17 results
Primary Objective The primary objective of this study is to compare the change from baseline in HbA1c after 24 weeks of double blinded treatment with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin.…
This protocol is designed to determine the safety, tolerability, and efficacy of SGI-110 in combination with irinotecan in previously treated patients with metastatic colorectal cancer who progressed on irinotecan.
To measure intraprostatic concentrations and serum levels of fosfomycine after a single oral or intravenous dose prior to TURP. This is done to achieve more insight in whether fosfomycin is a suitable antibiotic to use as profylaxis or treatment of…
The aim of this study is to evaluate and describe the PK of fosfomycin in individuals receiving oral treatment with multiple dosages of fosfomycin for recurrent and/or complicatedurinary tract infection. The results of this study will be used to…
Primary objectivesTo determine the bacterial eradication capacity of ertapenem, fosfomycine and gentamicine compared to the reference treatment (ceftriaxone) in uncomplicated anogenital gonococcal infections (at one included infection site) by…
A non-inferiority/superiority trial was designed for the treatment of uncomplicated cystitis in the Dutch community, in which we compare a 1-day and 3-day regimen of FT to a 5-day regimen of nitrofurantoin to investigate the effect on time to…
The DAPARHT trial is designed to assess effect of the SGLT2 inhibitor dapagliflozin to prevent deteriorating renal function in heart transplant recipients. Secondary objectives are to assess the impact of treatment on: i) weight, ii) glucose…
- To assess the effectiveness of rectal culture-guided antimicrobial prophylaxis for transrectal prostate biopsy (random ultrasound-guided, targeted MRI-guided or targeted MRI-ultrasound fusion guided) on infectious complications. - To compare the…
In this study we aim to evaluate the effectivity of the current, standard treatment of uncomplicated urinary tract infections with fosfomycin, based on urine concentrations of fosfomycin in urine in healthy volunteers after receiving a single, oral…
This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…
Primary Objective: To assess the change from baseline in 24-hr albuminuria with dapagliflozin for six weeks relative to placebo treatment in patients with diabetes and albuminuria > 100 mg/day on stable ACEi or ARB treatment.Secondary…
To determine the influence of concomitant administration of Lonsurf with metformin and cimetidine on Lonsurf and metformin exposure.
The primary objective is progression-free survival (PFS); defined as the time from randomization to the date of the first documented tumor progression; determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or death due…
To evaluate the efficacy of trifluridine/tipiracil by determination of the percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously…
To demonstrate the superiority of S 95005 + bevacizumab over capecitabine + bevacizumab in terms of Progression-free survival (PFS) based on Investigator assessment in first-line treatment of patients with unresectable metastatic colorectal cancer…
· To evaluate the effect of zibotentan anddapagliflozin in combination and alone versusplacebo on UACR.
To determine the efficacy of oral fosfomycin in comparison to the standard of care oral ciprofloxacin, in the treatment of FUTI after initial empirical treatment with intravenous antibiotics.To describe the pharmokinetic profile of men treated with…