786 results
Primary objective:- Improvement of walking distance in 6MWT immediately after the first treatment and cumulatively after 3 consecutive treatments with PESFSecundary objectives:- improvement of oxygen saturation - improvement of quality of life-…
The objectives of the study are to: • Assess the efficacy of 2 dose levels of COR388 HCl in Alzheimer*s disease (AD) subjects; and• Assess the safety and tolerability of 2 dose levels of COR388 HCl in AD subjects.
The primary objective is to the safety of long term administration of etrasimod in subjects with moderately to severely active UC. The secondary objective is to assess the the long-term efficacy of etrasimod in subjects with moderately to severely…
Primary Objectives: 1. To evaluate the safety and tolerability of UB-312. 2. To evaluate the immunogenicity of UB-312 as determined by anti-alpha-synuclein (anti-aSyn) antibodies in blood and cerebrospinal fluid (CSF).
Primary: • To assess the Major Pathological Response (MPR) rate (<= 10% of residual viable tumor cells) on the resected specimen at the time of surgery in all subjects randomized to canakinumab alone or in combination with pembrolizumab.…
This study has been transitioned to CTIS with ID 2023-507443-10-00 check the CTIS register for the current data. The pivotal Phase III NETTER-1 study showed that Lutathera with best supportive care (30mg octreotide long-acting) provided a…
To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on albuminuria (ACR) decrease at 12 months
What is the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an endometrioma when compared to treatment with medication?
Asses whether, in patients with heart failure with preserved ejection fraction and iron deficiency, ferric carboxymaltose improves leftventricular diastolic function and skeletal muscle function by improving energy metabolism
Our primary goal is to develop an easy access cognitive training for older patients with mood disorders suffering from (subjective) cognitive complaints. We want to study the effect on both objective and subjective functioning. Secondary, we aim to…
The primary objective of this pilot intervention study is to gain insight into vedolizumab distribution and to identify vedolizumab target cells in the inflamed gut, by performing in- and ex-vivo imaging using a tracer consisting of fluorescently…
This study has been transitioned to CTIS with ID 2022-502858-14-00 check the CTIS register for the current data. primary objective:To assess the long-term safety and tolerability of mavacamten in participants with hypertrophic cardiomyopathy (HCM)…
To examine the pharmacokinetics in maternal blood of standard regimen at the Erasmus MC of two doses of 12 mg betamethasone intramuscular with a 24 hours interval for pregnant women suspected of preterm birth with a gestational age between 23+5…
Primary• To evaluate the safety and tolerability of AMG 199 in adult subjects• To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) Secondary• To characterize the PK of AMG 199 • To evaluate preliminary anti-tumor…
Primary objective To evaluate the Overall Response Rate (CR/PRrate) in patients treated with pembrolizumab for recurrent or progressive PCNSL after MTX-based first-line therapy To evaluate the safety of pembrolizumab in subjects diagnosed with…
To investigate if patient controlled sublingual sufentanil tablets as compared to patient controlled intravenous morphine lead to improved independent mobilization on postoperative day 1 after laparoscopic donor nephrectomy (LDN).
There is evidence however that abdominal wall blocks, such as TAP blocks, could help managing the postoperative pain, but covering the visceral pain is not possible with this technique. It is not even clear to date which component of pain, the…
This study investigates the impact of a goal directed nutritional support protocol on sarcopenia in oncological patients undergoing an esophagectomy and secondary the incidence of anastomotic leakage and pneumonia, surgical infection and lenght of…
Safety:* Evaluate the safety of AVXS-101 through incidence of adverse events (AEs) and/or serious adverse events (SAEs)* Evaluate the safety of AVXS-101 based on the change from baseline in clinical laboratory parametersEfficacy objectives will be…
Primary objectiveTo evaluate if tralokinumab after 14 weeks of treatment (at steady state) changes the metabolism of substrates of CYP 1A2, 2C9, 2C19, 2D6, or 3A4 pathways in subjects with moderate-tosevere atopic dermatitisSecondary objectivesTo…