8 results
Primary objective:To compare the change in small airways obstruction (FEF75%) in patients with CF when inhaling one ampule of inhaled tobramycin with the Akita® compared to standard of treatment (twice daily nebulization of one ampule using standard…
1. To characterize the efficacy of topical Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in surgical subjects when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical2. To…
Primary:The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects undergoing spine, liver, vascular or soft tissue surgery, when…
Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…
- To assess the safety and tolerability and to determine the RP2D of T-DXd plus durvalumab in combination with cisplatin, carboplatin or pemetrexed
Primary objective:To describe the overall treatment effect of T DXd in HER2+ MBC patients with or without baseline brain metastasisSecondary objectives:- To describe the treatment effect on the development and progression of brain metastasis in…
The primary objective is to evaluate the ORR of trastuzumab deruxtecan in HER2-overexpressing and/or -HER2 mutated advanced NSCLC subjects.The secondary objectives are:- To evaluate DoR, DCR, PFS, and OS.- To further evaluate the safety of…
Primary objective:1. To evaluate IDFS with T-DXd treatment as compared to T-DM1Secundary objectives:1. To evaluate DFS with T-DXd treatment as compared to T-DM12. To evaluate OS with T-DXd treatment as compared to T-DM13. To evaluate DRFI with T-DXd…