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A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Homozygous or Heterozygous for the F508del Mutation

Primair eindpunt:Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Homozygous or Heterozygous for the F508del Mutation.Secundair eindpunt:Evaluate the long-term efficacy of VX-…

Electrical Brain Responses During Processing of Nociceptive Stimuli Around Detection Threshold: an Explorative Study in Pain Patients

The aim of this study is to combine measurements of the NDT with EEG recording and analysis to observe neurophysiological activity during nociceptive processing in CRPS patients. In this explorative study, multiple types of stimuli are delivered.…

Ulipristal versus standard surgical treatment in symptomatic uterine fibroids

This study has been transitioned to CTIS with ID 2024-512602-26-00 check the CTIS register for the current data. Evaluate the (cost-) effectiveness of ulipristal in comparison with standard surgical treatment for symptomatic uterine fibroids,…

A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab in Combination With Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)

To assess the safety and tolerability profile of durvalumab monotherapy, durvalumab + novel oncology therapy, durvalumab + chemotherapy, anddurvalumab + novel oncology therapy + chemotherapy combinations

EvaluaTIoN of Clinical and laboratory outcomes of Rivaroxaban in short Bowel syndrome patients dEpending on Long term parenteral nutrition: a prospective cohort study (TINCRBEL study)

This study has been transitioned to CTIS with ID 2024-519078-38-00 check the CTIS register for the current data. 1) To evaluate the efficacy and safety of the standard clinical care at the AMC in this patient population by the clinical outcomes (…

Neoadjuvant AXITINIB plus AVELUMAB for patients with localized RCC and a moderate to high risk of recurrence

This study has been transitioned to CTIS with ID 2024-515825-27-00 check the CTIS register for the current data. To investigate efficacy of neoadjuvant axitinib and avelumab in patients with localized renal cell carcinoma with moderate to high risk…

An open-label, multi-center, roll-over study to assess long term safety of lenvatinib monotherapy or lenvatinib combination regimen or comparator treatment arm to cancer patients in Eisai sponsored lenvatinib trials

The primary objective is to assess long-term safety of study drug(s) in subjects who are enrolled in Eisai-sponsored lenvatinib studies.

Evaluation of new blood collection systems

The objective of the study is to determine the quality and usability of blood collection systems.

Testing for sepsis in primary care: diagnostic and prognostic study investigating the potential benefits of point-of-care testing

The objective of the study is to improve the detection of sepsis in primary care by developing a clinical decision rule for GPs, consisting of the most relevant clinical features and point-of-care (POC) measurements of biomarkers. This decision rule…

A phase 1-2 immunoPET imaging study with ZED88082A in patients before and during treatment with 1) MPDL3280A or 2) PD-1 antibody plus or minus ipilimumab

Primary objectives: To evaluate safety of ZED88082A in combination with CED88004S. To determine appropriate ZED88082A/CED88004S dosing and PET imaging time-points. To evaluate pharmacokinetics (PK) of ZED88082A/CED88004S in patients before and…

A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in combination with Pembrolizumab in Adult Subjects with Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

• Primary- To determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adult subjects with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).• Secondary-To evaluate the safety, efficacy, and…

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAR443060 in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…

PERICLES (PEnile cancer Radio- and Immunotherapy CLinical Exploration Study) - a Phase 2 study of atezolizumab with or without radiotherapy in penile cancer

The primary objective is efficacy of atezolizumab in advanced penile cancer patients measured by progression-free survival.

A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 with and without Ruxolitinib in Patients with Myeloproliferative Neoplasms)

Phase 2 (MF Expansion-Prior JAKi Arm 1 and Add-on to JAKi Arm 2) Primary Objectives:- To evaluate splenic response rate by imaging after 24 weeks of treatment in Cohorts 1B and 2B (i.e., in non-TD cohorts)- To evaluate the rate of conversion from…

Malnutrition in Polytrauma Patients

The primary objective is to investigate whether polytrauma patients (Injury Severity Score [ISS] >= 16) admitted to the ICU who have or develop malnutrition have a higher complication rate than patients who are and remain well-nourished.…

TANGO-DM: Randomized trial of effective treatment according to new GDM criteria

To evaluate the effectiveness and cost-effectiveness of intensive GDM treatment as compared to routine maternity care in pregnant women with a discordant OGTT result between the new (2013) WHO criteria as compared to the old (1999) WHO criteria for…

A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy.

This study has been transitioned to CTIS with ID 2022-502832-37-00 check the CTIS register for the current data. To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy…

A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination with Ipilimumab or Nivolumab Monotherapy in Participants with Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Primary Objectives:• To compare Blinded Independent Committee for Radiology (BICR)-assessed objective response rate (ORR) in participants of tissue Tumor Mutational Burden-High (tTMB-H) treated with nivolumab combined with ipilimumab • To compare…

Nasal High-Flow Therapy to treat COPD exacerbations: a matter of monitoring and controlling settings?

The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background…

Cross-sectional study for evaluation of Platelet function and Immune profile in patients with Chronic ITP

To assess platelet function and coagulation parameters in adult chronic ITP patients in relation to their bleeding phenotype