11338 results
Primary objective:- To demonstrate that CT-P13 is noninferior to Remicade at Week 6 (Dose 3), in terms of efficacy, asdetermined by the Crohn*s Disease Activity Index (CDAI)-70 response rate.Secondary objectives:-To evaluate long-term secondary…
Primary ObjectiveTo determine the influence of treatment for OSA opioid-induced respiratory depression (minute ventilation (Vi); tidal volume (Vt); respiratory rate (RR); end-tidal pCO2; SpO2).Secondary ObjectivesAim 2: To determine the influence of…
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)…
Primary Objectives: To evaluate the overall bowel cleansing efficacy and the *Excellent plus Good* cleansing rate in the colon ascendens of a 1-day day before-only split-dosing regimen with NER1006 compared to a 1-day day before-only split-dosing…
The primary objective for part I of the study is the investigation of the pharmacokinetics. Although there is substantial clinical experience with all components of HTX-011, the formulation itself and the route of administration is new, which…
To obtain an estimate of the anterograde PCI success rate for patients with a confirmed target CTO in each treatment group and to explore safety and tolerability in these patients.
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…
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…
To Evaluate the safety and efficacy of the sirolimus-eluting stent system BioMime Compared to the Abbott's XIENCE (V Xpedition or Prime) Everolimus-eluting stent system in the treatment of patients with up to two de novo native coronary artery…
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…
Objectives:Primary Objective: • To assess the safety and tolerability of single and multiple ascending doses of BIM23B065 when given as a subcutaneous (s.c.) bolus injection in young healthy male subjects.Secondary objectives:• To determine the…
Primary Objectives:• Part 1: To evaluate the safety and tolerability of ruxolitinib in combination with pemetrexed/cisplatin and select a dose for further evaluation• Part 2: To evaluate and compare the overall survival of subjects with nonsquamous…
Primary Objectives:- To evaluate and compare the overall survival (OS) of subjects with advanced or metastatic adenocarcinoma of the pancreas when treated with JAK 1/2 Inhibitor in combination with capecitabine versus capecitabine alone.Secondary…
The primary study objective is to assess the proportion of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 24 weeks of treatment.Secondary study objectives are assessment of the…
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 Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…
To compare the efficacy of alitretinoin and azathioprine in the treatment of severe chronic non-hyperkeratotic hand eczema.
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…