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OptIcal MetAstatic Guidance in mInimally iNvasive Esophagectomy: a multicentre phase I/II diagnostic study

The aim of this present feasibility study is to determine the safety and preliminary accuracy by which we can intra-operatively detect residual disease in esophageal tumor and lymph nodes. This study is set up as a prospective multi-centre dose…

Nervus X- Atrial Fibrillation trial (NX-AF)

The primary objective is to examine the impact of t-LLVS on electrophysiological properties of the atria and ventricles. Secondary objectives are:- to elucidate the correlation between proteostasis marker levels in serum and atrial tissue, and the…

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Coadministration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging. (RESTORE)

Main objective:To assess the effects of selexipag on right ventricular (RV) function in participants with PAH.Secondary objectives:- To further assess the effects of selexipag on RV function using MRI.- To assess the effects of selexipag on disease…

Feasibility study: The effect of the low FODMAP diet on women suffering from endometriosis

This study aims to create an indication of the effect size during and after adherence to the low FODMAP diet to calculate a sample size for a future RCT on this subject.

A Non-Randomized, Open Label, Adaptive, Single Center, Positron Emission Tomography (PET) Study to Assess Distribution of RO7248824 in the Central Nervous System Following Single Intrathecal Doses of [89Zr]-Labeled RO7248824 in Healthy Male Participants

The new compound RO7248824 is being developed for the treatment of Angelman syndrome (AS). The purpose of this study is to find out how RO7248824 spreads in the brain and spine after injection into the spinal canal (intrathecal administration). This…

Comparison of non-invasive bedside methods to estimate central venous pressure

To compare the accuracy of the above-mentioned methods in patients admitted to the ward or intensive care unit in estimating CVP and to investigate the correlation between the different methods.

Early detection of Barrett's esophagus and esophageal cancer: accuracy and acceptability of a novel screening strategy in primary care.

To determine the accuracy and acceptability of a minimal-invasive screening strategy (breath testing (eNose) followed by unsedated transnasal endoscopy (uTNE)) for Barrett*s esophagus (BE) and esophageal adenocarcinoma (EAC).

Intra-operative visualization and treatment of salivary glands affected by sjögren*s syndrome using contrast enhanced ultrasound sialendoscopy (ceuss): a pilot study

our aim is to investigate practical applicability and safety of contrast enhanced ultrasound sialendoscopy (CEUSS) in salivary Parotid and Submandibular glands affected by Sjögren*s Syndrome

Gastric emptying and digestion of whey protein gels

Primary: To investigate the effect of protein density and texture on gastric emptying of protein-rich solid food. Secondary: To investigate the use of MRI T2 and T1 of gastric content on indicating protein hydrolysis in stomach.

PLEASE5+: Long-term outcomes and quality of life of patients with symptoms attributed to Lyme borreliosis

The primary objective is to assess the long-term (5-8 years) quality of life in patients who previously participated in the placebo-controlled randomized controlled trial on the effect of prolonged antibiotic treatment on persistent symptoms…

Clinical Observational Study into Mitochondrial Oxygenation Predicting Ominous Lactate In Trajectory around Abdominal Surgery

Primary objectives: - To test the hypothesis that a relationship between mitochondrial oxygenation and serum lactate existsSecondary objectives:- To provide data for estimating the number of patients needed for a clinical trial to prove the above…

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Con

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

Improving respiratory monitoring by directly capturing the electrical activity of the diaphragm

To collect reference data of dEMG in neonates to use for testing the Bambi Belt B.V. algorithm which is under development.

An Open-label, Randomized Study in Healthy Participants to Investigate Effects of Food (high-fat) and Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-67953964.

- To assess the effect of food (high-fat) on the bioavailability and pharmacokinetic (PK)- profile of a solid dosage formulation of JNJ-67953964.- To assess the effects of repeated QD administration of 200 mg of itraconazole (steady state) on the…

Early detection of head and neck cancer relapse by expression profiling of blood platelets and/or ctDNA analysis in plasma and oral rinses

Accuracy of early detection of recurrent/metastatic disease in HNSCC patients treated for cure, and the median and range of time intervals between relapse and presence of ctDNA in plasma and oral rinses as well as TEPs.

Adaptive and maladaptive emotions in patients with cancer: identification of indicators (EMOCA study)

We aim to identify indicators that distinguish between adaptive and maladaptive emotions in patients with cancer, derived from recent innovative developments in the field of mental health.

Effectiveness of corticosteroid injection in treatment of trigger fingers: a double blinded randomized clinical trial

We hypothesize that Kenalog-40, Kenalog-10 and Depo-Medrol 40 mg/ml have a different effectiveness in treating trigger fingers in both primary as secondary outcomes.

Open-label, Multicentre, Phase Ib/II Study of MEN1611, a PI3K Inhibitor, and Cetuximab in Patients with PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens

Main objectiveStep 1: To determine the recommended phase 2 dose (RP2D) of MEN1611 when administered orally in combination with cetuximab to patients with PIK3CA mutated colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing…

In vitro characterization of the immune response of recovered COVID-19 patients and healthy controls to SARS-CoV-2.

- To assess the in vitro memory T cell response to 20 therapeutic SARS-CoV-2 vaccine candidate synthetic long peptides (SLPs);- To assess the in vitro humoral immune response to 20 therapeutic SARS-CoV-2 vaccine candidate SLPs.