4970 results
The primary objective is to demonstrate that detoxification of benzodiazepines in high-dose benzodiazepine dependent patients using continuous subcutaneous infusion of flumazenil is feasible and safe.Secondary goals of the study are to explore 1)…
To assess the efficacy of rosuvastatin 20 mg on low-density lipoprotein cholesterol (LDL-C), compared to placebo, after 6 weeks of treatment in pediatric patients with HoFH.
Objectives:Primary:• To determine the absolute bioavailability of niraparib by using an intravenous (IV) niraparibmicrodose of 100 µg (containing approximately 1 µCi of [14C]-niraparib) in subjects with cancer.Secondary:• To characterize the…
To determine sensitivity, specificity, positive predictive value and negative predictive value of the spectroscopic cervical imaging device in detection of high grade cervical intraepithelial neoplasia.
The Primary objective is: 1) To investigate clinical effectiveness of the glutamatergic compound memantine in paediatric patients with: - Obessive-Compulsive Disorder (OCD) GOAT-1 - Autism Spectrum Disorder (ASD) GOAT-2 with respect to symptoms of…
Primary objective *To determine Maximum Tolerated Dose (MTD) of TH-302 combined with chemoradiotherapy (23 x1.8 Gy in combination with Carboplatinum and Paclitaxel) in patients with distal esophageal or esophago-gastric junction adenocarcinoma, and…
To investigate the efficacy of cognitive behaviour therapy (CBT) on reducing TTF in patients receiving TKIs for CML or GIST.
The study will collect data related to symptoms of recurrent biliary stent obstruction requiring reintervention, adverse events, and a variety of important secondary endpoints including technical success and time to symptomatic recurrent biliary…
Primary:The purpose of this study is to evaluate the safety, tolerability, orally administered LMI070 in patients with Type 1 SMA.pharmacokinetics (PK), pharmacodynamics (PD) and efficacy; and to estimate the Maximum Tolerated Dose (MTD) and optimal…
To study the efficacy, adverse events, logistic feasibility and costs of immunoadsorption for the removal of anti-GBM antibodies in patients with acute renal failure due to anti-GBM glomerulonephritis.
The Purpose of the study is to determine how quickly and to what extent two new formulations of UCB5857 (formulation A and B, administered by mouth) are absorbed and distributed into the body and how fast these are metabolized (broken down) and…
Primary:The primary objective of this study is to determine whether DMF taken over 12 months is effective in reducing MS-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in subjects with…
Investigate whether different resection modalities such as MO or TL cause a different amount of shrinkage in the mucosal margins of resected OSCCs.
To evaluate the safety, device-related complications, and performance of the NUsurface® meniscus implant as a device for the treatment of patients with degenerative and/or tears of the medial meniscus. .
The aims of this research are to estimate the efficacy of a relatively brief group CBT for bipolar disorders, by following the level of mood symptoms over time, and by assessing whether changes in dysfunctional attitudes and sense of mastery over…
Pharmacokinetic and pharmacodynamic properties of amlodipine oral liquid in the pediatric population
The primary objective of this study is to characterize the pharmacokinetic properties of amlodipine using the newly developed amlodipine oral solution 0.5 mg/ml in patients with chronic kidney diseases (CKD) and/or hypertension aged 6 months to…
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
The objective of the present trial is to investigate the safety of an allogenic tumor cell lysate loaded onto autologuous dendritic cells (AlloDen) in patients with malignant mesothelioma (MM). Heretoo we will perform a phase I study with a…
This study will evaluate the efficacy of the CbFAS with the optimal safe dose on the conversion of Barrett's epithelium to healthy squamous cell epithelium in a larger cohort. Furthermore, the device performance of the improved CbFAS will be…
Phase 1Primary objective- To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. See paragraph…