Safety and Immunogenicity of Heterologous Boost Immunisation With an Aerosolized Ad5-nCoV After Two-Dose Priming With an Inactivated SARS-CoV-2 Vaccine CoronaVac in Adults: A Randomised, Open-Label, Parallel-Control Trial

2022 ◽  
Author(s):  
Jing-Xin Li ◽  
Shi-Po Wu ◽  
Xi-Ling Guo ◽  
Rong Tang ◽  
Bao-Ying Huang ◽  
...  
Keyword(s):  
Open Label ◽  
Parallel Control ◽  
Heterologous Boost

scholarly journals Efficacy and Safety of the Traditional Japanese Medicine Keigairengyoto in the Treatment of Acne Vulgaris

2018 ◽  
Vol 2018 ◽  
pp. 1-7
Author(s):  
Kotaro Ito ◽  
Saori Masaki ◽  
Manabu Hamada ◽  
Tetsuo Tokunaga ◽  
Hisashi Kokuba ◽  
...  
Keyword(s):  
Acne Vulgaris ◽  
Control Treatment ◽  
Control Group ◽  
Open Label ◽  
Serious Adverse Events ◽  
Efficacy Analysis ◽  
Traditional Japanese Medicine ◽  
Significant Difference ◽  
Parallel Control ◽  
Robust Evidence

Several traditional Japanese medicines including Keigairengyoto (KRT) are used to treat acne vulgaris, but there is no robust evidence of their effectiveness. In this study, we examined the effectiveness and safety of KRT in treating acne vulgaris. An open-label, randomized, parallel control group comparison was conducted with a conventional treatment group (adapalene and topical antibiotics; control group) and a KRT group (control treatment plus KRT). The test drugs were administered for 12 weeks to patients (15 to 64 years, outpatient) with inflammatory acne on their face, and the amount of acne at 2, 4, 8, and 12 weeks was measured. Sixty-four patients were enrolled; 29 patients in each group were included in the analysis. Twenty-eight patients in the control group and 24 patients in the KRT group were included in the efficacy analysis. The number of inflammatory skin rashes at 4 and 8 weeks in the KRT group was significantly decreased compared with the control group. There was no significant difference between the two groups in noninflammatory eruptions and general rashes. There were no serious adverse events in both groups. KRT may be a useful agent in patients with inflammatory acne in combination with conventional treatments. This trial is registered with UMIN 000014831.

Azathloprise in refractory sprue. Results from a prospective open-label study

2001 ◽  
Vol 120 (5) ◽  
pp. A392-A392 ◽  
Author(s):  
S NIVELONI ◽  
A CHERNAVSKY ◽  
S PEDREIRA ◽  
R MAZURE ◽  
H VAZQUEZ ◽  
...  
Keyword(s):  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Refractory Sprue

Role of GERD in chronic resistant sinusitis (CRS): Results of a prospective, open-label pilot trial

2001 ◽  
Vol 120 (5) ◽  
pp. A425-A425
Author(s):  
B OLUSOLA ◽  
J DIBAISE ◽  
J HUERTER ◽  
E QUIGLEY
Keyword(s):  
Pilot Trial ◽  
Open Label

A Multicenter Study of Recombinant Factor VIII (RecombinateTM) in Previously Treated Patients with Hemophilia A

1997 ◽  
Vol 77 (04) ◽  
pp. 660-667 ◽  
Author(s):  
G C White ◽  
S Courter ◽  
G L Bray ◽  
M Lee ◽  
E D Gomperts ◽  
...  
Keyword(s):  
Hemophilia A ◽  
Recombinant Dna ◽  
Home Treatment ◽  
Pharmacokinetic Parameters ◽  
Pharmacokinetic Studies ◽  
Open Label ◽  
Treat Ment ◽  
Previously Treated Patients ◽  
Bleeding Episodes

SummaryA prospective, open-label multicenter investigation has been conducted to compare pharmacokinetic parameters of recombinant DNA-derived FVIII (rFVIII) and plasma-derived FVIII concentrate (pdFVIII) and to assess safety and efficacy of long-term home-treat- ment with rFVIII for subjects with hemophilia A. Following comparative in vivo pharmacokinetic studies, 69 patients with severe (n = 67) or moderate (n = 2) hemophilia A commenced a program of home treatment using rFVIII exclusively for prophylaxis and treatment of all bleeding episodes for a period of 1.0 to 5.7 years (median 3.7 years). The mean in vivo half-lives of rFVIII and pdFVIII were both 14.7 h. In vivo incremental recoveries at baseline were 2.40%/IU/kg and 2.47%/IU/kg, respectively (p = 0.59). The response to home treatment with rFVIII was categorized as good or excellent in 3,195 (91.2%) of 3,481 evaluated bleeding episodes. Thirteen patients received rFVIII for prophylaxis for twenty-four surgical procedures. In all cases, hemostasis was excellent. Adverse reactions were observed in only 13 of 13,591 (0.096%) infusions of rFVIII; none was serious. No patient developed an inhibitor to r FVIII.

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