8 results
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…
To improve overall survival of patients with a early-stage high grade uterine leiomyosarcoma.
Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.
To demonstrate the additive IOP lowering effect of SIMBRINZA (dosed BID) when added to DUOTRAV solution in subjects with open-angle glaucoma or ocular hypertension.
Primary objective:- To confirm in a multicenter setting an improvement in EFS to 95% at 2 years of DA-EPOCH-R in patients with newly diagnosed high risk Burkitt lymphoma as compared to an expected EFS of 72% at 2 years for the control arm R-CODOX-M/…
This study will investigates the effect of high dose alkylating chemotherapy compared to standard dose chemotherapy as part of a multimodality approach in patients with oligometastatic HRD positive and/or BRCA1/2 related breast cancer.
Primary objectiveThe primary objective of this study is to confirm non-inferiority of once-weekly somapacitan compared with once-daily Norditropin® in terms of longitudinal growth measured by height velocity at week 52 in children with each of the…
Primary Objective:• To compare the progression-free survival (PFS) of patients randomized to mirvetuximab soravtansine (MIRV) vs. Investigator*s choice of chemotherapy (IC Chemo) Key Secondary Objectives:• To compare the objective response rate (ORR…