Safety and efficacy of mucosal immunotherapy using human papillomavirus (HPV) type 16 E7-expressing Lactobacillus-based vaccine for the treatment of high-grade squamous intraepithelial lesion (HSIL): the study protocol of a randomized placebo-controlled clinical trial (MILACLE study)

2019 ◽  
Vol 49 (9) ◽  
pp. 877-880 ◽  
Author(s):  
Yuji Ikeda ◽  
Yukari Uemura ◽  
Mikiko Asai-Sato ◽  
Takehiro Nakao ◽  
Takahiro Nakajima ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Papillomavirus ◽  
Phase I ◽  
Study Protocol ◽  
Controlled Clinical Trial ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Intraepithelial Lesion

This is a concept paper of multicenter, placebo-controlled, double-blind randomized phase I/II trial to test the safety and efficacy of IGMKK16E7 for patients with HPV16-positive high-grade squamous intraepithelial lesion.

Impact of human papillomavirus coinfections on the risk of high-grade squamous intraepithelial lesion and cervical cancer

2014 ◽  
Vol 134 (3) ◽  
pp. 534-539 ◽  
Author(s):  
Adela Carrillo-García ◽  
Sergio Ponce-de-León-Rosales ◽  
David Cantú-de-León ◽  
Verónica Fragoso-Ontiveros ◽  
Imelda Martínez-Ramírez ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion

scholarly journals A Multisite, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Vigabatrin for Treating Cocaine Dependence

2013 ◽  
Vol 70 (6) ◽  
pp. 630 ◽  
Author(s):  
Eugene C. Somoza ◽  
Douglas Winship ◽  
Charles W. Gorodetzky ◽  
Daniel Lewis ◽  
Domenic A. Ciraulo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cocaine Dependence ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo

scholarly journals Immunogenicity and Safety of Inactivated Sabin-Strain Polio Vaccine “PoliovacSin”: Clinical Trials Phase I and II

Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 565
Author(s):  
Anastasia Piniaeva ◽  
Georgy Ignatyev ◽  
Liubov Kozlovskaya ◽  
Yury Ivin ◽  
Anastasia Kovpak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Safety Profile ◽  
Neutralizing Antibody ◽  
Polio Eradication ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Good Tolerability ◽  
Poliomyelitis Vaccine

Global polio eradication requires both safe and effective vaccines, and safe production processes. Sabin oral poliomyelitis vaccine (OPV) strains can evolve to virulent viruses and result in poliomyelitis outbreaks, and conventional inactivated poliomyelitis vaccine (Salk-IPV) production includes accumulation of large stocks of neurovirulent wild polioviruses. Therefore, IPV based on attenuated OPV strains seems a viable option. To increase the global supply of affordable inactivated vaccine in the still not-polio free world we developed an IPV made from the Sabin strains–PoliovacSin. Clinical trials included participants 18–60 years of age. A phase I single-center, randomized, double-blind placebo-controlled clinical trial included 60 participants, who received one dose of PoliovacSin or Placebo. A phase II multicenter, randomized, double-blind, comparative clinical trial included 200 participants, who received one dose of PoliovacSin or Imovax Polio. All vaccinations were well tolerated, and PoliovacSin had a comparable safety profile to the Placebo or the reference Imovax Polio preparations. A significant increase in neutralizing antibody levels to polioviruses types 1–3 (Sabin and wild) was observed in PoliovacSin and Imovax Polio vaccinated groups. Therefore, clinical trials confirmed good tolerability, low reactogenicity, and high safety profile of the PoliovacSin and its pronounced immunogenic properties. The preparation was approved for clinical trials involving infants.

Evaluation of Dynamic Thiol-Disulfide Balance in Preinvasive Lesions of the Cervix

2021 ◽  
Author(s):  
Burak Sezgin ◽  
Fatih Pirinççi ◽  
Aysun Camuzcuoğlu ◽  
Eda Adeviye Şahin ◽  
Özcan Erel ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Human Papillomavirus ◽  
Stress Index ◽  
Lesion Group ◽  
Control Group ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Oxidative Stress Index ◽  
Preinvasive Lesions ◽  
Intraepithelial Lesion

Abstract Purpose: This study aimed to determine the potential clinical use of dynamic thiol disulfide balance in cases with preinvasive lesions of the cervix.Methods: One hundred and sixteen patients with high-grade squamous intraepithelial lesion, one hundred patients with low-grade squamous intraepithelial lesion and one hundred and ten healthy controls were enrolled in the study. A fully automated colorimetric system was used to determine the levels of thiol-disulfide parameters. The ischemia-modified albumin, total oxidant-antioxidant capacity, oxidative stress index of the retrieved cases were further analysed.Results: Native thiol and total thiol levels are significantly lower in the high-grade squamous intraepithelial lesion group according to control group (p:0.004 and p:0.015, respectively). Disulfide level is significantly increased in the high-grade squamous intraepithelial lesion group compared to control group (p:0.004). Oxidative stress index levels in high-grade squamous intraepithelial lesion group were observed as significantly higher according to the control group (p:0.014). Ischemia-modified albumin levels in the high-grade squamous intraepithelial lesion group were observed as significantly higher compared to the control group (p:0.020). Disulfide levels are positively correlated with risk type of Human papillomavirus (r:0.420, p<0.001).Conclusion: The analysis of dynamic thiol disulfide balance revealed considerable oxidative damage in patients with Human papillomavirus -related cervical precursor lesions compared to women with ordinary cytology specimens. Therefore, investigation of thiol disulfide balance with presented method represents a new promising test for early diagnosis and management of women at high risk for cervical cancer.

scholarly journals Effects of Nicotine Gum Administration on Vision (ENIGMA-Vis): Study Protocol of a Double-Blind, Randomized, and Controlled Clinical Trial

2020 ◽  
Vol 14 ◽  
Author(s):  
Thiago P. Fernandes ◽  
Jeffery K. Hovis ◽  
Natalia Almeida ◽  
Jandirlly J. S. Souto ◽  
Thiago Augusto Bonifacio ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Study Protocol ◽  
Controlled Clinical Trial ◽  
Nicotine Gum ◽  
Double Blind
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