4940 results
The main objective of the present study is to determine the role of dopamine and stress in functional connectivity in neural substrates for habitual- and goal-directed behaviour and their effects in subsequent behaviour.
Primary objectives are:1.1) to study the effect of oral administration of morphine SR on health-related quality of life; 1.2) to explore whether morphine SR leads to respiratory adverse effects in patients with advanced COPD. Secondary objectives…
The primary objective of this study is:-To evaluate whether selonsertib (SEL, previously known as GS- 4997) can cause fibrosis regression and reduce progression tocirrhosis and associated complications in subjects with NASH and bridging (F3)…
Primary:- To evaluate the efficacy of Oxabact® following 52 weeks treatment in patients with maintained kidney function but below the lower limit of the normal range (eGFR < 90 ml/min/1.73 m2) and a total plasma oxalate concentration >…
- To assess the safety and tolerability of live-attenuated RSV vaccine in healthy adults.- To assess the immunogenicity of the live-attenuated RSV vaccine (systemic and mucosal immunity) - To assess the viral load/shedding of the live-attenuated RSV…
Primary Objective Blinded Phase:• To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency of seizures when compared with placebo in patients with TSC.Open-label Extension:• To evaluate via the adverse events (AE) profile…
To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related…
Primary Objective:To evaluate RBC transfusion independence in the 2 treatment arms (oral azacitidine plus best supportive care versus placebo plus best supportive care) in subjects with RBC transfusion-dependent anemia and thrombocytopenia (platelet…
The primary objective of this study is to evaluate the safety and tolerability using bleeding as the primary endpoint. Secondarily, this study will serve as a proof-of concept by evaluating the effect that DS-1040b administration has on total…
Recent studies show that treatment schedules of the first episode can safely be reduced (Hahn et al., 2015; Hoyer,2015), which may reduce steroid toxicity. The hypothesis of the REducing STEroids in Relapsing Nephroticsyndrome (RESTERN) study is…
Primary objectives: This study has co-primary objectives:• To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. • To compare DFS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. Secondary…
The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…
(1) To examine whether the exposure to BWL yields clinically significant reductions in CRF compared to exposure to dim white light in (non-)Hodgkin survivors. (2) To examine the effect of exposure to BWL compared to DWL on sleep quality and…
The primary objective is to evaluate the efficacy of V565 555 mg TID in subjects with active CD measured by the proportion of subjects achieving response to therapy. Response is defined as reduction in the Crohn's Disease Activity Index (CDAI)…
The purpose of this study is to analyse the effect on pain reduction of butylscopolamine in a continuous intravenous infusion compared to a placebo in patients with renal colics not responding to oral NSAIDs.
Primary objective: To evaluate the efficacy of IVIg treatment (4 courses of treatment, 3 weeks apart) compared to placebo on pain alleviation. Secondary objectives: 1. Pain intensity, pain qualities, and other SFN related complaints, daily and…
The purpose of the study is to investigate to what extent RO7049665 is tolerated. It will also be investigated how quickly and to what extent RO7049665 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the…
OBJECTIVES of the Study:Primary ObjectiveTo evaluate if the addition of ibrutinib to R-CHOP prolongs event-free survival (EFS) compared withR-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.Secondary ObjectivesTo compare ibrutinib in…
The primary objective of this study is to compare the progression-free survival (PFS) of ramucirumab in combination with docetaxel with the PFS of placebo in combination with docetaxel, in patients with locally advanced or unresectable or metastatic…
The primary objective of this study is to evaluate the efficacy of optimized thiopurine therapy. Secondary objectives are a cost-utility and budget impact analysis of optimized thiopurine therapy and the identification of biomarkers in mucosal…