13 results
Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…
Primary:To evaluate the effects of 15 mg E4/3 mg DRSP, of 30 mcg EE/150 mcg LNG, and of 20 mcg EE/3 mg DRSP on hemostasis, endocrine function and lipid and carbohydrate metabolism parameters during 6 treatment cycles.Secondary:To assess the safety…
The primary objective of the clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC. Secondary objective of the clinical part of EPISTOP is to…
Evaluate the efficacy of the combination therapie with azithromycin and metronidazole in a randomized trial
OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…
To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the previous year can decrease the exacerbation rate in the year of treatment.
Primary objectives1. Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?2. Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?Secondary objectives1. Is…
Primary Objective: To assess whether early postoperative AED withdrawal improves cognitive function compared to late withdrawal.Secondary objectives: * To confirm safety of earlier AED withdrawal; we will assess eventual seizure freedom, seizure…
To determine the effectiveness of the currently recommended treatment regimens.
1. To assess whether azithromycin enhances resolution of systemic inflammation in patients with drug susceptible pulmonary TB receiving HRZE treatment. 2. To assess whether azithromycin on top of HRZE treatment in patients with drug susceptible…
The primary objectives of this study are:· To assess the time to first exacerbation of COPD, measured from the time of randomization The secondary objectives of this study are:· To evaluate the improvement of quality of life by Saint George*s…
The primary objective of this study is to evaluate the effect of multiple doses of azithromycin, clarithromycin and ritonavir on the pharmacokinetics, safety and tolerability of a single oral 150 mg dose of ivacaftor in healthy controls and in…
The primary objective is to evaluate the potential efficacy of personalized adjunctive antibiotic therapy in maintaining clinical remission in pediatric subjects undergoing SOC induction therapy for mild to moderate Crohn*s disease who have a…