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https://www.readbyqxmd.com/read/28538644/validation-of-a-clinical-trial-composite-endpoint-for-patients-with-necrotizing-soft-tissue-infections
#1
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/28535507/cardiac-cell-therapies-for-the-treatment-of-acute-myocardial-infarction-a-meta-analysis-from-mouse-studies
#2
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
https://www.readbyqxmd.com/read/28534381/evaluation-of-complementary-and-alternative-medicine-trials-registered-in-clinicaltrials-gov-database
#3
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
#4
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/28532387/robust-estimation-of-the-expected-survival-probabilities-from-high-dimensional-cox-models-with-biomarker-by-treatment-interactions-in-randomized-clinical-trials
#5
Nils Ternès, Federico Rotolo, Stefan Michiels
BACKGROUND: Thanks to the advances in genomics and targeted treatments, more and more prediction models based on biomarkers are being developed to predict potential benefit from treatments in a randomized clinical trial. Despite the methodological framework for the development and validation of prediction models in a high-dimensional setting is getting more and more established, no clear guidance exists yet on how to estimate expected survival probabilities in a penalized model with biomarker-by-treatment interactions...
May 22, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28532202/experiences-of-establishing-an-academic-early-phase-clinical-trials-unit
#6
Sarah R Brown, Debbie Sherratt, Gill Booth, Julia Brown, Fiona Collinson, Walter Gregory, Louise Flanagan
BACKGROUND: Early phase trials are essential in drug development, determining appropriate dose levels and assessing preliminary activity. These trials are undertaken by industry and academia, with increasing collaborations between the two. There is pressure to perform these trials quickly, safely, and robustly. However, there are inherent differences between developing and managing early phase, compared to late phase, drug trials. This article describes an approach to establishing an academically led early phase trial portfolio, highlighting lessons learned and sharing experiences...
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28532177/targeting-non-hodgkin-lymphoma-with-blinatumomab
#7
Sheilagh Sanders, Douglas A Stewart
Management of patients with relapsed or refractory non-Hodgkin lymphoma (NHL) remains challenging, and novel effective agents are eagerly awaited. Blinatumomab is a bispecific T-cell engager, targeting CD19. While blinatumomab's primary clinical use has been in B-cell acute lymphoblastic leukemia (B-ALL), there are increasing data for its use in B-lineage lymphomas. Areas covered: The aim of this review is to highlight the clinical data for blinatumomab use in NHL. Herein, the authors provide an overview of blinatumomab, its mechanism of action, its proven efficacy against B-ALL, and its phase I-II data assessing its use in NHL Expert opinion: Blinatumomab has modest activity in phase I-II trials in NHL, and may represent a means of bridging patients with relapsed disease to hematopoietic stem cell transplant...
May 22, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28529549/abiraterone-acetate-and-prednisone-in-chemotherapy-na%C3%A3-ve-prostate-cancer-patients-rationale-evidence-and-clinical-utility
#8
REVIEW
E David Crawford, Neal D Shore, Daniel P Petrylak, Celestia S Higano, Charles J Ryan
Abiraterone acetate 1000 mg/day, combined with prednisone 5 mg PO twice daily, is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Abiraterone acetate is the oral prodrug of abiraterone, a specific CYP17 inhibitor that blocks androgen biosynthesis within the adrenal glands, testes and tumor microenvironment. In a phase III trial of men with asymptomatic or minimally symptomatic, chemotherapy-naïve mCRPC, treatment with oral abiraterone acetate plus prednisone led to a statistically significant improvement in the co-primary endpoints of overall survival and radiographic progression-free survival when compared with placebo plus prednisone...
May 2017: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/28529147/norursodeoxycholic-acid-improves-cholestasis-in-primary-sclerosing-cholangitis
#9
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/28528528/ustekinumab-a-review-in-moderate-to-severe-crohn-s-disease
#10
Yvette N Lamb, Sean T Duggan
Ustekinumab (Stelara(®)) has been recently approved in the EU and the USA as intravenous induction and subcutaneous maintenance therapy for adult patients with moderately to severely active Crohn's disease who have failed or were intolerant to treatment with immunomodulators, corticosteroids or at least one tumour necrosis factor (TNF) antagonist. Ustekinumab, a monoclonal antibody to the shared p40 subunit of the proinflammatory interleukin (IL)-12 and IL-23 cytokines, has a unique mechanism of action distinct from that of TNF antagonists...
May 20, 2017: Drugs
https://www.readbyqxmd.com/read/28527926/initial-and-midterm-results-of-the-bolton-relay-thoracic-aortic-endovascular-pivotal-trial
#11
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/28527063/the-role-of-anti-cgrp-antibodies-in-the-pathophysiology-of-primary-headaches
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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