20 results
The current research project will investigate the pressure relieving and preservation effects of felted foam. The aim of this study is to find the type of felted foam that is most effective in reducing plantar peak pressures. Furthermore, this study…
Question: Is it an added value for the patient if there will be a default capsaicin provocation test to diagnose chronic cough?It will be investigated or with the aid of the capsaicin provocation test the diagnosis sensory hyperreactivity (SHR) can…
-To investigate the feasibility, applicability, safety, tolerability, and reproducibility of addition of the capsaicin-heat model and the thermal grill to the existing nociceptive pain test battery in healthy subjects.-To investigate the feasibility…
The purpose of the study is to assess the safety and efficacy of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.
Primary:Part I:- to determine the effects of gabapentin and remifentanil on the evoked area of hyperalgesia, area of allodynia, pinprick hyperalgesia and background pain using a newly developed HCW sensitization modelPart II: - to determine…
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
The primary objective of this study is to document the incidence of unanticipated device and procedure related adverse events intra-operatively and through one year follow-up.
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
Primary objectivePart A• Evaluating the effect and reproducibility of the capsaicin sensitization model on the predefined primary endpoints in both primary and secondary hyperalgesia areas for LS• Evaluating the effect and reproducibility of the…
This study aims to demonstrate the effectiveness of dabrafenib with trametinib in pediatric patients with BRAF V600 mutant relapsed refractory HGG.This study aims to demonstrate the effectiveness of dabrafenib with trametinib compared to…
Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to overall response rate in subjects with rare BRAF V600E mutated solid tumors or hematologic malignancies.Secondary: duration of response,…
The main objective of this study is to study the feasibility and efficacy of neo-adjuvant treatment with BRAF/MEK inhibition to increase R0 rate of the tumor resection.
Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term effect of treatment with dabrafenib, trametinib or the combination on general health, growth and development.To…
Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
Part 1 primary objectives: To determine the safety, tolerability and range of tolerated combination doses in subjects with BRAF-V600E mutation-positive CRC intwo dosing groups:* dabrafenib dosed orally in combination with panitumumab * trametinib…
Primary: superiority of dabrafenib and trametinib combination therapy over vemurafenib monotherapy with respect to overall survival for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.Secondary: progression free…
Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…
This is an open-label, multi-center, roll-over study designed to provide continued access to subjects who have previously participated in a dabrafenib and/or trametinib parent study and who have fulfilled the requirements for the primary objective,…
Primary objective:To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies, by assessing the incidence and severity of AEs and SAEs; including changes in laboratory…