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Ultrasound and Magnetic Resonance Imaging

Radiodiagnostics strongly depends on high image or data quality, well-performed image analyses and information on how pathology appears on the image or data acquired. The objectives of the study are: - In order to improve radiodiagnostic imaging, it…

3D mini lung structures from skin cells

Studies have shown that generation of lung cells from human pluripotent stem cells is possible. The present study aims to develop cell cultures, such as 3D mini lung structures from skin cells from subjects with ILD and/or their family members. The…

Evaluation of two vaginal, uterussparing surgical methods for pelvic organ prolapse reconstruction: modified Manchester operation (MM) and sacrospinal hysteropexy (SSH).

Objective:The life-time risk for POP surgery is 20%, and 30% of these women will need surgery because of a recurrence. VaginalPOP surgery (VH, SSH and MM) is the first choice surgical treatment. The numbers of uterus sparing operations (SSH andMM)…

COLLISION trial - Colorectal liver metastases: surgery versus thermal ablation - a phase III prospective randomized controlled trial

The primary objective is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM (<=3cm) and no extrahepatic disease.

An open-label, multi-center, phase I, dose finding study of oral TNO155 in adult patients with advanced solid tumors

This study has been transitioned to CTIS with ID 2023-508925-29-00 check the CTIS register for the current data. Primary: To characterize safety and tolerability of TNO155 and identify a recommended dose and regimen for future studies in adult…

Management of low-risk ductal carcinoma in situ (low-risk DCIS): a non-randomized, multicenter, non-inferiority trial; standard therapy versus active surveillance.

The primary end-point is ipsilateral invasive breast tumor-free rate at 10 years. Secondary end-points are among others: overall survival, breast cancer-specific survival, mastectomy rate and patient reported outcomes.To determine whether low- risk…

Non-invasive axillary lymph node staging in breast cancer with PET/MRI

The main goal of this study is to study the accuracy (sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and false negative rate (FNR)) of dedicated axillary hybrid PET/MRI for the detection of negative…

HPV infections and immune status in a cohort of girls who are eligible for national HPV immunization.

zie protocol

instantaneous wave-free ratio guided multi-vessel revascularization during percutaneous coronary intervention for acute myocardial infarction

The iMODERN trial will compare iFR-guided revascularization of noninfarct lesions during acute intervention with a stress perfusion CMR-guided strategy during the outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients…

Exploratory study of neo-adjuvant treatment with carboplatin, paclitaxel and pembrolizumab in primary stage IV serous ovarian cancer

The primary objective of this study is to determine the immune-activating capacity of treatment with pembrolizumab and carboplatin/paclitaxel in the neo-adjuvant setting of primary stage IV ovarian cancer as measured by the alteration in magnitude…

Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome - a blinded randomized placebo controlled parallel group multicenter trial for superiority (Phase III)

This study has been transitioned to CTIS with ID 2024-511322-31-00 check the CTIS register for the current data. To evaluate whether in newborns with asphyxia and early clinical signs of hypoxic ischemic encephalopathy, early postnatal allopurinol…

Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)

Primary Objectives* To evaluate the efficacy of SCY-078 as determined by a Data Monitoring Committee(DMC) by assessing global success (composite assessment of clinical and mycologicalsuccess) at EoT* To evaluate the safety of SCY-078

The Efficacy and Safety of Intra-Arterial Administration of REX-001 to Treat Ischemic Ulcers in Subjects with Chronic Limb Threatening Ischaemia Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trial

To confirm the efficacy and safety of a single intra-arterial administration of REX-001 to treat ischemic ulcers in subjects with CLTI Rutherford Category 5 and DM.

Endoscopic management of patients with high risk T1a and T1b N0M0 esophageal adenocarcinoma:
a prospective multicenter registry

To evaluate the safety of an endoscopic follow-up strategy in patients with HR T1a and T1b N0M0 esophageal adenocarcinoma (EAC).

Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Complex Primary Total Knee Arthroplasty

Primary Objective There are two co-primary objectives; one regarding each tibial component configuration, fixed bearing (FB) and rotating platform (RP): 1) Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported…

A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer

This study has been transitioned to CTIS with ID 2022-501784-40-00 check the CTIS register for the current data. The study aims to demonstrate that treatment with nivolumab combined with ipilimumab will improve efficacy in cisplatin-ineligible…

Optimal early recognition of persons at high risk of aneurysmal subarachnoid haemorrhage

Objective 1)To determine the cost-effectiveness of screening for and preventive treatment of UIAs in persons with FDRs with UIAs. We will therefore assess the prevalence of UIA in persons with >=1 FDR with an UIA, the costs of the screening,…

Switching anticoagulant management from a VKA to a NOAC-based tratment strategy in frail elderly patients with atrial fibrillation

The primary objective is to evaluate whether the impact of a strategy aimed at switching INR-guided VKA management to a NOAC-based treatment strategy is superior in terms of the occurrence of major or clinically relevant non-major bleeding…

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-Oncology Study in
Participants with Advanced Gastric Cancer (FRACTION-Gastric Cancer)

The objective of this study is to investigate the safety and effectiveness of different combinations of cancer immunotherapies compared to either Nivolumab or Ipilimumab, as determined by comparing the Overall Response Rate, at 24 weeks in patients…

Determinants of long-term diabetes without complications: exploratory study of successful aging in patients with .+ 35 years T1 diabetes duration, or with autonomic neuropathy

Objective: To collect a broad array of clinical, behavioural, physical and biochemical parameters, to ensure that many clinical research questions or problems related to successful aging with T1D can be answered. Nevertheless, we have a priori…