12 results
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,…
Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…
The objective of this study is to assess the effects of an increased NE level on the trade-off between exploitation and exploration. More specifically, this study will compare the exploitative/explorative behavior of participants who received either…
Primary Objectives:- To investigate the effects of a single dose (plasma concentration) 5-HTP challenge test (5-HTP200mg/CBD100+50mg/granisetron2mg) on hypothalamic fMRS activation patterns in healthy male volunteers.Secondary Objectives:- To assess…
Primary:1. To establish the effect of MCP on the release of plasma AVP and subsequent ACTH and cortisol secretion in the absence of a 5HTP-challenge.2. To establish the effect of MCP on the release of plasma AVP and subsequent ACTH and cortisol…
Change from baseline in regional cerebral blood flow in response to various visual stimuli ascertained by Positron Emission Tomography scan after 8 weeks of flibanserin 100 mg treatment.
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…
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-…
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.
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 (…
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…
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.