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Smartphone based Monitoring and cognition Modification Against Recurrence of Depression

In the current protocol we describe 2 work packages in which we aim to perform: A. >=2 focus-groups to gauge acceptability of the smartphone-app (WP1); B. follow-up remitted patients with recurrent MDD for 1.5 year while the background app (…

Curing chronic wounds with fibrin.

To cure chronic wounds with fibrin treatment.

A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren*s Syndrome

To determine the dose-response relationship of VAY736 for key efficacy and safety parameters.

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (ESMART)

This study has been transitioned to CTIS with ID 2024-514791-40-00 check the CTIS register for the current data. Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed…

Intraoperative near-infrared fluorescence imaging of colorectal carcinoma with cRGD-ZW800-1 and dedicated imaging systems: A Phase II study

To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems

Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults. A phase II trial.

This study has been transitioned to CTIS with ID 2024-511050-44-00 check the CTIS register for the current data. Primary objective:-To assess the proportion of patients that achieve MRD negative response (by PCR/FCM) after the first consolidation…

Allogeneic bone marrow derived mesenchymal stromal cells for the treatment of refractory proctitis in Ulcerative Colitis

To assess the safety of endoscopic injected allogeneic bone marrow derived mesenchymal stromal cells (BMMSCs) in refractory proctitis.

Phase 2 Study testing the COmbination of Vemurafenib With Cobimetinib in BRAF V600 mutated Melanoma Patients to Normalize LDH and Optimize immunotherapY with Nivolumab and Ipilimumab (COWBOY)

Primary objective: • To compare efficacy of induction vemurafenib + cobimetinib followed by ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).Secondary Objectives• To describe duration of response and overall…

Phase I-II study combining Brentuximab Vedotin with second line salvage chemotherapy (R-DHAP) in CD30 positive diffuse large B-cell lymphoma patients refractory to first line chemotherapy or in first relapse who are eligible for high dose treatment followed by autologous stem cell transplantation. Transplant BRaVE NHL

This study has been transitioned to CTIS with ID 2023-510556-22-00 check the CTIS register for the current data. Lead in phase 1Primary objective:• To identify the feasibility and RDL (recommended dose level) of brentuximab vedotin in combination…

Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (*URANUS*)

This study has been transitioned to CTIS with ID 2024-514991-41-01 check the CTIS register for the current data. To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based…

Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases - a feasibility study

Primary Objective: The first objective of this study is to evaluate the safety and feasibility of adjuvant HAIP chemotherapy after resection of CLM in 2 centres in the Netherlands.Secondary Objective(s): The second objective is to determine whether…

CRP-POCT in suspected airway infected patients in the long-term care facility

The main objective is to investigate the additional value of CRP-POCT (C-reactive protein point-of-care-test) testing in patients suspected of airway infections in long-term care facilities.

Partial Breast Radiotherapy in Low-risk Breast cancer group using a stereotactic MR-guided adaptive approach; a phase II study

The main goal of this prospective phase II observational study of APBI for *low risk* breast cancer (cT1-T2N0M0) is to evaluate early and early-delayed toxicity with this approach, after daily adaptive radiotherapy treatment.

Safety of extended use of ModraDoc006/r in patients with advanced solid tumours

- evaluation of the safety of extended use of ModraDoc006/r - provide longterm access to ModraDoc006/r treatment for patients who have completed a phase I trial with ModraDoc006/r and who might have benefit from longterm treatment with weekly…

OPtimizing Preoperative EndoRectal BrachyTherapy (OPPER-BT)

Establishment of an image-guided brachytherapy procedure that is feasible for a multicenter randomized trial

Treatment of congenital vascular malformations using Sirolimus: improving quality of Life

As patients with congenital vascular malformations often suffer from severe pain and morbidity due to the vascular malformation, quality of life is often signifcantly impaired. The primairy objective of the present study is to reduce pain complaints…

Effectiveness of lipofilling in patients with impaired speech and/or swallowing function after treatment for head and neck cancer

The primary objective of this study is to evaluate the effectiveness of lipofilling in treatment of speech and swallowing impairment after treatment for head and neck cancer. The secondary objective is to evaluate the effect of lipofilling on tongue…

A prospective, multicenter, phase-II trial of ibrutinib plus venetoclax in physically fit patients with creatinine clearance >= 30 ml/min who have relapsed or refractory chronic lymphocytic leukemia (RR-CLL) with or without TP53 aberrations;HOVON 141 CLL / VIsion Trial of the HOVON and Nordic CLL study groups

This study has been transitioned to CTIS with ID 2023-510557-42-00 check the CTIS register for the current data. The primary objective: - Evaluate efficacy of ibrutinib + venetoclax (VI) in terms of proportion of patients fulfilling the criteria for…

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma

This study has been transitioned to CTIS with ID 2024-510634-41-00 check the CTIS register for the current data. Cohort 1 - LN-145 monotherapy in patients who have progressed during or following systemic therapy for recurrent, metastatic, or…

Ga-68-DOTA-(RGD)2 PET/CT: imaging angiogenesis in patients with low-flow vascular malformations

The primary objective of this study is to measure whether αvβ3 integrin expression and tracer uptake values of 68Ga-DOTA-(RGD)2 change in patients with (recurrent) low-flow vascular malformations after embolization therapy.