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Adding DNA-test for screening of HLA-DQ2 and DQ8 to improve the early diagnosis of celiac disease at the Dutch Preventive Youth Healthcare Centres

Primary Objective:1. To validate the HLA-DQ typing in blood taken by a fingerprick; to make it feasible in the regular Preventive YHCCs organization.2. To establish the feasibility of HLA-DQ2/8 typing in the active case-finding at the Preventive…

OPtimal stEnt deployment stRategy oF Contemporary sTents

Primary objectiveThe primary objective is to evaluate whether a standard pre- and postdilatation of the modern DES results in a more optimal stent implantation compared to DS as evaluated by OCT in patients with stable coronary artery disease.…

Role of the central brain clock in the pathophysiology of insulin resistance

Primary Objective: to determine the activity rhythm of the SCN in humans with progressive stages of insulin resistanceSecondary Objective(s): to determine the daily rhythm of the peripheral clock in buccal cells in humans with progressive stages of…

First In Human Clinical Investigation of the FIRE1* System in Heart Failure Patients_ Pilot Study of the FIRE1TM System in Heart Failure Patients

The objectives of this clinical investigation are:1. To demonstrate that the FIRE1* Sensor can be safely deployed into the inferior vena cava (IVC) 2. To demonstrate that the FIRE1* Sensor can provide a signal to the FIRE1* External System3. To…

Flow dysfunction of hemodialysis vascular access: a randomized controlled trial on the effectiveness of surveillance of arteriovenous fistulas and grafts

See above.

Phase III study assessing the *best of* radiotherapy compared to the *best of* surgery (trans-oral surgery (TOS)) in patients with T1-T2, N0-N1 oropharyngeal, supraglottic carcinoma and with T1, N0 hypopharyngeal carcinoma

The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC and HPSCC.

Tailored vs Anatomical Ablation Strategy for Persistent AF

In this study, our objective is to demonstrate that a tailored ablation strategy targeting areas exhibiting spatio-temporal dispersion in association with PVI, is superior to an anatomical probabilistic ablation strategy targeting PVI alone for the…

FORWARD PRO Study

The study purpose is to evaluate the acute and long term clinical performance and safety of the Evolut* PRO System used in routine hospital setting for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or…

Prospective, Multicenter, Post-market, Single Arm study to confirmthe performance of the RenzanTM Peripheral Stent System in treating Superficial Femoral and/or Popliteal artery disease

Primary objective: To confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease.Secondary objective: Assessment of the primary patency of the…

Amyloid PET in patients with carotid occlusive disease

We aim to use quantitative [18F]Florbetaben PET to investigate a potential lateralized distribution of cerebral amyloid-β deposition in patients with COD. To validate the assumption that the hypoperfusion is lateralized, we use relative perfusion (…

The ENCIRCLE Trial; SAPIEN M3 System TransCatheter MItral Valve ReplaCement via TransseptaL AccEss

To establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are not preferred/appropriate due to…

Multi-Interventional program for prevention and early Management of Anastomotic leakage
after total mesorectal excision in Rectal cancer patIents, IMARI-trial

To increase the one year anastomotic integrity rate in patients undergoing total mesorectal excision (TME) for rectal cancer by the routine and quality controlled implementation of a multi-interventional program, which includes:1. MBP with oral…

Exercise training in women with unexplained recurrent pregnancy loss to optimize receptive endometrial NK cell population and function

Is moderate exercise training for 12 weeks in women with RPL improving CD56bright eNK cell population and function?

Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)

Primary ObjectiveThe primary objective of the study is to evaluate the safety of The Ryme Medical Lung Denervation System.Secondary ObjectivesThe secondary objective of the study is to evaluate the performance of The Ryme Medical Lung Denervation…

Deep brain stimulation of the medial forebrain bundle for patients with treatment-resistant depression

Establishing efficacy of MFB DBS for TRD by comparing active DBS with sham DBS. Secondary aims are establishing an adverse events profile, establishing effects on quality of life, cost-effectiveness, (neuro)psychological and neuroimaging measures.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients with Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

Primary objective:To assess the efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Abdominal Symptoms domain of the Celiac Disease Patient- Reported Outcome (CeD PRO)…

ELDAPT: Elderly with locally advanced Lung cancer: Deciding through geriatric Assessment on the oPtimal Treatment strategy

Developing a clinically applicable geriatric screening instrument to stratify medically fit patients who may benefit from intensified treatment strategies and frail patients who will undergo best supportive care (which may include palliative RT), (2…

Zooming in on cerebral abnormalities in severely affected COVID-19 patients: a 3T and 7T MRI study

This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. By…

Prospective, multicenter, 36 months, comparative matched cohort study to evaluate the efficacy and safety of the ultra-lightweight mesh CAlistar S in transvaginal Pelvic Organ Prolapse repair

Aim of the Study:This prospective, single-arm study is to evaluate the mid-term efficacy and safety of the Calistar S pelvic floor repair system for prolapse repair.

A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma

* Safety Run inTo determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part (part 3)* Biomarker cohortTo evaluate changes in the immune microenvironment and biomarker modulations upon treatment…