scholarly journals Evaluation of Topical Polyinosinic Acid-Polycytidylic Acid in Treatment of Localized Herpes Zoster in Children with Cancer: a Randomized, Double-Blind Controlled Study

1975 ◽  
Vol 8 (3) ◽  
pp. 289-294 ◽  
Author(s):  
S. Feldman ◽  
W. T. Hughes ◽  
R. W. Darlington ◽  
H. K. Kim
Keyword(s):  
Herpes Zoster ◽  
Controlled Study ◽  
Children With Cancer ◽  
Double Blind ◽  
Polycytidylic Acid ◽  
Polyinosinic Acid

The Use of Aromatherapy to Reduce Chemotherapy-Induced Nausea in Children With Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial

2018 ◽  
Vol 35 (6) ◽  
pp. 392-398 ◽  
Author(s):  
Anna Evans ◽  
Jemily Malvar ◽  
Cassie Garretson ◽  
Eliza Pedroja Kolovos ◽  
Mary Baron Nelson
Keyword(s):  
Essential Oil ◽  
Assessment Tool ◽  
Controlled Trial ◽  
Controlled Study ◽  
Children With Cancer ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Statistical Significant Difference ◽  
Significant Difference

Introduction: Chemotherapy-induced nausea can be distressing and difficult to manage in children with cancer. The purpose of this study was to investigate the utility of ginger aromatherapy in relieving chemotherapy-induced nausea in children with cancer. Method: This randomized, double-blind, placebo-controlled study of 49 children with cancer explored whether inhalation of the aroma of essential oil of ginger during chemotherapy decreased nausea compared with a placebo (water) or control (Johnson’s baby shampoo) measured by prechemotherapy and postchemotherapy assessment with the Pediatric Nausea Assessment Tool (PeNAT). Results: While well received, well tolerated, nontoxic, and noninvasive, ginger aromatherapy did not significantly decrease nausea in patients enrolled in this study. Among 21 patients who indicated feeling nausea prechemotherapy, 67% reported improvement, 5% worsening, and 28% no change in their postinfusion PeNAT score. We failed to detect a statistical significant difference in the change in PeNAT scores among the three groups.

scholarly journals Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study

2021 ◽  
pp. annrheumdis-2020-219601
Author(s):  
Atul Deodhar ◽  
Paula Sliwinska-Stanczyk ◽  
Huji Xu ◽  
Xenofon Baraliakos ◽  
Lianne S Gensler ◽  
...  
Keyword(s):  
Herpes Zoster ◽  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Response Rate ◽  
Phase Iii ◽  
Controlled Study ◽  
Major Adverse Cardiovascular Events ◽  
Inadequate Response ◽  
Double Blind ◽  
Double Blind Placebo

ObjectiveTo assess the efficacy/safety of tofacitinib in adult patients with active ankylosing spondylitis (AS).MethodsThis phase III, randomised, double-blind, placebo-controlled study enrolled patients aged ≥18 years diagnosed with active AS, meeting the modified New York criteria, with centrally read radiographs, and an inadequate response or intolerance to ≥2 non-steroidal anti-inflammatory drugs. Patients were randomised 1:1 to receive tofacitinib 5 mg two times per day or placebo for 16 weeks. After week 16, all patients received open-label tofacitinib until week 48. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) and ≥40% improvement (ASAS40) responses, respectively, at week 16. Safety was assessed throughout.Results269 patients were randomised and treated: tofacitinib, n=133; placebo, n=136. At week 16, the ASAS20 response rate was significantly (p<0.0001) greater with tofacitinib (56.4%, 75 of 133) versus placebo (29.4%, 40 of 136), and the ASAS40 response rate was significantly (p<0.0001) greater with tofacitinib (40.6%, 54 of 133) versus placebo (12.5%, 17 of 136). Up to week 16, with tofacitinib and placebo, respectively, 73 of 133 (54.9%) and 70 of 136 (51.5%) patients had adverse events; 2 of 133 (1.5%) and 1 of 136 (0.7%) had serious adverse events. Up to week 48, with tofacitinib, 3 of 133 (2.3%) patients had adjudicated hepatic events, 3 of 133 (2.3%) had non-serious herpes zoster, and 1 of 133 (0.8%) had a serious infection; with placebo→tofacitinib, 2 (1.5%) patients had non-serious herpes zoster. There were no deaths, malignancies, major adverse cardiovascular events, thromboembolic events or opportunistic infections.ConclusionsIn adults with active AS, tofacitinib demonstrated significantly greater efficacy versus placebo. No new potential safety risks were identified.Trial registration numberNCT03502616

884: Phase I, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Investigate the Safety, Tolerability, and Pharmacokinetics of DA-8159

2004 ◽  
Vol 171 (4S) ◽  
pp. 234-234 ◽  
Author(s):  
Harin Padma-Nathan ◽  
Jae Seung Pacik ◽  
Byoung Ok Ahn ◽  
Kyung Koo Kang ◽  
Mi Young Bahng ◽  
...  
Keyword(s):  
Phase I ◽  
Controlled Study ◽  
Healthy Male ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Male Subjects
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