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clinical trial phase III

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https://www.readbyqxmd.com/read/28527063/the-role-of-anti-cgrp-antibodies-in-the-pathophysiology-of-primary-headaches
#1
Piero Barbanti, Cinzia Aurilia, Luisa Fofi, Gabriella Egeo, Patrizia Ferroni
Calcitonin gene-related peptide (CGRP), a potent vasodilator and pain-signaling neuropeptide, is a validated therapeutic target for migraine and cluster headache. Four anti-CGRP monoclonal antibodies (mAbs) have been developed, representing the first specific, mechanism-based, migraine prophylactic treatment. CGRP mAbs demonstrated good efficacy coupled to excellent tolerability and safety in 5 phase II clinical trials. Notably, CGRP mAbs induced complete migraine remission in a patients' subset. To date, more than 20 phase III trials using CGRP mAbs for of episodic and chronic migraine and cluster headache prevention are ongoing...
May 2017: Neurological Sciences
https://www.readbyqxmd.com/read/28525561/decade-long-profile-of-imaging-biomarker-use-in-ophthalmic-clinical-trials
#2
Edoardo Villani, Domenico Massaro, Matteo Scaramuzzi, Pedram Hamrah, Felipe A Medeiros, Paolo Nucci
Purpose: The purpose of this study was to investigate the use of imaging biomarkers in published clinical trials (CTs) in ophthalmology and its eventual changes during the past 10 years. Methods: We sampled from published CTs in the fields of cornea, retina, and glaucoma between 2005-2006 and 2015-2016. Data collected included year of publication, phase, subspecialty, location, compliance with Consolidated Standards for Reporting Trials, impact factor, presence and use of imaging biomarkers (diagnostic, prognostic and predictive; primary and secondary surrogate endpoints), and use of centralized reading centers...
May 1, 2017: Investigative Ophthalmology & Visual Science
https://www.readbyqxmd.com/read/28525403/genetic-diseases-associated-with-an-increased-risk-of-skin-cancer-development-in-childhood
#3
Alexander L Fogel, Kavita Y Sarin, Joyce M C Teng
PURPOSE OF REVIEW: Childhood skin cancers are relatively rare and may indicate an underlying genetic disorder. The increasing elucidation of genetic pathways is changing the diagnosis and management of genetic skin cancer susceptibility syndromes. In this review, we provide an overview of genetic conditions that predispose to skin cancer development in childhood and signs that providers should assess when evaluating affected individuals. RECENT FINDINGS: In basal cell nevus syndrome (BCNS), the patched2 (PTCH2) and suppressor of fused (SUFU) genes have been implicated in disease pathogenesis...
May 18, 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28524005/rivaroxaban-metabolism-pharmacologic-properties-and-drug-interactions
#4
Tomas Kvasnicka, Ivana Malikova, Zuzana Zenahlikova, Karolína Kettnerova, Radka Brzezkova, Tomas Zima, Jan Ulrych, Jan Briza, Ivan Netuka, Jan Kvasnicka
BACKGROUND: Rivaroxaban represents a selective direct inhibitor of activated coagulation factor X (FXa) having peroral bioavailability and prompt onset of action. OBJECTIVE: The absorbtion of rivaroxaban is quick, reaching maximum plasma concentration 2-4 hours following its administration. Peroral bioavailability is high (80-100 %) and pharmacokinetic variability is considered to be moderate (coefficient of variation 30-40 %). This review discusses the properties, drug interactions, pharmacokinetics and clinical indications of rivaroxaban...
May 18, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28523839/algorithm-based-pharmacotherapy-for-first-episode-schizophrenia-involuntarily-hospitalized-a-retrospective-analysis-of-real-world-practice
#5
Bunta Yoshimura, Kojiro Sato, Manabu Takaki, Norihito Yamada
BACKGROUND: Little is known about the clinical outcomes of severely ill patients with first-episode schizophrenia spectrum disorders (FES) who are considered to lack the capacity to consent to clinical trials. We investigated the feasibility of an algorithm-based pharmacotherapy (ABP) and clinical outcomes of patients with FES involuntarily hospitalized and treated with ABP. METHODS: We conducted a retrospective chart review of 160 patients admitted involuntarily between October 2012 and October 2015...
May 19, 2017: Early Intervention in Psychiatry
https://www.readbyqxmd.com/read/28522917/effects-of-chinese-herbal-medicine-xiangbin-prescription-on-gastrointestinal-motility
#6
Zhi Jiang, Li-Xing Cao, Bo Liu, Qi-Cheng Chen, Wen-Fan Shang, Lu Zhou, Dan-Yan Li, De-An Guo, Zhi-Qiang Chen
AIM: To investigate the effects of Xiangbin prescription (XBP), a Chinese herbal concoction, on gastrointestinal motility. METHODS: Forty healthy volunteers were recruited for this randomized controlled trial of XBP. Antroduodenojejunal manometry was used to monitor gastrointestinal motility in these subjects. After the subjects had fasted for at least 12 h, XBP (n = 30) or placebo (n = 10) was orally administrated and gastrointestinal motility was recorded for 4 h...
April 28, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28521614/overcoming-platinum-resistance-in-ovarian-cancer-treatment-from-clinical-practice-to-emerging-chemical-therapies
#7
Federica Tomao, Claudia Marchetti, Alessia Romito, Anna Di Pinto, Violante Di Donato, Innocenza Palaia, Marco Monti, Ludovico Muzii, Pierluigi Benedetti Panici
The objective of this review is to summarize results from clinical trials that tested cytotoxic drugs and target strategies for the treatment of platinum resistant (PR) recurrent ovarian cancer (ROC) with particular attention to Phase III and ongoing trials. Areas covered: Since platinum free interval (PFI) represents the most important predictive factor for response to platinum re-treatment in ROC, non-platinum regimens are conventionally considered the most appropriate approaches. Impressive progress has been made in recent decades, resulting in the identification of most effective cytotoxic agents and in the development of new target strategies...
May 18, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28521579/cognitive-behavioural-therapy-for-post-stroke-fatigue-and-sleep-disturbance-a-pilot-randomised-controlled-trial-with-blind-assessment
#8
Sylvia Nguyen, Dana Wong, Adam McKay, Shantha M W Rajaratnam, Gershon Spitz, Gavin Williams, Darren Mansfield, Jennie L Ponsford
The objective of this study was to evaluate the effectiveness of individual cognitive behavioural therapy (CBT) for post-stroke fatigue and sleep disturbance compared to treatment as usual (TAU). In a parallel two-group pilot randomised controlled trial of 15 participants, nine were allocated to eight weekly sessions of adapted CBT and six continued usual care rehabilitation. The primary outcome was the Fatigue Severity Scale (FSS-7) at two and four months from baseline. Secondary outcomes included measures of sleep, mood and quality of life...
May 19, 2017: Neuropsychological Rehabilitation
https://www.readbyqxmd.com/read/28521540/cost-effectiveness-analysis-of-rivaroxaban-for-treatment-and-secondary-prevention-of-venous-thromboembolism-in-the-netherlands
#9
Marieke Heisen, Maarten J Treur, Harald E Heemstra, Eric B W Giesen, Maarten J Postma
BACKGROUND: Until recently, standard treatment of venous thromboembolism (VTE) concerned a combination of short-term low-molecular-weight heparin (LMWH) and long-term vitamin-K antagonist (VKA). Risk of bleeding and the requirement for regular anticoagulation monitoring are, however, limiting their use. Rivaroxaban is a novel oral anticoagulant associated with a significantly lower risk of major bleeds (hazard ratio 0.54, 95% confidence interval 0.37-0.79) compared to LMWH/VKA therapy and does not require regular anticoagulation monitoring...
May 18, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28520849/beta-blockers-and-improved-progression-free-survival-in-patients-with-advanced-her2-negative-breast-cancer-a-retrospective-analysis-of-the-rose-trio-012-study
#10
G Spera, R Fresco, H Fung, J R B Dyck, E Pituskin, I Paterson, J R Mackey
Background: Recent retrospective studies suggest that beta-adrenergic blocking drugs (BB) are associated with improved outcomes in people with a range of cancers. Although limited and discordant data suggest that BB may increase overall survival (OS) of patients with localized breast cancer (BC), there is no information on the effects of BB in women with advanced BC. Patients and Methods: To explore the association between BB use and BC outcomes, we retrospectively reviewed the ROSE/TRIO-012, a double-blinded, multinational phase III trial that randomized 1,144 patients with HER2-negative advanced BC to first-line docetaxel in combination with ramucirumab or placebo...
May 18, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28516155/phase-i-clinical-trial-of-everolimus-combined-with-trimodality-therapy-in-patients-with-muscle-invasive-bladder-cancer
#11
Bassel G Bachir, Luis Souhami, Jose João Mansure, Fabio Cury, Marie Vanhuyse, Fadi Brimo, Armen G Aprikian, Simon Tanguay, Jeremy Sturgeon, Wassim Kassouf
Background: Local control following trimodality therapy (TMT) for muscle-invasive bladder cancer (MIBC) requires further optimization. Objective: Evaluating the biologic endpoint, feasibility, and toxicity of integrating everolimus to TMT in patients with MIBC. Methods: This was a phase I trial in patients with MIBC who were not surgical candidates or who refused cystectomy. Following maximal transurethral tumor resection, patients were treated by radiotherapy (50 Gy/20 fractions), gemcitabine (100 mg/m2/weekly) and escalating doses of everolimus (2...
April 27, 2017: Bladder Cancer
https://www.readbyqxmd.com/read/28511146/real-world-prospective-experience-of-axitinib-in-metastatic-renal-cell-carcinoma%C3%A2-in-a-large-comprehensive-cancer-centre
#12
Margarida Matias, Gwénaël Le Teuff, Laurence Albiges, Annalisa Guida, Caroline Brard, Giulia Bacciarelo, Yohann Loriot, Christophe Massard, Nathalie Lassau, Karim Fizazi, Bernard Escudier
BACKGROUND: Axitinib has shown activity in metastatic renal cell carcinoma (mRCC) in a large phase III clinical trial and was approved in patients who failed first-line therapy. This drug has been available in France since November 2012. The objective is to report efficacy and safety of axitinib in mRCC outside of clinical trials. METHODS: A prospective evaluation of mRCC patients treated by axitinib in second or further next-line therapy at Gustave Roussy was conducted from 2012 to 2015...
May 13, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28509605/safety-and-immunogenicity-of-bio-pox%C3%A2-a-live-varicella-vaccine-oka-strain-in-indian-children-a-comparative-multicentric-randomized-phase-ii-iii-clinical-trial
#13
Anand Prakash Dubey, Mohammad Moonis Akbar Faridi, Monjori Mitra, Iqbal Rajinder Kaur, Aashima Dabas, Jaydeep Choudhury, Mallar Mukherjee, Devendra Mishra
Varicella or chickenpox is a highly contagious disease with a high secondary attack rate. Almost 30% of Indian adolescents lack protective antibodies against varicella, emphasising the need of routine varicella immunization. The Oka VZV is a well-established, safe and efficacious vaccine strain that is highly immunogenic and produces lifelong protective immunity. The present multicentric, open label, randomized, controlled Phase II/III study, compared the Bio Pox™ (indigenous investigational vaccine) with a licensed vaccine, Varivax™, for its safety and immunogenicity profile in 252 healthy subjects in the age group of 1-12 years (cohort I: 6-12 years, II:1-6 years) in three tertiary medical institutions...
May 16, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28508936/phase-i-clinical-study-of-zyan1-a-novel-prolyl-hydroxylase-phd-inhibitor-to-evaluate-the-safety-tolerability-and-pharmacokinetics-following-oral-administration-in-healthy-volunteers
#14
Kevinkumar A Kansagra, Deven Parmar, Rajendra H Jani, Nuggehally R Srinivas, Jason Lickliter, Harilal V Patel, Devang P Parikh, Heather Heading, Hardik B Patel, Rahul J Gupta, Chintan Y Shah, Maulik R Patel, Vyom N Dholakia, Raghav Sukhadiya, Mukul R Jain, Krupi V Parmar, Kinjal Barot
OBJECTIVE: This phase I study of ZYAN1 was conducted to evaluate the safety, tolerability, and pharmacokinetics following oral administration in healthy volunteers. METHODS: The study was a randomized, double-blind, placebo-controlled phase I study carried out in two parts in addition to a third part involving an open-label study to evaluate the food/sex effect. A total of 100 subjects were enrolled into the study as follows: part I-single-dose study with ZYAN1 10, 25, 50, 100, 150, 200, and 300 mg (n = 56); part II-multiple-dose study with every other day dosing of ZYAN1 100, 150, 200, and 300 mg (n = 32); and part III-sex and food effect study with ZYAN1 150 mg (n = 12; open-label)...
May 16, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28508378/population-pharmacokinetic-and-pharmacodynamic-modeling-of-etelcalcetide-in-patients-with-chronic-kidney-disease-and-secondary-hyperparathyroidism-receiving-hemodialysis
#15
Ping Chen, Adimoolam Narayanan, Benjamin Wu, Per Olsson Gisleskog, John P Gibbs, Andrew T Chow, Murad Melhem
INTRODUCTION: Etelcalcetide is a novel calcimimetic that binds and activates calcium-sensing receptors (CaSRs) for the treatment of secondary hyperparathyroidism (SHPT). METHODS: To assess titrated dosing regimens, population pharmacokinetic (PK) and PK/pharmacodynamic (PKPD) modeling of etelcalcetide was performed using NONMEM 7.2. In this analysis, plasma etelcalcetide, serum parathyroid hormone (PTH) and calcium (Ca) concentration-time data were collected from five phase I, II, and III clinical trials following single or multiple intravenous doses of etelcalcetide ranging from 2...
May 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28508185/titan-phase-iii-study-of-doxorubicin-cyclophosphamide-followed-by-ixabepilone-or-paclitaxel-in-early-stage-triple-negative-breast-cancer
#16
Denise A Yardley, Edward R Arrowsmith, Brooke R Daniel, Janice Eakle, Adam Brufsky, David R Drosick, Fred Kudrik, Linda D Bosserman, Mark R Keaton, Sharon A Goble, Jeffrey A Bubis, Victor M Priego, Kelly Pendergrass, Yvonne Manalo, Martin Bury, Donald S Gravenor, Gladys I Rodriguez, Roger C Inhorn, Robyn R Young, William N Harwin, Caryn Silver, John D Hainsworth, Howard A Burris
PURPOSE: Ixabepilone is a microtubule stabilizer with activity in taxane-refractory metastatic breast cancer and low susceptibility to taxane-resistance mechanisms including multidrug-resistant phenotypes and high β-III tubulin expression. Since these resistance mechanisms are common in triple-negative breast cancer (TNBC), ixabepilone may have particular advantages in this patient population. This study evaluated the substitution of ixabepilone for paclitaxel following doxorubicin/cyclophosphamide (AC) in the adjuvant treatment of early-stage TNBC...
May 15, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28506408/genetics-of-medullary-thyroid-cancer-an-overview
#17
REVIEW
Giacomo Accardo, Giovanni Conzo, Daniela Esposito, Claudio Gambardella, Marco Mazzella, Filomena Castaldo, Carlo Di Donna, Andrea Polistena, Nicola Avenia, Vittorio Colantuoni, Dario Giugliano, Daniela Pasquali
Medullary thyroid carcinoma (MTC) represents 3-5% of thyroid cancers. 75% is sporadic and 25% is the dominant component of the hereditary multiple endocrine neoplasia (MEN) type 2 syndromes. Three different subtypes of MEN2, such as MEN2A, MEN2B, and Familial MTC (FMTC) have been defined, based on presence or absence of hyperparathyroidism, pheocromocytoma and characteristic clinical features. Mutations of the RET proto-oncogene are implicated in the pathogenesis of MTC, but there are many other mutational patterns involved...
May 2017: International Journal of Surgery
https://www.readbyqxmd.com/read/28505356/distinct-th1-and-th2-cellular-responses-associated-with-malaria-protection-and-risk-in-rts-s-as01e-vaccinees
#18
Gemma Moncunill, Maxmillian Mpina, Augusto J Nhabomba, Ruth Aguilar, Aintzane Ayestaran, Héctor Sanz, Joseph J Campo, Chenjerai Jairoce, Diana Barrios, Yan Dong, Núria Díez-Padrisa, José F Fernandes, Salim Abdulla, Jahit Sacarlal, Nana A Williams, Jaroslaw Harezlak, Benjamin Mordmüller, Selidji T Agnandji, John J Aponte, Claudia Daubenberger, Clarissa Valim, Carlota Dobaño
Background.: The RTS,S/AS01E malaria vaccine has moderate efficacy, lower in infants than children. Current efforts to enhance RTS,S/AS01E efficacy would benefit from learning about the vaccine-induced immunity and identifying correlates of malaria protection, which could, for instance, inform the choice of adjuvants. Here, we sought cellular immunity-based correlates of malaria protection and risk associated with RTS,S/AS01E vaccination. Methods.: We performed a matched case-control study nested within the multicenter African RTS,S/AS01E Phase III trial...
May 13, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28505028/cytomegalovirus-disease-in-hematopoietic-stem-cell-transplant-patients-current-and-future-therapeutic-options
#19
Shigeo Fuji, Hermann Einsele, Markus Kapp
PURPOSE OF REVIEW: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) has become one of the standard treatment for hematological diseases. Although the clinical outcome has improved significantly during the last decades, the morbidity and mortality after allo-HSCT are still obstacles to cure. Out of major morbidities, opportunistic virus infections such as cytomegalovirus (CMV) infection are important complications, in particular in patients who received human leukocyte antigen-mismatched HSCT...
May 12, 2017: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/28502694/phase-ii-trial-of-the-pi3-kinase-inhibitor-buparlisib-bkm-120-with-or-without-enzalutamide-in-men-with-metastatic-castration-resistant-prostate-cancer
#20
Andrew J Armstrong, Susan Halabi, Patrick Healy, Joshi J Alumkal, Carolyn Winters, Julie Kephart, Rhonda L Bitting, Carey Hobbs, Colleen F Soleau, Tomasz M Beer, Rachel Slottke, Kelly Mundy, Evan Y Yu, Daniel J George
BACKGROUND: Phosphatidylinositol-3-kinase (PI3K) and androgen receptor pathway activation is common in metastatic castration resistant prostate cancer (mCRPC). Buparlisib is an oral, pan-class I PI3 kinase inhibitor. METHODS: This was a multisite single arm phase II trial of buparlisib 100 mg ± enzalutamide daily in men with mCRPC whose disease progressed on or who were not candidates for docetaxel. The primary end-point was the rate of radiographic/clinical progression-free survival (PFS) at 6 months...
May 11, 2017: European Journal of Cancer
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