scholarly journals Comparison of efficacy and safety of choline fenofibrate (fenofibric acid) to micronized fenofibrate in patients of mixed dyslipidemia: A randomized, open-label, multicenter clinical trial in Indian population

2016 ◽  
Vol 20 (1) ◽  
pp. 67 ◽  
Author(s):  
Piyush Patel ◽  
Hanmant Barkate
Keyword(s):  
Clinical Trial ◽  
Indian Population ◽  
Efficacy And Safety ◽  
Fenofibric Acid ◽  
Multicenter Clinical Trial ◽  
Open Label ◽  
Mixed Dyslipidemia ◽  
Micronized Fenofibrate

Efficacy and safety of a novel vaginal medical device in recurrent bacterial vaginosis: a multicenter clinical trial

2020 ◽  
Vol 72 (5) ◽  
Author(s):  
Filippo Murina ◽  
Ciprian Crișan ◽  
Marius Biriș ◽  
Daniela Sîrbu ◽  
Dionisio F. Barattini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bacterial Vaginosis ◽  
Medical Device ◽  
Efficacy And Safety ◽  
Multicenter Clinical Trial

scholarly journals Rationale and Design of BeatNF2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Bevacizumab in Patients with Neurofibromatosis Type 2 Related Vestibular Schwannoma

2021 ◽  
Vol 28 (1) ◽  
pp. 726-739
Author(s):  
Masazumi Fujii ◽  
Masao Kobayakawa ◽  
Kiyoshi Saito ◽  
Akihiro Inano ◽  
Akio Morita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neurofibromatosis Type ◽  
Primary Objective ◽  
Neurofibromatosis Type 2 ◽  
Efficacy And Safety ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Hearing Function ◽  
Initial Intervention

Neurofibromatosis type 2 (NF2) causes bilateral vestibular schwannomas (VSs), leading to deafness. VS is treated by surgery or radiation, but neither treatments prevent hearing loss. Bevacizumab was found to be effective in suppressing the tumor’s growth and may help to improve hearing. We are conducting a randomized, double-blind, multicenter clinical trial to verify the efficacy and safety of bevacizumab in NF2-related VS. The primary objective is to evaluate the efficacy of bevacizumab in improving hearing in the affected ear. One of the secondary objectives is to evaluate bevacizumab’s efficacy in rechallenge treatment in relapsed cases. Sixty patients will randomly receive either bevacizumab or a placebo and will be clinically observed for 48 weeks in the initial intervention phase. In the first half (24 weeks), they will receive either 5 mg/kg of bevacizumab or a placebo drug. In the second half, all patients will receive 5 mg/kg of bevacizumab. If hearing function deteriorated in a patient who had shown improvement during the first phase, a rechallenge dose with bevacizumab would be offered.

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