21 results
Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn*s Disease.
To investigate the effect of AMG 785 compared to placebo on functionalhealing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjectswith fresh unilateral low energetic hip (intertrochanteric or femoral neck) fracture
Primary objective: * To assess the treatment effect on progression-free survival in patients who receive AUY922 on a once-weekly schedule versus patients who receive docetaxel or irinotecanSecondary Objectives* To estimate the overall survival…
Efficacy Objectives:- Primary objective of this study is to demonstrate non inferior efficacy of PGL4001 versus GnRH-agonist to reduce, prior to surgery, excessive uterine bleeding caused by uterine myomas.- Secondary objectives are to demonstrate…
The primary objective of this study is to assess the efficacy and safety of Genz-112638 compared with Cerezyme after 52 weeks of treatment in patients with Gaucher disease type 1 who have been stabilized with Cerezyme. The secondary objective of…
To compare in a randomized controlled trail (RCT) the risk of neonatal hyperbilirubinaemia between neonates treated with CFT and amoxicillin-clavulanic acid (augmentin, AUGM) combination versus neonates treated with the aminoglycoside, tobramycin (…
1.1 Safety To evaluate the safety of long-term exposure with AMG 827 in subjects with Crohn*s disease 1.2 Efficacy * To evaluate the efficacy of AMG 827 as measured by the Harvey-Bradshaw Index (HBI) and the Crohn*s Disease Activity Index (CDAI)* To…
Primary Objective: The primary objective is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12. Secondary Objectives: Evaluate the efficacy…
Does addition of inhalation tobramycin to standard IV treatment result in a higher clinical cure rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.The initial response to treatment will be evaluated…
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.…
Objectives:Primary Objective:* To compare the overall survival (OS) distributions of RP101 and gemcitabine to placebo and gemcitabine in subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinomaSecondary Objectives:* To…
Primary objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in…
The first objective to investigate is the pharmacokinetics of DP tobramycin using the Cyclops® at four different dosages. The other objective is the local tolerability of DP tobramycin using the Cyclops® at four different dosages.
To investigate the clinical pharmacokinetics of tobramycin and/or colistin after nasal administration. With this pharmacokinetic parameters the safety of this treatment can be investigated.
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…
The main objectives are to investigate the pharmacokinetic properties of DP tobramycin via the Cyclops® at different dosages in children with CF, together with the local tolerability.
* To evaluate the effect of different doses of TIP on the change in P. aeruginosa bacterial load in sputum as assessed by the change in colony forming units (CFUs) from baseline to Day 29 of treatment, each compared to placebo.* To assess the safety…
Primary objectives:- To identify whether EBC can be used as a non-invasive method to measure the PK of salbutamol and tobramycin.- To determine whether the relationship in mild-moderate asthmatics between pulmonary lung function parameters and…
Primary objective: To study the pharmacokinetics of gentamicin, tobramycin, vancomycin and ciprofloxacin in morbidly obese patients and compare with normal weight patients. Secondary objectives: To assess the influence of covariates (such as TBW,…
To determine the effect of Pre-OP, in addition to perioperative intravenous antimicrobial prophylaxis on the cumulative incidence of deep surgical site infections (SSI) and/or mortality within 30 days after surgery in patients undergoing elective…