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Treatment of chronic Respiratory failure in COPD patients with non-invasive ventilation: starting at home and selecting the right patient

Primary Objective: The aim of the present study is to investigate whether home initiation of chronic NIV in stable COPD patients with CHRF is non-inferior to inpatient initiation Secondary Objective(s): The secondary objective of the study is to…

Donor feces infusion for first episode of Clostridium difficile infection in patients at risk for recurrent infection

The primary objective of this study is to investigate whether FMT after antibiotic therapy is more effective than conventionalantibiotic therapy alone in patients with a first episode of CDI.

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.

To confirm the effect of continious subcutaneous insulin infusion (CSII treatment) with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 diabetes Mellitus, using a…

A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS

* To assess maintenance of biochemical control of octreotide capsules compared to parenteral SRLs in patients with acromegaly, who previouslydemonstrated biochemical control on both treatments.* To assess symptomatic response to octreotide capsules…

Clinical, microbiological and radiographical evaluation of implant surface decontamination using air polishing in the surgical treatment of peri-implantitis; a randomized controlled study

The primary objective of this randomized controlled trial is to compare the clinical effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using air polishing or hand instruments. The secondary objective…

AdreView* Myocardial Imaging for Risk Evaluation * A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 25% * LVEF * 35%. ADMIRE-ICD

To demonstrate the efficacy of AdreView* imaging for appropriately guiding the decision of ICD implantation in a population of New York Heart Association (NYHA) class II and III Heart Failure (HF) patients with 25% * left ventricular ejection…

Free-hand versus navigation guided percutaneous liver tumor ablation

The objective of the study is to compare free-hand needle placement with navigation guided needle placement.

RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding,
Effectiveness, Adverse evenT Trial)

The objective of this study is to demonstrate the safety and efficacy of thenew 6Fr sheath (Glidesheath slender 6Fr; GSS 6Fr) compared with thecontemporary 5Fr sheath (standard of care 5Fr; SOC 5Fr) both from Terumo;Tokyo, Japan.

A Randomized, Double-Blind, Multicenter, Equivalence Study of ONS-3010 and Humira® for the Treatment of Patients with Moderate to Severe Plaque Psoriasis

Primary:• To demonstrate the therapeutic equivalence of ONS-3010 (adalimumab biosimilar) compared toHumira® (adalimumab) in patients with plaque psoriasis Secondary:• To assess the safety, tolerability, and immunogenicity of ONS-3010 compared to…

Intensive endoscopic therapy versus conventional treatment for untreated benign anastomotic strictures after esophagectomy: a pilot and randomized controlled trial

To prolong the dysphagia-free period and to reduce the number of endoscopic dilations for patients with newly diagnosed, untreated benign anastomotic strictures after esophagectomy.

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

The chief aim of the proposed study is to compare the safety and efficacy of NiCord® single ex vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following…

Embryo selection using time-lapse monitoring in IVF and ICSI patients

Does embryo selection using time-lapse monitoring (TLM) with Eeva (Early Embryo Viability Assessment) improve the (cumulative) ongoing pregnancy rate after IVF & ICSI treatments?

Prevention of incisional hernias with prophylactic synthetic mesh placement during stoma reversal

The aim of this study is therefore to prospectively investigate whether prophylactic synthetic mesh placement reduces the rate of stomal site incisional hernias after stoma closure without increasing (infectious) complications.

COLOR III: A multicentre randomised clinical trial comparing transanal versus laparoscopic total mesorectal excision for rectal cancer.

In attempt to improve the quality of the TME procedure in low rectal cancer and further improve morbidity the TaTME has been developed, in which the rectum is dissected transanally according to TME principles. First series have been described since…

A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination
with Radiation Therapy in Newly Diagnosed Adult Subjects with Unmethylated MGMT (tumor O-6-methylguanine DNA methyltransferase) Glioblastoma.

This study will investigate whether treatment with Nivolumab in combination with radiation therapy, is comparable to Temozolomide in combination with radiation therapy in patients with Unmethylated MGMT Glioblastoma. We will measure this by…

A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician*s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

Primary:• To compare the overall survival (OS) of patients in the rigosertib group vs the Physician*s Choice group, in all patients and in a subgroup of patients with IPSS-R very high riskSecondary efficacy• To compare rigosertib to Physician*s…

The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy

Primary objective: To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to insulin (INS) treatment.Secondary objectives:…

A multi-center, randomized, double-blind, active-controlled, parallelgroup Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk
patients following an acute myocardial infarction

The purpose of this study is to evaluate the efficacy and safety of LCZ696 compared to ramipril, in reducing the occurrence of cardiovascular (CV) death, heart failure (HF) hospitalization and outpatient HF (time-to-first event analysis) in post-AMI…

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E mutant Metastatic Colorectal Cancer

Safety Lead-inIn patients with BRAF V600E mutant (BRAFV600E) metastatic colorectal cancer (mCRC):Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximabSecondary:• Assess the activity of encorafenib +…

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis

To demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS