115 results
to investigate the analgesic effect of high frequency 10 Hz rTMS on experimental pain measured through quantitative sensory testing (QST) in healthy subjects.
The primary objective of this study is to evaluate the effectiveness of lipofilling in treatment of speech and swallowing impairment after treatment for head and neck cancer. The secondary objective is to evaluate the effect of lipofilling on tongue…
The primary objective of this project is to evaluate the primary and secondary technique effectiveness of IRE for centrally located colorectal liver metastases that are neither amenable for resection nor for other local ablation methods due to the…
Safety (Primary) ObjectiveThe primary objective for this study is as follows:- To evaluate the safety and tolerability of cobimetinib in children and young adults, including estimation of the maximum-tolerated dose (MTD) or the maximum administered…
For the primary and secondary efficacy objectives, analyses will be performed in patients in different patient subpopulations according to programmed death*ligand 1 (PD-L1) expression in tumor tissue as evaluated by immunohistochemistry (IHC). The…
To determine the pharmacokinetics of two high dose regimens of intravenous vitamin C in critically ill patients, in particular the attained plasma concentration and the fraction retained in the body and excreted in urine.
Primary objectives:* To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study Secondary objectives:* To establish the safety and toxicity profile of adjuvant 166Ho-RE after…
To determine the effect size of three different doses of PRM-151 on reduction in bone marrow fibrosis by * 1 grade in intermediate-1, intermediate-2, and high risk subjects with PMF, post-PV MF, or post ET-MF who are anemic or thrombocytopenic and…
PRIMARY* To determine the efficacy on study Day 28 of T-Guard in inducing a clinical response in patients with severe acute GVHD refractory to first line steroid therapy.SECONDARY* To evaluate the overall safety and efficacy during the first 6…
To determine the tacrolimus bioavailability after tacrolimus administration via a rectiole.
Primary Objective: Visualization and quantification of tumor hypoxia with [18F] HX4 PET imagingSecondary Objectives: - Correlation of [18F] HX4 with local tumor recurrence and survival- Correlation of hypoxia imaging with blood hypoxia markers -…
To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…
To Evaluate the Safety and Effectiveness of the Essure® ESS505 Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception (*Study*)
The first objective of this study is to evaluate the potential of do-it-yourself devices for self-measuring health parameters by subjects in obtaining interesting data. The second objective of this study is to evaluate if increased awareness of own…
Primary objective: To evaluate the differences in digestion and absorption on the administration of enteral nutrition either gastric or distal to the ligament of Treitz in the jejunum.Secondary objective: To evaluate the differences in endocrine…
To determine the efficacy (as measured by objective tumor response) of single agent everolimus in the treatment of advanced malignancies or high risk polyps of patients known with PJS .
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…
The primary objective of this study is to test safety and performance of the APD Perfusion Measurement Catheter & Monitor for the measurement of gut perfusion in humans. The secondary objectives of this study are to assess the normal values…
Pertuzumab is an investigational agent being studied for the treatment of HER2-positive gastric cancer. This study intends to provide a dose of pertuzumab to find an acceptable minimum pertuzumabconcentratie pertuzumab effective when administered in…
The aim of the present study is to investigate the effectiveness of paracetamol as intravenous subscription form versus paracetamol as rectal subscription form in order to prevent pain in neonates. To study this, therapeutic doses, the doses…