27 results
The primary objective of this Registry is:• To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored hepatitis C study.The secondary objectives of this Registry are:• To determine whether subsequent…
The main objective is to examine the change in 68Ga-exendin tracer accumulation in the pancreas (i.e. beta cell mass) after RYGB by quantitative analysis of PET images before and one year after RYGB in morbid obese patients with type 2 diabetes.
The main study aim is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of children (< 16 years) with proven endogenous congenital hyperinsulinism who qualify for surgery based on response…
The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of patients with and without complete resolution of T2DM after RYGB by quantitative analysis of PET images.
The primary objective of this study is to provide access to SPD503 following participation in SPD503-315 or SPD503-316. The primary outcome of this study is to evaluate the long-term safety of SPD503. The evaluation of safety will be based on the…
The primary objectives of this study are as follows:• To determine the efficacy of treatment with GS-7977+ribavirin (RBV) compared as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (…
Primary Objective: To evaluate efficacy of SST looking at the change in uptake on SRS in a subset of chronically active patients in which intensification of corticosteroid therapy is not indicated. . Secondary Objective(s): To study the composite…
The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. The incidence of adverse events over 12 month treatment period will be the main…
This study is being conducted to provide a preliminary assessment of whether BL-5010 sloughs off SK lesions and has an acceptable safety profile (including no or minimal dermal irritation following the application at the site of the SK lesion).…
Primary objective:To determine the pharmacokinetics of E7080 and its excretion balance in order to elucidate its metabolic profile in plasma, urine, and feces following a single oral dose of radiolabeled 14C-E7080 in patients with advanced tumors or…
For Part A: the purpose of this part is to investigate the effect of multiple oral doses of the new study drug on how quickly and to what extent glimepiride is absorbed and eliminated from the body (this is called pharmacokinetics), if glimepiride…
The main objective of the trial is to identify at least one NGR that will demonstrate all of the following:1. Inhibition of ovulation2. Cycle control that is non-inferior to NuvaRing®, as judged by the incidence ofBTB-S during Treatment Cycle 3. The…
Primary objective: to investigate the safety of RFA in non-metastasized, irresectable locally advanced pancreatic cancer.Secondary objectives: to determine VAS pain score, length of hospital stay, survival, progression free survival and CA19-9…
The objective of this study is to assess the safety, efficacy and pharmacokinetics of 2 doses of LNG, delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 35 years of age during 3 years and with an extension…
The primary objective of this Registry is:• To evaluate HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral containing regimen…
The main objective of this study is to depict microglial activation behind a closed BBB in vivo and possibly establish an imaging marker of fast clinical progression, we will aim at visualizing microglial activity in vivo in cortical and hippocampal…
To evaluate the efficacy and safety of BIBF 1120 in HCC patients without prior systemic treatment as compared to Sorafenib.
The purpose of the study is to assess the effects of CER-001, given by intravenous infusion with regards to plaque burden of the carotid arteries and the descending thoracic aorta using 3T magnetic resonance imaging (3TMRI).The objective of the…
Primary objective: The primary objective is to assess the long-term safety of dupilumab administered in adult patients with AD.Secondary objective:The secondary objective of the study is to assess the immunogenicity of dupilumab in adult patients…
To assess short-term and long-term safety and tolerability of gantenerumab (RO4909832) given at doses up to 1200mg subcutaneous (SC) every 4 weeks (Q4W).Secondary Objective of the Open-label extension:- To evaluate of the effect of 1200 mg…