24 results
To evaluate the effectiveness of bilateral implantation over unilateral implantation in children with severe-to-profound sensorineural hearing loss. Furthermore with this study we will investigate whether simultaneous bilateral implantation is…
The main objective of the present study is to investigate the optimal stimulation pattern for tinnitus suppression in a structured way. Our study will focus on two parameters: stimulus level and anatomical stimulation site inside the cochlea.
The ENT clinic in Groningen has developed a new speech coding strategy: phase-lock speech (PLS) coding. This strategy distinguishes from existing strategies by the explicit coding of acoustic fine-structure. In normal hearing subjects, the…
The primary objective of this study is to determine the feasibility of intraoperative fluorescence imaging detection of PitNET tissue during TSS using the VEGF-targeting optical agent bevacizumab-800CW in tumors with a Knosp grade of 3 or 4.…
The aim of the current study is to examine whether it is possible to improve speech recognition in specific CI users by optimizing dynamic range and mean aided thresholds. Furthermore, we want to investigate to what extent patient counselling and…
Primary objectives Phase Ib: To estimate the MTD and/or RP2D of LGX818 in combination with cetuximab ± BYL719. Incidence of dose-limiting toxicities (DLTs). Phase II: To compare the efficacy of the dual (LGX818, cetuximab) and triple (LGX818, BYL719…
Safety Lead-inIn patients with BRAF V600E mutant (BRAFV600E) metastatic colorectal cancer (mCRC):Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximabSecondary:• Assess the activity of encorafenib +…
To assess the anti-tumor activity of LGX818/MEK162 in combination with third targeted agents after progression on LGX818/MEK162 combination therapy.
Primary: Phase Ib: To estimate the MTD(s) and/or RP2D(s) of the triple combination of WNT974, LGX818 andcetuximab in patients with BRAFV600-mutant CRC harboring Wnt pathway mutations.Phase II: To estimate the preliminary anti-tumor activity of the…
The objectives of this study are to evaluate the clinical outcome of a cochlear implant (CI) over standard health care therapy with either BAHA or CROSS in patients with SSD and to examine the cost efficiency of cochlear implantation in these…
The objectives are to evaluate the degree of bilateral benefit gained from having a second implant with respect to speech perception, spatial hearing, and listening effort.
To characterize the safety and tolerability.1. To describe the available RFS data by treatment arm.2. To describe the available DMFS data by treatment arm.3. To describe-reported health-related quality of life (HRQoL) bytreatment arm.
Encorafenib/binimetinb combination therapy can possibly reduce tumor size and thus making surgical treatment less comprehensive. In addition, the treatment can potentially improve recurrence-free survival, overall survival, and distant metastases-…
Sub-study APhase 1b:To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to determine the RP2D for the combination. Phase 2:To assess the durable ORR of sasanlimab in combination with encorafenib…
- To monitor the safety and tolerability of binimetinib- To monitor the safety and tolerability of encorafenib
To determine whether treatment with LGX818 plus MEK162 prolongs progression free survival (PFS) compared with vemurafenib, and/or whether treatment with LGX818 prolongs PFS compared with vemurafenib in patients with BRAF V600 mutant locally advanced…
Primary:- To evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the confirmed overall response rate (cORR) by local radiologist/investigator assessment in adult subjects with previously…
Primary objectives:The primary objectives are to evaluate the feasibility of oral administration of bevacizumab-800CW and cetuximab-800CW for detection of neoplasia in BE patients compared to HD-WLE to shorten the qFME procedure and test whether…
Primary Objective:To evaluate the efficacy of encorafenib + binimetinib in treatment-naïve and previously treated patients with BRAFV600E-mutant NSCLC as measured by ORR.Secondary objectives:1. To evaluate the efficacy of encorafenib + binimetinib…
The primary objective is to prospectively assess whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by an immunotherapy combination with nivolumab + ipilimumab improves Progression Free…