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An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil (RClb)or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities.

The primary objective of the study is to demonstrate clinically relevant statistical superiority in progression-free survival (PFS) with GClb compared to RClb and Clb alone and RClb compared to Clb [GClb vs Clb; GClb vs RClb; RClb vs Clb] in…

Weekly administration of Oral Docetaxel in combination with Ritonavir

To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…

Effect of nutritional conditioning on the pharmacokinetics of acetaminophen

To assess the effect of short term starvation and short term high fat diet on orally administered acetaminophen metabolism in healthy subjects.

Metabolic effects of morning light in obesity and type 2 diabetes

To determine the direct effects of morning light intensity on postprandial glucose and lipid metabolism and metabolic gene expression in adipose tissue in obese subjects with and without type 2 diabetes.

Pharmacokinetic drug interaction study between rAltegraVIr and ATORvastatin (AVIATOR).

Primary objective:To assess the effect of multiple dose atorvastatin on the steady state pharmacokinetics of raltegravir and vice versa by intrasubject comparison in healthy subjects.• The comparison of steady state raltegravir (400 mg BID for 7…

Bioequivalence study in healthy volunteers of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children, phase I (VALID I)

In this trial will be investigated if a new formulation of valacyclovir, e.g. oral solution, is bioequivalent to valacyclovir tablets. This comparison will be made by determining pharmacokinetic parameters (AUC0-*, Cmax, and tmax) of both…

Metabolic effects of morning light

To determine the direct effects of morning light intensity on postprandial glucose and lipid metabolism and metabolic gene expression in adipose tissue.

A Randomized, Multicenter, Phase II study to Investigate Efficacy and Safety of ITF2984 in Acromegalic patients.

- To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.- To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l…

A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of protease inhibitors to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml

1. To assess the effect of the switch from protease inhibitors to raltegravir on endothelial function. 2. To assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on…

A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN*S LYMPHOMA GRADES 1, 2 OR 3A

To evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the intravenous (IV) route of rituximab administration.

Pharmacologic optimization of voriconazole; a prospective cluster randomized controlled trial of therapeutic drug monitoring

The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to…

Modulation of immune function by parenteral fish oil in patients with Crohn*s disease and high inherent Tumor Necrosis Factor-alfa production, a randomized, single blinded, cross-over study

To evaluate the effect of parenteral supplementation of fishoil based emulsion (rich in omega-3 fatty acids) compared with a soy bean oil emulsion (rich in omega-6 fatty acids) on the leukocyte functions (amongst others production of TNF-α and other…

Effect of Carbon Dioxide Enriched Ambient Air on Pharmacokinetics and Deposition In Bronchiectasis Patients Using Tobramycin Inhalation: A proof of concept study.

1. To asses (with planar imaging) whether SPECT/CT scan are feasible in assessing pulmonary deposition of inhaled tobramycin.2. To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients.3. To…

Evaluation of two insulin regimens for control of glucocorticoid induced hyperglycemia during chemotherapy

Primary Objective: Compare achievement of glycemic control in SSI therapy and NPH insulinGlycemic control is defined as the proportion of glucose measurements within target range (Fasting target glucose 3.9 * 7.8 mmol/l. Random target glucose 3.9-10…

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…

A single-center, open-label, randomized, 3-way crossover study to compare the rate and extent of Rivastigmine absorption from two different formulations of 7 day Rivastigmine transdermal systems (7-day RTS) with 24-hour Exelon® patches applied daily for 7 days in healthy male and female subjects.

To compare the rate and extent of rivastigmine absorption from two different formulations of 7-day rivastigmine transdermal systems (7-day RTS) with 24-hour Exelon® patch applied daily for 7 days in healthy adult male and female subjects.To assess…

Behavioral and physiological responses to sensory-specific satiety

To investigate responses of the autonomic nervous system (ANS) and facial expressions to sensory-specific satiety.

A randomized, open label, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 following a single subcutaneous injection by an autoinjector and by a pre-filled syringe in healthy male subjects

Primary objective:To demonstrate bioequivalence of GP2015 applied by an autoinjector (delta-GP2015_50) and a pre-filled syringe (PFS) as single subcutaneous injection of 50 mg to healthy adult male subjectsSecondary objectives- To study and compare…

A Randomized, controlled, cross-over Study to assess Hypoallergenicity of an extensively hydrolyzed whey protein Infant formula in children with cow's milk allergy using amino-based infant formula as a reference.

The primary study objective is to assess the hypoallergenicity of an extensively hydroloyzed whey protein infant formula in children with cow's milk allergy.The second study objective is to assess the long-term effects on growth and tolerance…

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Primary Objective:To compare the efficacy of pacritinib with that of Best Available Therapy (BAT) in patients with PMF, PPV-MF, or PET-MF; the efficacy measure for this analysis is the proportion of patients achieving a * 35% reduction in spleen…