18 results
We want to answer the following research questions using a peri-operative infusion of lidocaine (PIL) protocol:1. Does low dose peri-operative intravenously administered lidocaine attenuate systemic inflammatory response measured by plasma cytokine…
This study looks if the third generation antipsychotic aripiprazole can improve activity of the prefrontal cortex and cognitive and social function, when compared to the second generation antipsychotic risperidone.
Primary ObjectivesThe primary objective is to assess the efficacy (primarily through time to relapse) of long-acting injectable (LAI) paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over…
Pilot study:Primary objective: feasibilitySecondary objectives: response rate, time to progression, overall survival and quality of life.Phase II study:Primary objective: efficacy.Secondary objectives: toxicity, especially grade 3 and 4 toxicities,…
The primary objective of this study is to evaluate whether lidocaine reduces the need of alfentanyl during colonoscopy in patients with IBD.The secondary objective of this study is to evaluate whether lidocaine reduces the incidence of respiratory…
Primary objective is to compare all cause discontinuation rates in patients with schizophrenia randomized to either one of the two depot medications (aripiprazole depot or paliperidone palmitate) with patients randomized to either one of the two…
Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…
Primary objectiveTo evaluate the efficacy of low dose intravenously lidocaine in comparison with placebo in terms of pain relief after the first oxaliplatin administration measured by a numeric rating scale (NRS 0-10).Secondary objectives1.…
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…
To prospectively explore the feasibility safety, tolerability, preliminary efficacy, costs, and pharmacokinetic profile of repetitive ePIPAC-OX as a palliative monotherapy for isolated unresectable colorectal PM under controlled circumstances.
Our objective is to investigate the value of a HVIGI in chronic midportion Achilles tendinopathy, using a dubbel-blind, placebo-controlled, randomised clinical trial. We expect that this study design gives us the opportunity to provide solid advise…
Part 1In Part 1 of the study, no study compound will be administered, but a bone marrow aspiration and a blood sample will be taken to evaluate an assay that will be used for Part 2 and Part 3 of the study. Because no nirogacestat is given, we can…
Primary Objectives:-To evaluate if the treatment of Low Risk HB can be reduced (Group B1)-To compare different induction treatment regimens for Intermediate risk HB (Group C)-To compare different post induction treatment regimens for High Risk HB (…
To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
Primary objective:To determine the percentage of the patients that achieve optimal 5-FU exposure within two dose cycles of 5-FU, which is defined by an AUC target of 5-FU between 20 and 30 mg h/L or dose limiting toxicity.Secondary objectives:-To…
Primary Objective: - To establish the population range (24-h AUC) of high-dose infusional 5-FU in patients with locally advanced, resectable gastric or gastro-esophageal junction cancer treated with perioperative FLOT.Secondary objectives: - To…
The aim of this study is to prove feasibility of HAIP chemotherapy (floxuridine) in combination with standard systemic chemotherapy consisting of FOLFOX or FOLFIRI.
In SPACe 2 STAR, we aim to reach further, we will test whether application of TDM in clinical practice is indeed able to reduce the number/severity of metabolic side effects, while retaining clinical effectiveness in children by means of a…