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https://www.readbyqxmd.com/read/28345833/efficacy-and-toxicity-of-low-dose-versus-conventional-dose-chemotherapy-for-malignant-tumors-a-meta-analysis-of-6-randomized-controlled-trials
#1
Xianhe Xie, Yupeng Wu, Shuimei Luo, Haitao Yang, Lina Li, Sijing Zhou, Ruifen Shen, Heng Lin
Low-dose chemotherapy has emerged as a new strategy for control of cancer. However, there is a controversy as to whether low-dose chemotherapy is an effective way to manage many human malignancies. To shed light on this controversy, we performed a meta-analysis of relative merits between low-dose and conventional-dose chemotherapy in different carcinomas. Studies published before February 29, 2016 were reviewed for the meta-analysis and selected according to defined criteria. The effect levels of low-dose chemotherapy regarding overall survival (OS), progression-free survival (PFS) and severe adverse events (SAEs) (Grade≥3) were calculated as risk ratios (ORs) or adjusted hazard ratios (HRs)...
February 1, 2017: Asian Pacific Journal of Cancer Prevention: APJCP
https://www.readbyqxmd.com/read/28339083/health-risk-assessment-of-environmental-selenium-emerging-evidence-and-challenges-review
#2
Marco Vinceti, Tommaso Filippini, Silvia Cilloni, Annalisa Bargellini, Anna Valeria Vergoni, Aristides Tsatsakis, Margherita Ferrante
New data have been accumulated in the scientific literature in recent years which allow a more adequate risk assessment of selenium with reference to human health. This new evidence comes from environmental studies, carried out in populations characterized by abnormally high or low selenium intakes, and from high-quality and large randomized controlled trials with selenium recently carried out in the US and in other countries. These trials have consistently shown no beneficial effect on cancer and cardiovascular risk, and have yielded indications of unexpected toxic effects of selenium exposure...
March 24, 2017: Molecular Medicine Reports
https://www.readbyqxmd.com/read/28336937/results-of-the-randomized-phase-iib-arctic-trial-of-low-dose-rituximab-in-previously-untreated-cll
#3
D R Howard, T Munir, L McParland, A C Rawstron, D Milligan, A Schuh, A Hockaday, D J Allsup, S Marshall, A S Duncombe, J L O'Dwyer, A F Smith, R Longo, A Varghese, P Hillmen
ARCTIC was a multi-center, randomized-controlled, open, phase IIB non-inferiority trial in previously untreated Chronic Lymphocytic Leukemia (CLL). Conventional frontline therapy in fit patients is fludarabine, cyclophosphamide and rituximab (FCR). The trial hypothesized that including mitoxantrone with low-dose rituximab (FCM-miniR) would be non-inferior to FCR. 200 patients were recruited to assess the primary endpoint of complete remission (CR) rates according to IWCLL criteria. Secondary endpoints were progression-free survival (PFS), overall survival (OS), overall response rate, minimal residual disease (MRD) negativity, safety and cost-effectiveness...
March 24, 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/28327944/a-phase-2-randomized-double-blind-placebo-%C3%A2-controlled-study-of-chemo-immunotherapy-combination-using-motolimod-with-pegylated-liposomal-doxorubicin-in-recurrent-or-persistent-ovarian-cancer-a-gynecologic-oncology-group-partners-study
#4
B J Monk, M F Brady, C Aghajanian, H A Lankes, T Rizack, J Leach, J M Fowler, R Higgins, P Hanjani, M Morgan, R Edwards, W Bradley, T Kolevska, P Foukas, E Swisher, K S Anderson, R Gottardo, J K Bryan, M Newkirk, K L Manjarrez, R S Mannel, R M Hershberg, G Coukos
Background: A phase 2, randomized, placebo-controlled trial was conducted in women with recurrent epithelial ovarian carcinoma to evaluate the efficacy and safety of motolimod-a Toll-like receptor 8 (TLR8) agonist that stimulates robust innate immune responses-combined with pegylated liposomal doxorubicin (PLD), a chemotherapeutic that induces immunogenic cell death. Patients and methods: Women with ovarian, fallopian tube, or primary peritoneal carcinoma were randomized 1 : 1 to receive PLD in combination with blinded motolimod or placebo...
February 21, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28327804/efficacy-and-safety-of-amphotericin-b-deoxycholate-versus-n-methylglucamine-antimoniate-in-pediatric-visceral-leishmaniasis-an-open-label-randomized-and-controlled-pilot-trial-in-brazil
#5
Myrlena Mescouto Borges, Maria Cristina da Silva Pranchevicius, Elza Ferreira Noronha, Gustavo Adolfo Sierra Romero, César Omar Carranza-Tamayo
INTRODUCTION: Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. METHODS: This was a randomized, open-label, 2-arm and controlled pilot clinical trial...
January 2017: Revista da Sociedade Brasileira de Medicina Tropical
https://www.readbyqxmd.com/read/28327089/uniform-fdg-pet-guided-gradient-dose-prescription-to-reduce-late-radiation-toxicity-upgrade-rt-study-protocol-for-a-randomized-clinical-trial-with-dose-reduction-to-the-elective-neck-in-head-and-neck-squamous-cell-carcinoma
#6
Sven van den Bosch, Tim Dijkema, Martina C Kunze-Busch, Chris H J Terhaard, Cornelis P J Raaijmakers, Patricia A H Doornaert, Frank J P Hoebers, Marije R Vergeer, Bas Kreike, Oda B Wijers, Wim J G Oyen, Johannes H A M Kaanders
BACKGROUND: In definitive radiation therapy for head and neck cancer, clinically uninvolved cervical lymph nodes are irradiated with a so-called 'elective dose' in order to achieve control of clinically occult metastases. As a consequence of high-resolution diagnostic imaging, occult tumor volume has significantly decreased in the last decades. Since the elective dose is dependent on occult tumor volume, the currently used elective dose may be higher than necessary. Because bilateral irradiation of the neck contributes to dysphagia, xerostomia and hypothyroidism in a dose dependent way, dose de-escalation to these regions can open a window of opportunity to reduce toxicity and improve quality of life after treatment...
March 21, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28324247/fulvestrant-plus-targeted-agents-versus-fulvestrant-alone-for-treatment-of-hormone-receptor-positive-advanced-breast-cancer-progressed-on-previous-endocrine-therapy-a-meta-analysis-of-randomized-controlled-trials
#7
REVIEW
Wen-Zhao Lin, Qi-Ni Xu, Hong-Biao Wang, Xu-Yuan Li
To compare the addition of targeted agents to fulvestrant with fulvestrant alone in hormone-receptor positive advanced breast cancer progressed on previous endocrine therapy; a meta-analysis of all relevant randomized controlled trials was performed. The PubMed, Embase databases and the Cochrane Central Register of Controlled Trials were searched for relevant publications reporting randomized controlled trials between January 2000 and June 2016. Progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and toxicity were assessed...
March 21, 2017: Breast Cancer: the Journal of the Japanese Breast Cancer Society
https://www.readbyqxmd.com/read/28320635/safety-and-efficacy-of-multipotent-adult-progenitor-cells-in-acute-ischaemic-stroke-masters-a-randomised-double-blind-placebo-controlled-phase-2-trial
#8
David C Hess, Lawrence R Wechsler, Wayne M Clark, Sean I Savitz, Gary A Ford, David Chiu, Dileep R Yavagal, Ken Uchino, David S Liebeskind, Alexander P Auchus, Souvik Sen, Cathy A Sila, Jeffrey D Vest, Robert W Mays
BACKGROUND: Multipotent adult progenitor cells are a bone marrow-derived, allogeneic, cell therapy product that modulates the immune system, and represents a promising therapy for acute stroke. We aimed to identify the highest, well-tolerated, and safest single dose of multipotent adult progenitor cells, and if they were efficacious as a treatment for stroke recovery. METHODS: We did a phase 2, randomised, double-blind, placebo-controlled, dose-escalation trial of intravenous multipotent adult progenitor cells in 33 centres in the UK and the USA...
March 17, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28316464/peritoneal-nebulization-of-ropivacaine-during-laparoscopic-cholecystectomy-dose-finding-and-pharmacokinetic-study
#9
Massimo Allegri, Martina Ornaghi, Catherine E Ferland, Dario Bugada, Yash Meghani, Serena Calcinati, Manuela De Gregori, Federica Lovisari, Krishnaprabha Radhakrishnan, Maria Cusato, Stefano Scalia Catenacci, Marta Somaini, Guido Fanelli, Pablo Ingelmo
Background. Intraperitoneal nebulization of ropivacaine reduces postoperative pain and morphine consumption after laparoscopic surgery. The aim of this multicenter double-blind randomized controlled trial was to assess the efficacy of different doses and dose-related absorption of ropivacaine when nebulized in the peritoneal cavity during laparoscopic cholecystectomy. Methods. Patients were randomized to receive 50, 100, or 150 mg of ropivacaine 1% by peritoneal nebulization through a nebulizer. Morphine consumption, pain intensity in the abdomen, wound and shoulder, time to unassisted ambulation, discharge time, and adverse effects were collected during the first 48 hours after surgery...
2017: Pain Research & Management: the Journal of the Canadian Pain Society
https://www.readbyqxmd.com/read/28315862/the-evolving-role-of-rituximab-in-adult-minimal-change-glomerulopathy
#10
Landon C Brown, Meghan A Jobson, Fernanda Payan Schober, Emily H Chang, Ronald J Falk, Patrick H Nachman, William F Pendergraft
BACKGROUND: Minimal-change glomerulopathy is defined histologically by the presence of normal glomeruli on light microscopy and diffuse podocyte effacement on electron microscopy. Although effective in children, corticosteroid treatment in adults is more variable and time to response can be prolonged. Data to support rituximab use in adults with corticosteroid-dependent or resistant minimal-change glomerulopathy are limited. Here, we describe the clinical course of adults with corticosteroid-dependent or -resistant minimal-change glomerulopathy who received rituximab...
March 18, 2017: American Journal of Nephrology
https://www.readbyqxmd.com/read/28295221/regosarc-regorafenib-versus-placebo-in-doxorubicin-refractory-soft-tissue-sarcoma-a-quality-adjusted-time-without-symptoms-of-progression-or-toxicity-analysis
#11
Vincent Berry, Laurent Basson, Emilie Bogart, Olivier Mir, Jean-Yves Blay, Antoine Italiano, François Bertucci, Christine Chevreau, Stéphanie Clisant-Delaine, Bernadette Liegl-Antzager, Emmanuelle Tresch-Bruneel, Jennifer Wallet, Sophie Taieb, Emilie Decoupigny, Axel Le Cesne, Thomas Brodowicz, Nicolas Penel
BACKGROUND: In a placebo-controlled, randomized phase 2 trial (ClinicalTrials.gov identifier NCT01900743), regorafenib improved progression-free survival (PFS) for patients with doxorubicin-pretreated advanced nonadipocytic sarcoma. A quality-adjusted time without symptoms of progression or toxicity (Q-TWiST) post hoc exploratory analysis was applied to provide an integrated measure of its clinical benefit. METHODS: In the base-case analysis, each patient's overall survival (OS) was partitioned into 3 mutually exclusive health states: the time with a grade 3 or 4 adverse event (TOX), the time without symptoms of disease or grade 3 or 4 toxicity from treatment, and the time after tumor progression or relapse...
March 10, 2017: Cancer
https://www.readbyqxmd.com/read/28293119/intensity-modulated-radiation-therapy-for-breast-cancer-current-perspectives
#12
REVIEW
Milly Buwenge, Silvia Cammelli, Ilario Ammendolia, Giorgio Tolento, Alice Zamagni, Alessandra Arcelli, Gabriella Macchia, Francesco Deodato, Savino Cilla, Alessio G Morganti
BACKGROUND: Owing to highly conformed dose distribution, intensity modulated radiation therapy (IMRT) has the potential to improve treatment results of radiotherapy (RT). Postoperative RT is a standard adjuvant treatment in conservative treatment of breast cancer (BC). The aim of this review is to analyze available evidence from randomized controlled trials (RCTs) on IMRT in BC, particularly in terms of reduction of side effects. METHODS: A literature search of the bibliographic database PubMed, from January 1990 through November 2016, was performed...
2017: Breast Cancer: Targets and Therapy
https://www.readbyqxmd.com/read/28291185/efficacy-of-surgical-site-multimodal-drug-injection-following-operative-management-of-femoral-fractures-a-randomized-controlled-trial
#13
Daniel Koehler, J Lawrence Marsh, Matthew Karam, Catherine Fruehling, Michael Willey
BACKGROUND: Multimodal analgesia inclusive of periarticular injection with a local anesthetic agent has been rapidly assimilated, with demonstrated safety and efficacy, into the care of patients undergoing elective lower-extremity arthroplasty. The present study was performed to evaluate the efficacy and safety of a surgical-site, multimodal drug injection for postoperative pain control following operative management of femoral fractures. METHODS: There were 102 patients undergoing operative intervention (plate fixation, intramedullary device, or arthroplasty) for a broad range of femoral fracture patterns who were prospectively randomized either to receive an intraoperative, surgical-site injection into the superficial and deep tissues containing ropivacaine, epinephrine, and morphine or to receive no injection...
March 15, 2017: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/28286189/safety-and-tolerability-of-a-dried-aqueous-spearmint-extract
#14
Joanne A Lasrado, Kristin M Nieman, Brenda A Fonseca, Kristen D Sanoshy, Arianne L Schild, Kelli A Herrlinger
Spearmint (Mentha spicata L.) and spearmint extracts are Generally Recognized as Safe (GRAS) for use as flavoring in beverages, pharmaceuticals, and confectionaries. Studies of spearmint extracts in humans and animals have reported conflicting results with respect to toxicity. Since the chemical composition of these extracts was not reported and the spearmint source material was different, the relevance of these existing data to evaluating the risks associated with ingestion of a dried aqueous spearmint extract standardized to rosmarinic acid is not clear...
March 7, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28285752/fluconazole-doses-used-for-prophylaxis-of-invasive-fungal-infection-in-neonatal-intensive-care-units-a-network-meta-analysis
#15
Letícia Paula Leonart, Fernanda Stumpf Tonin, Vinicius Lins Ferreira, Suelem Tavares da Silva Penteado, Fábio de Araújo Motta, Roberto Pontarolo
OBJECTIVES: To evaluate the safety and efficacy of different doses of fluconazole used for invasive prophylaxis of fungal infection in neonates. STUDY DESIGN: A systematic search was conducted with PubMed, Scopus, and Web of Science. A manual search was performed as well. Only randomized controlled trials of neonates in a neonatal intensive care unit (NICU) who received fluconazole prophylaxis for invasive fungal infection, regardless of the dose or therapeutic regimen, were included in this review...
March 10, 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/28284844/investigating-methotrexate-toxicity-within-a-randomized-double-blinded-placebo-controlled-trial-rationale-and-design-of-the-cardiovascular-inflammation-reduction-trial-adverse-events-cirt-ae-study
#16
Jeffrey A Sparks, Medha Barbhaiya, Elizabeth W Karlson, Susan Y Ritter, Soumya Raychaudhuri, Cassandra C Corrigan, Fengxin Lu, Jacob Selhub, Daniel I Chasman, Nina P Paynter, Paul M Ridker, Daniel H Solomon
BACKGROUND: The role of low dose methotrexate (LDM) in potential serious toxicities remains unclear despite its common use. Prior observational studies investigating LDM toxicity compared LDM to other active drugs. Prior placebo-controlled clinical trials of LDM in inflammatory conditions were not large enough to investigate toxicity. The Cardiovascular Inflammation Reduction Trial (CIRT) is an ongoing NIH-funded, randomized, double-blind, placebo-controlled trial of LDM in the secondary prevention of cardiovascular disease...
February 10, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28278717/a-randomized-controlled-trial-testing-an-adherence-optimized-vitamin-d-regimen-to-mitigate-bone-change-in-adolescents-being-treated-for-acute-lymphoblastic-leukemia
#17
Etan Orgel, Nicole M Mueske, Richard Sposto, Vicente Gilsanz, Tishya A L Wren, David R Freyer, Anna M Butturini, Steven D Mittelman
Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC). Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = ...
February 20, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28275117/randomized-phase-ii-trial-of-parsatuzumab-anti-egfl7-or-placebo-in-combination-with-folfox-and-bevacizumab-for-first-line-metastatic-colorectal-cancer
#18
Rocío García-Carbonero, Eric van Cutsem, Fernando Rivera, Jacek Jassem, Ira Gore, Niall Tebbutt, Fadi Braiteh, Guillem Argiles, Zev A Wainberg, Roel Funke, Maria Anderson, Bruce McCall, Mark Stroh, Eric Wakshull, Priti Hegde, Weilan Ye, Daniel Chen, Ilsung Chang, Ina Rhee, Herbert Hurwitz
LESSONS LEARNED: These negative phase II results for parsatuzumab highlight the challenges of developing an agent intended to enhance the efficacy of vascular endothelial growth factor inhibition without the benefit of validated pharmacodynamic biomarkers or strong predictive biomarker hypotheses.Any further clinical development of anti-EGFL7 is likely to require new mechanistic insights and biomarker development for antiangiogenic agents. BACKGROUND: EGFL7 (epidermal growth factor-like domain 7) is a tumor-enriched vascular extracellular matrix protein that supports endothelial cell survival...
March 8, 2017: Oncologist
https://www.readbyqxmd.com/read/28275115/safety-and-tolerability-of-pd-1-pd-l1-inhibitors-compared-with-chemotherapy-in-patients-with-advanced-cancer-a-meta-analysis
#19
Tomohiro F Nishijima, Shlomit S Shachar, Kirsten A Nyrop, Hyman B Muss
BACKGROUND: Compared with chemotherapy, significant improvement in survival outcomes with the programmed death receptor-1 (PD-1) inhibitors nivolumab and pembrolizumab and the programmed death-ligand 1 (PD-L1) inhibitor atezolizumab has been shown in several types of advanced solid tumors. We conducted a systematic review and meta-analysis to compare safety and tolerability between PD-1/PD-L1 inhibitors and chemotherapy. METHODS: PubMed and American Society of Clinical Oncology (ASCO) databases were searched 1966 to September 2016...
March 8, 2017: Oncologist
https://www.readbyqxmd.com/read/28272913/phase-i-study-of-sorafenib-in-combination-with-intermittent-hepatic-arterial-infusion-chemotherapy-for-unresectable-hepatocellular-carcinoma
#20
Morihiko Ishizaki, Masaki Kaibori, Kosuke Matsui, Hiroki Ikeda, Katsunori Yoshida, Kazuichi Okazaki, Syuji Kariya, Noboru Tanigawa, Richi Nakatake, Hideyuki Matsushima, Tatsuma Sakaguchi, Masanori Kon
OBJECTIVES: We conducted a phase I study of sorafenib and intermittent hepatic arterial infusion chemotherapy using cisplatin for unresectable hepatocellular carcinoma. METHODS: Sorafenib was administered continuously, whereas cisplatin was administered once every 3 weeks. We estimated the safety and efficacy. RESULTS: Fifteen patients were enrolled into this study. The dose-limiting toxicities occurred at sorafenib 800 mg and cisplatin 20 mg/m(2)...
March 8, 2017: Cancer Investigation
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