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A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis

Primary:The primary objective of the study is to evaluate the efficacy of KPL-301 versus placebo, coadministeredwith a 26 week steroid taper, for maintaining sustained remission for 26 weeks in subjects with newonsetor relapsing/refractory giant…

A Phase I/II open-label, single-arm, multi-center study of
ruxolitinib added to corticosteroids in pediatric patients
with grade II-IV acute graft vs. host disease after allogeneic
hematopoietic stem cell transplantation

The purpose of the study intends to assess safety, activity and pharmacokinetics of ruxolitinib treatment with corticosteroids in treatment-naïve and steroid refractory (SR)- acute Graft versus Host Disease (aGvHD) patients aged *28 days to <…

Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a randomized double blind placebo-controlled comparison (Triple M trial)

This study will compare sequential mifepristone and misoprostol treatment versus misoprostol treatment alone, which is currently the standard medical treatment in the Netherlands.

GGZ inteRvention In Prevention of suicidal behavior; A study investigating the effect of cognitive behavioral therapy for suicide prevention added to treatment as usual (TAU)

The main objective of this randomized controlled study is to investigate whether CT-sp in combination with treatment as usual (TAU) is more effective in reducing the severity and intensity of suicide ideation and suicidal behavior than only…

Stratifying Cystic Fibrosis Patients Based on Intestinal Organoid Response To Different CFTR-modulators

Identify the predicted best clinical responders and predicted low-responders (based on amount of organoid swelling) to new CFTR-modulators out of 500 unique patient-specific intestinal organoids screened for in-vitro drug efficacy. The 81 identified…

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU 285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…

A Phase III Open Label Extension Study to Assess the Long-Term Safety
and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy
(DMD) who completed the SIDEROS study

Primary:* To assess the long-term safety of idebenone in DMD patients who completed the SIDEROS study.Secondary:* To describe the long-term evolution of respiratory function in idebenone-treated DMD patients who completed the SIDEROS study,…

Robotic-assisted microsurgery in digital replantation in patients with traumatic digital amputation; a feasibility study

To assess the applicability of robotic-assisted microsurgery in replantation of amputated digits due to trauma.

Phase III confirmatory efficacy and safety trial of remimazolam (CNS7056) compared with propofol for intravenous anaesthesia during elective surgery

Primary ObjectiveThis is a confirmatory trial to establish non-inferior efficacy of remimazolam compared with propofol for induction and maintenance of GA for the purpose of elective surgery in patients classes III and IV based on the American…

Observational cohort of patients treated with stereotactic radiotherapy for
Oligo LYMPh nOde and other soft tissue metastasiS

Purpose of this studyThe main clinical challenge remains to identify patients who may benefit from aggressive local treatment (SBRT) of lymph nodesoft tissue oligometastases: for which patients can systemic treatment be postponed? Patients who are…

On-Site Augmented-Reality Computed Tomography Plus Angiography versus Angiography Alone for Guiding Percutaneous Coronary Intervention in Native Coronary Lesions * Randomized Study.

The objective is to assess whether analysis of the initial coronary CTA datasets using AR technology would affect the PCI treatment strategy and its immediate results as compared to traditional PCI under angiographic guidance alone.

An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (bintrafusp alfa) versus Pembrolizumab as a First-line Treatment in Patients with PD-L1 Expressing Advanced Non-small Cell Lung Cancer (MS200647-0037)

To demontrate improvement of progression-free survival (PFS) and/or overall survival (OS) with M7824 compared with pembrolizumab in first-line participants with advanced NSCLC with high PD-L1 tumor expression.

A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura.

The purpose of this study is to investigate how safe the new compound M254 is and how well it is tolerated when it is administered to healthy volunteers and patients with immune thrombocytopenia (ITP). M254 has not been administered to humans before…

First in-human study on the Safety, Tolerability and Efficacy of the Aqua Medical focal vapor ablation system, for the eradication of Barrett*s Esophagus

The aim of the current study is to assess the feasibility, safety and efficacy of the Steam ablation System for eradication of small BE areas

A randomized, double-blind, placebo-controlled, multi-centre, sequential design, phase IIa study to evaluate safety and tolerability of epicardial injections of AZD8601 during coronary artery bypass grafting surgery.

Primary Objective; To investigate safety and tolerability of AZD8601 following epicardial injection in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery with moderately impaired systolic function. In addition, exploratory objectives…

Evaluation of the effect of Duodenal Mucosal Resurfacing (DMR) using the Revita System in the
treatment of Type 2 diabetes (T2D)

Phase 1 (0 - 24 Weeks) Objective:To study the effect of DMR on glycemic and mechanistic endpoints24 weeks post-procedure in subjects with T2D.Phase 2 (24 - 48 Weeks) Objective:To study the effect of DMR on glycemic endpoints for assessment…

Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Arginase Inhibitor INCB001158 (formerly known as CB-1158) as a Single Agent and in Combination with Immune Checkpoint Therapy in Patients with Advanced/Metastatic Solid Tumors

Primary ObjectivesParts 2To evaluate the safety and tolerability of INCB001158 for patients with advanced/metastatic and/or treatment-refractory solid tumorsParts 3To evaluate the safety and tolerability of INCB001158 in combination with…

Tinnitus pitch matching by residual inhibition and contrast gain control.

The main objective is to improve the existing techniques for measuring the tinnitus pitch in patients, by exploring both the frequency dependence of the residual inhibition and the contrast gain control effect in the auditory system. Behavioral…

Efficacy of AlbenDazole to inDuce mUcosal healing in Patients on anti-TNF monotherapy: ADD UP trial

To evaluate the safety and efficacy of 12 weeks albendazole treatment added to anti-TNF monotherapy in adult patients with Crohn*s disease with incomplete mucosal healing.

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 (…