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Infection prevention and immune modulation by bacterial lysates in patients with asthma: gaining insight into the mechanism of an old therapy

To diminish the number of asthma exacerbations with the regular use of a bacterial lysate.

A randomized double-blind placebo-controlled phase I study on the safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM8101) in healthy male subjects during experimental endotoxemia.

Primary Objective:1. To assess the safety and tolerability of single escalating doses of Adrecizumab in healthy male volunteers during experimental endotoxemia.Secondary Objectives:2. To determine the pharmacokinetics of single escalating doses of…

Xylitol/saline nasal irrigations in patients with CRS without polyps, a multicenter double-blind, randomized study in 66 subjects with CRS without polyps

In this study we will compare the therapeutic value of saline only versus xylitol/saline nasal irrigations in patients with CRS without nasal polyposis (CRSsNP). We will investigate several parameters by means of 2 different questionnaires and…

A randomized, placebo-controlled, double-blind, multi-center Phase 2/3 trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease

This study has been transitioned to CTIS with ID 2023-505313-24-00 check the CTIS register for the current data. To evaluate the treatment effect of CAM2029 compared to placebo on liver volume in patients with polycystic liver disease (PLD)

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma (KEYNOTE 966)

This study has been transitioned to CTIS with ID 2023-506657-38-00 check the CTIS register for the current data. To compare pembrolizumab plus gemcitabine plus cisplatin to placebo plus gemcitabine plus cisplatin with respect to overall survival (OS…

'Early detection of hepatic metastasis in follow-up high-risk colorectal carcinoma*

1. The primary objective of this study is to investigate if follow-up of asymptomatic patients with high-risk colorectal carcinoma with reduced protocol MRI liver instead of US will affect the time to diagnosis recurrent liver metastasis (LM-2) in…

A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

To compare pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE with regard to progression-free survival (PFS) per RECIST 1.1 assessed by blinded, independent central review (BICR)

Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases in patients with a low clinical risk score - a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-512850-10-00 check the CTIS register for the current data. The primary objective is to compare the efficacy of surgery and adjuvant HAIP chemotherapy to surgery alone in patients with resectable…

Topical or oral antibiotics for children with acute otitis media presenting with ear discharge?*

To establish the clinical and cost-effectiveness of antibiotic-corticosteroid eardrops as compared with oral antibiotics in children with AOMd.

Endobiliary radiofrequency ablation for malignant biliary obstruction due to perihilar cholangiocarcinoma: a randomized controlled trial

The aim is to evaluate whether the use of eRFA prior to stenting prolongs stent patency in patients with biliary obstruction due to inoperable perihilar cholangocarcinoma.

DRAGON 2 - An international multicenter randomized controlled trial to compare combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE alone in patients with Colorectal Liver Cancer Metastases (CRLM) and a small Future Liver Remnant (FLR).

The primary objective of DRAGON 2 is to demonstrate the superiority of combined PVE/HVE over PVE alone in either the resectability of the patients within 3 weeks after intervention defined as FLR sufficient for resection on week 3 and the 5-year…

Study of EMF Neutrophil Activation effects phase 1

To show that this EMF exposure activates neutrophils in a group of subjects with diversity in age and gender.

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

This study has been transitioned to CTIS with ID 2024-513513-12-00 check the CTIS register for the current data. Primary ObjectivesEvaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants…

Radioembolization with 166Ho-microspheres in elderly and/or fragile patients with previously untreated unresectable liver-only metastases of colorectal cancer, CAIRO7 study endorsed by the Dutch Colorectal Cancer Group (DCCG)

Primary objective:The objective of this randomized phase 2 study is to demonstrate efficacy of RE in terms of PFS in colorectal cancer patients with liver-only metastases who are candidates for palliative systemic treatment with capecitabine plus…

The efficacy of a lock solution containing taurolidine, citrate and heparin for the prevention of tunneled central line-associated bloodstream infections in pediatric oncology patients, a randomized controlled, mono-center trial.

To determine wheter the use of the taurolidine 1.35%, citrate 4%, and heparin 100 IU/ml lock solution (TauroLock*-Hep100) reduces the incidence of first tunneled central line associated bloodstream inections (CLABSI) compared to the heparin 100 IU/…

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

The primary objective of this study is to evaluate the efficacy of cabozantinib in combination with atezolizumab versus sorafenib in subjects with advanced HCC who have not received previous systemic anticancer therapy. An secondary objective is to…

Dose individualization of Antibiotics in ICU patients: to TDM or not to TDM and the effects on outcome (DOLPHIN-trial)

The aim of this trial is to evaluate a new early dosage adjustment strategy (TDM) of beta-lactam and fluoroquinolones in adult ICU patients to achieve the adequate pharmacodynamic targets (PDT), compared to the usual treatment strategy.

Hepatic arterial infusion PUMP chemotherapy combined with systemic therapy versus systemic therapy alone as Induction Therapy for initially unresectable colorectal liver metastases: a randomised controlled trial

The main objective of this trial is to investigate whether HAIP with concomitant systemic therapy prolongs overall survival in chemo-naive patients with initially unresectable synchronous colorectal liver metastases as compared with systemic therapy…

A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

This study has been transitioned to CTIS with ID 2024-518065-10-00 check the CTIS register for the current data. The aim of the study is to demonstrate that HAI P chemotherapy is an effective treatment for unresectable intrahepatic…

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for
Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative
Hepatic Resection or Ablation

This study has been transitioned to CTIS with ID 2023-508726-10-00 check the CTIS register for the current data. Objectives of the studyPrimary ObjectiveTo compare recurrence-free survival (RFS)(based on BICR assessment) of nivolumab versus placebo…