wiggins, Russell M Viner
BACKGROUND: Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection...
May 25, 2017: Trials
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
#6
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/28542577/leptin-signals-via-tgfb1-to-promote-metastatic-potential-and-stemness-in-breast-cancer
#7
Ameet K Mishra, Christopher R Parish, Ma-Li Wong, Julio Licinio, Anneke C Blackburn
Epidemiological studies have shown obesity to be linked with poorer outcomes in breast cancer patients. The molecular mechanisms responsible for the increased risk of invasive/metastatic disease with obesity are complex, but may include elevated levels of adipokines such as leptin. Using physiological levels of leptin found in obesity in a novel chronic in vitro treatment model (≤200 ng/ml for 14 days), we confirmed the occurrence of leptin-mediated changes in growth, apoptosis and metastatic behavior, and gene expression changes representing epithelial-to-mesenchymal transition (EMT) and a cancer stem cell (CSC) like phenotype in breast epithelial and cancer cell lines (MCF10A, MCF10AT1, MCF7 and MDA-MB-231)...
2017: PloS One
https://www.readbyqxmd.com/read/28541963/correlation-of-structural-and-functional-outcome-measures-in-a-phase-one-trial-of-ciliary-neurotrophic-factor-in-type-2-idiopathic-macular-telangiectasia
#8
Ferenc B Sallo, Irene Leung, Traci E Clemons, Tunde Peto, Emily Y Chew, Daniel Pauleikhoff, Alan C Bird
PURPOSE: Macular telangiectasia Type 2 is a bilateral, progressive, potentially blinding retinal disease characterized by both vascular and neurodegenerative signs. Both the area of the break in the ellipsoid zone seen in "en face" optical coherence tomographic (OCT) images and microperimetric focal retinal sensitivity loss have been proposed as potential measures of progression in macular telangiectasia. The authors aimed to assess the characteristics and interrelationship of these structural and functional disease markers from the data collected in a phase one clinical trial of ciliary neurotrophic factor in macular telangiectasia...
May 23, 2017: Retina
https://www.readbyqxmd.com/read/28540737/investigational-drugs-in-phase-i-and-phase-ii-clinical-trials-for-thalassemia
#9
Irene Motta, Natalia Scaramellini, Maria Domenica Cappellini
Regular transfusion and iron chelation are the current treatment of severe forms of thalassemia. As a result of this demanding supportive treatment, there are several unmet therapeutic needs. Due to a deeper understanding in the pathophysiology of thalassemia, new therapeutic strategies have been developed that are now in pre-clinical and clinical trials. Areas covered: Activin receptor ligand traps (luspatercept and sotatercept), drugs targeting ineffective erythropoiesis, showed encouraging results in Phase I and II clinical trials...
May 25, 2017: Expert Opinion on Investigational Drugs
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
#10
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/28538644/validation-of-a-clinical-trial-composite-endpoint-for-patients-with-necrotizing-soft-tissue-infections
#11
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/28536494/adjuvant-chemotherapy-with-paclitaxel-and-cisplatin-in-lymph-node-positive-thoracic-esophageal-squamous-cell-carcinoma
#12
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/28536493/postoperative-chemotherapy-with-s-1-plus-oxaliplatin-versus-s-1-alone-in-locally-advanced-gastric-cancer-rescue-gc-study-a-protocol-for-a-phase-iii-randomized-controlled-trial
#13
Xiang Hu, Lin Chen, Yian Du, Biao Fan, Zhaode Bu, Xin Wang, Yingjiang Ye, Zhongtao Zhang, Gang Xiao, Fei Li, Qingsi He, Guoli Li, Xian Shen, Bin Xiong, Liming Zhu, Jiwei Liu, Lian Liu, Tao Wu, Jing Zhou, Jun Zhang, Gang Zhao, Xulin Wang, Pin Liang, Xinxin Wang, Yan Zhang, Xiaojiang Wu, Ji Zhang, Xin Ji, Xianglong Zong, Tao Fu, Ziyu Jia, Jiafu Ji
BACKGROUND: The ACTS-GC study had shown postoperative adjuvant therapy with S-1 improved survival of patients with locally advanced gastric cancer. Addition of oxaliplatin to S-1 is considered to be acceptable as one of the treatment options for gastric cancer patients after radical gastrectomy with D2 lymph node excision. METHODS: We have commenced a randomized phase III trial in December 2016 to evaluate S-1 plus oxaliplatin compared with S-1 alone in the adjuvant setting for locally advanced gastric cancer...
April 2017: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
https://www.readbyqxmd.com/read/28536487/current-status-and-challenges-in-sentinel-node-navigation-surgery-for-early-gastric-cancer
#14
Bang Wool Eom, Young-Il Kim, Hong Man Yoon, Soo-Jeong Cho, Jong Yeul Lee, Chan Gyoo Kim, Soo Jin Kim, Ji Yoon Rho, Seok Ki Kim, Myeong-Cherl Kook, Young-Woo Kim, Keun Won Ryu
Although a number of feasibility studies for sentinel node (SN) concepts in gastric cancer have been conducted since 2000, there remains a debate regarding detailed detection techniques and oncological safety. Two important multicenter phase II clinical trials were performed in Japan that used different methods and reached different conclusions; one confirmed acceptable results with a false-negative rate of 7%, and the other showed an unacceptably high false-negative rate of 46.4%. The Sentinel Node Oriented Tailored Approach (SENORITA) trial is a multicenter randomized controlled phase III trial being performed in Korea...
April 2017: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
https://www.readbyqxmd.com/read/28536308/immune-correlates-of-gm-csf-and-melanoma-peptide-vaccination-in-a-randomized-trial-for-the-adjuvant-therapy-of-resected-high-risk-melanoma-e4697
#15
Lisa H Butterfield, Fengmin Zhao, Sandra Lee, Ahmad A Tarhini, Kim A Margolin, Richard L White, Michael Atkins, Gary I Cohen, Theresa L Whiteside, John M Kirkwood, David H Lawson
Purpose: E4697 was a multi-center intergroup randomized placebo-controlled Phase III trial of adjuvant GM-CSF and/or a multi-epitope melanoma peptide vaccine for patients with completely resected, high-risk stage III/IV melanoma. <p>Experimental Design: 815 patients were enrolled from 12/99 to 10/06 into this 6-arm study. GM-CSF was chosen to promote the numbers and functions of dendritic cells (DC). The melanoma antigen peptide vaccine (Tyrosinase368-376 (370D), gp100209-217 (210M), MART-127-35) in Montanide was designed to promote melanoma specific CD8(+) T cell responses...
May 23, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28536156/gefitinib-delays-nsclc-recurrence-after-surgery
#16
(no author information available yet)
For patients with non-small cell lung cancer and activating EGFR mutations who have had surgery, gefitinib appears to be more effective than chemotherapy in delaying disease recurrence. In a phase III trial, patients given the EGFR inhibitor were disease-free for 10 months longer than those who received chemotherapy.
May 23, 2017: Cancer Discovery
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
#17
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/28535734/investigational-drugs-in-phase-i-and-phase-ii-for-levodopa-induced-dyskinesia
#18
Silvia Cerri, Francesca Siani, Fabio Blandini
prolonged treatment of Parkinson's disease with L-DOPA results in motor complications, including motor fluctuations and involuntary movements known as L-DOPA induced dyskinesias (LIDs). LIDs represent an additional cause of disability for PD patients and a major challenge for the clinical neurologist. Pre-clinical research has provided invaluable insights into the molecular and neural substrates of LIDs, identifying a number of potential targets for new anti-dyskinetic strategies. Areas covered: this review article is centered on drugs currently in Phase I and II clinical trials for LIDs and their relative pharmacological targets, which include glutamate, acetylcholine, serotonin, adrenergic receptors and additional targets of potential therapeutic interest...
May 24, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28535693/experience-with-sunitinib-in-metastatic-renal-cell-carcinoma-mrcc-patients-pooled-analysis-from-3-spanish-observational-prospective-studies
#19
Daniel Castellano, José Pablo Maroto, Enrique Espinosa, Enrique Grande, Victoria Bolos, Julia Linares, Emilio Esteban, Aranzazu Gonzalez Del Alba, M A Climent, J A Arranz, Mª José Méndez, Eva Fernadez Parra, Luis Antón-Aparicio, Cristina Bayona, Isabel Gallegos, Enrique Gallardo, Luz Samaniego, J Garcia Donas
BACKGROUND: A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon-α in metastatic renal cell carcinoma (mRCC) patients. OBJECTIVE: To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice. METHODS: Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals...
May 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28535507/cardiac-cell-therapies-for-the-treatment-of-acute-myocardial-infarction-a-meta-analysis-from-mouse-studies
#20
Cajetan Immanuel Lang, Markus Wolfien, Anne Langenbach, Paula Müller, Olaf Wolkenhauer, Arash Yavari, Hüseyin Ince, Gustav Steinhoff, Bernd Joachim Krause, Robert David, Änne Glass
AIMS: Stem cell-based regenerative therapies for the treatment of ischemic myocardium are currently a subject of intensive investigation. A variety of cell populations have been demonstrated to be safe and to exert some positive effects in human Phase I and II clinical trials, however conclusive evidence of efficacy is still lacking. While the relevance of animal models for appropriate pre-clinical safety and efficacy testing with regard to application in Phase III studies continues to increase, concerns have been expressed regarding the validity of the mouse model to predict clinical results...
May 25, 2017: Cellular Physiology and Biochemistry
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