Six-Month Follow-Up of a Booster Dose of CoronaVac: Two Single-Centre, Double-Blind, Randomised, Placebo-Controlled Phase 2 Clinical Trials

2021 ◽  
Author(s):  
Qianqian Xin ◽  
Qianhui Wu ◽  
Xinhua Chen ◽  
Bihua Han ◽  
Kai Chu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Booster Dose ◽  
Phase 2 ◽  
Single Centre ◽  
Double Blind ◽  
Phase 2 Clinical Trials

scholarly journals GNOSIS: Guidelines for neuro-oncology: Standards for investigational studies—reporting of phase 1 and phase 2 clinical trials

2005 ◽  
Vol 7 (4) ◽  
pp. 425-434 ◽  
Author(s):  
Susan M. Chang ◽  
Sharon L. Reynolds ◽  
Nicholas Butowski ◽  
Kathleen R. Lamborn ◽  
Jan C. Buckner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase 1 ◽  
Phase 2 ◽  
Phase 2 Clinical Trials

scholarly journals Olfactory ensheathing cells in chronic ischemic stroke: A phase 2, double-blind, randomized, controlled trial

2020 ◽  
Vol 8 (3) ◽  
pp. 182-193
Author(s):  
Yunliang Wang
Keyword(s):  
Ischemic Stroke ◽  
Olfactory Ensheathing Cells ◽  
Controlled Study ◽  
Cell Group ◽  
Placebo Control ◽  
Phase 2 ◽  
Double Blind ◽  
Assessment Scores ◽  
Ensheathing Cells

Olfactory ensheathing cells (OECs) have shown promising results for patients with neurologic diseases in non-double-blind, placebo control studies. Thirty patients with a unilateral ischemic stroke of more than a year were enrolled in a phase 2, multicenter, randomized, double-blind, and placebo-controlled cell therapy trial with a subsequent 12-month follow-up. The primary therapeutic objective has shown that after 12 months, there were significant differences in National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index (BI) assessment scores among the OEC group, Schwann cell group and placebo medium group at one-year follow-up. The second therapeutic objective found that there were significant differences in NIHSS, mRS, and BI assessment scores when comparing the endpoint data with the baseline data in the OEC group. There was neither hypersensitivity reaction nor adverse event. The results of this multicenter, randomized, double-blind, and placebo-controlled study indicate that injecting OECs into the olfactory sub-mucosa have neurorestorative effects, which can improve the quality of life for patients with chronic ischemic strokes without serious side effects.

Single-centre clinical follow-up of cladribine-treated patients from phase 2 and 3 trials

2020 ◽  
Author(s):  
Marcello Moccia ◽  
Roberta Lanzillo ◽  
Martina Petruzzo ◽  
Agostino Nozzolillo ◽  
Marcello De Angelis ◽  
...  
Keyword(s):  
Phase 2 ◽  
Single Centre

Abstract The authors have requested removal of this preprint.

scholarly journals Rezafungin versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis- The STRIVE Trial

2020 ◽  
Author(s):  
George R Thompson ◽  
Alex Soriano ◽  
Athanasios Skoutelis ◽  
Jose A Vazquez ◽  
Patrick M Honore ◽  
...  
Keyword(s):  
Invasive Candidiasis ◽  
Double Blind Study ◽  
Phase 2 ◽  
Double Blind ◽  
Once Daily ◽  
Secondary Endpoints ◽  
Intent To Treat ◽  
Cure Rates ◽  
Treat Population

Abstract Background Rezafungin (RZF) is a novel echinocandin exhibiting distinctive pharmacokinetics/pharmacodynamics. STRIVE was a phase 2, double-blind, randomized trial designed to compare the safety and efficacy of RZF once weekly (QWk) to caspofungin (CAS) once daily for treatment of candidemia and/or invasive candidiasis (IC). Methods Adults with systemic signs and mycological confirmation of candidemia and/or IC were randomized to RZF 400 mg QWk (400 mg), RZF 400 mg on week 1 then 200 mg QWk (400/200 mg), or CAS 70 mg as a loading dose followed by 50 mg daily for ≤ 4 weeks. Efficacy assessments included overall cure (resolution of signs of candidemia/IC + mycological eradication) at day 14 (primary endpoint), investigator-assessed clinical response at day 14, and 30-day all-cause mortality (ACM) (secondary endpoints), and time to negative blood culture. Safety was evaluated by adverse events and ACM through follow-up. Results Of 207 patients enrolled, 183 were in the microbiological intent-to-treat population (~21% IC). Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively. 30-day ACM was 15.8% for RZF 400 mg, 4.4% for RZF 400/200 mg, and 13.1% for CAS. Candidemia was cleared in 19.5 and 22.8 hours in RZF and CAS patients, respectively. No concerning safety trends were observed; ACM through follow-up was 15.2% (21/138) for RZF and 18.8% (13/69) for CAS. Conclusions RZF was safe and efficacious in the treatment of candidemia and/or IC.

scholarly journals Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

2010 ◽  
Vol 52 (10) ◽  
pp. 875-881 ◽  
Author(s):  
I. J. van den Elskamp ◽  
B. Boden ◽  
V. Dattola ◽  
D. L. Knol ◽  
M. Filippi ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Outcome Measure ◽  
Cerebral Atrophy ◽  
Phase 2 ◽  
Short Term ◽  
Phase 2 Clinical Trials

Low Dose (12 Gy) Total Skin Electron Beam Therapy (TSEBT) for Mycosis Fungoides (mf): Results of Three Phase 2 Clinical Trials

2014 ◽  
Vol 90 (1) ◽  
pp. S151
Author(s):  
R.T. Hoppe ◽  
C. Harrison ◽  
M. Tavallaee ◽  
S. Bashey ◽  
S. Li ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Electron Beam ◽  
Mycosis Fungoides ◽  
Low Dose ◽  
Phase 2 ◽  
Electron Beam Therapy ◽  
Three Phase ◽  
Phase 2 Clinical Trials

Survival following the documentation of platinum and taxane resistance in ovarian cancer: a single institution experience involving multiple phase 2 clinical trials

2004 ◽  
Vol 93 (3) ◽  
pp. 699-701 ◽  
Author(s):  
M MARKMAN ◽  
K WEBSTER ◽  
K ZANOTTI ◽  
G PETERSON ◽  
B KULP ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Trials ◽  
Phase 2 ◽  
Single Institution ◽  
Multiple Phase ◽  
Taxane Resistance ◽  
Phase 2 Clinical Trials
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