15 results
The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, de novo coronary artery lesions.
Based on the positive effects of Celecoxib on ultrafiltration and peritoneal injury during PD in rats, we would like to propose a pilot study using Celecoxib in PD-patients. In this pilot study we will investigate whether the Cox2 inhibitor…
The present proposal seeks to compare the cardiovascular and gastrointestinal safety and effectiveness of a strategy of initial randomisation to treatment with the selective COX-2 inhibitor celecoxib or to *usual-care* with their current non-…
The study objectives are:- to characterize the biotransformation pathways, the routes and rates of excretion, and total recovery of the 14C-labeled research medication and its radiolabeled metabolites- to characterize the pharmacokinetics (PK) of…
The primary objective of this study is to determine the excretion balance and to elucidate the metabolic pathway of eribulin in vivo after a single dose of carbon-14 radio-labeled eribulin (14C-eribulin), inpatients with advanced solid tumors.
Primary objective: To study the influence of repeated oral administration of ketoconazole, a potent CYP3A4 inhibitor, in a therapeutic dose on the plasma pharmacokinetics (PK) of eribulin administered via intravenous (IV) infusion.Secondary…
Primary objective• To assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin following intravenous (IV) administrationSecondary objectives• To assess the safety of eribulin when co-…
In the Netherlands, approximately 500 patients with FAP have been recognized, who are at high risk for developing duodenal carcinoma. Better insights in the pathogenesis of duodenal cancer and development of chemoprevention strategies are of pivotal…
To measure in vivo effect on neuroinflammation of treatment with celecoxib, a selective COX-2 inhibitor, in PD using PK111-95 and PET.Celecoxib showed broad utility in animal models of neurodegeneration. Neurochemical effect of the treatment on…
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
Dual Primary objective: - To demonstrate the superiority of Dato-DXd compared to ICC by assessment of PFS in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer, who have been treated with 1 or 2 lines of chemotherapy…
The primary objective of this study is to compare the overall survival (OS) associated with rAd-IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM…
The study objective is to assess the safety and efficacy of the Svelte DES-IDS and the Svelte DES-RX compared to a commercially available Xience or Promus Drug-Eluting Stent in subjects with up to three de novo coronary artery lesions in up to two…
Primary Objective: To determine the safety and feasibility of pre-operative immunotherapy in CRC. Additional Primary Objective for the expanded the MSI cohort: To assess efficacy of neoadjuvant ipilimumab plus nivolumab in terms of disease-free…
Among patients under treatment for depression, we will select 140 persons with IMD. In this specific group of patients, we will test whether celecoxib add-on (400 mg/d) is more effective than placebo in the treatment of depression through a 12-week…