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randomized controlled trial toxicity

Angela L Chiew, Christian Gluud, Jesper Brok, Nick A Buckley
BACKGROUND: Paracetamol (acetaminophen) is the most widely used non-prescription analgesic in the world. Paracetamol is commonly taken in overdose either deliberately or unintentionally. In high-income countries, paracetamol toxicity is a common cause of acute liver injury. There are various interventions to treat paracetamol poisoning, depending on the clinical status of the person. These interventions include inhibiting the absorption of paracetamol from the gastrointestinal tract (decontamination), removal of paracetamol from the vascular system, and antidotes to prevent the formation of, or to detoxify, metabolites...
February 23, 2018: Cochrane Database of Systematic Reviews
Young Kwok, Adeel Kaiser, Stephanie R Rice, Randi Cohen, Mark Mishra
PURPOSE OF REVIEW: The overview summarizes recent developments in radiation oncology for high risk and recurrent prostate cancer. RECENT FINDINGS: A number of well known phase III prostate hypofractionated radiation therapy (HFxRT) trials were finally published with long-term follow-ups. These trials demonstrate patterns of equivalent tumor control with several showing worse toxicity rates. The ASCENDE-RT randomized trial demonstrated the superiority of brachytherapy boost in intermediate and high-risk prostate cancer...
February 19, 2018: Current Opinion in Oncology
Chintan Shah, Rohit Bishnoi, Ankur Jain, Harini Bejjanki, Sican Xiong, Yu Wang, Fei Zou, Jan S Moreb
Carfilzomib is a second-generation proteasome inhibitor (PI) that is approved for patients with relapsed or refractory multiple myeloma (RRMM) who failed ≥1 prior lines of therapy. We performed a systematic review of carfilzomib literature with meta-analysis to determine cumulative incidence of cardiotoxicity. After the literature search, we included a total of 29 eligible phase I/II, phase II and phase III clinical trials which used carfilzomib. The cumulative incidence and overall odds ratios (OR) were calculated with random effect model, using 'R' software with metaphor package...
February 21, 2018: Leukemia & Lymphoma
Carlos Narvaez, Claudia Doemer, Christian Idel, Cornelia Setter, Denise Olbrich, Zaza Ujmajuridze, Jesper Hansen Carl, Dirk Rades
BACKGROUND: The aim of the present trial is to investigate a new option of skin protection in order to reduce the rate of grade ≥ 2 skin toxicity in patients receiving radiotherapy alone or radiochemotherapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). METHODS / DESIGN: This is a randomized, active-controlled, parallel-group multi-center trial that compares the following treatments of radiation dermatitis in patients with head-and-neck cancer: Mepitel® Film (Arm A) vs...
February 17, 2018: BMC Cancer
Surya Prasad Rimal, Pappu Rijal, Rabindra Bhatt, Kriti Thapa
INTRODUCTION: Magnesium sulfate is the drug of choice for prevention of seizures in the pre-eclamptic woman. There is no agreement in the published randomized trials regarding the optimal time to initiate magnesium sulfate, the dose to use (both loading and maintenance) as well as the duration of therapy. The objective of this study is to determine whether magnesium sulfate prophylaxis is needed for up to 24 hours postpartum in all patients with severe pre-eclampsia for the prevention of seizure...
October 2017: JNMA; Journal of the Nepal Medical Association
Shearwood McClelland, Kiri A Sandler, Catherine Degnin, Yiyi Chen, Timur Mitin
INTRODUCTION: Three randomized clinical trials have established brachytherapy (BT) boost in combination with external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) as superior to definitive EBRT and ADT alone in terms of biochemical control (but not overall survival) at the expense of increased toxicity in men with high-risk (HR) prostate cancer (PCa). The current view regarding these 2 treatment algorithms among North American genitourinary (GU) experts is not known...
February 2, 2018: Clinical Genitourinary Cancer
Marino Silvia, Vitaliti Giovanna, Marino Simona Domenica, Pavone Piero, Provvidenti Simona, Romano Catia, Falsaperla Raffaele
BACKGROUND: Few studies on adult and pediatric patients have shown pyridoxine efficacy as additional therapy for those receiving levetiracetam (LEV) to prevent and mitigate behavioral adverse effects (BAEs). OBJECTIVE: The aim of our study was to analyze the safety and efficacy of pyridoxine supplementation in the prevention of LEV adverse effects, including suicidal ideation. METHODS: This randomized, case-control trial included patients receiving LEV as monotherapy treatment...
February 1, 2018: Annals of Pharmacotherapy
Julie R Brahmer, Christina Lacchetti, Bryan J Schneider, Michael B Atkins, Kelly J Brassil, Jeffrey M Caterino, Ian Chau, Marc S Ernstoff, Jennifer M Gardner, Pamela Ginex, Sigrun Hallmeyer, Jennifer Holter Chakrabarty, Natasha B Leighl, Jennifer S Mammen, David F McDermott, Aung Naing, Loretta J Nastoupil, Tanyanika Phillips, Laura D Porter, Igor Puzanov, Cristina A Reichner, Bianca D Santomasso, Carole Seigel, Alexander Spira, Maria E Suarez-Almazor, Yinghong Wang, Jeffrey S Weber, Jedd D Wolchok, John A Thompson
Purpose To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, nursing, trialist, and advocacy was convened to develop the clinical practice guideline. Guideline development involved a systematic review of the literature and an informal consensus process...
February 14, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Ping Dai, Jing Li, Xiao-Ping Ma, Jian Huang, Juan-Juan Meng, Ping Gong
Background: The study of cyclooxygenase-2 (COX-2) inhibitors is now mired in controversy. We performed a meta-analysis to assess the efficacy and safety profile of COX-2 inhibitors in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: A literature search of PubMed, EMBASE, the Cochrane Central databases, and, up until March 26, 2017, identified relevant randomized controlled trials. Data analysis was performed using Stata 12...
2018: OncoTargets and Therapy
Kelly Liesse, Jamie Harris, Megan Chan, Mary L Schmidt, Bill Chiu
Cardiotoxicity is a dose-limiting and potentially lethal complication of anthracycline administration. Previous studies failed to determine definitive toxic doses or cardioprotective factors. Current dosing strategies may utilize unnecessarily high anthracycline doses, such that survival benefit may not outweigh increased toxicity rates. A systematic review of randomized controlled trials and prospective/retrospective studies investigating anthracycline treatment in pediatric solid tumors was performed from PubMed/MEDLINE and Cochrane databases...
February 9, 2018: Journal of Pediatric Hematology/oncology
Sudeep Gupta, Amita Maheshwari, Pallavi Parab, Umesh Mahantshetty, Rohini Hawaldar, Supriya Sastri Chopra, Rajendra Kerkar, Reena Engineer, Hemant Tongaonkar, Jaya Ghosh, Seema Gulia, Neha Kumar, T Surappa Shylasree, Renuka Gawade, Yogesh Kembhavi, Madhuri Gaikar, Santosh Menon, Meenakshi Thakur, Shyam Shrivastava, Rajendra Badwe
Purpose We compared the efficacy and toxicity of neoadjuvant chemotherapy followed by radical surgery versus standard cisplatin-based chemoradiation in patients with locally advanced squamous cervical cancer. Patients and Methods This was a single-center, phase III, randomized controlled trial ( identifier: NCT00193739). Eligible patients were between 18 and 65 years old and had stage IB2, IIA, or IIB squamous cervical cancer. They were randomly assigned, after stratification by stage, to receive either three cycles of neoadjuvant chemotherapy using paclitaxel and carboplatin once every 3 weeks followed by radical hysterectomy or standard radiotherapy with concomitant cisplatin once every week for 5 weeks...
February 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Brandon J Warrick, Andrew King, Susan Smolinske, Ronald Thomas, Cynthia Aaron
BACKGROUND/OBJECTIVES: The threshold salicylate concentration commonly recommended to initiate extracorporeal elimination, in the absence of significant end-organ toxicity, is 100 mg/dL. Unfortunately, the grade of evidence to support this decision is low. Our primary aim is to describe highest reported salicylate concentrations in patients who died from acute salicylate ingestions. Our secondary aim is to determine if age or coingestants varied with highest reported salicylate concentration...
February 12, 2018: Clinical Toxicology
Kristin E Morrill, Benjamin Aceves, Luis A Valdez, Cynthia A Thomson, Iman A Hakim, Melanie L Bell, Jessica A Martinez, David O Garcia
BACKGROUND: In the U.S., Hispanics have among the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Identifying intervention strategies to reduce caloric intake and/or improve cardiometabolic health in Hispanics is critical to reducing morbidity and mortality among this large and growing population. Evidence exists to support diet-specific behavioral interventions, including beverage modifications, in reducing obesity-related health risks...
February 9, 2018: Nutrition Journal
(no author information available yet)
Two hundred thirteen patients participated in the Fluorouracil Filtering Surgery Study, a randomized clinical trial, to determine the efficacy and safety of subconjunctivally injected 5-fluorouracil after filtering surgery in eyes with poor prognoses. Twenty-eight (27%) of the 105 eyes in the 5-fluorouracil group and 54 (50%) of the 108 eyes in the standard group were classified as failures, defined by reoperation for control of intraocular pressure during the first year or an intraocular pressure greater than 21 mm Hg at the one-year visit (P = ...
February 2018: American Journal of Ophthalmology
Jian Zhou, Zheng Wang, Zhenggang Ren, Yi Chen, Jie Hu, Guo-Huan Yang, Lei Yu, Xin-Rong Yang, Ao Huang, Xin Zhang, Shao Lai Zhou, Hui-Chuan Sun, Yan Hong Wang, Ning Ling Ge, Xiao-Yu Xu, Zhaoyou Tang, Wan Yee Lau, Jia Fan, Jiping Wang
PURPOSE: The survival of patients with hepatocellular carcinoma (HCC) recurrence after curative resection are usually poor. We sought to evaluate the safety and efficacy of adjuvant transarterial chemoembolization (TACE) in HBV-related HCC patients with an intermediate (a single tumor larger than 5 cm without microvascular invasion) or high risk (a single tumor with microvascular invasion, or two or three tumors) of recurrence. EXPERIMENTAL DESIGN: In this randomized phase 3 trial, 280 eligible patients were assigned to adjuvant TACE (n=140) or no adjuvant treatment (control; n = 140) groups...
February 2, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Steven C Brousell, Joseph J Fantony, Megan G Van Noord, Michael R Harrison, Brant A Inman
Background: A systematic review and meta-analysis of the use of systemic vinflunine (VIN) in the treatment of urothelial carcinoma (UC) was performed to evaluate its efficacy based on current available clinical data. Methods: This review was prospectively registered at the International Prospective Register of Systematic Reviews, PROSPERO (registration CRD42016049294). Electronic databases including MEDLINE®, Embase®, Cochrane Central Register of Controlled Trials, and Web of Science were searched through December 2016...
2018: Core Evidence
Susan Patricia Mollan, John Horsburgh, Bhaskar Dasgupta
Giant cell arteritis (GCA) remains a medical emergency due to the threat of permanent sight loss. High-dose glucocorticoids (GCs) are effective in inducing remission in the majority of patients, however, relapses are common which lengthen GC therapy. GC toxicity remains a major morbidity in this group of patients, and conventional steroid-sparing therapies have not yet shown enough of a clinical benefit to change the standard of care. As the understanding of the underlying immunopathophysiology of GCA has increased, positive clinical observations have been made with the use of IL-6 receptor inhibitor therapies, such as tocilizumab (TCZ)...
2018: Eye and Brain
Ane Sørlie Kværner, Jun Minaguchi, Naouale El Yamani, Christine Henriksen, Hanna Ræder, Ingvild Paur, Hege Berg Henriksen, Gro Wiedswang, Sigbjørn Smeland, Rune Blomhoff, Andrew Richard Collins, Siv Kjølsrud Bøhn
DNA damage can be considered as a biomarker for toxicity and response to chemotherapy. It is not known whether the chemotherapy-induced genotoxicity is associated with malnutrition. In this pilot study, we assess genotoxicity by means of DNA damage in patients with lymph-node positive colorectal cancer (CRC) and explore associations with chemotherapy treatment and nutritional status. DNA damage was compared between patients receiving chemotherapy (n = 24) and those not receiving chemotherapy (n = 20)...
January 11, 2018: DNA Repair
Chuang-Wei Wang, Lan-Yan Yang, Chun-Bing Chen, Hsin-Chun Ho, Shuen-Iu Hung, Chih-Hsun Yang, Chee-Jen Chang, Shih-Chi Su, Rosaline Chung-Yee Hui, See-Wen Chin, Li-Fang Huang, Yang Yu-Wei Lin, Wei-Yang Chang, Wen-Lang Fan, Chin-Yi Yang, Ji-Chen Ho, Ya-Ching Chang, Chun-Wei Lu, Wen-Hung Chung
BACKGROUND: Cytotoxic T lymphocyte-mediated (CTL-mediated) severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are rare but life-threatening adverse reactions commonly induced by drugs. Although high levels of CTL-associated cytokines, chemokines, or cytotoxic proteins, including TNF-α and granulysin, were observed in SJS-TEN patients in recent studies, the optimal treatment for these diseases remains controversial...
February 5, 2018: Journal of Clinical Investigation
Xiaojie Wu, Yunfei Li, Jing Zhang, Yingyuan Zhang, Jicheng Yu, Guoying Cao, Yuancheng Chen, Beining Guo, Yaoguo Shi, Jun Huang, Yuran Cao, Xiaofang Liu, Jufang Wu, Mikhail Fedorovich Gordeev, Hong Yuan, Wen Wang
PURPOSE: This study was designed to evaluate the safety and pharmacokinetic profiles of MRX-I tablet, an oxazolidinone antibacterial agent, in healthy Chinese subjects. METHODS: The study was composed of 3 sequential periods. Period 1 was a randomized, double-blind, placebo-controlled, sequential ascending dose (50 to 1800 mg) study. Period 2 included one arm as a randomized, open-label, 3-period, 3 × 3 Latin square single-dose study of 300, 600, and 900 mg MRX-I administration and another arm as a crossover study to evaluate high-fat diet effect...
February 2, 2018: Clinical Therapeutics
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