754 results
Primary To determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLT) of LEE011 when administered orally once daily for 21 consecutive days followed by a 7 day break.Secondary *Safety and tolerability of LEE011.*…
Primary:- To test the hypothesis that the clinical effect of KJD (determined by WOMAC) is not (clinically relevant) different from TKP at 2 years post treatment (equivalence hypothesis). Secondary:- To describe and compare the clinical efficacy over…
The objective of this extension study is to find out the potential long-term benefits and safety of tolvaptan. During this study all participants will receive tolvaptan.PRIMARY OBJECTIVE is to demonstrate whether tolvaptan modifies ADPKD progression…
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo as maintenance therapy in subjects…
Primary objective* To demonstrate the effect of ACT-293987 on time to first morbidity and mortality (MM) event in patients with pulmonary arterial hypertension (PAH).Secondary objective * To evaluate the effect of ACT-293987 on exercise capacity and…
The primary objectives of this study consist of:1. To assess the accuracy of different pulse contour methods to measure CO compared to thermodilution CO measured with a PAC in major abdominal surgery patients.2. To assess the effect of propofol…
The purpose of this study is to investigate the effectiveness of pelvic physical therapy as a SURPLUS to the paediatric usual care in children (5-17 years) with functional constipation.Other research questions are: Does pelvic physiotherapy…
Primary: To evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.Secondary: To evaluate the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride…
Primary obejective is the evaluation a ventral patch is associtaed with less complications than a conventional mesh for epigastric and umbilical hernias. Complications are defined as unexpected events necessitating a treatment within the period of…
To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)
To compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to compare the duration of hospitalisation, quality of Life, cost and to compare the satisfaction of the patients.
The primary objective of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with PAH. This will be assessed by time…
The objective of the study is to determine the effectivity of this consolidation treatment, as well as the conversion rate of PR to CR in patients in PR before consolidation and the effect on the immunological recovery.
Objectives:Primary* Phase Ib: to determine the maximum tolerated dose (MTD) recommended for Phase II of eribulin mesylate (eribulin), administered in combination with gemcitabine plus cisplatin in patients with locally advanced or metastatic bladder…
To evaluate the long term safety, efficacy, predictability, stability, complications and patient satisfaction after implantation of Artisan phakic intraocular lenses for the correction of high degree myopia.
Primary objective:Evaluate the effect of two doses versus placebo gantenerumab subcutaneous injections on the change in Clinical Dementia Rating Sum of Boxes scale (CDR SOB), a global measure of cognition and functional capacitySecondary objectives:…
Primary ObjectiveThe primary objective of this double-blind, randomized, placebo-controlled, Phase 3 study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA amyloidosis. Efficacy will be assessed by the time…
The main of objectives are to study the effect of the start of dialysis treatment (hemodialysis and peritoneal transplantation), on selected cardiovascular, nutritional parameters as well as physical activity. Secondly, a differentiation will be…
The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…
The primary objective of this study is to estimate the effect of endovascular treatment on overall functional outcome after acute ischemic stroke of less than six hour duration, in patients with a symptomatic anterior circulation IAO. The secondary…